Study of peri-articular anaesthetic for replacement of the knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine by Knight, R, Poulton, L, Strickland, L, Hamilton, T, Beard, D, Cook, J, Dutton, S, Leal, J, Lamb, S, Cooper, C, Barker, K, Murray, D, Pandit, H

“…</p> <p><strong>Methods:</strong> SPAARK is a patient-blinded, multi-centre, active comparator, superiority, two-arm, parallel-group, randomised controlled trial. …”

Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain predominant stage protocol for a multi-centre, randomised, double blind, parallel group, feasibility trial by Hopewell, S, Kenealy, N, Knight, R, Rangan, A, Dutton, S, Srikesavan, C, Feldmann, M, Lamb, S, Nanchahal, J

Beta Agonist Lung Injury TrIal-2 (BALTI-2) trial protocol: a randomised, double-blind, placebo-controlled of intravenous infusion of salbutamol in the acute respiratory distress syndrome. by Perkins, G, Gates, S, Lamb, S, McCabe, C, Young, D, Gao, F

“…The Beta Agonist Lung Injury TrIal (BALTI-2) is a multicentre, pragmatic, randomised, double-blind, placebo-controlled clinical trial which aims to determine if sustained treatment with intravenous (IV) salbutamol will improve survival in ARDS. …”

Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial by Schlüssel, M, Keene, D, Wagland, S, Alsousou, J, Lamb, S, Willett, K, Dutton, S

“…</p> <h4>Methods</h4> <p>PATH-2 is a pragmatic, parallel-group, multi-centre, double-blinded, randomised, placebo-controlled, superiority trial. …”

The administration of intermittent parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: a protocol for a prospective mixed method pilot study with randomisation of treatment allocation and blinded assessment (FRACTT) by Chesser, T, Fox, R, Harding, K, Greenwood, R, Javaid, K, Barnfield, S, Halliday, R, Willett, K, Lamb, S

“…Functional outcomes will be assessed at 6 weeks and 12 weeks. Blinded assessment will be used to minimise the effect of bias of an open label study design. …”

Beta-Agonist Lung injury TrIal-2 (BALTI-2): a multicentre, randomised, double-blind, placebo-controlled trial and economic evaluation of intravenous infusion of salbutamol versus placebo in patients with acute respiratory distress syndrome. by Gates, S, Perkins, G, Lamb, S, Kelly, C, Thickett, DR, Young, J, McAuley, D, Snaith, C, McCabe, C, Hulme, C, Gao Smith, F

Beta-Agonist Lung injury TrIal-2 (BALTI-2): a multicentre, randomised, double-blind, placebo-controlled trial and economic evaluation of intravenous infusion of salbutamol versus placebo in patients with acute respiratory distress syndrome. by Gates, S, Perkins, G, Lamb, S, Kelly, C, Thickett, DR, Young, J, McAuley, D, Snaith, C, McCabe, C, Hulme, C, Gao Smith, F

Study protocol: A multi-centre, double blind, randomised, placebo-controlled, parallel group, phase II trial (RIDD) to determine the efficacy of intra-nodular injection of anti-TNF to control disease progression in early Dupuytren’s disease, with an embedded dose response study by Nanchahal, J, Ball, C, Swettenham, J, Dutton, S, Barber, V, Black, J, Copsey, B, Dritsaki, M, Taylor, P, Gray, A, Feldmann, M, Lamb, S

Platelet rich Plasma in Achilles Tendon Healing 2 (PATH-2) trial: protocol for a multicentre, participant and assessor-blinded, parallel-group randomised clinical trial comparing platelet-rich plasma (PRP) injection versus placebo injection for Achilles tendon rupture by Alsousou, J, Keene, D, Hulley, P, Harrison, P, Wagland, S, Byrne, C, Maia Schlussel, M, Dutton, S, Lamb, S, Willett, K

“…All participants will be blinded to the intervention and will receive standardised rehabilitation to reduce efficacy interference.…”

Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial by Smith, TO, Parsons, S, Ooms, A, Dutton, S, Fordham, B, Garrett, A, Hing, C, Lamb, S

“…<br><br> <strong>Randomisation and blinding</strong> Initial 75 participants were randomised 1:1 before changing the allocation ratio to 2:1 (experimental:usual care). …”

Exercise for people with a fragility fracture of the pelvis or lower limb: A systematic review of interventions evaluated in clinical trials and reporting quality by Keene, D, Forde, C, Sugavanam, T, Williams, M, Lamb, S

“…Trials would be improved by consistent blinded outcome assessor use and with consensus on which mobility outcomes should be assessed.…”

Neuromuscular stimulation of the quadriceps muscle after hip fracture: a randomized controlled trial. by Lamb, S, Oldham, J, Morse, R, Evans, J

“… OBJECTIVE: To study the feasibility and effect of neuromuscular stimulation on recovery of mobility after surgical fixation for hip fracture. DESIGN: Double-blind study with stratified randomization. SETTING: Home-based rehabilitation program. …”

Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation by Gates, S, Lall, R, Quinn, T, Deakin, C, Cooke, M, Horton, J, Lamb, S, Slowther, A, Woollard, M, Carson, A, Smyth, M, Wilson, K, Parcell, G, Rosser, A, Whitfield, R, Williams, A, Jones, R, Pocock, H, Brock, N, Black, J, Wright, J, Han, K, Shaw, G, Blair, L, Marti, J, Hulme, C, McCabe, C, Nikolova, S, Ferreira, Z, Perkins, G

“…Ambulance dispatch staff and those collecting the primary outcome were blind to treatment allocation. Blinding of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. …”

The Beta Agonist Lung Injury TrIal (BALTI)--prevention trial protocol. by Perkins, G, Park, D, Alderson, D, Cooke, M, Gao, F, Gates, S, Lamb, S, Mistry, D, Thickett, DR

“…METHODS/DESIGN: The Beta Agonist Lung Injury TrIal (prevention) is a multi-centre, randomised, double blind, placebo-controlled trial. The aim of the trial is to determine in patients undergoing elective transthoracic oesphagectomy, if treatment with inhaled salmeterol 100 mcg twice daily started at induction of anaesthesia and continued for 72 hours thereafter compared to placebo affect the incidence of early acute lung injury and other clinical, resource and patient focused outcomes. …”

A randomized controlled trial of exercise to improve mobility and function after elective knee arthroplasty. Feasibility, results and methodological difficulties. by Frost, H, Lamb, S, Robertson, S

“…OBJECTIVE: To assess the feasibility of comparing two types of exercise regime aiming to improve mobility and function following knee arthroplasty. DESIGN: A single-blind randomized controlled trial. SUBJECTS: Patients with primary, unilateral knee osteoarthritis undergoing elective knee joint replacement. …”

Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial. by Barker, K, Javaid, M, Newman, M, Minns Lowe, C, Stallard, N, Campbell, H, Gandhi, V, Lamb, S

“…The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. …”

Pre-hospital assessment of the role of adrenaline: Measuring the effectiveness of drug administration in cardiac arrest (PARAMEDIC-2): Trial protocol by Perkins, G, Quinn, T, Deakin, C, Nolan, J, Lall, R, Slowther, A, Cooke, M, Lamb, S, Petrou, S, Achana, F, Finn, J, Jacobs, I, Carson, A, Smyth, M, Han, K, Byers, S, Rees, N, Whitfield, R, Moore, F, Fothergill, R, Stallard, N, Long, J, Hennings, S, Horton, J, Kaye, C, Gates, S

“…This is a pragmatic, individually randomised, double blind, controlled trial with a parallel economic evaluation. …”

Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention--ISRCTN89936343. by Adams, J, Bridle, C, Dosanjh, S, Heine, P, Lamb, S, Lord, J, McConkey, C, Nichols, V, Toye, F, Underwood, MR, Williams, M, Williamson, E

“…The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. …”

TIDieR-Placebo: a guide and checklist for reporting placebo and sham controls by Howick, J, Webster, RK, Rees, JL, Turner, R, Macdonald, H, Price, A, Evers, AWM, Bishop, F, Collins, GS, Bokelmann, K, Hopewell, S, Knottnerus, A, Lamb, S, Madigan, C, Napadow, V, Papanikitas, AN, Hoffmann, T

“…The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. …”

The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgica... by Keene, D, Mistry, D, Nam, J, Tutton, E, Handley, R, Morgan, L, Roberts, E, Gray, B, Briggs, A, Lall, R, Chesser, T, Pallister, I, Lamb, S, Willett, K

“…MAIN OUTCOME MEASURES: Follow-up was conducted at 6 weeks and, by blinded outcome assessors, at 6 months after randomisation. …”