METHODS AND ANALYSIS: A feasibility study to test the practicality of running a multicentre, randomised clinical trial of surgery for UVFP, including: (1) a qualitative study to understand the recruitment process and how it operates in clinical centres and (2) a small randomised trial of 30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty. Participants will be followed up for 12 months. The primary outcome focuses on recruitment and retention, with secondary outcomes covering voice, swallowing and quality of life.
ETHICS AND DISSEMINATION: Ethical approval was received from National Research Ethics Service-Committee Bromley (reference 11/LO/0583). In addition to dissemination of results through presentation and publication of peer-reviewed articles, results will be shared with key clinician and patient groups required to develop the future large-scale randomised controlled trial.
TRIAL REGISTRATION NUMBER: ISRCTN90201732; 16 December 2015.
METHODS: ClinicalTrials.gov was searched for all randomized, interventional, phase II-IV trials that were registered between 1 January 2000 and 31 December 2009 and included adults with Alzheimer's disease, motor neurone disease, multiple sclerosis or Parkinson's disease. Publications from these trials were identified by extensive online searching and contact with authors, and multiple logistic regression analysis was performed to identify characteristics associated with trial discontinuation and non-publication.
RESULTS: In all, 362 eligible trials were identified, of which 12% (42/362) were discontinued. 28% (91/320) of completed trials remained unpublished after 5 years. Trial discontinuation was independently associated with number of patients (P = 0.015; more likely in trials with ≤100 patients; odds ratio 2.65, 95% confidence interval 1.21-5.78) and phase of trial (P = 0.009; more likely in phase IV than phase III trials; odds ratio 3.90, 95% confidence interval 1.41-10.83). Trial non-publication was independently associated with blinding status (P = 0.005; more likely in single-blind than double-blind trials; odds ratio 5.63, 95% confidence interval 1.70-18.71), number of centres (P = 0.010; more likely in single-centre than multi-centre trials; odds ratio 2.49, 95% confidence interval 1.25-4.99), phase of trial (P = 0.041; more likely in phase II than phase IV trials; odds ratio 2.88, 95% confidence interval 1.04-7.93) and sponsor category (P = 0.001; more likely in industry-sponsored than university-sponsored trials; odds ratio 5.05, 95% confidence interval 1.87-13.63).
CONCLUSIONS: There is evidence of non-dissemination bias in randomized trials of interventions for neurodegenerative diseases. Associations with trial discontinuation and non-publication were similar to findings in other diseases. These biases may distort the therapeutic information available to inform clinical practice.
METHODS AND ANALYSIS: This is a community-based prospective cohort study using randomly selected households from the national census. A multistage sampling method was employed to obtain a total of 2496 older adults living in the rural Kuala Pilah district. The study is divided into two phases: cross-sectional study (baseline), and a longitudinal follow-up study at the third and fifth years. Elder mistreatment was measured using instrument derived from the previous literature and modified Conflict Tactic Scales. Outcomes of elder mistreatment include mortality, physical function, mental health, quality of life and health utilisation. Logistic regression models are used to examine the relationship between risk factors and abuse estimates. Cox proportional hazard regression will be used to estimate risk of mortality associated with abuse. Associated annual rate of hospitalisation and health visit frequency, and reporting of abuse, will be estimated using Poisson regression.
ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee of the University of Malaya Medical Center (MEC Ref 902.2) and the Malaysian National Medical Research Register (NMRR-12-1444-11726). Written consent was obtained from all respondents prior to baseline assessment and subsequent follow-up. Findings will be disseminated to local stakeholders via forums with community leaders, and health and social welfare departments, and published in appropriate scientific journals and presented at conferences.
STUDY DESIGN AND SETTINGS: The Online Randomized Controlled Trials of Health Information Database was used as the sampling frame to identify a subset of self-recruited online trials of self-management interventions. The authors cataloged what these online trials were assessing, appraised study quality, extracted information on how trials were run, and assessed the potential for bias. We searched out how public and patient participation was integrated into online trial design and how this was reported. We recorded patterns of use for registration, reporting, settings, informed consent, public involvement, supplementary materials, and dissemination planning.
RESULTS: The sample included 41 online trials published from 2002 to 2015. The barriers to replicability and risk of bias in online trials included inadequate reporting of blinding in 28/41 (68%) studies; high attrition rates with incomplete or unreported data in 30/41 (73%) of trials; and 26/41 (63%) of studies were at high risk for selection bias as trial registrations were unreported. The methods for (23/41, 56%) trials contained insufficient information to replicate the trial, 19/41 did not report piloting the intervention. Only 2/41 studies were cross-platform compatible. Public involvement was most common for advisory roles (n = 9, 22%), and in the design, usability testing, and piloting of user materials (n = 9, 22%).
CONCLUSION: This study catalogs the state of online trials of self-management in the early 21st century and provides insights for online trials development as early as the protocol planning stage. Reporting of trials was generally poor and, in addition to recommending that authors report their trials in accordance with CONSORT guidelines, we make recommendations for researchers writing protocols, reporting on and evaluating online trials. The research highlights considerable room for improvement in trial registration, reporting of methods, data management plans, and public and patient involvement in self-recruited online trials of self-management interventions.
METHODS: Eleven databases were searched without date or language restrictions for systematic reviews of public and patient involvement (PPI) in clinical trials design. This systematic overview of PPI included 27 reviews from which areas of good and bad practice were identified. Strengths, weaknesses, opportunities, and threats of PPI were explored through use of meta-narrative analysis.
RESULTS: Inclusion criteria were met by 27 reviews ranging in quality from high (n = 7), medium (n = 14) to low (n = 6) reviews. Reviews were assessed using CERQUAL NICE, CASP for qualitative research and CASP for systematic reviews. Four reviews report risk of bias. Public involvement roles were primarily in agenda setting, steering committees, ethical review, protocol development, and piloting. Research summaries, follow-up, and dissemination contained PPI, with lesser involvement in data collection, analysis, or manuscript authoring. Trialists report difficulty in finding, retaining, and reimbursing volunteers. Respectful inclusion, role recognition, mutual flexibility, advance planning, and sound methods were reported as facilitating public involvement in research. Public involvement was reported to have increased the quantity and quality of patient relevant priorities and outcomes, enrollment, funding, design, implementation, and dissemination. Challenges identified include lack of clarity within common language, roles, and research boundaries, while logistical needs include extra time, training, and funding. Researchers report struggling to report involvement and avoid tokenism.
CONCLUSIONS: Involving patients and the public in clinical trials design can be beneficial but requires resources, preparation, training, flexibility, and time. Issues to address include reporting deficits for risk of bias, study quality, and conflicts of interests. We need to address these tensions and improve dissemination strategies to increase PPI and health literacy.
OBJECTIVE: This systematic review aims to provide a critical summary of EEs of PCVs and identify key drivers of EE findings in LMICs.
METHODS: We searched Scopus, ISI Web of Science, PubMed, Embase and Cochrane Central from their inception to 30 September 2015 and limited the search to LMICs. The search was undertaken using the search strings 'pneumococc* AND conjugat* AND (vaccin* OR immun*)' AND 'economic OR cost-effectiveness OR cost-benefit OR cost-utility OR cost-effectiveness OR cost-benefit OR cost-utility' in the abstract, title or keyword fields. To be included, each study had to be a full EE of a PCV and conducted for an LMIC. Studies were extracted and reviewed by two authors. The review involved standard extraction of the study overview or the characteristics of the study, key drivers or parameters of the EE, assumptions behind the analyses and major areas of uncertainty.
RESULTS: Out of 134 records identified, 22 articles were included. Seven studies used a Markov model for analysis, while 15 studies used a decision-tree analytic model. Eighteen studies performed a cost-utility analysis (CUA), with disability-adjusted life-years, quality-adjusted life-years or life-years gained as a measure of health outcome, while four studies focused only on cost-effectiveness analysis (CEA). Both CEA and CUA findings were provided by eight studies. Herd effects and serotype replacement were considered in 10 and 13 studies, respectively. The current evidence shows that both the 10-valent and 13-valent PCVs are probably cost effective in comparison with the 7-valent PCV or no vaccination. The most influential parameters were vaccine efficacy and coverage (in 16 of 22 studies), vaccine price (in 13 of 22 studies), disease incidence (in 11 of 22 studies), mortality from IPD and pneumonia (in 8 of 22 studies) and herd effects (in 4 of 22 studies). The findings were found to be supportive of the products owned by the manufacturers.
CONCLUSION: Our review demonstrated that an infant PCV programme was a cost-effective intervention in most LMICs (in 20 of 22 studies included). The results were sensitive to vaccine efficacy, price, burden of disease and sponsorship. Decision makers should consider EE findings and affordability before adoption of PCVs.
METHODS: A stochastic model was developed using respiratory elastance (Ers) data from two clinical cohorts and averaged over 30-minute time intervals. The stochastic model was used to generate future Ers data based on current Ers values with added normally distributed random noise. Self-validation of the VPs was performed via Monte Carlo simulation and retrospective Ers profile fitting. A stochastic VP cohort of temporal Ers evolution was synthesised and then compared to an independent retrospective patient cohort data in a virtual trial across several measured patient responses, where similarity of profiles validates the realism of stochastic model generated VP profiles.
RESULTS: A total of 120,000 3-hour VPs for pressure control (PC) and volume control (VC) ventilation modes are generated using stochastic simulation. Optimisation of the stochastic simulation process yields an ideal noise percentage of 5-10% and simulation iteration of 200,000 iterations, allowing the simulation of a realistic and diverse set of Ers profiles. Results of self-validation show the retrospective Ers profiles were able to be recreated accurately with a mean squared error of only 0.099 [0.009-0.790]% for the PC cohort and 0.051 [0.030-0.126]% for the VC cohort. A virtual trial demonstrates the ability of the stochastic VP cohort to capture Ers trends within and beyond the retrospective patient cohort providing cohort-level validation.
CONCLUSION: VPs capable of temporal evolution demonstrate feasibility for use in designing, developing, and optimising bedside MV guidance protocols through in-silico simulation and validation. Overall, the temporal VPs developed using stochastic simulation alleviate the need for lengthy, resource intensive, high cost clinical trials, while facilitating statistically robust virtual trials, ultimately leading to improved patient care and outcomes in mechanical ventilation.
METHODS AND ANALYSIS: The methodology draws on Arksey and O'Malley's seminal framework for the scoping review. The literature search will be conducted by using keywords to find suitable published literature. The existing literature will be searched using selected electronic databases such as PubMed/MEDLINE, CINAHL, Scopus, ProQuest and Web of Science from the years 2011 and 2021. The selected publications will focus on 10 Southeast Asian countries: Malaysia, Indonesia, Singapore, Thailand, Brunei, Philippines, Laos, Vietnam, Cambodia and Myanmar. Two reviewers will be performing title and abstract screening for the criteria of each publication, in which they will be working independently of each other. The included publication will undergo a full-text review and references cited will be examined for relevance using the same inclusion criteria. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram will guide throughout the process. Data will be extracted, analysed and charted within each category from the selected publications for each Southeast Asian country.
ETHICS AND DISSEMINATION: The results of this scoping review will illustrate an overview of the 3D printing healthcare research in the Southeast Asian context, which can be a guide for the advancement of 3D printing that can be accentuated in future research. The results will undergo dissemination which will be submitted for publication in a scientific journal.
METHODS AND ANALYSIS: This scoping review will be guided by the smart technology adoption behaviours of elder consumers theoretical model (Elderadopt) by Golant and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews. First, we will conduct an internet search for nursing homes and websites and databases related to the stakeholders to retrieve the definitions, concepts and criteria of a smart nursing home (phase 1). Second, we will conduct an additional systematic electronic database search for published articles on any measures of technological feasibility and integration of medical services in nursing home settings and their acceptability by nursing home residents and caregivers (phase 2). The electronic database search will be carried out from 1999 to 30 September 2020 and limited to works published in English and Chinese languages. For phase 2, the selection of literature is further limited to residents of nursing homes aged ≥60 years old with or without medical needs but are not terminally ill or bed-bound. Qualitative data analysis will follow the Framework Methods and thematic analysis using combined inductive and deductive approaches, conducted by at least two reviewers.
ETHICS AND DISSEMINATION: This protocol is registered on osf.io (URL: https://osf.io/qtwz2/). Ethical approval is not necessary as the scoping review is not a primary study, and the information is collected from selected articles that are publicly available sources. All findings will be disseminated at conferences and published in peer-reviewed journals.
METHODS AND ANALYSIS: We will conduct a systematic search in PubMed, Scopus, Web of Science and grey literature. Descriptive statistics will be used to report the characteristics of included studies. The facilitators and barriers to DHTs implementation, gathered from both quantitative and qualitative data, will be synthesised using a parallel-results convergent synthesis design. A thematic analysis, employing an inductive approach, will be conducted to categorise these facilitators and barriers into coherent themes. Additionally, we will identify and categorise all available DHTs based on their equipment types and methods of operation to develop an innovative classification framework.
ETHICS AND DISSEMINATION: Formal ethical approval is not required, as primary data collection is not involved in this study. The findings will be disseminated through peer-reviewed publications, conference presentations and meetings with key stakeholders and partners in the field of digital health.
DESIGN: Data-based convergent mixed-method systematic review.
METHODS: Three electronic databases (Web of Science, Scopus, and Cumulative Index to Nursing and Allied Health Literature) will be used in the identification stage. The first search will use the search string for each database to identify relevant studies. The articles retrieved will be screened by year of publication, article type and language. Abstracts and full-text of selected studies will be screened for eligibility independently by a minimum of two reviewers. The reference lists will be manually screened to identify additional publications. The quality assessment will be conducted by two reviewers using the Mixed Methods Appraisal Tools. Quantitative and mixed-method studies will be transformed into qualitative. A thematic approach will be used to synthesize and report the data. Ethics approval and funding have been approved in April 2020.
DISCUSSION: This study will synthesize the types of challenges perceived by final-year undergraduate nursing students in different clinical learning environments across the country.
IMPACT: The proposed study findings will help nursing education stakeholders and faculty provide assistance to final-year nursing students in their transition year to become registered nurses.