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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Conclusions | EARLY PREGNANCY | We showed that fish oil administered from early pregnancy onwards increased the | PMC10751948 | |
Acknowledgements | Diabetes | DIABETES | We want to thank Helena Fisk and Chris Gelauf for their assistance with the fatty acid analyses.The work (clinical trial execution) was supported by the Academy of Finland (#258606), State research funding for university-level health research of the Turku University Hospital Expert Responsibility Area, the Diabetes Res... | PMC10751948 |
Supplementary material | For supplementary material accompanying this paper visit https://doi.org/10.1017/S0007114523001915.click here to view supplementary material | PMC10751948 | ||
References | PMC10751948 | |||
Background | itching, hand and foot eczema, pain | SKIN | Chronic hand and foot eczema is a polyetiological dermatological condition. Patients experience pain, itching, and sleep disturbances and have a reduced quality of life. Skin care programs and patient education can improve the clinical outcome. eHealth devices offer a new opportunity to better inform and monitor patien... | PMC10031439 |
Objective | hand and foot eczema | This study aimed to systematically analyze the effect of a monitoring smartphone app combined with patient education on the quality of life and clinical outcome of patients with hand and foot eczema. | PMC10031439 | |
Methods | pruritus, Eczema, pain | SECONDARY, ECZEMA | Patients in the intervention group received an educational program; attended study visits on weeks 0, 12, and 24; and had access to the study app. Patients in the control group attended the study visits only. The primary end point was a statistically significant reduction in Dermatology Life Quality Index, pruritus, an... | PMC10031439 |
Results | itch, pain | In total, 87 patients were included in the study and randomized to the intervention group (n=43, 49%) or control group (n=44, 51%). Of the 87 patients, 59 (68%) completed the study visit at week 24. There were no significant differences between the intervention and control groups regarding quality of life, pain, itch, ... | PMC10031439 | |
Conclusions | hand and foot eczema | An educational program combined with a monitoring app that connects patients with their treating dermatologists can improve quality of life if the app is not used too frequently. In addition, telemedical care can at least partially replace personal care in patients with hand and foot eczema because the analysis of the ... | PMC10031439 | |
Trial Registration | Deutsches Register Klinischer Studien DRKS00020963; https://drks.de/search/de/trial/DRKS00020963 | PMC10031439 | ||
Introduction | PMC10031439 | |||
Background | itching, injuries or disabilities, psoriasis, pain, eczema | DISEASE, DISEASES, PSORIASIS, SKIN CONDITION, PATHOGENESIS, ECZEMA, FOOT ECZEMA | The prevalence of combined chronic hand and foot eczema in industrialized cities is 5.4% [Hand and foot eczema is considered to be chronic if it persists for >3 months despite adequate therapy or recurs with a frequency of more than twice a year [The severity of eczema ranges from very mild to very severe, with therapy... | PMC10031439 |
Objectives | Hand Eczema, hand and foot eczema, NRS, pain | DISEASE, FOOT ECZEMA | The aim of this prospective randomized controlled intervention study was to analyze whether a monitoring smartphone app combined with patient education would improve the quality of life and clinical outcome of patients with hand and foot eczema. The study app was developed specifically for this study. With the app, our... | PMC10031439 |
Methods | PMC10031439 | |||
Study Design | itching, itch, NRS, pain | DISEASE, PATHOGENESIS, SECONDARY, FOOT ECZEMA | The aim of this 60-week randomized controlled intervention study was to investigate the effect of patient education in combination with a monitoring smartphone app on patients experiencing chronic hand and foot eczema. This is an interim analysis of the data from study weeks 0, 12, and 24.The study was carried out at t... | PMC10031439 |
Ethics Approval | The medical ethics committee of the Medical Faculty Mannheim, Heidelberg University, approved the study (2017-655N-MA), and the implementation complied with the Declaration of Helsinki. All participants were instructed in detail regarding the study design and gave their informed consent before participating in the stud... | PMC10031439 | ||
Results | PMC10031439 | |||
Patient Demographics | hand and foot eczema | In total, 90 patients were included in the study. The main reasons for declining participation were lack of time, amelioration of hand and foot eczema, or distance to our outpatient clinic.Of the 90 patients who signed the informed consent form, 87 (97%) took part in the baseline visit and were randomized 1:1 to the in... | PMC10031439 | |
Male Patients Profit More From the Intervention Regarding the Clinical Outcome | In a further subgroup analysis of the intervention group in regard to the sex-specific development of the HECSI, we found a significant improvement in the HECSI compared with baseline only for male participants (V2: | PMC10031439 | ||
Correlation of the eHECSI With the HECSI | Correlating the eHECSI assessed on the basis of pictures taken by the patients of their hands and feet with the HECSI recorded by physicians during regular personal visits, the eHECSI correlated strongly with the in-person–assessed HECSI ( | PMC10031439 | ||
Discussion | PMC10031439 | |||
Principal Findings | anxiety, psoriasis, pain, depressive, hand and foot eczema, eczema | DISEASE, PSORIASIS, DERMATOLOGICAL DISEASES, SKIN CONDITION, ECZEMA | In our intervention study, we showed that the use of our monitoring app in combination with a patient education session has a significant effect on quality of life, pain, activity, and clinical outcome if the app is not used more than once every 5 weeks. In addition, men seem to profit more from app use frequency than ... | PMC10031439 |
Conclusions | hand and foot eczema, eczema, pain | ECZEMA | Overall, our intervention had a positive effect on quality of life, pain, activity, and possibly the clinical outcome in a subgroup of patients with hand and foot eczema.We were able to show that a monitoring app for patients with hand and foot eczema that allows direct contact with their treating physicians combined w... | PMC10031439 |
Abbreviations | Hand Eczema, Eczema | ECZEMA | German acronym for Digital Health ApplicationsDermatology Life Quality Indexelectronic Hand Eczema Severity IndexHand Eczema Severity Indexnumeric rating scalevisit time point | PMC10031439 |
Author summary | depression, psychiatric, treatment-resistant depression | DISEASE, DISORDERS, REMISSION, SYNDROME, CORTEX | The authors have declared that no competing interests exist.Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative therapy for treatment-resistant depression, although its limited remission rate indicates room for improvement. As depression is a phenomenological construction, the biological hete... | PMC10019702 |
Data Availability | The structural data used for creating the computational models is openly available at | PMC10019702 | ||
1. Introduction | avolition, depression, treatment-resistant depression, anhedonia | SAID | Repetitive transcranial magnetic stimulation (rTMS), which consists of temporally structured magnetic pulse trains, is an emerging therapy for treatment-resistant depression [While rTMS is an effective treatment for decreasing the overall symptoms of depression, it has been found that conventional rTMS protocols over t... | PMC10019702 |
2. Materials and methods | PMC10019702 | |||
2.1 Ethics statement | The study involved human participants and was accordingly reviewed and approved by the Central Ethical Review Board, Uppsala University, Sweden. Moreover, all aspects of the study comply with the ethical standards of relevant human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. Written i... | PMC10019702 | ||
2.2 Study design and participants | depression, bipolar depression, psychiatric, depressive | This study uses data from a randomized parallel double-blind sham-controlled trial that was pre-registered at the U.S. National Library of Medicine (i.e., ClinicalTrials.gov), with the registration ID of NCT02905604. In the current work, the sample size was based on a previous study with a similar design, in which the ... | PMC10019702 | |
2.3 Treatment | ADVERSE EFFECTS | We applied the neuro-navigated iTBS [The iTBS treatment was applied twice daily with a 15-min interval to promote plasticity [Moreover, in all patients, two transcutaneous electrical nerve stimulation (TENS) electrodes were placed on the forehead directly beneath the center of the coil. Thereby, a current of up to 4 mA... | PMC10019702 | |
2.4 Phenotype characterization and behavioral measurements | Depression | All participants were assessed using different symptom ratings and executive functioning tests at baseline and after the treatment, including Montgomery Åsberg Depression Rating Scale, self-report (MADRS-S), Brief Psychiatric Rating Scale (BPRS), Clinical Assessment Interview for Negative Symptoms (CAINS) and Trail Mak... | PMC10019702 | |
2.4.1 Montgomery Åsberg Depression Rating Scale, Self-report (MADRS-S) | MADRS-S, mood disorders, depressive symptoms | MADRS-S is a self-reported questionnaire to assess the depressive symptoms in patients with mood disorders, based upon the individual’s ratings in the range of 0 (none) to 6 (severe) [ | PMC10019702 | |
2.4.2 Brief Psychiatric Rating Scale (BPRS) | psychotic symptoms, psychiatric, BPRS | The BPRS is a widely used test based on a clinician’s interview with the patient, that is used to comprehensively measure psychiatric symptoms ranging from affective to psychotic symptoms. We used the extended 24-item version [ | PMC10019702 | |
2.4.3 Clinical Assessment Interview for Negative Symptoms (CAINS) | The CAINS is a semi-structured interview, mainly performed by RB in this study, and a rating scale with items ranging from 0 (none) to 4 (severe), assessing motivation and pleasure (based on patient report), and emotional expression (based on observation of the patient during the interview) [ | PMC10019702 | ||
2.4.4 Trail Making Test (TMT) | depressive symptoms | The patients completed a computerized cognitive test battery starting with the TMT, which is a test of visual attention and task switching. TMT consists of two tasks with an increasing level of difficulty from task A to task B [After the last day of active (i.e., iTBS over dmPFC) or sham treatment, all participants com... | PMC10019702 | |
2.5 Acquisition and prepossessing of resting state functional MRI data | REGRESSION, BEST | We acquired T1-weighted and functional scans in a Philips 3T Achieva scanner (Philips Medical Systems, Best, Netherlands), with a 32-channel head coil. The image acquisition consisted of structural T1-weighted scans with a 3D Turbo Spin Echo sequence and the following parameters: TR/TE = 8.2/3.8 ms, flip angle = 8°, fi... | PMC10019702 | |
2.6 Whole-brain computational modeling of resting-state network | To be able to assess the resting-state functional architecture of the brain beyond the conventional large sample statistical approach, we used our previously developed whole-brain model that is based on weakly coupled oscillators [Here, every individual’s brain was parceled into 68 regions based on Desikan-Killiany par... | PMC10019702 | ||
2.7 Parameter optimization | In order to fit the model to the fMRI data, we need to find an optimal working point, which is a combination of parameters (i.e., A, G, F and M) within the search interval that maximizes the similarity between the simulated and empirical FC patterns and captures the intrinsic attractor dynamics of the brain. Therefore,... | PMC10019702 | ||
2.8 Statistical analysis | depression, MADRS-S, AFF | REGRESSION | All statistical analysis was performed using Statistical and Machine Learning toolboxes in MATLAB 2021b. At the optimal working point within the search interval, our whole-brain model simulated BOLD signals with FC patterns similar to the empirical resting state data. Based on the similarity between each individual’s e... | PMC10019702 |
3. Results | PMC10019702 | |||
3.1 Baseline data | depression | There were no statistical differences in demographics or baseline summative clinical measures across the two treatment groups, as well as the two detected depression subtypes | PMC10019702 | |
3.2 Whole-brain dynamics of depression is heterogeneous | personality disorder, comorbidity, anxiety, attention deficit hyperactivity disorder, depression, autism | DISORDERS | Parameter-sets were estimated by non-parametric fitting of the model to the resting-state FC at baseline (Global feedback parameter F and global modulation index M were larger for DEP1 compared with DEP2; however, the bifurcation parameter A and global coupling parameter G were larger in DEP2 subtype compared to DEP1. ... | PMC10019702 |
Whole-brain modeling stratifies the depression sample. | (A) The whole-brain model was constructed from oscillators with amplitude and angular frequency dynamics, which were coupled through the structural connectome. The model parameters were optimized in an iterative Monte Carlo procedure based on the similarity between model-derived functional connectivity with that of the... | PMC10019702 | ||
3.3 Individual factors of MADRS-S total, BPRS AFF and CAINS differentiate depression subtypes at baseline | depression, MADRS-S, AFF | Our modelling approach resulted in the detection of two covert subtypes exhibiting different pre-treatment attractor dynamics. We asked whether the specific symptoms of MADRS-S total or BPRS AFF or CAINS dissociated the depression subtypes at baseline. Therefore, we fitted a LoM, separately for MADRS-S total, BPRS AFF ... | PMC10019702 | |
Specific symptoms of MADRS-S, BPRS AFF and CAINS predict depression subtypes at baseline. | depression, AFF | REGRESSION | The bootstrap 95% confidence intervals of the logistic regression coefficients for MADRS-S, BPRS AFF and CAINS at baseline. The numbers on the horizontal axes of each panel correspond to the symptoms listed in Treatment section for a given symptom rating. The blue and orange colors indicate the individual items that we... | PMC10019702 |
Depression subtypes modulate the changes in behavior. | depression, MADRS-S, AFF | Violin plots show the distributions of changes in MADRS-S total, BPRS AFF, CAINS total, CAINS motivation and pleasure subscale (CAINS MAP), CAINS expression subscale (CAINS EXP), TMT A and TMT B across two depression subtypes and treatments. Within each violin plot, there is a box plot summarizing the bootstrap results... | PMC10019702 | |
3.4 The therapeutic effect of iTBS on dmPFC is modulated by intrinsic brain dynamics at baseline | depression, affective psychiatric | Prior to assessing the effect of iTBS and the depression subtypes, we checked the integrity of our blinding. After the first treatment day, two thirds of patients in both groups correctly anticipated the treatment allocation. Yet, because there was no difference in the number of patients who correctly guessed their tre... | PMC10019702 | |
3.5 The iTBS treatment modulates individual items in a certain depression subgroup | depression, MADRS-S, AFF | Earlier we found that BPRS AFF and CAINS MAP were modulated by the interaction of the treatment and depression subtype. To increase the sensitivity of our analysis we further assessed if the treatment modulated any of the individual items of the behavioral measure as a function of depression subtype. We used a nested 2... | PMC10019702 | |
Treatment and depression subtypes modulate certain items of MADRS-S, BPRS AFF and CAINS. | depression, AFF | (A) The table summarizes the nested ANOVA results for MADRS-S, BPRS AFF and CAINS items. (B) Violin plots depict the distributions of the differences in MADRS-S1, MADRS-S6, BPRS AFF3, BPRS AFF4 and CAINS 5 changes (follow-up–baseline) between active treatment and the median score in the sham treatment for each depressi... | PMC10019702 | |
4. Discussion | depression, depressive symptoms, treatment-resistant depression, AFF | Whole-brain computational modeling combined with nonparametric probabilistic fitting applied to the pre-treatment resting-state fMRI data from patients with treatment-resistant depression, disclosed a dichotomy in the attractor dynamics of our depression sample. According to the derived optimal model parameters within ... | PMC10019702 | |
Supporting information | PMC10019702 | |||
The distribution of intrinsic angular frequencies. | The peak of spectral density that was derived from Welch method was identified for each region at the individual level. The median value across the cohort was used as the group-representative value of (TIF)Click here for additional data file. | PMC10019702 | ||
Estimated intrinsic angular frequency map. | The intrinsic angular frequency is represented on the Desikan-Killany atlas using a color-coded scheme. Warmer colors indicate a higher intrinsic angular frequency whereas the cooler colors indicate a lower intrinsic angular frequency.(TIF)Click here for additional data file. | PMC10019702 | ||
Distribution of parameter-sets as a function of Monte Carlo threshold. | In Monte Carlo resampling, we randomly selected 30%, 50% or 70% (i.e., Monte Carlo threshold) of patients with 500 iterations per threshold. In all three threshold choices, we observed bimodal distributions with similar peak values (optimal parameter-sets), indicating that two subtypes were detectable at all three thre... | PMC10019702 | ||
Bootstrap distribution for the logistic regression models. | depression, AFF | REGRESSION | The distributions in each column represent a coefficient in the logistic regression model for MADRS-S (upper panel), BPRS AFF (middle panel) and CAINS (bottom panel) at baseline. The dashed red line depicts 0, which represents no association with the stratification of the depression cohort. At baseline, the bootstrap 9... | PMC10019702 |
Bootstrap distribution for the linear regression models predicting behavioural change from baseline to follow-up session. | AFF | REGRESSION | The distributions in each column represent a coefficient in the linear regression model where each row corresponds to a behavioral measure (i.e., outcome). The dashed red line depicts 0, which represents no association with the outcome. In this analysis, the coefficient of interest was the last column (treatment_active... | PMC10019702 |
Functional connectome for depression subtypes. | The empirical functional connectivity (FC) was derived from band-pass filtered BOLD signals. The resulting FCs were Fisher’s z-transformed, and any negative values were replaced with 0.(TIF)Click here for additional data file. | PMC10019702 | ||
Functional connectome as a function of subtypes and treatment. | depression | The band-pass filtered BOLD time-series were used to compute functional connectivity (FC) for depression subtypes and treatment groups. The resulting FCs were Fisher’s z-transformed, and any negative values were replaced with 0. The number of individuals contributing to each FC plot is written in the second line of the... | PMC10019702 | |
Demographic, treatment allocation and dynamical brain measures: individual model-driven prediction and correlations with empirical data. | (XLSX)Click here for additional data file.We appreciate the Human Connectome Project for providing the open access data used in this study. | PMC10019702 | ||
ABSTRACT | infectious, itch, swelling, lymphadenopathy, erythema, tuberculosis, pain, abscess, tenderness | LYMPHADENOPATHY, ADVERSE EVENTS, ERYTHEMA, TUBERCULOSIS, ABSCESS, REGIONAL LYMPHADENOPATHY, INJECTION SITE REACTION, HAND SWELLING, DISEASES | Joint Senior AuthorsBCG vaccination and revaccination are increasingly being considered for the protection of adolescents and adults against tuberculosis and, more broadly, for the off-target protective immunological effects against other infectious and noninfectious diseases. Within an international randomized control... | PMC10411308 |
KEYWORDS | PMC10411308 | |||
Introduction | tuberculosis, coronavirus disease 2019 | CORONAVIRUS DISEASE 2019, TUBERCULOSIS | Bacille Calmette-Guérin (BCG) vaccine is extensively and safely used in children in over 150 countries, to protect against tuberculosis (TB).BRACE (BCG vaccination to reduce the impact of COVID-19 in healthcare workers) is a multicentre randomized controlled trial (ClinicalTrials.gov NCT04327206; date of registration 3... | PMC10411308 |
Materials and methods | PMC10411308 | |||
Setting and participants | This prospective cohort study is nested within the BRACE trial, which recruited healthcare workers (HCW) in two stages. The trial protocol is described in detail elsewhere. | PMC10411308 | ||
Intervention | Participants randomized to BCG received a single dose of BCG-Denmark (AJ Vaccines, Copenhagen), 0.1 ml (corresponding to 2–8 × 10 | PMC10411308 | ||
Data collection | Data were collected using REDCap web applicationInformation on hospitalizations was collected through questionnaires at 3, 6, 9 and 12 months following vaccination. In the latter questionnaire, female participants were additionally asked regarding any pregnancy during the trial, to follow-up any participants who were ... | PMC10411308 | ||
Active safety surveillance | Toxicity | ABSCESSES, ADVERSE EVENT FOLLOWING IMMUNIZATION | Designated safety medical doctors actively followed-up participants who reported a potential adverse event following immunization (AEFI) through the questionnaires or by notification of the study team. Reactions of grade 1 or 2 severity (as per the Food and Drug Administration (FDA) Toxicity Grading Scale for Healthy A... | PMC10411308 |
Case definitions | BCG-osis, allergic reaction, regional lymphadenopathy, abscess, osteitis/osteomyelitis, ulcer | SCAR, ALLERGIC REACTION, ADVERSE EVENT, BCG INFECTION, ABSCESS, REGIONAL LYMPHADENOPATHY, VASOVAGAL EPISODE, ULCER | BCG-revaccination was defined as BCG vaccination in a participant who had any prior BCG vaccination history. Adverse events of special interest included: injection site abscess, large ulcer (>1.5 cm diameter), keloid scar, unusual local reaction, regional lymphadenopathy, BCG osteitis/osteomyelitis, disseminated BCG in... | PMC10411308 |
Statistical analysis | swelling, toxicity, erythema, pain, tenderness | VACCINATION SITE REACTIONS, ERYTHEMA | StataIC 14.0 (Statacorp LP, College Station, TX, USA) was used for statistical analysis. The cumulative incidence of AEFI in the three-month post vaccination was calculated among participants who received either BCG or placebo, and who provided vaccine safety data. Local vaccination site reactions (pain, tenderness, er... | PMC10411308 |
Results | PMC10411308 | |||
Demographics | TUBERCULOSIS INFECTION | Among 3411 participants who received BCG (1415 in BRACE Stage 1 and 1996 in Stage 2) and 1982 participants who received placebo in Stage 2, 5351 (99%) provided vaccine safety data (BRACE participants who received BCG or placebo in a) Stage 1 and b) Stage 2.Demographics.Abbreviations: BCG, Bacille Calmette-Guérin; LTBI,... | PMC10411308 | |
Local injection site reactions | PMC10411308 | |||
Itch | itching | A significantly higher proportion of participants in the BCG group experienced itching at the vaccination site, compared with the placebo group (862/1900 [45.4%] versus 64/1872 [3.4%], | PMC10411308 | |
Injection site abscess | pain, abscess | ADVERSE REACTIONS, INFECTIOUS DISEASES, LYMPHADENOPATHY, ABSCESS, ABSCESSES | The median time of onset was 20 days (IQR 9–26), with a median diameter of 2.0 cm (IQR 2.0–2.5) (Clinical features of BCG local adverse reactions (abscess and lymphadenopathy).Abbreviations: FNA, fine needle aspiration; nr, not reported.*Two participants took opioid analgesia for axillary pain associated with lymphaden... | PMC10411308 |
Regional lymphadenopathy | lymphadenopathy | REGIONAL LYMPHADENOPATHY, LYMPHADENOPATHY | Location of BCG-associated lymphadenopathy was ipsilateral axillary (Among the placebo group, regional lymphadenopathy was ipsilateral axillary ( | PMC10411308 |
Other adverse events of special interest | allergic reaction | ALLERGIC REACTION | Keloid scars occurred in 2/3379 (0.06%) BCG recipients and BCG-related allergic reaction in 1/3379 (0.03%) within the study period ( | PMC10411308 |
Serious adverse events | lethargy, death, Crohn’s disease, abscess | ADVERSE EVENT, ABSCESS | Overall, 38 participants reported a serious adverse event (SAE): 9 BCG recipients in Stage 1, 29 participants in Stage 2 including 20 in the BCG group and 9 in the placebo group (see Supplementary Table S2). All but two SAE were deemed ‘unrelated’ to the intervention by the study site investigator and the BRACE expert ... | PMC10411308 |
Vaccination during pregnancy | birth defects, congenital anomalies | BCG VACCINE | Four female participants were vaccinated whilst unknowingly pregnant at the time; one of these received the BCG vaccine at gestational age of 2 weeks and the other three placebo (see Supplementary Table S3). There were no congenital anomalies or birth defects. All pregnancies resulted in healthy babies born at term ges... | PMC10411308 |
Discussion | itch, lymphadenopathy, swelling, erythema, non-suppurative lymphadenopathy, regional lymphadenopathy, Crohn’s disease, abscess, osteitis/osteomyelitis, urticarial reaction, ulcer | SCAR, LYMPHADENOPATHY, BCG VACCINE, ADVERSE EVENTS, EVENT, ERYTHEMA, BCG INFECTION, ABSCESS, REGIONAL LYMPHADENOPATHY, INJECTION SITE REACTION, ABSCESSES, HAND SWELLING, ULCER, COMPLICATIONS | Using active safety surveillance, we evaluated the safety of BCG vaccination and revaccination in over 5000 healthcare workers within a large international trial. The majority of BCG recipients experienced the expected normal well-described local injection site reactions characterized by the appearance of a small, red ... | PMC10411308 |
Supplementary Material | PMC10411308 | |||
Supplemental Material | Click here for additional data file. | PMC10411308 | ||
Supplemental Material | Click here for additional data file. | PMC10411308 | ||
Acknowledgments | Alison, Joyce Chan | BANNISTER, GOODALL | We thank the BRACE trial participants for making this study possible. We also thank the researchers involved in establishing the BRACE trial (see Supplementary Material 2 for the BRACE trial Consortium Group), in particular: Ms Veronica Abruzzo, Ms Sonja Elia, Ms Casey Goodall, Dr Ellie McDonald, Ms Ann Krastev, Dr Sam... | PMC10411308 |
Disclosure statement | No potential conflict of interest was reported by the authors. | PMC10411308 | ||
Author contributions | Conceptualization or design of the work: P.V., L.P., N.M. and N.C. Acquisition of data: all authors. Analysis, or interpretation of data: P.V. and L.P. Original drafting: P.V. Revising, editing, and final approval of the manuscript: all authors. | PMC10411308 | ||
Data availability statement | Deidentified participant data and data dictionary are available to others on request and on completion of a signed data access agreement. Requests can be made in writing to braceresearch@mcri.edu.au. | PMC10411308 | ||
Supplementary data | Supplemental data for this article can be accessed on the publisher’s website at | PMC10411308 | ||
References | PMC10411308 | |||
Objective | acute stroke, spasticity | ACUTE STROKE | To estimate the cost-consequence of treating spasticity early with botulinum
toxin in the acute stroke unit. | PMC9912301 |
Design | Secondary cost-consequence analysis, using data from a double-blind
randomised-controlled trial. | PMC9912301 | ||
Setting | stroke | STROKE | Single-centre specialised stroke unit. | PMC9912301 |
Subjects and Interventions | stroke, spasticity | STROKE | Patients with Action Research Arm Test grasp-score of <2 and who developed
spasticity within six weeks of a first stroke were randomised to receive
injections of: 0.9% sodium-chloride solution (placebo) or
onabotulinumtoxin-A (treatment). | PMC9912301 |
Main measures | contracture | Resource use costs were calculated for the study. Mean contracture costs for
each group were calculated. The Barthel Index and Action Research Arm Test
were used to generate a cost per unit of improvement. | PMC9912301 | |
Results | contracture | There were no significant differences associated with early treatment use.
The mean contracture cost for the treatment group was £817 and for the
control group was £2298 (mean difference = −£1481.1(95% CI −£2893.5, −£68.7)
( | PMC9912301 | |
Conclusions | stroke, contracture, spasticity | STROKE | Treating spasticity early in stroke patients at risk of contractures with
botulinum toxin leads to a significant reduction in contracture costs. The
cost per improvement of Barthel and Action Research Arm Test indicates that
the intervention costs less and is more effective. | PMC9912301 |
Trial Registration data | EudraCT(2010-021257-39) and ClinicalTrials.gov-Identifier:NCT01882556. | PMC9912301 | ||
Introduction | stroke, post-stroke spasticity, spasticity, pain | STROKE | The cost of managing stroke places a significant burden on the individual, families
and the economy.Botulinum toxin is one treatment that can reduce spasticityWe have previously demonstrated that screening and treating spasticity early, on
first presentation after the first stroke in patients who have no useful arm
fun... | PMC9912301 |
Methods | protocolFurther, post-stroke spasticity, post-stroke | WEST | This study reports on the cost-consequences of the early use of botulinum toxin in
post-stroke spasticity. The trial was approved by North West – Greater Manchester
South Ethics Committee Reference number 10/H1003/111. It was registered with EudraCT
(2010-021257-39) and at ClinicalTrials.gov-Identifier: NCT01882556.The... | PMC9912301 |
Results | SAH | SUBARACHNOID HAEMORRHAGE | Between January 2012 and December 2013, 93 participants were randomised and received
injections (see Consort flow chart summarising the flow of participants through the study.
The last value was carried forward in cases of missing values. SAH:
subarachnoid haemorrhage; SOL: space occupying lesion. | PMC9912301 |
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