Disentangling the effects of plea discount and potential trial sentence on decisions to plead guilty

Background Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms. Results The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses. Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000776707; Universal Trial Number (UTN) is U1111-1145-4130.

Download Full-text

Study finds up to $5 billion in potential trial cost savings

Nature Medicine ◽

10.1038/nm0812-1159b ◽

2012 ◽

Vol 18 (8) ◽

pp. 1159-1159 ◽

Cited By ~ 1

Author(s):

Kathleen Raven

Keyword(s):

Cost Savings ◽

Trial Cost ◽

Potential Trial

Download Full-text

Randomisation in trials: do potential trial participants understand it and find it acceptable?

Journal of Medical Ethics ◽

10.1136/jme.2002.001123 ◽

2004 ◽

Vol 30 (1) ◽

pp. 80-84 ◽

Cited By ~ 35

Author(s):

C Kerr

Keyword(s):

Trial Participants ◽

Potential Trial

Download Full-text

Functional lesional neurosurgery for tremor: back to the future?

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2017-316301 ◽

2017 ◽

Vol 89 (7) ◽

pp. 727-735 ◽

Cited By ~ 5

Author(s):

Sebastian R Schreglmann ◽

Joachim K Krauss ◽

Jin Woo Chang ◽

Ernst Martin ◽

Beat Werner ◽

...

Keyword(s):

Focused Ultrasound ◽

Unsolved Problem ◽

State Of The Art ◽

Meta Analysis ◽

High Intensity Focused Ultrasound ◽

Functional Neurosurgery ◽

Future Directions ◽

Dystonic Tremor ◽

Potential Trial ◽

Deep Brain

For nearly a century, functional neurosurgery has been applied in the treatment of tremor. While deep brain stimulation has been in the focus of academic interest in recent years, the establishment of incisionless technology, such as MRI-guided high-intensity focused ultrasound, has again stirred interest in lesional approaches.In this article, we will discuss the historical development of surgical technique and targets, as well as the technological state-of-the-art of conventional and incisionless interventions for tremor due to Parkinson’s disease, essential and dystonic tremor and tremor related to multiple sclerosis (MS) and midbrain lesions. We will also summarise technique-inherent advantages of each technology and compare their lesion characteristics. From this, we identify gaps in the current literature and derive future directions for functional lesional neurosurgery, in particularly potential trial designs, alternative targets and the unsolved problem of bilateral lesional treatment. The results of a systematic review and meta-analysis of the consistency, efficacy and side effect rate of lesional treatments for tremor are presented separately alongside this article.

Download Full-text

Multimodal Retinal Imaging and Microperimetry Reveal a Novel Phenotype and Potential Trial End Points in CRB1-Associated Retinopathies

Translational Vision Science & Technology ◽

10.1167/tvst.10.2.38 ◽

2021 ◽

Vol 10 (2) ◽

pp. 38

Author(s):

Danial Roshandel ◽

Jennifer A. Thompson ◽

Rachael C. Heath Jeffery ◽

Danuta M. Sampson ◽

Enid Chelva ◽

...

Keyword(s):

Retinal Imaging ◽

End Points ◽

Potential Trial

Download Full-text

Are investigators’ access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials

BMC Medical Ethics ◽

10.1186/s12910-021-00681-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Asger S. Paludan-Müller ◽

Michelle C. Ogden ◽

Mikkel Marquardsen ◽

Karsten J. Jørgensen ◽

Peter C. Gøtzsche

Keyword(s):

Informed Consent ◽

Ethics Committees ◽

Freedom Of Information ◽

Trial Conduct ◽

Industry Partner ◽

Trial Protocols ◽

Information Requests ◽

Trial Participants ◽

Specific Reason ◽

Potential Trial

Abstract Objectives To determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators. Methods Cohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and if this was mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early. Results The industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%). Conclusions Publication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct.

Download Full-text

The Natural Sit-to-Stand-Walk of the Frail

Volume 3: Biomedical and Biotechnology Engineering ◽

10.1115/imece2019-11889 ◽

2019 ◽

Cited By ~ 2

Author(s):

Dorothy Taylor ◽

Andrew Merryweather ◽

Janice Morse ◽

Bob Wong

Keyword(s):

Biomechanical Model ◽

Visual Observation ◽

Coding System ◽

Initiation Phase ◽

Sit To Stand ◽

Bed Height ◽

Preparation Phase ◽

Position Data ◽

Potential Trial ◽

Significant Factors

Abstract Sit-to-stand-walk (STW) is a complex task that sequentially transitions an individual from sitting through standing to walking. In this study we evaluate the unrestricted, natural pattern of movement of the STW task from a hospital bed of 21 (5 Female, 16 Male) frail (MFS > 55) adults (68.0±11.2 years) with a total of 144 unique trials. Bed height (low, medium, high) and bed rail condition (no rails, Hill-Rom®, Stryker®), were varied, generating 9 potential trial types per participant. A new STW phase, Stand Preparation, is defined specifically for the frail that occurs just prior to the Flexion Momentum Phase, also named here as the Stand Initiation Phase. In conjunction with the newly defined Stand Preparation Phase, movements used by the frail to maintain or regain balance during STW task are newly defined as corrective behaviors (CBs). These include hand, foot, leg and torso CBs. In 144 unique STW trials, 678 hand and foot CBs were observed and recorded. The most frequent CB type was the hand CB (335), followed by the foot CB (316). A coding system for use in the kinematic analysis of the natural STW task was developed that identifies CBs through visual observation. In addition, a 3D biomechanical model was generated from collected marker position data and will be used in future biomechanical analyses with the visually observed CB data. The Stand Initiation Phase contained the most CBs. Significant factors included bed height and phase, as well as their interaction (all with p-values ≤ 0.006). This is the first study to establish a more accurate and complete STW of the frail elderly, as well as to define CBs employed during their natural STW. The dataset from this coding system, along with the newly established STW phases of the frail, are currently being used for further analyses to determine the exact timing and position of fall initiations during STW of the frail.

Download Full-text

Statistical Analysis Plan for EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) trial

International Journal of Stroke ◽

10.1177/1747493018816101 ◽

2018 ◽

Vol 15 (2) ◽

pp. 231-238 ◽

Cited By ~ 4

Author(s):

Leonid Churilov ◽

Henry Ma ◽

Bruce CV Campbell ◽

Stephen M Davis ◽

Geoffrey A Donnan

Keyword(s):

Statistical Analysis ◽

Time Window ◽

Statistical Analysis Plan ◽

Steering Committee ◽

Stroke Onset ◽

Neurological Deficits ◽

Trial Analysis ◽

Detailed Statistical Analysis ◽

Double Blinded ◽

Potential Trial

Background EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND) is a randomized, multicenter, double-blinded, placebo-controlled phase 3 trial to test the hypothesis of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke (WUS) patients. Objective To formulate the detailed statistical analysis plan for the EXTEND trial prior to database lock. This statistical analysis plan is based on the published and registered EXTEND trial protocol and is developed by the blinded steering committee and management team. Results The developed EXTEND statistical analysis plan is transparent, verifiable, and predetermined before the database lock. It is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions Publication of a statistical analysis plan serves to reduce potential trial analysis and reporting bias and outlines pre-specified analyses to quantify the benefits and harms of extending the thrombolysis time window to 9 h from stroke onset and in wake-up stroke patients. Trial registration: ClinicalTrials.gov number NCT00887328 registered 23/Apr/2009 and NCT01580839 (EXTEND International) registered 19/Apr/2012

Download Full-text

A Feasibility Study of a One-to-One Mindfulness-Based Intervention for Improving Mood in Stroke Survivors

Mindfulness ◽

10.1007/s12671-020-01583-4 ◽

2021 ◽

Author(s):

Wendy Wrapson ◽

Marlies Dorrestein ◽

Jill Wrapson ◽

Alice Theadom ◽

Nicola M. Kayes ◽

...

Keyword(s):

Feasibility Study ◽

Well Being ◽

Stroke Survivors ◽

Evidence Based Treatment ◽

Face To Face ◽

Cognitive Component ◽

The Face ◽

Trauma Informed ◽

Potential Trial

Abstract Objectives Mindfulness is an evidence-based treatment for depression but has never been rigorously tested with stroke survivors with depression. This feasibility study examined several issues relevant to a potential trial of a mindfulness-based intervention (MBI) for improving mood after stroke. Methods In 2017–2019 in New Zealand, we recruited 20 stroke survivors with low mood to undergo a 6-week, one-on-one MBI course delivered by an occupational therapist experienced in MBIs. Pre, post, and 4-week follow-up assessments were completed. Results Fifteen participants completed all six sessions and a 4-week “booster” or top-up session. The 1-hour session duration was considered appropriate by participants and all enjoyed the face-to-face individualized format. Mean Beck Depression Inventory-II scores improved by more than one standard deviation and this was maintained at follow-up. However, the baseline assessment package was too long for some participants due to the cognitive component. Three participants indicated feeling emotionally challenged by some of the practices. These effects were managed by the mindfulness facilitator by adjusting the practice, so participants maintained their sense of agency, well-being, and overall benefit from the program. Conclusions MBI training delivered individually over six weekly sessions was acceptable to stroke survivors with 14/15 participants reporting improved mood. Three participants reported feeling emotionally challenged by some of the practices and we recommend MBIs for stroke survivors be provided by practitioners experienced in mindfulness, working with stroke, and trauma-informed therapy. It is important now to conduct rigorous randomized controlled trials to test the effectiveness and efficacy of MBIs for stroke survivors.

Download Full-text