ABSTRACT
BACKGROUND: Social barriers to health care, such as food insecurity, financial distress, and housing instability, may impede effective clinical management for individuals with chronic illness. Systematic strategies are needed to more efficiently identify at-risk individuals who may benefit from proactive outreach by health care systems for screening and referral to available social resources. OBJECTIVE: To create a predictive model to identify a higher likelihood of food insecurity, financial distress, and/or housing instability among adults with multiple chronic medical conditions. RESEARCH DESIGN AND SUBJECTS: We developed and validated a predictive model in adults with 2 or more chronic conditions who were receiving care within Kaiser Permanente Northern California (KPNC) between January 2017 and February 2020. The model was developed to predict the likelihood of a "yes" response to any of 3 validated self-reported survey questions related to current concerns about food insecurity, financial distress, and/or housing instability. External model validation was conducted in a separate cohort of adult non-Medicaid KPNC members aged 35-85 who completed a survey administered to a random sample of health plan members between April and June 2021 (n = 2820). MEASURES: We examined the performance of multiple model iterations by comparing areas under the receiver operating characteristic curves (AUCs). We also assessed algorithmic bias related to race/ethnicity and calculated model performance at defined risk thresholds for screening implementation. RESULTS: Patients in the primary modeling cohort (n = 11,999) had a mean age of 53.8 (±19.3) years, 64.7% were women, and 63.9% were of non-White race/ethnicity. The final, simplified model with 30 predictors (including utilization, diagnosis, behavior, insurance, neighborhood, and pharmacy-based variables) had an AUC of 0.68. The model remained robust within different race/ethnic strata. CONCLUSIONS: Our results demonstrated that a predictive model developed using information gleaned from the medical record and from public census tract data can be used to identify patients who may benefit from proactive social needs assessment. Depending on the prevalence of social needs in the target population, different risk output thresholds could be set to optimize positive predictive value for successful outreach. This predictive model-based strategy provides a pathway for prioritizing more intensive social risk outreach and screening efforts to the patients who may be in greatest need.
Subject(s)
Electronic Health Records , Food Insecurity , Self Report , Humans , Female , Male , Middle Aged , Aged , Adult , California , Electronic Health Records/statistics & numerical data , Financial Stress , Aged, 80 and over , Chronic Disease , Risk AssessmentABSTRACT
BACKGROUND: Severe hypoglycemia is a serious adverse drug event associated with hypoglycemia-prone medications; older patients with diabetes are particularly at high risk. Economic food insecurity (food insecurity due to financial limitations) is a known risk factor for hypoglycemia; however, less is known about physical food insecurity (due to difficulty cooking or shopping for food), which may increase with age, and its association with hypoglycemia. OBJECTIVE: Study associations between food insecurity and severe hypoglycemia. DESIGN: Survey based cross-sectional study. PARTICIPANTS: Survey responses were collected in 2019 from 1,164 older (≥ 65 years) patients with type 2 diabetes treated with insulin or sulfonylureas. MAIN MEASURES: Risk ratios (RR) for economic and physical food insecurity associated with self-reported severe hypoglycemia (low blood glucose requiring assistance) adjusted for age, financial strain, HbA1c, Charlson comorbidity score and frailty. Self-reported reasons for hypoglycemia endorsed by respondents. KEY RESULTS: Food insecurity was reported by 12.3% of the respondents; of whom 38.4% reported economic food insecurity only, 21.1% physical food insecurity only and 40.5% both. Economic food insecurity and physical food insecurity were strongly associated with severe hypoglycemia (RR = 4.3; p = 0.02 and RR = 4.4; p = 0.002, respectively). Missed meals ("skipped meals, not eating enough or waiting too long to eat") was the dominant reason (77.5%) given for hypoglycemia. CONCLUSIONS: Hypoglycemia prevention efforts among older patients with diabetes using hypoglycemia-prone medications should address food insecurity. Standard food insecurity questions, which are used to identify economic food insecurity, will fail to identify patients who have physical food insecurity only.
ABSTRACT
AIMS: PTC518 is an orally administered, centrally and peripherally distributed huntingtin (HTT) pre-mRNA splicing modifier being developed for the treatment of Huntington's disease (HD) for which there is a high unmet medical need as there are currently no approved disease-modifying treatments. This first-in-human study investigated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PTC518 in healthy volunteers. METHODS: This phase 1, single-centre, randomized study in 77 healthy male and female volunteers evaluated the safety and tolerability and PK of PTC518 following single ascending doses and multiple ascending doses, PD as assessed by HTT mRNA and HTT protein levels after single and multiple doses, and food effects. RESULTS: PTC518 demonstrated a favourable safety profile. The majority of treatment-emergent adverse events were mild and transient. PTC518 Tmax was reached at 6-7 h and the terminal T1/2 was 54.0-75.3 h following a single oral dose. Exposure increased with dose though less than dose proportionally. The PTC518 concentrations in cerebrospinal fluid were approximately 2.6-fold higher than the unbound free-drug concentrations in plasma. A significant dose-dependent reduction of up to approximately 60% in HTT mRNA and a significant dose-dependent, time-dependent and sustained reduction in HTT protein levels of up to 35% were observed after PTC518 treatment. CONCLUSIONS: PTC518 was well tolerated, and proof of mechanism of this novel splicing modifier was demonstrated by the dose-dependent decrease in systemic HTT mRNA and HTT protein levels. Results from this first-in-human study support further studies in patients with HD and demonstrate the potential for PTC518 as a breakthrough treatment for HD.
ABSTRACT
Coccidioides spp. are dimorphic fungi that are capable of infecting human and non-human mammals and can cause diverse manifestations of coccidioidomycosis or Valley fever (VF). In combination with clinical symptoms and radiographic findings, antibody-based diagnostic tests are often used to diagnose and monitor patients with VF. Chitinase 1 (CTS1) has previously been identified as the seroreactive antigen used in these diagnostic assays to detect anticoccidial IgG. Here, an indirect enzyme-linked immunosorbent assay to detect IgG to CTS1 demonstrated 165 of 178 (92.7%) patients with a positive result by immunodiffusion (ID) and/or complement fixation (CF) had antibodies to the single antigen CTS1. We then developed a rapid antibody lateral flow assay (LFA) to detect anti-CTS1 antibodies. Out of 143 samples tested, the LFA showed 92.9% positive percent agreement [95% confidence interval (CI), 84.3%-96.9%] and 97.7% negative percent agreement (95% CI, 87.9%-99.6%) with ID and CF assays. Serum or plasma from canines, macaques, and dolphins was also tested by the CTS1 LFA. Test line densities of the CTS1 LFA correlated in a linear manner with the reported CF and ID titers for human and non-human samples, respectively. This 10-min point-of-care test for the rapid detection of anti-coccidioidal antibodies could help to inform healthcare providers in real-time, potentially improving the efficiency of healthcare delivery.
Subject(s)
Biological Assay , Coccidioidomycosis , Humans , Animals , Dogs , Coccidioides , Coccidioidomycosis/diagnosis , Enzyme-Linked Immunosorbent Assay , Macaca , Immunoglobulin G , MammalsABSTRACT
BACKGROUND: Estimated life expectancy for older patients with diabetes informs decisions about treatment goals, cancer screening, long-term and advanced care, and inclusion in clinical trials. Easily implementable, evidence-based, diabetes-specific approaches for identifying patients with limited life expectancy are needed. OBJECTIVE: Develop and validate an electronic health record (EHR)-based tool to identify older adults with diabetes who have limited life expectancy. DESIGN: Predictive modeling based on survival analysis using Cox-Gompertz models in a retrospective cohort. PARTICIPANTS: Adults with diabetes aged ≥ 65 years from Kaiser Permanente Northern California: a 2015 cohort (N = 121,396) with follow-up through 12/31/2019, randomly split into training (N = 97,085) and test (N = 24,311) sets. Validation was conducted in the test set and two temporally distinct cohorts: a 2010 cohort (n = 89,563; 10-year follow-up through 2019) and a 2019 cohort (n = 152,357; 2-year follow-up through 2020). MAIN MEASURES: Demographics, diagnoses, utilization and procedures, medications, behaviors and vital signs; mortality. KEY RESULTS: In the training set (mean age 75 years; 49% women; 48% racial and ethnic minorities), 23% died during 5 years follow-up. A mortality prediction model was developed using 94 candidate variables, distilled into a life expectancy model with 11 input variables, and transformed into a risk-scoring tool, the Life Expectancy Estimator for Older Adults with Diabetes (LEAD). LEAD discriminated well in the test set (C-statistic = 0.78), 2010 cohort (C-statistic = 0.74), and 2019 cohort (C-statistic = 0.81); comparisons of observed and predicted survival curves indicated good calibration. CONCLUSIONS: LEAD estimates life expectancy in older adults with diabetes based on only 11 patient characteristics widely available in most EHRs and claims data. LEAD is simple and has potential application for shared decision-making, clinical trial inclusion, and resource allocation.
Subject(s)
Diabetes Mellitus , Humans , Female , Aged , Male , Retrospective Studies , Diabetes Mellitus/epidemiology , Diabetes Mellitus/therapy , Aging , Life Expectancy , Risk FactorsABSTRACT
Background: Adults with chronic medical conditions complicated by food insecurity or physical limitations may have higher barriers to accessing telehealth implemented during the COVID-19 pandemic. Objective: To examine the relationships of self-reported food insecurity and physical limitations with changes in health care utilization and medication adherence comparing the year before (March 2019-February 2020) and the first year of the COVID-19 pandemic (April 2020-March 2021) among patients with chronic conditions insured by Medicaid or Medicare Advantage. Methods: A prospective cohort study of 10,452 Kaiser Permanente Northern California members insured by Medicaid and 52,890 Kaiser Permanente Colorado members insured by Medicare Advantage was conducted. Difference-in-differences (DID) between the pre-COVID and COVID years in telehealth versus in-person health care utilization and adherence to chronic disease medicines by food insecurity and by physical limitation status were measured. Results: Food insecurity and physical limitations were each associated with small but significantly greater shifts from in-person to telehealth. Medicare Advantage members with physical limitations also had significantly greater decline in adherence to chronic medications from year to year compared with those without physical limitations (DID from pre-COVID year to COVID year ranged from 0.7% to 3.6% greater decline by medication class, p < 0.01). Conclusions: Food insecurity and physical limitations did not present significant barriers to the transition to telehealth during the COVID pandemic. The greater decrease in medication adherence among older patients with physical limitations suggests that care systems must further address the needs of this high-risk population.
Subject(s)
COVID-19 , Telemedicine , Humans , Adult , Aged , United States/epidemiology , COVID-19/epidemiology , Self Report , Pandemics , Prospective Studies , Medicare , Chronic Disease , Food InsecurityABSTRACT
BACKGROUND: Adverse social conditions are a key contributor to health disparities. Improved understanding of how social risk factors interact with each other and with neighborhood characteristics may inform efforts to reduce health disparities. DATA: A questionnaire of 29,281 patients was collected through the enrollment of Medicaid beneficiaries in a large Northern California integrated health care delivery system between May 2016 and February 2020. EXPOSURES: Living in the least resourced quartile of neighborhoods as measured by a census-tract level Neighborhood Deprivation Index score. MAIN OUTCOMES: Five self-reported social risk factors: financial need, food insecurity, housing barriers, transportation barriers, and functional limitations. RESULTS: Nearly half (42.0%) of patients reported at least 1 social risk factor; 22.4% reported 2 or more. Mean correlation coefficient between social risk factors was ρ=0.30. Multivariable logistic models controlling for age, race/ethnicity, sex, count of chronic conditions, and insurance source estimated that living in the least resourced neighborhoods was associated with greater odds of food insecurity (adjusted odds ratio=1.07, 95% confidence interval: 1.00-1.13) and transportation barriers (adjusted odds ratio=1.20, 95% confidence interval: 1.11-1.30), but not financial stress, housing barriers, or functional limitations. CONCLUSIONS AND RELEVANCE: We found that among 5 commonly associated social risk factors, Medicaid patients in a large Northern California health system typically reported only a single factor and that these factors did not correlate strongly with each other. We found only modestly greater social risk reported by patients in the least resourced neighborhoods. These results suggest that individual-level interventions should be targeted to specific needs whereas community-level interventions may be similarly important across diverse neighborhoods.
Subject(s)
Medicaid , Residence Characteristics , Ethnicity , Housing , Humans , Self Report , United StatesABSTRACT
BACKGROUND: Communities of color have been disproportionately impacted by the COVID-19 epidemic in the USA. OBJECTIVES: To examine the relationship of self-reported social health needs with SARS-COV-2 infection by race/ethnicity among insured adults with access to high-quality health care. DESIGN AND PARTICIPANTS: A prospective cohort study of 26,741 adult Kaiser Permanente Northern California members insured by Medicaid and 58,802 Kaiser Permanente Colorado members insured by Medicare Advantage who completed social risk assessments prior to the onset of the COVID-19 pandemic. MAIN MEASURES: We examined the independent relationships of demographic, medical, and social factors on SARS-COV-2 testing and positivity between March 1, 2020, and November 30, 2020, by race/ethnicity. KEY RESULTS: Findings were similar in the two cohorts, with Latino (16-18%), Asian (11-14%), and Black (11-12%) members having the highest prevalence of SARS-COV-2 infection (ORs adjusted for age, gender, and use of interpreter ranging from 1.68 to 2.23 compared to White member [7-8%], p < 0.001). Further adjustment for medical comorbidity (e.g., obesity, diabetes, chronic lung disease); neighborhood measures; and self-reported social risk factors (e.g., trouble paying for basics, food insecurity, housing concerns, transportation barriers) did not appreciably change these results. CONCLUSIONS: Compared to non-Latino White members, members of other race/ethnic groups had higher positivity rates that were only minimally reduced after controlling for medical and neighborhood conditions and self-reported social risk factors. These findings suggest that traditional infection transmission factors such as essential work roles and household size that have disproportionate representation among communities of color may be important contributors to SARS-COV-2 infection among insured adults.
Subject(s)
COVID-19 , Adult , Aged , COVID-19 Testing , Cohort Studies , Ethnicity , Humans , Medicare , Pandemics , Prospective Studies , SARS-CoV-2 , United States/epidemiologyABSTRACT
In efforts to increase rigor and reproducibility, the USA National Primate Research Centers (NPRCs) have focused on qualification of reagents, cross-laboratory validations, and proficiency testing for methods to detect infectious agents and accompanying immune responses in nonhuman primates. The pathogen detection working group, comprised of laboratory scientists, colony managers, and leaders from the NPRCs, has championed the effort to produce testing that is reliable and consistent across laboratories. Through multi-year efforts with shared proficiency samples, testing percent agreement has increased from as low as 67.1% for SRV testing in 2010 to 92.1% in 2019. The 2019 average agreement for the four basic SPF agents improved to >96% (86.5% BV, 98.9 SIV, 92.1 SRV, and 97.0 STLV). As new pathogens such as SARS coronavirus type 2 emerge, these steps can now be quickly replicated to develop and implement new assays that ensure rigor, reproducibly, and quality for NHP pathogen detection.
Subject(s)
Simian T-lymphotropic virus 1 , Animals , Primates , Reference Standards , Reproducibility of Results , Specific Pathogen-Free OrganismsABSTRACT
Our objective was to investigate the effects of prepartum metabolizable protein (MP) supply and management strategy on milk production and blood biomarkers in early lactation dairy cows. Ninety-six multigravida Holstein cows were used in a randomized complete block design study, blocked by calving date, and then assigned randomly to 1 of 3 treatments within block. Cows on the first treatment were fed a far-off lower MP diet [MP = 83 g/kg of dry matter (DM)] between -55 and -22 d before expected calving and then a close-up lower MP diet (MP = 83 g/kg of DM) until parturition (LPLP). Cows on the second treatment were fed the far-off lower MP diet between -55 to -22 d before expected parturition and then a prepartum higher MP diet (MP = 107 g/kg of DM) until calving (LPHP). Cows on the third treatment had a shortened 43-d dry period and were fed the prepartum higher MP diet from dry-off to parturition (SDHP). After calving, cows received the same fresh diet from d 0 to 14 and the same high diet from d 15 to 84. Data were analyzed separately for wk -6 to -1 and wk 1 to 12, relative to parturition. Dry matter intake from wk -6 to -1 was not different between LPHP and LPLP and increased for SDHP compared with LPLP. In contrast, dry matter intake for wk 1 to 12 postpartum did not change for LPHP versus LPLP or for SDHP versus LPLP. Compared with LPLP cows, LPHP cows had lower energy-corrected milk yield and tended to have decreased milk fat yield during wk 1 to 12 of lactation. Conversely, yields of energy-corrected milk and milk fat and protein were similar for SDHP compared with LPLP. Plasma urea N during wk -3 to -1 increased for LPHP versus LPLP and for SDHP versus LPLP; however, no differences in plasma urea N were observed postpartum. Elevated prepartum MP supply did not modify circulating total fatty acids, ß-hydroxybutyrate, total protein, albumin, or aspartate aminotransferase during the prepartum and postpartum periods. Increased MP supply prepartum combined with a shorter dry period (SDHP vs. LPLP) tended to increase whole-blood ß-hydroxybutyrate postpartum; however, other blood metabolites were not affected. Taken together, under the conditions of this study, elevated MP supply in close-up diets reduced milk production without affecting blood metabolites in multiparous dairy cows during early lactation. A combination of a shorter dry period and increased prepartum MP supply (i.e., SDHP vs. LPLP) improved prepartum dry matter intake without modifying energy-corrected milk yield and blood biomarkers in early lactation cows.
Subject(s)
Energy Metabolism , Lactation , 3-Hydroxybutyric Acid , Animals , Biomarkers/metabolism , Cattle , Diet/veterinary , Female , Milk/metabolism , Postpartum Period/metabolism , Urea/metabolismABSTRACT
BACKGROUND: Adults diagnosed with type 2 diabetes at a younger age are at increased risk for poor outcomes. Yet, little is known about the early experiences of these individuals, starting with communication of the diagnosis. Addressing this knowledge gap is important as this initial interaction may shape subsequent disease-related perceptions and self-management. OBJECTIVE: We examined diagnosis disclosure experiences and initial reactions among younger adults with newly diagnosed type 2 diabetes. PARTICIPANTS: Purposive sample of adult members of Kaiser Permanente Northern California, an integrated healthcare delivery system, diagnosed with type 2 diabetes before age 45 years. APPROACH: We conducted six focus groups between November 2017 and May 2018. Transcribed audio recordings were coded by two coders using thematic analysis. KEY RESULTS: Participants (n = 41) were 38.4 (± 5.8) years of age; 10 self-identified as Latinx, 12 as Black, 12 as White, and 7 as multiple or other races. We identified variation in diagnosis disclosure experiences, centered on four key domains: (1) participants' sense of preparedness for diagnosis (ranging from expectant to surprised); (2) disclosure setting (including in-person, via phone, via secure message, or via review of results online); (3) perceived provider tone (from nonchalant, to overly fear-centered, to supportive); and (4) participants' emotional reactions to receiving the diagnosis (including acceptance, denial, guilt, and/or fear, rooted in personal and family experience). CONCLUSIONS: For younger adults, the experience of receiving a diabetes diagnosis varies greatly. Given the long-term consequences of inadequately managed diabetes and the need for early disease control, effective initial disclosure represents an opportunity to optimize initial care. Our results suggest several opportunities to improve the type 2 diabetes disclosure experience: (1) providing pre-test counseling, (2) identifying patient-preferred settings for receiving the news, and (3) developing initial care strategies that acknowledge and address the emotional distress triggered by this life-altering, chronic disease diagnosis.
Subject(s)
Diabetes Mellitus, Type 2 , Adult , Child , Delivery of Health Care , Diabetes Mellitus, Type 2/diagnosis , Disclosure , Focus Groups , Humans , Middle Aged , Qualitative ResearchABSTRACT
In studies based on electronic health records (EHR), the frequency of covariate monitoring can vary by covariate type, across patients, and over time, which can limit the generalizability of inferences about the effects of adaptive treatment strategies. In addition, monitoring is a health intervention in itself with costs and benefits, and stakeholders may be interested in the effect of monitoring when adopting adaptive treatment strategies. This paper demonstrates how to exploit nonsystematic covariate monitoring in EHR-based studies to both improve the generalizability of causal inferences and to evaluate the health impact of monitoring when evaluating adaptive treatment strategies. Using a real world, EHR-based, comparative effectiveness research (CER) study of patients with type II diabetes mellitus, we illustrate how the evaluation of joint dynamic treatment and static monitoring interventions can improve CER evidence and describe two alternate estimation approaches based on inverse probability weighting (IPW). First, we demonstrate the poor performance of the standard estimator of the effects of joint treatment-monitoring interventions, due to a large decrease in data support and concerns over finite-sample bias from near-violations of the positivity assumption (PA) for the monitoring process. Second, we detail an alternate IPW estimator using a no direct effect assumption. We demonstrate that this estimator can improve efficiency but at the potential cost of increase in bias from violations of the PA for the treatment process.
Subject(s)
Diabetes Mellitus, Type 2 , Bias , Causality , Diabetes Mellitus, Type 2/drug therapy , Electronic Health Records , Humans , ProbabilityABSTRACT
Our objective was to evaluate the effect of metabolizable protein (MP) supply on milk production, blood metabolites, and health in dairy cows during early lactation. Three experimental diets were formulated to contain 114, 107, 101 g of MP/kg of dry matter (DM; 114MP, 107MP, and 101MP, respectively) with crude protein contents of 17.0, 16.2, and 15.3% of DM, respectively. One hundred multiparous Holstein cows were fed 1 of these 3 diets during wk 1 to 3 and wk 4 to 13 of lactation in one of the following sequences: (1) 114MP and 107MP (114MP/107MP), (2) 114MP and 101MP (114MP/101MP), or (3) 101MP and 101MP (101MP/101MP). During wk 1 to 3, the 114MP and 101MP treatments were 20 and 27% deficient in estimated MP, respectively. From wk 4 to 13, the 114MP/107MP, 114MP/101MP, and 101MP/101MP treatments were 8, 12, and 13% deficient in estimated MP, respectively. Data were analyzed separately for wk 1 to 3, 4 to 13, and 1 to 13. Dry matter intake and energy-corrected milk (ECM) yield were not affected by treatment during wk 4 to 13 or wk 1 to 13; however, ECM yield decreased for 101MP versus 114MP from wk 1 to 3. Similarly, feed efficiency was not affected by treatment from wk 4 to 13 or wk 1 to 13, and was reduced with 101MP versus 114MP during wk 1 to 3. Milk N efficiency tended to increase for 101MP versus 114MP for wk 1 to 3 and increased with 101MP/101MP and 114MP/101MP relative to 114MP/107MP during wk 4 to 13 and wk 1 to 13. Treatment had no influence on yields and concentrations of milk components from wk 4 to 13 or wk 1 to 13; however, compared with 114MP, feeding 101MP tended to decrease milk fat yield and decreased yields of milk true protein and lactose for wk 1 to 3. Both milk and blood urea N concentrations decreased for 101MP/101MP and 114MP/101MP relative to 114MP/107MP during wk 4 to 13 and wk 1 to 13, and were reduced with feeding 101MP versus 114MP from wk 1 to 3. Treatment had no effect on the incidence of diseases in cows throughout the study. Serum concentrations of total fatty acids, albumin, and aspartate aminotransferase did not differ between 101MP and 114MP; however, serum ß-hydroxybutyrate concentration was lower in cows receiving 101MP during the first 3 wk of lactation. Compared with 114MP, feeding 101MP during wk 1 to 3 increased plasma concentrations of creatinine and 3-methylhistidine (3-MHis) but did not change the ratio of plasma 3-MHis to creatinine. We found no differences in plasma creatinine or the ratio of 3-MHis-to-creatinine among treatments from wk 4 to 13; however, 101MP/101MP and 114MP/101MP had elevated plasma 3-MHis compared with 114MP/107MP. Treatment had no effect on body weight and body condition score over the duration of the study. Collectively, despite reduced milk production for the first 3 wk of lactation, feeding the 101MP/101MP treatment sustained lactational performance and improved milk N efficiency without negatively affecting the frequency of diseases in dairy cows during the first 13 wk postpartum.
Subject(s)
Animal Feed , Milk , Animal Feed/analysis , Animals , Cattle , Diet/veterinary , Dietary Proteins , Female , LactationABSTRACT
During 2017-2018, Barmah Forest virus was recovered from mosquitoes trapped in military training areas in Australia and from a soldier infected at 1 of these areas. Phylogenies of the nucleotide sequences of the envelope glycoprotein gene E2 and the 3' untranslated region suggest that 2 lineages are circulating in eastern Australia.
Subject(s)
Alphavirus , Arboviruses , Culicidae , Military Personnel , Alphavirus/genetics , Animals , Australia/epidemiology , HumansABSTRACT
Importance: Following surgery to treat major trauma-related fractures, deep wound infection rates are high. It is not known if negative pressure wound therapy can reduce infection rates in this setting. Objective: To assess outcomes in patients who have incisions resulting from surgery for lower limb fractures related to major trauma and were treated with either incisional negative pressure wound therapy or standard wound dressing. Design, Setting, and Participants: A randomized clinical trial conducted at 24 trauma hospitals representing the UK Major Trauma Network that included 1548 patients aged 16 years or older who underwent surgery for a lower limb fracture caused by major trauma from July 7, 2016, through April 17, 2018, with follow-up to December 11, 2018. Interventions: Incisional negative pressure wound therapy (n = 785), which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure (n = 763). Main Outcomes and Measures: The primary outcome measure was deep surgical site infection at 30 days diagnosed according to the criteria from the US Centers for Disease Control and Prevention. A preplanned secondary analysis of the primary outcome was performed at 90 days. The secondary outcomes were patient-reported disability (Disability Rating Index), health-related quality of life (EuroQol 5-level EQ-5D), surgical scar assessment (Patient and Observer Scar Assessment Scale), and chronic pain (Douleur Neuropathique Questionnaire) at 3 and 6 months, as well as other local wound healing complications at 30 days. Results: Among 1548 participants who were randomized (mean [SD] age, 49.8 [20.3] years; 561 [36%] were aged ≤40 years; 583 [38%] women; and 881 [57%] had multiple injuries), 1519 (98%) had data available for the primary outcome. At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52). There was no significant difference in the deep surgical site infection rate at 90 days (11.4% [72 of 629 patients] in the incisional negative pressure wound therapy group vs 13.2% [78 of 590 patients] in the standard wound dressing group; odds ratio, 0.84 [95% CI, 0.59 to 1.19]; absolute risk difference, -1.76% [95% CI, -5.41% to 1.90%]; P = .32). For the 5 prespecified secondary outcomes reported, there were no significant differences at any time point. Conclusions and Relevance: Among patients who underwent surgery for major trauma-related lower limb fractures, use of incisional negative pressure wound therapy, compared with standard wound dressing, resulted in no significant difference in the rate of deep surgical site infection. The findings do not support the use of incisional negative pressure wound therapy in this setting, although the event rate at 30 days was lower than expected. Trial Registration: isrctn.org Identifier: ISRCTN12702354.
Subject(s)
Bandages , Fracture Fixation, Internal , Fractures, Open/surgery , Lower Extremity/injuries , Negative-Pressure Wound Therapy , Surgical Wound Infection/prevention & control , Adolescent , Adult , Female , Fracture Fixation, Internal/adverse effects , Humans , Injury Severity Score , Male , Middle Aged , Surgical Wound Infection/epidemiologyABSTRACT
BACKGROUND: Personal health records offer patients access to view their own health information and to manage their care online through secure patient portal tools. Little is known about the patient-reported experience in using health portals to manage chronic conditions. OBJECTIVE: In a patient-centered research study, we examined how using portal tools affects patient health care experiences among patients with chronic conditions. We also examined barriers among nonportal users. RESEARCH DESIGN: A cross-sectional patient survey. SUBJECTS: Patients with a chronic condition in an integrated delivery system offering a patient portal. MEASURES: Respondents reported barriers, preferences, and experiences in using the patient portal, and whether using the portal changed their overall health. RESULTS: Among all the 1824 respondents (70% response rate), portal nonusers reported preferring in-person health care (54%) or experiencing internet access barriers (41%). Portal users reported that using the portal was convenient (90%), the information available was useful (92%), and that it integrated well with other health care (92%). Among users, 31% reported that using the portal had improved their overall health. After adjustment, patients were significantly more likely to report that portal use improved their health if they had also reported convenience, information usefulness, or integration with other care (P<0.05). Reassuringly, patient-reported impacts on overall health did not vary by patient characteristics (including age, race, sex, education, income, complex conditions). CONCLUSION: Patients with chronic conditions using the portal reported convenience, information usefulness, and integration of the patient portal with their health care; these may act as potential pathways improving health.
Subject(s)
Chronic Disease/psychology , Patient Acceptance of Health Care/statistics & numerical data , Patient Portals/statistics & numerical data , Adolescent , Adult , Aged , California , Cross-Sectional Studies , Delivery of Health Care, Integrated , Disease Management , Female , Health Services Accessibility , Humans , Male , Middle Aged , Patient Acceptance of Health Care/psychology , Patient Reported Outcome Measures , Surveys and Questionnaires , Young AdultABSTRACT
BACKGROUND: Most patients with diabetes do not meet all evidence-based goals of care, and many patients report poor communication and lack of involvement in decision-making during primary care visits. OBJECTIVE: To test the hypothesis that a "Pre-Visit Prioritization" secure email message could improve visit communication and glycemic control among patients with type 2 diabetes. DESIGN: We conducted a pragmatic, provider-randomized, multi-site clinical trial from March 2015 to October 2016 across 30 primary care practices within Kaiser Permanente Northern California (KPNC), a large integrated care delivery system. PARTICIPANTS: Eligible patients had at least 1 year of KPNC membership, type 2 diabetes with most recently measured hemoglobin A1c (HbA1c) > = 8.0%, and were registered users of the KPNC online patient portal. INTERVENTIONS: Patients in the intervention arm, upon booking an appointment, received a secure email through the KPNC online portal with a link to the EHR allowing them to submit their top one or two priorities prior to the visit. Control patients received usual care. MAIN MEASURES: Glycemic control; change in HbA1c 6 and 12 months after the initial visit; patient-reported outcomes related to patient-provider communication and patient care experiences. KEY RESULTS: During the study period, 1276 patients had at least one eligible visit. In post-visit surveys (n = 457), more intervention arm patients reported preparing questions for their visit (72% vs 63%, p = 0.048) and being given treatment choices to consider (81% vs 73%, p = 0.041). Patients in both arms had similar reductions in HbA1c over the 12-month study period (0.56% ± 1.45%), with no significant differences between arms. CONCLUSIONS: A "light touch" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care. Improving diabetes clinical outcomes through more effective primary care visits may require more intensive approaches to patient visit preparation. TRIAL REGISTRY: NCT02375932.
Subject(s)
Diabetes Mellitus, Type 2/therapy , Patient Preference , Primary Health Care/organization & administration , Adult , Aged , Diabetes Mellitus, Type 2/psychology , Female , Humans , Male , Middle Aged , Physician-Patient Relations , Reminder SystemsABSTRACT
Electronic health records (EHR) data provide a cost- and time-effective opportunity to conduct cohort studies of the effects of multiple time-point interventions in the diverse patient population found in real-world clinical settings. Because the computational cost of analyzing EHR data at daily (or more granular) scale can be quite high, a pragmatic approach has been to partition the follow-up into coarser intervals of pre-specified length (eg, quarterly or monthly intervals). The feasibility and practical impact of analyzing EHR data at a granular scale has not been previously evaluated. We start filling these gaps by leveraging large-scale EHR data from a diabetes study to develop a scalable targeted learning approach that allows analyses with small intervals. We then study the practical effects of selecting different coarsening intervals on inferences by reanalyzing data from the same large-scale pool of patients. Specifically, we map daily EHR data into four analytic datasets using 90-, 30-, 15-, and 5-day intervals. We apply a semiparametric and doubly robust estimation approach, the longitudinal Targeted Minimum Loss-Based Estimation (TMLE), to estimate the causal effects of four dynamic treatment rules with each dataset, and compare the resulting inferences. To overcome the computational challenges presented by the size of these data, we propose a novel TMLE implementation, the "long-format TMLE," and rely on the latest advances in scalable data-adaptive machine-learning software, xgboost and h2o, for estimation of the TMLE nuisance parameters.
Subject(s)
Algorithms , Electronic Health Records , Longitudinal Studies , Causality , Computer Simulation , Diabetes Mellitus , Humans , Machine Learning , Reproducibility of ResultsABSTRACT
PURPOSE: Time during primary care visits is limited. We tested the hypothesis that a waiting room health information technology (IT) tool to help patients identify and voice their top visit priorities would lead to better visit interactions and improved quality of care. METHODS: We designed a waiting room tool, the Visit Planner, to guide adult patients through the process of identifying their top priorities for their visit and effectively expressing these priorities to their clinician. We tested this tool in a cluster-randomized controlled trial with usual care as the control. Eligible patients had at least 1 clinical care gap (eg, overdue for cancer screening, suboptimal chronic disease risk factor control, or medication nonadherence). RESULTS: The study (conducted March 31, 2016 through December 31, 2017) included 750 English- or Spanish-speaking patients. Compared with usual care patients, intervention patients more often reported "definitely" preparing questions for their doctor (59.5% vs 45.1%, P <.001) and "definitely" expressing their top concerns at the beginning of the visit (91.3% vs 83.3%, P = .005). Patients in both arms reported high levels of satisfaction with their care (86.8% vs 89.9%, P = .20). With 6 months of follow-up, prevalence of clinical care gaps was reduced by a similar amount in each study arm. CONCLUSIONS: A simple waiting room-based tool significantly improved visit communication. Patients using the Visit Planner were more prepared and more likely to begin the visit by communicating their top priorities. These changes did not, however, lead to further reduction in aggregate clinical care gaps beyond the improvements seen in the usual care arm.
Subject(s)
Communication , Medical Informatics , Patient Satisfaction , Physician-Patient Relations , Primary Health Care , Quality of Health Care , Adult , Aged , Appointments and Schedules , Female , Humans , Male , Middle AgedABSTRACT
We have fabricated an open-cavity microcavity structure containing a thin film of the biologically-derived molecule ß-carotene. We show that the ß-carotene absorption can be described in terms of a series of Lorentzian functions that approximate the 0-0, 0-1, 0-2, 0-3 and 0-4 electronic and vibronic transitions. On placing this molecular material into a microcavity, we obtain anti-crossing between the cavity mode and the 0-1 vibronic transition, however other electronic and vibronic transitions remain in the intermediate or weak-coupling regime due to their lower oscillator strength and broader linewidth. We discuss the consequences of strong-coupling for the possible modification of photosynthetic processes, or a re-ordering of allowed and optically-forbidden states.