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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Statistical analysis | All analyses were performed according to the intention-to-treat principle. Baseline characteristics were presented descriptively. For between-group comparisons, the study used crude analysis with χ | PMC9926282 | ||
Use of the intervention | All participants from the intervention group used the pulse oximeter and a total of 727 SpOHypoxemia (SpO
No adjustments to the study protocol were necessary during the study.In the usual care group, eight participants (40.0%) reported to have used a pulse oximeter in the 14 days following randomisation ( | PMC9926282 | ||
Feeling of safety | After 14 days, participants reported a high feeling of safety: 71.8 (SD 19.1, range 30–100) in the intervention group versus 59.8 (SD 24.5, range 10–100) in the control group ( | PMC9926282 | ||
Disability score (WHODAS) | a decrease, disability | After 45 days, participants reported a decrease in disability as measured with WHODAS 2.0 compared with baseline. The intervention versus control was 53.2% versus 65.7% (Disability score WHODAS 2.0 for the intervention and usual care group participants
| PMC9926282 | |
Healthcare utilisation and health outcomes | SD | SECONDARY | Healthcare resource use and health outcomes during the 45-day follow-up period are presented in Healthcare utilisation and other health-related secondary outcomes for the intervention and usual care group participants
In total, 31 participants had at least one contact with their GP after inclusion (intervention 71.4% [... | PMC9926282 |
DISCUSSION | PMC9926282 | |||
Summary | cardiovascular comorbidity, hypoxemia | This pilot RCT showed that (a trial of) home monitoring of patients with cardiovascular comorbidity and moderate-to-severe COVID-19 with a validated pulse oximeter is feasible; patients were willing to participate, there was a high level of adherence to pulse oximetry measurements, and no protocol changes were necessar... | PMC9926282 | |
Strengths and limitations | hypoxemia, anxiety | The authors performed, to their knowledge, the first entirely primary care-based pilot RCT to assess the feasibility of a trial of home monitoring by pulse oximetry of high-risk patients with COVID-19. Most of the eligible patients were willing to be randomised and adhere to study procedures. The lower than anticipated... | PMC9926282 | |
Comparison with existing literature | infection, disability, anxiety | INFECTION | In line with the present study’s findings, adherence to pulse oximetry use was high in previous observational studies among patients with COVID-19.While it has been suggested by expert opinion that pulse oximetry could induce anxiety, the study found the opposite. Patients reported they felt safe when using the pulse o... | PMC9926282 |
Implications for practice | Home monitoring by pulse oximetry is already recommended by the WHO as part of a COVID-care package, and incorporated in UK guidelines for breathless, unwell, or high-risk patients with COVID-19.In conclusion, the pilot RCT showed that home monitoring of patients with moderate-to-severe COVID-19 with a validated pulse ... | PMC9926282 | ||
Funding | This independent research was supported by the foundation ‘Hartstichting’ (grant number: 2020T063) and foundation ‘Stoffels-Hornstra’ (grant number: 90), both residing in the Netherlands. | PMC9926282 | ||
Ethical approval | The Medical Ethics Review Committee Utrecht reviewed and approved the trial protocol (reference: 20-638/D) and the trial has been registered at the Netherlands Trial Register (reference: NL8954): | PMC9926282 | ||
Data | Datasets are available. Any supplementary data can be requested from the corresponding author. | PMC9926282 | ||
Provenance | Freely submitted; externally peer reviewed. | PMC9926282 | ||
Competing interests | The authors have declared no competing interests. | PMC9926282 | ||
Discuss this article | Contribute and read comments about this article: | PMC9926282 | ||
REFERENCES | PMC9926282 | |||
Background | schizophrenia | It remains a challenge to predict the long-term response to antipsychotics in patients with schizophrenia who do not respond at an early stage. This study aimed to investigate the optimal predictive cut-off value for early non-response that would better predict later non-response to antipsychotics in patients with schi... | PMC10354903 | |
Methods | psychiatric | SYNDROME | This multicenter, 8-week, open-label, randomized trial was conducted at 19 psychiatric centers throughout China. All enrolled participants were assigned to olanzapine, risperidone, amisulpride, or aripiprazole monotherapy for 8 weeks. The positive and negative syndrome scale (PANSS) was evaluated at baseline, week 2, w... | PMC10354903 |
Results | schizophrenia | At week 2, a reduction of < 5% in the PANSS total score showed the highest total accuracy in the severe and mild schizophrenia patients (total accuracy, 75.0% and 80.8%, respectively), and patients who were treated with the risperidone and amisulpride groups (total accuracy, 82.4%, and 78.2%, respectively). A 10% decre... | PMC10354903 | |
Conclusions | schizophrenia | Symptom reduction at week 2 has acceptable discrimination in predicting later non-response to antipsychotics in schizophrenia, and a more accurate predictive cut-off value should be determined according to the medication regimen and baseline illness severity. The response to treatment during the next 2 weeks after week... | PMC10354903 | |
Trial registration | This study was registered on Clinicaltrials.gov (NCT03451734). | PMC10354903 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12916-023-02968-7. | PMC10354903 | ||
Keywords | PMC10354903 | |||
Background | schizophrenia | Antipsychotic drugs are the main treatment method for schizophrenia. However, the effectiveness of this therapy in clinical practice is unsatisfactory; 19.8–66.9% of patients with schizophrenia do not or only partially respond to antipsychotic in 4–6 weeks [The assertions in treatment guidelines continue to be diverse ... | PMC10354903 | |
Methods | PMC10354903 | |||
Participants | ’, substance abuse, intellectual disability, psychiatric, psychotic symptoms, schizophrenia, DSM-5 | DISEASES, SYSTEMIC DISEASE, DISORDERS, PHYSICAL ILLNESS, DISORDERS | This study was a multicenter, 8-week, open-label, randomized clinical trial conducted at 19 psychiatric centers throughout China and was registered on Clinicaltrials.gov (NCT03451734). The full trial protocol, including sample size calculation, has been published previously [Participants met the following criteria: (1)... | PMC10354903 |
Assessments | DISEASE, SYNDROME | Participants were evaluated and followed at four time points after titration (baseline, week 2, week 4, and week 8), and all assessments were performed by psychiatrists trained by a positive and negative syndrome scale (PANSS) institute-certified professor of psychiatry. All the assessors involved in this study receive... | PMC10354903 | |
Outcome measures | To examine the ability to predict non-response at the endpoint by the magnitude of PANSS total score improvement at earlier assessment (week 2 or week 4), receiver operating characteristic (ROC) curves with area under the curve (AUC) values were calculated. The predictive values, including total accuracy, sensitivity, ... | PMC10354903 | ||
Statistical analysis | The Statistical Package for Social Sciences (version 26.0) was used for statistical analyses. Continuous variables were described using means and standard deviations. Categorical variables were described using frequencies and percentages. The PANSS total score reduction rate, PANSS total score change from baseline, age... | PMC10354903 | ||
Discussion | schizophrenia, ill, SUD, psychosis | DISORDER | To investigate the optimum predictive cut-off value defining early non-response at week 2 and week 4 for schizophrenia patients using different atypical antipsychotics (olanzapine, risperidone, amisulpride, and aripiprazole) with different baseline severities of illness (severe, moderate and mild), we evaluated the pre... | PMC10354903 |
Conclusions | schizophrenia | DISEASE | In conclusion, based on a large multicenter, open-label, randomized trial of 964 patients with schizophrenia receiving monotherapy with olanzapine, risperidone, amisulpride, and aripiprazole, this study confirmed that early non-response to antipsychotics is a predictor of later non-response. Moreover, antipsychotic non... | PMC10354903 |
Acknowledgements | We thank all patients for their enduring participation. | PMC10354903 | ||
Authors’ contributions | RECRUITMENT | YJ.L., Y.Y., JM.X., JD.C., ZQ.L., YF.X., Y.C., ML.H., RG.Z., XJ.X., J.H., ZF.L., F.L., YJ.Z., HQ.M., ZM.W., YQ.T., XQ.S., YC.C., XY.W., TB.L., XL.W., MS.F., CL.W., and JP.Z. are involved in participant recruitment, follow-up evaluation, and data and sample collection. RR.W. is involved in the study design and acquisiti... | PMC10354903 | |
Funding | This work was supported by the National Natural Science Foundation of China (Grant No. 82072096 and Grant No. 82271545) and the Fundamental Research Funds for the Central Universities of Central South University (Grant No. 2021zzts0400). | PMC10354903 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10354903 | ||
Declarations | PMC10354903 | |||
Ethics approval and consent to participate | All participants provided written informed consent. The authors declare that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human research and with the Helsinki Declaration of 1975, as revised in 2008. All procedures involving human su... | PMC10354903 | ||
Consent for publication | Not applicable. | PMC10354903 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10354903 | ||
References | PMC10354903 | |||
Background | postoperative stiffness | There is a current lack of knowledge regarding optimal rehabilitation and duration of sling immobilization after an open Latarjet procedure. A shift towards immediate self-rehabilitation protocols in shoulder surgery is observed to avoid postoperative stiffness and fasten return to sport. Avoiding sling immobilization ... | PMC9969622 | |
Methods | pain | This study is a single-center, randomized control trial. Sixty-eight patients will be instructed with the same standardized immediate postoperative self-rehabilitation protocol. Patients will be allocated 1:1 between a sling immobilization group for the first three postoperative weeks and no sling group without postope... | PMC9969622 | |
Discussion | This study will allow further insights into the optimal rehabilitation protocol after open Latarjet surgery and enhance patient care by helping identify rehabilitation and coracoid graft-related factors influencing functional outcomes, bony union, range of motion, and patient satisfaction. | PMC9969622 | ||
Trial registration | The protocol was approved by the ethical committee board (CCER 2019–02,469) in April 2020 and by ClinicalTrials.gov (Identifier: | PMC9969622 | ||
Keywords | Open access funding provided by University of Geneva | PMC9969622 | ||
Administrative information | Pierre Decker 4, 1005 Lausanne, Trauma |
Goetti Patrick1. Department of Orthopedic Surgery and Traumatology, Lausanne University Hospital and University of Lausanne, Avenue Pierre Decker 4, 1005 Lausanne, Switzerland2.Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Rue J.-D. Maillard 3, 1217 Meyrin, Switzerland3. Department of Physiotherapy, L... | PMC9969622 | |
Introduction | PMC9969622 | |||
Background and rationale {6a} | traumatic anterior shoulder instability | Recurrent traumatic anterior shoulder instability occurs most commonly in young to middle-aged male athletes [Recent research has highlighted the negative effect of immobilization on shoulder rehabilitation [ | PMC9969622 | |
Objectives {7} | This study will aim to compare immediate self-rehabilitation protocol using a sling to immediate self-rehabilitation without a sling after a Latarjet procedure for recurrent anterior shoulder instability. The effect of sling immobilization after open Latarjet surgery on self-reported functional outcomes, bone graft hea... | PMC9969622 | ||
Trial design {8} | This superiority prospective case–control clinical trial is randomized 1:1 between the sling-wearing and no sling groups. | PMC9969622 | ||
Methods: participants, interventions, and outcomes | PMC9969622 | |||
Study setting {9} | This study will be monocentric and performed at the department of orthopedic surgery of the Hôpital de la Tour in Meyrin, Geneva, Switzerland. The design is a two-arm, parallel group (sling versus no sling), randomized superiority trial with a 1:1 allocation ratio with as primary outcome 6-month functional outcomes as ... | PMC9969622 | ||
Eligibility criteria {10} | dislocation),Preoperative stiffness, Polytrauma, cardiorespiratory insufficiency, scapular or clavicular fractures, dementia, anemia, arthropathy, psychological disorders, alcohol abuse, Anterior shoulder instability, abduction, trauma | ANEMIA, ARTHROPATHY | Participants fulfilling all of the following inclusion criteria are eligible for the study:Anterior shoulder instability with one or more of the following criteria:A glenoid bone defect > 20%Contact athleteFailed Bankart repair—either open or arthroscopicInformed consent as documented by signature,Age between 18 and 65... | PMC9969622 |
Who will take informed consent? {26a} | Informed consent will be collected by the scientific secretary (Anne-Sophie Guillarme, fondation.fore@latour.ch) at La Tour Hospital. The principal investigator (AL) will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits an... | PMC9969622 | ||
Additional consent provisions for collection and use of participant data and biological specimens {26b} | No biological specimens are collected in this study, and no additional consent provision for collection and future use of participant data is included in the informed consent form. | PMC9969622 | ||
Interventions | PMC9969622 | |||
Explanation for the choice of comparators {6b} | The control group will wear a sling during the first three postoperative weeks. The interventional group will not wear any brace. We therefore compare the two extremes of reported immobilization periods currently reported in the literature for open Latarjet [ | PMC9969622 | ||
Intervention description {11a} | PMC9969622 | |||
Surgical intervention | The surgeon (AL) and surgical techniques will be identical for all patients. The standardized surgical procedure uses a 90° angulated saw and an osteotome to harvest the coracoid [ | PMC9969622 | ||
Postoperative rehabilitation | In the sling group, patients will be instructed to wear the sling with the arm at the side of the body for 3 weeks. In the no sling group, patients will not wear any sling at all after surgery. Both groups will start immediate postoperative auto-mobilization in all axes during the first 3 weeks as described by Roulet e... | PMC9969622 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | CRF | ADVERSE EVENTS, CRF | All adverse events must be transmitted to the sponsor-investigator (AL). He will manage or supervise reporting of adverse events and ensure that the follow-up of concerned patients is performed. He will be advised of all patients who withdraw or discontinue. He will plan additional monitoring visits, rehabilitation, or... | PMC9969622 |
Strategies to improve adherence to interventions {11c} | In both groups, rehabilitation will be done at home by patients themselves according to Liotard protocol [ | PMC9969622 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | Concomitant care such as physiotherapy will be prohibited during the trial as it would add potential bias. | PMC9969622 | ||
Provisions for post-trial care {30} | There is no anticipated harm and compensation for trial participation. All patients in our trial will undergo shoulder surgery; they will all benefit from long-term follow-up if clinically requested by the operating physician and principal investigator (AL) and therefore receive adequate post-trial care. | PMC9969622 | ||
Outcomes {12} | hematoma, non-union, fibrous, pain | HEMATOMA, HAND INFECTION, COMPLICATIONS | As a primary outcome, we will evaluate functional outcomes using the disease-specific Rowe score [Secondary outcomes include pain on a visual analog scale (VAS) which is a widely used single-item test where a patient rates pain intensity between 0 and 10. The single assessment numeric evaluation (SANE) for instability ... | PMC9969622 |
Participant timeline {13} | PMC9969622 | |||
Sample size {14} | Sample size calculation was based on primary study outcome measurement. Rowe’s score minimal clinically important difference is 9.7 points [ | PMC9969622 | ||
Recruitment {15} | RECRUITMENT, RECRUITMENT | Recruitment will be performed by the senior author and principal investigator who operates around 100 shoulder instability cases per year, two-thirds being stabilization according to Latarjet. The recruitment period should thus spread over a 12-month period. Patients are approached by the principal investigator during ... | PMC9969622 | |
Assignment of interventions: allocation | PMC9969622 | |||
Sequence generation {16a} | After informed consent is obtained and just past baseline visit, patient will be randomized into a sling and no sling groups. To allocate patients into the two groups, the investigators will use a computer-generated list of random numbers with an allocation of 1:1 using block sizes of four or six using R (version 3.6.2... | PMC9969622 | ||
Concealment mechanism {16b} | An independent researcher from the clinical research department (who is not participating in this study) will keep the randomization list on a secure server that is not accessible to the principal investigator. The allocation will be concealed until the principal investigator (AL) decides to enrol a patient based on de... | PMC9969622 | ||
Implementation {16c} | CRF | CRF | The principal investigator (AL) will first verify the eligibility of each patient based on study inclusion and exclusion criteria. If the eligibility is confirmed, the principal investigator (AL) will enter the patient baseline information in the CRF. Then, an independent researcher from the clinical research departmen... | PMC9969622 |
Assignment of interventions: blinding | PMC9969622 | |||
Who will be blinded {17a} | The independent physiotherapist (AS) will be responsible for range of motion assessment and will be blinded to the patient allocation group. Radiologic assessment and statistical analysis will be also blinded. | PMC9969622 | ||
Procedure for unblinding if needed {17b} | As the intervention is not blinded to the primary investigator and patient, there is no need for an unblinding procedure. | PMC9969622 | ||
Data collection and management | PMC9969622 | |||
Plans for assessment and collection of outcomes {18a} | Patients will be screened in the preoperative consultations. Anamnesis, physical examination, and a magnetic resonance arthrography are needed for screening. The randomization procedure will occur on the same day of the intervention after the patient gives written informed consent. Investigators will access the next pa... | PMC9969622 | ||
Plans to promote participant retention and complete follow-up {18b} | The protocol is part of a normal and usual 6-month follow-up for such surgical procedure and therefore no particular plan was developed to maximize retention. Especially, there was no payment to incentivize participants to complete the study. | PMC9969622 | ||
Data management {19} | CRF | CRF | All data will be saved in the corresponding electronic case report form (CRF) and stored on servers (FollowHealth, | PMC9969622 |
Confidentiality {27} | A sequential unique patient number (UPN) will be attributed to each patient randomized into the trial. Identification of patients will be stored on a randomization list. Patients must be informed of and agree to data and material handling in accordance with Swiss data protection law. | PMC9969622 | ||
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | Given that no biological specimens will be collected in this trial, no specific plan is needed. | PMC9969622 | ||
Statistical methods | PMC9969622 | |||
Statistical methods for primary and secondary outcomes {20a} | Statistical analysis will be performed with the “intention to treat” method. Clinical parameters of interest listed above will be compared between the two groups with adapted statistic tests (chi-squared, Wilcoxon, or | PMC9969622 | ||
Interim analyses {21b} | No interim analysis has been planned because mobilization and immobilization management are now considered good clinical practices. Therefore, their potential benefits are limited. Moreover, interim analysis would be a waste of statistical power. | PMC9969622 | ||
Methods for additional analyses (e.g., subgroup analyses) {20b} | No additional analysis has been planned. | PMC9969622 | ||
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | The analyses were performed following the intention to treat analysis method, known to avoid any bias in superiority trials. The missing data was completed using either the last observation carried forward when possible or by a multiple imputation by chained equation (MICE) method. | PMC9969622 | ||
Plans to give access to the full protocol, participant-level data, and statistical code {31c} | The full trial protocol will be made available on the free and participative wiki of BeeMed ( | PMC9969622 | ||
Oversight and monitoring | PMC9969622 | |||
Composition of the coordinating center and trial steering committee {5d} | The trial is coordinated by a scientific secretary (Anne-Sophie Guillarme) and the clinical research manager of La Tour Hospital (HB) a research scientist under supervision of the senior author and principal investigator (AL). The coordination center meets at least once per month. The steering committee includes an ind... | PMC9969622 | ||
Composition of the data monitoring committee, its role and reporting structure {21a} | ADVERSE EVENT | The abovementioned data monitoring committee is composed of two persons working in a clinical research organization. The role of this monitoring committee is to ensure that the data obtained throughout the study period corresponds to what has been previously defined in the research protocol. Furthermore, this committee... | PMC9969622 | |
Adverse event reporting and harms {22} | congenital anomaly/birth defect, death, disability/incapacity | EVENTS, DISEASE, ADVERSE EVENT | No specific adverse event is expected in the no sling and sling group other than those related to the surgical procedure for which both groups receive standard of care and postoperative visits. Intervention is therefore regarded as low risk. In the unexpected case of an adverse event occurrence, patients will call the ... | PMC9969622 |
Frequency and plans for auditing trial conduct {23} | humain | RECRUITMENT | The protocol was approved by the local ethical committee board (CCER 2019–02,469) in April 2020. The recruitment started in January 2022. The local ethical committee board (CCER, Commission Cantonale d'Ethique de la Recherche sur l'être humain du canton de Genève) is in charge of auditing the trial conduct. | PMC9969622 |
Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} | Substantial amendments are only implemented after approval of the CEC and CA respectively.Under emergency circumstances, deviations from the protocol to protect the rights, safety, and well-being of human subjects may proceed without prior approval of the sponsor and the CEC/CA. Such deviations shall be documented and ... | PMC9969622 | ||
Dissemination plans {31a} | Trial results will be sent to participants and an article submitted to a peer-review journal indexed in PubMed. Moreover, the study will be summarized, and relevant content added on the free and participative wiki of BeeMed ( | PMC9969622 | ||
Discussion | fractures, non-union, abduction | RECURRENCE, MUSCLE ATROPHY, COMPLICATION, SECONDARY, COMPLICATIONS | This randomized control study is designed to evaluate the impact of sling immobilization on early rehabilitation after open Latarjet surgery and its impact on patient functional outcomes. Rehabilitation after open Latarjet surgery currently remains a matter of surgeon preference rather than driven by a scientific ratio... | PMC9969622 |
Trial status | RECRUITMENT | The trial is currently ongoing. The protocol was approved by the ethical committee board (CCER 2019–02,469) in April 2020 and by ClinicalTrials.gov (Identifier: NCT04479397) in July 2020. The recruitment started in January 2022 and is planned to be completed in January 2023. | PMC9969622 | |
Acknowledgements | None. | PMC9969622 | ||
Authors’ contributions {31b} | PG conceived the study and led the proposal and protocol development. He wrote the present manuscript. TM contributed to study design and to the development of the proposed methodology. AS will record all motion captures and provide range of motion analysis. HB is the clinical research manager. He will supervise data c... | PMC9969622 | ||
Funding {4} | Trauma | Open access funding provided by University of Geneva. FORE (Foundation for Research and Teaching in Orthopedics, Sports Medicine, Trauma and Imaging in the Musculoskeletal System). Grant#2022–29. | PMC9969622 |
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