Serious Illness Conversation-Evaluation Exercise: A Novel Assessment Tool for Residents Leading Serious Illness Conversations.

Background/Objectives: The serious illness conversation (SIC) is an evidence-based framework for conversations with patients about a serious illness diagnosis. The objective of our study was to develop and validate a novel tool, the SIC-evaluation exercise (SIC-Ex), to facilitate assessment of resident-led conversations with oncology patients. Design: We developed the SIC-Ex based on SIC and on the Royal College of Canada Medical Oncology milestones. Seven resident trainees and 10 evaluators were recruited. Each trainee conducted an SIC with a patient, which was videotaped. The evaluators watched the videos and evaluated each trainee by using the novel SIC-Ex and the reference Calgary-Cambridge guide (CCG) at months zero and three. We used Kane's validity framework to assess validity. Results: Intra-class correlation using average SIC-Ex scores showed a moderate level of inter-evaluator agreement (range 0.523-0.822). Most evaluators rated a particular resident similar to the group average, except for one to two evaluator outliers in each domain. Test-retest reliability showed a moderate level of consistency among SIC-Ex scores at months zero and three. Global rating at zero and three months showed fair to good/very good inter-evaluator correlation. Pearson correlation coefficients comparing total SIC-Ex and CCG scores were high for most evaluators. Self-scores by trainees did not correlate well with scores by evaluators. Conclusions: SIC-Ex is the first assessment tool that provides evidence for incorporating the SIG guide framework for evaluation of resident competence. SIC-Ex is conceptually related to, but more specific than, CCG in evaluating serious illness conversation skills.

Impact of early in-hospital medication review by clinical pharmacists on health services utilization.

BACKGROUND: Adverse drug events are a leading cause of emergency department visits and unplanned admissions, and prolong hospital stays. Medication review interventions aim to identify adverse drug events and optimize medication use. Previous evaluations of in-hospital medication reviews have focused on interventions at discharge, with an unclear effect on health outcomes. We assessed the effect of early in-hospital pharmacist-led medication review on the health outcomes of high-risk patients. METHODS: We used a quasi-randomized design to evaluate a quality improvement project in three hospitals in British Columbia, Canada. We incorporated a clinical decision rule into emergency department triage pathways, allowing nurses to identify patients at high-risk for adverse drug events. After randomly selecting the first eligible patient for participation, clinical pharmacists systematically allocated subsequent high-risk patients to medication review or usual care. Medication review included obtaining a best possible medication history and reviewing the patient's medications for appropriateness and adverse drug events. The primary outcome was the number of days spent in-hospital over 30 days, and was ascertained using administrative data. We used median and inverse propensity score weighted logistic regression modeling to determine the effect of pharmacist-led medication review on downstream health services use. RESULTS: Of 10,807 high-risk patients, 6,416 received early pharmacist-led medication review and 4,391 usual care. Their baseline characteristics were balanced. The median number of hospital days was reduced by 0.48 days (95% confidence intervals [CI] = 0.00 to 0.96; p = 0.058) in the medication review group compared to usual care, representing an 8% reduction in the median length of stay. Among patients under 80 years of age, the median number of hospital days was reduced by 0.60 days (95% CI = 0.06 to 1.17; p = 0.03), representing 11% reduction in the median length of stay. There was no significant effect on emergency department revisits, admissions, readmissions, or mortality. LIMITATIONS: We were limited by our inability to conduct a randomized controlled trial, but used quasi-random patient allocation methods and propensity score modeling to ensure balance between treatment groups, and administrative data to ensure blinded outcomes ascertainment. We were unable to account for alternate level of care days, and therefore, may have underestimated the treatment effect in frail elderly patients who are likely to remain in hospital while awaiting long-term care. CONCLUSIONS: Early pharmacist-led medication review was associated with reduced hospital-bed utilization compared to usual care among high-risk patients under 80 years of age, but not among those who were older. The results of our evaluation suggest that medication review by pharmacists in the emergency department may impact the length of hospital stay in select patient populations.

Orientation and transition programme component predictors of new graduate workplace integration.

AIM: To examine the relationships between selected components of new graduate nurse transition programmes and transition experiences. BACKGROUND: Transition support for new graduates is growing increasingly multifaceted; however, an investigation of the effectiveness of the constituent components of the transition process is lacking. METHODS: An online survey was disseminated to new graduates working in acute care settings and included questions related to new graduate transition programmes. The Casey Fink Graduate Nurse Experience Survey was used to quantify the transition experience. RESULTS: New graduate nurses who participated in a formal new graduate (NG) transition programme had significantly higher total transition scores than non-programme nurses. The orientation length and the average number of hours worked in a two week period were significant predictors of transition; the percentage of preceptored shifts was statistically insignificant. CONCLUSIONS: New graduate transition is enhanced with participation in a formal transition programme. Orientation should be at least four weeks in length, and new graduates should work at least 49 hours in a two week period. IMPLICATIONS FOR NURSING MANAGEMENT: Nurse managers are in key positions to advocate for new graduate nurse transition programmes with adequate resources to support a four week orientation phase and shift scheduling to ensure an adequate number of hours over two week periods to facilitate transition.

A model of environmental correlates of adolescent obesity in the United States.

PURPOSE: The purpose of this study was to test a conceptual model of proximal (home) and distal (neighborhood) environmental correlates of adolescent obesity. METHODS: This was a descriptive, cross-sectional study, using the 2007 National Survey of Children's Health, of 39,542 children aged 11-17 years. Structural equation modeling was used to test the fit of the model, identify direct and indirect effects of the proximal and distal environmental correlates, and determine reliabilities for latent constructs (Access to Physical Activity, Neighborhood Conditions, Social Capital Home Sedentary Behavior, and Physical Activity). RESULTS: The model fitted the data well (Root Mean Square Standard Error of Approximation: .038 (90% confidence interval .038-.039), Comparative Fit Index: .950, and Tucker-Lewis Index: .934). Access to Physical Activity, Social Capital, Home Sedentary Behavior, and Physical Activity had direct effects on obesity (-.026, p = .001; .061, p < .001; .110, p < .001; and -.119, p < .001, respectively). Neighborhood Condition had indirect effects on obesity through Access to Physical Activity, Social Capital, and Home Sedentary Behavior (-.001, p = .009; .032, p < .001; and .044, p < .001, respectively). Access to Physical Activity had indirect effects on obesity through Physical Activity, Social Capital, and Home Sedentary Behavior (-.013, p < .001; -.005, p < .001; and -.005, p = .003, respectively). Home Sedentary Behavior had indirect effect on obesity through Physical Activity (.052, p <.001). CONCLUSIONS: Results of this model fit to the U. S. population-based data suggest that interventions should target not only sedentary behavior and physical activity but also parent perceptions of safety, access to physical activity, and the neighborhood condition.

The importance of baseline viral load when assessing relative efficacy in treatment-naïve HBeAg-positive chronic hepatitis B: a systematic review and network meta-analysis.

BACKGROUND: To date no network meta-analysis (NMA) has accounted for baseline variations in viral load when assessing the relative efficacy of interventions for chronic hepatitis B (CHB). We undertook baseline-adjusted and unadjusted analyses using the same data to explore the impact of baseline viral load (BVL) on CHB treatment response. METHODS: We searched Embase, Medline, Medline in Process and the Cochrane CENTRAL databases for randomised clinical trials (RCTs) of monotherapy interventions at licensed doses for use in CHB. Search strategies comprised CHB disease and drug terms (a combination of controlled vocabulary and free text terms) and also a bespoke RCT filter.The NMA was undertaken in WinBUGs using fixed and random effects methods, using data obtained from a systematic review. Individual patient data (IPD) from an entecavir clinical trial were used to quantify the impact of different baseline characteristics (in particular undetectable viral load (UVL) at 1 year) on relative treatment effect. Study level mean baseline values from all identified studies were used. Results were generated for UVL and presented as relative risks (RRs) and 95% credible intervals (CrIs) using entecavir as reference treatment. RESULTS: Overall, for all eight relevant interventions we identified 3,000 abstracts. Following full text review a total of 35 (including the contents of six clinical study reports) met the inclusion critera; 19 were in hepatitis B e antigen (HBeAg)-positive patients and 14 of the 19 contained outcome information of relevance to the NMA.Entecavir and tenofovir studies had heterogeneous patient populations in terms of BVL (mean values 9.29 and 8.65 log10 copies/ml respectively). After adjusting UVL for BVL using an informative prior based on the IPD analysis, the difference between entecavir and tenofovir was not statistically significant (RR 1.27, 95% CrI 0.96 to 1.47-fixed effects). A similar conclusion was found in all sensitivity analyses. Adjusted tenofovir results were more consistent with observed clinical trial response rates. CONCLUSIONS: This study demonstrates the importance of adjusting for BVL when assessing the relative efficacy of CHB interventions in achieving UVL. This has implications for both clinical and economic decision making.

A network meta-analysis of the efficacy of belatacept, cyclosporine and tacrolimus for immunosuppression therapy in adult renal transplant recipients.

Belatacept is a first in-class co-stimulation blocker developed for primary maintenance immunosuppression following renal transplantation. The objective of this study was to estimate the efficacy of belatacept relative to tacrolimus and cyclosporine among adults receiving a single kidney transplant. A systematic review was conducted of randomized clinical trials (RCTs) published between January 1990 and December 2013 using EMBASE, MEDLINE, the Cochrane Central Register of Controlled Trials, and unpublished study reports from two belatacept RCTs. Bayesian network meta-analysis (NMA) methods were used to compare the efficacy measures, mortality, graft loss, acute rejection and glomerular filtration rate (GFR). Heterogeneity was quantified using statistical metrics and potential sources were evaluated using meta-regression and subgroup analysis. A total of 28 RCTs comparing tacrolimus with cyclosporine, and three comparing belatacept with cyclosporine, were identified. All three agents provided comparable graft and patient survival, despite a higher risk of acute rejection associated with belatacept and cyclosporine. Belatacept was associated with significant improvement in GFR versus cyclosporine. Compared with tacrolimus, this difference was clinically meaningful yet statistically non-significant. The probability of being the best treatment was highest for belatacept for graft survival (68%), patient survival (97%) and renal function (89%), and highest for tacrolimus for acute rejection (99%).Variability in donor, recipient, and trial characteristics was present in the included RCTs; however, minimal statistical heterogeneity was detected in the analysis of acute rejection, graft or patient survival, and none of the characteristics were found to be significantly associated with relative effect. Although the direction of effect of immunosuppressants on GFR was consistent across RCTs, precise estimation of its magnitude was limited by a small number of RCTs and heterogeneity in relative effect sizes. Clinicians often seek an alternative to CNIs due to their nephrotoxic effects. The results of this indirect comparison indicate that belatacept is an effective immunosuppressive agent in renal transplantation among adults.

The helpfulness and timing of transition program education.

The purpose of this study was to examine relationships between transition program education and new graduate nurse transition. Although new graduates preferred hands-on learning, the helpfulness of workshops was associated with better transition. New graduates, many of whom were from the Millennial Generation, liked a variety of educational modalities. Access to support was better for nurse graduates who received education delivered throughout the first year of transition.

Multiple treatment comparison meta-analyses: a step forward into complexity.

The use of meta-analysis has become increasingly useful for clinical and policy decision making. A recent development in meta-analysis, multiple treatment comparison (MTC) meta-analysis, provides inferences on the comparative effectiveness of interventions that may have never been directly evaluated in clinical trials. This new approach may be confusing for clinicians and methodologists and raises specific challenges relevant to certain areas of medicine. This article addresses the methodological concepts of MTC meta-analysis, including issues of heterogeneity, choice of model, and adequacy of sample sizes. We address domain-specific challenges relevant to disciplines of medicine, including baseline risks of patient populations. We conclude that MTC meta-analysis is a useful tool in the context of comparative effectiveness and requires further study, as its utility and transparency will likely predict its uptake by the research and clinical community.

Pharmacotherapies for chronic obstructive pulmonary disease: a multiple treatment comparison meta-analysis.

BACKGROUND: Most patients with moderate and severe chronic obstructive pulmonary disease (COPD) receive long-acting bronchodilators (LABA) for symptom control. It is, however, unclear if and what drug treatments should be added to LABAs to reduce exacerbations, which is an important goal of COPD management. Since current guidelines cannot make strong recommendations yet, our aim was to determine the relative efficacy of existing treatments and combinations to reduce the risk for COPD exacerbations. METHODS: We included randomized clinical trials (RCTs) evaluating long-acting ß(2) agonists (LABA), long-acting muscarinic antagonists (LAMA), inhaled glucocorticosterioids (ICS), and the phosphodiesterase-4 (PDE4) inhibitor roflumilast, and combinations of these interventions in moderate to severe COPD populations. Our primary outcome was the event rate of exacerbations. We conducted a random-effects Bayesian mixed-treatment comparison (MTC) and applied several sensitivity analyses. In particular, we confirmed our findings using a binomial MTC analysis examining whether a patient experienced at least one exacerbation event or not during the trial. We also used an additive assumption to calculate the combined effects of treatments that were not included in the systematic review. RESULTS: Twenty-six studies provided data on the total number of exacerbations and/or the mean annual rate of exacerbations among a combined 36,312 patients. There were a total of 10 treatment combinations in the MTC and 15 in the additive analysis. Compared with all other treatments, the combination of roflumilast plus LAMA exhibited the largest treatment effects, and had the highest probability (45%) of being the best first-line treatment. This was consistent whether applying the incidence rate analysis or the binomial analysis. When applying the additive assumption, most point estimates suggested that roflumilast may provide additional benefit by further reducing exacerbations. CONCLUSIONS: Using various meta-analytic approaches, our study demonstrates that depending on the choice of drug, combined treatments offer a therapeutic advantage.

Estimating the power of indirect comparisons: a simulation study.

BACKGROUND: Indirect comparisons are becoming increasingly popular for evaluating medical treatments that have not been compared head-to-head in randomized clinical trials (RCTs). While indirect methods have grown in popularity and acceptance, little is known about the fragility of confidence interval estimations and hypothesis testing relying on this method. METHODS: We present the findings of a simulation study that examined the fragility of indirect confidence interval estimation and hypothesis testing relying on the adjusted indirect method. FINDINGS: Our results suggest that, for the settings considered in this study, indirect confidence interval estimation suffers from under-coverage while indirect hypothesis testing suffers from low power in the presence of moderate to large between-study heterogeneity. In addition, the risk of overestimation is large when the indirect comparison of interest relies on just one trial for one of the two direct comparisons. INTERPRETATION: Indirect comparisons typically suffer from low power. The risk of imprecision is increased when comparisons are unbalanced.

Incorporating multiple interventions in meta-analysis: an evaluation of the mixed treatment comparison with the adjusted indirect comparison.

BACKGROUND: Comparing the effectiveness of interventions is now a requirement for regulatory approval in several countries. It also aids in clinical and public health decision-making. However, in the absence of head-to-head randomized trials (RCTs), determining the relative effectiveness of interventions is challenging. Several methodological options are now available. We aimed to determine the comparative validity of the adjusted indirect comparisons of RCTs with the mixed treatment comparison approach. METHODS: Using systematic searching, we identified all meta-analyses evaluating more than 3 interventions for a similar disease state with binary outcomes. We abstracted data on each clinical trial including population n and outcomes. We conducted fixed effects meta-analysis of each intervention versus mutual comparator and then applied the adjusted indirect comparison. We conducted a mixed treatment meta-analysis on all trials and compared the point estimates and 95% confidence/credible intervals (CIs/CrIs) to determine important differences. RESULTS: We included data from 7 reviews that met our inclusion criteria, allowing a total of 51 comparisons. According to the a priori consistency rule, we found 2 examples where the analytic comparisons were statistically significant using the mixed treatment comparison over the adjusted indirect comparisons and 1 example where this was vice versa. We found 6 examples where the direction of effect differed according to the indirect comparison method chosen and we found 9 examples where the confidence intervals were importantly different between approaches. CONCLUSION: In most analyses, the adjusted indirect comparison yields estimates of relative effectiveness equal to the mixed treatment comparison. In less complex indirect comparisons, where all studies share a mutual comparator, both approaches yield similar benefits. As comparisons become more complex, the mixed treatment comparison may be favoured.