Trial Endorsement

Backgrounds and Aims

One of the key roles of ANZMUSC is to facilitate high quality clinical trials in the area of musculoskeletal health. The principal ways of doing this are to provide an advisory service for ANZMUSC members planning or conducting a trial (e.g. scientific and operational support to improve the design and conduct of the trial, fund-raising, dissemination of results/implementation plan, engagement with stakeholders, consumer input) and to endorse high quality clinical trials that are being conducted by its members.

 

What does endorsement mean?

Endorsement means more than a ‘rubber-stamp’ of approval. It includes a process of ensuring high quality trial design and conduct but also confers a degree of ‘ownership’ to ANZMUSC members.

Trials endorsed by ANZMUSC will need to be prospectively registered, conform to best practice guidelines (e.g. those from the Equator Network) and regulatory standards (e.g. ICH GCP, National Statement), require regular reporting to ANZMUSC and presentation of updates at the annual scientific meeting, and agree to abide by ICMJE authorship guidelines and ANZMUSC Publication Policy.

ANZMUSC endorsement will provide benefits to both parties: ANZMUSC will gain greater recognition in the research community to enable it to act as a peak body for musculoskeletal research and to achieve its goals. Trialists and their trials will benefit from methodological input, and ANZMUSC endorsement may assist with gaining community and professional acceptance, funding, and implementation.

Process of ANZMUSC endorsement

The following process is required for all studies seeking ANZMUSC endorsement. All applicants will apply to present their trial in an open forum at an ANZMUSC meeting. Only proposals that fit ANZMUSC criteria will be accepted. Presentations will normally occur at the annual ANZMUSC scientific meeting.

  1. Following the open forum, trialists that feel their trial is fully developed may submit an endorsement application to the Executive Committee. This is done by submitting an application form and a copy of the trial protocol. The application is then sent to the Scientific Advisory Committee (SAC) and Consumer Advisory Group (CAG for review).
  2. Reviews are completed by two members of the SAC and two consumers of the CAG. Reviewers will be asked to provide comments to the trialists within 2 weeks of submission. In the rare instances where this is not possible, triallists will be notified and an acceptable time frame agreed with the trialist. Trialists will be asked to provide responses to comments to the SAC and CAG within 2 weeks of submission. In the rare instances where this is not possible, the SAC Chair will be notified and an acceptable time frame agreed with the trialist.
  3. SAC Chair and CAG chair to present endorsement recommendations, reviewers’ comments and responses to EC for final decision. The EC will decide to endorse, not endorse, or suggest further development.
  4. The applicant is notified of the decision with a formal letter from the Executive Committee within six weeks of submission. This letter lists the conditions and requirements of endorsement that must be accepted by the applicant.
  5. Projects marked for development will need to be revised and resubmitted totheExecutive Committeefor endorsement. This process is expected to involve interaction between the investigators and the SAC / condition specific working group prior to resubmission in order to increase the likelihood of endorsement.

Criteria for ANZMUSC endorsements

Only clinical trials in the field of musculoskeletal health will be considered and must:

  1. Satisfy an ANZMUSC research priority (reflecting important disease burden and an important evidence or evidence-practice gap)
  2. Present evidence confirming that the research question is one that the clinical and/or consumer community want answered
  3. Be of high quality (e.g. minimising risk of bias, ensuring appropriate power) and include an economic evaluation and process measures where relevant
  4. Be feasible (reflecting cost, logistics, track record and likely recruitment rate)
  5. Show strong potential to change practice and/or policy (reflecting academic impact, implementation, and generalisability)
  6. Be multicentre (to encourage collaboration, increase power and increase implementation of findings). Multicentre means that participants are recruited from more than one hospital/research institute/practice or university site. Trials that include sites across multiple regions, states or territories or countries will be highly regarded.
  7. Have clear evidence of consumer partnership during the design of the trial and plans to actively engage with consumers in the dissemination of results.
  8. Have a Chief Investigator who is a registered full member of the ANZMUSC Clinical Trials Network.

Endorsed Trials

Browse our endorsed trials

NumberAward YearChief Investigator
ProjectRegistrationPublicationsOther
12017Professor Ian Harris, University of New South WalesA Combined Randomised and Observational Study of Surgery for Fractures In the distal  Radius in the Elderly (CROSSFIRE).ACTRN12616000969460https://doi.org/10.1001/jamasurg.2020.5672
22017Professor Michele Sterling, The University of QLDTargeting pro-nociception to prevent chronic pain after whiplash injuryACTRN12617000059369 https://doi.org/10.1186/s13063-018-2450-9
32017Professor Rebecca Ivers, The University of New South WalesPreventing Falls in Older Aboriginal people: The IRONBARK TrialACTRN12619000349145https://doi.org/10.1136/injuryprev-2020-043915
42017Professor Richard Day, University of New South WalesEffectiveness of an electronic patient-centred self-management tool for Gout sufferers: a Cluster randomised controlled trialACTRN12616000455460https://doi.org/10.1136/bmjopen-2017-017281
52017Professor Manuela Ferreira, The University of SydneySUcceSS: SUrgery for Spinal Stenosis - a randomised placebo-controlled trialACTRN12617000884303https://doi.org/10.1136/bmjopen-2018-024944https://www.sydney.edu.au/research/volunteer-for-research-study/pain-and-injury/success--surgery-for-spinal-stenosis.html
62018Professor Christine Lin, The University of SydneyOASIS - Oral Steroids for Acute SciaticaACTRN12619001716156https://doi.org/10.1136/bmjopen-2020-040559
72018Dr Gustavo Machado, Institute for Musculoskeletal Health, The University of Sydney Sydney Health Partners Emergency Department (SHAPED) trial: Implementation of an evidence-based model of care for low back pain in emergency departments ACTRN12617001160325 https://doi.org/10.1136/bmjopen-2017-019052
82018Associate Professor Dawn Aitken, Menzies Institute for Medical Research, TasmaniaDICKENS - A randomised controlled trial of DIaCerein to treat KneE osteoarthritis with effusioN-SynovitisACTRN12618001656224https://doi.org/10.1186/s13063-022-06715-w
92018Professor Ian Harris, University of New South WalesCRISTAL: A randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis and safety in hip or knee arthroplasty, a registry nested studyACTRN12618001879257https://doi.org/10.1001/jama.2022.13416
102018Professor Cathy Sherrington, Institute for Musculoskeletal Health, The University of SydneyCOaching Exercise Better wAlKing”: Physical activity coaching for adults with physical disability: The COmEBAcK pragmatic randomised controlled trialACTRN12618001983291https://doi.org/10.1136/bmjopen-2019-034696
112018Professor Lisa Keay, UNSW, The George InstituteExpedited cataract surgery to prevent falls: the BRIGhT trial - Best pRactIce surGical and refractTive management for cataractACTRN12618002018291N/A
122018
Professor Christine Lin, The University of SydneyOPAL - OPioids for Acute spinaL pain  ACTRN12615000775516https://doi.org/10.1016/S0140-6736(23)00404-X
132019Professor Ian Harris, University of New South WalesThe ARC (Australian Rotator Cuff) Trial, a placebo controlled randomised trial of repair of degenerative rotator cuff tearsACTRN12620000789965https://www.arcstudy.org
142019Dr Adrian Traeger, Institute for Musculoskeletal Health, The University of SydneyNUDG-ED: Trial of a behavioural ‘nudging’ intervention to reduce unnecessary imaging of low back pain in the Emergency DepartmentACTRN12623001000695https://doi.org/10.1136/bmjopen-2023-079870
152019Professor Bill Vicenzino, The University of QueenslandNovel Education and Exercise, multi-modal physical Therapy or brief advice for patellofemoral pain: a randomized clinical trial (The NEET trial)
162019Dr Laura Laslett, Menzies Institute for Medical Research, TasmaniaA randomised trial of denosumab to treat Modic associated low back painACTRN12614000719639https://doi.org/10.1002/jbmr.3376
172019Dr Denise O'Connor, Monash Univerity & Cabrini InstituteEvaluating a patient decision aid for people with knee osteoarthritis considering arthroscopic surgery: a randomised controlled trialACTRN12622000204741
182019Professor Rana Hinman, The University of MelbourneTelerehabilitation consultations with a physiotherapist for chronic knee pain versus in-person consultations in Australia: the PEAK non-inferiority randomised controlled trialACTRN12619001240134https://doi.org/10.1016/S0140-6736(23)02630-2
19
2019Professor Kim Bennell, University of MelbourneEffects of an intensive diet program in addition to exercise in people with hip osteoarthritis who are overweight or obese: a randomised controlled trialACTRN12619001045101https://doi.org/10.1186/s12891-022-05128-9
202019Associate Professor Jane Fitzpatrick, The University of MelbourneAutologous Protein Solution (APS)– the BIOlogical symptom management of HIP osteoarthritis. The BIOHIP TrialN/AN/A
212020Professor Mark Hancock, Macquarie UniversityWalkBack: Preventing recurrence of low back painACTRN12619001134112
222020Associate Professor Anne Tiedemann, The University of SydneyPreventing falls in older age with yoga-based exercise: effectiveness, cost-effectiveness and implementationACTRN12619001183178
232020Dr Benny AntonyA randomised trial of Curcuma longa extract for treating Knee OsteoArthritis (CurKOA trial)ACTRN12618000080224https://doi.org/10.7326/M20-0990
242020Professor Rebecca Ivers, The University of New South WalesImplementation and adaptation of models of care for hip fracture in resource poor settings
252020Associate Professor Peter Malliaras, Monash UniversityThe efficacy of high-dose exercise for rotator cuff disease: a randomised placebo controlled trialN/AN/A
262020Dr Adam Semciw, La Trobe UniversityHip Osteoarthritis and foot Orthotics Trial (HOOT)NCT05138380https://doi.org/10.1136/bmjopen-2022-062954
272020Dr Stephanie MathiesonTesting Analgesics for Musculoskeletal Pain upon Emergency department Discharge (TAMED)N/AN/A
282021Associate Professor Ben Darlow, University of OtagoTe Tauwhiro Turi mā te Rongoā: Knee Care for Arthritis through Pharmacy Study (KneeCAPS)ACTRN12622000469718https://doi.org/10.1002/msc.1785
292022Professor Christine Lin, The University of SydneyORACLE: Opioid reduction after arthroplasty, a cluster randomised trial
302022Dr Gustavo Machado, Institute for Musculoskeletal Health, The University of Sydney IMPROV-ED: A de-implementation trial to reduce low-value care for low back pain in emergency departments
312022Dr Gustavo Machado, Institute for Musculoskeletal Health, The University of Sydney ADAPT-ED: An adaptive, multi-arm multi-stage trial of analgesics for low back pain in the emergency department
322022Dr Rana Dhillon, University of Melbourne & St Vincent's HospitalPosterior Laminectomy and FIXation for Degenerative Cervical Myelopathy (POLYFIX)
332023Prof Lyn MarchPROSPECT trial: PRedicting disease-mOdifying anti-rheumatic drug doSe reduction response in rheumatoid and Psoriatic arthritis with EConomic evaluaTion