Objectives: To describe a new, rigorous, comprehensive practicebased evidence for clinical practice improvement (PBE-CPI) study methodology, and compare its features, advantages, and disadvantages to ...those of randomized controlled trials and sophisticated statistical methods for comparative effectiveness research. Research Design: PBE-CPI incorporates natural variation within data from routine clinical practice to determine what works, for whom, when, and at what cost. It uses the knowledge of front-line caregivers, who develop study questions and define variables as part of a transdisciplinary team. Its comprehensive measurement framework provides a basis for analyses of significant bivariate and multivariate associations between treatments and outcomes, controlling for patient differences, such as severity of illness. Results: PBE-CPI studies can uncover better practices more quickly than randomized controlled trials or sophisticated statistical methods, while achieving many of the same advantages. We present examples of actionable findings from PBE-CPI studies in postacute care settings related to comparative effectiveness of medications, nutritional support approaches, incontinence products, physical therapy activities, and other services. Conclusions: Outcomes improved when practices associated with better outcomes in PBE-CPI analyses were adopted in practice.
Sound rigorous methods are needed by researchers and providers to address practical questions about risks, benefits, and costs of interventions as they occur in routine clinical practice such as: Are ...treatments used in daily practice associated with intended outcomes? For whom does an intervention work best? With limited clinical resources, what are the best interventions to use for specific types of patients? Answers to such questions can help clinicians, patients, researchers, and health care administrators learn from, and improve, real-world everyday clinical practice. In this article, we describe existing research designs to demonstrate clinical usefulness and comparative effectiveness of rehabilitation treatments. We compare randomized controlled trials and observational cohort studies of various types, including those that use instrumental variables or propensity scores to control for potential patient or treatment selection effects. We argue that practice-based evidence (PBE) study designs include features that address limitations inherent in both randomized trials and traditional observational studies, and also reduce the need for instrumental variables and propensity scores methods. We give examples of how PBE designs have been used in various rehabilitation areas to determine better treatments for specific types of patients.
To explore the patterns of cognitive and motor recovery at 4 time points from admission to 9 months after discharge from inpatient rehabilitation (IR) and to investigate the association of ...therapeutic factors and conditions before and after discharge with long-term outcomes.
Secondary analysis of traumatic brain injury (TBI) and practice-based evidence dataset.
IR in Ontario, Canada.
Patients with TBI consecutively admitted for IR between 2008 and 2011 who had data available from admission to 9 months after discharge (N=85).
Not applicable.
FIM-Rasch cognitive and motor scores at admission, discharge, 3 months after discharge, and 9 months after discharge.
Cognitive and motor recovery showed similar patterns of improvement with recovery up to 3 months but no significant change from 3 to 9 months. Having fewer postdischarge health conditions was associated with better long-term cognitive scores (95% confidence interval, -13.06 to -1.2) and added 9.9% to the explanatory power of the model. More therapy time in complex occupational therapy activities (95% confidence interval, .02 to .09) and fewer postdischarge health conditions (95% confidence interval, -19.5 to -3.8) were significant predictors of better long-term motor function and added 14.3% and 7.2% to the explanatory power of the model, respectively.
Results of this study inform health care providers about the influence of the timing of IR on cognitive and motor recovery. In addition, it underlines the importance of making patients and families aware of residual health conditions following discharge from IR.
To determine rates of rehospitalization among discharged rehabilitation patients with traumatic spinal cord injury (SCI) in the first 12 months postinjury, and to identify factors associated with ...rehospitalization.
Prospective observational cohort study.
Six geographically dispersed rehabilitation centers in the U.S.
Consecutively enrolled individuals with new traumatic SCI (N=951), who were discharged from participating rehabilitation centers and participated in a 1-year follow-up survey.
Not applicable.
Occurrence of postrehabilitation rehospitalization within 1 year of injury, length of rehospitalization stays, and causes of rehospitalizations.
More than one third (36.2%) of participants were rehospitalized at least once in the 12-month follow-up period; 12.5% were rehospitalized at least twice. The average number of rehospitalizations among those rehospitalized at least once was 1.37 times, with an average length of stay (LOS) of 15.5 days across all rehospitalization episodes. The 3 most common health conditions associated with rehospitalization were those related to the genitourinary system (eg, urinary tract infection), respiratory system (eg, pneumonia), and skin and subcutaneous tissue (eg, pressure ulcer). Being a woman (95% confidence interval CI, 1.034-2.279), having Medicaid as the main payer (95% CI, 1.303-2.936), and more severe case mix were associated with increased odds of rehospitalization. Those who had more intensive physical therapy (95% CI, .960-.981) had lower odds of rehospitalization. Some center-to-center variation in rehospitalization rates remained unexplained after case mix and practice differences were considered. The 6 SCI rehabilitation centers varied nearly 2-fold in rates at which their former SCI patients were rehospitalized--from 27.8% to 50%. Center-to-center variation diminished when patient case mix was considered.
Compared with earlier studies, rehospitalization rates among individuals with SCI in the first postinjury year remain high and vary by level and completeness of injury. Rehospitalization risk was associated with younger age, being a woman, unemployment and retirement, and Medicaid coverage. Those who had more intensive physical therapy had lower odds of rehospitalization. Future studies should examine center-to-center variations in rehospitalization rates and availability of patient education and community resources.
Background: Comparative effectiveness research analyzes groups of patients and looks for associations between medical treatments and patient outcomes. To make meaningful comparisons of medical ...interventions, one must consider clinical heterogeneity of patient populations, intervention combinations, and outcomes. Objectives: To explain how practice-based evidence (PBE) study methodology measures and controls for heterogeneity of patients, treatments, and outcomes seen in real-world clinical settings. Research Design: Overview of PBE methodology. Conclusions: PBE study designs address comparative effectiveness by creating a comprehensive set of patient, treatment, and outcome variables, and analyzing them to identify treatments associated with better outcomes for specific types of patients. PBE studies are an alternative to randomized controlled trials, well suited to determine what works best for specific patient types, and provide clinicians with a rational basis for treatment recommendations for individual patients. They provide a holistic picture of patients, treatments, and outcomes, with no preset limits to the number of variables that can be included. Such an approach is needed for high quality comparative effectiveness research.
The hepatitis C virus (HCV) is a single-strand RNA virus that infects millions of people worldwide. Recent advances in therapy have led to viral cure using two- and three- drug combinations of direct ...acting inhibitors of viral replication. CCR5 is a chemokine receptor that is expressed on hepatocytes and represents a key co-receptor for HIV. We evaluated the effect of CCR5 blockade or knockdown on HCV replication in Huh7.5JFH1 cells.
Cells were exposed to varying concentrations of maraviroc (CCR5 inhibitor), cenicriviroc (CCR2/CCR5 inhibitor), sofosbuvir (nucleotide polymerase inhibitor), or raltegravir (HIV integrase inhibitor).
HCV RNA was detected utilizing two qualitative strand-specific RT-PCR assays. HCV core antigen and NS3 protein was quantified in the supernatant and cell lysate, respectively. siRNA was utilized to knockdown CCR5 gene expression in hepatocytes. Alternatively, anti-CCR5 antibodies were employed to block the receptor. Supernatant levels of HCV RNA (expressed as fold change) were not reduced in the presence of raltegravir but were reduced 8.55-fold and 12.42-fold with cenicriviroc and maraviroc, respectively. Sofosbuvir resulted in a 16.20-fold change in HCV RNA levels. HCV core and NS3 protein production was also reduced in a dose-dependent manner. Two distinct anti-CCR5 antibodies also resulted in a significant reduction in HCV protein expression, as did siRNA knockdown of CCR5 gene expression.
These data provide evidence that CCR5 modulation could have a significant effect on HCV replication in an in vitro system. Further evaluation of the role of CCR5 inhibition in clinical settings may be warranted.
Aim
To establish a patient‐centered research agenda for cerebral palsy (CP).
Method
We engaged a large cross‐section of the extended community of people living with CP and those providing healthcare ...to people with CP (‘the community’) in an educational series and collaborative survey platform to establish an initial list of prioritized research ideas. After online workshops, a facilitated Delphi process was used to select the 20 highest priorities. Select participants attended an in‐person workshop to provide comment and work toward consensus of research priorities.
Results
A research agenda for CP was developed by the community, which included consumers, clinicians, and researchers interested in advancing the established research agenda. The results included the top 16 research concepts produced by the process to shape and steward the research agenda, and an engaged cross‐section of the community.
Interpretation
It has been shown that proactively engaging consumers with clinical researchers may provide more meaningful research for the community. This study suggests that future research should have more focus on interventions and outcomes across the lifespan with increased emphasis on the following outcome measures: function, quality of life, and participation.
What this paper adds
A patient‐centered research agenda for cerebral palsy was established.
Comparative effectiveness of interventions, physical activity, and understanding ageing were leading themes.
Longitudinal studies across the lifespan, clinical spectrum, and ages were highly ranked.
Participants reported high value for participation outcomes.
Participants reported great appreciation for the engagement between consumers and clinician researchers.
Resumen
Establecer una agenda de investigación centrada en el paciente para la parálisis cerebral: una iniciativa de investigación de acción participativa
Objetivo
Establecer una agenda de investigación centrada en el paciente para la parálisis cerebral (PC).
Método
Incluimos a una gran muestra de la comunidad extendida de personas que viven con PC y aquellos que brindan atención médica a personas con PC (‘la comunidad’) en una serie educativa y plataforma de encuesta colaborativa para establecer una lista inicial de ideas de investigación priorizadas. Después de los talleres en línea, se utilizó un proceso Delphi facilitado para seleccionar las 20 prioridades más relevantes. Se seleccionaron participantes que asistieron a un taller en persona para proporcionar comentarios y trabajar hacia el consenso de prioridades de investigación.
Resultados
Una agenda de investigación para PC fue desarrollada por la comunidad, que incluyó consumidores, clínicos e investigadores interesados en avanzar en la agenda de investigación establecida. Los resultados incluyeron los 16 conceptos de investigación principales identificados por el proceso para configurar y administrar la agenda de investigación, y una sección transversal comprometida de la comunidad.
Interpretación
Se ha demostrado que involucrar de forma proactiva a los consumidores con investigadores clínicos puede proporcionar una investigación más significativa para la comunidad. Este estudio sugiere que la investigación futura debería tener más enfoque en las intervenciones y los resultados a lo largo de la vida con un mayor énfasis en las siguientes medidas de resultado: función, calidad de vida y participación.
Estabelecendo uma agenda de pesquisa centrada no paciente para paralisia cerebral: uma iniciativa de pesquisa participatória
Objetivo
Estabelecer uma agenda de pesquisa centrada no paciente para paralisia cerebral (PC).
Método
Engajamos uma grande amostra da comunidade extendida de pessoas com PC e aqueles que oferecem serviços de saúde para pessoas com PC (“a comunidade”) em uma série educacional e plataforma de questionário colaborativo para estabelecer uma lista inicial para idéias prioritárias para pesquisas. Após workshops virtuais, um processo Delphi facilitado foi usado para selecionar as 20 prioridades mais altas. Participantes selecionados participaram de um workshop presencial para comentar e trabalhar em um consenso de prioridades para pesquisa.
Resultados
Uma agenda de pesquisas para PC foi desenvolvida pela comunidade, que incluiu consumidores, clínicos, e pesquisadores interessados em avançar a agenda de pesquisa estabelecida. Os resultados incluíram os 16 conceitos de pesquisa produzido pelo processo para dar forma e conduzir a agenda de pesquisas, e uma amostra engajada da comunidade.
Interpretação
Mostrou‐se que engajar consumidores proativamente com pesquisadores clínicos pode gerar pesquisas mais significativas para a comunidade. Este estudo sugere que pesquisas futuras tenham maior foco em intervenções e resultados ao longo da vida, com maior ênfase nas seguintes medidas de resultado: função, qualidade de vida, e participação.
What this paper adds
A patient‐centered research agenda for cerebral palsy was established.
Comparative effectiveness of interventions, physical activity, and understanding ageing were leading themes.
Longitudinal studies across the lifespan, clinical spectrum, and ages were highly ranked.
Participants reported high value for participation outcomes.
Participants reported great appreciation for the engagement between consumers and clinician researchers.
This article's has been translated into Spanish and Portuguese.
Follow the links from the to view the translations.
This article is commented on by Samson‐Fang on pages 1198–1199 of this issue.
Objectives
To determine optimal repositioning frequency of nursing home (NH) residents at risk for pressure ulcers (PrUs) when cared for on high‐density foam mattresses.
Design
Multisite, randomized, ...clinical trial, known as Turning for Ulcer ReductioN (TURN Study).
Settings
NHs in the United States (n = 20) and Canada (n = 7) using high‐density foam mattresses.
Participants
Consenting residents (N = 942) aged 65 and older without PrUs at moderate (scores 13–14) or high (scores 10–12) risk of PrUs according to the Braden Scale.
Intervention
Participants were randomly allocated using risk stratification (moderate vs high) to a repositioning schedule (2, 3, or 4 hour) for 3 weeks. Blinded assessors assessed skin weekly.
Measurements
PrU incidence (coccyx or sacrum, trochanter, heels).
Results
Participants were mostly female (77.6%) and Caucasian (80.5%) and had a mean age of 85.1 ± 7.7. The most common diagnoses were cardiovascular (76.9%) and dementia (72.5%). Nineteen (2.0%) participants developed superficial PrUs. There was no significant difference (Wilcoxon test for ordered categories) in PrU incidence (P = .68) according to repositioning group (2 hour, 8/321, 2.5%; 3 hour, 2/326, 0.6%; 4 hour, 9/295, 3.1%), nor was there a statistically significant difference in the incidence of PrU between the high and moderate‐risk groups (P = .79). Also, PrU incidence was not statistically significantly different between high‐risk participants based on repositioning schedule (6/325, 1.8%, P = .90) or between moderate‐risk participants based on repositioning schedule (13/617, 2.1%, P = .68).
Conclusion
There was no difference in PrU incidence over 3 weeks of observation between those turned at 2‐, 3‐, or 4‐hour intervals in this population of residents using high‐density foam mattresses at moderate and high risk of developing PrUs when they were repositioned consistently and skin was monitored. This finding has major implications for use of nursing staff and cost of NH care.
To describe psychotropic medication administration patterns during inpatient rehabilitation for traumatic brain injury (TBI) and their relation to patient preinjury and injury characteristics.
...Prospective observational cohort.
Multiple acute inpatient rehabilitation units or hospitals.
Individuals with TBI (N=2130; complicated mild, moderate, or severe) admitted for inpatient rehabilitation.
Not applicable.
Not applicable.
Most frequently administered were narcotic analgesics (72% of sample), followed by antidepressants (67%), anticonvulsants (47%), anxiolytics (33%), hypnotics (30%), stimulants (28%), antipsychotics (25%), antiparkinson agents (25%), and miscellaneous psychotropics (18%). The psychotropic agents studied were administered to 95% of the sample, with 8.5% receiving only 1 and 31.8% receiving ≥6. Degree of psychotropic medication administration varied widely between sites. Univariate analyses indicated younger patients were more likely to receive anxiolytics, antidepressants, antiparkinson agents, stimulants, antipsychotics, and narcotic analgesics, whereas those older were more likely to receive anticonvulsants and miscellaneous psychotropics. Men were more likely to receive antipsychotics. All medication classes were less likely administered to Asians and more likely administered to those with more severe functional impairment. Use of anticonvulsants was associated with having seizures at some point during acute care or rehabilitation stays. Narcotic analgesics were more likely for those with history of drug abuse, history of anxiety and depression (premorbid or during acute care), and severe pain during rehabilitation. Psychotropic medication administration increased rather than decreased during the course of inpatient rehabilitation in each of the medication categories except for narcotics. This observation was also true for medication administration within admission functional levels (defined by cognitive FIM scores), except for those with higher admission FIM cognitive scores.
Many psychotropic medications are used during inpatient rehabilitation. In general, lower admission FIM cognitive score groups were administered more of the medications under investigation compared with those with higher cognitive function at admission. Considerable site variation existed regarding medications administered. The current investigation provides baseline data for future studies of effectiveness.
Pressure ulcers/injuries (PrUs), a critical concern for nursing homes (NH), are responsible for chronic wounds, amputations, septic infections, and premature deaths. PrUs occur most commonly in older ...adults and NH residence is a risk factor for their development, with at least one of every nine U.S. NH residents experiencing a PrU and many NHs having high incidence and prevalence rates, in some instances well over 20%. PrU direct treatment costs are greater than prevention costs, making prevention-focused protocols critical. Current PrU prevention protocols recommend repositioning residents at moderate, high, and severe risk every 2 h. The advent of visco-elastic (VE) high-density foam support-surfaces over the past decade may now make it possible to extend the repositioning interval to every 3 or 4 h without increasing PrU development. The TEAM-UP (Turn Everyone And Move for Ulcer Prevention) study aims to determine: 1) whether repositioning interval can be extended for NH residents without compromising PrU incidence and 2) how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development.
In this proposed cluster randomized study, 9 NHs will be randomly assigned to one of three repositioning intervals (2, 3, or 4 h) for a 4-week period. Each enrolled site will use a single NH-wide repositioning interval as the standard of care for residents at low, moderate, and high risk of PrU development (N = 951) meeting the following criteria: minimum 3-day stay, without PrUs, no adhesive allergy, and using VE support surfaces (mattresses). An FDA-cleared patient monitoring system that records position/movement of these residents via individual wireless sensors will be used to visually cue staff when residents need repositioning and document compliance with repositioning protocols.
This study will advance knowledge about repositioning frequency and clinically assessed PrU risk level in relation to PrU incidence and medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines.
Clinical Trial Registration: NCT02996331 .
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