Effectiveness of guided telerehabilitation on functional performance in community-dwelling older adults: A systematic review.

OBJECTIVE: To systematically review the effectiveness of guided telerehabilitation on improving functional performance in community-dwelling older adults. DATA SOURCES: Articles published in PubMed, Cochrane Library and Embase (Ovid) from 01 January 2010 up to 17 October 2023. REVIEW METHODS: Included studies had (1) a randomised controlled trial design, (2) an average population age of 65 years or older, (3) a home-based setting and (4) evaluated the effectiveness of functional performance outcome measures. The intervention was considered telerehabilitation when guided by a healthcare professional using video, audio and/or text communication technologies with a minimum frequency of once per week. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020 statement guideline was followed. Methodological quality was appraised using the revised Cochrane Risk of Bias tool. RESULTS: A total of 26 randomised controlled trials were included. Telerehabilitation had superior (N = 15), non-superior (N = 16) or non-inferior (N = 11) effectiveness for improving functional performance outcome measures compared to control interventions. No studies found the control intervention to be superior over telerehabilitation. Between study differences in intervention characteristics contributed to significant clinical heterogeneity. Five studies were found to present an overall 'low' risk of bias, 12 studies to present 'some' risk of bias and 9 studies to present an overall 'high' risk of bias. CONCLUSION: The findings suggest that telerehabilitation could be a promising alternative to in-person rehabilitation for improving functional performance in community-dwelling older adults. Additional well-designed studies with minimised bias are needed for a better understanding of effective telerehabilitation intervention strategies.

The development and acceptability of an educational and training intervention for recruiters to neonatal trials: the TRAIN project.

BACKGROUND: Suboptimal or slow recruitment affects 30-50% of trials. Education and training of trial recruiters has been identified as one strategy for potentially boosting recruitment to randomised controlled trials (hereafter referred to as trials). The Training tRial recruiters, An educational INtervention (TRAIN) project was established to develop and assess the acceptability of an education and training intervention for recruiters to neonatal trials. In this paper, we report the development and acceptability of TRAIN. METHODS: TRAIN involved three sequential phases, with each phase contributing information to the subsequent phase(s). These phases were 1) evidence synthesis (systematic review of the effectiveness of training interventions and a content analysis of the format, content, and delivery of identified interventions), 2) intervention development using a Partnership (co-design/co-creation) approach, and 3) intervention acceptability assessments with recruiters to neonatal trials. RESULTS: TRAIN, accompanied by a comprehensive intervention manual, has been designed for online or in-person delivery. TRAIN can be offered to recruiters before trial recruitment begins or as refresher sessions during a trial. The intervention consists of five core learning outcomes which are addressed across three core training units. These units are the trial protocol (Unit 1, 50 min, trial-specific), understanding randomisation (Unit 2, 5 min, trial-generic) and approaching and engaging with parents (Unit 3, 70 min, trial-generic). Eleven recruiters to neonatal trials registered to attend the acceptability assessment training workshops, although only four took part. All four positively valued the training Units and resources for increasing recruiter preparedness, knowledge, and confidence. More flexibility in how the training is facilitated, however, was noted (e.g., training divided across two workshops of shorter duration). Units 2 and 3 were considered beneficial to incorporate into Good Clinical Practice Training or as part of induction training for new staff joining neonatal units. CONCLUSION: TRAIN offers a comprehensive co-produced training and education intervention for recruiters to neonatal trials. TRAIN was deemed acceptable, with minor modification, to neonatal trial recruiters. The small number of recruiters taking part in the acceptability assessment is a limitation. Scale-up of TRAIN with formal piloting and testing for effectiveness in a large cluster randomised trial is required.

Understanding and optimising patient and public involvement in trial oversight: an ethnographic study of eight clinical trials.

BACKGROUND: Trial oversight is important for trial governance and conduct. Patients and/or lay members of the public are increasingly included in trial oversight committees, influenced by international patient and public involvement (PPI) initiatives to improve the quality and relevance of research. However, there is a lack of guidance on how to undertake PPI in trial oversight and tokenistic PPI remains an issue. This paper explores how PPI functions in existing trial oversight committees and provides recommendations to optimise PPI in future trials. This was part of a larger study investigating the role and function of oversight committees in trials facing challenges. METHODS: Using an ethnographic study design, we observed oversight meetings of eight UK trials and conducted semi-structured interviews with members of their trial steering committees (TSCs) and trial management groups (TMGs) including public contributors, trial sponsors and funders. Thematic analysis of data was undertaken, with findings integrated to provide a multi-perspective account of how PPI functions in trial oversight. RESULTS: Eight TSC and six TMG meetings from eight trials were observed, and 66 semi-structured interviews conducted with 52 purposively sampled oversight group members, including three public contributors. PPI was reported as beneficial in trial oversight, with public members contributing a patient voice and fulfilling a patient advocacy role. However, public contributors were not always active at oversight meetings and were sometimes felt to have a tokenistic role, with trialists reporting a lack of understanding of how to undertake PPI in trial oversight. To optimise PPI in trial oversight, the following areas were highlighted: the importance of planning effective strategies to recruit public contributors; considering the level of oversight and stage(s) of trial to include PPI; support for public contributors by the trial team between and during oversight meetings. CONCLUSIONS: We present evidence-based recommendations to inform future PPI in trial oversight. Consideration should be given at trial design stage on how to recruit and involve public contributors within trial oversight, as well as support and mentorship for both public contributors and trialists (in how to undertake PPI effectively). Findings from this study further strengthen the evidence base on facilitating meaningful PPI within clinical trials.

Metabolic measures 12 months after a randomised controlled trial of treatment of clozapine associated obesity and diabetes with exenatide (CODEX).

Clozapine is associated with obesity and type 2 diabetes. Glucagon-like-peptide-1 (GLP-1) receptor agonists such as exenatide can counter clozapine-associated GLP-1 dysregulation. Our 24-week randomized, controlled, open-label, pilot trial of once-weekly extended-release subcutaneous exenatide or usual care (CODEX) (n = 28), found exenatide was associated with significantly greater weight loss. We examined whether this effect was maintained at 12-months post-intervention. We followed up CODEX trial participants at 12-months post trial endpoint, collecting information on weight, BMI, waist circumference, blood pressure, fasting glucose, HbA1c, and use of metformin. The primary outcome of interest was change in weight from trial baseline to 12-months post endpoint and trial endpoint to 12-months post endpoint compared between former exenatide and usual care participants. Only HbA1c differed between baseline and 12-months post endpoint between the exenatide and control groups. From endpoint to 12-month follow up there were significantly greater increases among the former exenatide versus former usual care participants for weight, BMI, HbA1c and proportion with >5% weight gain. Stratifying results by whether participants used metformin post trial did not alter proportion with >5% weight gain. Although there were no significant differences in weight and BMI between baseline and 12-month post endpoint, there were significant increases in weight and BMI in the 12 months post endpoint for the former exenatide group. This was irrespective of metformin use and is in keeping with studies of other GLP-1RA agents. Further studies on GLP-1RAs use beyond 24 weeks for people with clozapine associated weight gain are needed.

Value of surgical pilot and feasibility study protocols.

BACKGROUND: RCTs in surgery are challenging owing to well established methodological issues. Well designed pilot and feasibility studies (PFS) may help overcome such issues to inform successful main trial design and conduct. This study aimed to analyse protocols of UK-funded studies to explore current use of PFS in surgery and identify areas for practice improvement. METHODS: PFS of surgical interventions funded by UK National Institute for Health Research programmes from 2005 to 2015 were identified, and original study protocols and associated publications sourced. Data extracted included study design characteristics, reasons for performing the work including perceived uncertainties around conducting a definitive main trial, and whether the studies had been published. RESULTS: Thirty-five surgical studies were identified, of which 29 were randomized, and over half (15 of 29) included additional methodological components (such as qualitative work examining recruitment, and participant surveys studying current interventions). Most studies focused on uncertainties around recruitment (32 of 35), with far fewer tackling uncertainties specific to surgery, such as intervention stability, implementation or delivery (10 of 35). Only half (19 of 35) had made their results available publicly, to date. CONCLUSION: The full potential of pretrial work to inform and optimize definitive surgical studies is not being realized.

Evaluating the short-term cost-effectiveness of liraglutide versus lixisenatide in patients with type 2 diabetes in the United States.

AIMS: Bringing patients with type 2 diabetes to recommended glycated hemoglobin (HbA1c) treatment targets can reduce the risk of developing diabetes-related complications. The aim of the present analysis was to evaluate the short-term cost-effectiveness of once-daily liraglutide 1.8 mg vs once-daily lixisenatide 20 µg as an add-on to metformin for treatment of type 2 diabetes in the US by assessing the cost per patient achieving HbA1c-focused and composite treatment targets. MATERIALS AND METHODS: Percentages of patients achieving recommended targets were obtained from the LIRA-LIXI trial, which compared the efficacy and safety of once-daily liraglutide 1.8 mg and once-daily lixisenatide 20 µg as an add-on to metformin in patients with type 2 diabetes failing to achieve glycemic control with metformin. Annual costs were estimated from a healthcare payer perspective. An economic model was developed to evaluate the annual cost per patient achieving target (cost of control) with liraglutide 1.8 mg vs lixisenatide 20 µg for five end-points. RESULTS: Annual treatment costs were higher with liraglutide 1.8 mg than lixisenatide 20 µg, but this was offset by greater clinical efficacy, and the cost of control was lower with liraglutide 1.8 mg than lixisenatide 20 µg for all five end-points. The annual cost of control was USD 3,850, USD 11,404, USD 3,807, USD 4,299, and USD 6,901 lower for liraglutide 1.8 mg than lixisenatide 20 µg for targets of HbA1c < 7.0%, HbA1c ≤ 6.5%, HbA1c < 7.0% and no weight gain, HbA1c < 7.0% with no weight gain and no confirmed hypoglycemia, and HbA1c < 7.0% with no weight gain and systolic blood pressure <140 mmHg, respectively. CONCLUSIONS: Once-daily liraglutide 1.8 mg was associated with greater clinical efficacy than once-daily lixisenatide 20 µg, which resulted in a lower annual cost of control for HbA1c-focused and composite treatment targets.

Response to letter to editor: 'Comment on Arch et al., Trials. 2016;17:517'.

In October 2015 we published the paper 'Measurement of HbA1c in multicentre diabetes trials - should blood samples be tested locally or sent to a central laboratory: an agreement analysis'. Chatterjee and Pradhan have submitted a letter to the editor asking critical questions regarding the methods we used. We offer this letter in response. TRIAL REGISTRATION: Eudract No. 2010-023792-25. Registered on 4 November 2010. ISRCTN No. ISRCTN29255275 . Registered on 12 November 2010.

Intralocus sexual conflict and insecticide resistance.

The BA allele of the Drosophila cytochrome P450 gene Cyp6g1 confers resistance to a range of insecticides. It is also subject to intralocus sexual conflict when introgressed into the Canton-S background, whose collection predates the widespread use of insecticides. In this genetic background, the allele confers a pleiotropic fitness benefit to females but a cost to males, and exhibits little sexual dimorphism in conferred insecticide resistance. It is unclear whether these sexually antagonistic effects also exist in current populations that have naturally evolved with insecticides, where genetic modifiers that offset male costs might be expected to evolve. Here, we explore these issues using Drosophila melanogaster caught recently from an Australian population in which the BA allele naturally segregates. While we find increased fecundity in insecticide-resistant BA females and no consistent evidence of fitness costs in males, experimental evolution indicates balancing selection at the locus. We suggest that this apparent discrepancy may be due to reduced investment in reproduction in resistant males. Our results at the population level are consistent with previous work, and suggest that individual-level fitness assays do not always capture sexually antagonistic fitness effects that emerge in a population context.

Brief Assessment of Parental Perception (BAPP): Development and validation of a new measure for assessing paediatric outcomes after bilateral cochlear implantation.

OBJECTIVE: In contrast to previous clinical practice, current guidelines recommend bilateral cochlear implantation in children, resulting in a cohort of children who initially received one implant, but have subsequently had a second, contralateral implant. This study aimed to explore satisfaction and quality of life in children implanted simultaneously or sequentially. DESIGN: A novel measure of satisfaction and quality of life following paediatric bilateral cochlear implantation (the Brief Assessment of Parental Perception; BAPP) was developed and preliminary validation undertaken as part of a large, national project of bilateral implantation. Children's parents completed the measure yearly for up to three years following implantation. STUDY SAMPLE: Children from 14 UK implant centres were recruited into the study; data were available for 410 children one year post-implantation. RESULTS: The BAPP was found to have good face and convergent validity, and internal consistency. Results indicated very high levels of satisfaction with the devices, and improvements in quality of life. However there was evidence that children implanted sequentially were less willing to wear their second implant in the first two years than those children receiving simultaneous implants. CONCLUSION: Simultaneous and sequential cochlear implants have a positive impact on the quality of life of deaf children.

The development of a family intervention competency assessment and reflection scale (FICARS) for psychosis.

Family intervention (FI) for psychosis has a robust evidence base. In recommending its use the revised NICE schizophrenia guideline states 'Healthcare professionals providing psychological interventions should have an appropriate level of competence'. Yet, no definitive instrument exists to outline what competences are required during and post FI training or help recruit staff with the appropriate knowledge and skill. This paper reports on the development of a Family Intervention competency assessment and reflection scale (FICARS). Using a systematic three-staged approach commonly used in health outcomes measurement development, a comprehensive literature review on UK-based FI training and commonly used assessment tools was undertaken. A FICARS draft was then constructed and revised in consultation with expert FI clinicians. Finally, a content validity study with FI trainers and students across three FI training programmes was undertaken to optimize FICARS aim to promote reflective assessment and professional development in FI skills and practice.

Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial.

OBJECTIVE: To assess the effectiveness and safety of melatonin in treating severe sleep problems in children with neurodevelopmental disorders. DESIGN: 12 week double masked randomised placebo controlled phase III trial. SETTING: 19 hospitals across England and Wales. PARTICIPANTS: 146 children aged 3 years to 15 years 8 months were randomised. They had a range of neurological and developmental disorders and a severe sleep problem that had not responded to a standardised sleep behaviour advice booklet provided to parents four to six weeks before randomisation. A sleep problem was defined as the child not falling asleep within one hour of lights out or having less than six hours' continuous sleep. INTERVENTIONS: Immediate release melatonin or matching placebo capsules administered 45 minutes before the child's bedtime for a period of 12 weeks. All children started with a 0.5 mg capsule, which was increased through 2 mg, 6 mg, and 12 mg depending on their response to treatment. MAIN OUTCOME MEASURES: Total sleep time at night after 12 weeks adjusted for baseline recorded in sleep diaries completed by the parent. Secondary outcomes included sleep onset latency, assessments of child behaviour, family functioning, and adverse events. Sleep was measured with diaries and actigraphy. RESULTS: Melatonin increased total sleep time by 22.4 minutes (95% confidence interval 0.5 to 44.3 minutes) measured by sleep diaries (n=110) and 13.3 (-15.5 to 42.2) measured by actigraphy (n=59). Melatonin reduced sleep onset latency measured by sleep diaries (-37.5 minutes, -55.3 to -19.7 minutes) and actigraphy (-45.3 minutes, -68.8 to -21.9 minutes) and was most effective for children with the longest sleep latency (P=0.009). Melatonin was associated with earlier waking times than placebo (29.9 minutes, 13.6 to 46.3 minutes). Child behaviour and family functioning outcomes showed some improvement and favoured use of melatonin. Adverse events were mild and similar between the two groups. CONCLUSIONS: Children gained little additional sleep on melatonin; though they fell asleep significantly faster, waking times became earlier. Child behaviour and family functioning outcomes did not significantly improve. Melatonin was tolerable over this three month period. Comparisons with slow release melatonin preparations or melatonin analogues are required. TRIAL REGISTRATION: ISRCT No 05534585.

The use of MElatonin in children with neurodevelopmental disorders and impaired sleep: a randomised, double-blind, placebo-controlled, parallel study (MENDS).

BACKGROUND: Difficulties in initiating and maintaining sleep are common in children with neurodevelopmental disorders. Melatonin is unlicensed in children yet widely prescribed for sleep problems. OBJECTIVE: To determine whether or not immediate-release melatonin is beneficial compared with placebo in improving total duration of night-time sleep in children with neurodevelopmental problems. DESIGN: Randomised, double-blind, placebo-controlled, parallel study. SETTING: Hospitals throughout England and Wales recruited patients referred by community paediatricians and other clinical colleagues. PARTICIPANTS: Children with neurodevelopmental problems aged from 3 years to 15 years 8 months who did not fall asleep within 1 hour of lights out or who had < 6 hours of continuous sleep. Before randomisation, patients meeting eligibility criteria entered a 4- to 6-week behaviour therapy period in which a behaviour therapy advice booklet was provided. Sleep was measured using sleep diaries and actigraphy. After this period the sleep diaries were reviewed to determine if the sleep problem fulfilled the eligibility criteria. Eligible participants were randomised and followed for 12 weeks. INTERVENTIONS: Melatonin or placebo capsules in doses of 0.5 mg, 2 mg, 6 mg and 12 mg for a period of 12 weeks. The starting dose was 0.5 mg and the dose could be escalated through 2 mg and 6 mg to 12 mg during the first 4 weeks, at the end of which the child was maintained on that dose. MAIN OUTCOME MEASURES: The primary outcome was total night-time sleep time (TST) calculated using sleep diaries at 12 weeks compared with baseline. Secondary outcome measures included TST calculated using actigraphy data, sleep-onset latency (SOL) (time taken to fall asleep), sleep efficiency, Composite Sleep Disturbance Index score, global measure of child's sleep quality, Aberrant Behaviour Checklist, Family Impact Module of the Pediatric Quality of Life Inventory (PedsQL™), the Epworth Sleepiness Scale, number and severity of seizures and adverse events. Salivary melatonin concentrations and association of genetic variants with abnormal melatonin production were also investigated. RESULTS: A total of 275 children were screened to enter the trial; 263 (96%) children were registered and completed the 4- to 6-week behaviour therapy period and 146 (56%) children were randomised, of whom 110 (75%) contributed data for the primary outcome. The difference in TST time between the melatonin and placebo groups adjusted for baseline was 22.43 minutes [95% confidence interval (CI) 0.52 to 44.34 minutes; p = 0.04] measured using sleep diaries. A reduction in SOL, adjusted for baseline, was seen for melatonin compared with placebo when measured by sleep diaries (-37.49 minutes, 95% CI -55.27 to -19.71 minutes; p < 0.0001) and actigraphy (-45.34 minutes, 95% CI -68.75 to -21.93 minutes; p = 0.0003). There were no significant differences between the two groups in terms of the reporting of adverse events. The results of other secondary outcomes favoured melatonin but were not statistically significant. CONCLUSIONS: On average, the children treated with melatonin slept 23 minutes longer than those in the placebo group; however, the upper limit of the confidence interval was less than 1 hour, the minimum clinically worthwhile difference specified at the outset of the trial. Melatonin is effective in reducing SOL in children with neurodevelopmental delay by a mean of 45 minutes; a value of 30 minutes was specified a priori to be clinically important. Future studies should be conducted over longer periods and directly compare different formulations of melatonin with conventional hypnotic and sedative medications. It would also be important to study groups of children with specific neurological disorders. TRIAL REGISTRATION: Current Controlled Trials ISRCTN05534585. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 40. See the HTA programme website for further project information.

Who benefits most from guided self-help for binge eating? An investigation into the clinical features of completers and non-completers.

Guided self-help (GSH) is a recommended first step in treatment for bulimia nervosa (BN) and binge eating disorder (BED) (NICE, 2004). It remains unclear what makes some individuals more likely to respond to this form of treatment than others. Forty-eight patients participated in this study using a GSH programme for binge eating. Profiles of treatment completers and non-completers are compared, and reasons for non-completion explored. Completion of treatment was associated with significant improvements in mood, general functioning and on measures of dietary restraint, frequency of objective binge eating (OBE), laxative misuse, self-induced vomiting (SIV) and driven exercise. Improvements were maintained at follow-up. Treatment non-completers reported significantly higher pre-treatment levels of depression and weight concern, and lower levels of general health and vitality. Reasons for discontinuing treatment were related to perceptions of the GSH programme; practicalities of the programme; and readiness to change. Whilst GSH can be effective for a sub-group of patients, factors such as pre-morbid level of depression, degree of weight concern, perceptions of the programme, and readiness to change may increase the likelihood of non-completion.

Baculoviral expression of telomerase in primary human fibroblasts to rejuvenate cells for tissue engineering.

Tissue engineering involves the use of synthetic or natural materials as a scaffold to support the growth of replacement tissue or organs. The use of autologous cells to populate the scaffold avoids problems associated with rejection; however, a major limitation of this approach is the finite lifespan of primary cells in culture. This finite lifespan is due to the shortening of telomeres, short repetitive sequences of DNA located at the ends of eukaryotic chromosomes. Ectopic expression of telomerase reverse transcriptase (hTERT) is able to reconstitute telomerase activity and maintain the length of telomeres. This study investigated an alternative gene delivery vector, baculovirus, for the expression of hTERT in primary human cells. A recombinant baculovirus was used to efficiently deliver the hTERT gene to primary fibroblasts and the telomerase enzyme was found to be active. Although no increase in telomere length was detected, expression of hTERT in primary fibroblasts resulted in a significant extension of replicative lifespan. To our knowledge this is a novel attempt to use a recombinant baculovirus for the extension of cellular lifespan by exogenous expression of telomerase.

Working length determination in general dental practice: a randomised controlled trial.

OBJECTIVE: To evaluate the ability of apex locators as a tool in determining working length in comparison to traditional working length radiographs in general dental practice. DESIGN: Randomised controlled clinical trial. SETTING: General dental practices in the North West of England.Subjects Adults requiring root canal treatment of at least one tooth with minimal or moderate difficulty. INTERVENTION: Root canal treatment was carried out with the working length determined by apex locator in the treatment group (AL), and periapical radiograph in the control group (PA). OUTCOME MEASURE: The acceptability of the master cone gutta percha measured from a radiograph before obturation was used as the primary outcome. RESULTS: Twenty-one of 23 fillings in the AL group were judged as acceptable, compared to 17 of 23 fillings in the PA group. This difference was not statistically significant. CONCLUSION: In general dental practice, no significant difference was found in working length determined using apex locator combined with a master cone GP radiograph or using the conventional method. There is a need for larger trials to investigate these methods further.

Supporting mental health nurses to address the physical health needs of people with serious mental illness in acute inpatient care settings.

There is overwhelming evidence that the physical health needs of those with serious mental illness have been neglected by health service professionals. Mental health nurses (MHNs) could play a key role in meeting these needs particularly during hospital admissions, yet they are uncertain about their role, have variable levels of confidence and lack appropriate skills and training. This study investigated MHNs' views and practices of physical health management for adults receiving acute inpatient treatment and found a difference between MHNs' perceived responsibility and their practice, which highlighted a need for role clarification and further skills training.

Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists.

OBJECTIVES: To provide information on the frequency and reasons for outcome reporting bias in clinical trials. DESIGN: Trial protocols were compared with subsequent publication(s) to identify any discrepancies in the outcomes reported, and telephone interviews were conducted with the respective trialists to investigate more extensively the reporting of the research and the issue of unreported outcomes. PARTICIPANTS: Chief investigators, or lead or coauthors of trials, were identified from two sources: trials published since 2002 covered in Cochrane systematic reviews where at least one trial analysed was suspected of being at risk of outcome reporting bias (issue 4, 2006; issue 1, 2007, and issue 2, 2007 of the Cochrane library); and a random sample of trial reports indexed on PubMed between August 2007 and July 2008. SETTING: Australia, Canada, Germany, the Netherlands, New Zealand, the United Kingdom, and the United States. MAIN OUTCOME MEASURES: Frequency of incomplete outcome reporting-signified by outcomes that were specified in a trial's protocol but not fully reported in subsequent publications-and trialists' reasons for incomplete reporting of outcomes. RESULTS: 268 trials were identified for inclusion (183 from the cohort of Cochrane systematic reviews and 85 from PubMed). Initially, 161 respective investigators responded to our requests for interview, 130 (81%) of whom agreed to be interviewed. However, failure to achieve subsequent contact, obtain a copy of the study protocol, or both meant that final interviews were conducted with 59 (37%) of the 161 trialists. Sixteen trial investigators failed to report analysed outcomes at the time of the primary publication, 17 trialists collected outcome data that were subsequently not analysed, and five trialists did not measure a prespecified outcome over the course of the trial. In almost all trials in which prespecified outcomes had been analysed but not reported (15/16, 94%), this under-reporting resulted in bias. In nearly a quarter of trials in which prespecified outcomes had been measured but not analysed (4/17, 24%), the "direction" of the main findings influenced the investigators' decision not to analyse the remaining data collected. In 14 (67%) of the 21 randomly selected PubMed trials, there was at least one unreported efficacy or harm outcome. More than a quarter (6/21, 29%) of these trials were found to have displayed outcome reporting bias. CONCLUSION: The prevalence of incomplete outcome reporting is high. Trialists seemed generally unaware of the implications for the evidence base of not reporting all outcomes and protocol changes. A general lack of consensus regarding the choice of outcomes in particular clinical settings was evident and affects trial design, conduct, analysis, and reporting.

Zoning: focused support: a trust wide implementation project.

Applying pragmatic risk management procedures to facilitate the sharing of clinical knowledge in and across mental health teams. Abstract Zoning: focused support is pragmatic risk management support procedure that enhances adherence to operational policies, provides a forum in which staff can receive support and visually facilitates the sharing of clinical knowledge. This paper presents a 3-year multi-method management project that sought to introduce zoning principles into all teams of an inner city Mental Health NHS Trust. By changing the language and culture of the organization findings indicate that there has been a positive attitudinal shift in how the approach is perceived. It is considered to be of value to staff, service users and their families and 73% of teams are now using it routinely.