bluuebunny/crossref_metadata_2025_split huggingface dataset:
Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?
Authors: Meyer Bernhard , Baranto Adad , Schils Frederic , Collignon Frederic , Zoega Bjorn , Tan Leong , LeHuec Jean-Charles ,   NICE Trial Study Group
Published: May 2017

Abstract

BACKGROUND
Standalone interspinous process devices (IPDs) to treat degenerative lumbar spinal stenosis with neurogenic intermittent claudication (NIC) have shown ambiguous results in the literature.

OBJECTIVE
To show that a minimally invasive percutaneous IPD is safe and noninferior to standalone decompressive surgery (SDS) for patients with degenerative lumbar spinal stenosis with NIC.

METHODS
A multicenter, international, randomized, controlled trial (RCT) was con- ducted. One hundred sixty-three patients, enrolled at 19 sites, were randomized 1:1 to treatment with IPD or SDS and were followed for 24 mo.

RESULTS
There was significant improvement in Zurich Claudication Questionnaire physical function, as mean percentage change from baseline, for both the IPD and the SDS groups at 12 mo (primary endpoint) and 24 mo (−32.3 ± 32.1, −37.5 ± 22.8; and −37.9 ± 21.7%, −35.2 ± 22.8, both P < .001). IPD treatment was not significantly noninferior (margin: 10%) to SDS treatment at 12 mo (P = .172) but was significantly noninferior at 24 mo (P = .005). Symptom severity, patient satisfaction, visual analog scale leg pain, and SF-36 improved in both groups over time. IPD showed lower mean surgical time and mean blood loss (24 ± 11 min and 6 ± 11 mL) compared to SDS (70 ± 39 min and 189 ± 148 mL, both P < .001). Reoperations at index level occurred in 18.2% of the patients in the IPD group and in 9.3% in the SDS group.

CONCLUSION
Confirming 3 recent RCTs, we could show that IPD as well as open decompression achieve similar results in relieving symptoms of NIC in highly selected patients. However, despite some advantages in secondary outcomes, a higher reoperation rate for IPD is confirmed.
Low Back Pain: Investigation of Biases in Outpatient Canadian Physical Therapy
Authors: Laliberté Maude , Mazer Barbara , Orozco Tatiana , Chilingaryan Gevorg , Williams-Jones Bryn , Hunt Matthew , Feldman Debbie Ehrmann 
Published: May 2017

Abstract

Background
Previous research suggested that physical therapy services can be influenced by patient characteristics (age, sex, socioeconomic status) or insurance status rather than their clinical need.

Objective
The aim of this study was to determine whether patient-related factors (age, sex, SES) and the source of reimbursement for physical therapy services (insurance status) influence wait time for, frequency of, and duration of physical therapy for low back pain.

Design
This study was an empirical cross-sectional online survey of Canadian physical therapy professionals (defined as including physical therapists and physical rehabilitation specialists).

Methods
A total of 846 physical therapy professionals received 1 of 24 different (and randomly selected) clinical vignettes (ie, patient case scenarios) and completed a 40-item questionnaire about how they would treat the fictional patient in the vignette as well as their professional clinical practice. Each vignette described a patient with low back pain but with variations in patient characteristics (age, sex, socioeconomic status) and insurance status (no insurance, private insurance, Workers’ Compensation Board insurance).

Results
The age, sex, and socioeconomic status of the fictional vignette patients did not affect how participants would provide service. However, vignette patients with Workers’ Compensation Board insurance would be seen more frequently than those with private insurance or no insurance. When asked explicitly, study participants stated that insurance status, age, and chronicity of the condition were not factors associated with wait time for, frequency of, or duration of treatment.

Limitations
This study used a standardized vignette patient and may not accurately represent physical therapy professionals’ actual clinical practice.

Conclusions
There appears to be an implicit professional bias in relation to patients’ insurance status; the resulting inequity in service provision highlights the need for further research as a basis for national guidelines to promote equity in access to and provision of quality physical therapy services.
The Crucible simulation: Behavioral simulation improves clinical leadership skills and understanding of complex health policy change
Authors: Cohen Daniel , Vlaev Ivo , McMahon Laurie , Harvey Sarah , Mitchell Andy , Borovoi Leah , Darzi Ara 
Published: May 2017

Background:
The Health and Social Care Act 2012 represents the most complex National Health Service reforms in history. High-quality clinical leadership is important for successful implementation of health service reform. However, little is known about the effectiveness of current leadership training.

Purpose:
This study describes the use of a behavioral simulation to improve the knowledge and leadership of a cohort of medical doctors expected to take leadership roles in the National Health Service.

Methodology:
A day-long behavioral simulation (The Crucible) was developed and run based on a fictitious but realistic health economy. Participants completed pre- and postsimulation questionnaires generating qualitative and quantitative data. Leadership skills, knowledge, and behavior change processes described by the “theory of planned behavior” were self-assessed pre- and postsimulation.

Results:
Sixty-nine medical doctors attended. Participants deemed the simulation immersive and relevant. Significant improvements were shown in perceived knowledge, capability, attitudes, subjective norms, intentions, and leadership competency following the program. Nearly one third of participants reported that they had implemented knowledge and skills from the simulation into practice within 4 weeks.

Conclusions:
This study systematically demonstrates the effectiveness of behavioral simulation for clinical management training and understanding of health policy reform. Potential future uses and strategies for analysis are discussed.

Practice Implications:
High-quality care requires understanding of health systems and strong leadership. Policymakers should consider the use of behavioral simulation to improve understanding of health service reform and development of leadership skills in clinicians, who readily adopt skills from simulation into everyday practice.
Reaction of the BCG Scar in the Acute Phase of Kawasaki Disease in Mexican Children
Authors: Garrido-García Luis Martín , Castillo-Moguel Ariel , Vázquez-Rivera Mirella , Cravioto Patricia , Fernando Galván 
Published: May 2017

Background:Kawasaki disease (KD) is an acute self-limited systemic vasculitis that primarily affects children <5 years old. There is no specific diagnostic test. A reaction at the Bacille Calmette-Guérin (BCG) inoculation site has been reported as a common finding in patients with KD where BCG vaccination is mandatory. The purpose of this study was to evaluate the frequency of reactivation of the BCG in Mexican children diagnosed with KD.Methods:A retrospective study of all patients diagnosed with KD from August 1, 1995, to August 31, 2015, at our Institution was performed. The clinical profile, laboratory results, treatment used and coronary artery abnormalities in the BCG reactive and the BCG nonreactive groups were analyzed and compared.Results:We included 399 patients with KD. Ninety-seven (24.3%) had BCG reaction at the inoculation site. The BCG(+) group was younger than the BCG(−) group (P< 0.000). There were 18 (18.55%) incomplete cases in the BCG(+) group compared with 65 (21.52%) in the BCG(−) group without statistical significance. The BCG+ group developed coronary artery aneurysms in 37 cases and the BCG(−) group developed coronary artery aneurysms in 111 cases without statistical significance. Multivariate analysis showed that younger age at diagnosis was the only variable associated with a reaction at the BCG inoculation site in patients with KD.Conclusions:In Mexico, a country with a National BCG Vaccination Program and a low incidence of KD, reaction at the BCG inoculation site could be a useful diagnostic sign of KD.
Borrelia miyamotoi Polymerase Chain Reaction Positivity on a Tick-Borne Disease Panel in an Endemic Region of Rhode Island
Authors: Fiorito Theresa M. , Reece Rebecca , Flanigan Timothy P. , Silverblatt Fredric J. 
Published: May 2017

Background

Borrelia miyamotoi is a newer cause of ixodid (hard-bodied) tick-borne illness. Because symptoms are generally nonspecific and pathognomonic clinical features are lacking, whole blood polymerase chain reaction (PCR) may be useful for confirming a diagnosis. A tick-borne disease panel (“TBD-3”) bundled with Borrelia species (including B. miyamotoi) PCR (“TBD-3M”) was offered for patients with suspicion of TBD during 2014–2015 at South County Hospital in Rhode Island, an endemic region for many tick-borne illnesses.

Materials and Methods
Imugen laboratory was queried for all TBD-3M panels and Borrelia PCR’s sent from South County Hospital patients between January 1, 2014, and August 31, 2015. One positive whole blood B. miyamotoi PCR sample (genus and species specific) was considered evidence for B. miyamotoi infection. Demographics, clinical presentations, coinfections, laboratory abnormalities, and treatment courses for B. miyamotoi disease were examined.

Results
A total of 2324 patients had a bundled tick-borne panel performed for unexplained fever and other symptoms. In addition, 258 patients had individual Borrelia PCR’s performed. Overall, 78 patients were positive for B. burgdorferi PCR (3.0% positivity rate) and 18 patients were positive for B. miyamotoi PCR (0.7% positivity rate). Most patients presented with a “summer influenza”–like illness (94% reporting fever). Sixteen of these 18 patients were empirically prescribed doxycycline. One patient was concomitantly positive for B. miyamotoi PCR, B. microti PCR, and IgM Lyme antibodies. Three additional B. miyamotoi positive patients had positive Lyme serology.

Conclusions

Borrelia whole blood PCR was bundled to a pre-existing tick-borne panel to potentially account for unexplained fevers and other nonlocalizing symptoms in high-risk patients. Treatment recommendations for B. miyamotoi are based on case reports of successful treatments in other causes of relapsing fever, and the same antibiotics regimens are used for both. The utility of B. miyamotoi PCR in first-line screening of patients with unexplained fever may be minimal, given the low positivity rate observed and uniform effective empiric treatments prescribed.
Real-Time Intracochlear Electrocochleography Obtained Directly Through a Cochlear Implant
Authors: Harris Michael S. , Riggs William Jason , Koka Kanthaiah , Litvak Leonid M. , Malhotra Prashant , Moberly Aaron C. , O’Connell Brendan P. , Holder Jourdan , Di Lella Federico Alberto , Boccio Carlos Mario , Wanna George B. , Labadie Robert F. , Adunka Oliver F. 
Published: May 2017

Hypothesis:
Utilizing the cochlear implant to record electrophysiologic responses during device placement is a feasible and efficacious technique for monitoring near real-time cochlear physiology during and following electrode insertion.

Background:
Minimizing intracochlear trauma during cochlear implantation has emerged as a highly researched area to help improve patient performance. Currently, conventional cochlear implant technology allows for the recording of electrically evoked compound action potentials (eCAPs). Acoustically evoked potentials may be more sensitive in detecting physiologic changes occurring as a result of electrode insertion. Electrocochleography obtained from within the cochlea allows hair cell and neural response monitoring along the cochlear spiral at locations where changes most likely would occur.

Methods:
Intracochlear electrocochleography (ECochG) was recorded from the cochlear implant during surgery in 14 subjects. A long acquisition time (54.5 ms), capable of measuring potentials from the low frequency-serving apical region of the cochlea (125 and 500 Hz) was employed. Two distinct intracochlear processing methods were used and compared in obtaining electrophysiologic data.

Results:
Measureable intracochlear ECochG responses were obtained from all 14 participants. The 1st harmonic distortions (cochlear microphonic and auditory nerve neurophonic) generally increased steadily with electrode insertion. Electrode and frequency scan following insertion revealed that response amplitude varied based on location of recording electrode and frequency of stimulation. Exquisite sensitivity to manipulation during round window muscle packing was demonstrated.

Conclusion:
Intracochlear ECochG recorded from the electrode array of the cochlear implant is a highly feasible technique that sheds light on cochlear micromechanics during cochlear implant electrode placement.
The Potential Return on Public Investment in Detecting Adverse Drug Effects
Authors: Huybrechts Krista F. , Desai Rishi J. , Park Moa , Gagne Joshua J. , Najafzadeh Mehdi , Avorn Jerry 
Published: May 2017

Background:
Many countries lack fully functional pharmacovigilance programs, and public budgets allocated to pharmacovigilance in industrialized countries remain low due to resource constraints and competing priorities.

Objective:
Using 3 case examples, we sought to estimate the public health and economic benefits resulting from public investment in active pharmacovigilance programs to detect adverse drug effects.

Research Design:
We assessed 3 examples in which early signals of safety hazards were not adequately recognized, resulting in continued exposure of a large number of patients to these drugs when safer and effective alternative treatments were available. The drug examples studied were rofecoxib, cerivastatin, and troglitazone. Using an individual patient simulation model and the health care system perspective, we estimated the potential costs that could have been averted by early systematic detection of safety hazards through the implementation of active surveillance programs.

Results:
We found that earlier drug withdrawal made possible by active safety surveillance would most likely have resulted in savings in direct medical costs of $773–$884 million for rofecoxib, $3–$10 million for cerivastatin, and $38–$63 million for troglitazone in the United States through the prevention of adverse events. By contrast, the yearly public investment in Food and Drug Administration initiated population-based pharmacovigilance activities in the United States is about $42.5 million at present.

Conclusion:
These examples illustrate a critical and economically justifiable role for active adverse effect surveillance in protecting the health of the public.
Perceived Impairment in Sports Participation in Adolescents With Inflammatory Bowel Diseases
Authors: Plevinsky Jill M. , Wojtowicz Andrea A. , Poulopoulos Natasha , Schneider Kristin L. , Greenley Rachel N. 
Published: May 2017

ABSTRACTObjective:Physical activity (PA) is important for adolescents with inflammatory bowel diseases (IBDs) given the increased risk of developing osteoporosis and the increased risk of IBD‐related complications among those with IBD and obesity. Symptoms such as fatigue, abdominal pain, nausea, and frequent bowel movements can interfere with PA. Sports participation is an important source of PA for adolescents; however, the extent to which IBD interferes with sports participation is unstudied. The present study aimed to examine demographic, health‐related, physical, and psychosocial correlates of perceived impairment in sports participation.Method:Seventy‐six adolescents (M[SD] = 14.5 [1.8] years, 45% girls) completed surveys of perceived impairment in sports participation, demographics, physical health, and psychosocial health. Physicians rated disease activity at enrolment. All participants were diagnosed with IBD for at least a year and prescribed a daily oral medication.Results:Nearly half of participants reported at least occasional interference in sports participation because of their IBD. Active disease (P = 0.014), older age (P = 0.006), and poorer disease‐specific quality of life, and quality of life in physical health and psychosocial domains were associated with greater impairment in sports participation in bivariate analyses (P < 0.001). In regression analyses, systemic disease‐related symptoms, body image concerns, and older age emerged as the strongest predictors of impairment in sports participation (P < 0.05).Conclusions:Older adolescents, those with greater systemic symptoms, and those with poorer body image may be particularly at risk for impairment in sports participation. Addressing barriers to sports participation may be a useful strategy in enhancing PA in this patient group.
Fornix Structural Connectivity and Allostatic Load: Empirical Evidence From Schizophrenia Patients and Healthy Controls
Authors: Savransky Anya , Chiappelli Joshua , Rowland Laura M. , Wisner Krista , Shukla Dinesh K. , Kochunov Peter , Hong L. Elliot 
Published: May 2017

ABSTRACTObjectiveThe fornix is a white matter tract carrying the fibers connecting the hippocampus and the hypothalamus, two essential stress-regulatory structures of the brain. We tested the hypothesis that allostatic load (AL), derived from a battery of peripheral biomarkers indexing the cumulative effects of stress, is associated with abnormalities in brain white matter microstructure, especially the fornix, and that higher AL may help explain the white matter abnormalities in schizophrenia.MethodsUsing 13 predefined biomarkers, we tested AL in 44 schizophrenic patients and 33 healthy controls. Diffusion tensor imaging was used to obtain fractional anisotropy (FA) values of the fornix and other white matter tracts.ResultsAL scores were significantly elevated in patients compared with controls (F(3,77) = 7.87,p= .006). AL was significantly and inversely correlated with FA of fornix in both controls (r= −.58,p= .001) and patients (r= −.36,p= .023). Several nominally significant (p< .05 but did not survive Bonferroni correction for multiple comparison) correlations were also observed between AL and FA of other white matter tracts in schizophrenic patients. However, the fornix was the only tract exhibiting a correlation with AL in both groups.ConclusionsThese results provide initial evidence that allostatic processes are linked to fornix microstructure in clinical participants.
Effectiveness of a Stepped, Collaborative, and Coordinated Health Care Network for Somatoform Disorders (Sofu-Net): A Controlled Cluster Cohort Study
Authors: Löwe Bernd , Piontek Katharina , Daubmann Anne , Härter Martin , Wegscheider Karl , König Hans-Helmut , Shedden-Mora Meike 
Published: May 2017

ABSTRACT

Objective
Stepped, collaborative, and coordinated approaches have been proposed as the optimal treatment strategy for somatic symptom and related disorders, but evidence supporting this strategy is lacking. The aim of this study was to assess the effectiveness of a guideline-based health care network for patients who are at high risk of somatoform disorder (Sofu-Net).

Methods
In a controlled, prospective, observer-blinded cluster cohort study, patients who were at high risk of somatoform disorder were recruited at 18 primary care practices in the Sofu-Net and at 15 primary care practices that provided care as usual (CAU). The primary outcome at 6-month follow-up was the rate at which the patients received mental health treatment since the establishment of Sofu-Net. The secondary outcomes included the patients' clinical symptom severity.

Results
A total of 119 patients in the Sofu-Net intervention group and 100 patients in the CAU control group who were at high risk of somatoform disorder were followed for 6 months. A significantly greater proportion of Sofu-Net patients than CAU patients received mental health treatment (47.9% versus 31.0%; odds ratio = 1.96; 95% confidence interval, 1.07–3.58). However, the Sofu-Net group did not show greater reductions in clinical symptom burden compared with the CAU group.

Conclusions
The treatment of somatoform disorders within a guideline-based health care network resulted in increased rates of mental health treatment but failed to improve patient clinical outcomes. Future investigations are needed to investigate the combined value of health care networks with specialized psychotherapy interventions in patients at high risk of somatic symptom and related disorders.

Trial Registration: ISRCTN55870770.
Impact of Mother–Infant Pair Clinics and Short-Text Messaging Service (SMS) Reminders on Retention of HIV-Infected Women and HIV-Exposed Infants in eMTCT Care in Malawi: A Cluster Randomized Trial
Authors: Mwapasa Victor , Joseph Jessica , Tchereni Timothy , Jousset Aurelie , Gunda Andrews 
Published: May 2017

Background:
Poor retention of mothers and HIV-exposed infants (HEIs) in HIV care threatens efforts to eliminate pediatric HIV. Novel strategies are required to address this challenge. We compared 12-month maternal and HEI postpartum retention in health facilities implementing the following HIV care delivery models: integrated HIV and maternal, neonatal, and child health services [mother–infant pair (MIP) clinics], MIP clinics plus short-text messaging service (SMS) reminders to prevent default (MIP + SMS), and standard of care (SOC).

Methods:
From May 2013 to August 2016, a cluster randomized trial was conducted in rural Malawi, which randomized 30 health facilities to the 3 service delivery models. HIV+ pregnant women and HEIs were enrolled and followed up to monitor compliance with prescheduled visits and retention. Log binomial regression, using generalized estimated equation, was used to assess the impact of the models on retention.

Results:
The trial enrolled 461, 493, and 396 HIV+ pregnant women and 386, 399, and 300 HEIs into the MIP, MIP + SMS, and SOC arms, respectively. Compared with the 12-month maternal retention rate in the SOC arm (22.2%), the rates were similar in the MIP arm [19.3%, risk ratio (RR): 0.85, 95% confidence interval (CI): 0.56 to 1.30] and in the MIP + SMS arm (24.9%, RR: 1.08, 95% CI: 0.87 to 1.35). Compared with the 12-month infant retention rate in the SOC arm (9.8%), the rates were similar in the MIP arm (8.0%, RR: 0.89, 95% CI: 0.31 to 2.58) and in the MIP + SMS arm (19.5%, RR: 1.40, 95% CI: 0.85 to 2.31).

Conclusions:
MIP and MIP + SMS service delivery models were ineffective in improving maternal and infant retention in rural Malawi.