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Adaptive trial design

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https://www.readbyqxmd.com/read/29234725/computerized-cognitive-training-for-older-diabetic-adults-at-risk-of-dementia-study-protocol-for-a-randomized-controlled-trial
#1
Rachel Bloom, Michal Schnaider-Beeri, Ramit Ravona-Springer, Anthony Heymann, Hai Dabush, Lior Bar, Shirel Slater, Yuri Rassovsky, Alex Bahar-Fuchs
Introduction: Older adults with type 2 diabetes are at high risk of cognitive decline and dementia and form an important target group for dementia risk reduction studies. Despite evidence that computerized cognitive training (CCT) may benefit cognitive performance in cognitively healthy older adults and those with mild cognitive impairment, whether CCT may benefit cognitive performance or improve disease self-management in older diabetic adults has not been studied to date. In addition, whether adaptive difficulty levels and tailoring of interventions to individuals' cognitive profile are superior to generic training remains to be established...
November 2017: Alzheimer's & Dementia: Translational Research & Clinical Interventions
https://www.readbyqxmd.com/read/29234504/the-effects-of-low-intensity-blood-flow-restricted-exercise-compared-with-conventional-resistance-training-on-the-clinical-outcomes-of-active-uk-military-personnel-following-a-3-week-in-patient-rehabilitation-programme-protocol-for-a-randomized-controlled-feasibility
#2
Peter Ladlow, Russell J Coppack, Shreshth Dharm-Datta, Dean Conway, Edward Sellon, Stephen D Patterson, Alexander N Bennett
Background: A challenge for rehabilitation practitioners lies in designing optimal exercise programmes that facilitate musculoskeletal (MSK) adaptations whilst simultaneously accommodating biological healing and the safe loading of an injured limb. A growing body of evidence supports the use of resistance training at a reduced load in combination with blood flow restriction (BFR) to enhance hypertrophic and strength responses in skeletal muscle. In-patient rehabilitation has a long tradition in the UK Military, however, the efficacy of low intensity (LI) BFR training has not been tested in this rehabilitation setting...
2017: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/29233085/an-oncology-clinical-trial-design-with-randomization-adaptive-to-both-short-and-long-term-responses
#3
Hao Liu, Xiao Lin, Xuelin Huang
In oncology clinical trials, both short-term response and long-term survival are important. We propose an urn-based adaptive randomization design to incorporate both of these two outcomes. While short-term response can update the randomization probability quickly to benefit the trial participants, long-term survival outcome can also change the randomization to favor the treatment arm with definitive therapeutic benefit. Using generalized Friedman's urn, we derive an explicit formula for the limiting distribution of the number of subjects assigned to each arm...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/29232697/self-management-of-type-2-diabetes-in-gulf-cooperation-council-countries-a-systematic-review
#4
Thamer Al Slamah, Barbara I Nicholl, Fatima Y Alslail, Craig A Melville
AIMS: This study aimed to systematically review intervention studies on self-management of type 2 diabetes in Gulf Cooperation Council (GCC) countries to determine the most effective self-management strategies for individuals with type 2 diabetes in this region. METHODS: A search strategy was developed using multiple databases: Medline and Embase (via Ovid), CINAHL (via EBSCO), and PubMed. Study and intervention characteristics, intervention structure, content, cultural adaptation, and outcomes were extracted from the included studies...
2017: PloS One
https://www.readbyqxmd.com/read/29220633/developing-adaptive-treatment-strategies-to-address-suicidal-risk-in-college-students-a-pilot-sequential-multiple-assignment-randomized-trial-smart
#5
Jacqueline Pistorello, David Jobes, Scott Compton, Nadia Samad Locey, Joseph C Walloch, Robert Gallop, Josephine S Au, Samantha K Noose, Maria Young, Jacquelyn Johnson, Yani Dickens, Patricia Chatham, Tami Jeffcoat, Georgia Dalto, Spondita Goswami
OBJECTIVES: This pilot study investigated the potential to utilize adaptive treatment strategies for treating moderate to severe suicidal risk among college students. This paper will describe the unique design and report on feasibility and acceptability findings. METHODS: A two-stage Sequential Multiple Assignment Randomized Trial (SMART) was conducted: In Stage 1, 62 suicidal college students were randomized to either a suicide-focused or a treatment-as-usual condition (4-8 weeks)...
December 8, 2017: Archives of Suicide Research: Official Journal of the International Academy for Suicide Research
https://www.readbyqxmd.com/read/29214573/post-approval-studies-for-rare-disease-treatments-and-orphan-drugs
#6
William C Maier, Ronald A Christensen, Patricia Anderson
Drug development involves a multi-stage process of drug discovery, animal studies and human clinical trials to assess the safety and efficacy of new medications. Rare disease drug development involves a much smaller number of affected patients, a predominance of pediatric patients and more complicated disease presentation. Post-approval studies are designed to address several limitations associated with the rare disease clinical trials.National and international regulatory agencies in the US and Europe have adopted similar approaches to requirements post-approval data for rare diseases and orphan drug indications...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29208017/a-multisession-evaluation-of-an-adaptive-competitive-arm-rehabilitation-game
#7
Maja Goršič, Imre Cikajlo, Nika Goljar, Domen Novak
BACKGROUND: People with neurological injuries such as stroke should exercise frequently and intensely to regain their motor abilities, but are generally hindered by lack of motivation. One way to increase motivation in rehabilitation is through competitive exercises, but such exercises have only been tested in single brief sessions and usually did not adapt difficulty to the patient's abilities. METHODS: We designed a competitive arm rehabilitation game for two players that dynamically adapts its difficulty to both players' abilities...
December 6, 2017: Journal of Neuroengineering and Rehabilitation
https://www.readbyqxmd.com/read/29207966/study-protocol-for-a-cluster-randomized-trial-to-compare-human-papillomavirus-based-cervical-cancer-screening-in-community-health-campaigns-versus-health-facilities-in-western-kenya
#8
Megan J Huchko, James G Kahn, Jennifer S Smith, Robert A Hiatt, Craig R Cohen, Elizabeth Bukusi
BACKGROUND: Despite guidelines for cervical cancer prevention in low-resource countries, a very small proportion of women in these settings undergo screening, and even fewer women are successfully treated. Using pilot data from western Kenya and World Health Organization recommendations, we developed a protocol to implement evidence-based cervical cancer screening and linkage to treatment strategies to the rural communities. We describe the protocol for a cluster-randomized trial to compare two implementation strategies for human-papillomavirus (HPV)-based cervical cancer screening program using metrics described in the RE-AIM (reach, efficacy, adaption, implementation and maintenance) framework...
December 6, 2017: BMC Cancer
https://www.readbyqxmd.com/read/29207572/fixed-and-adaptive-parallel-subgroup-specific-design-for-survival-outcomes-power-and-sample-size
#9
Miranta Antoniou, Andrea L Jorgensen, Ruwanthi Kolamunnage-Dona
Biomarker-guided clinical trial designs, which focus on testing the effectiveness of a biomarker-guided approach to treatment in improving patient health, have drawn considerable attention in the era of stratified medicine with many different designs being proposed in the literature. However, planning such trials to ensure they have sufficient power to test the relevant hypotheses can be challenging and the literature often lacks guidance in this regard. In this study, we focus on the parallel subgroup-specific design, which allows the evaluation of separate treatment effects in the biomarker-positive subgroup and biomarker-negative subgroup simultaneously...
December 4, 2017: Journal of Personalized Medicine
https://www.readbyqxmd.com/read/29206358/implementing-and-evaluating-early-intervention-for-children-with-autism-where-are-the-gaps-and-what-should-we-do
#10
Giacomo Vivanti, Connie Kasari, Jonathan Green, David Mandell, Melissa Maye, Kristelle Hudry
Despite recent advances, the evidence base supporting early intervention for young children with autism spectrum disorder (ASD) remains relatively sparse. The International Society for Autism Research (INSAR) recently sponsored a Special Interest Group (SIG) on Implementing and Evaluating Community-Based Early Intervention. Across three meetings, in 2015, 2016, and 2017, conveners of this SIG engaged >200 members to identify knowledge gaps and research priorities for moving the field forward. Here, we summarize the perspectives that emerged from group discussion at the SIG meetings as represented by scholars working actively in the field...
December 5, 2017: Autism Research: Official Journal of the International Society for Autism Research
https://www.readbyqxmd.com/read/29205206/applications-of-pharmacogenomics-in-regulatory-science-a-product-life-cycle-review
#11
W C Tan-Koi, P C Leow, Y Y Teo
With rapid developments of pharmacogenomics (PGx) and regulatory science, it is important to understand the current PGx integration in product life cycle, impact on clinical practice thus far and opportunities ahead. We conducted a cross-sectional review on PGx-related regulatory documents and implementation guidelines in the United States and Europe. Our review found that although PGx-related guidance in both markets span across the entire product life cycle, the scope of implementation guidelines varies across two continents...
December 5, 2017: Pharmacogenomics Journal
https://www.readbyqxmd.com/read/29203509/protocol-for-a-feasibility-study-and-randomised-pilot-trial-of-a-low-intensity-psychological-intervention-for-depression-in-adults-with-autism-the-autism-depression-trial-adept
#12
Ailsa Russell, Kate Cooper, Stephen Barton, Ian Ensum, Daisy Gaunt, Jeremy Horwood, Barry Ingham, David Kessler, Chris Metcalfe, Jeremy Parr, Dheeraj Rai, Nicola Wiles
INTRODUCTION: High rates of co-occurring depression are reported in autism spectrum disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive-behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group cognitive-behavioural therapy for co-occurring depression, but no randomised trials investigating low-intensity psychological interventions as recommended in clinical guidelines for mild-moderate depression...
December 3, 2017: BMJ Open
https://www.readbyqxmd.com/read/29202852/nutrition-education-for-cardiovascular-disease-prevention-in-individuals-with-spinal-cord-injuries-study-protocol-for-a-randomized-controlled-trial
#13
Jesse A Lieberman, Jacquelyn W McClelland, David C Goff, Elizabeth Racine, Michael F Dulin, William A Bauman, Janet Niemeier, Mark A Hirsch, H James Norton, Charity G Moore
BACKGROUND: Individuals with chronic spinal cord injuries (SCIs) have an increased prevalence of cardiovascular disease (CVD) and associated risk factors compared with age-matched control subjects. Exercise has been shown to improve selected CVD risk factors in individuals with SCI, but using nutrition education as an intervention has not been evaluated in this population. This paper describes our research plan for evaluating the effect of nutrition education on individuals with SCI. In the present study, called Eat Smart, Live Better, we are using a randomized controlled design to test an intervention adapted from an existing evidence-based program that showed a positive effect on nutrition knowledge and behavior of older adults from the general population...
December 4, 2017: Trials
https://www.readbyqxmd.com/read/29202708/erdo-a-framework-to-select-an-appropriate-randomization-procedure-for-clinical-trials
#14
Ralf-Dieter Hilgers, Diane Uschner, William F Rosenberger, Nicole Heussen
BACKGROUND: Randomization is considered to be a key feature to protect against bias in randomized clinical trials. Randomization induces comparability with respect to known and unknown covariates, mitigates selection bias, and provides a basis for inference. Although various randomization procedures have been proposed, no single procedure performs uniformly best. In the design phase of a clinical trial, the scientist has to decide which randomization procedure to use, taking into account the practical setting of the trial with respect to the potential of bias...
December 4, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/29202079/increasing-protocol-suitability-for-clinical-trials-in-sub-saharan-africa-a-mixed-methods-study
#15
Nerina Vischer, Constanze Pfeiffer, Jennifer Kealy, Christian Burri
Background: The trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa. Methods: We used an exploratory mixed methods design...
2017: Global Health Research and Policy
https://www.readbyqxmd.com/read/29198951/prospective-evaluation-of-chronic-pain-disorders-and-treatments
#16
REVIEW
Charles J Vierck, C Richard Chapman
BACKGROUND: The incidence of chronic pain is variable among individuals who have sustained traumatic or surgical injury. Also, treatments for pain rarely are effective consistently for a procedure or agent, and no therapies are considered effective for pain that is chronic. NEW METHOD: Difficulties with standard methods for conducting clinical trials call attention to a need for protocols that provide a new understanding of the development of and control over chronic pain...
November 30, 2017: Journal of Neuroscience Methods
https://www.readbyqxmd.com/read/29195615/pet-ct-for-lymphoma-post-therapy-response-assessment-in-hodgkin-lymphoma-and-diffuse-large-b-cell-lymphoma
#17
REVIEW
Carsten Kobe, Markus Dietlein, Dirk Hellwig
Over the course of many decades, combined chemotherapy and radiotherapy adapted to the stage of disease have become the optimal and standard treatment for Hodgkin lymphoma (HL) and diffuse large B-cell lymphoma. Besides achieving optimized cure rates of the underlying disease, reduction of toxicity has become a major goal. Since the introduction of FDG-PET for the staging and restaging of patients with lymphoma, a high predictive value of F-18-FDG-PET in response assessment has been observed. Several PET-response-guided therapy regimens have already been established, and even more PET-adapted study designs are being tested in large study groups...
January 2018: Seminars in Nuclear Medicine
https://www.readbyqxmd.com/read/29190182/checkpoint-inhibition-in-pediatric-hematologic-malignancies
#18
Kara L Davis, Archana M Agarwal, Anupam R Verma
Immune surveillance comprising of adaptive and innate immune systems is naturally designed to eliminate cancer development; overexpression of inhibitory receptors and their ligands prevent this check and lead to evasion and hence cancer progression and metastasis. The use of tumor-specific monoclonal antibodies (MAbs) targeting these checkpoint regulators is promising and has led to this novel field of cancer immunotherapy. The first antibody directed against cytotoxic T-lymphocyte associated protein 4 (CTLA-4), ipilimumab, showed promising results in clinical trials and was approved by the US Food and Drug Administration (FDA) for the treatment of metastatic melanoma in 2011...
November 30, 2017: Pediatric Hematology and Oncology
https://www.readbyqxmd.com/read/29188764/assessing-the-performance-of-methodological-search-filters-to-improve-the-efficiency-of-evidence-information-retrieval-five-literature-reviews-and-a-qualitative-study
#19
Carol Lefebvre, Julie Glanville, Sophie Beale, Charles Boachie, Steven Duffy, Cynthia Fraser, Jenny Harbour, Rachael McCool, Lynne Smith
BACKGROUND: Effective study identification is essential for conducting health research, developing clinical guidance and health policy and supporting health-care decision-making. Methodological search filters (combinations of search terms to capture a specific study design) can assist in searching to achieve this. OBJECTIVES: This project investigated the methods used to assess the performance of methodological search filters, the information that searchers require when choosing search filters and how that information could be better provided...
November 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29187552/implantable-computer-controlled-adaptive-multi-electrode-positioning-system-amep
#20
Enrico Ferrea, Lalitta Suriya-Arunroj, Dirk Hoehl, Uwe Thomas, Alexander Gail
Acute neuronal recordings performed with metal microelectrodes in non-human primates allow investigating the neural substrate of complex cognitive behaviors. Yet, the daily re-insertion and positioning of the electrodes prevents recording from many neurons simultaneously, limiting the suitability of these types of recordings for brain-computer-interface applications or for large-scale population statistical methods on a trial-by-trial basis. In contrast, chronically implanted multi-electrode arrays offer the opportunity to record from many neurons simultaneously, but immovable electrodes prevent optimization of the signal during and after implantation and cause the tissue response to progressively impair the transduced signal quality, thereby limiting the number of different neurons that can be recorded over the lifetime of the implant...
November 29, 2017: Journal of Neurophysiology
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