Methodology Issues in Implementation Science

Background: Putting evidence into practice at the point of care delivery requires an understanding of implementation strategies that work, in what context and how. Objective: To identify methodological issues in implementation science using 4 studies as cases and make recommendations for further methods development. Research Design: Four cases are presented and methodological issues identified. For each issue raised, evidence on the state of the science is described. Results: Issues in implementation science identified include diverse conceptual frameworks, potential weaknesses in pragmatic study designs, and the paucity of standard concepts and measurement. Conclusions: Recommendations to advance methods in implementation include developing a core set of implementation concepts and metrics, generating standards for implementation methods including pragmatic trials, mixed methods designs, complex interventions and measurement, and endorsing reporting standards for implementation studies

Errors and discrepancies in the administration of intravenous infusions: a mixed methods multihospital observational study

Introduction Intravenous medication administration has traditionally been regarded as error prone, with high potential for harm. A recent US multisite study revealed few potentially harmful errors despite a high overall error rate. However, there is limited evidence about infusion practices in England and how they relate to prevalence and types of error. Objectives To determine the prevalence, types and severity of errors and discrepancies in infusion administration in English hospitals, and to explore sources of variation, including the contribution of smart pumps. Methods We conducted an observational point prevalence study of intravenous infusions in 16 National Health Service hospital trusts. Observers compared each infusion against the medication order and local policy. Deviations were classified as errors or discrepancies based on their potential for patient harm. Contextual issues and reasons for deviations were explored qualitatively during observer debriefs. Results Data were collected from 1326 patients and 2008 infusions. Errors were observed in 231 infusions (11.5%, 95% CI 10.2% to 13.0%). Discrepancies were observed in 1065 infusions (53.0%, 95% CI 50.8% to 55.2%). Twenty-three errors (1.1% of all infusions) were considered potentially harmful; none were judged likely to prolong hospital stay or result in long-term harm. Types and prevalence of errors and discrepancies varied widely among trusts, as did local policies. Deviations from medication orders and local policies were sometimes made for efficiency or patient need. Smart pumps, as currently implemented, had little effect, with similar error rates observed in infusions delivered with and without a smart pump (10.3% vs 10.8%, p=0.8). Conclusion Errors and discrepancies are relatively common in everyday infusion administrations but most have low potential for patient harm. Better understanding of performance variability to strategically manage risk may be a more helpful tactic than striving to eliminate all deviations

Understanding physicians’ behavior toward alerts about nephrotoxic medications in outpatients: a cross-sectional analysis

Background: Although most outpatients are relatively healthy, many have chronic renal insufficiency, and high override rates for suggestions on renal dosing have been observed. To better understand the override of renal dosing alerts in an outpatient setting, we conducted a study to evaluate which patients were more frequently prescribed contraindicated medications, to assess providers’ responses to suggestions, and to examine the drugs involved and the reasons for overrides. Methods: We obtained data on renal alert overrides and the coded reasons for overrides cited by providers at the time of prescription from outpatient clinics and ambulatory hospital-based practices at a large academic health care center over a period of 3 years, from January 2009 to December 2011. For detailed chart review, a group of 6 trained clinicians developed the appropriateness criteria with excellent inter-rater reliability (κ = 0.93). We stratified providers by override frequency and then drew samples from the high- and low-frequency groups. We measured the rate of total overrides, rate of appropriate overrides, medications overridden, and the reason(s) for override. Results: A total of 4120 renal alerts were triggered by 584 prescribers in the study period, among which 78.2% (3,221) were overridden. Almost half of the alerts were triggered by 40 providers and one-third was triggered by high-frequency overriders. The appropriateness rates were fairly similar, at 28.4% and 31.6% for high- and low-frequency overriders, respectively. Metformin, glyburide, hydrochlorothiazide, and nitrofurantoin were the most common drugs overridden. Physicians’ appropriateness rates were higher than the rates for nurse practitioners (32.9% vs. 22.1%). Physicians with low frequency override rates had higher levels of appropriateness for metformin than the high frequency overriders (P = 0.005). Conclusion: A small number of providers accounted for a large fraction of overrides, as was the case with a small number of drugs. These data suggest that a focused intervention targeting primarily these providers and medications has the potential to improve medication safety

Implementation, evaluation, and recommendations for extension of AHRQ Common Formats to capture patient- and carepartner-generated safety data

Abstract Objectives The Common Formats, published by the Agency for Healthcare Research and Quality, represent a standard for safety event reporting used by Patient Safety Organizations (PSOs). We evaluated its ability to capture patient-reported safety events. Materials and methods We formally evaluated gaps between the Common Formats and a safety concern reporting system for use by patients and their carepartners (ie friends/families) at Brigham and Women’s Hospital. Results Overall, we found large gaps between Common Formats (versions 1.2, 2.0) and our patient/carepartner reporting system, with only 22–30% of the data elements matching. Discussion We recommend extensions to the Common Formats, including concepts that capture greater detail about the submitter and safety categories relevant to unsafe conditions and near misses that patients and carepartners routinely observe. Conclusion Extensions to the Common Formats could enable more complete safety data sets and greater understanding of safety from key stakeholder perspectives, especially patients, and carepartners. </jats:sec

Preventive chemotherapy reverses covert, lymphatic associated tissue change in young people with lymphatic filariasis in Myanmar

Objectives This longitudinal comparative study investigated the effect of preventive chemotherapy (PC) on covert tissue changes associated with lymphatic filariasis (LF) among young people living in an LF-endemic area in Myanmar. Methods Tissue compressibility and extracellular free fluid in the lower limbs of people aged 10– 21 years were measured using indurometry and bioimpedance spectroscopy (BIS). Baseline measures were taken in October 2014, annual mass drug administration (MDA) of PC was delivered in December, and in March 2015 further PC was offered to LF-positive cases who had missed MDA. Follow-up measures were taken in February and June 2015. Results A total of 50 antigen‐positive cases and 46 antigen‐negative controls were included. Self‐reported PC consumption was 60.1% during 2014 MDA and 66.2% overall. At second follow‐up, 24 of 34 cases and 27 of 43 controls had consumed PC. Significant and clinically relevant between‐group differences at baseline were not found post‐PC. Bayesian linear mixed models showed a significant change in indurometer scores at both calves for antigen‐positive cases who consumed any PC (dominant calf: −0.30 [95% CI −0.52, −0.07], P < 0.05 and non‐dominant calf: −0.35 [95% CI −0.58, −0.12], P < 0.01). Changes in antigen‐negative participants or those not consuming PC were not significant. Conclusion This study is the first attempt to use simple field‐friendly tools to track fluid and tissue changes after treatment of asymptomatic people infected with LF. Results suggested that PC alone is sufficient to reverse covert lymphatic disturbance. Longer follow‐up of larger cohorts is required to confirm these improvements and whether they persist over time. These findings should prompt increased efforts to overcome low PC coverage, which misses many infected young people, particularly males, who are unaware of their infection status, unmotivated to take PC and at risk of developing lymphoedema. Indurometry and BIS should be considered in assessment of lymphatic filariasis‐related lymphedema

Optimizing Retention in a Pragmatic Trial of Community‐Living Older Persons: The STRIDE Study

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/155912/1/jgs16356.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/155912/2/jgs16356_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/155912/3/jgs16356-sup-0001-supinfo.pd

High Viral Fitness during Acute HIV-1 Infection

Several clinical studies have shown that, relative to disease progression, HIV-1 isolates that are less fit are also less pathogenic. The aim of the present study was to investigate the relationship between viral fitness and control of viral load (VL) in acute and early HIV-1 infection. Samples were obtained from subjects participating in two clinical studies. In the PULSE study, antiretroviral therapy (ART) was initiated before, or no later than six months following seroconversion. Subjects then underwent multiple structured treatment interruptions (STIs). The PHAEDRA study enrolled and monitored a cohort of individuals with documented evidence of primary infection. The subset chosen were individuals identified no later than 12 months following seroconversion to HIV-1, who were not receiving ART. The relative fitness of primary isolates obtained from study participants was investigated ex vivo. Viral DNA production was quantified using a novel real time PCR assay. Following intermittent ART, the fitness of isolates obtained from 5 of 6 PULSE subjects decreased over time. In contrast, in the absence of ART the fitness of paired isolates obtained from 7 of 9 PHAEDRA subjects increased over time. However, viral fitness did not correlate with plasma VL. Most unexpected was the high relative fitness of isolates obtained at Baseline from PULSE subjects, before initiating ART. It is widely thought that the fitness of strains present during the acute phase is low relative to strains present during chronic HIV-1 infection, due to the bottleneck imposed upon transmission. The results of this study provide evidence that the relative fitness of strains present during acute HIV-1 infection may be higher than previously thought. Furthermore, that viral fitness may represent an important clinical parameter to be considered when deciding whether to initiate ART during early HIV-1 infection