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Study setting {9} | This study will be conducted across three subsidiary hospitals, within a single major metropolitan Australian academic hospital (site details available on ANZ Trial Registry). All patients will be recruited from the adult orthopaedic outpatient clinic. A total of 66 participants will be recruited and randomised to a tr... | PMC10037835 | ||
Eligibility criteria {10} | ACL injury, rupture, re-rupture | INFLAMMATORY ARTHRITIS, PATHOLOGY | All inclusion criteria will be assessed by the treating surgeon and associate investigators.Participants can be included if they are:Waitlisted for ACLR with either of the associated investigators (S.T or L.B). Waitlisting is based on evidence of complete ACL rupture, based on clinical assessment and MRI imaging. Patie... | PMC10037835 |
Who will take informed consent? {26a} | EVENT | Participants will undergo assessment and provide written informed consent for ACLR surgery with their treating surgeon or one of the orthopaedic department’s trainee surgeons in consultation with the treating surgeon. Patients waitlisted for primary ACLR with either of the Associate Investigators (ST or LB) will be app... | PMC10037835 | |
Additional consent provisions for collection and use of participant data and biological specimens {26b} | Participants will undergo extended consent for use of study information in ancillary studies emanating from this trial. Participants will be advised that the results of this study may be utilised in a de-identified manner within publications or scientific research presentations. | PMC10037835 | ||
Interventions | PMC10037835 | |||
Explanation for the choice of comparators {6b} | This study will compare ACL reconstruction with hamstrings autograft with (ST-ACLR) and without (ACLR) suture tape augmentation. The suture tape will be looped through the proximal femoral button. Both procedures are standard care at our institution. The surgical technique has been decided at the discretion of the seni... | PMC10037835 | ||
Intervention description {11a} | PMC10037835 | |||
Graft fixation | Fixation will be performed with an adjustable suspensory ACL TightRope® 2 RT device (Arthrex, Naples, FL, USA) on the femoral side and a PEEK interference screw (Arthrex, Naples, FL, USA) on the tibial side with a diameter the same size as the tibial tunnel. | PMC10037835 | ||
Graft harvest and preparation | The semitendinosus and gracilis tendons will be harvested from the ipsilateral knee with a tendon harvester. Each tendon will be doubled over the ACL TightRope® 2 RT device (Arthrex, Naples, FL, USA) and the free ends sutured together with 2-Fibreloop suture (Arthrex, Naples, FL, USA) to create a 4-strand hamstring gra... | PMC10037835 | ||
Femoral tunnel preparation | An anatomic single-bundle reconstruction will be performed. The ACL femoral footprint will be identified and a point between the AM and PL bundles will be selected, erring towards the AM bundle. The position will be confirmed from the medial portal. A Spade Tip guide wire (Arthrex, Naples, FL, USA) will be passed via t... | PMC10037835 | ||
Tibia tunnel preparation | The tibial footprint will be identified and any residual tibial stump will be preserved where possible. An Arthrex ACL aimer set to 55° will be passed via the medial portal to facilitate the passage of a guide wire through the mid-point of the tibial ACL attachment. The full tibial tunnel will be created with a cylindr... | PMC10037835 | ||
Graft passage, tensioning and fixation technique | knee | The femoral button sutures will be passed through the femoral tunnel using the shuttling suture. The cortical suspensory button will be passed and confirmed to have flipped with a toggle test and reference to a marking on the tightrope corresponding to the femoral tunnel length and a second mark 7 mm closer to the graf... | PMC10037835 | |
Suture tape augmentation technique | SwiveLock, knee | Patients randomised to the SA arm will use the Tightrope 2 femoral cortical button, which has a single strand of Fibertape looped through the proximal Tightrope to be run alongside the graft to serve as an augment. The femoral button and graft will then be docked into the femoral tunnel, 5 mm short of the tunnel depth ... | PMC10037835 | |
Closure | Closure is performed after irrigation and haemostasis in a layered fashion. | PMC10037835 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | ACL knee rupture, rupture | ADVERSE EVENT | Owing to the nature of the intervention, being a surgical technique and use of specific implant, and the timing following randomisation, it is not anticipated that any participants will be discontinued from allocated intervention following randomisation. If a participant suffers graft failure or contralateral ACL knee ... | PMC10037835 |
Strategies to improve adherence to interventions {11c} | All follow-up, short of one interaction, will be performed in conjunction with standard surgical care. All PROMs will be collected by easily accessible medium, including text message or email contact. This study will be co-ordinated by a dedicated research assistant in order to give participants the time to ask and hav... | PMC10037835 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | lower extremity musculoskeletal dysfunction, sports-related, effusion, pain | EFFUSION | Post-operatively, all patients will undergo standardised medical and rehabilitative protocols according to the Fowler Kennedy Physiotherapy following ACL Reconstruction Protocol. All patients will receive day 1 physiotherapy and standard post-discharge management including wound review at 2 weeks, with clinical reviews... | PMC10037835 |
Provisions for post-trial care {30} | All participants will be offered routine medical and surgical post-trial care commensurate with their condition at the discretion of the treating surgeon. There will be no compensation offered to participants either for their involvement in the study. This is outlined in the participant information and consent form. | PMC10037835 | ||
Outcomes {12} | PMC10037835 | |||
Primary outcome | arthrometer, osteoarthritis | OSTEOARTHRITIS, SECONDARY | The primary outcome will be the side-to-side difference in anterior tibial translation as measured on the GNRB arthrometer at 2 years post-operatively, between groups. Maximum anteroposterior tibial translation at 134 N will be recorded on both the operative and non-operative knees pre-operatively and post-operatively ... | PMC10037835 |
Secondary outcomes | postoperative pain, Osteoarthritis, anxiety/depression, ACL, knee ACL rupture, Knee injury, pain, infection, knee injuries, knee effusion, arthrofibrosis, knee pain | OSTEOARTHRITIS, ADVERSE EVENTS, INFECTION, STERILE, EFFUSION, COMPLICATIONS, ARTHROFIBROSIS, COMPLICATIONS | Secondary outcomes are fourfold and will include (i) PROMs, (ii) return to sport rates, (iii) complications and (iv) examination findings.PROMs will be recorded preoperatively and post-operatively at 6 weeks, 3 months, 12 months and 24 months. PROMs collected will include the following:EQ5D-5L: The EuroQol EQ-5D-5L is ... | PMC10037835 |
Participant timeline {13} | arthrometer | COMPLICATION | Participants will be recruited from the orthopaedic outpatient clinic at our institution. Participants will be eligible for assessment if they are referred to either of the associated investigators’ clinic (L.B or S.T) and are consented for ACLR. Eligibility for trial participation based on inclusion and exclusion crit... | PMC10037835 |
Sample size {14} | All statistical methods and power analysis were developed through consultation with an independent statistician. Power analysis was performed with G*power 3.1 Software. To achieve a minimum 80% statistical power with an alpha value of 0.05, power analysis based on a hypothesised mean residual side-to-side difference of... | PMC10037835 | ||
Recruitment {15} | RECRUITMENT, RECRUITMENT | Recruitment will be conducted continuously across patients eligible until the target randomised sample size is achieved. Based on institutional caseloads, it is anticipated this will take 1–2 years. A dedicated member of the research team will be tasked with recruitment on clinic days, such that all prospective partici... | PMC10037835 | |
Assignment of interventions: allocation | PMC10037835 | |||
Sequence generation {16a} | The randomisation design is a computer-generated permuted single-blind block randomisation. The randomisation sequence will be developed by an independent statistician, with all other research team members blinded to the randomisation sequence. Participants will be randomised using permuted block randomisation which al... | PMC10037835 | ||
Concealment mechanism {16b} | The centrally managed, blinded randomisation model will ensure allocation concealment and prevent selection bias. The allocation sequence will be stored within the REDCap database and inaccessible to all but the statistician, ensuring concealment. Following randomisation, the allocation details will be displayed on the... | PMC10037835 | ||
Implementation {16c} | The allocation sequence will be developed by an independent statistician. It will be integrated into the REDCap automated randomisation platform and will be blinded to all other investigators. Enrolment of participants will be overseen by the lead surgeons, and associate investigators ST and LB, and will be carried out... | PMC10037835 | ||
Assignment of interventions: blinding | PMC10037835 | |||
Who will be blinded {17a} | SECONDARY | Trial participants will be blinded to the allocation arm for the duration of the study. GNRB arthrometric measurements are inherently low in bias, secondary to the computer-generated application of force to the posterior tibia; however, technicians taking the measures will be blinded to allocation arm. Owing to the nat... | PMC10037835 | |
Procedure for unblinding if needed {17b} | As the surgeon and only outcome assessors are not blinded, unblinding will not be required. | PMC10037835 | ||
Data collection and management | PMC10037835 | |||
Plans for assessment and collection of outcomes {18a} | PROM | All data will be entered into a custom web-based REDCap database accessible by study research staff only. All GNRB data will be transposed from automated Genuroub software outputs to custom-designed data entry forms in the preoperative and postoperative setting by a member of the research team specifically trained in b... | PMC10037835 | |
Plans to promote participant retention and complete follow-up {18b} | PROMs and return to sport data will be collected by online survey, deliverable by email or text message with the aims to increase follow-up rates among a technologically inclined patient cohort. All follow-up examinations and GNRB assessments will be performed concurrently with follow-up surgical appointments until the... | PMC10037835 | ||
Data management {19} | All data will be stored on a secure institutional REDCap server in a database custom-built for this study. Validation of data fields will be built into this platform where relevant, as well as the use of “required” fields to minimise missing data. Double data entry will not be possible. | PMC10037835 | ||
Confidentiality {27} | The research information will be re-identifiable. All participants will be assigned a study ID. A data re-identification key file will be stored as an encrypted file separate to the file containing the data. This will be a password-protected file stored on the hospital server. Only the research team can match the parti... | PMC10037835 | ||
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | No biological specimens will be collected as part of this study. | PMC10037835 | ||
Statistical methods | PMC10037835 | |||
Statistical methods for primary and secondary outcomes {20a} | Side-to-side difference in anterior tibial translation (the primary outcome), overall ACL-RSI, EQ5D-5L, Marx activity scales, IKDC and KOOS-QOL will be calculated as means, with measures of dispersion reported as standard deviation. Differences between groups will be reported as mean differences, with dispersion report... | PMC10037835 | ||
Interim analyses {21b} | Interim analysis will be performed 1 year after the surgery of the final randomised participant. There will be no formal criteria for trial termination; however, if it is observed that the intervention is associated with significant harm to subsequently enrolled participants, then consideration of trial termination wil... | PMC10037835 | ||
Methods for additional analyses (e.g. subgroup analyses) {20b} | arthrometer, knee laxity | Subgroup analysis will be explored to identify possible treatment effect modifying baseline factors such as age, sex, return to sport expectations and pre-operative ipsilateral knee laxity as measured on the GNRB arthrometer. | PMC10037835 | |
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | All principal analyses will be based on the intention-to-treat principle, analysing participants in the groups to which they are randomised. Missing data will be quantified and if possible multiple imputation will be used; otherwise, simple imputation will be used. Owing to the nature of enrolment and randomisation in ... | PMC10037835 | ||
Plans to give access to the full protocol, participant-level data and statistical code {31c} | The protocol will be registered at the Australia New Zealand Clinical Trials Registry (ANZCTR), where specifics not present in the current publication may be reviewed. | PMC10037835 | ||
Oversight and monitoring | PMC10037835 | |||
Composition of the coordinating centre and trial steering committee {5d} | ADVERSE EVENTS | The Principal Investigator, the research assistant/co-ordinator and at least one other Investigator (Internal Trial Monitoring Committee) will meet at least monthly to monitor the progress of the trial to discuss study progress and procedures, adverse events and any other issues, | PMC10037835 | |
Composition of the data monitoring committee, its role and reporting structure {21a} | The Principal Investigator will act as the data manager for the trial. The research team will meet as above in lieu of an official Data Monitoring Committee. Direct access to the data will be granted to authorised representatives from the sponsor, host institution or ethics board for monitoring and/or audit to ensure c... | PMC10037835 | ||
Adverse event reporting and harms {22} | death, bleeding, congenital anomaly, birth defect, disability or incapacity | BLEEDING, DELAYED WOUND HEALING, THROMBOEMBOLIC EVENT, ADVERSE EVENTS, WOUND INFECTION, COMPLICATIONS | Participant safety will be ensured via standard institutional protocols. The use of the GNRB is established to be safe in pre-operative [Serious adverse events (SAE) are defined as any untoward and unexpected medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of exis... | PMC10037835 |
Frequency and plans for auditing trial conduct {23} | Auditing of trial conduct will be performed at a frequency and depth as determined by the local ethics board, independent of investigators and research team. | PMC10037835 | ||
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} | All modifications to study protocols, following approval with the local ethics board, will be documented as amendments in the ANZ clinical trial registry. All participants having previously signed consent forms prior to change in protocol will be notified by email including the detail of the change and its impact on th... | PMC10037835 | ||
Dissemination plans {31a} | By signing the consent form, the participants give their permission to allow the de-identified data generated by this research to be shared/discussed with the local institutional orthopaedic unit and those working within it. Information may be used in publication in peer-reviewed medical journals. The results may also ... | PMC10037835 | ||
Discussion | ANTERIOR, COMPLICATION, COMPLICATIONS | This manuscript reports on the methodological design of the STACLR trial (Suture Tape Augmentation of Anterior Cruciate Ligament Reconstruction), the first randomised design prospective trial comparing suture tape-augmented ACL reconstruction to standard ACL reconstruction in adult patients. In this study, 2-year objec... | PMC10037835 | |
Trial status | RECRUITMENT | The current protocol is Version 1.3, dated 30 August 2021. Recruitment commenced on 03 March 2022. Recruitment is anticipated to finish on 30 June 2024. | PMC10037835 | |
Acknowledgements | The authors would like to acknowledge Dr Sara Vogrin, Statistician, The University of Melbourne, for her time and expertise in developing the statistical design of the present study. We would like to acknowledge the orthopaedic registrars at our institution who undertake substantial work in preparing patients for, deli... | PMC10037835 | ||
Authors’ contributions {31b} | RP | ST conceived the idea of the study. PT is the chief investigator and will oversee the governance and delivery of the study. LH led the proposal and protocol development, in consultation with ST and LB, and led the submission for ethical approval. LB and ST are lead surgeons and will perform all surgical cases. LH, EN a... | PMC10037835 | |
Funding {4} | This study is funded both self-funded by the Western Health Orthopaedic Special Purpose Fund, administered by the Department of Surgery, Western Health. Secondary funding has been obtained via the Arthrex (Arthrex 2021 Inc) Investigator-Initiated Research Grant, and the Victorian Orthopaedic Foundation Grant. | PMC10037835 | ||
Availability of data and materials {29} | All study personnel will have access to the final trial dataset. | PMC10037835 | ||
Declarations | PMC10037835 | |||
Ethics approval and consent to participate {24} | This study was approved by the Melbourne Health Human Research Ethics Committee (HREC 2021.073), given governance approval by Western Health and was registered on the Australian New Zealand Clinical Trials Registry on 27/8/21 under Trial Number ACTRN12621001162808. Written informed consent will be obtained by the resea... | PMC10037835 | ||
Consent for publication {32} | Not applicable.Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request. | PMC10037835 | ||
Competing interests {28} | This study has been allocated funding by Arthrex Inc via the Investigator-Initiated Research Grant. This funding was sought and approved only following final protocol approval and ethical and local governance approval. This funding will be utilised to supply the GNRB for use in the study and for the employment of a par... | PMC10037835 | ||
References | PMC10037835 | |||
Supplementary Information | Schools offer an advantageous setting for the prevention, early identification, and treatment of mental health problems for youth. However, school mental health (SMH) services are typically not based on evidence for effectiveness, nor are they efficiently delivered, with SMH practitioners (SMHPs) able to only treat a s... | PMC10227122 | ||
Keywords | suicidality, depression, anxiety | Since 2010, rates of depression, anxiety, and suicidality in children and adolescents have risen to historic highs (Ivey-Stephenson et al., | PMC10227122 | |
Improving Efficiency and Effectiveness of School Mental Health Care | MH, MTSS, depressed | FRANKLIN | School-based services are characterized by large caseloads and clinician time constraints; they also tend to be crisis-driven (Langley et al., Education frameworks taking a broader public health approach, such as Multi-Tiered Systems of Supports (MTSS; National Center on Response to Intervention, While there is substan... | PMC10227122 |
Developing and Testing an Efficient SMH Model for “Real World” Schools | Working with local school districts, the current research team developed a SMH approach that incorporates problem-focused assessment, problem-solving, and flexibly applied evidence-based elements (Bruns et al., The current paper describes an initial efficacy test of this school-based triage and brief intervention appro... | PMC10227122 | ||
Methods | This study was pre-registered at ClinicalTrials.gov (protocol number 52229). Block randomization occurred at the level of the school, and participants completed assessments at baseline, 3, and 6-months follow-up for the primary outcome measures of interest. Academic outcomes were collected; however, the current paper f... | PMC10227122 | ||
Participants | PMC10227122 | |||
Schools | The study was conducted in 15 school districts in 3 states: Maryland (13 schools, 2 districts), Minnesota (16 schools, 8 districts), and Washington (20 schools, 5 districts). School enrollment ranged from 67 to 2851 ( | PMC10227122 | ||
School Mental Health Practitioners (SMHPs) | All SMHPs in participating schools were included. Licensed mental health clinicians ( | PMC10227122 | ||
Youth Participants | All students seeking or referred to services from participating SMHPs in participating high schools were eligible. Students were referred to or requested SMH through standard procedures used by their school/district. Students were ineligible if they currently or in the past year received therapy or counseling. Students... | PMC10227122 | ||
Measures | PMC10227122 | |||
Mental Health Services Received | The Service Assessment for Children and Adolescents (SACA; Stiffman et al., | PMC10227122 | ||
Service Processes and Satisfaction | The Multidimensional Adolescent Satisfaction Scale (MASS) is a 21-item measure of client satisfaction with mental health services. Response options are on a 4-point scale from 1 (“strongly disagree”) to 4 (“strongly agree”). The MASS has demonstrated acceptable to excellent overall internal and test–retest reliability ... | PMC10227122 | ||
Therapeutic Alliance | It was collected using the Therapeutic Alliance Scale for Adolescents (TASA) and the Therapeutic Alliance Scale for Clinicians (TASC) at a 2-month follow-up (Faw et al., | PMC10227122 | ||
Student-Identified Top Problems | At baseline, the Youth Top Problem Assessment (YTPA; Weisz et al., | PMC10227122 | ||
Mental Health Symptoms and Functioning | anxiety | Mental health outcomes were measured using the Patient Health Questionnaire (PHQ-9; Richardson et al., The GAD-7 is a brief scale that queries about anxiety symptoms. Response options are on a 4-point scale from 0 (“not at all”) to 3 (“nearly every day"). Interrater reliability is good, with self-report scales correlat... | PMC10227122 | |
Treatment Outcome | MH | At the end of the third year of the study, SMHPs in both groups reported on the treatment outcome and triage decision for the five students with whom treatment was most recently completed. SMHPs reported whether, after four sessions, treatment was concluded or continued. For students who completed service, SMHPs report... | PMC10227122 | |
BRISC Fidelity | BECT | The BRISC External Coding Tool (BECT) was developed for the study and includes 24 items derived from the 4 to 8 treatment components of each of the four BRISC sessions (e.g., “conducted stress rating”). Items are scored dichotomously (0 = criteria not met; 1 = met). For each BRISC clinician, the two BRISC trainer-consu... | PMC10227122 | |
BRISC Feasibility and Acceptability | Appropriateness | SMHPs were administered an exit interview after each school year that incorporated the Acceptability, Likely Effectiveness, Feasibility, and Appropriateness Questionnaire (ALFA-Q; Cook & Lyon, | PMC10227122 | |
Procedures | PMC10227122 | |||
Randomization | To ensure condition comparability, we used stratified sampling. Within each state, a nearest neighbor matching algorithm matched schools based on characteristics of practitioners (e.g., degree, years’ experience, score on Evidence-Based Practices Attitudes Scale (Aarons, | PMC10227122 | ||
Recruitment and Enrollment | RECRUITMENT | Students were recruited and enrolled from October 2016 to November 2018. Figure CONSORT diagram for student recruitment and study participation by condition (BRISC and SAU) in the BRISC study | PMC10227122 | |
Data Collection | Study procedures were approved by the Institutional Review Board at the University of Washington. Informed consent was obtained from students, caregivers, and SMHPs. Students completed measures at baseline, 2, and 6 months. Briefer surveys (YTPA only) were also conducted with students at 1 and 4 months. At the end of e... | PMC10227122 | ||
BRISC Intervention | The core BRISC strategy is implemented in four sessions. In session 1, the SMHP engages the student, assesses current functioning using brief standardized assessment measures, and identifies “top problems” (Weisz et al., BRISC-assigned SMHPs attended a 1.5-day in-person training by two Ph.D.-level clinical psychologist... | PMC10227122 | ||
Services as Usual | Students in SAU-assigned schools received individual counseling/therapy as usual from SMHPs. Based on previous research, the primary orientation of SMHPs in the SAU condition is supportive psychotherapy and crisis response (Holmes et al., | PMC10227122 | ||
Data Analysis | Overall, attrition and differential attrition were calculated to examine potential selection bias. Mixed effects modeling with random effects at the clinician and client level were used for statistical testing of between-group differences. If models failed to converge, resulted in Hessian errors, or had no significant ... | PMC10227122 | ||
Results | PMC10227122 | |||
BRISC Fidelity | BECT | SESSION | Fidelity ratings via the BECT found excellent adherence for sessions 1, 2, and 4, at 94.2%, 90.8%, and 90.1% of items in each session, respectively. Adherence was acceptable but lower for session 3 with 77.4% of items meeting criteria. Session 3 focused on continued problem solving and skill-based elements of mental he... | PMC10227122 |
BRISC Feasibility and Acceptability | Results of anonymous exit surveys indicated that SMHPs perceived BRISC to be feasible and acceptable. Mean ratings across all items on the ALFA-Q were 3.05 ( | PMC10227122 | ||
Service Processes | Therapeutic alliance as evaluated by total scores of the TASA and TASC and youth satisfaction as evaluated by the MASS total score and its four subscales found no significant differences, with one exception: Students in SAU rated their SMHP significantly higher than students in BRISC on the Counselor Qualities subscale... | PMC10227122 | ||
Services Received | PMC10227122 | |||
Mental Health Symptoms and Functioning | Table | PMC10227122 | ||
Discussion | MTSS | This project evaluated the potential for improving the efficiency of SMH via a school-based assessment, brief intervention, and triage approach for students with socio-emotional concerns. BRISC provides a first-line intervention using consistent assessment to inform level and type of ongoing services needed in a preven... | PMC10227122 | |
Limitations | Although the current study used rigorous methods, attrition from follow-up data collection was not trivial (15% at 2 months and 22% at 6 months) and significantly higher for students assigned to BRISC. Debriefs with interviewers suggested that SAU students were easier to schedule for follow-up interviews due to their c... | PMC10227122 | ||
Implications for School-Based Prevention and Treatment | MTSS | MITCHELL | Results indicate that BRISC holds promise as a method for equipping SMHPs with a structured approach to meeting the needs of a greater number of students with an array of problems. Developing such targeted strategies is important given that there are a limited number of such “Tier 2” SMH strategies available in schools... | PMC10227122 |
Funding | The research reported here was supported by the Institute of Education Sciences, US Department of Education, through Grants R305A160111 and R305A120128 R305A16001 (PIs Bruns & McCauley). The opinions expressed are those of the authors and do not represent views of the Institute or the US Department of Education. | PMC10227122 | ||
Declarations | PMC10227122 | |||
Ethics Approval | All procedures in the present study were in accordance with the ethical standards of the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study was pre-registered at ClinicalTrials.gov (protocol number 52229). The study protocol was approved by the Institutional Review Board of t... | PMC10227122 | ||
Informed Consent | Informed consent to participate in the study was obtained from parents or legal guardians of all student participants; assent to participate was obtained from all students. | PMC10227122 | ||
Conflict of Interest | The authors declare no competing interests. | PMC10227122 |
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