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Background | MINOR, MUSCULOSKELETAL DISORDERS | Advanced practice physiotherapy (APP) models of care where physiotherapists are primary contact emergency department (ED) providers are promising models of care to improve access, alleviate physicians’ burden, and offer efficient centered patient care for patients with minor musculoskeletal disorders (MSKD). | PMC9900999 | |
Objectives | MINOR | To compare the effectiveness of an advanced practice physiotherapist (APPT)-led model of care with usual ED physician care for persons presenting with a minor MSKD, in terms of patient-related outcomes, health care resources utilization, and health care costs. | PMC9900999 | |
Methods | Pain | ADVERSE EVENT, MINOR | This trial is a multicenter stepped-wedge cluster randomized controlled trial (RCT) with a cost analysis. Six Canadian EDs (clusters) will be randomized to a treatment sequence where patients will either be managed by an ED APPT or receive usual ED physician care. Seven hundred forty-four adults with a minor MSKD will ... | PMC9900999 |
Discussion | MSKD have a significant impact on health care systems. By providing innovative efficient pathways to access care, APP models of care could help relieve pressure in EDs while providing efficient care for adults with MSKD. | PMC9900999 | ||
Keywords | PMC9900999 | |||
Administrative information | EMERGENCY |
Matifat, E.: Maisonneuve-Rosemont Hospital Research Center, University of Montreal Affiliated Research Center, Montréal, Québec, Canada.Berger Pelletier, E.: Faculty of Medicine, Université Laval Québec, Québec, CanadaBrison, R.: Department of Emergency Medicine, Queen’s University, Kingston, Ontario, Canada.Hébert, L... | PMC9900999 | |
Introduction | PMC9900999 | |||
Background and rationale {6a} | CHRONIC DISORDERS | Overcrowding in emergency departments (ED) is one of the biggest concerns in several health care systems. This challenge will worsen in years to come given the aging populations, the increasing prevalence of chronic disorders, and physician shortages [Traditionally, ED physicians are the primary contact practitioners w... | PMC9900999 | |
Objectives {7} | disability, Pain, pain | ADVERSE EVENTS, MINOR | Thus, the aim of our project is to evaluate the impact of an APP-led model of care compared to usual physician ED care for persons presenting with minor MSKD. The specific objectives are:To compare the effectiveness of both types of care in terms of patient-related outcomes for patients with minor MSKD in six Canadian ... | PMC9900999 |
Trial design {8} | This project is a multicenter pragmatic stepped-wedge (3 steps with 4 periods of 6 weeks each) cluster RCT with a cost analysis conducted in six Canadian EDs. | PMC9900999 | ||
Methods: participants, interventions, and outcomes | PMC9900999 | |||
Study setting {9} | Patients will be recruited from the following six Canadian EDs: Maisonneuve-Rosemont Hospital (MRH) (CIUSSS-de-l’Est-de-l’Ile-de-Montréal, Montréal, Québec), Centre Hospitalier Universitaire de l’Université Laval (CHUL) and Enfant-Jésus Hospital (EJH) (CHU de Québec, Québec), Hotel-Dieu Hospital (Kingston Health Scienc... | PMC9900999 | ||
Eligibility criteria {10} | dislocations, musculoskeletal injury, pain, fractures, muscle pain, psychiatric, tendinopathy, neurological deficits, joint sprain, trauma | OSTEOARTHRITIS, MINOR, INFLAMMATORY ARTHRITIS, VEHICLE ACCIDENT | The inclusion criteria are (1) patients presenting with complaints related to minor MSKD (e.g., back pain, joint sprain, osteoarthritis, muscle pain, or tendinopathy) triaged as level 3, 4, or 5 on the Canadian Triage and Acuity Scale (CTAS); (2) aged 18 years or more; (3) legally able to consent; (4) able to understan... | PMC9900999 |
Who will take informed consent? {26a} | Research professionals in each site will explain the study, including the purpose and the required implication by participants, to eligible patients and will answer any remaining questions. Research professionals will then obtain written informed consent from patients who agree to enroll in this study. Information and ... | PMC9900999 | ||
Additional consent provisions for collection and use of participant data and biological specimens {26b} | N/A, no ancillary studies | PMC9900999 | ||
Interventions | PMC9900999 | |||
Explanation for the choice of comparators {6b} | In the Canadian health care system, patients presenting to EDs will receive the usual care from an ED physician. As this is the most prevalent model of care for patients with MSKD, this will be used as our control arm. | PMC9900999 | ||
Intervention description {11a} | The experimental arm will receive APP-led care. Patients will be independently managed (assessment and intervention) by a PT (The control arm will receive the usual ED physician care delivered by an ED physician. This will include independent assessment, treatment, and discharge by an ED physician with no physiotherapy... | PMC9900999 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | No specific criteria for modifying allocated interventions were defined since this is a punctual intervention. However, participants in both arms presenting a non-MSKD condition after assessment will be excluded from the study and will receive usual ED physician care outside the trial according to their condition. | PMC9900999 | ||
Strategies to improve adherence to interventions {11c} | This pragmatic trial will evaluate the impact of an assessment and intervention offered only within the ED either by a PT or a physician. | PMC9900999 | ||
Relevant concomitant care permitted or prohibited during trial {11d} | There will be no restriction in terms of care during this trial. Participants will be asked to complete a treatment diary regarding compliance with ED treatments and any health services or interventions they sought for their initial problem during the follow-up period. | PMC9900999 | ||
Provisions for post-trial care {30} | ADVERSE EVENTS | The main potential risk in this trial is a diagnostic error by PTs or physicians. Any adverse events will be documented within the current study, and we will ensure study participants receive the appropriate care if needed. | PMC9900999 | |
Outcomes {12} | PMC9900999 | |||
Baseline data collection | depression | DISORDER, AIDS | At trial inclusion, eligible participants will answer a series of questions covering socio-demographic characteristics, such as age, sex, gender, education level, household income, and living status. Clinical variables such as anthropometric data, affected body area, reason for consultation, CTAS level, duration of sym... | PMC9900999 |
Primary outcome measure | Pain, pain | The main outcome measure will be the Brief Pain Inventory–Short Form, Pain Interference Scale (BPI), and the primary endpoint at 4 weeks after discharge. The BPI is a self-administered questionnaire that includes seven items where the patient is asked to rate the impact of pain on various functional activities (pain in... | PMC9900999 | |
Other patient-related outcomes | neck-related disorders, disability | In order to further assess the impact of MSKD on function, participants will complete self-reported validated and reliable disability questionnaires relevant to the affected body area. Depending on the affected body area(s), participants will complete one or more of the following questionnaires: Neck Disability Index (... | PMC9900999 | |
Health care resource utilization outcomes | ADVERSE EVENTS | The ED physician or PT will complete a standardized form following their assessment and interventions, indicating diagnoses, requests for additional medical imaging or laboratory tests (if relevant), treatment plan (e.g., conservative treatment options, medication or physiotherapy care), discharge plan, and referral to... | PMC9900999 | |
Health care costs | The EQ-5D-5L will be the primary outcome measure for the cost analysis outcomes. It is a generic health-related quality of life questionnaire for which validity has been established. It has been widely used in economic evaluations, including in trials with patients suffering from MSKD and in our pilot RCT [ | PMC9900999 | ||
Wait to initial assessment and ED length of stay measures | Wait in the ED, which is defined as the time between the arrival in the ED and the initial evaluation by a physician or a PT will be recorded. The total length of stay in the ED will also be recorded in minutes by research professionals onsite. | PMC9900999 | ||
Participant timeline {13} | The participant timeline is presented in Table | PMC9900999 | ||
Sample size {14} | The main hypothesis is that APP-led care will be at least as effective as usual ED physician care based on the results of our literature review [ | PMC9900999 | ||
Recruitment {15} | All new patients presenting to participating EDs and triaged by nurses (based on the usual triage process used in each ED) as having a possible MSKD will be considered for this study. In addition, a research professional in each site will screen the triage lists to identify any other potential participants for the tria... | PMC9900999 | ||
Assignment of interventions: allocation | PMC9900999 | |||
Sequence generation {16a} | All eligible and consenting sites will be randomly assigned to a sequence of models of care (APP-led or usual). All sites will begin the trial with a baseline period where no site is in the intervention arm. Then, during 6-week intervals, two sites (clusters) will move to the intervention arm with this timing randomize... | PMC9900999 | ||
Concealment mechanism {16b} | Sites will be informed at the beginning of the trial of the intervention sequence as this will allow efficient planning of the intervention arm at each ED. | PMC9900999 | ||
Implementation {16c} | Randomization procedures will be performed by an independent research professional not involved in other aspects of the trial. | PMC9900999 | ||
Assignment of interventions: blinding | PMC9900999 | |||
Who will be blinded {17a} | Neither participants nor providers will be blinded in this study in the context of this pragmatic RCT. Even if the patient’s perception can be influenced by the type of provider they see, this approach is necessary because of the pragmatic nature of the proposed care model, and it is important that patients know which ... | PMC9900999 | ||
Procedure for unblinding if needed {17b} | Neither participants nor providers are blinded. | PMC9900999 | ||
Data collection and management | PMC9900999 | |||
Plans for assessment and collection of outcomes {18a} | All data will be collected using the REDCap platform. Outcome measures will be collected at inclusion, before ED discharge, and at 4-week, 12-week, and 26-week follow points (Table | PMC9900999 | ||
Plans to promote participant retention and complete follow-up {18b} | In order to limit loss to follow-up, we will validate with participants at each time point their contact information and preferred means of communication. | PMC9900999 | ||
Data management {19} | The databases will be centralized at the coordination center (Maisonneuve-Rosemont Hospital - MRH - Research Center). MRH will store all data captured in REDCap on its own servers. All data is therefore stored and hosted at MRH, and no project information is ever transmitted at any time by REDCap from MRH to any other ... | PMC9900999 | ||
Confidentiality {27} | Data will be kept in REDCap at the end of the study in a de-identified form using an identification code. Only the investigators will have access to the link key linking codes to individuals. The data will be kept for seven years. | PMC9900999 | ||
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | No biological specimens were collected. | PMC9900999 | ||
Statistical methods | PMC9900999 | |||
Statistical methods for primary and secondary outcomes {20a} | Descriptive statistics will be used to present the participants’ characteristics. Baseline demographic data will be compared across groups and the participating EDs to establish the comparability of study samples across intervention arms and clusters. If differences are observed, statistical models will be adjusted, an... | PMC9900999 | ||
Interim analyses {21b} | Interim analyses will be conducted at the 1-month follow-up to ensure no safety issue is detected and final analyses will be conducted at the end of the trial. | PMC9900999 | ||
Methods for additional analyses (e.g., subgroup analyses) {20b} | SECONDARY, RECRUITMENT | Secondary analyses will be performed according to the affected body area (upper limb, lower limb, neck, or back) and will consider site recruitment clustering, since these factors can impact care utilization as well as other outcomes measured in the study. The same is also true for sex and gender for which secondary an... | PMC9900999 | |
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | Participants withdrawing from the study and reasons for withdrawal will be analyzed. Characteristics of participants and non-participants will also be compared. Multiple imputation will be used for missing data handling. | PMC9900999 | ||
Plans to give access to the full protocol, participant-level data, and statistical code {31c} | The protocol, data, and statistical code that support the findings of this study will be available from the corresponding author, upon reasonable request. | PMC9900999 | ||
Oversight and monitoring | PMC9900999 | |||
Composition of the coordinating center and trial steering committee {5d} | TSC | The trial steering committee (TSC) will include co-PIs Drs. Desmeules, Perreault, and Émond, with co-Is and assistants hired in each site. They will be at the core of trial management (as described above). The TSC will meet at the beginning of the study to plan/organize, to ensure the study integrates well within each ... | PMC9900999 | |
Composition of the data monitoring committee, its role, and reporting structure {21a} | Since this is a low-risk intervention and not required by the Ethics Committee, there is no external data monitoring committee. | PMC9900999 | ||
Adverse event reporting and harms {22} | ADVERSE EVENTS | The current literature on the safety of ED physiotherapy care with MSKD patients found no increase in adverse events associated with ED physiotherapist-led care [ | PMC9900999 | |
Frequency and plans for auditing trial conduct {23} | TSC | RECRUITMENT | The TSC will meet every month to discuss issues with recruitment, protocol adherence, and follow-up of participants. | PMC9900999 |
Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} | If any important protocol amendments are required, the TSC will meet to discuss the relevance of the proposed changes. Ethics committees of all participating sites will be informed of potential changes. Amendments will be undertaken only after approval of all committees. | PMC9900999 | ||
Dissemination plans {31a} | trauma | Several stakeholders and knowledge users, such as patients, administrators, health care practitioners, and decision-makers, have been engaged in the entire process from project inception to preparation of this protocol. They will pursue their active involvement until project completion and dissemination of the results.... | PMC9900999 | |
Discussion | Current evidence shows that an increasing number of MSKD patients turn to EDs for care [ | PMC9900999 | ||
Strength and limitations | APPTs | STILL | This study is the first multicenter pragmatic trial with a cost analysis assessing APP-led ED care. The trial has been designed by a group of experts with expertise in the management of MSKD, public health, epidemiology, cost analyses, health services, ED medicine, interprofessional collaboration, rehabilitation, and d... | PMC9900999 |
Trial status | RECRUITMENT | Recruitment for this trial should start in the fall of 2022 and be completed by the spring of 2023. | PMC9900999 | |
Acknowledgements | Not applicable. | PMC9900999 | ||
Authors’ contributions {31b} | FD, KP, ME, and co-principal investigators for this study were involved in the study protocol development and revision as well as the funding proposal. All authors reviewed, edited, and approved the final version of this protocol. | PMC9900999 | ||
Authors’ information | Not provided. | PMC9900999 | ||
Funding {4} | This research is funded by the Canadian Institutes of Health Research (CIHR) (202010PJT-451693-CIB-CFCC-130299). | PMC9900999 | ||
Availability of data and materials {29} | After all analyses have been conducted and results published, the data that support the findings of this trial will be available upon reasonable request. | PMC9900999 | ||
Declarations | PMC9900999 | |||
Ethics approval and consent to participate {24} | This study was approved by the Research Ethics Committee of the CIUSSS-de-l’Est-de-l’Ile-de-Montréal (MP-12-2022-2730). This study will be undertaken following approval from the ethics review boards of all participating EDs.In regard to participants’ consent, research professionals in each site will explain the study, ... | PMC9900999 | ||
Consent for publication {32} | Not applicable. No identifying images or other personal or clinical details of participants are presented here nor will be presented in reports of the trial results. Informed consent materials are available from the corresponding author upon request. | PMC9900999 | ||
Competing interests {28} | The authors declare that they have no competing interests. | PMC9900999 | ||
References | PMC9900999 | |||
Purpose | SBS-IF, intestinal failure, short bowel syndrome | INTESTINAL FAILURE, SHORT BOWEL SYNDROME | The short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF). | PMC9950205 |
Methods | Patients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307). Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years. | PMC9950205 | ||
Results | ADVERSE EVENTS, DISEASE, ADVERSE DRUG REACTIONS | The parenteral support (PS) volume decreased by ≥ 20% for 9/18 patients at 24 weeks and in all 11 patients by data cut-off in SHP633-307. The mean (standard deviation) PS volume decreased from baseline at 24 weeks in TED-C14-004 (−30.1 ± 25.9%) and SHP633-306 (−25.6 ± 25.5%), and at data cut-off in SHP633-307 (−57.08 ±... | PMC9950205 | |
Conclusions | In Japanese adults with SBS-IF, teduglutide treatment was associated with clinically meaningful reductions in PS requirements, similar to findings in prior international studies. No new safety concerns specific to the Japanese SBS-IF patient population were identified with short- or long-term teduglutide treatment. Ant... | PMC9950205 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00595-022-02587-4. | PMC9950205 | ||
Keywords | PMC9950205 | |||
Introduction | intestinal failure, malignancy, Short bowel syndrome, Crohn’s disease, mesenteric ischemia, SBS, SBS-IF | INTESTINAL FAILURE, INTESTINAL OBSTRUCTION, SHORT BOWEL SYNDROME, MESENTERIC ISCHEMIA, PATHOLOGY | Short bowel syndrome (SBS) is a rare condition resulting from significant physical or functional loss of portions of the bowel and is the most common cause of intestinal failure (IF) [Patients with SBS-IF comprise a heterogeneous population differing in underlying pathology, the function of the remnant bowel, and demog... | PMC9950205 |
Methods | PMC9950205 | |||
Study design | SBS-IF, Crohn’s disease, SBS | STERILE, REMISSION | Two open-label, multicenter phase III clinical trials of teduglutide in adult patients with SBS-IF and their extension study were conducted in Japan: TED-C14-004 (ClinicalTrials.gov identifier NCT02340819) involved short-term (24 weeks) and long-term (up to 30 months) treatment with teduglutide; SHP633-306 (ClinicalTri... | PMC9950205 |
Data collection | BLOOD | For TED-C14-004 and SHP633-306, patient demographic and clinical characteristics were captured at baseline, defined as the last visit before initiation of treatment with teduglutide. The baseline for the analysis of the efficacy and PK assessments for each patient was the baseline from core studies TED-C14-004 or SHP63... | PMC9950205 | |
Data analyses | stoma, Crohn’s disease | ADVERSE EVENTS | The intent-to-treat (ITT) population consisted of patients who enrolled and were eligible at baseline (i.e., after PS optimization and stabilization) to receive teduglutide. Efficacy analyses were based on the ITT population, all of whom received teduglutide. The safety population comprised all patients in the ITT popu... | PMC9950205 |
Statistical analyses | The small size of the study populations precluded any formal statistical testing; data were summarized using descriptive statistics. All data values are reported as the mean ± standard deviation (SD) unless otherwise stated. | PMC9950205 | ||
Results | PMC9950205 | |||
Mean exposure to teduglutide | Patients who completed the extension study until the interim data cut-off point received teduglutide up to a maximum of 14 months (SHP633-306) or 57 months (TED-C14-004). The mean extents of teduglutide exposure only in TED-C14-004 and SHP633-306 were 26.8 ± 17.0 months and 4.8 ± 1.6 months, respectively. The mean cumu... | PMC9950205 | ||
Efficacy | Crohn’s disease, teduglutidePatients |
Short-term treatment with teduglutideThe first 24 weeks of treatment with teduglutide were considered short-term use.Change in PS requirementsA reduction in weekly PS volume of ≥ 20% from baseline at both weeks 20 and 24 was achieved by 9 of 18 patients (50%) (5 of 11 patients [45.5%] in TED-C14-004 and 4 of 7 patient... | PMC9950205 | |
Post hoc analyses of TED-C14-004 | Crohn’s disease | Post hoc analyses of TED-C14-004 were performed for both short- and long-term treatment of patients in this study. In the subgroup of patients with Crohn’s disease, the mean baseline PS volume requirement was 16.3 ± 8.4 L/week ( | PMC9950205 | |
PK analyses | In TED-C14-004, data for PK analyses were available for 8 patients (72.7%); teduglutide was undetectable in the plasma of the other 3 patients at all time points, most likely because of dosing errors (improved training of patients or caregivers to administer teduglutide was then implemented in SHP633-306 and SHP633-307... | PMC9950205 | ||
Safety | colon or gastrointestinal cancers | There were no clinically meaningful changes during any of the studies concerning the clinical laboratory measures, vital signs, body weight, BMI, or ECG findings. There were also no AEs related to growth of pre-existing polyps of the colon or gastrointestinal cancers observed during the studies. | PMC9950205 | |
Anti-teduglutide antibodies | hypersensitivity | HYPERSENSITIVITY, HYPERSENSITIVITY REACTION | At 24 weeks, 5 out of 14 patients (35.7%; Detection of anti-teduglutide antibodies from baseline to the interim data cut-off pointThe patient with the highest titer of anti-teduglutide antibodies (1:650 at month 12) had sustained reductions in PS volume at the time of the interim data cut-off (28.6% reduction in PS vol... | PMC9950205 |
Discussion | DISEASE, DISEASE CHARACTERISTIC | Teduglutide is the first and only GLP-2 analogue currently available worldwide for treatment of SBS-IF [The efficacy and safety profile of teduglutide observed in Japanese patients was generally consistent across these studies as well as with the previously reported values in pivotal multinational STEPS studies [As wel... | PMC9950205 | |
Conclusion | In adult Japanese patients with SBS-IF, treatment with teduglutide 0.05 mg/kg SC once daily elicited clinically meaningful reductions in PS requirements. Teduglutide was quickly absorbed and did not accumulate following multiple doses. The effects of teduglutide continued during long-term treatment. No new safety conce... | PMC9950205 | ||
Author contributions | All authors contributed to the conception and design of the research and to the analysis and interpretation of the data. All authors critically revised the manuscript, agreed to be fully accountable for ensuring the integrity and accuracy of the work, and read and approved the final manuscript. | PMC9950205 | ||
Funding | The clinical trials were funded by Shire Human Genetic Therapies, Inc., a Takeda company (Cambridge, MA, USA). The sponsor of the studies participated in the study design, data collection, data analysis, data interpretation, and review and approval of the final clinical study reports and provided the study drug. | PMC9950205 | ||
Data availability | The datasets generated are not publicly available due to the limited number of study participants, such that there is a reasonable likelihood of re-identification of individual patients. | PMC9950205 | ||
Declarations | PMC9950205 | |||
Conflict of interest | S.N. received Honoraria from Mitsubishi Tanabe Pharma, EA Pharma Co., Ltd., Janssen Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and AbbVie Inc., and has received research funding from Mitsubishi Tanabe Pharma. M.W. received research funding from Shire, a Takeda company. ... | PMC9950205 | ||
Ethical approval | RECRUITMENT | These studies were performed in accordance with the World Medical Association Declaration of Helsinki and applicable laws and standards of good clinical practice in Japan. The study protocols, any protocol amendments, the final approved informed consent documents, relevant supporting information, and all types of patie... | PMC9950205 | |
References | PMC9950205 | |||
1. Introduction | fatigue, PLF, impaired judgment [Until now, collecting a small, hypoglycemia, irritability | HYPOGLYCEMIA, BLOOD | This study examined the effects of continuous carbohydrate intake during a golf round on interstitial glucose, golf performance, and the cognitive performance of competitive golfers. Eleven competitive golfers participated and played 18 holes of golf in this study. Participants were randomly assigned to the group indic... | PMC10384188 |
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