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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% [During follow-up, 10 patients visited the ED 11 times: eight from intervention versus three usual care (There was no significant difference in number of days alive at home between groups: intervention 42.4 days (SD 8.3) versus control 44.7 days (SD 1.6) ( | 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 necessary. Patients reported a high feeling of safety, which tended to be higher in those using a pulse oximeter, and using the tool did not lead to an increase in primary care consultations compared with usual care.The hospitalisation rate in the intervention group was higher than in the control group, and the median length of stay in hospital was shorter in the intervention group than in the control group. These differences must be interpreted with caution because it may be a chance finding given the small numbers. It could, however, be owing to detection of ‘silent’ hypoxemia in the intervention arm, which was followed by adequate referral to hospital. | 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 participation rate was partly owing to a decline in SARS-CoV-2 prevalence in the Netherlands at the end of the study period, and a more widespread use of pulse oximetry by patients with COVID-19. In the study, 8/20 (40.0%) control participants used an ‘own’ pulse oximeter at least once during the study. This could have reduced the contrast between groups, meaning a possible reduction of effect.Overall, in the pilot trial, the use of pulse oximetry tended to reduce anxiety and there were no unsafe situations. A limitation is that an electronic real-time connection was not used between pulse oximeter and medical assistance, so it is possible that detection of hypoxemia measurements was missed or delayed, even though explicit instructions were given to patients when to contact the GP. | 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 oximeter, which is comparable with a high feeling of safety reported by patients in a 2020 case-control study.In 45 days, the mean percentage decrease in disability score, as measured with WHODAS 2.0, was 53.2% in the intervention group and 65.7% in the control group. Currently, as far as the authors are aware, there are no known studies that define which change would be deemed a clinically relevant improvement. The large decrease from baseline observed in the present study is likely explained by the serious clinical impact of COVID-19, where participants at baseline scored a high score above the 95th percentile compared with the general population. This decreased to a disability score around the 75th percentile (summary score 6.5) at day 45, which indicates that patients with COVID-19 have residual disabilities after their infection. | 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 oximeter is feasible; adherence was high, patients reported a high feeling of safety, and the use of pulse oximetry did not result in an increase in primary care consultations compared with usual care. It is believed these findings are an important building block for safe implementation of pulse oximetry as a home monitoring tool in primary care.The authors would like to thank all study participants and all employees of the participating primary care centres for their cooperation in this study. | 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 schizophrenia. | 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, week 4, and week 8. The main outcome was the prediction of nonresponse. Nonresponse is defined as a < 20% reduction in the total scores of PANSS from baseline to endpoint. Severity ratings of mild, moderate, and severe illness corresponded to baseline PANSS total scores of 58, 75, and 95, respectively. | 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% decrease exhibited the best overall accuracy in the moderate schizophrenia patients (total accuracy, 84.0%), olanzapine (total accuracy, 79.2%), and aripiprazole group (total accuracy, 77.4%). At week 4, the best predictive cut-off value was < 20%, regardless of the antipsychotic or severity of illness (total accuracy ranging from 89.8 to 92.1%). | 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 2 could be further assessed to determine whether there is a need to change antipsychotic medication during the first four weeks. | 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 and commonly lack sufficient supportive evidence. The World Federation of Societies of Biological Psychiatry (WFBSP) gave a wide range of 2–8 weeks at the recommended dose before switching medication [Baseline severity of schizophrenia has been reported to influence the response to antipsychotics that patients with more severe initial symptoms tend to experience greater reductions in symptoms [Besides the baseline severities of illness, the type of antipsychotics also plays a role in predicting early nonresponse in subsequent treatment nonresponse. For instance, one study focusing on acute-phase schizophrenia with the definition of early response as a Clinical Global Impressions-Improvement Scale (CGI-I) ≤ 3 after 2 weeks of treatment found that response to risperidone at 2 weeks can effectively predict long-term treatment response, whereas olanzapine required 4 weeks [In this study, we investigate whether early phase treatment response on weeks 2 and 4 could predict therapeutic outcome at week 8 using data from a large multicenter, open-label clinical trial. Secondly, we defined mild, moderate, and severe schizophrenia by PANSS and aimed to investigate the optimum predictive cut-off value defining early non-response in subgroups with different baseline severities of illness. Thirdly, we investigate whether the cut-off value is consistent in different atypical antipsychotic drugs (olanzapine, risperidone, amisulpride, and aripiprazole). | 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) aged 18–65 years and meeting the criteria for schizophrenia (diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or International Classification of Diseases, Tenth Edition (ICD-10)); (2) experiencing a current episode of psychotic symptoms with a duration of illness less than 5 years; (3) with at least one guardian that accompanies the patient and supervises patients’ medications; and (4) who signed an informed consent form. The exclusion criteria for participants were as follows: (1) with serious physical illness; (2) with disorders such as alcohol or substance abuse, intellectual disability, or other specific systemic diseases; (3) who are pregnant or breastfeeding; and (4) enrolled in other clinical trials. | 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 received consistency training before the research began. At baseline, sociodemographic information was collected, and disease severity was evaluated using PANSS. Antipsychotics were initially administered at a low dose, gradually adding to the therapeutic dose in 1 week according to the study protocol, and remained the same after titration. Drug dose at 8 weeks was recorded. | 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, specificity, positive predictive value (PPV), and negative predictive value (NPV), were calculated for response status at an earlier assessment (week 2 or week 4) to predict later (week 8) response or non-response, referring to previous literature [Non-response rate to antipsychotic medication, change from baseline to week 8 in PANSS total score, and rate of reduction in PANSS total score after 8 weeks were used for efficacy evaluation. Non-response was defined as a < 20% reduction of the PANSS total score from baseline to week 8. The PANSS total score reduction rate was calculated as (baseline PANSS total score − follow-up PANSS total score)/(baseline PANSS total score − 30) × 100% [ | 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, and duration among treatment groups were compared by one-way analysis of variance (ANOVA) followed by Bonferroni’s post hoc multiple comparison test. The chi-square or Fisher’s exact test was used to test for differences in the distribution of categorical variables. Further comparisons between groups were performed using the Dunn-Bonferroni post hoc test. Missing values were handled using the last-observation carried-forward method. All statistical tests were two-tailed. Statistical significance was set at | 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 prediction power under a series reduction of PANSS ranging from 0 to 20%. The main findings were as follows: first, in patients with schizophrenia treated with olanzapine, risperidone, amisulpride, or aripiprazole, those who show poorer early improvement after 2 weeks of antipsychotic treatment were less likely to respond later, and 4 weeks is sufficient to make a definitive determination of ultimate non-responders. Second, overall, the definition of early non-response that < 10% symptom reduction at week 2 and < 20% symptom reduction at week 4 had the best predictive value for non-response at week 8. Third, the optimum predictive cut-off value varies depending on the severity of the psychosis and the atypical antipsychotics being used.We investigated whether early non-response at week 2 and week 4 could be useful as a marker for assessing later non-response by performing a ROC analysis. The AUC in different subgroups were all ranging from 80 to 95%, indicating moderate diagnostic accuracy to high diagnostic accuracy [In addition, our study revealed that the optimal prediction thresholds varied with respect to different prediction time points. A < 10% symptom reduction at week 2 and a < 20% symptom reduction at week 4 (early non-response) had the best predictive value for non-response at week 8, which differs from a < 20% symptom reduction at week 2 and a < 30% symptom reduction at week 4 in patients treated with aripiprazole or quetiapine [The optimal cut-off values found in our research are inconsistent with a previous study, in which the optimal cut-off value was < 15% reduction in PANSS total score at week 2 and < 27% at week 4 for moderately-to-severely ill patients, < 12% reduction at week 2 and < 20% at week 4 in less than moderately ill patient group [Our study examined the effects of olanzapine, risperidone, amisulpride, and aripiprazole on patients with early schizophrenia over an 8-week period. We found that all three drugs were equally effective in improving symptoms in patients with severe schizophrenia, while aripiprazole was slightly less effective. In patients with mild schizophrenia, all four drugs showed similar effectiveness during the first 8 weeks of treatment. These results are consistent with previous research [The results of this study should be interpreted taking its limitations into consideration. This study included only four antipsychotics; therefore, further comparisons between drugs were unavailable. Moreover, the endpoint was set at week 8 which limits the prediction of long-term outcomes. Another limitation of our study is the absence of individual comorbidities, including substance use disorder (SUD), which are prevalent in this population. Lastly, we used the full 30-item PANSS to assess early response and non-response, which is a lengthy and unusual measure in clinical practice, potentially limiting the clinical applicability of the findings in real-world settings. | 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-response at week 8 can be predicted as early as week 2, but the optimum predictive cut-offs should be determined based on the antipsychotic type and baseline severity. Moreover, when non-response at week 4 was used as a predictor, the most appropriate predictive cut-off was consistently observed regardless of antipsychotic types or disease severity. | 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 acquisition of funding and responsible for the project concept. YJ.L. and QQ.W. are responsible for the original draft and final revision. All authors read and approved the final manuscript. | 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 subjects/patients were approved by the ethics committee of the Second Xiangya Hospital of Central South University (ref: 2016S035), the ethics committee of Xiangya Hospital of Central South University (ref: 201606587), and the Institutional Review Board of Shanghai Mental Health Center (ref: 2016KY-25). | 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 could further simplify rehabilitation and provide an even faster return to activities of daily living and enhance patient satisfaction. | 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 postoperative immobilization. The primary endpoint will be functional outcome at 6 months postoperative evaluated by the disease-specific Rowe score. Secondary endpoints will include baseline, 1.5-, 6-, and 12-month single assessment numeric evaluation (SANE) of instability score and visual analog pain scale (VAS). At the 6-month time point, graft bony union and position will be assessed by computed tomography. Motion capture technology will evaluate the baseline and 6-month postoperative range of motion. Finally, time to return to work and sport during the first postoperative year, along with patient satisfaction at one postoperative year, will also be recorded. | 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, La Tour Hospital, 1217 Meyrin, Switzerland4. Research Department, La Tour Hospital, 1217 Meyrin, Switzerland5. Faculty of Medicine, University of Geneva, Rue Michel-Servet 1, 1211 Geneva 4, Switzerland6. Division of Orthopaedics and Trauma Surgery, Department of Surgery, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, 1211 Geneva 14, SwitzerlandCorresponding authorAlexandre Lädermann, PD-MDDivision of Orthopaedics and Trauma Surgery, La Tour Hospital,Av. J.-D. Maillard 3, CH-1217 Meyrin, SwitzerlandTelephone number: + 41 22 719 75 55Fax number: + 41 22 719 60 77E-mail address: alexandre.laedermann@gmail.com | 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 healing, range of motion, patient satisfaction, and time to return to sport and work will be analyzed. The hypothesis was that immediate self-rehabilitation without immobilization would result in improved functional outcome scores at 6 months follow-up compared to patients wearing a sling for the first three postoperative weeks. To our best knowledge, no study has sought to compare the usefulness of sling wearing after Latarjet procedure. Avoiding the sling could simplify rehabilitation and should provide a return to normal function faster, with greater satisfaction. | 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 assessed by the disease-specific Rowe score. | 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 years.The presence of any one of the following exclusion criteria will lead to the exclusion of the participant:Subscapularis tear,Polytrauma inducing significant limitation of a rehabilitation program,Significant other trauma of the involved upper member (e.g., associated scapular or clavicular fractures, acromioclavicular dislocation),Preoperative stiffness (defined by active and passive limitation in at least two directions, abduction and anterior elevation < 100°, external rotation < 20°, internal rotation < L3),Dislocation arthropathy,Patients suffering from symptomatic anemia or patients with severe cardiorespiratory insufficiency,Known or suspected non-compliance, drug or alcohol abuse,Patients incapable of judgment or under tutelage,Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, and contraindication for CT scan (i.e., pregnancy) of the participant,Enrolment of the investigator, their family members, employees, and other dependent persons. | 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 and any discomfort it may entail. Each participant will be informed that the participation in the study is voluntary and that he/she may withdraw from the study at any time and that withdrawal of consent will not affect his/her subsequent medical assistance and treatment. All participants for the study will be provided a participant information sheet and a consent form describing the study and providing sufficient information for participant to make an informed decision about their participation in the study. Patients will have until the surgery’s day to decide whether they will participate or not. The patient information sheet and the consent form will be submitted to the CEC and to the competent authority (as applicable) to be reviewed and approved. The formal consent of a participant, using the approved consent form, must be obtained before the participant is submitted to any study procedure. The participant should read and consider the statement before signing and dating the informed consent form, and should be given a copy of the signed document. The consent form must also be signed and dated by the investigator (or his designee, the scientific secretary) and it will be retained as part of the study records. | 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 et al. (Liotard’s protocol) [ | 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 data collection if he judges it necessary. Trial data of the patient will be stored in a coded manner. The names of the patients will not be disclosed on CRF. 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 |
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 [Secondary outcomes also include radiological criteria evaluated on X-rays and computed tomography (CT) at 6 months for bony union. The bony union will be assessed using the classification proposed by Hovelius et al. differentiating between union (absence of a radiolucent line), fibrous union (radiolucent line of 5 mm or less), and non-union (radiolucent line of more than 5 mm) [Bone graft characteristics, including lateral and medial overhang and graft height, will be assessed according to the method described by Kraus et al. and Ernstbrunner et al. [All complications (including recurrent shoulder dislocation, hematoma, and infection will also be collected) and the aforementioned subjective and clinical scores will be recorded before surgery and at 1.5, 6, and 12 months postoperative.Following clinical parameters will be collected at the beginning of the study: age, gender, working compensation status (office/mild load/full load), sports activity soliciting shoulders: none, light (< = 4 h/week), intensive (> 4 h/week), hand dominance. | 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 appointment at his clinic. The principal investigator is further the only shoulder surgery consultant at his institution and is thus able to screen all patients presenting with shoulder instability. | 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, R Foundation for Statistical Computing, Vienna, Austria). No stratification techniques will be used in the randomization process. | 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 defined inclusion and exclusion criteria. | 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 department will inform the principal investigator (AL) of the allocation group, which will be thereafter communicated to the patient. | 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 patient of randomization from the data management system. Patient withdrawal will occur when they withdraw their informed consent, in case of loss of follow-up, or if they do not follow the protocol. | 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 independent chairperson, one shoulder expert and one clinical trials methodologist. The trial steering committee monitors and supervises the progress of the study and meets on regular intervals (quarterly at least). | 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 will ensure that any adverse event is monitored and reported to the local ethical committee if needed. | 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 investigators, and additional visits will be organized.A serious adverse event (SAE) is classified as any untoward medical occurrence that:Results in death,Is life-threatening,Requires in-patient hospitalization or prolongation of existing hospitalization,Results in persistent or significant disability/incapacity, or.Is a congenital anomaly/birth defect.In addition, important medical events that may not be immediately life-threatening or result in death, or require hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed above should also usually be considered serious.SAEs should be followed until resolution or stabilization. Participants with ongoing SAEs at study termination (including safety visit) will be further followed up until recovery or until stabilization of the disease after termination.All SAEs must be reported immediately and within a maximum of 24 h to the Sponsor-Investigator (AL) of the study. The Sponsor-Investigator will re-evaluate the SAE and return the form to the site. SAEs resulting in death are reported to the local Ethics Committee (via local Investigator) within 7 days. The other in the trial involved Ethics Committees who receive SAEs resulting in death in Switzerland via Sponsor-Investigator within 7 days. | 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 reported to the sponsor and the CEC/CA as soon as possible.All non-substantial amendments are communicated to the CA as soon as possible if applicable and to the CEC within the Annual Safety Report. In case substantial amendments are implemented and approved by CEC and CA, the trial protocol will be updated on ClinicalTrials.gov (Identifier: NCT04479397). | 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 rationale. Rehabilitation is therefore subject to high variability between centers [Along with functional scores and recurrence rates, return to sport is an essential factor in evaluating the success rate of anterior shoulder stabilization [Finally, one of the most feared complications after open Latarjet surgery is the failure of screw fixation and non-union of the graft. Previous systematic reviews reported early graft complications, including fractures and non-union rates around 1.9–3.2% as the most common complication [Another interesting outcome will result from using a motion capture system that allows a precise and reliable measurement of patient range of motion [Lastly, a potential benefit of avoiding a sling postoperatively is the prevention of muscle atrophy. Recent studies suggested a negative impact on internal rotation at 90° of abduction after the Latarjet procedure secondary to subscapularis rerouting compared to iliac bone grafts (As aforementioned, the strength of this randomized control trial is the use of computed tomography to confirm bony union after open Latarjet procedure, along with the help of motion capture technology to assess patients’ range of motion. Randomization will ensure certain homogeneity between both groups, which will be operated by the same senior surgeon using the same operative technique.The main limitation concerns the inherent variability of the patient’s implication towards the self-rehabilitation protocol as well as coping with postoperative sling immobilization after the randomization process. Indeed, patient implication can differ, while randomization and systematic patient education at all follow-up visits should limit their impact on our results.We are confident that our study will allow precious insights into rehabilitation after open Latarjet surgery. | 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 collection. He leads the trial methodology and is responsible for statistical analysis and will review the manuscript. AL is the senior surgeon and chief investigator. He conceived with PG the study design and led the proposal and protocol development. All authors read and approved the final manuscript. | 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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