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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Intervention cost | contracture | The costs related to the intervention arm of the trial were summed to give the
total cost per participant (NHS costs). Where possible, unit costs for the UK
were applied (e.g. Personal Social Services Research Unit, British National
FormularySummary of all intervention costs.Resource use analysis is presented in Betwee... | PMC9912301 | |
Sensitivity Analysis | A one-way sensitivity analysis was undertaken to assess the extent of potential
changes in the main cost parameters and outcomes of the treatment using the mean
difference, lower and upper bounds of the confidence intervals for the Barthel
score (Table 3) and the Action Research Arm Test (Incremental cost of interventi... | PMC9912301 | ||
Discussion | stroke, post-stroke spasticity, spasticity | STROKE | We have previously demonstrated that the early use of botulinum toxin reduced
spasticity and contractures after stroke and that the effects lasted for
approximately 12 weeks.This indicates that the early use of botulinum toxin for post-stroke spasticity can
be cost-saving to the NHS when assessed in terms of gain in th... | PMC9912301 |
Clinical messages | contracture, spasticity | The early use of botulinum toxin, as soon as spasticity is identified,
appears to be cost-neutral.Mean contracture costs for the treatment group were £817 while the costs
for the control group were £2298 (Both base case results for cost per improvement of Barthel and Action
Research Arm Test scores indicate that the in... | PMC9912301 | |
References | PMC9912301 | |||
Background | malaria | MALARIA | In recent years, the downward trajectory of malaria transmission has slowed and, in some places, reversed. New tools are needed to further reduce malaria transmission. One approach that has received recent attention is a novel house-based intervention comprising window screening (S) and general house repairs to make th... | PMC10161487 |
Methods | malaria, infection, malaria infection | MALARIA, INFECTION, MALARIA | This study evaluated the impact of SET on malaria infection prevalence in Côte d’Ivoire and compares the result in the primary outcome, malaria case incidence. Malaria infection prevalence was measured in a cross-sectional survey in 40 villages, as part of a cluster-randomised trial evaluating the impact of SET on mala... | PMC10161487 |
Results | Infection | INFECTION | Infection prevalence, measured by rapid diagnostic test (RDT), was 50.4% and 36.7% in the control arm and intervention arm, respectively, corresponding to an odds ratio of 0.57 (0.45–0.71), | PMC10161487 |
Conclusions | malaria, infection, Infection | MALARIA, INFECTION, INFECTION | In addition to reducing malaria case incidence, house screening and EaveTubes substantially reduced malaria infection prevalence 18 months after installation. Infection prevalence may be a good metric to use for evaluating malaria interventions in areas of similar transmission levels to this setting. | PMC10161487 |
Trial registration | ISRCTN18145556, registered 1 February 2017. | PMC10161487 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12916-023-02871-1. | PMC10161487 | ||
Keywords | PMC10161487 | |||
Background | malaria, infection, deaths, malaria infection | MALARIA, INFECTION, PVC | Vector control has been credited with a large contribution to the decline in malaria cases and deaths in the past 15 years [One such tool is the In2Care® EaveTube. EaveTubes comprise PVC tubes which are inserted into a house at eave level and are closed off using an insecticide treated netted insert. EaveTubes exploit ... | PMC10161487 |
Methods | PMC10161487 | |||
Study site | malaria | MALARIA, MAY | The trial took place in 40 villages (clusters) within 50 km of the city of Bouaké, central Côte d’Ivoire. The study setting has moderate to high malaria transmission with seasonal transmission primarily occurring between May to November each year. There is a high level of pyrethroid resistance in the local anopheline v... | PMC10161487 |
Trial overview | malaria, Febrile | MALARIA, MAY | The protocol and primary results for the trial have been previously published [The main epidemiological outcome of the trial was malaria case incidence. This was measured in a cohort of 50 children aged 6 months to 10 years per cluster. The cohorts were visited every 2 weeks during the transmission season (May to Novem... | PMC10161487 |
Endline prevalence survey | malaria | MALARIA, MALARIA | An endline cross-sectional survey took place in November 2018, 18 months after the installation of SET. In contrast to the baseline survey where households were the sampling unit, compounds (ranging from 1 to 5 households) were randomly selected from census lists of each cluster, and individuals were tested until appro... | PMC10161487 |
Statistical methods | HAND INFECTION | Descriptive statistics (proportions and means) and infection status associations were calculated with confidence intervals adjusting standard errors for clustering at the village level using the svy command in Stata. To assess the impact of the intervention, a mixed effect logit model with arm as a fixed effect and clu... | PMC10161487 | |
Results | PMC10161487 | |||
Baseline survey results | malaria | MALARIA | In the baseline survey, 2559 children aged 6 months to 10 years from 1217 households were tested for malaria. The mean age of children tested was 5 years. Similar proportions of males and females were tested. The majority of children reported always using a bed net (76.8%), whilst 19% reporting never using a net. Child... | PMC10161487 |
Endline survey results (18 months post-installation) | infection, Infection | INFECTION, INFECTION | For the endline survey, 2843 people from 275 compounds were included across the 40 clusters. The median age of participants was 12 years old (range: 6 months to 98 years). Net use was relatively high, with 72.5% of people reporting using a net the previous night, though this appeared lower in the intervention arm (68.0... | PMC10161487 |
Impact of Screening and EaveTubes (SET) on infection prevalence measured by RDT | infection, malaria infection, Infection | INFECTION, HAND INFECTION, INFECTION | Infection prevalence was lower in the intervention arm (36.7%) compared to the control arm (50.4%), with 43% lower odds of infection in the SET arm compared to the control arm (odds ratio (OR) 0.57 (0.45–0.71), Infection prevalence in each cluster (open circles) by intervention arm. The mean of the cluster results and ... | PMC10161487 |
Infection prevalence at endline compared to baseline (RDT) | infection, Infection | INFECTION, INFECTION | Infection prevalence in children aged 6 months to 10 years for each arm was compared between baseline and endline surveys to assess whether there was a reduction in either arm, with the caveats that the two surveys took place at different times of the year and had slightly different sampling methodologies. The interact... | PMC10161487 |
Comparison of diagnostics: RDT and microscopy | infection | INFECTION, CNS INFECTIONS | The majority of participants in the endline survey also had a blood smear taken for microscopy (Overall, 57.3% (707/1233) of positive RDT results were also positive by microscopy. Whilst age patterns of infection prevalence appeared similar for the two diagnostics, the agreement between the two was lowest in older part... | PMC10161487 |
Infection prevalence (RDT) compared to incidence | malaria, infection | MALARIA, INFECTION | Cluster-level infection prevalence in the endline survey was associated with malaria case incidence measured in the child cohort at the end of the two years (Fig. Association between endline prevalence (all ages) and malaria case incidence in children aged 6 months to 10 years | PMC10161487 |
Discussion | malaria, infections, Infection | MALARIA, INFECTIONS, MALARIA, INFECTION | New paradigms of vector control tools are urgently needed if we are to continue the downward trajectory of malaria transmission that has been achieved over the past few decades. Housing modifications are a paradigm that has rarely been explored in cluster randomised trials. In this large trial, EaveTubes combined with ... | PMC10161487 |
Conclusions | malaria, infection | MALARIA, INFECTION, HAND INFECTION | Epidemiological metrics are essential for a comprehensive evaluation of interventions and for those interventions to receive a recommendation from the WHO. In this high transmission setting, malaria case incidence and infection prevalence were similarly reduced in the SET intervention clusters, highlighting the usefuln... | PMC10161487 |
Acknowledgements | This research was supported by a grant to the Pennsylvania State University from the Bill & Melinda Gates Foundation (OPP1131603). We thank our trial steering committee, the field staff, and the community health workers involved in the trial, the district health officials, and all the trial participants. | PMC10161487 | ||
Authors’ contributions | JC, EDS, and SBA conceived and designed the study. EDS, JC, IK, and MBT conceived and designed the wider trial. CA, EDS, and SBA supervised the epidemiological field work. RN, AAK, and SBA advised on the study communities and coordination with local and national authorities. EDS coordinated the trial and oversaw data c... | PMC10161487 | ||
Funding | The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. | PMC10161487 | ||
Availability of data and materials | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10161487 | ||
Declarations | PMC10161487 | |||
Ethics approval and consent to participate | The trial was reviewed and approved by the Côte d’Ivoire Ministry of Health ethics committee (039/MSLS/CNER-dkn), the Pennsylvania State University’s Human Research Protection Program under the Office for Research Protections (STUDY00003899 and STUDY00004815), and the London School of Hygiene & Tropical Medicine ethica... | PMC10161487 | ||
Consent for publication | Not applicable. | PMC10161487 | ||
Competing interests | The authors declare they have no competing interests. | PMC10161487 | ||
References | PMC10161487 | |||
Background | pain | ACHILLES TENDINOPATHY | The Achilles tendon is the largest and strongest tendon in the human body. Achilles tendinopathy (AT) is a common clinical problem with Achilles overuse. Eccentric exercise is often used as an initial treatment for these patients. Most patients with AT experienced moderate to severe pain, limiting the incentive to perf... | PMC10258964 |
Methods | This prospective randomised double-blinded, placebo-controlled trial aims to investigate the treatment effects of PEMF for participants with AT. All participants are randomised into two groups: the intervention group ( | PMC10258964 | ||
Discussion | pain | AT is a common clinical condition affecting athletes and sedentary populations. It is essential to investigate treatment adjuncts to improve rehabilitation outcomes for these patients. This trial may demonstrate the effectiveness of PEMF in relieving pain, improving function, and restoring mechanical changes of the ten... | PMC10258964 | |
Trial registration | ClinicalTrials.gov NCT05316961. Registered on 7th April 2022. | PMC10258964 | ||
Keywords | PMC10258964 | |||
Introduction | PMC10258964 | |||
Background and rationale {6a} | tendinopathies, tendinopathy, pain | ACHILLES TENDINOPATHY, HAND SWELLING | The Achilles tendon is the largest and strongest tendon in the human body. Achilles tendinopathy (AT) is a common clinical problem with Achilles overuse; it is a clinical condition characterised by a combination of pain and swelling in the posterior leg and heel region. AT results from an altered tendon structure and m... | PMC10258964 |
Objectives {7} | tendons, pain | This study aims to investigate the clinical effectiveness of PEMF as a treatment adjunct to eccentric exercise in patients with AT. The objective is to establish whether PEMF plus eccentric exercise in people with AT will improve rehabilitation outcomes compared to eccentric exercise only. The second objective is to in... | PMC10258964 | |
Trial design {8} | This is a prospective randomised, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the treatment effects of PEMF for participants with AT. All participants will be randomised into two groups: the intervention group ( | PMC10258964 | ||
Methods: participants, interventions, and outcomes | PMC10258964 | |||
Study setting {9} | This study will be conducted at the Prince of Wales Hospital in Hong Kong which is the teaching hospital of the Chinese University of Hong Kong. The assessment and intervention will be conducted at the Prince of Wales Hospital Sports Performance and Biomechanics Laboratory. | PMC10258964 | ||
Eligibility criteria {10} | cognitive impairment, Achilles’ tendons, psychiatric, tenderness, hemiplegia, major injury, Fractures | ANKLE ARTHRITIS, DISORDERS | Participants will be recruited based on the inclusion and exclusion criteria (Table Inclusion and exclusion criteria (1) Age between 18 and 70 (2) Focal clinical signs of AT with localised tenderness on palpation of the Achilles tendon (3) Recurrent complaints in 1 or both Achilles’ tendons at rest and during exercise ... | PMC10258964 |
Additional consent provisions for collection and use of participant data and biological specimens {26b} | The written consent form consists of the consent provisions for collecting and using participant data. The researcher will keep the information collected for a maximum of 5 years after publication results in PhD thesis and scientific papers. The data collected will be published to the public and in peer-reviewed scient... | PMC10258964 | ||
Interventions | knee in flexion), pain | HEAT, RECRUITMENT | The intervention will be held at the Prince of Wales Hospital in Hong Kong. Participants in the intervention group will be exposed to PEMF treatment by a PEMF device (Quantum Tx, Singapore). The active PEMF does not produce heat or cause any sensation to the tissue, which allows the participants to be blinded to the tr... | PMC10258964 |
Criteria for discontinuing or modifying allocated interventions {11b} | pain | ADVERSE EFFECTS | The treatment will be stopped, and immediate care will be provided if any significant adverse effects happen during the treatment period, including a substantial increase in the severity of pain or discomfort. | PMC10258964 |
Strategies to improve adherence to interventions {11c} | Participants may choose the time of sessions that suits them the most during working days. The opening hours of the Sports Performance and Biomechanics Laboratory will be extended to cover the evening hours so that participants may come for assessment after work. A record of compliance to eccentric exercise will be mad... | PMC10258964 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | There are no restrictions on relevant concomitant care. Participants are allowed to continue with their usual care. | PMC10258964 | ||
Provisions for post-trial care {30} | Participants may have access to the research clinic at the Prince of Wales Hospital if they suffer from orthopaedic conditions after the trial. | PMC10258964 | ||
Outcomes {12} | PMC10258964 | |||
Patient-reported outcomes | pain | ACHILLES TENDINOPATHY | The primary outcome is the score of the Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire, which is explicitly designed for Achilles tendinopathy. VISA-A will be used to evaluate pain and symptom severity with activity in participants with AT. Chinese-speaking participants will complete the valid... | PMC10258964 |
Functional outcomes | PMC10258964 | |||
Ankle range of motion | Weight-bearing lunge test will be used to measure ankle dorsiflexion’s range of motion (ROM). It will be used as an indicator of the flexibility of the gastrocnemius muscle. The participant will maximally dorsiflex the ankle while keeping the knee extended and the heel on the floor [ | PMC10258964 | ||
Calf muscle strength | The heel-rise test will be used to measure calf muscle strength. The participant will stand on a pressure mat (Tekscan, USA). The information on the plantar pressure will be collected for analysis [ | PMC10258964 | ||
Ultrasonographic outcomes | The ultrasonographic outcomes are measured by a PhD candidate with 2 years of experience performing ultrasound measurements of the Achilles tendon. A standardised imaging procedure is used to ensure repeatability. Ultrasound examinations for this study will be performed during baseline assessment and all follow‐up visi... | PMC10258964 | ||
Tendon thickness | All parameters are measured on the left side of the Achilles tendon and then the right side of the Achilles tendon. Greyscale ultrasound is used initially to identify the Achilles tendon. Longitudinal scans are performed medially and laterally across the Achilles tendon until the scan plane shows the Achilles tendon cl... | PMC10258964 | ||
Neovascularity | peritendinous, transducer | NEOVASCULARIZATION | The transducer is placed perpendicular to obtain a sagittal view of the Achilles tendon at the most painful part on palpation. The upper limit of the colour box is set on the dorsal side of the tendon. Pressure from the transducer is kept to a minimum to prevent the occlusion of neovascularization. The assessor screens... | PMC10258964 |
Tendon elasticity | tendon stiffness, tendinopathy | Shear wave elastography (SWE) quantifies soft tissue stiffness and provides an absolute value of tendon stiffness [The ultrasound normalisation procedure for subjects with bilateral tendinopathy will be done by using the mean values measured in healthy individuals as stated in current evidence. The mean value of a heal... | PMC10258964 | |
Sample size {14} | A minimum clinically significant difference is 16 points on the VISA-A scores based on the pilot study using VISA-A as the primary outcome in treating AT [ | PMC10258964 | ||
Recruitment {15} | Achilles tendinopathy, Sports Injury | ACHILLES TENDINOPATHY, RECRUITMENT | Participants will be recruited from the Department of Orthopaedics and Traumatology at the Prince of Wales Hospital in Hong Kong. The orthopaedic surgeons will explain the details of the trial based on the eligibility criteria. They will screen all patients with Achilles tendinopathy coming for consultation in the outp... | PMC10258964 |
Assignment of interventions: allocation | PMC10258964 | |||
Sequence generation {16a} | The randomisation is performed using an online research randomiser ( | PMC10258964 | ||
Concealment mechanism {16b} | The randomisation is performed using an online research randomiser by the chief engineer at Quantum TX. He will only share the randomisation results with the biostatistician at the Chinese University of Hong Kong. It will not be disclosed to the participants and assessors of this trial before the end of the treatment p... | PMC10258964 | ||
Implementation {16c} | The chief engineer from Quantum TX performs the randomisation. The randomisation result is shared with the biostatistician at the Chinese University of Hong Kong. The orthopaedic surgeon and PhD candidate from CUHK recruit participants. The PhD candidate will complete the assessment and assigns participants to interven... | PMC10258964 | ||
Assignment of interventions: blinding | PMC10258964 | |||
Who will be blinded? {17a} | HEAT | Assessors and participants will be blinded to the interventions. Participants will be blinded to the PEMF given to them as active and sham PEMF will not produce heat or other perceivable sensations. The engineer performs the randomisation from Quantum TX, and it will not be disclosed to the assessors before the end of ... | PMC10258964 | |
Procedure for unblinding if needed {17b} | ADVERSE EVENT | There will be unblinding of the participants and assessors if a severe adverse event occurs. The adverse event will be reported to the Joint Clinical Research Ethics Committee of the Chinese University of Hong Kong and the New Territories East Cluster of the Hospital Authority. | PMC10258964 | |
Data collection and management | PMC10258964 | |||
Plans for assessment and collection of outcomes {18a} | RECRUITMENT | The collection of demographic data will be done during screening and before recruitment. Participants that fulfil all the inclusion criteria will be randomised into PEMF or sham groups. Follow-up assessments with various outcome parameters will be conducted with data processing details as shown in the section “Outcomes... | PMC10258964 | |
Plans to promote participant retention and complete follow-up {18b} | Participants will choose the time for each PEMF session during the week. The working hours will be extended to the evenings so that participants may come for assessment and treatment after work. | PMC10258964 | ||
Data management {19} | All data collected will be entered into the online database in Excel files and SPSS files. All data will be kept in password-protected computers and destroyed 5 years after publication in PhD thesis and peer-reviewed journals. The PhD candidate will be responsible for data collection, data entry, and data analysis. She... | PMC10258964 | ||
Confidentiality {27} | All personal information and consent forms will be stored in locked cabinets at the Sports Performance and Biomechanics Laboratory. The online electronic database with personal information will be kept on password-protected computers. All data collected will be kept strictly confidential and only accessed by members of... | PMC10258964 | ||
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | Not applicable. This study will not require the use of biological specimens. | PMC10258964 | ||
Statistical methods | PMC10258964 | |||
Statistical methods for primary and secondary outcomes {20a} | Statistical analysis will be performed using SPSS software (SPSS 26.0) based on the intention-to-treat principle. The normality of the data will be tested using the Kolmogorov–Smirnov test. A repeated-measures two-way analysis of variance (ANOVA) will be used to compare muscle strength, ankle range of motion, and resul... | PMC10258964 | ||
Interim analyses {21b} | ADVERSE EVENT | An interim analysis will be performed on the primary endpoint when 20% of participants have completed the eight weeks of PEMF. The interim analysis ensures that there is no serious adverse event that happened during the study period. | PMC10258964 | |
Methods for additional analyses (e.g. subgroup analyses) {20b} | midportion tendinopathy, tendinopathy | ACHILLES TENDINOPATHY | The heterogeneity in tendinopathy will be addressed by sub-group analysis. AT will be categorised into midportion and insertional tendinopathy. The assessor will make the diagnosis of the type of Achilles tendinopathy. Midportion AT will be diagnosed by local thickening and a colour doppler flow of at least two out of ... | PMC10258964 |
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | The intention-to-treat analysis will be used to include all study participants in the groups to which they are randomised, regardless of any departures from the original assigned group. The missing values will be estimated by multiple imputations with the assumption that values are missing at random. | PMC10258964 | ||
Plans to give access to the full protocol, participant-level data, and statistical code {31c} | The protocol has been shown on ClinicalTrials.gov (ID: NCT05316961). The participant-level data and statistical code can be provided upon request. | PMC10258964 | ||
Oversight and monitoring | PMC10258964 | |||
Composition of the coordinating centre and trial steering committee {5d} | RECRUITMENT | The principal investigator will monitor the progress of the study. The trial steering committee are research team members who will participate in participant recruitment, data collection, and management. | PMC10258964 | |
Composition of the data monitoring committee, its role, and reporting structure {21a} | MUSCULOSKELETAL DISORDERS | The trial steering committee consists of orthopaedic surgeons, a physiotherapist, and a biostatistician. The orthopaedic surgeons and physiotherapists will participate in data collection and analysis. The biostatistician will monitor data collection and perform interim analysis. There is no independent data monitoring ... | PMC10258964 | |
Adverse events reporting and harms {22} | adverse reaction | ADVERSE EFFECTS, EVENT, ADVERSE REACTION | The PhD candidate will have thorough training on the operation of the machine, familiarise herself with the troubleshooting scheme, and closely monitor adverse effects during PEMF. In the event of a severe adverse reaction to the PEMF, it will be reported to the trial steering committee immediately. The participant wil... | PMC10258964 |
Plans for communicating necessary protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} | The investigators will apply for protocol amendments to the ethics committee and should be approved by the ethics committee before implementation. Trial participants will be informed about the amendments to the protocol. The protocol changes will be published in the Trial Register. | PMC10258964 | ||
Dissemination plans {31a} | EVENT | The early findings of the research will be presented at the Hong Kong Orthopaedic Association annual congress, the flagship event attended by all local orthopaedic surgeons. Final results will be presented at regional sports medicine conferences such as the Asia–Pacific Knee Arthroscopy and Sports Medicine (APKASS) Con... | PMC10258964 | |
Discussion | swelling, inflammation, tendon stiffness, pain, chronic tendon pain, tendinopathy | NEOVASCULARITY, INFLAMMATION, DEGENERATIVE, CLINICAL SYNDROME, PATHOGENESIS | AT is a clinical syndrome characterised by pain, swelling, and functional impairment, indicating a degenerative inflammatory process in the Achilles tendon. The overall incidence rate of AT was 2.45 per 1000 in the adult population between 21 and 60 years in their lifetime. It can affect athletes and non-athletes. Pati... | PMC10258964 |
Trial status | RECRUITMENT | Enrolment in the study started on 1 July 2021. Recruitment is expected to be completed by the end of September 2023. | PMC10258964 | |
Acknowledgements | Not applicable. | PMC10258964 | ||
Author contributions {31b} | VMCK, XH, SCF, PSHY, and SKKL participate in study design, data collection, and management. VMCK and SKKL wrote this manuscript. All authors read and approved this manuscript before publication. | PMC10258964 | ||
Funding {4} | This trial is fully funded by the Health and Medical Research Fund (HMRF), Food and Health Bureau of the government of HKSAR (Ref: 10210186). The study funder does not take on the legal responsibility and management of the research study. It only provides financial support to this research study. | PMC10258964 | ||
Availability of data and materials {29} | All investigators will have access to the final trial dataset upon request. Any data required to support the protocol can be supplied on request. | PMC10258964 | ||
Declarations | PMC10258964 | |||
Ethics approval and consent to participate {24} | Clinical research ethics approval is obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (Reference number: 2021.150). Written, informed consent to participate will be obtained from all participants. | PMC10258964 | ||
Consent for publication {32} | Not applicable. This manuscript does not include details, images, or videos relating to a person. A model consent form will be provided on request. | PMC10258964 | ||
Competing interests {28} | The authors declare that they have no competing interests. | PMC10258964 |
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