Reference Fitness Values in the Untrained Spinal Cord Injury Population

ObjectiveEstablish reference values of cardiorespiratory fitness applicable to the general, untrained spinal cord injury (SCI) population.DesignData were retroactively obtained from 12 studies (May 2004 to May 2012).SettingAn institution-affiliated applied physiology research laboratory.ParticipantsA total of 153 men and 26 women (age, 18–55y) with chronic SCI (N=179) were included. Participants were not involved in training activities for 1 or more months before testing and were able to complete a progressive resistance exercise test to determine peak oxygen consumption (Vo₂peak).InterventionsNot applicable.Main Outcome MeasurePercentile ranking (poor<20%; fair; 20%–40%; average, 40%–60%; good, 60%–80%; excellent, 80%–100%) used to establish reference values.ResultsReference cardiorespiratory fitness values based on functional classification as paraplegic or tetraplegic were established (paraplegic: median, 16.0mL·kg⁻¹·min⁻¹; range, 1.4–35.2mL·kg⁻¹·min⁻¹; tetraplegic: median, 8.8mL·kg⁻¹·min⁻¹; range, 1.5–21.5mL·kg⁻¹·min⁻¹) for untrained men and women. For the primary outcome measure (Vo₂peak), persons with paraplegia had significantly higher values than did persons with tetraplegia (P<.001). Although men had higher values than did women, these differences did not reach significance (P=.256). Regression analysis revealed that motor level of injury was associated with 22.3% of the variability in Vo₂peak (P<.001), and an additional 8.7% was associated with body mass index (P<.001). No other measure accounted for additional significant variability.ConclusionsEstablished reference fitness values will allow investigators/clinicians to stratify the relative fitness of subjects/patients from the general SCI population. Key determinants are motor level of injury and body habitus, yet most variability in aerobic capacity is not associated with standard measures of SCI status or demographic characteristics.     

Impact of Pressure Ulcers on Individuals Living With a Spinal Cord Injury

ObjectiveTo describe the impact of pressure ulcers on the ability to participate in daily and community activities, health care utilization, and overall quality of life in individuals living with spinal cord injury (SCI).DesignCross-sectional study.SettingNationwide survey.ParticipantsParticipants (N=1137) with traumatic SCI who were >1 year postinjury and living in the community were recruited. Of these, 381 (33.5%, 95% confidence interval, 30.8%–36.3%) had a pressure ulcer over the last 12 months.InterventionsNot applicable.Main Outcome MeasuresMeasures developed for the Rick Hansen Spinal Cord Injury Registry Community Follow-up Survey Version 2.0.ResultsOf the 381 individuals with pressure ulcers, 65.3% reported that their pressure ulcer reduced their activity to some extent or more. Pressure ulcers reduced the ability of individuals with SCI to participate in 19 of 26 community and daily activities. Individuals with 1 or 2 pressure ulcers were more dissatisfied with their ability to participate in their main activity than those without pressure ulcers (P=.0077). Pressure ulcers were also associated with a significantly higher number of consultations with family doctors, nurses, occupational therapists, and wound care nurses/specialists (P<.05).ConclusionsPressure ulcers have a significant impact on the daily life of individuals with SCI. Our findings highlight the importance of implementing pressure ulcer prevention and management programs for this high-risk population and require the attention of all SCI-related health care professionals.     

Bone Mass in Individuals With Chronic Spinal Cord Injury: Associations With Activity-Based Therapy,Neurologic and Functional Status,a Retrospective Study

ObjectiveTo describe the prevalence of osteoporosis and its association with functional electrical stimulation (FES) use in individuals with spinal cord injury (SCI)-related paralysis.DesignRetrospective cross-sectional evaluation.SettingClinic.ParticipantsConsecutive persons with SCI (N=364; 115 women, 249 men) aged between 18 and 80 years who underwent dual-energy x-ray absorptiometry (DXA) examinations.InterventionsNot applicable.Main Outcome MeasurePrevalence of osteoporosis defined as DXA T score ≤−2.5.ResultsThe prevalence of osteoporosis was 34.9% (n=127). Use of FES was associated with 31.2% prevalence of osteoporosis compared with 39.5% among persons not using FES. In multivariate adjusted logistic regression analysis, FES use was associated with 42% decreased odds of osteoporosis after adjusting for sex, age, body mass index, type and duration of injury, Lower Extremity Motor Scores, ambulation, previous bone fractures, and use of calcium, vitamin D, and anticonvulsant; (adjusted odds ratio [OR]=.58; 95% confidence interval [CI], .35–.99; P=.039). Duration of injury >1 year was associated with a 3-fold increase in odds of osteoporosis compared with individuals with injury <1 year; (adjusted OR=3.02; 95% CI, 1.60–5.68; P=.001).ConclusionsFES cycling ergometry may be associated with a decreased loss of bone mass after paralysis. Further prospective examination of the role of FES in preserving bone mass will improve our understanding of this association.     

Activity-Based Therapy for Recovery of Walking in Individuals With Chronic Spinal Cord Injury: Results From a Randomized Clinical Trial

ObjectiveTo examine the effects of activity-based therapy (ABT) on neurologic function, walking ability, functional independence, metabolic health, and community participation.DesignRandomized controlled trial with delayed treatment design.SettingOutpatient program in a private, nonprofit rehabilitation hospital.ParticipantsVolunteer sample of adults (N=48; 37 men and 11 women; age, 18–66y) with chronic (≥12mo postinjury), motor-incomplete (ASIA Impairment Scale grade C or D) spinal cord injury (SCI).InterventionsA total of 9h/wk of ABT for 24 weeks including developmental sequencing; resistance training; repetitive, patterned motor activity; and task-specific locomotor training. Algorithms were used to guide group allocation, functional electrical stimulation utilization, and locomotor training progression.Main Outcome MeasuresNeurologic function (International Standards for Neurological Classification of Spinal Cord Injury); walking speed and endurance (10-meter walk test, 6-minute walk test, and Timed Up and Go test); community participation (Spinal Cord Independence Measure, version III, and Reintegration to Normal Living Index); and metabolic function (weight, body mass index, and Quantitative Insulin Sensitivity Check).ResultsSignificant improvements in neurologic function were noted for experimental versus control groups (International Standards for Neurological Classification of Spinal Cord Injury total motor score [5.1±6.3 vs 0.9±5.0; P=.024] and lower extremity motor score [4.2±5.2 vs −0.6±4.2; P=.004]). Significant differences between experimental and control groups were observed for 10-meter walk test speed (0.096±0.14m/s vs 0.027±0.10m/s; P=.036) and 6-minute walk test total distance (35.97±48.2m vs 3.0±25.5m; P=.002).ConclusionsABT has the potential to promote neurologic recovery and enhance walking ability in individuals with chronic, motor-incomplete SCI. However, further analysis is needed to determine for whom ABT is going to lead to meaningful clinical benefits.     

Brain Machine Interface and Limb Reanimation Technologies: Restoring Function After Spinal Cord Injury Through Development of a Bypass System

Functional restoration of limb movement after traumatic spinal cord injury (SCI) remains the ultimate goal in SCI treatment and directs the focus of current research strategies. To date, most investigations in the treatment of SCI focus on repairing the injury site. Although offering some promise, these efforts have met with significant roadblocks because treatment measures that are successful in animal trials do not yield similar results in human trials. In contrast to biologic therapies, there are now emerging neural interface technologies, such as brain machine interface (BMI) and limb reanimation through electrical stimulators, to create a bypass around the site of the SCI. The BMI systems analyze brain signals to allow control of devices that are used to assist SCI patients. Such devices may include a computer, robotic arm, or exoskeleton. Limb reanimation technologies, which include functional electrical stimulation, epidural stimulation, and intraspinal microstimulation systems, activate neuronal pathways below the level of the SCI. We present a concise review of recent advances in the BMI and limb reanimation technologies that provides the foundation for the development of a bypass system to improve functional outcome after traumatic SCI. We also discuss challenges to the practical implementation of such a bypass system in both these developing fields.     

Physical Activity Promotion in the Health Care System

Physical activity (PA) and exercise training (ET) have great potential in the prevention, management, and rehabilitation of a variety of diseases, but this potential has not been fully realized in clinical practice. The health care system (HCS) could do much more to support patients in increasing their PA and ET. However, counseling on ET is not used widely by the HCS owing partly to attitudes but mainly to practical obstacles. Extensive searches of MEDLINE, the Cochrane Library, the Database of Abstracts of Reviews of Effects, and ScienceDirect for literature published between January 1, 2000, and January 31, 2013, provided data to assess the critical characteristics of ET counseling. The evidence reveals that especially brief ET counseling is an efficient, effective, and cost-effective means to increase PA and ET and to bring considerable clinical benefits to various patient groups. Furthermore, it can be practiced as part of the routine work of the HCS. However, there is a need and feasible means to increase the use and improve the quality of ET counseling. To include PA and ET promotion as important means of comprehensive health care and disease management, a fundamental change is needed. Because exercise is medicine, it should be seen and dealt with in the same ways as pharmaceuticals and other medical interventions regarding the basic and continuing education and training of health care personnel and processes to assess its needs and to prescribe and deliver it, to reimburse the services related to it, and to fund research on its efficacy, effectiveness, feasibility, and interactions and comparability with other preventive, therapeutic, and rehabilitative modalities. This change requires credible, strong, and skillful advocacy inside the medical community and the HCS.     

Activity-Based Therapy for Recovery of Walking in Chronic Spinal Cord Injury: Results From a Secondary Analysis to Determine Responsiveness to Therapy

ObjectiveTo gain insight into who is likely to benefit from activity-based therapy (ABT), as assessed by secondary analysis of data obtained from a clinical trial.DesignSecondary analysis of results from a randomized controlled trial with delayed treatment design.SettingOutpatient program in a private, nonprofit rehabilitation hospital.ParticipantsVolunteer sample of adults (N=38; 27 men; 11 women; age, 22–63y) with chronic (≥12mo postinjury), motor-incomplete (American Spinal Injury Association [ASIA] Impairment Scale [AIS] grade C or D) spinal cord injury (SCI).InterventionsA total of 9h/wk of ABT for 24 weeks including developmental sequencing; resistance training; repetitive, patterned motor activity; and task-specific locomotor training. Algorithms were used to guide group allocation, functional electrical stimulation utilization, and locomotor training progression.Main Outcome MeasuresWalking speed and endurance (10-meter walk test and 6-minute walk test) and functional ambulation (timed Up and Go test).ResultsThis secondary analysis identified likely responders to ABT on the basis of injury characteristics: AIS classification, time since injury, and initial walking ability. Training effects were the most clinically significant in AIS grade D participants with injuries <3 years in duration. This information, along with information about preliminary responsiveness to therapy (gains after 12wk), can help predict the degree of recovery likely from participation in an ABT program.ConclusionsABT has the potential to promote neurologic recovery and enhance walking ability in individuals with chronic, motor-incomplete SCI. However, not everyone with goals of walking recovery will benefit. Individuals with SCI should be advised of the time, effort, and resources required to undertake ABT. Practitioners are encouraged to use the findings from this trial to assist prospective participants in establishing realistic expectations for recovery.     

Outbreaks of Infections Associated With Drug Diversion by US Health Care Personnel

ObjectiveTo summarize available information about outbreaks of infections stemming from drug diversion in US health care settings and describe recommended protocols and public health actions.Patients and MethodsWe reviewed records at the Centers for Disease Control and Prevention related to outbreaks of infections from drug diversion by health care personnel in US health care settings from January 1, 2000, through December 31, 2013. Searches of the medical literature published during the same period were also conducted using PubMed. Information compiled included health care setting(s), infection type(s), specialty of the implicated health care professional, implicated medication(s), mechanism(s) of diversion, number of infected patients, number of patients with potential exposure to blood-borne pathogens, and resolution of the investigation.ResultsWe identified 6 outbreaks over a 10-year period beginning in 2004; all occurred in hospital settings. Implicated health care professionals included 3 technicians and 3 nurses, one of whom was a nurse anesthetist. The mechanism by which infections were spread was tampering with injectable controlled substances. Two outbreaks involved tampering with opioids administered via patient-controlled analgesia pumps and resulted in gram-negative bacteremia in 34 patients. The remaining 4 outbreaks involved tampering with syringes or vials containing fentanyl; hepatitis C virus infection was transmitted to 84 patients. In each of these outbreaks, the implicated health care professional was infected with hepatitis C virus and served as the source; nearly 30,000 patients were potentially exposed to blood-borne pathogens and targeted for notification advising testing.ConclusionThese outbreaks revealed gaps in prevention, detection, and response to drug diversion in US health care facilities. Drug diversion is best prevented by health care facilities having strong narcotics security measures and active monitoring systems. Appropriate response includes assessment of harm to patients, consultation with public health officials when tampering with injectable medication is suspected, and prompt reporting to enforcement agencies.     

Drug-Induced Liver Injury

Drug hepatoxicity can be nonidiosyncratic (predictable), as in the case of acetaminophen, or idiosyncratic (unpredictable). This review article focuses primarily on idiosyncratic drug-induced liver injury (DILI). New epidemiologic data suggest that approximately 20 new cases of DILI per 100,000 persons occur each year. Idiosyncratic DILI accounts for 11% of the cases of acute liver failure in the United States. Risk factors for DILI include medication dose, drug lipophilicity, and extent of hepatic metabolism. There is mixed evidence to support the role of host factors such as age, sex, and chronic liver disease in the development of DILI. For specific drugs, a genetic predisposition appears to be a risk factor for DILI. Suspected cases of idiosyncratic DILI should be categorized as hepatitic, cholestatic, or mixed on the basis of the degree/ratio of abnormalities in the alanine aminotransferase and alkaline phosphatase. A careful evaluation for other causes of liver disease should be performed, though a liver biopsy is rarely needed. There is evidence that some patients with DILI may actually have hepatitis E and this diagnosis should be considered. Amoxicillin/clavulanate isoniazid, and nonsteroidal anti-inflammatory drugs are among the most common causes of DILI. Drug discontinuation or dechallenge should lead to an improvement in liver biochemistries in most patients, though a bilirubin value of more than 3 g/dL is associated with mortality of at least 10%. New biomarkers for DILI using proteomics and micro RNA appear promising but require further study. New studies on drugs with potential for causing DILI are reviewed herein, including tumor necrosis factor-alpha antagonists, fluoroquinolones, tyrosine kinase inhibitors, statins, and supplements. PubMed was used with search terms of drug induced liver injury OR DILI with filter settings of “English language” and “humans” and custom date range of “January 1, 2000.” The authors also manually searched bibliographies from key references and included seminal references before the year 2000.     

Stroke Risk and Outcomes in Patients With Traumatic Brain Injury: 2 Nationwide Studies

ObjectiveTo investigate whether patients with traumatic brain injury (TBI) have an increased risk of stroke or poststroke mortality.Participants and MethodsUsing Taiwan's National Health Insurance Research Database, we conducted a retrospective cohort study of 30,165 patients with new TBI and 120,660 persons without TBI between January 1, 2000, and December 31, 2004. The risk of stroke was compared between 2 cohorts through December 31, 2008. To investigate the association between in-hospital mortality after stroke and history of TBI, we conducted a case-control study of 7751 patients with newly diagnosed stroke between January 1, 2005, and December 31, 2008.ResultsThe TBI cohort had an increased stroke risk (hazard ratio [HR], 1.98; 95% CI, 1.86-2.11). Among patients with stroke, those with a history of TBI had a higher risk of poststroke mortality compared with those without TBI (odds ratio, 1.57; 95% CI, 1.13-2.19). In the TBI cohort, factors associated with stroke were history of TBI hospitalization (HR, 3.14; 95% CI, 2.77-3.56), emergency care for TBI (HR, 3.37; 95% CI, 2.88-3.95), brain hemorrhage (HR, 2.69; 95% CI, 2.43-2.99), skull fracture (HR, 3.00; 95% CI, 2.42-3.71), low income (HR, 2.65; 95% CI, 2.16-3.25), and high medical expenditure for TBI care (HR, 2.26; 95% CI, 2.09-2.43). The severity of TBI was also correlated with poststroke mortality.ConclusionsTraumatic brain injury was associated with risk of stroke and poststroke mortality. The relationship between TBI and poststroke mortality does not seem to transcend all age groups. This research shows the importance of prevention, early recognition, and treatment of stroke in this vulnerable population.     

Drug Shortages: A Complex Health Care Crisis

National tracking of drug shortages began in 2001. However, a significant increase in the number of shortages began in late 2009, with numbers reaching what many have termed crisis level. The typical drug in short supply is a generic product administered by injection. Common classes of drugs affected by shortages include anesthesia medications, antibiotics, pain medications, nutrition and electrolyte products, and chemotherapy agents. The economic and clinical effects of drug shortages are significant. The financial effect of drug shortages is estimated to be hundreds of millions of dollars annually for health systems across the United States. Clinically, patients have been harmed by the lack of drugs or inferior alternatives, resulting in more than 15 documented deaths. Drug shortages occur for a variety of reasons. Generic injectable drugs are particularly susceptible to drug shortages because there are few manufacturers of these products and all manufacturers are running at full capacity. In addition, some manufacturers have had production problems, resulting in poor quality product. Although many suppliers are working to upgrade facilities and add additional manufacturing lines, these activities take time. A number of stakeholder organizations have been involved in meetings to further determine the causes and effects of drug shortages. A new law was enacted in July 2012 that granted the Food and Drug Administration additional tools to address the drug shortage crisis. The future of drug shortages is unknown, but there are hopeful indications that quality improvements and additional capacity may decrease the number of drug shortages in the years to come.     

Characteristics of Resistant Hypertension in a Large,Ethnically Diverse Hypertension Population of an Integrated Health System

ObjectiveTo evaluate the prevalence of and characterize resistant hypertension in a large representative population with successful hypertension management and reliable health information.Patient and MethodsWe performed a cross-sectional study using clinical encounter, laboratory, and administrative information from the Kaiser Permanente Southern California health system between January 1, 2006, and December 31, 2007. From individuals older than 17 years with hypertension, resistant hypertension was identified and prevalence was determined. Multivariable logistic regression was used to calculate odds ratios (ORs), with adjustments for demographic characteristics, clinical variables, and medication use.ResultsOf 470,386 hypertensive individuals, 60,327 (12.8%) were identified as having resistant disease, representing 15.3% of those taking medications. Overall, 37,061 patients (7.9%) had uncontrolled hypertension while taking 3 or more medicines. The ORs (95% CIs) for resistant hypertension were greater for black race (1.68 [1.62-1.75]), older age (1.11 [1.10-1.11] for every 5-year increase), male sex (1.06 [1.03-1.10]), and obesity (1.46 [1.42-1.51]). Medication adherence rates were higher in those with resistant hypertension (93% vs 89.8%; P<.001). Chronic kidney disease (OR, 1.84; 95% CI, 1.78-1.90), diabetes mellitus (OR, 1.58; 95% CI, 1.53-1.63), and cardiovascular disease (OR, 1.34; 95% CI, 1.30-1.39) were also associated with higher risk of resistant hypertension.ConclusionIn a more standardized hypertension treatment environment, we observed a rate of resistant hypertension comparable with that of previous studies using more fragmented data sources. Past observations have been limited due to nonrepresentative populations, reliability of the data, heterogeneity of the treatment environments, and less than ideal control rates. This cohort, which was established using an electronic medical record–based approach, has the potential to provide a better understanding of resistant hypertension and outcomes.     

A Clinician's Primer on the Role of the Microbiome in Human Health and Disease

The importance of the commensal microbiota that colonizes the skin, gut, and mucosal surfaces of the human body is being increasingly recognized through a rapidly expanding body of science studying the human microbiome. Although, at first glance, these discoveries may seem esoteric, the clinical implications of the microbiome in human health and disease are becoming clear. As such, it will soon be important for practicing clinicians to have an understanding of the basic concepts of the human microbiome and its relation to human health and disease. In this Concise Review, we provide a brief introduction to clinicians of the concepts underlying this burgeoning scientific field and briefly explore specific disease states for which the potential role of the human microbiome is becoming increasingly evident, including Clostridium difficile infection, inflammatory bowel disease, colonization with multidrug-resistant organisms, obesity, allergic diseases, autoimmune diseases, and neuropsychiatric illnesses, and we also discuss current and future roles of microbiome restorative therapies.     

Effect of Soft Braces on Pain and Physical Function in Patients With Knee Osteoarthritis: Systematic Review With Meta-Analyses

ObjectivesTo systematically review and synthesize the effects of soft braces on pain and on self-reported and performance-based physical function in patients with knee osteoarthritis.Data SourcesThe following electronic databases were searched from inception to April 20, 2016: The Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, CINAHL, SPORTDiscus, Web of Science, and PEDro.Study SelectionRandomized controlled trials (RCTs) and nonrandomized controlled trials (non-RCTs), such as controlled clinical trials, crossover studies, and case-control studies, were included. Two reviewers independently screened articles and determined inclusion through predefined criteria.Data ExtractionData related to participant demographics, study design and methods, interventions, and outcomes, including numerical means and SDs, were extracted by 1 reviewer. Methodological quality assessment was independently performed by 2 reviewers.Data SynthesisEleven studies were identified, including 6 RCTs and 5 non-RCTs. The methodological quality of included RCTs was low. There was a moderate improvement in pain (standardized mean difference [SMD]=.52; 95% confidence interval [CI], .14–.89; P=.007; 284 participants) in favor of wearing a brace compared with not wearing a brace for the immediate, within-group comparison. There was a moderate improvement in pain (SMD=.61; 95% CI, .33–.89; P<.001; 206 participants) and a small to moderate improvement in self-reported physical function (SMD=.39; 95% CI, .11–.67; P=.006; 206 participants) in favor of patients receiving a soft brace versus standard care for the prolonged effect, between-group comparison.ConclusionsCurrently available evidence indicates that soft braces have moderate effects on pain and small to moderate effects on self-reported physical function in knee osteoarthritis. These findings highlight the importance of soft braces as a technique to improve pain and physical function in both the short- and long-term. Additional high-quality studies are warranted to improve confidence in the findings.     

Hospitalizations and Emergency Department Use in Mayo Clinic Biobank Participants Within the Employee and Community Health Medical Home

ObjectiveTo evaluate the participants in the Mayo Clinic Biobank for their representativeness to the entire Employee and Community Health program (ECH) primary care population with regard to hospital utilization.Patients and MethodsParticipants enrolled in the Mayo Clinic Biobank from April 1, 2009, to December 31, 2010, were linked to the ECH population. These individuals were categorized into risk tiers (0-4) on the basis of the number of health conditions present as of December 31, 2010. Outcomes were ascertained through December 31, 2011. Hazard ratios (HRs) and 95% CIs for risk of hospitalization, emergency department (ED) visits, and for risk of hospitalization and emergency department (ED) visits were estimated.ResultsThe 8927 Biobank participants were part of ECH (N=84,872). Compared with the entire ECH population, the Biobank-ECH participants were more likely to be female (64.3% vs 54.6%), older (median age, 58 years vs 47 years), and categorized to tier 0 (6.4% vs 24.0%). There were strong positive associations between tier (tier 4 vs combined tiers 0 and 1) and risk of hospitalization (HR, 5.8; 95% CI, 4.6-7.5) and ED visits (HR, 5.4; 95% CI, 4.2-6.8) among Biobank-ECH participants. Similar associations for risk of hospitalization (HR, 8.5; 95% CI, 7.8-9.3) and ED visits (HR, 6.9; 95% CI, 6.4-7.5) were observed for the entire ECH population.ConclusionAlthough the Biobank-ECH participants were older and had more chronic conditions compared with the overall ECH population, the associations of risk tier with utilization outcomes were similar, supporting the use of the Biobank participants to assess biomarkers for health care outcomes in the primary care setting.     

Body Composition and Mortality in a Large Cohort With Preserved Ejection Fraction: Untangling the Obesity Paradox

ObjectiveTo evaluate the effects of body composition as a function of lean mass index (LMI) and body fat (BF) on the correlation between increasing body mass index (BMI; calculated as the weight in kilograms divided by the height in meters squared) and decreasing mortality, which is known as the obesity paradox.Patients and MethodsWe retrospectively assessed 47,866 patients with preserved left ventricular ejection fraction (≥50%). We calculated BF by using the Jackson-Pollock equation and LMI using (1 − BF) × BMI. The population was divided according to the sex-adjusted BMI classification, sex-adjusted LMI classification, and sex-adjusted BF tertiles. The population was analyzed by using multivariate analysis for total mortality over a mean follow-up duration of 3.1 years by using the National Death Index, adjusting for left ventricular ejection fraction, left ventricular mass index, age, sex, and relative wall thickness.ResultsIn the entire population, higher BMI was narrowly associated (hazard ratio [HR], 0.99; P<.001) with lower mortality. The higher LMI group was clearly protective (HR, 0.71; P<.001), whereas BF tertile was associated with lower mortality only if no adjustment was made for LMI (HR, 0.87; P<.001 without LMI; HR, 0.97; P=.23 with LMI). In the lean patients, low BMI was clearly associated with higher mortality (HR, 0.92; P<.001) and lower BF tertile was associated with lower mortality only if no adjustment was made for LMI (HR, 0.80; P<.001 without LMI; HR, 1.01; P=.83 with LMI). The underweight patients stratified by BF seemed to have an increased mortality (HR, 1.91; 95% CI, 1.56-2.34) that was independent of LMI. However, in obese patients, both BMI (HR, 1.03; P<.001) and BF (HR, 1.18; P=.003) were associated with higher mortality, even after adjusting for LMI, which remained protective (HR, 0.57; P<.001) independently of BF.ConclusionBody composition could explain the inverse J shape of the mortality curve noted with increasing BMI. Body fat seems to be protective in this cohort only if no adjustment was made for LMI, although being underweight stratified by BF seems to be an independent risk factor. Lean mass index seems to remain protective in obese patients even when BMI is not.     

Toward a Strategy of Patient-Centered Access to Primary Care

Patient-centered access (PCA) to primary care services is rapidly becoming an imperative for efficiently delivering high-quality health care to patients. To enhance their PCA-related efforts, some medical practices and health systems have begun to use various tactics, including team-based care, satellite clinics, same-day and group appointments, greater use of physician assistants and nurse practitioners, and remote access to health services. However, few organizations are addressing the PCA imperative comprehensively by integrating these various tactics to develop an overall PCA management strategy. Successful integration means taking into account the changing competitive and reimbursement landscape in primary care, conducting an evidence-based assessment of the barriers and benefits of PCA implementation, and attending to the particular needs of the institution engaged in this important effort. This article provides a blueprint for creating a multifaceted but coordinated PCA strategy—one aimed squarely at making patient access a centerpiece of how health care is delivered. The case of a Wisconsin-based health system is used as an illustrative example of how other institutions might begin to conceive their fledgling PCA strategies without proposing it as a one-size-fits-all model.     

Recovery Over 6 Months of Medical Decision-Making Capacity After Traumatic Brain Injury

ObjectiveTo investigate recovery of medical decision-making capacity (MDC) over 6 months in persons with traumatic brain injury (TBI) stratified by injury severity.DesignLongitudinal study comparing controls and patients with TBI 1 month after injury (t1) and 6 months after injury (t2).SettingInpatient TBI rehabilitation unit and outpatient neurology department.ParticipantsParticipants (N=151) consisted of control subjects (n=60) and patients with TBI (n=91) stratified by injury severity: mild TBI (mTBI; n=27), complicated mild TBI (cmTBI; n=20), and moderate/severe TBI (msevTBI; n=44).InterventionsNot applicable.Main Outcome MeasuresWe used the Capacity to Consent to Treatment Instrument to evaluate MDC performance on 5 consent standards (expressing choice, reasonable choice, appreciation, reasoning, and understanding). We also assigned capacity impairment ratings on the consent standards to each participant with TBI using cut scores referenced to control performance.ResultsControl performance was stable across time on the consent standards. Patients with mTBI and cmTBI performed below controls on the understanding standard at t1 but not t2. Patients with msevTBI performed below controls on appreciation, reasoning, and understanding at t1, and on appreciation and understanding at t2, but showed substantial improvement over time.ConclusionsRegardless of injury severity, all groups with TBI demonstrated baseline impairment of MDC with subsequent partial or full recovery of MDC over a 6-month period. However, a sizeable proportion of individual patients with TBI in each group continued to demonstrate capacity compromise at 6 months postinjury. Clinically, this finding suggests that individuals with TBI, regardless of injury severity, need continued monitoring regarding MDC for at least 6 months after injury.     

Comparative Effectiveness of Telaprevir-Based Triple Therapy in Patients With Chronic Hepatitis C

ObjectiveTo examine the effectiveness and tolerability of triple therapy with pegylated interferon (p-IFN), ribavirin (RBV), and telaprevir in patients with chronic hepatitis C receiving treatment in an academic practice setting and in a more clinically diverse population compared with patients receiving treatment in phase 3 trials.Patients and MethodsA prospective database of all patients with viral hepatitis undergoing antiviral therapy from January 1, 2006, to July 1, 2012, was queried to identify treatment-naive and -experienced patients with chronic hepatitis C receiving dual and triple therapies. On-treatment response categories included rapid virologic response, extended rapid virologic response, early virologic response, and sustained virologic response. These patients were compared with matched controls, namely, patients who underwent dual therapy with p-IFN and RBV. Matching was performed for age, cirrhosis status, and prior treatment.ResultsThere were 55 patients who received triple therapy and met the eligibility criteria, consisting of treatment-naive (n=35) and -experienced patients (n=20: those with relapse, 9; those with nonresponse, 9; and those who terminated the treatment early, 2). Rapid virologic response was achieved in 41% of the patients, extended rapid virologic response in 41%, and early virologic response in 75%. Sustained virologic response was observed in 51% (18/35) of treatment-naive patients, 67% (6/9) of the patients with prior nonresponse, and 56% (5/9) of those with prior relapse. Corresponding results after dual therapy were 37% (23/62), 11% (2/18), and 27% (3/11), respectively. The mean decrease in the hemoglobin level at weeks 4, 8, and 24 of triple therapy was 2.8, 3.8, and 3.2 mg/dL compared with 2.4, 2.6, and 2.4 mg/dL with dual therapy (to convert mg/dL to mmol/L, multiply values by 0.0259).ConclusionTelaprevir-based triple therapy in clinical practice is considerably more effective than dual therapy with p-IFN and RBV despite the significant degree of anemia that complicated therapy, requiring RBV dose reduction and erythropoietin support.