Computable phenotype for diagnostic error: developing the data schema for application of symptom-disease pair analysis of diagnostic error (SPADE).

OBJECTIVES: Diagnostic errors are the leading cause of preventable harm in clinical practice. Implementable tools to quantify and target this problem are needed. To address this gap, we aimed to generalize the Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) framework by developing its computable phenotype and then demonstrated how that schema could be applied in multiple clinical contexts. METHODS: We created an information model for the SPADE processes, then mapped data fields from electronic health records (EHR) and claims data in use to that model to create the SPADE information model (intention) and the SPADE computable phenotype (extension). Later we validated the computable phenotype and tested it in four case studies in three different health systems to demonstrate its utility. RESULTS: We mapped and tested the SPADE computable phenotype in three different sites using four different case studies. We showed that data fields to compute an SPADE base measure are fully available in the EHR Data Warehouse for extraction and can operationalize the SPADE framework from provider and/or insurer perspective, and they could be implemented on numerous health systems for future work in monitor misdiagnosis-related harms. CONCLUSIONS: Data for the SPADE base measure is readily available in EHR and administrative claims. The method of data extraction is potentially universally applicable, and the data extracted is conveniently available within a network system. Further study is needed to validate the computable phenotype across different settings with different data infrastructures.

Burden of serious harms from diagnostic error in the USA.

BACKGROUND: Diagnostic errors cause substantial preventable harms worldwide, but rigorous estimates for total burden are lacking. We previously estimated diagnostic error and serious harm rates for key dangerous diseases in major disease categories and validated plausible ranges using clinical experts. OBJECTIVE: We sought to estimate the annual US burden of serious misdiagnosis-related harms (permanent morbidity, mortality) by combining prior results with rigorous estimates of disease incidence. METHODS: Cross-sectional analysis of US-based nationally representative observational data. We estimated annual incident vascular events and infections from 21.5 million (M) sampled US hospital discharges (2012-2014). Annual new cancers were taken from US-based registries (2014). Years were selected for coding consistency with prior literature. Disease-specific incidences for 15 major vascular events, infections and cancers ('Big Three' categories) were multiplied by literature-based rates to derive diagnostic errors and serious harms. We calculated uncertainty estimates using Monte Carlo simulations. Validity checks included sensitivity analyses and comparison with prior published estimates. RESULTS: Annual US incidence was 6.0 M vascular events, 6.2 M infections and 1.5 M cancers. Per 'Big Three' dangerous disease case, weighted mean error and serious harm rates were 11.1% and 4.4%, respectively. Extrapolating to all diseases (including non-'Big Three' dangerous disease categories), we estimated total serious harms annually in the USA to be 795 000 (plausible range 598 000-1 023 000). Sensitivity analyses using more conservative assumptions estimated 549 000 serious harms. Results were compatible with setting-specific serious harm estimates from inpatient, emergency department and ambulatory care. The 15 dangerous diseases accounted for 50.7% of total serious harms and the top 5 (stroke, sepsis, pneumonia, venous thromboembolism and lung cancer) accounted for 38.7%. CONCLUSION: An estimated 795 000 Americans become permanently disabled or die annually across care settings because dangerous diseases are misdiagnosed. Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined.

Optimizing measurement of misdiagnosis-related harms using symptom-disease pair analysis of diagnostic error (SPADE): comparison groups to maximize SPADE validity.

Diagnostic errors in medicine represent a significant public health problem but continue to be challenging to measure accurately, reliably, and efficiently. The recently developed Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) approach measures misdiagnosis related harms using electronic health records or administrative claims data. The approach is clinically valid, methodologically sound, statistically robust, and operationally viable without the requirement for manual chart review. This paper clarifies aspects of the SPADE analysis to assure that researchers apply this method to yield valid results with a particular emphasis on defining appropriate comparator groups and analytical strategies for balancing differences between these groups. We discuss four distinct types of comparators (intra-group and inter-group for both look-back and look-forward analyses), detailing the rationale for choosing one over the other and inferences that can be drawn from these comparative analyses. Our aim is that these additional analytical practices will improve the validity of SPADE and related approaches to quantify diagnostic error in medicine.

Improving cancer care for underserved populations in an academic and community practice setting: protocol for a community health worker pilot navigation programme.

INTRODUCTION: Delaying cancer treatment following diagnosis impacts health outcomes, including increasing patient distress and odds of mortality. Interventions to promote timely healthcare engagement may decrease patient-reported stress and improve quality of life. Community health workers (CHWs) represent an enabling resource for reducing delays in attending initial oncology treatment visits. As part of an ongoing programme evaluation coordinated by the Merck Foundation, we will implement a pilot navigation programme comprising CHW-conducted needs assessments for supporting patients and their caregivers. We aim to investigate (1) the programme's influence on patients' healthcare utilisation within the period between their first diagnosis and initial treatment visit and (2) the logistic feasibility and acceptability of programme implementation. METHODS AND ANALYSIS: We will employ a hybrid implementation design to introduce the CHW navigation programme at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. CHW team members will use a consecutive sampling approach. Participants will complete the Problem-Checklist, Chronic Illness Distress Scale and the Satisfaction with Life Domains instruments. CHWs will provide tailored guidance by sharing information available on the Johns Hopkins Electronic Resource databases. The investigators will evaluate patients' time to initial oncology treatment and healthcare utilisation by reviewing electronic medical records at 3 and 6 months postintervention. Bivariate analyses will be completed to evaluate the relationships between receiving the programme and all outcome measures. ETHICS AND DISSEMINATION: This study's protocol was approved by the Johns Hopkins School of Medicine's institutional review board (IRB00160610). Informed consent will be obtained by phone by the CHW navigator. Dissemination planning is ongoing through regular meetings between members of the investigator team and public members of two community advisory groups. Study plans include collaborating with other experts from the Johns Hopkins Institute for Clinical and Translational Research and the Johns Hopkins Center for Health Equity for ideating dissemination strategies.

Implementing patient navigation programs: Considerations and lessons learned from the Alliance to Advance Patient-Centered Cancer Care.

BACKGROUND: Six multidisciplinary cancer centers were selected and funded by the Merck Foundation (2017-2021) to collaborate in the Alliance to Advance Patient-Centered Cancer Care ("Alliance"), an initiative to improve patient access, minimize health disparities, and enhance the quality of patient-centered cancer care. These sites share their insights on implementation and expansion of their patient navigation efforts. METHODS: Patient navigation represents an evidence-based health care intervention designed to enhance patient-centered care and care coordination. Investigators at 6 National Cancer Institute-designated cancer centers outline their approaches to reducing health care disparities and synthesize their efforts to ensure sustainability and successful transferability in the management of patients with cancer and their families in real-world health care settings. RESULTS: Insights are outlined within the context of patient navigation program effectiveness and supported by examples from Alliance cancer center sites: 1) understand the patient populations, particularly underserved and high-risk patients; 2) capitalize on the existing infrastructure and institutional commitment to support and sustain patient navigation; and 3) build capacity by mobilizing community support outside of the cancer center. CONCLUSIONS: This process-level article reflects the importance of collaboration and the usefulness of partnering with other cancer centers to share interdisciplinary insights while undergoing intervention development, implementation, and expansion. These collective insights may be useful to staff at other cancer centers that look to implement, enhance, or evaluate the effectiveness of their patient navigation interventions.

Eye and Head Movement Recordings Using Smartphones for Telemedicine Applications: Measurements of Accuracy and Precision.

Objective: Smartphones have shown promise in the assessment of neuro-ophthalmologic and vestibular disorders. We have shown that the head impulse test results recorded using our application are comparable with measurements from clinical video-oculography (VOG) goggles. The smartphone uses ARKit's capability to acquire eye and head movement positions without the need of performing a calibration as in most eye-tracking devices. Here, we measure the accuracy and precision of the eye and head position recorded using our application. Methods: We enrolled healthy volunteers and asked them to direct their eyes, their heads, or both to targets on a wall at known eccentricities while recording their head and eye movements with our smartphone application. We measured the accuracy as the error between the eye or head movement measurement and the location of each target and the precision as the standard deviation of the eye or head position for each of the target positions. Results: The accuracy of head recordings (15% error) was overall better than the accuracy of eye recordings (23% error). We also found that the accuracy for horizontal eye movements (17% error) was better than for vertical (27% error). Precision was also better for head movement (0.8 degrees) recordings than eye movement recordings (1.3 degrees) and variability tended to increase with eccentricity. Conclusion: Our results provide basic metrics evaluating the utility of smartphone applications in the quantitative assessment of head and eye movements. While the new method may not replace the more accurate dedicated VOG devices, they provide a more accessible quantitative option. It may be advisable to include a calibration recording together with any planned clinical test to improve the accuracy.

Are Mental Health and Substance Use Disorders Risk Factors for Missed Acute Myocardial Infarction Diagnoses Among Chest Pain or Dyspnea Encounters in the Emergency Department?

STUDY OBJECTIVE: To assess if having a mental health and/or substance use disorder is associated with a missed acute myocardial infarction diagnosis in the emergency department (ED). METHODS: This was a retrospective cohort analysis (2009 to 2017) of adult ED encounters at Kaiser Permanente Southern California. We used the validated symptom-disease pair analysis of diagnostic error methodological approach to "look back" and "look forward" and identify missed acute myocardial infarctions within 30 days of a treat-and-release ED visit. We use adjusted logistic regression to report the odds of missed acute myocardial infarction among patients with a history of mental health and/or substance use disorders. RESULTS: The look-back analysis identified 44,473 acute myocardial infarction hospital encounters; 574 (1.3%) diagnoses were missed. The odds of missed diagnoses were higher in patients with mental health disorders (odds ratio [OR] 1.48, 95% confidence interval [CI] 1.23 to 1.77) but not in those with substance abuse disorders (OR 1.22, 95% CI 0.91 to 1.62). The highest risk was observed in those with co-occurring disorders (OR 1.90, 95% CI 1.30 to 2.76). The look-forward analysis identified 325,088 chest pain/dyspnea ED encounters; 508 (0.2%) were missed acute myocardial infarctions. No significant associations of missed acute myocardial infarction were revealed in either group (mental health disorder: OR 0.92, 95% CI 0.71 to 1.18; substance use disorder: OR 1.22, 95% CI 0.80 to 1.85). CONCLUSION: The look-back analysis identified patients with mental illness at increased risk of missed acute myocardial infarction diagnosis, with the highest risk observed in those with a history of comorbid substance abuse. Having substance use disorders alone did not increase this risk in either cohort. The look-forward analysis revealed challenges in prospectively identifying high-risk patients to target for improvement.

Cerebrovascular disease hospitalizations following emergency department headache visits: A nested case-control study.

BACKGROUND: Delayed diagnosis of cerebrovascular disease (CVD) among patients can result in substantial harm. If diagnostic process failures can be identified at emergency department (ED) visits that precede CVD hospitalization, interventions to improve diagnostic accuracy can be developed. METHODS: We conducted a nested case-control study using a cohort of adult ED patients discharged from a single medical center with a benign headache diagnosis from October 1, 2015 to March 31, 2018. Hospitalizations for CVD within 1 year of index ED visit were identified using a regional health information exchange. Patients with subsequent CVD hospitalization (cases) were individually matched to patients without subsequent hospitalization (controls) using patient age and visit date. Demographic, clinical, and ED process characteristics were assessed via detailed chart review. McNemar's test for categorical and paired t-test for continuous variables were used with statistical significance set at ≤0.05. RESULTS: Of the 9157 patients with ED headache visits, 57 (0.6%, 95% confidence interval [CI] = 0.5-0.8) had a subsequent CVD hospitalization. Median time from ED visit to hospitalization was 107 days. In 25 patients (43.9%, 25/57) the CVD hospitalization and the index ED visit were at different hospitals. Fifty-three cases and 53 matched controls were included in the final study analysis. Cases and controls had similar baseline demographic and headache characteristics. Cases more often had a history of stroke (32.1% vs. 13.2%, p = 0.02) and neurosurgery (13.2% vs. 1.9%, p = 0.03) prior to the index ED visit. Cases more often had less than two components of the neurologic examination documented (30.2% vs. 11.3%, p = 0.03). CONCLUSION: We found that 0.6% of patients with an ED headache visit had subsequent CVD hospitalization, often at another medical center. ED visits for headache complaints among patients with prior stroke or neurosurgical procedures may be important opportunities for CVD prevention. Documented neurologic examinations were poorer among cases, which may represent an opportunity for ED process improvement.

Randomized trial of two artificial intelligence coaching interventions to increase physical activity in cancer survivors.

Physical activity (PA) has numerous health benefits. Personalized coaching may increase adherence to PA recommendations, but it is challenging to deliver personalized coaching in a scalable manner. The objective of our study was to determine whether novel artificially intelligent (AI) coaching interventions increase PA among overweight or obese, physically inactive cancer survivors compared to a control arm that receives health information. We conducted a single-center, three-arm randomized trial with equal allocation to (1) voice-assisted AI coaching delivered by smart speaker (MyCoach), (2) autonomous AI coaching delivered by text message (SmartText), and (3) control. Data collection was automated via sensors and voice technology, effectively masking outcome ascertainment. The primary outcome was change in mean steps per day from baseline to the end of follow-up at 4 weeks. Of the 42 randomized participants, 91% were female, and 36% were Black; mean age was 62.1 years, and mean BMI was 32.9 kg/m2. The majority were breast cancer survivors (85.7%). At the end of 4 weeks follow-up, steps increased in the MyCoach arm by an average of 3618.2 steps/day; the net gain in this arm was significantly greater [net difference = 3568.9 steps/day (95% CI: 1483-5655), P value <0.001] compared to control arm, and [net difference = 2160.6 steps/day (95% CI: 11-4310), P value 0.049] compared to SmartText. In conclusion, AI-based voice-assisted coaching shows promise as a practical method of delivering scalable, individualized coaching to increase physical activity in sedentary cancer survivors. Additional research is needed to replicate these findings in a broader population of cancer survivors and to investigate the effects of these interventions in the general population.ClinicalTrials.gov Identifier: NCT03212079, July 11, 2017, https://clinicaltrials.gov/ct2/show/NCT03212079 .

Effects of Behavioral Weight Loss and Metformin on IGFs in Cancer Survivors: A Randomized Trial.

CONTEXT: Higher levels of insulin-like growth factor-1 (IGF-1) are associated with increased risk of cancers and higher mortality. Therapies that reduce IGF-1 have considerable appeal as means to prevent recurrence. DESIGN: Randomized, 3-parallel-arm controlled clinical trial. INTERVENTIONS AND OUTCOMES: Cancer survivors with overweight or obesity were randomized to (1) self-directed weight loss (comparison), (2) coach-directed weight loss, or (3) metformin treatment. Main outcomes were changes in IGF-1 and IGF-1:IGFBP3 molar ratio at 6 months. The trial duration was 12 months. RESULTS: Of the 121 randomized participants, 79% were women, 46% were African Americans, and the mean age was 60 years. At baseline, the average body mass index was 35 kg/m2; mean IGF-1 was 72.9 (SD, 21.7) ng/mL; and mean IGF1:IGFBP3 molar ratio was 0.17 (SD, 0.05). At 6 months, weight changes were -1.0% (P = 0.07), -4.2% (P < 0.0001), and -2.8% (P < 0.0001) in self-directed, coach-directed, and metformin groups, respectively. Compared with the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/mL, P = 0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, P = 0.011) at 3 months. The significant decrease of IGF-1 remained in participants with obesity at 6 months (mean difference in change: -7.2 ng/mL; 95% CI: -13.3 to -1.1), but not in participants with overweight (P for interaction = 0.045). There were no significant differences in changes between the coach-directed and self-directed groups. There were no differences in outcomes at 12 months. CONCLUSIONS: In cancer survivors with obesity, metformin may have a short-term effect on IGF-1 reduction that wanes over time.

Rate of sepsis hospitalizations after misdiagnosis in adult emergency department patients: a look-forward analysis with administrative claims data using Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) methodology in an integrated health system.

OBJECTIVES: Delays in sepsis diagnosis can increase morbidity and mortality. Previously, we performed a Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) "look-back" analysis to identify symptoms at risk for delayed sepsis diagnosis. We found treat-and-release emergency department (ED) encounters for fluid and electrolyte disorders (FED) and altered mental status (AMS) were associated with downstream sepsis hospitalizations. In this "look-forward" analysis, we measure the potential misdiagnosis-related harm rate for sepsis among patients with these symptoms. METHODS: Retrospective cohort study using electronic health record and claims data from Kaiser Permanente Mid-Atlantic States (2013-2018). Patients ≥18 years with ≥1 treat-and-release ED encounter for FED or AMS were included. Observed greater than expected sepsis hospitalizations within 30 days of ED treat-and-release encounters were considered potential misdiagnosis-related harms. Temporal analyses were employed to differentiate case and comparison (superficial injury/contusion ED encounters) cohorts. RESULTS: There were 4,549 treat-and-release ED encounters for FED or AMS, 26 associated with a sepsis hospitalization in the next 30 days. The observed (0.57%) minus expected (0.13%) harm rate was 0.44% (absolute) and 4.5-fold increased over expected (relative). There was a spike in sepsis hospitalizations in the week following FED/AMS ED visits. There were fewer sepsis hospitalizations and no spike in admissions in the week following superficial injury/contusion ED visits. Potentially misdiagnosed patients were older and more medically complex. CONCLUSIONS: Potential misdiagnosis-related harms from sepsis are infrequent but measurable using SPADE. This look-forward analysis validated our previous look-back study, demonstrating the SPADE approach can be used to study infectious disease syndromes.

Antecedent treat-and-release diagnoses prior to sepsis hospitalization among adult emergency department patients: a look-back analysis employing insurance claims data using Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) methodology.

OBJECTIVES: The aim of this study was to identify delays in early pre-sepsis diagnosis in emergency departments (ED) using the Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) approach. METHODS: SPADE methodology was employed using electronic health record and claims data from Kaiser Permanente Mid-Atlantic States (KPMAS). Study cohort included KPMAS members ≥18 years with ≥1 sepsis hospitalization 1/1/2013-12/31/2018. A look-back analysis identified treat-and-release ED visits in the month prior to sepsis hospitalizations. Top 20 diagnoses associated with these ED visits were identified; two diagnosis categories were distinguished as being linked to downstream sepsis hospitalizations. Observed-to-expected (O:E) and temporal analyses were performed to validate the symptom selection; results were contrasted to a comparison group. Demographics of patients that did and did not experience sepsis misdiagnosis were compared. RESULTS: There were 3,468 sepsis hospitalizations during the study period and 766 treat-and-release ED visits in the month prior to hospitalization. Patients discharged from the ED with fluid and electrolyte disorders (FED) and altered mental status (AMS) were most likely to have downstream sepsis hospitalizations (O:E ratios of 2.66 and 2.82, respectively). Temporal analyses revealed that these symptoms were overrepresented and temporally clustered close to the hospitalization date. Approximately 2% of sepsis hospitalizations were associated with prior FED or AMS ED visits. CONCLUSIONS: Treat-and-release ED encounters for FED and AMS may represent harbingers for downstream sepsis hospitalizations. The SPADE approach can be used to develop performance measures that identify pre-sepsis.

Missed acute myocardial infarction in the emergency department-standardizing measurement of misdiagnosis-related harms using the SPADE method.

OBJECTIVES: Diagnostic error is a serious public health problem. Measuring diagnostic performance remains elusive. We sought to measure misdiagnosis-related harms following missed acute myocardial infarctions (AMI) in the emergency department (ED) using the symptom-disease pair analysis of diagnostic error (SPADE) method. METHODS: Retrospective administrative data analysis (2009-2017) from a single, integrated health system using International Classification of Diseases (ICD) coded discharge diagnoses. We looked back 30 days from AMI hospitalizations for antecedent ED treat-and-release visits to identify symptoms linked to probable missed AMI (observed > expected). We then looked forward from these ED discharge diagnoses to identify symptom-disease pair misdiagnosis-related harms (AMI hospitalizations within 30-days, representing diagnostic adverse events). RESULTS: A total of 44,473 AMI hospitalizations were associated with 2,874 treat-and-release ED visits in the prior 30 days. The top plausibly-related ED discharge diagnoses were "chest pain" and "dyspnea" with excess treat-and-release visit rates of 9.8% (95% CI 8.5-11.2%) and 3.4% (95% CI 2.7-4.2%), respectively. These represented 574 probable missed AMIs resulting in hospitalization (adverse event rate per AMI 1.3%, 95% CI 1.2-1.4%). Looking forward, 325,088 chest pain or dyspnea ED discharges were followed by 508 AMI hospitalizations (adverse event rate per symptom discharge 0.2%, 95% CI 0.1-0.2%). CONCLUSIONS: The SPADE method precisely quantifies misdiagnosis-related harms from missed AMIs using administrative data. This approach could facilitate future assessment of diagnostic performance across health systems. These results correspond to ∼10,000 potentially-preventable harms annually in the US. However, relatively low error and adverse event rates may pose challenges to reducing harms for this ED symptom-disease pair.

The incidence of vocal fold motion impairment after primary thyroid and parathyroid surgery for a single high-volume academic surgeon determined by pre- and immediate post-operative fiberoptic laryngoscopy.

BACKGROUND: Vocal fold motion impairment (VFMI) is a well-recognized complication of thyroid and parathyroid surgery. Preoperative counseling requires a thorough understanding of the incidence, risk factors, and value of early diagnosis of postoperative VFMI. Our objective is to describe the incidence of and risk factors for VFMI for a single high-volume academic surgeon, and to assess the utility of immediate postoperative fiberoptic laryngoscopy (FOL) in early diagnosis of VFMI. METHODS: Retrospective cohort study of patients undergoing primary thyroid and parathyroid procedures by a single high-volume surgeon at an academic tertiary care center. All patients underwent preoperative and immediate postoperative FOL. The primary outcome was incidence of VFMI, either temporary (<1 year) or permanent (1 year or more). The unit of analysis was number of recurrent laryngeal nerves (RLN) at risk. Risk factors for VFMI were analyzed using logistic regression, reporting unadjusted and adjusted odds ratios (OR and aOR) and 95% confidence intervals (CI). RESULTS: The study population comprised 1547 patients undergoing 1580 procedures for a total of 2527 nerves at risk, excluding the 27 nerves found to have motion impairment on preoperative FOL. Sixty-seven new incidents of VFMI were identified on postoperative FOL, with an additional six new incidents detected after voice complaints prompted FOL upon follow-up. Thus, the incidence of postoperative VFMI was 2.9% of RLNs at risk (73 of 2527). The sensitivity and negative predictive value of immediate postoperative FOL were 92% and 99.8% respectively. Permanent VFMI occurred in 9 cases (0.4%), 3 of which were from intentional RLN transection for malignancy. Odds of VFMI were significantly lower after parathyroidectomy (aOR = 0.1, 95%CI = 0.01-0.8 compared with hemithryoidectomy) and higher with central neck dissection (aOR = 2.4, 95CI = 1.0-5.9). Among cases of malignancy, odds of VFMI increased significantly with increasing T-stage (adjusted ptrend<0.001). CONCLUSION: VFMI is rare and usually temporary after primary thyroid and parathyroid procedures, with increased risk associated with larger primary malignancies and the inclusion of central neck dissection. Immediate postoperative FOL is useful for early detection of VFMI that may allow for clear definition of temporary and permanent immobility rehabilitation especially if there is evidence to support early intervention.

Effects of Different Dietary Interventions on Calcitriol, Parathyroid Hormone, Calcium, and Phosphorus: Results from the DASH Trial.

The "Dietary Approaches to Stop Hypertension" (DASH) diet, rich in fiber and low-fat dairy, effectively lowers blood pressure. DASH's effect on calcitriol and other markers of bone-mineral metabolism is unknown. This secondary analysis of the DASH trial aimed to determine the effect of dietary patterns on blood concentrations of calcitriol, parathyroid hormone (PTH), ionized calcium, and urinary excretion of calcium and phosphorus. Outcomes were available in 334 participants in the trial. After a 3-week run-in on the control diet, participants were randomized to control, fruits and vegetables (F&V), or DASH diets. Outcomes were assessed at the end of run-in, and during the last week of the intervention period. Mean age of participants was 45.7 ± 10.7 years, 46% female, and 57% African-American. Mean ± Standard Deviation(SD) baseline serum concentrations of calcitriol, PTH, and ionized calcium were 37.8 ± 9.2 pg/mL, 46.1 ± 18.5 pg/mL and 5.2 ± 0.23 mg/dL, respectively. Mean (±SD) urinary calcium and phosphorus excretions were 150.1 ± 77.8 and 708.0 ± 251.8 mg/24 h, respectively. Compared with control, DASH reduced calcitriol -3.32 pg/mL (p = 0.004). Otherwise, there was no significant effect on other biomarkers. DASH lowered serum calcitriol perhaps more among African-Americans. These results raise important questions about the interpretation and clinical significance of low calcitriol concentrations in the setting of recommended diets.

Increasing Physical Activity Amongst Overweight and Obese Cancer Survivors Using an Alexa-Based Intelligent Agent for Patient Coaching: Protocol for the Physical Activity by Technology Help (PATH) Trial.

BACKGROUND: Physical activity has established health benefits, but motivation and adherence remain challenging. OBJECTIVE: We designed and launched a three-arm randomized trial to test artificial intelligence technology solutions to increase daily physical activity in cancer survivors. METHODS: A single-center, three-arm randomized clinical trial with an allocation ration of 1:1:1: (A) control, in which participants are provided written materials about the benefits of physical activity; (B) text intervention, where participants receive daily motivation from a fully automated, data-driven algorithmic text message via mobile phone (Coachtext); and (C) Voice Assist intervention, where participants are provided with an in-home on demand autonomous Intelligent Agent using data driven Interactive Digital Voice Assist on the Amazon Alexa/Echo (MyCoach). RESULTS: The study runs for 5 weeks: a one-week run-in to establish baseline, followed by 4 weeks of intervention. Data for study outcomes is collected automatically through a wearable sensor, and data are transferred in real-time to the study server. The recruitment goal is 42 participants, 14 in each arm. Electronic health records are used to prescreen candidates, with 39 participants recruited to date. DISCUSSION: This study aims to investigate the effects of different types of intelligent technology solutions on promoting physical activity in cancer survivors. This innovative approach can easily be expanded and customized to other interventions. Early lessons from our initial participants are helping us develop additional advanced solutions to improve health outcomes. TRIAL REGISTRATION: Retrospectively registered on July 10, 2017 at ClinicalTrials.gov: NCT03212079; https://clinicaltrials.gov/ct2/show/NCT03212079 (Archived by WebCite at http://www.webcitation.org/6wgvqjTji).

Diabetes and Back Pain: Markers of Diabetes Disease Progression Are Associated With Chronic Back Pain.

IN BRIEF Diabetes has been associated with the incidence of back pain. However, the relationship between markers of diabetes progression and back pain has not been studied. The objective of this study was to correlate clinical and laboratory measures of diabetes disease severity to the presence of back pain to provide insight into the relationship between these conditions. Findings showed that markers of diabetes disease progression were associated with the presence of back pain, suggesting that uncontrolled diabetes may contribute to the development of chronic back pain.

Chronic low-back pain in adult with diabetes: NHANES 2009-2010.

The aim of this study was to test the hypothesis that diabetes mellitus (DM) is associated with an increased prevalence of chronic low back pain (CLBP) in the general population. We analyzed data for 5106 adults (4591 without DM & 515 with diagnosed DM), who were part of the National Health and Nutrition Examination Survey (NHANES) from 2009 through 2010. Adults with DM were older (mean age 54.2years' vs. 42.1years), more likely to be obese (BMI>30, 69.5% vs. 33.3%), less educated (college or above 44.4% vs. 57.3%), had a lower annual income (<$20,000, 16.8% vs. 13.4%), were more likely to be a former smoker (31.5% vs. 20.9%), less physically active (43.5% vs. 59.4%). The prevalence of CLBP was 19.8% in adults with DM vs. 12.9% in adults without DM (age-adjusted OR 1.46; 95% CI, 1.00-1.94, P=.050). After the adjustments for CLBP's known risk factors, the association remained significant (OR 1.39; 95% CI, 1.02-1.92, P=.041). Adults with DM have a higher prevalence of CLBP. Further research is needed to examine the association and pathophysiology of DM and CLBP as well as the role of shared risk factors. SUMMARY: Adults with diabetes have higher prevalence of chronic low back pain (CLBP), and higher odds of CLBP after adjusting for LBP risk factors.

Association Between Vitamin D Deficiency and Outcomes Following Spinal Fusion Surgery: A Systematic Review.

BACKGROUND: Vitamin D deficiency is a relatively common occurrence in patients presenting for spinal surgery; however, whether this abnormality has any effect on spinal fusion outcomes remains unclear. We performed a systematic review of the available literature relevant to the association between vitamin D deficiency and spinal fusion outcomes. METHODS: We conducted a systematic and critical review of recent literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The following databases were searched: MEDLINE/PubMed, Google Scholar, Cochrane, Web of Science, and Scopus. Key search terms were "vitamin D," "spinal surgery outcomes," "spinal fusion," and "pseudarthrosis." Papers included in the review were original research articles in peer-reviewed journals. The articles were thoroughly examined and compared on the basis of study design, outcomes, and results. RESULTS: A total of 5 studies were included in the qualitative analysis. In these studies, patients presenting with vitamin D deficiency achieved lower fusion rates and suffered higher rates of recurrent-persistent low back pain compared with patients with normal vitamin D levels. Studies examining the effect of postoperative vitamin D supplementation in deficient patients reported significant improvements in low back pain intensity, patient-reported outcomes scores, and fusion rates compared with baseline as well as with control groups. CONCLUSIONS: The literature suggests that patients presenting for spinal fusion may benefit from correction of vitamin D deficiency to maximize the chance of a successful arthrodesis and to achieve optimal surgical outcomes. Future prospective studies are needed to determine whether routine preoperative treatment of this metabolic derangement is warranted.