All Outputs (22)

A randomised controlled trial of Pre-Operative Oncotype DX testing in early-stage breast cancer (PRE-DX study) - Study protocol (2024)
Journal Article
Northgraves, M., Cohen, J., Harvey, J., Huang, C., Palmieri, C., Pinder, S., Roy, P., Reynia, S., Soares, M., & Cain, H. (2024). A randomised controlled trial of Pre-Operative Oncotype DX testing in early-stage breast cancer (PRE-DX study) - Study protocol. PLoS ONE, 19(3), Article e0300339. https://doi.org/10.1371/journal.pone.0300339

Background
The Oncotype DX® Breast Recurrence Score assay can guide recommendations made to patients with oestrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer regarding post-surgery adjuvant the... Read More about A randomised controlled trial of Pre-Operative Oncotype DX testing in early-stage breast cancer (PRE-DX study) - Study protocol.

Mixed-methods feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): study findings (2022)
Journal Article
Hutchinson, A., Allgar, V., Cohen, J., Currow, D. C., Griffin, S., Hart, S., Hird, K., Hodge, A., Mason, S., Northgraves, M., Reeve, J., Swan, F., & Johnson, M. J. (2022). Mixed-methods feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): study findings. ERJ Open Research, 8(4), Article 00257-2022. https://doi.org/10.1183/23120541.00257-2022

Introduction: One-fifth of emergency department presentations by ambulance are due to acute-on-chronic breathlessness. We explored the feasibility of an evaluation-phase, cluster randomised controlled trial (cRCT) of the effectiveness and cost-effect... Read More about Mixed-methods feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): study findings.

A prospective registry-based cohort study of the diagnosis and management of acute leukaemia in pregnancy: Study protocol (2022)
Journal Article
Northgraves, M., Allsup, D., Cohen, J., Huang, C., Turgoose, J., & Ali, S. (2022). A prospective registry-based cohort study of the diagnosis and management of acute leukaemia in pregnancy: Study protocol. PLoS ONE, 17(2), Article e0263195. https://doi.org/10.1371/journal.pone.0263195

Background
Acute leukaemias (AL) are aggressive but potentially curable blood cancers that can potentially affect women of childbearing age. When a pregnancy is complicated by a diagnosis of AL, clinicians face a complex dilemma: to balance risking... Read More about A prospective registry-based cohort study of the diagnosis and management of acute leukaemia in pregnancy: Study protocol.

Experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST): a nested qualitative study (2021)
Journal Article
Srikesavan, C., Toye, F., Brealey, S., Goodchild, L., Northgraves, M., Charalambous, C. P., Rangan, A., & Lamb, S. (2021). Experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST): a nested qualitative study. BMJ open, 11(6), Article e040829. https://doi.org/10.1136/bmjopen-2020-040829

Objectives To explore the experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST), a multicentre randomised controlled trial that compared manipulation under anaesthesia (MUA), arthros... Read More about Experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST): a nested qualitative study.

A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults (2021)
Journal Article
Flett, L., Adamson, J., Barron, E., Brealey, S., Corbacho, B., Costa, M. L., Gedney, G., Giotakis, N., Hewitt, C., Hugill-Jones, J., Hukins, D., Keding, A., McDaid, C., Mitchell, A., O'carroll, G., Parker, A., Scantlebury, A., Stobbart, L., Torgerson, D., Turner, E., …Sharma, H. (2021). A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults. Bone & Joint Open, 2(3), 150-163. https://doi.org/10.1302/2633-1462.23.BJO-2020-0178

Aims A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outco... Read More about A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults.

A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): Study protocol (2021)
Journal Article
Northgraves, M., Cohen, J., Allgar, V., Currow, D., Hart, S., Hird, K., Hodge, A., Johnson, M., Mason, S., Swan, F., & Hutchinson, A. (2021). A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): Study protocol. ERJ Open Research, 7(1), Article 00955-2020. https://doi.org/10.1183/23120541.00955-2020

Introduction: Chronic breathlessness, persistent and disabling despite optimal treatment of underlying causes, is a prevalent and frightening symptom and is associated with many emergency presentations and admission to hospital. Breathlessness manage... Read More about A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): Study protocol.

Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST three-arm RCT (2020)
Journal Article
Brealey, S., Northgraves, M., Kottam, L., Keding, A., Corbacho, B., Goodchild, L., Srikesavan, C., Rex, S., Charalambous, C. P., Hanchard, N., Armstrong, A., Brooksbank, A., Carr, A., Cooper, C., Dias, J., Donnelly, I., Hewitt, C., Lamb, S. E., McDaid, C., Richardson, G., …Rangan, A. (2020). Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST three-arm RCT. Health Technology Assessment, 24(71), 1-161. https://doi.org/10.3310/hta24710

Background Frozen shoulder causes pain and stiffness. It affects around 10% of people in their fifties and is slightly more common in women. Costly and invasive surgical interventions are used, without high-quality evidence that these are effective.... Read More about Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST three-arm RCT.

Surgical fixation compared with cast immobilisation for adults with a bicortical fracture of the scaphoid waist: the SWIFFT RCT (2020)
Journal Article
Dias, J., Brealey, S., Cook, L., Fairhurst, C., Hinde, S., Leighton, P., Choudary, S., Costa, M., Hewitt, C., Hodgson, S., Jefferson, L., Jeyapalan, K., Keding, A., Northgraves, M., Palmer, J., Rangan, A., Richardson, G., Taub, N., Tew, G., Thompson, J., & Torgerson, D. (2020). Surgical fixation compared with cast immobilisation for adults with a bicortical fracture of the scaphoid waist: the SWIFFT RCT. Health Technology Assessment, 24(52), 1-234. https://doi.org/10.3310/hta24520

Participants: Adults (aged ≥ 16 years) presenting within 2 weeks of injury with a clear, bicortical fracture of the scaphoid waist on plain radiographs. Interventions: Early surgical fixation using Conformité Européenne-marked headless compression sc... Read More about Surgical fixation compared with cast immobilisation for adults with a bicortical fracture of the scaphoid waist: the SWIFFT RCT.

Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial (2020)
Journal Article
Ahrens, P., Baldwick, C., Bidwai, A., Butt, A., Candal-Couto, J., Crowther, M., Malal, J. G., Drew, S., Garg, S., Hawken, R., Kelly, C., Kent, M., Kumar, K., Lawrence, T., Little, C., Macleod, I., Motkur, P., Matthews, T., Venateswaran, B., McClelland, D., …Toye, F. (2020). Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial. Lancet, 396(10256), 977-989. https://doi.org/10.1016/S0140-6736%2820%2931965-6

© 2020 The Author(s). Publishedx by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Background: Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, bu... Read More about Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial.

Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial (2020)
Journal Article
Dias, J., Brealey, S., Fairhurst, C., Amirfeyz, R., Bhowal, B., Blewitt, N., Brewster, M., Brown, D., Choudhary, S., Coapes, C., Cook, L., Costa, M., Davis, T., DisMascio, L., Giddins, G., Hedley, H., Hewitt, C., Hinde, S., Hobby, J., Hodgson, S., …Warwick, D. (2020). Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial. Lancet, 396(10248), 390-401. https://doi.org/10.1016/S0140-6736%2820%2930931-4

Background
Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non... Read More about Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.

Management of adults with primary frozen shoulder in secondary care: the UK FROST randomised controlled trial with economic evaluation (2020)
Journal Article
Brealey, S., Northgraves, M., Kottam, L., Keding, A., Corbacho, B., Goodchild, L., Srikesevan, C., Rex, S., Charalambous, C., Hanchard, N., Armstrong, A., Brooksbank, A., Carr, A., Cooper, C., Dias, J., Donnelly, I., Hewitt, C., Lamb, S., McDaid, C., Richardson, G., …Rangan, A. (in press). Management of adults with primary frozen shoulder in secondary care: the UK FROST randomised controlled trial with economic evaluation. Health Technology Assessment,

Timing of electronic reminders did not improve trial participant questionnaire response: a randomized trial and meta-analyses (2020)
Journal Article
Partha Sarathy, P., Kottam, L., Mitchell, A., Parker, A., Brealey, S., Coleman, E., Northgraves, M., Torgerson, D., Rangan, A., & Keding, A. (2020). Timing of electronic reminders did not improve trial participant questionnaire response: a randomized trial and meta-analyses. Journal of clinical epidemiology, 122, 70-77. https://doi.org/10.1016/j.jclinepi.2020.03.001

Objectives: The objective of this study was to assess whether timing of short messaging service (SMS) reminders improved postal questionnaire return rates from participants in a randomized controlled trial (RCT). Study Design and Setting: A Study Wit... Read More about Timing of electronic reminders did not improve trial participant questionnaire response: a randomized trial and meta-analyses.

Feasibility of a novel exercise prehabilitation programme in patients scheduled for elective colorectal surgery: a feasibility randomised controlled trial (2019)
Journal Article
Northgraves, M. J., Arunachalam, L., Madden, L. A., Marshall, P., Hartley, J. E., MacFie, J., & Vince, R. V. (2019). Feasibility of a novel exercise prehabilitation programme in patients scheduled for elective colorectal surgery: a feasibility randomised controlled trial. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, https://doi.org/10.1007/s00520-019-05098-0

© 2019, The Author(s). Background and objectives: To investigate the feasibility of delivering a functional exercise-based prehabilitation intervention and its effects on postoperative length of hospital stay, preoperative physical functioning and he... Read More about Feasibility of a novel exercise prehabilitation programme in patients scheduled for elective colorectal surgery: a feasibility randomised controlled trial.

Effectiveness of surgical fixation for lateral compression type one (LC-1) fragility fractures of the pelvis: a systematic review (2019)
Journal Article
Booth, A., Ingoe, H. M. A., Northgraves, M., Coleman, E., Harden, M., Kassam, J., Kwok, I., Hilton, C., Bates, P., & McDaid, C. (2019). Effectiveness of surgical fixation for lateral compression type one (LC-1) fragility fractures of the pelvis: a systematic review. BMJ open, 9(5), Article e024737. https://doi.org/10.1136/bmjopen-2018-024737

© 2019 Author(s). Objectives: To undertake a systematic review of the evidence base for the effectiveness of surgical fixation of lateral compression (LC-1) fragility fractures of the pelvis compared with non-surgical approaches. Searches: MEDLINE, E... Read More about Effectiveness of surgical fixation for lateral compression type one (LC-1) fragility fractures of the pelvis: a systematic review.

Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial. (2019)
Journal Article
Cook, L., Northgraves, M. J., Fairhurst, C., Ronaldson, S., Torgerson, D. J., Kent, J., & Reed, M. (2019). Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial. Trials, 20(1), Article 261. https://doi.org/10.1186/s13063-019-3344-1

Background: Data from a feasibility study suggest that the use of an inelastic, short-stretch compression bandage following total knee arthroplasty is a safe technique that may improve patient-reported health outcomes, and that it is feasible to recr... Read More about Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial..

Study reporting guidelines : how valid are they? (2019)
Journal Article
Arundel, C., James, S., Northgraves, M., & Booth, A. (2019). Study reporting guidelines : how valid are they?. Contemporary clinical trials communications, 14, Article 100343. https://doi.org/10.1016/j.conctc.2019.100343

Reporting guidelines help improve the reporting of specific study designs, and clear guidance on the best approaches for developing guidelines is available. The methodological strength, or validation of guidelines is however unclear. This article exp... Read More about Study reporting guidelines : how valid are they?.

Tissue inflammation signatures point towards resolution in adhesive capsulitis (2019)
Journal Article
Dakin, S. G., Rangan, A., Martinez, F., Brealey, S., Northgraves, M., Kottam, L., Cooper, C., Buckley, C. D., & Carr, A. J. (2019). Tissue inflammation signatures point towards resolution in adhesive capsulitis. Rheumatology, 58(6), 1109–1111. https://doi.org/10.1093/rheumatology/kez007

Proresolving receptors, macrophage and fibroblast activation point towards a resolving inflammatory milieu in adhesive capsulitis.

Exercise prehabilitation in elective intra-cavity surgery: A role within the ERAS pathway? A narrative review (2018)
Journal Article
Orange, S. T., Northgraves, M. J., Marshall, P., Madden, L. A., & Vince, R. V. (2018). Exercise prehabilitation in elective intra-cavity surgery: A role within the ERAS pathway? A narrative review. International journal of surgery, 56, 328-333. https://doi.org/10.1016/j.ijsu.2018.04.054

The Enhanced Recovery after Surgery (ERAS) model integrates several elements of perioperative care into a standardised clinical pathway for surgical patients. ERAS programmes aim to reduce the rate of complications, improve surgical recovery, and lim... Read More about Exercise prehabilitation in elective intra-cavity surgery: A role within the ERAS pathway? A narrative review.

Remote or on-site visits were feasible for the initial setup meetings with hospitals in a multicenter surgical trial: an embedded randomized trial (2018)
Journal Article
Jefferson, L., Fairhurst, C., Brealey, S., Coleman, E., Cook, L., Hewitt, C., Keding, A., Northgraves, M., Rangan, A., Tew, G. A., Torgerson, D. J., & Dias, J. (2018). Remote or on-site visits were feasible for the initial setup meetings with hospitals in a multicenter surgical trial: an embedded randomized trial. Journal of clinical epidemiology, 100, 13-21. https://doi.org/10.1016/j.jclinepi.2018.04.011

© 2018 Elsevier Inc. Objectives: To investigate the effects, costs, and feasibility of providing on-site compared with remote meetings to set up hospital sites in a multicenter, surgical randomized controlled trial. Study Design and Setting: Hospital... Read More about Remote or on-site visits were feasible for the initial setup meetings with hospitals in a multicenter surgical trial: an embedded randomized trial.

United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial. (2017)
Journal Article
Brealey, S., Armstrong, A., Brooksbank, A., Carr, A., Charalambous, C., Cooper, C., Corbacho, B., Dias, J., Donnelly, I., Goodchild, L., Hewitt, C., Keding, A., Kottam, L., Lamb, S. E., McDaid, C., Northgraves, M., Richardson, G., Rodgers, S., Shah, S., Sharp, E., …Rangan, A. (2017). United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial. Trials, 18(1), Article 614. https://doi.org/10.1186/s13063-017-2352-2

Background: Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects a... Read More about United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial..