bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adaptive Designs with Discrete Test Statistics and Consideration of Overrunning
Authors: Burkhardt B. , Faldum A. , Schmidt R. 
Published: October 2015

Summary
Background: Interim analyses are used in clinical trials in order to enable early decisions for medical, ethical, and economic reasons. However, it appears unfeasible to stop a trial during such an interim analysis. New patients will thus enter the trial while the interim analysis is ongoing. Moreover, depending on the event kinetics of the specific disease, the trial design, and the corresponding endpoints, some patients might still be unevaluable at the interim analysis due to not yet completed follow-up. Occur-rence of these types of patients is characteristic for sequentially analyzed trials. Such patients are referred to as interim patients. In trials with multiple primary endpoints, another type of interim patients occurs. If some but not all null hypotheses can be rejected at the interim analysis, the trial might be continued to a second stage in order to answer the remaining questions. These second stage patients, however, provide new data to all trial questions including the already rejected ones and thus formally act as interim patients regarding the already rejected null hypotheses. Although all kinds of interim patients are not part of the interim analysis, the data collected on those patients have to be sent to the office of regulatory affairs and will be analyzed. If a smaller or contrasting treatment effect is observed in interim patients, this might lead to a withdrawal of an earlier superiority proof.
Objectives: Presently, interim patients and their data are usually not considered in the confirmatory test. We offer a strategy to deal with interim patients in sequentially analyzed trials with discrete test statistics. The method covers sequentially analyzed single-and multi-arm trials with one or multiple primary endpoints.
Methods: When planning adaptive designs, it is common practice to assume that the stage-wise p-values are independent and standard uniformly distributed under the null hypothesis. In the context of discrete test statistics, this implies conservative tests. We provide an algorithm which iteratively optimizes an initially given design while adjusting for both discreteness of test statistics and interim patients. The algorithm is described verbally, graphically and formally to facilitate immediate implementation in computer software.
Results: The optimized design exploits the aspired significance level better and is more powerful than the initial one. The algorithm applies to fixed sample and planned flexible adaptive designs for single- and multi-arm trials with one or multiple primary endpoints. The benefit increases with the number of interim patients.
Conclusions: When planning a trial with interim analyses, the rules for decisions must be adjusted to interim patients. Otherwise, the test procedure is conservative resulting in loss of power. This is essential in situations where the number of interim patients is important compared to the first stage, particularly in trials with multiple primary endpoints.
Patient Acceptability of the Yorkshire Dialysis Decision AID (YODDA) Booklet: A Prospective Non-Randomized Comparison Study across 6 Predialysis Services
Authors: Winterbottom Anna E. , Gavaruzzi Teresa , Mooney Andrew , Wilkie Martin , Davies Simon J. , Crane Dennis , Tupling Ken , Baxter Paul D. , Meads David M. , Mathers Nigel , Bekker Hilary L. 
Published: October 2015

Background Patients are satisfied with their kidney care but want more support in making dialysis choices. Predialysis leaflets vary across services, with few being sufficient to enable patients’ informed decision making. We describe the acceptability of a patient decision aid and feasibility of evaluating its effectiveness within usual predialysis practice. Methods Prospective non-randomized comparison design, Usual Care or Usual Care Plus Yorkshire Dialysis Decision Aid Booklet (+YoDDA), in 6 referral centers (Yorkshire-Humber, UK) for patients with sustained deterioration of kidney function. Consenting (C) patients completed questionnaires after predialysis consultation (T1), and 6 weeks later (T2). Measures assessed YoDDA's utility to support patients’ decisions and integration within usual care. Results Usual Care ( n = 105) and +YoDDA ( n = 84) participant characteristics were similar: male (62%), white (94%), age (mean = 62.6; standard deviation [SD] 14.4), kidney disease severity (glomerular filtration rate [eGFR] mean = 14.7; SD 3.7); decisional conflict was < 25; choice-preference for home versus hospital dialysis approximately 50:50. Patients valued receiving YoDDA, reading it on their own (96%), and sharing it with family (72%). The +YoDDA participants had higher scores for understanding kidney disease, reasoning about options, feeling in control, sharing their decision with family. Study engagement varied by center (estimated range 14 – 49%; mean 45%); participants varied in completion of decision quality measures. Conclusions Receiving YoDDA as part of predialysis education was valued and useful to patients with worsening kidney disease. Integrating YoDDA actively within predialysis programs will meet clinical guidelines and patient need to support dialysis decision making in the context of patients’ lifestyle.
Dino del Garbo et le pouvoir de l’imagination sur le corps
Authors: Robert Aurélien 
Published: October 2015

Dino del Garbo, médecin actif dans les premières décennies du xiv	e siècle, est surtout connu pour son commentaire au poème de Guido Cavalcanti Donna me prega . La présente étude propose l’édition d’une question quodlibétique sur la capacité de l’imagination à altérer le corps, disputée à Bologne ou Sienne dans les années 1320. Nous examinons le contexte médical et philosophique dans lequel s’inscrit cette question, en montrant notamment comment le débat s’est progressivement cristallisé autour de l’opposition entre un modèle avicennien et un modèle aristotélicien des rapports entre l’âme et le corps. L’analyse de ce débat permet d’éclairer d’un jour nouveau la glose de Dino del Garbo à Donna me prega et aussi, de manière incidente, le poème lui-même.
Baseline Indicators and Implementation Strategies in a Statewide Correctional Nurse Competencies Program: Mid-Year Report
Authors: Shelton Deborah , Reagan Louise , Weiskopf Constance , Panosky Denise , Nicholson Michael , Diaz Desiree 
Published: October 2015

Background:
This 3-year, public–academic workforce development project aimed to establish indicators for quality correctional nursing care to empirically test the translation of correctional nursing standards into practical and applied competencies.

Method:
Approaches to document indicators and achieve implementation of a correctional nurse competency system include (a) knowledge transfer and exchange, (b) system mapping, (c) adherence to implementation plan and strategy, and (d) practice-based action research.

Results:

Indicators were established. Twenty-five percent (
n
= 111) of nurses maintained clinical credentials beyond the basic requirements; 86% (
n
= 381) of nurses received continuing nursing education certificates, 98% (
n
= 434) of nurses were satisfied with the program, and 43% (
n
= 9,052) of inmate/patients were satisfied with clinical care. Quality ratings of program educators averaged 4.79 on a 5-point scale.

Conclusion:
Innovation is supported by adding continuous improvement components to the implementation of a correctional nurse competency system effort. Team members’ consensus decision making enabled them to apply their domain-specific knowledge to assess the success of the implementation strategy.

J Contin Educ Nurs.
2015;46(10):455–461.
Ophthalmological Findings of Turkish Children With Muscular Dystrophies
Authors: Ozer Pinar Altiaylik , Kabatas Emrah Utku , Ertugrul Gokce Tasdemir , Kurtul Bengi Ece , Aksoy Ayse , Yuksel Deniz , Ozkan Mehpare 
Published: October 2015

Purpose:
To present the results of ophthalmological examinations in children with muscular dystrophies and highlight the importance of their ophthalmological evaluation.

Methods:
Retrospective analysis of the ophthalmological examination records in 74 children with a type of muscular dystrophy, examined between January 2011 and January 2015, was performed.

Results:
The most common type of muscular dystrophy observed in our patients was Duchenne muscular dystrophy (67.5%), followed by Becker muscular dystrophy (9.4%), myotonic dystrophy (8%), limb-girdle muscular dystrophy (6.7%), merosin-negative muscular dystrophy (4%), and Ullrich muscular dystrophy (4%). Ten cases of Duchenne muscular dystrophy had both macular and retinal pigmentary changes (20%) and 9 had abnormal electroretinographies with decreased photopic and scotopic responses. Ptosis was the most common finding (83.3%). No abnormalities of light reflexes, pupil size, or saccadic and smooth pursuit movements were seen among cases with myotonic dystrophy.

Conclusions:
Ophthalmological problems are commonly seen in children with muscular dystrophies. Simple ophthalmological screening and early intervention can improve their communication skills by way of increasing their visual talents.

[
J Pediatr Ophthalmol Strabismus.
2015;52(5):311–316.]
The Characteristics and Short-term Refractive Error Outcomes of Cystoid Macular Edema in Premature Neonates as Detected by Spectral-Domain Optical Coherence Tomography
Authors: Bondalapati Sailaja , Milam Ronald W. , Ulrich J. Niklas , Cabrera Michelle T. 
Published: October 2015

BACKGROUND AND OBJECTIVE:
To explore characteristics associated with cystoid macular edema (CME) in neonates screened for retinopathy of prematurity (ROP).

PATIENTS AND METHODS:
In this institutional review board-approved, prospective, observational study, premature neonates underwent imaging with handheld spectral-domain optical coherence tomography.

RESULTS:

Of 73 included infants (median gestational age [GA]: 28 weeks, range 23–33 weeks; birth weight: 966 g, range 506 g – 1695 g), 28 (38%) had CME and 17/28 (61%) had ROP. CME was associated with ROP (
P
= .03) and younger GA (
P
= .04), but not associated with sex, race, birth weight, postmenstrual age at imaging, ROP severity, or myopia at median 6 months corrected age. CME resolved in three cases after bevacizumab treatment for type 1 ROP and in five cases without treatment. CME appeared in two cases several weeks following injections.

CONCLUSION:
CME was associated with ROP and younger GA, but not with myopia. Intravitreal bevacizumab for type 1 ROP has inconclusive effects on CME.

[
Ophthalmic Surg Lasers Imaging Retina
. 2015;46:806–812.]
SLO-Microperimetry in Wet Age-Related Macular Degeneration During Anti-VEGF Therapy
Authors: Hartmann Kathrin I. , Oster Stephen F. , Amini Payam , Bartsch Dirk-Uwe , Cheng Lingyun , Freeman William R. 
Published: October 2015

BACKGROUND AND OBJECTIVE:
To evaluate the morphological and functional outcome of wet age-related macular degeneration (AMD) during antivascular endothelial growth factor therapy with bevacizumab using SLO microperimetry (SLO-MP) with eye tracking.

PATIENTS AND METHODS:
First, reproducibility was tested over the choroidal neovascularization (CNV) in 21 eyes of 19 patients with wet AMD. Second, 21 eyes of 19 patients with active CNV were studied longitudinally during bevacizumab therapy. Best-corrected visual acuity, SLO-MP, spectral-domain optical coherence tomography and fluorescein angiography were performed.

RESULTS:

There was good reproducibility with a concordance correlation coefficient of 0.85. In the longitudinal study, eyes with anatomical response demonstrated a significant increase of retinal sensitivity. Non-responders showed no change in SLO-MP. Retinal sensitivity at baseline had a significant predictive value for the change in retinal sensitivity during therapy with bevacizumab (
P
= .032).

CONCLUSION:
SLO-MP is able to analyze retinal function overlying lesions in wet AMD and can be a useful tool to monitor therapy in patients with macular diseases.

[
Ophthalmic Surg Lasers Imaging Retina
. 2015;46:824–830.]
A Monte Carlo Analysis of Alternative Meta-Analysis Estimators in the Presence of Publication Bias
Authors: Reed W. Robert 
Published: October 2015

AbstractA meta-analysis (MA) aggregates estimated effects from many studies to calculate a single, overall effect. There is no one, generally accepted procedure for how to do this. Several estimators are commonly used, though little is known about their relative performance. A complication arises when the sample of published studies is subject to sample selection due to “publication bias.” This study uses Monte Carlo simulations to investigate the performance of five different MA estimators in the presence of publication bias. The author considers two kinds of publication bias: publication bias directed against statistically insignificant estimates, and publication bias directed against wrong-signed estimates. The experiments simulate two data environments. In the Random Effects environment, each study produces only one estimate and the true effect differs across studies. In the Panel Random Effects environment, each study produces multiple estimates, and the true effect differs both within and across studies. The simulations produce a number of findings that challenge results from previous research.
Law and Corporate Behaviour
Authors: Hodges Christopher 
Published: October 2015

This book examines the theories and practice of how to control corporate behaviour through legal techniques. The principal theories examined are deterrence, economic rational acting, responsive regulation, and the findings of behavioural psychology. Leading examples of the various approaches are given in order to illustrate the models: private enforcement of law through litigation in the USA, public enforcement of competition law by the European Commission, and the recent reform of policies on public enforcement of regulatory law in the United Kingdom. Noting that behavioural psychology has as yet had only limited application in legal and regulatory theory, the book then analyses various European regulatory structures where behavioural techniques can be seen or could be applied. Sectors examined include financial services, civil aviation, pharmaceuticals, and workplace health and safety. Key findings are that ‘enforcement’ has to focus on identifying the causes of non-compliance, so as to be able to support improved performance, rather than be based on fear motivating complete compliance. Systems in which reporting is essential for safety only function with a no-blame culture. The book concludes by proposing an holistic model for maximising compliance within large organisations, combining public regulatory and criminal controls with internal corporate systems and external influences by stakeholders, held together by a unified core of ethical principles. Hence, the book proposes a new theory of ethical regulation.
Volume 3 in the series Civil Justice Systems
Bilateral Type III Duane Syndrome: A Case Report
Authors: García Esperanza , Fernández De Arévalo Bernardo T. , Arévalo Eva M. , Mhanna Hasan , Alija María 
Published: October 2015

Purpose Duane syndrome (DS) belongs to a group of congenital retraction syndromes, the incidence of which varies between 2% and 4% in patients with strabismus. In most cases the damage is unilateral, but it manifests as bilateral in about 20% of cases. According to the classification of Huber, type III DS exhibits a limitation of abduction and adduction. Methods We report the case of a 5-year-old boy from Eastern Europe who was taken to the hospital because he was unable to move both eyes horizontally from birth and had not been previously seen by an ophthalmologist. Results The examination showed inability to abduct and adduct bilaterally, with narrowing of the palpebral fissures on attempted adduction. The patient was diagnosed with bilateral type III DS. Conclusions Treatment is individualized on a case-by-case basis. For our patient, monitoring by way of regular checkups was chosen, with the parents rejecting surgery for now.
Intravitreal Ranibizumab for Choroidal Neovascularization Secondary to Gyrate Atrophy in a Young Patient: A Multimodal Imaging Analysis
Authors: Chatziralli Irini , Theodossiadis George , Emfietzoglou Ioannis , Theodossiadis Panagiotis 
Published: October 2015

Purpose To present a case of choroidal neovascularization (CNV) due to gyrate atrophy (GA) treated with intravitreal ranibizumab. Methods A 35-year-old man presented with sudden loss of vision and central scotoma in the right eye, as well as progressive night vision deterioration over the past several years in both eyes. His best-corrected visual acuity (BCVA) was 6/60 in the right eye and 6/5 in the left eye. Funduscopy revealed bilateral confluent areas of chorioretinal atrophy and optical coherence tomography showed subretinal fluid consistent with CNV development in the right eye, which was confirmed by fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA). The left eye was normal. The patient had a family history of GA. Elevated levels of plasma ornithine were detected, establishing the diagnosis. Results The patient received a regimen of 3 monthly off-label intravitreal ranibizumab injections in the right eye. At the 6-month follow-up, no subretinal fluid was noticed and BCVA was 6/48. No other injections were performed, but the patient was advised to start an arginine-restricted diet and take vitamin B6 (pyridoxine) 300 mg daily. The BCVA was preserved and chorioretinal atrophy had not progressed on funduscopy, FFA, or ICGA 1 year later. Conclusions Intravitreal ranibizumab can offer promising anatomical and functional results, maintaining visual acuity in patients with CNV secondary to GA, especially if used in combination with arginine-restricted diet and vitamin B6 supplementation.
Prevalence of Reticular Pseudodrusen in Eyes with Newly Presenting Neovascular Age-Related Macular Degeneration
Authors: Wilde Craig , Patel Moneesh , Lakshmanan Arun , Morales Marco A. , Dhar-Munshi Sushma , Amoaku Winfried M.K. 
Published: October 2015

Purpose To use multimodal imaging to evaluate the prevalence of reticular pseudodrusen (RPD) in eyes with newly presenting neovascular age-related macular degeneration (nAMD) in a UK population and explore associations with RPD and angiographic subtypes of nAMD. Methods A retrospective review of all spectral-domain optical coherence tomography, color fundus photographs, red-free and blue channel images, and fundus fluorescein angiograms of 202 consecutive patients who presented to a rapid access macular clinic over a 4-year period was performed. All images were graded by at least 2 ophthalmologists for the presence of RPD and choroidal neovascular membrane (CNV) subtypes. Results A total of 231 consecutive eyes were studied, of which 131 (56.7%) were in women. Of these, 51 eyes with CNV (22.1%) had identifiable RPD, with one or more imaging methods in that eye. A total of 30.3% of patients with newly presenting CNV in either or both eyes had identifiable RPD. The RPD were bilateral in 85.4% of patients and were identified more commonly in women than men (72.5% vs 27.5%), a difference that reached statistical significance (p = 0.011). No association between RPD and any particular CNV subtype was demonstrated, including for retinal angiomatous proliferations (RAP). Conclusions Reticular pseudodrusen have a high prevalence in eyes presenting with nAMD (22.1%), although at rates much lower than that of conventional drusen. They are largely a bilateral finding, occurring more frequently in women. Unlike other previous reports, we found no difference in their occurrence between the different subtypes of CNV including RAPs.
Phacoemulsification at High-Altitude Himalayan Region: Comparison
Authors: Parihar Jitendra Kumar Singh , Chaturvedi Piyush , Kaushik Jaya , Jain Vaibhav Kumar , Mukherjee Shantanu , Mishra Sanjay Kumar 
Published: October 2015

Purpose To compare phacoemulsification parameters at different high-altitude regions as well as between peristaltic and Venturi-based machines. Methods In this prospective, nonrandomized clinical study, 160 eyes of 160 patients with senile cataract underwent phacoemulsification using either peristaltic or Venturi system at a high-altitude Himalayan region (>10,000 feet). Patients (n = 200, including 100 each with either peristaltic or Venturi system) operated at mean altitude of 1115 feet (Delhi) were included as controls (group 1). At Leh (11,203 feet), 110 patients were operated with peristaltic (62) or Venturi (48) system (group 2), whereas 50 patients (group 3) (peristaltic = 37; Venturi = 13) were operated either with peristaltic (37) or Venturi (13) system at Tangtse (14,106 feet). Intraoperative parameters–i.e., bottle height (BH), vacuum (V), and flow rate (FR)–were compared for different phacoemulsification steps–i.e., central chopping (CC), segment removal (SR), epinucleus removal (ER), and cortex removal (CR)–between all groups and between peristaltic and Venturi pump-based machines in each group. Results Mean BH, V, and FR for CC, SR, ER, and CR significantly increased with the increment in altitude of surgery (p = 0.000). Venturi and peristaltic-based phacoemulsification showed higher values of the mean BH and V, respectively, for CC, SR, ER, and CR at Leh as well as Tangtse. Conclusions At the high-altitude region, the higher setting of BH, FR, and V is required in phacoemulsification.
Vitrectomy without Laser Treatment for Macular Serous Detachment Associated with Optic Disc Pit: Long-Term Outcomes
Authors: Talli Pietro Maria , Fantaguzzi Paolo Maria , Bendo Edlira , Pazzaglia Alberto 
Published: October 2015

Purpose To evaluate the clinical outcome of surgical treatment for macular serous detachment associated with optic disc pit with pars plana vitrectomy (PPV) without laser photocoagulation on the temporal edge. Methods Vitrectomy was performed in 8 eyes of 8 patients (mean age 27.25 years; range 12-57 years) with unilateral macular detachment associated with optic disc pit. All patients underwent pars plana vitrectomy (cases 1, 2, 3, and 4, PPV 20 G; cases 5, 6, 7, and 8, PPV 25 G), internal limiting membrane (ILM) peeling, and SF6 20% gas tamponade (case 1 was treated with silicone oil tamponade). Endolaser on the temporal margin of the optic disk was not performed. Every patient was observed for a follow-up period of 59.25 months after surgery. Statistical analysis was carried out using Student t test paired data. p Value <0.05 was considered to be significant. Results Complete retinal reattachment was achieved in 7 of 8 patients. Case 8 was operated 11 months ago and he still has a small area of subretinal fluid not completely reabsorbed. Mean preoperative best-corrected visual acuity (BCVA) was 20/83 and the mean postoperative BCVA was 20/40. Mean preoperative foveal thickness was 973 μm and mean postoperative foveal thickness was 363.5 μm. Case 7 developed a macular hole after treatment. Conclusions Pars plana vitrectomy, ILM peeling, and endotamponade (SF6 20% gas) without endolaser on the temporal edge of optic disc is an effective treatment. This procedure achieved successful anatomical and functional results.