Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes

Background: A pilot study can be an important step in the assessment of an intervention by providing information to design the future definitive trial. Pilot studies can be used to estimate the recruitment and retention rates and population variance and to provide preliminary evidence of efficacy potential. However, estimation is poor because pilot studies are small, so sensitivity analyses for the main trial's sample size calculations should be undertaken. Methods: We demonstrate how to carry out easy-to-perform sensitivity analysis for designing trials based on pilot data using an example. Furthermore, we introduce rules of thumb for the size of the pilot study so that the overall sample size, for both pilot and main trials, is minimized. Results: The example illustrates how sample size estimates for the main trial can alter dramatically by plausibly varying assumptions. Required sample size for 90% power varied from 392 to 692 depending on assumptions. Some scenarios were not feasible based on the pilot study recruitment and retention rates. Conclusion: Pilot studies can be used to help design the main trial, but caution should be exercised. We recommend the use of sensitivity analyses to assess the robustness of the design assumptions for a main trial

Which psychological factors exacerbate irritable bowel syndrome? Development of a comprehensive model

There is evidence that psychological factors affect the onset, severity and duration of Irritable Bowel Syndrome (IBS). However, it is not clear which psychological factors are the most important and how they interact. The aims of the current study are to identify the most important psychological factors predicting IBS symptom severity and to investigate how these psychological variables are related to each other

Tibiofemoral Contact Forces in the Anterior Cruciate Ligament-Reconstructed Knee.

PURPOSE: To investigate differences in ACL reconstructed (ACLR) and healthy individuals in terms of the magnitude of the tibiofemoral contact forces, as well as the relative muscle and external load contributions to those contact forces, during walking, running and sidestepping gait tasks. METHODS: A computational electromyography-driven neuromusculoskeletal model was used to estimate the muscle and tibiofemoral contact forces in those with combined semitendinosus and gracilis tendon autograft ACLR (n=104, 29.7±6.5 years, 78.1±14.4 kg) and healthy controls (n=60, 27.5±5.4 years, 67.8±14.0 kg) during walking (1.4±0.2 ms), running (4.5±0.5 ms) and sidestepping (3.7±0.6 ms). Within the computational model, the semitendinosus of ACLR participants was adjusted to account for literature reported strength deficits and morphological changes subsequent to autograft harvesting. RESULTS: ACLRs had smaller maximum total and medial tibiofemoral contact forces (~80% of control values, scaled to bodyweight) during the different gait tasks. Compared to controls, ACLRs were found to have a smaller maximum knee flexion moment, which explained the smaller tibiofemoral contact forces. Similarly, compared to controls, ACLRs had both a smaller maximum knee flexion angle and knee flexion excursion during running and sidestepping, which may have concentrated the articular contact forces to smaller areas within the tibiofemoral joint. Mean relative muscle and external load contributions to the tibiofemoral contact forces were not significantly different between ACLRs and controls. CONCLUSION: ACLRs had lower bodyweight-scaled tibiofemoral contact forces during walking, running and sidestepping, likely due to lower knee flexion moments and straighter knee during the different gait tasks. The relative contributions of muscles and external loads to the contact forces were equivalent between groups

An Invitation to Higher Gauge Theory

In this easy introduction to higher gauge theory, we describe parallel transport for particles and strings in terms of 2-connections on 2-bundles. Just as ordinary gauge theory involves a gauge group, this generalization involves a gauge '2-group'. We focus on 6 examples. First, every abelian Lie group gives a Lie 2-group; the case of U(1) yields the theory of U(1) gerbes, which play an important role in string theory and multisymplectic geometry. Second, every group representation gives a Lie 2-group; the representation of the Lorentz group on 4d Minkowski spacetime gives the Poincar\'e 2-group, which leads to a spin foam model for Minkowski spacetime. Third, taking the adjoint representation of any Lie group on its own Lie algebra gives a 'tangent 2-group', which serves as a gauge 2-group in 4d BF theory, which has topological gravity as a special case. Fourth, every Lie group has an 'inner automorphism 2-group', which serves as the gauge group in 4d BF theory with cosmological constant term. Fifth, every Lie group has an 'automorphism 2-group', which plays an important role in the theory of nonabelian gerbes. And sixth, every compact simple Lie group gives a 'string 2-group'. We also touch upon higher structures such as the 'gravity 3-group' and the Lie 3-superalgebra that governs 11-dimensional supergravity.Comment: 60 pages, based on lectures at the 2nd School and Workshop on Quantum Gravity and Quantum Geometry at the 2009 Corfu Summer Institut

Examining the Context of Strategy Instruction

The goal of literacy instruction is to teach reading and writing as tools to facilitate thinking and reasoning in a broad array of literacy events. An important difference in the disposition of children to participate in literacy experiences is the extent to which they engage in intentional self-regulated learning. The contexts attending six traditional models of strategy instruction are examined. An exploratory study, conducted with heterogeneous third graders, is reported, examining the implementation and outcomes of three models of strategy instruction—Direct Instruction, Reciprocal Teaching, and Collaborative Problem Solving—which manipulated teacher and student control of activity, as well as the instructional context.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/69008/2/10.1177_074193259101200306.pd

Effects of a Cognitive Behavioral Therapy Intervention Trial to Improve Disease Outcomes in Children with Inflammatory Bowel Disease:

Studies testing the efficacy of behavioral interventions to modify psychosocial sequelae of IBD in children are limited. This report presents outcomes through a six month follow up from a large RCT testing the efficacy of a cognitive-behavioral intervention for children with IBD and their parents

The role of coping with symptoms in depression and disability: Comparison between Inflammatory Bowel Disease and Abdominal Pain

Inflammatory Bowel Disease (IBD) and abdominal pain of functional origin (AP) are common gastrointestinal disorders in children that are associated with increased risk for depression and disability. Both symptom severity and coping with symptoms may contribute to these outcomes. We hypothesized that children with AP use different coping strategies compared to those with IBD for a number of reasons, including the fact that fewer treatment options are available to them. We also examined if coping was related to depression and functional disability beyond the contributions of symptom severity

Cognitive Mediators of Treatment Outcomes in Pediatric Functional Abdominal Pain

Cognitive-behavioral interventions improve outcomes for many pediatric health conditions, but little is known about which mechanisms mediate these outcomes. The goal of this study was to identify whether changes in targeted process variables from baseline to one week post-treatment mediate improvement in outcomes in a randomized controlled trial of a brief cognitive-behavioral intervention for idiopathic childhood abdominal pain