title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Provisions for post-trial care {30} | Not applicable—as there is no intervention directly to participants. The intervention, additional hospital cleaning, carries no additional risk to participants. | PMC9944767 | ||
Outcomes {12} | SECONDARY | The primary outcome is the proportion of inpatients aged ≥ 18 years old with a HAI as measured by a HAI point prevalence study (PPS). The secondary outcomes are the thoroughness of cleaning as being the proportion of dots that were completely removed, as measured by the FM gel and ultraviolet light system, and the cost... | PMC9944767 | |
Sample size {14} | HAI infection, FM | The participant timeline is shown in Fig. Timeline for enrolment, interventions and assessments of the study. FM fluorescent markers, HAI healthcare-associated infectionThe study design ensures a sample size sufficient to detect a relative reduction of at least 35% in total HAI infection, with a baseline point prevalen... | PMC9944767 | |
Recruitment {15} | DISEASE | In alignment with past approaches in Australia and the European Centre for Disease Prevention and Control protocol, all patients admitted to the ward before or at 08:00 h on the first survey day and not discharged from the ward at the time of the survey will be eligible and will be evaluated for a HAI. Patients transfe... | PMC9944767 | |
Assignment of interventions: allocation | PMC9944767 | |||
Sequence generation {16a} | FM | There will be two wards allocated to each cluster. The allocation of when each cluster will commence the intervention will be randomised using Microsoft Excel. This will be undertaken by the study statistician, not involved in data collection or the determination of outcomes. The equipment to be tested in the FM audit ... | PMC9944767 | |
Concealment mechanism {16b} | Once randomisation has occurred and each ward is allocated into a cluster, this information will be kept by the person undertaking randomisation on their own (work) computer. This allocation will not be available to the participating wards or PSAs or those involved in data collection. Each participating ward and PSAs w... | PMC9944767 | ||
Implementation {16c} | The allocation sequence will be generated by the study statistician and each ward will be randomly assigned to a cluster. As each cluster enters the intervention phase, the trial coordinator will facilitate PSA training sessions and auditing feedback. | PMC9944767 | ||
Assignment of interventions: blinding | PMC9944767 | |||
Who will be blinded {17a} | FM | The researcher collecting the data on the primary outcome (HAI data) will be blinded to the intervention (i.e. knowing whether the ward is an intervention or control ward). Similarly, the researcher collecting FM audit data will be blinded to the intervention. Results of the audit process will not be made available to ... | PMC9944767 | |
Procedure for unblinding if needed {17b} | Once data collection and statistical analysis have been finalised, the interventions can be unblinded for the purpose of interpreting the data. | PMC9944767 | ||
Data collection and management | PMC9944767 | |||
Plans for assessment and collection of outcomes {18a} | infection | INFECTION, PATHOLOGY | A data extraction tool has been developed and piloted in REDCap®. This tool was adapted from a previous multi-centre point prevalence study (1). The researcher responsible for collecting the data will be trained in the use of the survey instrument to extract relevant data pertaining to the intervention and relevant out... | PMC9944767 |
Plans to promote participant retention and complete follow-up {18b} | Not applicable—as patients are not recruited and there is no patient follow-up in this study. | PMC9944767 | ||
Data management {19} | The data which will be obtained from patients’ hospital medical record will be non-identifiable and there are clear processes in place to ensure that the privacy of data is maintained. These processes include appropriate storage of data in password-protected files and the destruction of these data after completion of t... | PMC9944767 | ||
Confidentiality {27} | No identifiable data is collected. The project is supervised and overseen by a clinician, registered with the Australian Health Practitioner Regulation Authority. | PMC9944767 | ||
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | There will be no biological specimens tested in this study. | PMC9944767 | ||
Statistical methods | PMC9944767 | |||
Statistical methods for primary and secondary outcomes {20a} | PMC9944767 | |||
Primary outcome analysis | RSV, pneumonia, viral respiratory infections, generalised, bloodstream infections | BLOODSTREAM INFECTION, PNEUMONIA, URINARY TRACT INFECTIONS, SURGICAL SITE INFECTION, VIRAL RESPIRATORY INFECTION, INFLUENZA | The primary outcome is defined as the total fortnightly rates of HAI identified. The primary outcome will be analysed by a generalised linear mixed model (GLMM) with a logit link function, where the dependent variable is defined as will be used, to estimate changes in fortnightly cases of HAI. To standardise rates, the... | PMC9944767 |
Secondary outcome analysis | PMC9944767 | |||
FM
audits | We will analyse data from fortnightly cleaning audits using a binomial generalised linear mixed model with a logit link function on the proportion of equipment that were deemed ‘cleaned’. A random intercept will be included for each ward. The effect of the intervention will be tested in three ways: a binary interventio... | PMC9944767 | ||
Cost-effectiveness | ’ | The costs of adopting the intervention will be prospectively collected from hospital records, such as the cost of cleaning consumables. Excess length-of-stay estimates will be sourced from studies identified by systematic reviews to estimate the value of bed days saved. The cost-effectiveness of the intervention will b... | PMC9944767 | |
Interim analyses {21b} | There will be no interim analysis as we do not expect there to be any negative effects from this study. | PMC9944767 | ||
Methods for additional analyses (e.g. subgroup analyses) {20b} | Not applicable—there are no subgroup analyses planned. | PMC9944767 | ||
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | SECONDARY | Statistical analyses will be performed as intention-to-treat, in accordance with the published protocol. For the specified study design, the intention-to-treat analysis will assume cluster transitions from control to intervention according to randomised sequence allocation and include all patients who meet the study in... | PMC9944767 | |
Plans to give access to the full protocol, participant-level data and statistical code {31c} | Fully de-identified data sets and statistical codes will only be available by contacting a chief investigator and providing the appropriate ethical approvals. | PMC9944767 | ||
Oversight and monitoring | PMC9944767 | |||
Composition of the coordinating centre and trial steering committee {5d} | The project consists of a management and steering committee. The management committee (coordinating centre) will oversee the day-to-day running of the trial and decide on the operational elements of the trial. Members of the coordinating centre are two chief investigators and the trial coordinator. The steering committ... | PMC9944767 | ||
Composition of the data monitoring committee, its role and reporting structure {21a} | The study does not have a data monitoring committee. The intervention is an enhancement of existing health services delivery (cleaning) with no anticipated risks. There is no planned interim analysis. | PMC9944767 | ||
Adverse event reporting and harms {22} | ADVERSE EVENTS, ADVERSE EVENT | The trial coordinator is responsible for ensuring that all adverse events observed by the investigator/s, study team or reported by sites are collected and recorded in the source documents. The trial coordinator will notify the approving ethics committee of serious adverse events occurring at any of the sites. Adverse ... | PMC9944767 | |
Frequency and plans for auditing trial conduct {23} | The HREC granting approval for this study may conduct an external audit at any point in the trial. The steering committee will be responsible for monitoring risks and the progress of the trial. | PMC9944767 | ||
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} | Where there are any ethical amendments to the trial protocol, approval will be sought from the approving HREC. Similarly, important protocol modification will be updated on the Australian and New Zealand Clinical Trial registry. | PMC9944767 | ||
Dissemination plans {31a} | The investigators will implement a dissemination plan that will include key communication strategies for all stakeholders, an open-access publication plan, authorship requirements and publication standards that align with NHMRC Australian Code for the Responsible Conduct of Research ( | PMC9944767 | ||
Discussion | infection | INFECTION | The CLEEN study is a large cluster randomised controlled trial conducted in an Australian tertiary hospital. The study represents the first randomised controlled study in the world to provide level 1 evidence on the impact of additional cleaning of shared equipment on rates of HAIs (5). The advantages of the study desi... | PMC9944767 |
Trial status | RECRUITMENT | The trial protocol V1.1. is the current and approved version as of 21 September 2022. Hospital recruitment is completed, including all required ethical approvals. Data collection will begin in March 2023 with an expected end date for data collection in November 2023.
| PMC9944767 | |
Acknowledgements | Not applicable. | PMC9944767 | ||
Authors’ contributions {31b} | DB, NW | AC is a chief investigator who helped develop the protocol and revised the manuscript. AS is a chief investigator who helped develop the protocol and revised the manuscript. BM is the lead and chief investigator who conceived the study, led the proposal and protocol development and revised the manuscript. DB is a chief... | PMC9944767 | |
Authors’ information | Not applicable | PMC9944767 | ||
Funding {4} | MITCHELL | This project is funded by a National Health and Medical Research Council Emerging Leadership Investigator grant (Prof Brett Mitchell, (GNT2008392)) and administered by Avondale University. AJS is supported by an Australian National Health and Medical Research Council Early Career Fellowships (GNT1141398).Industry partn... | PMC9944767 | |
Availability of data and materials {29} | Details about the study will be posted on information boards in the participating hospital. Standard operating procedures for cleaning specific items of shared medical equipment will be developed and subsequently explained at the in-service (if they are not already in existence at the hospital). These will also be read... | PMC9944767 | ||
Declarations | PMC9944767 | |||
Ethics approval and consent to participate {24} | This trial has ethical approval from the Hunter New England Local Health District (2022/ETH01780) and governance approval from the Central Coast Local Health District (2022/STE02925). | PMC9944767 | ||
Consent for publication {32} | Not applicable. | PMC9944767 | ||
Competing interests {28} | The authors declare that they have no competing interests. | PMC9944767 | ||
References | PMC9944767 | |||
Introduction | arrhythmias, arrhythmia, syncope | ARRHYTHMIAS, RECURRENCE, ARRHYTHMIA | Diagnosing underlying arrhythmia in emergency department (ED) syncope patients is difficult. There is a evidence that diagnostic yield for detecting underlying arrhythmia is highest when cardiac monitoring devices are applied early, ideally at the index visit. This strategy has the potential to change current syncope m... | PMC9950891 |
Methods and analyses | syncope | This is a UK open prospective parallel group multicentre randomised controlled trial of an immediate 14-day ambulatory patch heart monitor vs standard care in 2234 patients presenting acutely with unexplained syncope. Our patient focused primary endpoint will be number of episodes of syncope at 1 year. Health economic ... | PMC9950891 | |
Ethics and dissemination | Informed consent for participation will be sought. The ASPIRED trial received a favourable ethical opinion from South East Scotland Research Ethics Committee 01 (21/SS/0073). Results will be disseminated via scientific publication, lay summary and visual abstract. | PMC9950891 | ||
Trial registration number | ISRCTN 10278811. | PMC9950891 | ||
STRENGTHS AND LIMITATIONS OF THIS STUDY | syncope | The ASPIRED trial uses non-blinded randomisation to compare immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients.The primary outcome measure is a patient focussed measure very relevant to the population of patients who suffer syncope.We are using health economic ... | PMC9950891 | |
Introduction | PMC9950891 | |||
Background and rationale | arrhythmia, heart disease, syncope, Syncope, cardiac arrhythmia, neurocardiogenic, cardiac disease | RECURRENCE, ARRHYTHMIA, HEART DISEASE, SIMPLE FAINT, CARDIAC ARRHYTHMIA, CARDIAC DISEASE, POSTURAL HYPOTENSION | Syncope (or blackout) is common; 650 000 patients present to UK emergency departments (EDs) every year. The three underlying causes are neurocardiogenic (including simple faint), postural hypotension (blood pressure fall on standing) and cardiac disease (structural heart disease or cardiac arrhythmia). Diagnosis is dif... | PMC9950891 |
Study objectives | PMC9950891 | |||
Primary | syncope | To determine whether immediate, enhanced (14 days) ambulatory ECG monitoring decreases the number of self-reported episodes of syncope at 1 year compared with standard care monitoring in acute unexplained syncope patients. | PMC9950891 | |
Secondary | death, syncope, cardiac arrhythmia | RECURRENCE, CARDIAC ARRHYTHMIA | To determine whether immediate, enhanced (14 days) ambulatory ECG monitoring in acute unexplained syncope patients can:Decrease the number of episodes of self-reported syncope at 90 days, and 2 years compared with standard care monitoring.Decrease the time to detection of clinically significant cardiac arrhythmia compa... | PMC9950891 |
Methods and analysis | PMC9950891 | |||
Study design | syncope | This is a UK open prospective parallel group multicentre RCT of an immediate 14-day ambulatory patch heart monitor versus standard care monitoring in 2234 participants presenting acutely with unexplained syncope. The patient focused primary endpoint will be number of episodes of syncope at 1 year (Study summary in PICO... | PMC9950891 | |
Study eligibility | syncope, Syncope, TLOC, transient loss of consciousness, thirty-four | Two thousand two hundred and thirty-four adult (16 years or older) participants presenting acutely to UK hospitals with syncope remaining unexplained after initial ED or acute medicine unit (AMU) assessment will be enrolled. Syncope will be defined as transient loss of consciousness (TLOC) with inability to maintain po... | PMC9950891 | |
Inclusion criteria | syncope, Syncope | Syncope remains unexplained after initial ED/AMU assessment.Aged ≥16 years.Patient has capacity.Local resident (ie, resident within local health board so will not be lost to medical record follow-up).<5 self-reported episodes of syncope in the previous month. | PMC9950891 | |
Exclusion criteria | cerebrovascular accident/transient ischaemic, TLOC.Inability, Haemorrhage, syncope, pulmonary embolus, Arrhythmia, Head trauma, vasovagal syncope | ACUTE MYOCARDIAL INFARCTION, HAEMORRHAGE, SUBARACHNOID HAEMORRHAGE, RECRUITMENT, PULMONARY EMBOLUS, EPILEPTIC SEIZURE, ARRHYTHMIA, HYPOGLYCAEMIA, VASOVAGAL SYNCOPE, POSTURAL HYPOTENSION | Obvious underlying cause after assessment.Features of vasovagal syncope (see Arrhythmia on prehospital or hospital ECG as likely cause of syncope.Postural hypotension (symptomatic postural drop >20 mm Hg AND suggestive history).Confirmed diagnosis of pulmonary embolus or acute myocardial infarction.Radiological diagnos... | PMC9950891 |
Features of vasovagal/postural syncope | nausea, light-headedness, syncope, pain, cough, blood phobia, tumour, vomiting).After sudden | TUMOUR | Associated with typical symptoms of reflex syncope (eg, light-headedness, feeling of warmth, nausea, vomiting).After sudden unexpected unpleasant sight, sound, smell or pain.In association with micturition, defaecation, cough, laughter, venepuncture, blood phobia.After prolonged standing or crowded, hot places.During a... | PMC9950891 |
Participant recruitment | RECRUITMENT, RECRUITMENT | Recruitment will take place in around 30–40 NHS acute tertiary and district hospitals. Schematic diagram of the study design and participant recruitment. AMU, acute medicine unit; ED, emergency department; GP, general practitioner. | PMC9950891 | |
Randomisation and interventions | syncope | RECRUITMENT, EVENT | Randomisation will be performed using a web-based randomisation service to ensure allocation concealment, managed by Edinburgh Clinical Trials Unit (ECTU). The allocation sequence will be created by an ECTU database programmer using computer-generated pseudo-random numbers. Participants will be randomised, 1:1, between... | PMC9950891 |
Outcome measures | PMC9950891 | |||
Primary endpoint | syncope | Number of self-reported episodes of syncope at 1 year. | PMC9950891 | |
Secondary endpoints | death, syncope, cardiac arrhythmia | RECURRENCE, CARDIAC ARRHYTHMIA | Within trial cost-effectiveness (cost per syncope avoided and cost per quality-adjusted life year (QALY) gained), and lifetime cost per QALY gained at (a) 1 year and (b) 2 years.Number of self-reported episodes of syncope at (a) 90 days and (b) 2 years, those identified in the medical records at (c) 90 days, (d) 1 year... | PMC9950891 |
Definitions of clinically significant cardiac arrhythmias | Bradycardia, bradycardia, tachycardia, arrhythmias, VT, atrial flutter/fibrillation, Atrial flutter/fibrillation | SINUS PAUSE, SINUS BRADYCARDIA, SUPRAVENTRICULAR TACHYCARDIA, 3RD DEGREE HEART BLOCK, MOBITZ, SECOND DEGREE ATRIOVENTRICULAR HEART BLOCK, CARDIAC ARRHYTHMIA, SICK SINUS SYNDROME, ARRHYTHMIAS | Ventricular fibrillation.Ventricular tachycardia (VT) ≥120 beats per minute (bpm) for ≥30s.VT ≥120 bpm for <30 s (≥4 beats).Complete or 3rd degree heart block.Second degree atrioventricular heart block Mobitz type II.Second degree atrioventricular heart block Mobitz type I.Pause ≥6 s.Sinus pause ≥2.5 s when awake or ≥4... | PMC9950891 |
Trial assessments | PMC9950891 | |||
Participant identification | Potential participants will be identified from EDs/AMUs or other acute settings and approached either during their ED/AMU or hospital stay or contacted after discharge and invited to take part in the study. | PMC9950891 | ||
Participant consent | arrhythmia, syncope, PIS | EVENTS, EVENT, ARRHYTHMIA, SECONDARY | Potential participants will be given a Participant Information Sheet (PIS). Potential participants will be randomised within 72 hours of their hospital attendance. If a patient has been discharged from the hospital, then they will be contacted by the local clinical team or research team (if part of the clinical team), ... | PMC9950891 |
Timelines | RECRUITMENT | The study started on 1 August 2021 and the first patient was recruited on 15 July 2022. Recruitment is planned to end on 31 December 2023, the with study completing on 31 July 2025. | PMC9950891 | |
Sample size | death, thirty-four, syncope | RECURRENCE | Two thousand two hundred and thirty-four participants (1117 standard and 1117 intervention) presenting acutely with syncope whose syncope remains unexplained after initial ED/AMU assessment will be recruited. Using an estimated mean 1-year recurrence rate in untreated patients of 42.5%The study will recruit an extra 5%... | PMC9950891 |
Study progression criteria | RECRUITMENT | This study will include an internal recruitment pilot phase with stop-go recruitment milestone criteria to mitigate risk to the funder. This internal pilot will be used to confirm recruitment rates and aims to recruit the first 400 participants (almost one-fifth of the sample size) from 10 sites by the end of study mon... | PMC9950891 | |
Data analysis plan | syncope | REGRESSION, EVENT, SECONDARY | The primary outcome, number of self-reported episodes of syncope in the 12 months following randomisation, will be analysed by negative binomial regression. The primary outcome event rate ratio (14-day ambulatory heart monitor vs standard care) will be reported with its 95% CI. An offset term for follow-up duration wil... | PMC9950891 |
Cost-effectiveness analysis | death, syncope | EVENTS | Anonymised electronic healthcare record data will be sent to our health economist in Sheffield to apply unit costs and tariffs, to estimate within trial costs and QALYs, and then to undertake lifetime economic modelling. Both within trial and lifetime cost-effectiveness analysis will be performed. In within trial analy... | PMC9950891 |
Interim analysis | RECRUITMENT | In addition to the blinded sample size review to ensure that the trial achieves the required statistical power, there will be a single interim futility analysis for the primary outcome performed after the 18th month of recruitment (end of study month 25). At this point 6 months of 1-year follow-up data will be availabl... | PMC9950891 | |
Patient and public involvement | ARRHYTHMIA | The ASPIRED study patient and public involvement group is made up of patient representatives, lay members and a representative from the Arrhythmia Alliance. They have been involved in informing the study research questions and study protocol in particularly the methods and timings of patient follow-up, and the developm... | PMC9950891 | |
Ethics and dissemination | The ASPIRED trial received a favourable ethical opinion from South East Scotland Research Ethics Committee 01 (21/SS/0073). | PMC9950891 | ||
Participant capacity and consent | temporary incapacity | Capacity will be assessed by the research team or a clinician responsible for the treatment of the participant. The trial excludes patients who have inability to give informed consent and therefore patients with temporary incapacity due to their current illness or with permanent incapacity will not be recruited. | PMC9950891 | |
Safety considerations | PMC9950891 | |||
Bias | syncope | The primary outcome is a quantitative endpoint (number of syncope episodes) collected through automated participant reporting importing directly into the ECTU central study database to reduce reporting bias. Central research staff who phone participants will be blinded to participant allocation. | PMC9950891 | |
Adverse events | SECONDARY, ADVERSE EVENT, COMPLICATIONS | A secondary endpoint for the study is serious outcomes at 90 days, 1 and 2 years. This data will therefore be routinely collected as part of the study and not recorded as an adverse event (AE). Hospital admission will also not be recorded as an AE. The only AEs recorded will be those directly related to the use of init... | PMC9950891 | |
Data management | Identifiable data collected by the study will not be transferred to any external individuals or organisations outside of the sponsoring organisations. | PMC9950891 | ||
Study dissemination | ARRHYTHMIA | We will disseminate the results of this study widely through high impact peer-reviewed publications, presentations at international conferences, local and national websites, charity newsletters and websites and media outlets such as television and radio. We will also share our results through specific interest groups s... | PMC9950891 | |
Supplementary Material | PMC9950891 | |||
Reviewer comments | PMC9950891 | |||
Ethics statements | PMC9950891 | |||
Patient consent for publication | Not applicable. | PMC9950891 | ||
References | PMC9950891 | |||
Objective | The objective of this clinical trial was to compare facial expressions (magnitude, shape change, time, and symmetry) before (T0) and after (T1) orthognathic surgery by implementing a novel method of four-dimensional (4D) motion capture analysis, known as videostereophotogrammetry, in orthodontics. | PMC10560183 | ||
Methods | This prospective, single-centre, single-arm trial included a total of 26 adult patients (mean age 28.4 years; skeletal class II: | PMC10560183 | ||
Results | 4D motion capture analysis was feasible in all cases. The magnitude of the expression maximum smile increased from 15.24 to 17.27 mm ( | PMC10560183 | ||
Conclusions | Orthodontic-surgical treatment not only affects static soft tissue but also soft tissue dynamics while smiling or lip pursing. | PMC10560183 | ||
Clinical relevance | To achieve comprehensive orthodontic treatment plans, the integration of facial dynamics via videostereophotogrammetry provides a promising approach in diagnostics. | PMC10560183 | ||
Trial registration number | DRKS00017206. | PMC10560183 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00784-023-05195-9. | PMC10560183 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10560183 | ||
Introduction | Facial expressions as a type of nonverbal communication play an essential role in daily conversations. When assessing emotions, facial expressions carry more weight than the spoken message [Since orthodontic treatment, and in particular orthodontic-surgical treatment, always affects the appearance of the facial soft ti... | PMC10560183 | ||
Subjects and methods | PMC10560183 |
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