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https://www.readbyqxmd.com/read/28809988/methods-for-imputing-missing-efficacy-data-in-clinical-trials-of-biologic-psoriasis-therapies-implications-for-interpretations-of-trial-results
#1
Richard G B Langley, Kristian Reich, Charis Papavassilis, Todd Fox, Yankun Gong, Achim Gu Ttner
<p>BACKGROUND: An issue in long-term clinical trials of biologics in psoriasis is how to handle missing efficacy data. This methodological challenge may not be understood by clinicians, yet can have a significant effect on the interpretation of clinical trials.</p> <p>OBJECTIVE Evaluate the effects of different data imputation methods on apparent secukinumab response rates.</p> <p>METHODS: Post hoc analyses were conducted on efficacy data from 2 phase III, multicenter, randomized, double-blind trials (FIXTURE and ERASURE) of secukinumab in moderate to severe plaque psoriasis...
August 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28806966/an-exploratory-study-assessing-psychological-distress-of-indigents-in-burkina-faso-a-step-forward-in-understanding-mental-health-needs-in-west-africa
#2
Émilie Pigeon-Gagné, Ghayga Hassan, Maurice Yaogo, Valéry Ridde
BACKGROUND: Poverty is known as an important determinant of health, but empirical data are still missing on the relationships between poverty, other adverse living conditions, and psychological distress, particularly in low-income countries. This study aimed to assess mental health needs and psychological distress among the poorest in rural settings in Burkina Faso where food security and access to water, electricity, schooling, and healthcare are limited. METHODS: We randomly selected 2000 individuals previously identified as indigents by a community-targeting process...
August 14, 2017: International Journal for Equity in Health
https://www.readbyqxmd.com/read/28799963/factors-associated-with-health-related-quality-of-life-in-patients-with-open-fractures
#3
Sheila Sprague, Brad A Petrisor, Kyle J Jeray, Paula McKay, Taryn Scott, Diane Heels-Ansdell, Emil H Schemitsch, Susan Liew, Gordon H Guyatt, Stephen D Walter, Mohit Bhandari
OBJECTIVES: To analyze FLOW data to identify baseline patient, injury, fracture, and treatment factors associated with lower HRQL at 12-months post-fracture. DESIGN: Prognostic study using data from a prospective randomized controlled trial. SETTING: 31 clinical centers in the United States, Canada, Australia, and India. PATIENTS/PARTICIPANTS: 1427 open fracture patients from the FLOW trial with complete 12-month Short Form-12 (SF-12) follow-up assessment and no missing data for selected baseline factors...
July 26, 2017: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/28799171/outcomes-with-a-posterior-reduced-dental-arch-a-randomized-controlled-trial
#4
Saadika Khan, Usuf Mohammed Chikte, Ridwaan Omar
OBJECTIVE: To compare function, patient satisfaction and quality of life of patients with a posterior reduced mandibular arch with those who had all missing teeth replaced with removable partial dentures. METHODS: Patients with at least 3 and not more than 6 posterior occluding pairs of teeth were enrolled sequentially and randomized into one of two treatment groups: a denture and no denture group. A research assistant allocated interventions; concealment was ensured using opaque-sealed envelopes...
August 11, 2017: Journal of Oral Rehabilitation
https://www.readbyqxmd.com/read/28796882/cytology-versus-hpv-testing-for-cervical-cancer-screening-in-the-general-population
#5
REVIEW
George Koliopoulos, Victoria N Nyaga, Nancy Santesso, Andrew Bryant, Pierre Pl Martin-Hirsch, Reem A Mustafa, Holger Schünemann, Evangelos Paraskevaidis, Marc Arbyn
BACKGROUND: Cervical cancer screening has traditionally been based on cervical cytology. Given the aetiological relationship between human papillomavirus (HPV) infection and cervical carcinogenesis, HPV testing has been proposed as an alternative screening test. OBJECTIVES: To determine the diagnostic accuracy of HPV testing for detecting histologically confirmed cervical intraepithelial neoplasias (CIN) of grade 2 or worse (CIN 2+), including adenocarcinoma in situ, in women participating in primary cervical cancer screening; and how it compares to the accuracy of cytological testing (liquid-based and conventional) at various thresholds...
August 10, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28794617/sociodemographic-profile-and-predictors-of-outpatient-clinic-attendance-among-hiv-positive-patients-initiating-antiretroviral-therapy-in-selangor-malaysia
#6
Surajudeen Abiola Abdulrahman, Lekhraj Rampal, Norlijah Othman, Faisal Ibrahim, Kadir Shahar Hayati, Anuradha P Radhakrishnan
BACKGROUND: Inconsistent literature evidence suggests that sociodemographic, economic, and system- and patient-related factors are associated with clinic attendance among the HIV-positive population receiving antiretroviral therapy (ART) around the world. We examined the factors that predict outpatient clinic attendance among a cohort of HIV-positive patients initiating ART in Selangor, Malaysia. PATIENTS AND METHODS: This cross-sectional study analyzed secondary data on outpatient clinic attendance and sociodemographic, economic, psychosocial, and patient-related factors among 242 adult Malaysian patients initiating ART in Selangor, Malaysia...
2017: Patient Preference and Adherence
https://www.readbyqxmd.com/read/28783884/a-pattern-mixture-model-approach-for-handling-missing-continuous-outcome-data-in-longitudinal-cluster-randomized-trials
#7
Mallorie H Fiero, Chiu-Hsieh Hsu, Melanie L Bell
We extend the pattern-mixture approach to handle missing continuous outcome data in longitudinal cluster randomized trials, which randomize groups of individuals to treatment arms, rather than the individuals themselves. Individuals who drop out at the same time point are grouped into the same dropout pattern. We approach extrapolation of the pattern-mixture model by applying multilevel multiple imputation, which imputes missing values while appropriately accounting for the hierarchical data structure found in cluster randomized trials...
August 7, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28783880/identifiability-and-estimation-of-causal-mediation-effects-with-missing-data
#8
Wei Li, Xiao-Hua Zhou
Mediation analysis is a standard approach to understanding how and why an intervention works in social and medical sciences. However, the presence of missing data, especially missing not at random data, poses a great challenge for the applicability of this approach in practice. Current methods for handling such missingness are still lacking in causal mediation analysis. In this article, we first show the identifiability of causal mediation effects with different types of missing outcomes under different missingness mechanisms...
August 7, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28780236/tenecteplase-versus-alteplase-for-management-of-acute-ischaemic-stroke-nor-test-a-phase-3-randomised-open-label-blinded-endpoint-trial
#9
Nicola Logallo, Vojtech Novotny, Jörg Assmus, Christopher E Kvistad, Lars Alteheld, Ole Morten Rønning, Bente Thommessen, Karl-Friedrich Amthor, Hege Ihle-Hansen, Martin Kurz, Håkon Tobro, Kamaljit Kaur, Magdalena Stankiewicz, Maria Carlsson, Åse Morsund, Titto Idicula, Anne Hege Aamodt, Christian Lund, Halvor Næss, Ulrike Waje-Andreassen, Lars Thomassen
BACKGROUND: Tenecteplase is a newer thrombolytic agent with some pharmacological advantages over alteplase. Previous phase 2 trials of tenecteplase in acute ischaemic stroke have shown promising results. We aimed to investigate the safety and efficacy of tenecteplase versus alteplase in patients with acute stroke who were eligible for intravenous thrombolysis. METHODS: This phase 3, randomised, open-label, blinded endpoint, superiority trial was done in 13 stroke units in Norway...
August 2, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28777450/self-management-interventions-including-action-plans-for-exacerbations-versus-usual-care-in-patients-with-chronic-obstructive-pulmonary-disease
#10
REVIEW
Anke Lenferink, Marjolein Brusse-Keizer, Paul Dlpm van der Valk, Peter A Frith, Marlies Zwerink, Evelyn M Monninkhof, Job van der Palen, Tanja W Effing
BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) self-management interventions should be structured but personalised and often multi-component, with goals of motivating, engaging and supporting the patients to positively adapt their behaviour(s) and develop skills to better manage disease. Exacerbation action plans are considered to be a key component of COPD self-management interventions. Studies assessing these interventions show contradictory results. In this Cochrane Review, we compared the effectiveness of COPD self-management interventions that include action plans for acute exacerbations of COPD (AECOPD) with usual care...
August 4, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28772310/development-and-initial-validation-of-a-consumer-questionnaire-to-predict-the-presence-of-ear-disease
#11
Samantha J Kleindienst, David A Zapala, Donald W Nielsen, James W Griffith, Dania Rishiq, Larry Lundy, Sumitrajit Dhar
Importance: The already large population of individuals with age- or noise-related hearing loss in the United States is increasing, yet hearing aids remain largely inaccessible. The recent decision by the US Food and Drug Administration to not enforce the medical examination prior to hearing aid fitting highlights the need to reengineer consumer protections when increasing accessibility. A self-administered tool to estimate ear disease risk would provide disease surveillance without posing an unreasonable barrier to hearing aid procurement...
August 3, 2017: JAMA Otolaryngology—Head & Neck Surgery
https://www.readbyqxmd.com/read/28766089/reweighted-estimators-for-additive-hazard-model-with-censoring-indicators-missing-at-random
#12
Xiaolin Chen, Jianwen Cai
Survival data with missing censoring indicators are frequently encountered in biomedical studies. In this paper, we consider statistical inference for this type of data under the additive hazard model. Reweighting methods based on simple and augmented inverse probability are proposed. The asymptotic properties of the proposed estimators are established. Furthermore, we provide a numerical technique for checking adequacy of the fitted model with missing censoring indicators. Our simulation results show that the proposed estimators outperform the simple and augmented inverse probability weighted estimators without reweighting...
August 1, 2017: Lifetime Data Analysis
https://www.readbyqxmd.com/read/28761069/evidence-for-treatment-by-biomarker-interaction-for-fda-approved-oncology-drugs-with-required-pharmacogenomic-biomarker-testing
#13
Alexandre Vivot, Isabelle Boutron, Geoffroy Béraud-Chaulet, Jean-David Zeitoun, Philippe Ravaud, Raphaël Porcher
For oncology drugs that were approved by the US Food and Drug Administration (FDA) and required pharmacogenomic biomarker testing, we describe 1) the use of enrichment (biomarker-positive patients) and a randomized controlled design by pre-approval trials and 2) the treatment-by-biomarker interaction. From the 137 drugs included in the FDA table, we selected the 22 oncology drugs with required genetic testing in their labels. These drugs corresponded to 35 approvals supported by 80 clinical studies included in the FDA medical officer reviews of efficacy...
July 31, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28756628/harnessing-electronic-healthcare-data-for-wound-care-research-wound-registry-analytic-guidelines-for-less-biased-analyses
#14
Marissa J Carter
Publications based on large healthcare databases that contain data pertaining to wound-related outcomes are starting to appear more frequently. However, concern exists in regard to study design adequacy, the methodology used to minimize misclassifications, bias, and confounding, and lack of full reporting. The STROBE guidelines were published to encourage fuller reporting of observational studies and have now been extended using the RECORD statement to better document routinely collected healthcare data. In this paper, elements of the RECORD statement have been used to create guidelines for study design, cohort matching, reporting criteria, and analysis frameworks in regard to analyses of populations involving comparative effectiveness research...
July 29, 2017: Wound Repair and Regeneration
https://www.readbyqxmd.com/read/28755437/phase-contrast-cell-detection-using-multi-level-classification
#15
Ehab Essa, Xianghua Xie
In this paper, we propose a fully automated learning based approach for detecting cells in time-lapse phase contrast images. The proposed system combines two machine learning approaches to achieve bottom-up image segmentation. We apply pixel-wise classification using random forests (RF) classifiers to determine the potential location of the cells. Each pixel is classified into four categories (cell, mitotic cell, halo effect, and background noise). Various image features are extracted at different scales to train the RF classifier...
July 28, 2017: International Journal for Numerical Methods in Biomedical Engineering
https://www.readbyqxmd.com/read/28755244/a-brief-smoking-cessation-advice-by-youth-counselors-for-the-smokers-in-the-hong-kong-quit-to-win-contest-2010-a-cluster-randomized-controlled-trial
#16
Sophia Siu Chee Chan, Yee Tak Derek Cheung, Yee Man Bonny Wong, Antonio Kwong, Vienna Lai, Tai-Hing Lam
Smoking cessation counseling by healthcare professionals is effective, but very few healthcare professionals can deliver these interventions in the busy clinical settings. This study aimed to evaluate the effectiveness of a brief smoking cessation advice delivered by briefly-trained youth counselors at the enrolment of an incentive-based smoking cessation campaign. The study design was a cluster 2-arm randomized controlled trial of 831 Chinese adult smokers who were recruited in public areas to participate in the Hong Kong Quit to Win Contest 2010...
July 28, 2017: Prevention Science: the Official Journal of the Society for Prevention Research
https://www.readbyqxmd.com/read/28753702/probe-based-endomicroscopy-for-in-vivo-detection-of-gastric-intestinal-metaplasia-and-neoplasia-a-multicenter-randomized-controlled-trial
#17
Xiu-Li Zuo, Zhen Li, Chang-Qing Li, You-You Zheng, Li-Dong Xu, Jie Chen, Rong Lin, Jun Song, Chao-Hui Yu, Min Yue, Qi Zhou, Zhi-Yan Liu, Yan-Qing Li
Background and study aims Owing to the indistinctive endoscopic appearance of gastric intestinal metaplasia (GIM), gastric intraepithelial neoplasia (GIN), and early gastric cancer (EGC), a significant number of such lesions may be missed during surveillance endoscopy. The aim of this clinical trial was to assess the value of combined computed virtual chromoendoscopy (flexible spectral imaging color enhancement [FICE]) and probe-based confocal laser endomicroscopy (pCLE) for in vivo detection of GIM, GIN, and EGC...
July 28, 2017: Endoscopy
https://www.readbyqxmd.com/read/28750905/automated-problem-list-generation-and-physicians-perspective-from-a-pilot-study
#18
Murthy V Devarakonda, Neil Mehta, Ching-Huei Tsou, Jennifer J Liang, Amy S Nowacki, John Eric Jelovsek
OBJECTIVE: An accurate, comprehensive and up-to-date problem list can help clinicians provide patient-centered care. Unfortunately, problem lists created and maintained in electronic health records by providers tend to be inaccurate, duplicative and out of date. With advances in machine learning and natural language processing, it is possible to automatically generate a problem list from the data in the EHR and keep it current. In this paper, we describe an automated problem list generation method and report on insights from a pilot study of physicians' assessment of the generated problem lists compared to existing providers-curated problem lists in an institution's EHR system...
September 2017: International Journal of Medical Informatics
https://www.readbyqxmd.com/read/28749571/l-ornithine-l-aspartate-in-bouts-of-overt-hepatic-encephalopathy
#19
Sandeep Singh Sidhu, Barjesh Chander Sharma, Omesh Goyal, Harsh Kishore, Navpreet Kaur
High quality data on efficacy of L-Ornithine L-Aspartate (LOLA) in cirrhotics with bouts of overt hepatic encephalopathy (OHE) is missing. We aimed to evaluate the efficacy of intravenous LOLA in reversal of bouts of OHE in cirrhotics. In this prospective double-blind randomized placebo controlled trial conducted at two tertiary care institutes in India, 370 cirrhotics with bouts of OHE were screened. After exclusion, 193 (52.16%) patients were randomized to receive either intravenous infusions of LOLA (n=98), 30 grams daily or Placebo (n=95) for 5 days...
July 27, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28749016/trends-in-study-design-and-the-statistical-methods-employed-in-a-leading-general-medicine-journal
#20
M Gosho, Y Sato, K Nagashima, S Takahashi
WHAT IS KNOWN AND OBJECTIVE: Study design and statistical methods have become core components of medical research, and the methodology has become more multifaceted and complicated over time. The study of the comprehensive details and current trends of study design and statistical methods is required to support the future implementation of well-planned clinical studies providing information about evidence-based medicine. Our purpose was to illustrate study design and statistical methods employed in recent medical literature...
July 27, 2017: Journal of Clinical Pharmacy and Therapeutics
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