Building Capacity for Pragmatic Trials of Digital Technology in Primary Care.

Frontline primary care teams face important challenges in seeking to transform the quality of care delivered to patients and to reduce clerical burden for clinicians. Digital technologies using artificial intelligence hold substantial promise to aid in this transformation. Both pragmatic clinical trials and implementation science are key tools to successfully introduce, evaluate, and sustain innovations in real-world primary care practices. Previous articles in this thematic series have provided an in-depth overview of pragmatic trials and implementation science. This paper demonstrates and provides a framework for how these concepts, together with digital transformation, can be used to solve many of the challenges facing primary care. This framework is conceived as the collaboration of frontline primary care teams with innovators in academic institutions and industry through pragmatic trials and implementation science.

Treatment of vitamin D deficiency in children.

INTRODUCTION: Vitamin D deficiency affects from 10% to 50% in various pediatric population groups and causes life-threatening hypocalcemia in infants, crippling rickets in infants and children, and increased risk of subsequent adult metabolic and neurologic problems. AREAS COVERED: An English language literature search of PubMed was performed since 1940 as were the authors' personal literature collections. References identified in the reviewed literature are considered. DIAGNOSIS: The diagnosis of vitamin D deficiency is based on serum 25-hydroxyvitamin D levels. Clinical features of rickets include bone deformities and elevated alkaline phosphatase. Most children and adolescents who are biochemically vitamin D deficient do not have specific symptoms or signs of deficiency. PREVENTION: Prevention of vitamin D deficiency is via exposure to sunshine, food and beverage fortification, and dietary supplementation. TREATMENT: Effective treatment of vitamin D deficiency is via oral or injectable administration of vitamin D. Dosing and duration of vitamin D therapy have been described for healthy children and for children with underlying medical conditions, but recommendations vary. EXPERT OPINION: Further investigation is needed to determine long-term non-skeletal effects of childhood vitamin D deficiency, benefits of supplementation in asymptomatic individuals with biochemical vitamin D deficiency, and appropriate screening for vitamin D deficiency in asymptomatic children and adolescents.

The effect of primary care clinician type and care team characteristics on health care costs.

OBJECTIVE: To evaluate health care costs as a function of assigned primary care clinician type and care team characteristics. METHODS: Administrative data were collected for 68 family medicine clinicians (40 physicians and 28 nurse practitioners [NPs]/physician assistant [PAs]), on 11 care teams (variable MD, NP and PA on teams), caring for 77,141 patients. We performed a generalized linear mixed multivariable regression model of standardized per member per month (PMPM) median cost as the outcome, with four practice sites included as random effects. RESULTS: In bivariate analysis, cost was higher in physicians than NP/PAs, in more complex patients, and associated with emergency department (ED) visit rate. On multivariate analysis, patient complexity, ED visit rate and higher patient experience ratings were independently associated with greater PMPM cost. More time in practice was associated with lower PMPM cost. In the adjusted multivariate model, physicians had 8.3% lower median PMPM costs than NP/PAs (p = 0.046). CONCLUSIONS: The primary drivers of greater PMPM cost were patient complexity, ED visits and patient satisfaction.

Artificial intelligence-enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial.

We have conducted a pragmatic clinical trial aimed to assess whether an electrocardiogram (ECG)-based, artificial intelligence (AI)-powered clinical decision support tool enables early diagnosis of low ejection fraction (EF), a condition that is underdiagnosed but treatable. In this trial ( NCT04000087 ), 120 primary care teams from 45 clinics or hospitals were cluster-randomized to either the intervention arm (access to AI results; 181 clinicians) or the control arm (usual care; 177 clinicians). ECGs were obtained as part of routine care from a total of 22,641 adults (N = 11,573 intervention; N = 11,068 control) without prior heart failure. The primary outcome was a new diagnosis of low EF (≤50%) within 90 days of the ECG. The trial met the prespecified primary endpoint, demonstrating that the intervention increased the diagnosis of low EF in the overall cohort (1.6% in the control arm versus 2.1% in the intervention arm, odds ratio (OR) 1.32 (1.01-1.61), P = 0.007) and among those who were identified as having a high likelihood of low EF (that is, positive AI-ECG, 6% of the overall cohort) (14.5% in the control arm versus 19.5% in the intervention arm, OR 1.43 (1.08-1.91), P = 0.01). In the overall cohort, echocardiogram utilization was similar between the two arms (18.2% control versus 19.2% intervention, P = 0.17); for patients with positive AI-ECGs, more echocardiograms were obtained in the intervention compared to the control arm (38.1% control versus 49.6% intervention, P < 0.001). These results indicate that use of an AI algorithm based on ECGs can enable the early diagnosis of low EF in patients in the setting of routine primary care.

Assessing Biomarkers of Breast Cancer Risk in Underserved Women in a Midwestern County.

OBJECTIVE: The primary aim of this study was to evaluate the feasibility of collecting risk factor information and accessing digitized mammographic data in a medically marginalized population. A secondary aim was to examine the association between vitamin D status and mammographic density. METHODS: Breast-screening examinations were provided for age-appropriate patients, and a referral for no-cost screening mammography was offered. Study participants were asked to undergo 25-hydroxyvitamin D testing at mammography and 1-year follow-up. RESULTS: Of 62 women approached, 35 (56%) consented to participate. Of 32 participants who had baseline mammography, the median mammographic density measured by VolparaDensity (Volpara Solutions Limited) was 5.7%. After 1 year, 9 women obtained follow-up mammograms, with a median density of 5.7%. Vitamin D status was measured for 31 participants at baseline and 13 participants in the following year. Insufficient vitamin D status (<30 ng/mL) was noted in 77% at each time point. Mammographic density was not significantly correlated with vitamin D status (P = .06). CONCLUSIONS: On the basis of this small pilot study, vitamin D insufficiency is common in this study population. Owing to the small sample size, an association between vitamin D insufficiency and breast density was not clear. Additional unexpected findings included substantial barriers in initial access to care and longitudinal follow-up in this population. Further study of these issues is needed.

Thiamin deficiency in low- and middle-income countries: Disorders, prevalences, previous interventions and current recommendations.

BACKGROUND: Thiamin deficiency is a major public health concern in several low- and middle-income countries (LMICs)-current attention to the problem is lacking. AIM: This review discusses prevalence of thiamin insufficiency and thiamin-deficiency disorders (TDDs) in LMICs, outlines programmatic experience with thiamin interventions, and offers recommendations to improve public-health and research attention to thiamin in LMICs. DISCUSSION: Thiamin insufficiency, i.e. low-blood-thiamin status, is endemic among several Southeast Asian countries: Cambodia (70-100% of infants and 27-100% of reproductive-age women); Laos (13% of hospitalized infants); Thailand (16-25% of children and 30% of elderly adults). Thiamin deficiency accounts for up to 45% of under-5 deaths in Cambodia, 34% of infant deaths in Laos, and 17% of infant deaths in Myanmar. Deficiency also exists in Africa, Asia, and the Americas, but these instances have typically been isolated. Exclusively breastfed infants of thiamin-deficient mothers are at highest risk for TDD and related death. Intervention strategies that have been employed to combat thiamin deficiency include food processing, fortification, supplementation, dietary diversification, and dietary behaviors, all of which have shown varying levels of effectiveness. CONCLUSIONS: We recommend universal thiamin-fortification of context-specific staple-foods in LMICs as a promising solution, as well as thiamin supplementation, particularly for pregnant and lactating women. Food processing regulations, dietary diversification, and modification of dietary behaviors to increase consumption of thiamin-rich foods may provide benefits in some circumstances, especially in countries without universal fortification programs or in populations dependent on food aid.

Knowledge of venomous snakes, snakebite first aid, treatment, and prevention among clinicians in northern Nigeria: a cross-sectional multicentre study.

Background: Snakebite envenoming causes considerable morbidity and mortality in northern Nigeria. The clinician's knowledge of snakebite impacts outcome. We assessed clinicians' knowledge of snakebite envenoming to highlight knowledge and practice gaps for possible intervention to improve snakebite outcomes. Methods: This was a cross-sectional multicentre study of 374 doctors selected from the accident and emergency, internal medicine, family medicine/general outpatient, paediatrics and surgery departments of nine tertiary hospitals in northern Nigeria using a multistage sampling technique. A self-administered questionnaire was used to assess their sociodemographics, knowledge of common venomous snakes, snakebite first aid, snake antivenom treatment and prevention. Results: The respondents' mean age was 35.6±5.8 y. They were predominantly males (70.6%) from urban hospitals (71.9%), from the northwest region (35.3%), in family medicine/general outpatient departments (33.4%), of <10 years working experience (66.3%) and had previous experience in snakebite management (78.3%). Although their mean overall knowledge score was 70.2±12.6%, only 52.9% had an adequate overall knowledge score. Most had adequate knowledge of snakebite clinical features (62.3%), first aid (75.7%) and preventive measures (97.1%), but only 50.8% and 25.1% had adequate knowledge of snake species that caused most injuries/deaths and anti-snake venom treatment, respectively. Overall knowledge predictors were ≥10 y working experience (odd ratio [OR] 1.72 [95% confidence interval {CI} 1.07 to 2.76]), urban hospital setting (OR 0.58 [95% CI 0.35 to 0.96]), surgery department (OR 0.44 [95% CI 0.24 to 0.81]), northwest/north-central region (OR 2.36 [95% CI 1.46 to 3.82]) and previous experience in snakebite management (OR 2.55 [95% CI 1.49 to 4.36]). Conclusions: Overall knowledge was low. Improvements in overall knowledge may require clinicians' exposure to snakebite management and training of accident and emergency clinicians in the region.

Variables associated with utilization of a centralized medical post in the Andean community of Pampas Grande, Peru.

CONTEXT: Integral to the location of health resources is the distance decay of utilization observed in a population. In rural Peru, a nongovernmental organization planning to increase the availability of health services needed this information. PURPOSE: To determine variables associated with utilization of a central medical clinic and determine whether, because of the mountainous topography, travel time (TT) would be a better predictor of utilization than distance. METHODS: A door-to-door survey of all available households (81% of total), using a Spanish translation of questions excerpted from the Behavioral Risk Factor Surveillance System Survey, was conducted in the summer of 2008 to determine variables associated with self-reported history of clinic utilization. RESULTS: Utilization was inversely related to TT and distance. Of those living within 5 minutes of the clinic, 61% had been to the clinic whereas only 25% of those living 30 or more minutes away had sought care. Female gender and fever predicted increased odds of clinic utilization. Having a disability reduced one's odds (OR 0.55) of visiting the clinic, after adjusting for gender, TT, and fever. The inverse correlation of utilization with travel distance and TT was not significantly different, thus failing to demonstrate that TT is a better predictor of utilization than distance. CONCLUSION: In health service planning, care for common conditions should be available within 5 minutes' TT or a few kilometers' distance from each person's home in order to improve health care access and reduce health care disparities worsened by disability.

Self-assessed disability and self-rated health among rural villagers in Peru: a brief report.

CONTEXT: Risks for poor self-rated overall health in rural areas of developing nations have not been thoroughly investigated. PURPOSE: The objective of this study was to assess potential risk factors for poor self-rated health among rural villagers in Peru. METHODS: A door-to-door survey of villagers residing in the Pampas Grande region in Peru, which is in the Andes Mountains, yielded complete data for 337 adults. FINDINGS: Adjusting for age and gender using multiple logistic regression analysis revealed that having self-reported disabilities was inversely and independently related to good self-rated health (OR 0.48 [95% CI, 0.26-0.88]). Joint pain also was related to self-rated health (OR 0.23 [95% CI, 0.13-0.41]). CONCLUSIONS: Increasing access to affordable, effective analgesics may reduce this disparity. Health agencies should consider these actions as possible planning priorities for the region.

Cervical dysplasia in Nigerian women infected with HIV.

OBJECTIVE: To determine the prevalence of and risk factors for cervical dysplasia in HIV-positive women receiving care at the Jos University Teaching Hospital in Nigeria. METHODS: A total of 369 HIV-positive women had cervical cytology performed; HIV-1 RNA viral load and CD4 counts were measured. RESULTS: Of 369 participants, cervical dysplasia was present in 107 (29.0%) women. However, cervical cytology was abnormal in 252 (68.3%). Among those with abnormal cytology, 145 (57.5%) women had ASCUS, 56 (22.2%) had LSIL, and 51 (20.2%) had HSIL. Median CD4 lymphocyte count was lower in women with dysplasia compared with those without (142 vs 170 cells/mm(3); P=0.04), while median HIV RNA viral load was higher in women with dysplasia (101781 vs 77479 copies/mL; P=0.002). Low CD4 count (<200 cells/mm(3)) and evidence of HPV infection were significantly associated with cervical dysplasia. CONCLUSION: A high prevalence of cervical dysplasia was found among HIV-positive Nigerian women, which was associated with increased immune suppression.