Outcomes of a multifaceted intervention to prevent eclampsia and eclampsia-related deaths in Nigerian referral facilities.

BACKGROUND: Eclampsia causes maternal mortality in Nigeria. This study presents the effectiveness of multifaceted interventions that addressed institutional barriers in reducing the incidence and case fatality rates associated with eclampsia. METHODS: The design was quasi-experimental and the activities implemented at intervention hospitals included a new strategic plan, retraining health providers on eclampsia management protocols, clinical reviews of delivery care and educating pregnant women and their partners. Prospective data were collected monthly on eclampsia and related indicators from study sites over 2 y. The results were analysed by univariate, bivariate and multivariable logistic regression. RESULTS: The results show a higher eclampsia rate (5.88% vs 2.45%) and a lower use of partograph and antenatal care (ANC; 17.99% vs 23.42%) in control compared with intervention hospitals, but similar case fatality rates of <1%. Overall, adjusted analysis shows a 63% decrease in the odds of eclampsia at intervention compared with control hospitals. Factors associated with eclampsia were ANC, referral for care from other facilities and older maternal age. CONCLUSION: We conclude that multifaceted interventions that address challenges associated with managing pre-eclampsia and eclampsia in health facilities can reduce eclampsia occurrence in referral facilities in Nigeria and potential eclampsia death in resource-poor African countries.

The effect of broadband access on electronic patient engagement activities: Assessment of urban-rural differences.

OBJECTIVES: Lack of access to high-speed internet may explain disparities in the use of technologies that support electronic patient engagement (EPE). This study describes trends in how people with and without fixed broadband connectivity in urban and rural communities used EPE tools to interact with health care providers between 2014 and 2018. METHODS: We linked Federal Communications Commission fixed broadband data with the Association of American Medical Colleges Consumer Survey of Health Care Access data for years 2014-2018 (n = 23,131). ZIP Codes with a 25Mbps download speed and 3Mbps upload speed were determined to have broadband connectivity access. We evaluated 6 activities involving the use of 4 EPE tools (email, text, website, chat, video, and mobile app) and the intensity of use (0 = none, 1-3 = low, 4-6 = high). Multivariate logistic and multinomial regression models were used to determine factors associated with EPE. RESULTS: More than half (57.1%) of those without broadband access lived in rural areas. Overall, the intensity in the use of EPE tools increased from 2014 to 2016, then declined steadily with higher increases in use observed in urban and suburban than in rural areas. Lack of broadband access was associated with increased odds of zero intensity versus low-intensity use of EPE tools in rural areas (OR = 1.72, 95% CI: 1.42-2.09). CONCLUSIONS: Inequality in broadband connectivity access may explain why rural communities lag in using various electronic tools for interacting with health care providers. Continued efforts to increase broadband connectivity in rural communities could improve their engagement with care providers.

Outcomes of a multifaceted intervention to improve maternal satisfaction with care in secondary hospitals in Nigeria.

Background: Data in Nigeria suggests a high level of dissatisfaction among women attending maternity care in health facilities due to long wait times, disrespectful care, and poor attention by healthcare personnel. Objective: To examine the effectiveness of a multifaceted intervention in improving self-reported indicators of maternal healthcare satisfaction by women who use referral facilities in two regions of Nigeria. Method: The design was quasi-experimental and consisted of two intervention facilities and two control facilities. The interventions included strategic planning, staff re-training, a computerized appointment system, health education/feedback, maternal death reviews and surveillance, and advocacy. A random sample of 2262 women was selected (1205 in the intervention sites and 1057 in the two control sites) to respond to a 24-item questionnaire on service satisfaction as they exited the health facilities. Adjusted Poisson and binary regression analyses were used to assess and compare proportions of reported satisfaction by women between the intervention and control sites. Results: Women in the intervention sites were 54% more likely than those in control sites to report overall satisfaction with services. They were significantly less likely to report inadequate security arrangements in accessing the health facilities (p < .1); and three times more likely to agree that health workers were extremely thorough and careful in attending to them (p < .1). Conclusion: The interventions had positive effects on improving women's satisfaction with care. The findings from this study have implications for the design and implementation of interventions that address women's concerns relating to the provision of care and consequently improve service utilization.

Occurrence of hemolytic reactions on the same day as immune globulin product administrations during 2008 to 2014.

BACKGROUND: Hemolytic reactions (HRs) are rare serious adverse events after immune globulin (IG) use. Our large claims-based study evaluated occurrence of same-day hemolysis after administration of different IG products and potential risk factors, during the 2008 to 2014 study period. STUDY DESIGN AND METHODS: We conducted a retrospective cohort study using a large commercial administrative database. The study included individuals exposed to IG products as identified by procedure codes. HRs were ascertained using ICD-9-CM diagnosis codes. Unadjusted same-day hemolysis rates (per 1000 persons) were estimated overall, by age, sex, and IG products. Multivariable regression analyses were used to evaluate potential risk factors. RESULTS: Of 20,440 persons exposed, 211 (10.3 per 1000) had same-day HRs. The median numbers of doses for IG users with versus without same-day hemolysis were one and six, respectively. The unadjusted product-specific HR rates ranged from 1.92 for subcutaneous product Hizentra to 17.99 for intravenous Octagam. The multivariable regression analyses showed significantly increased same-day HR risk in males and in IG users with histories of hemolysis, pneumonia, and hereditary hemolytic anemias. Compared to Gammagard Liquid, significantly elevated overall hemolysis risk was identified with Octagam (odds ratio, 2.36; 95% confidence interval, 1.04-5.35), using Firth's method to account for small sample size bias. CONCLUSION: The study showed variation in the same-day IG-related hemolysis by age, sex, and IG products administered. The results suggest importance of underlying health conditions, especially prior hemolysis, and first IG product dose. Differences in HR occurrence may also be explained by product manufacturing processes, indications, routes, and rates of administration, which warrant further investigation.

Occurrence of acute renal failure on the same day as immune globulin product administrations during 2008 to 2014.

BACKGROUND: Acute renal failure (ARF) is a rare serious adverse event after immune globulin (IG) use. Our large claims-based study evaluated occurrence of same-day ARF after administration of different IGs and ascertained potential risk factors, during the 2008 to 2014 study period. STUDY DESIGN AND METHODS: A retrospective cohort study was conducted using a large commercial administrative database. The cohort included individuals exposed to IG products as identified by procedure codes. ARF was ascertained using ICD-9-CM diagnoses. Unadjusted same-day ARF rates (per 1000 persons exposed) were estimated overall and by age, sex, and IG products. Regression analyses were conducted to control for confounding and assess potential risk factors. RESULTS: Of 20,440 persons exposed, 163 (7.97 per 1000) had a recorded same-day ARF. The unadjusted nonzero same-day ARF rates (per 1000) ranged from 1.92 (95% confidence interval [CI], 0.05-10.69) for Hizentra to 16.97 (95% CI, 11.36-24.37) for Privigen and differed by sex. In multivariate analyses, compared to Gammagard Liquid, no significantly elevated ARF risks were identified with any IGs. A significantly lower odds ratio was identified with Gamunex, 0.53 (95% CI, 0.30-0.93). Age 45 and over, prior renal impairment, hypertension, and other factors were associated with increased risk of same-day ARF. CONCLUSION: The study showed variation in the risk of IG-related ARF by age, sex, and IG products. The study results suggest the importance of recipient factors, such as older age and underlying health conditions. Variations in ARF occurrence may also be explained by product dosage, administration route and rate, and manufacturing processes, which warrant further evaluation.

Adoption of Gene Expression Profiling for Breast Cancer in US Oncology Practice for Women Younger Than 65 Years.

BACKGROUND: A number of practice guidelines incorporate the use of gene expression profiling (GEP) tests for early-stage, hormone receptor-positive, HER2-negative breast tumors. Few studies describe factors associated with GEP testing in US oncology practice. We assessed the relationship between clinical, demographic, and group-level socioeconomic variables and test use in women younger than 65 years. PATIENTS AND METHODS: Data from 5 state cancer registries were linked with insurance claims data and GEP test results. We assessed rates of testing and variables associated with test use in an incident cohort of 9,444 commercially insured women younger than 65 years, newly diagnosed with stage I or II hormone receptor-positive breast cancer from 2006 through 2012. RESULTS: Rates of testing for women with N0 disease increased from 20.4% in 2006 to 35.2% in 2011. Variables associated with higher rates of testing, beyond clinical factors such as nodal status (P<.001), included being diagnosed from 2008 through 2012 versus 2006 through 2007 (adjusted odds ratio [OR], 1.67; 95% CI, 1.47-1.90), having preexisting comorbidities (adjusted OR, 1.35; 95% CI, 1.14-1.59), and higher out-of-pocket pharmacy costs (adjusted OR, 1.66; 95% CI, 1.40-1.97). Women younger than 50 years were more likely to be tested if they had stage I versus stage II disease (P<.0001). CONCLUSIONS: In an insured population of women younger than 65 years, GEP testing increased after its inclusion in clinical practice guidelines and mounting evidence. Additional research is needed to better understand oncologists' decision not to order GEP testing for their patients who are otherwise eligible.

Population-based study of the effect of gene expression profiling on adjuvant chemotherapy use in breast cancer patients under the age of 65 years.

BACKGROUND: Gene expression profiling (GEP) testing can help to predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy for breast cancer (BC). However, no prior US studies have evaluated the relation between GEP testing and the use of adjuvant chemotherapy by women treated in a general oncology practice. METHODS: Eligible patients were women under the age 65 of years who were newly diagnosed with their first stage I or II, hormone receptor-positive BC between 2006 and 2011 (n = 9405). This retrospective study was conducted with a data set consisting of registry data, health claims data, and GEP testing results. The distribution of GEP test results was reported in terms of the risk of recurrence predicted, and logistic regression was used to assess the association of test results with chemotherapy use, with adjustments made for multiple patient characteristics. RESULTS: The proportions of tested women with low, intermediate, and high recurrence score results were 51%, 39%, and 10%, respectively. Among these women, 11%, 47%, and 88%, respectively, received adjuvant chemotherapy. There was a significant, positive linear relation of assay scores with chemotherapy use within the low and intermediate subgroups after adjustments for all other factors (adjusted odds ratios, 1.17 and 1.20, respectively). CONCLUSIONS: Adjuvant chemotherapy use after GEP testing is generally consistent with the recommended test interpretation for women with a high or low predicted risk of recurrence. Chemotherapy use in the intermediate-risk group increased with Recurrence Score values, and evidence from ongoing randomized trials may help to clarify whether this finding reflects optimal interpretation of GEP test results. These results demonstrate the principle that genomic testing, on the basis of research establishing its utility, can be applied appropriately in general practice in accordance with guideline recommendations.

Immune globulins and same-day thrombotic events as recorded in a large health care database during 2008 to 2012.

BACKGROUND: Thrombotic events (TEs) are rare and serious adverse events after administration of immune globulin (IG) products. Our study evaluated the occurrence of same-day TEs for different IG products and ascertained potential risk factors. STUDY DESIGN AND METHODS: This retrospective cohort study utilized HealthCore's Integrated Research Database (HIRD) to assess individuals exposed to IGs during 2008 to 2012. IG products were identified using recorded procedure codes and TEs were ascertained using ICD-9-CM diagnosis codes. The unadjusted same-day TE rates (per 1000 persons exposed) were estimated overall and by IG products, age, and sex. Multivariable logistic regression analyses were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for same-day TEs by IG products. RESULTS: Of 14,944 individuals exposed to IG products, 233 (15.6 per 1000 persons) had TE diagnosis code(s) recorded on the same-day as the IG exposure. Compared to Gammagard Liquid, Gammaplex (OR, 20.96; 95% CI, 2.45-179.33) and Vivaglobin (OR, 2.74; 95% CI, 1.19-6.32) users had a significantly increased same-day TE risk. Elevated, but nonsignificant TE risks were identified for Octagam, Gamunex, Privigen, and Lyophilized IG(s). An increased TE risk was also found with older age (≥45 years), prior TEs, and other health conditions. CONCLUSION: Our claims-based cohort study suggests a potentially elevated TE risk with different IG products and shows importance of recipient factors such as older age, previous TE, hypercoagulable state(s), and other health conditions. The results of this study suggest the need for continuous evaluation of procoagulant activity and manufacturing processes for IG products to further assure their safety.

Classification tree analysis of race-specific subgroups at risk for a central venous catheter-related bloodstream infection.

BACKGROUND: Studies of racial disparities in patient safety events often do not use race-specific risk adjustment and do not account for reciprocal covariate interactions. These limitations were addressed by using classification tree analysis separately for black patients and white patients to identify characteristics that segment patients who have increased risks for a venous catheter-related bloodstream infection. METHODS: A retrospective, cross-sectional analysis of 5,236,045 discharges from 103 Florida acute hospitals in 2005-2009 was conducted. Hospitals were rank ordered on the basis of the black/white Patient Safety Indicator (PSI) 7 rate ratio as follows: Group 1 (white rate higher), Group 2, (equivalent rates), Group 3, (black rate higher), and Group 4, (black rate highest). Predictor variables included 26 comorbidities (Elixhauser Comorbidity Index) and demographic characteristics. Four separate classification tree analyses were completed for each race/hospital group. RESULTS: Individual characteristics and groups of characteristics associated with increased PSI 7 risk differed for black and white patients. The average age for both races was different across the hospital groups (p < .01). Weight loss was the strongest single delineator and common to both races. The black subgroups with the highest PSI 7 risk were Medicare beneficiaries who were either < or = 25.5 years without hypertension or < or = 39.5 years without hypertension but with an emergency or trauma admission. The white subgroup with the highest PSI 7 risk consisted of patients < or = 45.5 years who had congestive heart failure but did not have either hypertension or weight loss. DISCUSSION: Identifying subgroups of patients at risk for a rare safety event such as PSI 7 should aid effective clinical decisions and efficient use of resources and help to guide patient safety interventions.

Diabetes complications and adverse health outcomes after coronary revascularization.

AIMS: To examine effects of diabetes complications on health outcomes following coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI), comparing outcomes for patients with diabetes complications to those without diabetes complications. METHODS: Retrospective analysis of discharge data for 61,566 patients with diabetes age 45 or older who had CABG or PCI in 2007 in United States community hospitals, using data from the Nationwide Inpatient Sample. Analysis included propensity score-adjusted logistic regression. RESULTS: Of all patients, 21.2% of the weighted sample had diabetes complications. Older patients, Blacks and Hispanics, and those with greater illness severity were more likely to have diabetes complications. Unadjusted rates of in-hospital mortality, postoperative stroke, and renal failure were higher for patients with diabetes complications (rate ratios 2.2, 1.8, and 9.8, respectively; all p<0.0001). In adjusted results, having diabetes complications was associated with higher odds of in-hospital mortality (odds ratio, OR 1.62, 95% confidence interval, CI 1.37-1.91) and renal failure (OR 3.03, CI 1.71-5.39). Compared to CABG, PCI was associated with extra risk of postoperative renal failure for those with diabetes complications. CONCLUSION: Among patients with diabetes having revascularization, those with diabetes complications have higher risks of in-hospital death and renal failure irrespective of having CABG or PCI.

Disparity in race-specific comorbidities associated with central venous catheter-related bloodstream infection (AHRQ-PSI7).

Studies of racial disparities in hospital-level patient safety outcomes typically apply a race-common approach to risk adjustment. Risk factors specific to a minority population may not be identified in a race-common analysis if they represent only a small percentage of total cases. This study identified patient comorbidities and characteristics associated with the likelihood of a venous catheter-related bloodstream infection (Agency for Healthcare Research and Quality Patient Safety Indicator 7 [PSI7]) separately for blacks and whites using race-specific logistic regression models. Hospitals were ranked by the racial disparity in PSI7 and segmented into 4 groups. The analysis identified both black- and white-specific risk factors associated with PSI7. Age showed race-specific reverse association, with younger blacks and older whites more likely to have a PSI7 event. These findings suggest the need for race-specific covariate adjustments in patient outcomes and provide a new context for examining racial disparities.

Underassessment of weight and weight management in patients with diabetes: one more reason in support of weight management advice.

AIMS: The purpose of this study was to determine whether underassessment of weight affects weight management behaviors of overweight and obese individuals with diabetes and to determine whether weight management advice from health care professionals modifies the effect of underassessment of weight. METHODS: Data (n=979) from the 2006 and 2008 National Health and Nutrition Examination Survey were analyzed. Multivariate logistic regression was used to identify factors associated with underassessment of weight, weight management behaviors, and receipt of weight management advice from health care professionals. RESULTS: Underassessment of weight was common (26%). Men, overweight persons, Blacks and Hispanics were more likely to underassess their weight. Those who underassessed their weight were 53% less likely to report weight management behaviors, odds ratio 0.47 (95% CI=0.31-0.73). Weight management advice increased weight management behaviors among individuals who underassessed their weight, 3.49 (95% CI=1.70-7.18). CONCLUSIONS: Underassessment of weight can negatively affect weight management behaviors of overweight and obese individuals with diabetes. Weight management advice from health care professionals is important, and can modify the effect of underassessment of weight on weight management behaviors in this high risk group.