Rigorous Clinical Data Research Articles

The Influence of Social Media in Orthopaedics

Social media's presence has extended to almost every industry in the world. In orthopaedics, this lends benefits to practitioners, allowing them to interact with patients, build their practice, recruit research subjects, advertise residency programs, and disperse research findings. It also allows advantages to patients, allowing them to learn about their conditions and potential treatments as many patients use social media to get health information. However, patients can also be heavily influenced by what they read online. Much of this information is not vetted by governing bodies such as the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), organizational bodies such as the American Academy of Orthopaedic Surgeons (AAOS), or the social media companies themselves. Manufacturers have started to exploit this lack of oversight by marketing products to patients with false claims that do not have rigorous clinical data behind them, creating the potential for harm. Patients are not well equipped to understand what is appropriate for the specifics of their conditions but are convinced by these powerful marketing techniques. They then come to appointments requesting treatments that are not indicated for their conditions. This strains the patient-physician relationship and can cause worse patient outcomes. Products are marketed in many fields of medicine, and orthopaedic device companies are increasingly targeting patients. This review, therefore, explores the potential benefits and drawbacks of social media in medicine in general and orthopaedics specifically and possible solutions to these issues. Namely, the introduction of some form of filtering from the FDA, CDC, other orthopaedic governing bodies, or social media platforms.

Management of Acne Vulgaris With Trifarotene.

Topical retinoids have an essential role in treatment of acne. Trifarotene, a topical retinoid selective for retinoic acid receptor (RAR) γ, is the most recent retinoid approved for treatment of acne. RAR-γ is the most common isoform of RARs in skin, and the strong selectivity of trifarotene for RAR-γ translates to efficacy in low concentration. Trifarotene, like other topical retinoids, acts by increasing keratinocyte differentiation and decreasing proliferation, which reduces hyperkeratinization. Retinoids have also been shown to inhibit inflammatory pathways via effects on leukocyte migration, toll-like receptors, and Activator Protein (AP)-1. Large-scale randomized, controlled clinical trials have demonstrated trifarotene to be safe, well tolerated, and efficacious in reducing both comedones and papules/pustules of acne. However, unlike all other retinoids, trifarotene is the first topical retinoid with rigorous clinical data on safety and efficacy in truncal acne. Data supporting use of trifarotene to manage acne are reviewed in this publication.

Clinical practice recommendations for the diagnosis and management of human herpesvirus-6B encephalitis after allogeneic hematopoietic stem cell transplantation: the Japan Society for Hematopoietic Cell Transplantation.

Reactivation of human herpesvirus (HHV)-6B is relatively common after allogeneic hematopoietic stem cell transplantation (HSCT) and HHV-6B diseases may consequently develop. Among them, HHV-6B encephalitis is a serious and often fatal complication. The aim of these clinical practice recommendations is to provide diagnostic and therapeutic guidance for HHV-6B encephalitis after allogeneic HSCT. In this evidence-based review, we critically evaluated data from the published literature. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assist in generating recommendations. We have summarized the findings that contribute to decision-making and we have provided our recommendations. In cases where rigorous clinical data are unavailable, recommendations have been developed in discussions with physicians who have relevant expertize.

Can Foot Exercises Alter Foot Posture, Strength, and Walking Foot Pressure Patterns in People with Severe Flat Foot?

Category: Midfoot/Forefoot, Sports Introduction/Purpose: Muscle training muscle control for barefoot running (i.e. doming seated[DS] and standing[DSt]) and post foot and ankle injury (i.e. seated plantar flexion and inversion[SPFI]) are common. Although studies demonstrated improvement in foot posture (validated foot posture index [FPI]) immediately following a 4-week exercise program this was not assessed in people with flatfoot. Also, more rigorous assessment of foot function is lacking (i.e. foot posture, strength, and plantar pressure during walking). There is clearly a need for more rigorous clinical data on the effect of foot exercises. The purpose of this pilot study was to assess the immediate effect of a 4-week exercise program on a comprehensive assessment of foot function to evaluate the potential for a more rigorous clinical trial. Methods: Eighteen individuals, 8 with a severe flatfoot (SFF), measured by FPI (> 6/12, average=8.4±0.7), age=27.8±6.9, 7 females and 1 male) and 9 age/gender matched controls (AMC) with a normal foot (FPI=0-5, average=2.2±2.0) participated. The SFF group completed 3 foot exercises (DS, DSt, SPFI) 5 days/week twice daily. The SFF group were assessed before and after 4 weeks of exercise (called weekly for exercise progression). The control participants were tested once. Testing sessions included plantar pressure during a controlled walking cadence (110 bpm) (average of 5 steps over 40 feet). Masks were applied (medial/lateral toes and forefoot, heal, midfoot) and specific variables calculated (peak pressure, percent mean pressure) during stance phase. Clinical tests included heel rise repetitions, navicular drop, and paper pull test (peak force). T-tests were used to assess the effects of pre to post in the SFF group and between the SFF group and AMC pre and post exercise. Results: Two clinical tests significantly improved from pre to post in the SFF group (heel rises increased on right = 6.1± 3.7, p<0,01, left = 7.9± 6.1, p<0.01, and navicular drop indicated less arch lowering on the right (p=0.4) and left (p=0.06)), however, the paper pull test was not significant. Lateral forefoot mask for percent total mean pressure was lower in the SSF group pre exercise versus AMC (right p=0.02, left p=0.07). However, pre to post exercise the lateral forefoot mask for peak plantar pressure increased (left p=0.014, right p=0.02) and percent of total mean pressure also increased (right p=0.04, left p = 0.07) in the SFF group. Post exercise the SFF group lateral percent total mean pressure was no longer significant compared to controls. Conclusion: This data suggests that 4 weeks of foot only exercises (no ankle exercises) improved walking (Figure 1) and increased ankle strength (heel raise ability). Previous studies have not included rigorous assessment of foot function after foot exercises. This pilot data extends previous studies by suggesting foot muscle control may directly influence foot function during walking (i.e. plantar pressure). A power analysis using this data supports the conclusions with a larger sample of approximately 20-30 people. This pilot data supports the pursuit of a more rigorous trial of the positive effect of foot exercises in patients with severe flatfoot.

Fiber supplements and clinically proven health benefits: How to recognize and recommend an effective fiber therapy.

BackgroundOnly 5% of adults consume the recommended level of dietary fiber. Fiber supplements appear to be a convenient and concentrated source of fiber, but most do not provide the health benefits associated with dietary fiber.PurposeThis review will summarize the physical effects of isolated fibers in small and large intestines, which drive clinically meaningful health benefits.Data sourcesA comprehensive literature review was conducted (Scopus and PubMed) without limits to year of publication (latest date included: October 31, 2016).ConclusionsThe physical effects of fiber in the small intestine drive metabolic health effects (e.g., cholesterol lowering, improved glycemic control), and efficacy is a function of the viscosity of gel‐forming fibers (e.g., psyllium, β‐glucan). In the large intestine, fiber can provide a laxative effect if (a) it resists fermentation to remain intact throughout the large intestine, and (b) it increases percentage of water content to soften/bulk stool (e.g., wheat bran and psyllium).Implications for practiceIt is important for nurse practitioners to understand the underlying mechanisms that drive specific fiber‐related health benefits, and which fiber supplements have rigorous clinical data to support a recommendation.Clinical pearlFor most fiber‐related beneficial effects, “Fiber needs to gel to keep your patients well.”

2017 Infectious Diseases Society of America’s Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis*

Abstract The Infectious Diseases Society of America (IDSA) Standards and Practice Guidelines Committee collaborated with partner organizations to convene a panel of 10 experts on healthcare-associated ventriculitis and meningitis. The panel represented pediatric and adult specialists in the field of infectious diseases and represented other organizations whose members care for patients with healthcare-associated ventriculitis and meningitis (American Academy of Neurology, American Association of Neurological Surgeons, and Neurocritical Care Society). The panel reviewed articles based on literature reviews, review articles and book chapters, evaluated the evidence and drafted recommendations. Questions were reviewed and approved by panel members. Subcategories were included for some questions based on specific populations of patients who may develop healthcare-associated ventriculitis and meningitis after the following procedures or situations: cerebrospinal fluid shunts, cerebrospinal fluid drains, implantation of intrathecal infusion pumps, implantation of deep brain stimulation hardware, and general neurosurgery and head trauma. Recommendations were followed by the strength of the recommendation and the quality of the evidence supporting the recommendation. Many recommendations, however, were based on expert opinion because rigorous clinical data are not available. These guidelines represent a practical and useful approach to assist practicing clinicians in the management of these challenging infections. Keywords. ventriculitis; meningitis; cerebrospinal fluid shunts; cerebrospinal fluid drains; central nervous system infections.

2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis.

The Infectious Diseases Society of America (IDSA) Standards and Practice Guidelines Committee collaborated with partner organizations to convene a panel of 10 experts on healthcare-associated ventriculitis and meningitis. The panel represented pediatric and adult specialists in the field of infectious diseases and represented other organizations whose members care for patients with healthcare-associated ventriculitis and meningitis (American Academy of Neurology, American Association of Neurological Surgeons, and Neurocritical Care Society). The panel reviewed articles based on literature reviews, review articles and book chapters, evaluated the evidence and drafted recommendations. Questions were reviewed and approved by panel members. Subcategories were included for some questions based on specific populations of patients who may develop healthcare-associated ventriculitis and meningitis after the following procedures or situations: cerebrospinal fluid shunts, cerebrospinal fluid drains, implantation of intrathecal infusion pumps, implantation of deep brain stimulation hardware, and general neurosurgery and head trauma. Recommendations were followed by the strength of the recommendation and the quality of the evidence supporting the recommendation. Many recommendations, however, were based on expert opinion because rigorous clinical data are not available. These guidelines represent a practical and useful approach to assist practicing clinicians in the management of these challenging infections.

Antimicrobial stewardship

Antimicrobial stewardship is a key component of a multifaceted approach to preventing emergence of antimicrobial resistance. Good antimicrobial stewardship involves selecting an appropriate drug and optimizing its dose and duration to cure an infection while minimizing toxicity and conditions for selection of resistant bacterial strains. Studies conducted over the years indicate that antibiotic use is unnecessary or inappropriate in as many as 50% of cases in the United States, and this creates unnecessary pressure for the selection of resistant species. Because the pharmaceutical industry pipeline for new antibiotics has been curtailed in recent years, and it may be > or = 10 years before important new antibiotics to treat certain resistant bacteria find their way to market, a premium has been set on maintaining the effectiveness of currently available agents. Several strategies, including prescriber education, formulary restriction, prior approval, streamlining, antibiotic cycling, and computer-assisted programs have been proposed to improve antibiotic use. Although rigorous clinical data in support of these strategies are lacking, the most effective means of improving antimicrobial stewardship will most likely involve a comprehensive program that incorporates multiple strategies and collaboration among various specialties within a given healthcare institution. Computer-assisted software programs may be especially useful in implementing these comprehensive programs. The antimicrobial stewardship program at the Hospital of the University of Pennsylvania, which has been shown to improve appropriateness of antibiotic use and cure rates, decrease failure rates, and reduce healthcare-related costs, is used as an example in support of this multifaceted, multidisciplinary approach. At this time, data from well-controlled studies examining the effect of antibacterial stewardship on emergence of resistance are limited, but available data suggest that good antibiotic stewardship reduces rates of Clostridium difficile-associated diarrhea, resistant gram-negative bacilli, and vancomycin-resistant enterococci.

Antimicrobial Stewardship

Antimicrobial stewardship is a key component of a multifaceted approach to preventing emergence of antimicrobial resistance. Good antimicrobial stewardship involves selecting an appropriate drug and optimizing its dose and duration to cure an infection while minimizing toxicity and conditions for selection of resistant bacterial strains. Studies conducted over the years indicate that antibiotic use is unnecessary or inappropriate in as many as 50% of cases in the United States, and this creates unnecessary pressure for the selection of resistant species. Because the pharmaceutical industry pipeline for new antibiotics has been curtailed in recent years, and it may be ≥10 years before important new antibiotics to treat certain resistant bacteria find their way to market, a premium has been set on maintaining the effectiveness of currently available agents. Several strategies, including prescriber education, formulary restriction, prior approval, streamlining, antibiotic cycling, and computer-assisted programs have been proposed to improve antibiotic use. Although rigorous clinical data in support of these strategies are lacking, the most effective means of improving antimicrobial stewardship will most likely involve a comprehensive program that incorporates multiple strategies and collaboration among various specialties within a given healthcare institution. Computer-assisted software programs may be especially useful in implementing these comprehensive programs. The antimicrobial stewardship program at the Hospital of the University of Pennsylvania, which has been shown to improve appropriateness of antibiotic use and cure rates, decrease failure rates, and reduce healthcare-related costs, is used as an example in support of this multifaceted, multidisciplinary approach. At this time, data from well-controlled studies examining the effect of antibacterial stewardship on emergence of resistance are limited, but available data suggest that good antibiotic stewardship reduces rates of Clostridium difficile–associated diarrhea, resistant gram-negative bacilli, and vancomycin-resistant enterococci.

Combination chemotherapy for invasive fungal infections: what laboratory and clinical studies tell us so far.

Despite potential benefits, few objective clinical data (with the exception of cryptococcocal meningitis) are available supporting the routine use of combination antifungal regimens in patients with invasive mycoses, importantly aspergillosis or candidiasis. There is considerable debate on what constitutes synergy or antagonism in vitro and whether these laboratory findings are translated to beneficial interactions in patients. Given the lack of rigorous clinical data, a better understanding of the important concepts for the justification of the clinical and pharmacoeconomic threshold of antifungal therapy is needed. Such concepts include standardized methods for screening antifungal combinations in culture or in animals and collaborative efforts to collect clinical data on the efficacy and safety of combination regimens.

Combined SSCP and Heteroduplex Analysis of the Human Plasma Membrane Ca2+-ATPase Isoform 1 in Patients with Essential Hypertension

In recent theories concerning the pathogenesis of essential hypertension, altered calcium homeostasis plays an important role. Increased intracellular Ca2+ levels have repeatedly been reported in different cell types of hypertensive subjects. In vascular smooth muscle cells the plasma membrane Ca2+-ATPase (PMCA) represents the most important Ca2+-ejection system. Modifications of this pump therefore have been assumed to increase contractile tone of small vessels. For this reason, the purpose of this study was to determine if genetic alterations in the hPMCA1 gene might be associated with arterial hypertension. For detection of polymorphisms all 22 PMCA1 exons from 44 patients with essential hypertension (based on rigorous clinical data in addition to a positive family history) and from 40 normotensives without a family history of hypertension were PCR amplified and subsequently subjected to combined single-strand conformation polymorphism (SSCP) and heteroduplex (HTX) analysis. Despite the high sensitivity of almost 100%, differences could not be identified between hypertensives and normotensives within the two groups. These data indicate that at least in this population PMCA1 polymorphisms are presumably not related to common forms of essential hypertension. Furthermore, the high degree of evolutionary conservation of the PMCA1 gene underlines the pivotal role of this ATPase for cell physiology.