A path analysis of the effects of the doctor-patient encounter and expectancy in an open-label randomized trial of spinal manipulation for the care of low back pain

BACKGROUND: The doctor-patient encounter (DPE) and associated patient expectations are potential confounders in open-label randomized trials of treatment efficacy. It is therefore important to evaluate the effects of the DPE on study outcomes. METHODS: Four hundred participants with chronic low back pain (LBP) were randomized to four dose groups: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for six weeks. They received light massage control at visits when manipulation was not scheduled. Treating chiropractors were instructed to have equal enthusiasm for both interventions. A path analysis was conducted to determine the effects of dose, patient expectations of treatment success, and DPE on LBP intensity (100-point scale) at the end of care (6 weeks) and primary endpoint (12 weeks). Direct, indirect, and total standardized effects (β(total)) were computed. Expectations and DPE were evaluated on Likert scales. The DPE was assessed as patient-rated perception of chiropractor enthusiasm, confidence, comfort with care, and time spent. RESULTS: The DPE was successfully balanced across groups, as were baseline expectations. The principal finding was that the magnitude of the effects of DPE on LBP at 6 and 12 weeks (|β|(total) = 0.22 and 0.15, p < .05) were comparable to the effects of dose of manipulation at those times (|β|(total) = 0.11 and 0.12, p < .05). In addition, baseline expectations had no notable effect on follow-up LBP. Subsequent expectations were affected by LBP, DPE, and dose (p < .05). CONCLUSIONS: The DPE can have a relatively important effect on outcomes in open-label randomized trials of treatment efficacy. Therefore, attempts should be made to balance the DPE across treatment groups and report degree of success in study publications. We balanced the DPE across groups with minimal training of treatment providers. TRIAL REGISTRATION: ClinicalTrials.gov NCT0037635

Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021

BACKGROUND: The efficacy of messenger RNA (mRNA)-1273 against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is not well defined, particularly among young adults. METHODS: Adults aged 18-29 years with no known history of SARS-CoV-2 infection or prior vaccination for coronavirus disease 2019 (COVID-19) were recruited from 44 US sites from 24 March to 13 September 2021 and randomized 1:1 to immediate vaccination (receipt of 2 doses of mRNA-1273 vaccine at months 0 and 1) or the standard of care (receipt of COVID-19 vaccine). Randomized participants were followed up for SARS-CoV-2 infection measured by nasal swab testing and symptomatic COVID-19 measured by nasal swab testing plus symptom assessment and assessed for the primary efficacy outcome. A vaccine-declined observational group was also recruited from 16 June to 8 November 2021 and followed up for SARS-CoV-2 infection as specified for the randomized participants. RESULTS: The study enrolled 1149 in the randomized arms and 311 in the vaccine-declined group and collected >122 000 nasal swab samples. Based on randomized participants, the efficacy of 2 doses of mRNA-1273 vaccine against SARS-CoV-2 infection was 52.6% (95% confidence interval, -14.1% to 80.3%), with the majority of infections due to the Delta variant. Vaccine efficacy against symptomatic COVID-19 was 71.0% (95% confidence interval, -9.5% to 92.3%). Precision was limited owing to curtailed study enrollment and off-study vaccination censoring. The incidence of SARS-CoV-2 infection in the vaccine-declined group was 1.8 times higher than in the standard-of-care group. CONCLUSIONS: mRNA-1273 vaccination reduced the incidence of SARS-CoV-2 infection from March to September 2021, but vaccination was only one factor influencing risk. CLINICAL TRIALS REGISTRATION: NCT04811664

Linking Workplace Aggression to Employee Well-Being and Work: The Moderating Role of Family-Supportive Supervisor Behaviors (FSSB)

Purpose: The present study examined the moderating effects of family-supportive supervisor behaviors (FSSB) on the relationship between two types of workplace aggression (i.e., patient-initiated physical aggression and coworker-initiated psychological aggression) and employee well-being and work outcomes. Methodology: Data were obtained from a field sample of 417 healthcare workers in two psychiatric hospitals. Hypotheses were tested using moderated multiple regression analyses. Findings: Psychiatric care providers’ perceptions of FSSB moderated the relationship between patient-initiated physical aggression and physical symptoms, exhaustion and cynicism. In addition, FSSB moderated the relationship between coworker-initiated psychological aggression and physical symptoms and turnover intentions. Implications: Based on our findings, family-supportive supervision is a plausible boundary condition for the relationship between workplace aggression and well-being and work outcomes. This study suggests that, in addition to directly addressing aggression prevention and reduction, family-supportive supervision is a trainable resource that healthcare organizations should facilitate to improve employee work and well-being in settings with high workplace aggression. Originality: This is the first study to examine the role of FSSB in influencing the relationship between two forms of workplace aggression: patient-initiated physical and coworker-initiated psychological aggression and employee outcomes

Patterns of Hospital Bypass and Interhospital Transfer Among Patients With Heart Failure.

BACKGROUND: We describe how patient characteristics influence hospital bypass, interhospital transfer, and in-hospital mortality in patients with heart failure in Washington. Rural patients with heart failure may bypass their nearest hospital or be transferred for appropriate therapies. The frequency, determinants, and outcomes of these practices remain uncharacterized. METHODS AND RESULTS: Mean excess travel times based on hospital and patient residence ZIP codes were calculated using published methods. Hospitals and servicing areas were coded based on bed size and ZIP code, respectively. Transfer patterns were analyzed using bootstrap inference for clusters. Analysis of mortality and transfer-associated factors was performed using logistic regression with generalized estimating equations. There were 48,163 patients, representing 1106 instances of transfer, studied. The mean excess travel time increased 7.14 minutes per decrease in population density (metropolitan, micropolitan, small town, rural; P \u3c .0001). The rural mean excess travel time was greatest at 28.56 minutes. Transfer likelihood increased with younger age, male gender, admitting hospital rurality, higher Charlson Comorbidity Index, and stroke. Transfer was less likely among women (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.72-0.94) and patients over 70 years old (OR, 0.15-0.46; 95% CI, 0.10-0.65). Adjusting for comorbidities and transfer propensity, transfer exhibited a stronger association with mortality than any other measured patient risk factor (OR, 2.15; 95% CI, 1.69-2.73), excluding stroke (OR, 7.09; 95% CI, 4.99-10.06). CONCLUSIONS: Rural hospital bypass is prevalent among patients with heart failure, although its clinical significance is unclear. Female and older patients were found to have a lesser likelihood of transfer adjusted for other factors. Interhospital transfer is associated with increased mortality when adjusted for comorbidities

Pregnancy-associated plasma protein-A is a stronger predictor for adverse cardiovascular outcomes after acute coronary syndrome in type-2 diabetes mellitus

Abstract Background The risk prediction of pregnancy-associated plasma protein-A (PAPP-A) for future cardiovascular (CV) events post acute coronary syndrome (ACS) in patients with type-2 diabetes mellitus (T2DM) was investigated in comparison to other risk factors. Methods PAPP-A was measured at hospital admission in 320 consecutive ACS patients (136 with T2DM and 184 without). All patients were followed for 2 years for occurrence of CV death, non-fatal MI or stroke. Effect of PAPP-A on the CV event risk was estimated using Cox regression models. Receiver operating characteristics (ROC) curves were generated to demonstrate the sensitivity and specificity of PAPP-A in predicting CV events. Results ACS patients with T2DM had higher PAPP-A (19.29 ± 16.36 vs. 13.29 ± 13.90 ng/ml, p < 0.001) and higher rate of CV events 2 years post ACS (27.2 vs. 13.6%, p = 0.002) than those without. Higher levels of PAPP-A were significantly associated with increased risk of CV events during 2-year follow-up [HR = 2.97 for 1 SD increase in log10(PAPP-A), 95% CI 2.11–4.18, p < 0.001] in T2DM and (HR = 3.16, 95% CI 2.27–4.39, p < 0.001) in non-T2DM. Among patients with T2DM, PAPP-A showed a larger area under the curve (AUC 0.79) that was significantly more predictive than hsCRP (AUC 0.64), eGFR (AUC 0.66) and LVEF < 50% (AUC 0.52); predictive ability did not improve significantly by including those factors into the model. Conclusions Patients with T2DM had higher levels of PAPP-A and increased risk of CV events. Elevated PAPP-A compared to other risk factors was a stronger predictor for future CV events 2 years post ACS in patients with T2DM. Trial registration ISRCTN10805074. Registered on 20 January 2017, retrospectively registered

Distribution of evaluated cytochrome P-450 (CYP) metabolic phenotypes between the Home Health Trial and another published study population [16].

<p>Distribution of evaluated cytochrome P-450 (CYP) metabolic phenotypes between the Home Health Trial and another published study population [<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0170905#pone.0170905.ref001" target="_blank">1</a><a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0170905#pone.0170905.ref006" target="_blank">6</a>].</p

Influenza Pneumonia Surveillance among Hospitalized Adults May Underestimate the Burden of Severe Influenza Disease

<div><p>Background</p><p>Studies seeking to estimate the burden of influenza among hospitalized adults often use case definitions that require presence of pneumonia. The goal of this study was to assess the extent to which restricting influenza testing to adults hospitalized with pneumonia could underestimate the total burden of hospitalized influenza disease.</p><p>Methods</p><p>We conducted a modelling study using the complete State Inpatient Databases from Arizona, California, and Washington and regional influenza surveillance data acquired from CDC from January 2003 through March 2009. The exposures of interest were positive laboratory tests for influenza A (H1N1), influenza A (H3N2), and influenza B from two contiguous US Federal Regions encompassing the study area. We identified the two outcomes of interest by ICD-9-CM code: respiratory and circulatory hospitalizations, as well as critical illness hospitalizations (acute respiratory failure, severe sepsis, and in-hospital death). We linked the hospitalization datasets with the virus surveillance datasets by geographic region and month of hospitalization. We used negative binomial regression models to estimate the number of influenza-associated events for the outcomes of interest. We sub-categorized these events to include all outcomes with or without pneumonia diagnosis codes.</p><p>Results</p><p>We estimated that there were 80,834 (95% CI 29,214–174,033) influenza-associated respiratory and circulatory hospitalizations and 26,760 (95% CI 14,541–47,464) influenza-associated critical illness hospitalizations. When a pneumonia diagnosis was excluded, the estimated number of influenza-associated respiratory and circulatory hospitalizations was 24,816 (95% CI 6,342–92,624). The estimated number of influenza-associated critical illness hospitalizations was 8,213 (95% CI 3,764–20,799). Around 30% of both influenza-associated respiratory and circulatory hospitalizations, as well as influenza-associated critical illness hospitalizations did not have pneumonia diagnosis codes.</p><p>Conclusions</p><p>Surveillance studies which only consider hospitalizations that include a diagnosis of pneumonia may underestimate the total burden of influenza hospitalizations.</p></div