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Adaptive trial design

Luke Osborn, Rahul Kaliki, Alcimar Soares, Nitish Thakor
Upper limb amputees lack the valuable tactile sensing that helps provide context about the surrounding environment. Here we utilize tactile information to provide active touch feedback to a prosthetic hand. First, we developed fingertip tactile sensors for producing biomimetic spiking responses for monitoring contact, release, and slip of an object grasped by a prosthetic hand. We convert the sensor output into pulses, mimicking the rapid and slowly adapting spiking responses of receptor afferents found in the human body...
April 2016: IEEE Transactions on Haptics
Helena S Stöckle, Sigrid Haarmann-Doetkotte, Claudia Bausewein, Martin J Fegg
BACKGROUND: Existential behavioural therapy (EBT) is a recently developed intervention to support informal caregivers of patients in a specialist palliative care unit and was initially established as a six-session group programme. This pilot study aimed to test the feasibility and acceptability of an adapted short-term, individual approach of EBT in preparation for a randomized controlled trial (RCT). METHODS: The study was conducted in a prospective, mixed methods design including four quantitiative assessments with embedded qualitative interviews at one assessment...
October 24, 2016: BMC Palliative Care
Wentian Guo, Yuan Ji, Daniel V T Catenacci
In precision medicine, a patient is treated with targeted therapies that are predicted to be effective based on the patient's baseline characteristics such as biomarker profiles. Oftentimes, patient subgroups are unknown and must be learned through inference using observed data. We present SCUBA, a Subgroup ClUster-based Bayesian Adaptive design aiming to fulfill two simultaneous goals in a clinical trial, 1) to treatments enrich the allocation of each subgroup of patients to their precision and desirable treatments and 2) to report multiple subgroup-treatment pairs (STPs)...
October 24, 2016: Biometrics
Cathleen E Willging, Amy E Green, Mary M Ramos
BACKGROUND: Reducing youth suicide in the United States (U.S.) is a national public health priority, and lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ) youth are at elevated risk. The Centers for Disease Control and Prevention (CDC) endorses six evidence-based (EB) strategies that center on meeting the needs of LGBTQ youth in schools; however, fewer than 6 % of U.S. schools implement all of them. The proposed intervention model, "RLAS" (Implementing School Nursing Strategies to Reduce LGBTQ Adolescent Suicide), builds on the Exploration, Preparation, Implementation, and Sustainment (EPIS) conceptual framework and the Dynamic Adaptation Process (DAP) to implement EB strategies in U...
October 22, 2016: Implementation Science: IS
Denise M Hynes, Michael Fischer, Linda A Schiffer, Rani Gallardo, Ifeanyi Beverly Chukwudozie, Anna Porter, Michael Berbaum, Jennifer Earheart, Marian L Fitzgibbon
INTRODUCTION: Using a quasi-experimental design, we implemented the Patient-Centered Medical Home for Kidney Disease (PCMH-KD), a comprehensive, multidisciplinary care team to improve quality of life and healthcare coordination for adult chronic hemodialysis (CHD) patients. This paper highlights our experience in the first two years of the study.We focus on the process dimensions of Reach, Adoption, and Implementation within the context of the RE-AIM framework. MATERIALS AND METHODS: We established a new PCMH-KD model at two outpatient dialysis centers...
October 18, 2016: Contemporary Clinical Trials
Allan Riis, Cathrine Elgaard Jensen, Flemming Bro, Helle Terkildsen Maindal, Karin Dam Petersen, Mette Dahl Bendtsen, Martin Bach Jensen
BACKGROUND: Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS). METHODS: In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate...
October 21, 2016: Implementation Science: IS
Michelle A Giuffrida
OBJECTIVE To evaluate methods used to ascertain, define, and report adverse events (AEs) in companion animal clinical trials involving cancer treatment. DESIGN Systematic review. SAMPLE English-language articles describing prospective clinical trials involving dogs and cats with naturally occurring cancer published in peer-reviewed journals between 2008 and 2014. PROCEDURES Reports were identified via MEDLINE and CAB database searches combined with a hand-searching strategy. General article characteristics were abstracted and summarized...
November 1, 2016: Journal of the American Veterinary Medical Association
Geerte C Den Hollander, Joyce L Browne, Daniel Arhinful, Rieke van der Graaf, Kerstin Klipstein-Grobusch
To address the burden of maternal morbidity and mortality in low- and middle-income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC-context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle-income setting. This qualitative research used participant observation, in-depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana...
October 20, 2016: Developing World Bioethics
Karol Kumpfer, Catia Magalhães, Jing Xie
Family evidence-based interventions (FEBIs) are effective in creating lasting improvements and preventing children's behavioral health problems, even in genetically at-risk children. Most FEBIs, however, were designed for English-speaking families. Consequently, providers have difficulty engaging non-English-speaking populations in their own country or in other countries where the content, language, and recruitment methods of the FEBIs do not reflect their culture. The practical solution has been to culturally adapt existing FEBIs...
October 18, 2016: Prevention Science: the Official Journal of the Society for Prevention Research
Laura M Gault, Robert A Lenz, Craig W Ritchie, Andreas Meier, Ahmed A Othman, Qi Tang, Scott Berry, Yili Pritchett, Weining Z Robieson
BACKGROUND: Results from a phase 2a study indicated that treatment with the novel α7 nicotinic acetylcholine receptor agonist ABT-126 25 mg once daily (QD) was associated with a trend for improvement in cognition in subjects with mild-to-moderate Alzheimer's dementia (AD). A phase 2b program was designed to evaluate a broader dose range of ABT-126 as monotherapy in subjects with mild-to-moderate AD. The program consisted of a double-blind, placebo and active controlled study of ABT-126 (dose range 25-75 mg) and an open-label extension study (75 mg)...
October 18, 2016: Alzheimer's Research & Therapy
Dawn P Gill, Wendy Blunt, Ashleigh De Cruz, Brendan Riggin, Kate Hunt, Guangyong Zou, Shannon Sibbald, Karen Danylchuk, Merrick Zwarenstein, Cindy M Gray, Sally Wyke, Christopher Bunn, Robert J Petrella
BACKGROUND: Effective approaches that engage men in weight loss and lifestyle change are important because of worldwide increases, including in Canada, in obesity and chronic diseases. Football Fans in Training (FFIT), developed in Scotland, successfully tackled these problems by engaging overweight/obese male football fans in sustained weight loss and positive health behaviours, through program deliveries at professional football stadia. METHODS: Aims: 1) Adapt FFIT to hockey within the Canadian context and integrate with HealtheSteps™ (evidence-based lifestyle program) to develop Hockey Fans in Training (Hockey FIT); 2) Explore potential for Hockey FIT to help overweight/obese men lose weight and improve other outcomes by 12 weeks, and retain these improvements to 12 months; 3) Evaluate feasibility of recruiting and retaining overweight/obese men; 4) Evaluate acceptability of Hockey FIT; and 5) Conduct program optimization via a process evaluation...
October 19, 2016: BMC Public Health
Peter C Wever, Mike B J M Korst, Maarten Otte
In December 1913, a board of medical officers was appointed to adapt new U.S. Army equipment to the needs of the Hospital Corps. One of the improvements concerned substitution of the satchel-like Hospital Corps pouch used to carry first aid equipment. A waist belt with 10 pockets, known as the medical belt, was devised, and supplied with a tourniquet, adhesive plaster, safety pins, iodine swabs, sublimated gauze, individual dressing packets, gauze bandages, aromatic spirit of ammonia, and common pins. In addition, an ax carrier accommodating a hand ax, a canteen hanger, and a pouch to carry diagnosis tags and instruments were attached to the medical belt...
October 2016: Military Medicine
Alex S Ribeiro, Brad J Schoenfeld, Steven J Fleck, Fábio L C Pina, Matheus A Nascimento, Edilson S Cyrino
The purpose of the present study was to investigate the effect of resistance training (RT) performed in a pyramid (PR) versus a traditional (TD) system on muscular strength, muscle mass, and hormonal responses in older women. Twenty-five older women (67.6 ± 5.1 years, 65.9 ± 11.1 kg, 154.7 ± 5.8 cm, and 27.5 ± 4.5 kg m) performed both a TD and PR system RT program in a balanced crossover design. The TD program consisted of 3 sets of 8-12 RM with a constant load for the 3 sets, whereas the PR system consisted of 3 sets of 12/10/8 RM with incrementally higher loads for each set...
September 23, 2016: Journal of Strength and Conditioning Research
Emily F Law, Jessica L Fales, Sarah E Beals-Erickson, Alessandro Failo, Deirdre Logan, Edin Randall, Karen Weiss, Lindsay Durkin, Tonya M Palermo
OBJECTIVE : To adapt problem-solving skills training (PSST) for parents of children receiving intensive pain rehabilitation and evaluate treatment feasibility, acceptability, and satisfaction. METHODS : Using a prospective single-arm case series design, we evaluated the feasibility of delivering PSST to 26 parents (84.6% female) from one of three pediatric pain rehabilitation programs. Parents completed four to six sessions of PSST delivered during a 2-4-week period. A mixed-methods approach was used to assess treatment acceptability and satisfaction...
October 15, 2016: Journal of Pediatric Psychology
Denise D Walker, Thomas O Walton, Clayton Neighbors, Debra Kaysen, Lyungai Mbilinyi, Jolee Darnell, Lindsey Rodriguez, Roger A Roffman
Objective: Alcohol use disorders (AUDs) are prevalent in the military and are a major public health concern. Although efficacious AUD interventions exist, few service members seek treatment. Army-specific barriers to AUD treatment include treatment being recorded on health records, command being notified of participation, and perceptions that seeking treatment would interfere with promotion or retention in the military. Evaluate a telephone delivered motivational interviewing plus feedback (MIF) intervention designed to attract self-referral and reduce substance use from active-duty military with untreated AUD...
October 13, 2016: Journal of Consulting and Clinical Psychology
W Kievit, F A C Berden, J P H Drenth
Pharmaceutical companies are under increasing scrutiny because of their strategy for gaining market access and reimbursement authorisation for novel drugs. The tool most often used is that of a randomised controlled trial (RCT) in a highly selected population that has a high chance of responding on the treatment but a low chance of developing side effects. This population differs to a large extent from real-life patients, who have diverging characteristics that can influence effectiveness and safety; these include co-morbidity, age and disease severity...
2016: Nederlands Tijdschrift Voor Geneeskunde
Andrew P Grieve
The past 15 years has seen many pharmaceutical sponsors consider and implement adaptive designs (AD) across all phases of drug development. Given their arrival at the turn of the millennium, we might think that they are a recent invention. That is not the case. The earliest idea of an AD predates Bradford Hill's MRC tuberculosis study, appearing in Biometrika in 1933. In this paper, we trace the development of response-ADs, designs in which the allocation to intervention arms depends on the responses of subjects already treated...
October 12, 2016: Pharmaceutical Statistics
Ka Hei Chan, Rahul Krishnan, Michael Alexander, Jonathan Rt Lakey
The islets of Langerhans are endocrine tissue clusters that secrete hormones that regulate the body's glucose, carbohydrate and fat metabolism, the most important of which is insulin, a hormone secreted by β cells within the islets. In certain instances, a person's own immune system attacks and destroys them leading to the development of Type 1 diabetes (T1D), a lifelong condition that needs daily insulin administration to maintain health and prolong survival. Islet transplantation is a surgical procedure that has demonstrated the ability to normalize blood sugar levels for up to a few years, but the need for chronic immunosuppression relegates it to a last resort that is often only used sparingly, and in seriously-ill patients...
October 10, 2016: Cell Transplantation
John A Todd, Marina Evangelou, Antony J Cutler, Marcin L Pekalski, Neil M Walker, Helen E Stevens, Linsey Porter, Deborah J Smyth, Daniel B Rainbow, Ricardo C Ferreira, Laura Esposito, Kara M D Hunter, Kevin Loudon, Kathryn Irons, Jennie H Yang, Charles J M Bell, Helen Schuilenburg, James Heywood, Ben Challis, Sankalpa Neupane, Pamela Clarke, Gillian Coleman, Sarah Dawson, Donna Goymer, Katerina Anselmiova, Jane Kennet, Judy Brown, Sarah L Caddy, Jia Lu, Jane Greatorex, Ian Goodfellow, Chris Wallace, Tim I Tree, Mark Evans, Adrian P Mander, Simon Bond, Linda S Wicker, Frank Waldron-Lynch
BACKGROUND: Interleukin-2 (IL-2) has an essential role in the expansion and function of CD4+ regulatory T cells (Tregs). Tregs reduce tissue damage by limiting the immune response following infection and regulate autoreactive CD4+ effector T cells (Teffs) to prevent autoimmune diseases, such as type 1 diabetes (T1D). Genetic susceptibility to T1D causes alterations in the IL-2 pathway, a finding that supports Tregs as a cellular therapeutic target. Aldesleukin (Proleukin; recombinant human IL-2), which is administered at high doses to activate the immune system in cancer immunotherapy, is now being repositioned to treat inflammatory and autoimmune disorders at lower doses by targeting Tregs...
October 2016: PLoS Medicine
Antoine Tanet, Annik Hubert-Barthelemy, Graciela C Crespin, Nicolas Bodeau, David Cohen, Catherine Saint-Georges
INTRODUCTION: Individuals with autism spectrum disorder (ASD) who also exhibit severe-to-moderate ranges of intellectual disability (ID) still face many challenges (i.e., less evidence-based trials, less inclusion in school with peers). METHODS: We implemented a novel model called the "Developmental and Sequenced One-to-One Educational Intervention" (DS1-EI) in 5- to 9-year-old children with co-occurring ASD and ID. The treatment protocol was adapted for school implementation by designing it using an educational agenda...
2016: Frontiers in Pediatrics
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