Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial

Introduction Acute kidney injury (AKI) is a frequent complication after cardiac surgery with adverse short-term and long-term outcomes. Although prevention of AKI (PrevAKI) is strongly recommended, the optimal strategy is uncertain. The Kidney Disease: Improving Global Outcomes (KDIGO) guideline recommended a bundle of supportive measures in high-risk patients. In a single-centre trial, we recently demonstrated that the strict implementation of the KDIGO bundle significantly reduced the occurrence of AKI after cardiac surgery. In this feasibility study, we aim to evaluate whether the study protocol can be implemented in a multicentre setting in preparation for a large multicentre trial. Methods and analysis We plan to conduct a prospective, observational survey followed by a randomised controlled, multicentre, multinational clinical trial including 280 patients undergoing cardiac surgery with cardiopulmonary bypass. The purpose of the observational survey is to explore the adherence to the KDIGO recommendations in routine clinical practice. The second phase is a randomised controlled trial. The objective is to investigate whether the trial protocol is implementable in a large multicentre, multinational setting. The primary endpoint of the interventional part is the compliance rate with the protocol. Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes

Fidelity protocol for the Action Success Knowledge (ASK) trial: A psychosocial intervention administered by speech and language therapists to prevent depression in people with post-stroke aphasia

Introduction: Treatment fidelity is a complex, multifaceted evaluative process which refers to whether a studied intervention was delivered as intended. Monitoring and enhancing fidelity is one recommendation of the TiDIER (Template for Intervention Description and Replication) checklist, as fidelity can inform interpretation and conclusions drawn about treatment effects. Despite the methodological and translational benefits, fidelity strategies have been used inconsistently within health behaviour intervention studies; in particular, within aphasia intervention studies, reporting of fidelity remains relatively rare. This paper describes the development of a fidelity protocol for the Action Success Knowledge (ASK) study, a current cluster randomised trial investigating an early mood intervention for people with aphasia (a language disability caused by stroke). Methods and analysis: A novel fidelity protocol and tool was developed to monitor and enhance fidelity within the two arms (experimental treatment and attention control) of the ASK study. The ASK fidelity protocol was developed based on the National Institutes of Health Behaviour Change Consortium fidelity framework. Ethics and dissemination: The study protocol was approved by the Darling Downs Hospital and Health Service Human Research Ethics Committee in Queensland, Australia under the National Mutual Acceptance scheme of multicentre human research projects. Specific ethics approval was obtained for those participating sites who were not under the National Mutual Agreement at the time of application. The monitoring and ongoing conduct of the research project is in line with requirements under the National Mutual Acceptance. On completion of the trial, findings from the fidelity reviews will be disseminated via publications and conference presentations. Trial registration number ACTRN12614000979651

The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial

Background: Despite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33 % of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion. The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response. Methods/Design: Cluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m2. Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥ 15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years. Discussion: This study will establish whether a structured weight management programme, delivered in Primary Care by practice nurses or dietitians, is a viable treatment to achieve T2DM remission. Results, available from 2018 onwards, will inform future service strategy

The OPERA trial : a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation

Background: The OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale. Methods/design: Quantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control). Discussion: Although process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation

Report on the mission to SIAT Gabon, 7 to 19 December 2006

The purpose of the mission was to make a phytosanitary inspection of the Mitzic estate, make recommendations for controlling leaf diseases, draw up an experimental protocol for ULV defoliant treatment and propose a system of general foliage monitoring at the estate. In addition to those recommendations, the expert proposed that a clone trial be resumed and touched upon "parasitic phanerogams" and root diseases (with a view to new plantations), but no experimental protocol was set in place for those subjects. The expert will ensure scientific monitoring of the trials set up. Two other missions have been requested by SIAT in 2007

The effects of morning preconditioning protocols on testosterone, cortisol and afternoon sprint cycling performance [conference presentation]

Opportunities exist for athletes to undertake morning exercise protocols in an attempt to potentate afternoon performance. Four sub elite track sprint cyclists completed a morning cycling (Cyc) or weights-based protocol (WP) prior to an afternoon cycling time trial (500m) in a repeated measures, counterbalance crossover design. Measured variables included heart rate, blood lactate, cycling peak power, salivary testosterone (T) and cortisol levels along with time trial performance. Standardised differences in means via magnitude-based inferences were calculated using paired samples T-tests in SPSS version 24 with statistical significance set at p < 0.05. The WP produced significantly faster times in the final 250m in comparison to CycP. The anticipated circadian decline of T was observed after the CycP but was however mitigated following the WP. While slight decreases in 500m times were experienced during the WP, they were not significant and were considered within the normal variations experienced between performances by elite athletes. The effect of the WP on the circadian rhythm of T could be linked to a greater recruitment of muscle fibres. Results suggest a morning resistance protocol can positively affect testosterone levels for afternoon performance. Possible gender and individual responses from conducting a W over Cyc protocol were observed and require further investigation

Total or Partial Knee Arthroplasty Trial - TOPKAT : study protocol for a randomised controlled trial

Peer reviewedPublisher PD

Fidelity Assessment in Community Programs: An Approach to Validating Simplified Methodology.

Fidelity to intervention protocol is linked to best outcomes for individuals with autism spectrum disorder (ASD; see Boyd &amp; Corley [Autism 5(4):430-441, 2001]; Pellecchia et al. [J Autism Dev Disord 45(9):2917-2927, 2015]); however, fidelity measurement tools that are both accurate and feasible for community use are often not available. In this paper we explore methods for validated simplification of fidelity assessment procedures toward the goal of increased use in clinical practice. Video recordings (n = 36) of therapists working with children with ASD were coded using three variations of fidelity assessment methodology (trial-by-trial, 5-point Likert Scale, and 3-point Likert Scale), and the results were compared for exact agreement, mastery criterion agreement, and overall reliability. The results indicated overall a very high percentage of exact agreement (mean 99.44%, range 94.4-100%) and excellent reliability (mean Krippendorff's alpha [Kα] 1.0) between the trial-by-trial and 5-point Likert Scale across all components; however, the 3-point method may be viewed as being the more feasible strategy within community programs