Publications 2023 to Date

2024

[A2B] Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): Protocol for a mixed methods process evaluation of a randomised controlled trialAitken, L. M., Emerson, L. M., Kydonaki, K., Blackwood, B., Creagh-Brown, B., Lone, N. I., McKenzie, C., Reade, M. C., Weir, C. J., Wise, M. P. & Walsh, T. S., 5 Apr 2024, In: BMJ Open. 14, 4, 7 p., e081637.

[ABC Sepsis] Gray AJ, Oatey K, Grahamslaw J, Irvine S, Cafferkey J, Kennel T, Norrie J, Walsh T, Lone N, Horner D, Appelboam A, Hall P, Skipworth RJE, Bell D, Rooney K, Shankar-Hari M, Corfield AR; Albumin, Balanced, and Crystalloid-Sepsis (ABC-Sepsis) Investigators. Albumin Versus Balanced Crystalloid for the Early Resuscitation of Sepsis: An Open Parallel-Group Randomized Feasibility Trial. The ABC-Sepsis Trial. Crit Care Med. 2024 Jun 24. doi: 10.1097/CCM.0000000000006348. 

[CARE] Addressing barriers and identifying facilitators to support informed consent and recruitment in the Cavernous malformations A Randomised Effectiveness (CARE) pilot phase trial: insights from the integrated QuinteT recruitment intervention (QRI)Wade, J., Farrar, N., Realpe, A. X., Donovan, J. L., Forsyth, L., Harkness, K. A., Hutchinson, P. J. A., Kitchen, N., Lewis, S. C., Loan, J. J. M., Stephen, J., Al-Shahi salman, R. & The CARE pilot trial collaboration, 18 Apr 2024, In: EClinicalMedicine. 71, p. 102557

[CARE] CARE pilot trial collaboration. Medical management and surgery versus medical management alone for symptomatic cerebral cavernous malformation (CARE): a feasibility study and randomised, open, pragmatic, pilot phase trial. Lancet Neurol 18 Apr 2024; 23: 565–76. https://doi.org/10.1016/S1474-4422(24)00096-6

[DAShED] McLatchie R, Reed MJ, Freeman N, Parker RA, Wilson S, Goodacre S, Cowan A, Boyle J, Clarke B, Clarke E. Diagnosis of Acute Aortic Syndrome in the Emergency Department (DAShED) study: an observational cohort study of people attending the emergency department with symptoms consistent with acute aortic syndrome. Emergency Medicine Journal. 2024 Mar 1;41(3):136-44.

[EVOLVED] Loganath K, Craig NJ, Everett RJ, Bing R, Tsampasian V, Molek P, Botezatu S, Aslam S, Lewis S, Graham C, White AC, MacGillivray T, Tuck CE; Rayson P, Cranley D, Irvine S, Armstrong R, Milne L, Chin CWL, Hillis GS, Fairbairn T, Greenwood JP, Steeds R, Leslie SJ, Lang CC, Bucciarelli-Ducci C, Joshi NV, Kunadian V, Vassiliou VS, Dungu JN, Hothi SS, Boon N, Prasad SK, Keenan NG, Dawson D, Treibel TA, Motwani M, Miller CA, Mills NL, Rajani R, Ripley DP, McCann GP, Prendergast B, Singh A, Newby DE, Dweck MR; for the EVOLVED investigators. Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis: The EVOLVED Randomized Clinical Trial. JAMA 2024. doi:10.1001/jama.2024.22730

[MND-SMART] Safety and efficacy of memantine and trazodone versus placebo for motor neuron disease (MND SMART): stage two interim analysis from the first cycle of a phase 3, multiarm, multistage, randomised, adaptive platform trial. Pal S, Chataway J, Swingler R, Macleod MR, Carragher NO, Hardingham G, Selvaraj BT, Smith C, Wong C, Newton J, Lyle D, Stenson A, Dakin RS, Ihenacho A, Colville S, Mehta AR, Stallard N, Carpenter JR, Parker RA, Keerie C, Weir CJ, Virgo B, Morris S, Waters N, Gray B, MacDonald D, MacDonald E, Parmar MKB, Chandran S; MND SMART Investigators. Lancet Neurol. 2024 Sep 19:S1474-4422(24)00326-0. doi: 10.1016/S1474-4422(24)00326-0. Online ahead of print.

[OPPORTUNITY] A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, and topical and oral analgesia (OPPORTUNITY): a two-centre, open-label, randomised controlled feasibility trial. Simpson, A. H. R. W., Clement, N. D., Simpson, S. A., Pandit, H., Smillie, S., Leeds, A. R., Conaghan, P. G., Kingsbury, S. R., Hamilton, D., Craig, P., Ray, D., Keerie, C., Kinsella, E., Bell-Higgs, A., McGarty, A., Beadle, C., Howie, C. R. & Norrie, J., 26 Feb 2024, (E-pub ahead of print) In: The Lancet Rheumatology.

[PIONEER] Hazelton C, Todhunter-Brown A, Campbell P, Thomson K, Nicolson DJ, McGill K, et al. Interventions for people with perceptual disorders after stroke: the PIONEER scoping review, Cochrane systematic review and priority setting project. Health Technol Assess 2024;28(69)

[PROGRAM A] Protocol for a pilot cluster randomised controlled trial of PRoGRAM-A (Preventing gambling-related harm in adolescents): A secondary school-based social network interventionDobbie, F., Wardle, H., Dahlby, L., Weir, C. J., Niven, A., Stoddart, A., Griffiths, D., Noble, L. & White, J., 13 Aug 2024, In: Pilot and Feasibility Studies. 10, p. 1-11 11 p., 109.

[PROSPECT] Adjuvant radiotherapy omission in early breast cancer: the PROSPECT trialKunkler, I., Cameron, D., Dixon, M. & Williams, L., 8 Aug 2024, In: Lancet (London, England). 404, 10452, P525.

[RACE-IT] Rapid Acute Coronary Syndrome Evaluation Over One Hour With High-Sensitivity Cardiac Troponin I: A United States-Based Stepped-Wedge, Randomized TrialRACE-IT Research Group, Mills, N. L., Keerie, C. & McCord, J., 15 Jun 2024, (E-pub ahead of print) In: Annals of Emergency Medicine. 10 p.

[RadiotypeDX] Postoperative radiotherapy in women with early operable breast cancer (Scottish Breast Conservation Trial): 30-year update of a randomised, controlled, phase 3 trial.  Williams LJ, Kunkler IH, Taylor KJ, Dunlop J, Piper T, Caldwell J, Jack W, Loane JF, Elder K, Bartlett JMS, Dixon JM, Cameron DA. Lancet Oncology 2024. Doi:10.1016/S1470-2045(24)00347-4

[SCOT-HEART2] Rationale and Design of SCOT-HEART 2 Trial: CT Angiography for the Prevention of Myocardial Infarction. McDermott, M., Meah, M. N., Khaing, P., Wang, K-L., Ramsay, J., Scott, G., Rickman, H., Burt, T., Mcgowan, I., Fairbairn, T., Bucukoglu, M., Bull, R., Timmis, A., Van Beek, E. J. R., Roditi, G., Adamson, P. D., Lewis, S., Norrie, J., Mckinstry, B., Guthrie, B., & 5 others, 10 Jul 2024, (E-pub ahead of print) In: JACC: Cardiovascular Imaging.

[STOPPIT3] Study protocol: a randomised placebo-controlled trial of antenatal corticosteroids for planned birth in twins (STOPPIT-3).Murray, S. R., Thompson, J., Townsend, R. C., Deidda, M., Boyd, K. A., Norman, J., Norrie, J., Boardman, J. P., Luyt, K., Khalil, A., Bick, D., Reed, K., Denton, J., Fenwick, N., Keerie, C., Reynolds, R. & Stock, S. J., 18 Jan 2024, In: BMJ Open. 14, p. 1-6

[THRIVE] Evaluating pharmacological THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment across NHS and private clinics in the UK: a multi-centre, assessor-blind, randomised controlled trial-THRIVE trial. Machin M, Whittley S, Norrie J, Burgess L, Hunt BJ, Bolton L, Shalhoub J, Everington T, Gohel M, Whiteley MS, Rogers S, Onida S, Turner B, Nandhra S, Lawton R, Stephens-Boal A, Singer C, Dunbar J, Carradice D, Davies AH. BMJ Open. 2024 Feb 17;14(2):e083488. doi: 10.1136/bmjopen-2023-083488.

[ZIPP] Prophylactic zoledronic acid therapy to prevent or modify Paget’s disease of bone progression in adults with SQSTM1 mutations: the ZiPP RCTPhillips, J., Subedi, D., Lewis, S. C., Keerie, C. & Ralston, S. H., 28 Jun 2024, In: Efficacy and Mechanism Evaluation. 11, 10, 78 p.

Feasibility of forecasting future critical care bed availability using bed management data. Palmer, J., Manataki, A., Moss, L., Neilson, A. & Lo, T-Y. M., 19 Aug 2024, In: BMJ Health & Care Informatics. 31, 1, 7 p., e101096.

Postoperative radiotherapy in women with early operable breast cancer (Scottish Breast Conservation Trial): 30-year update of a randomised, controlled, phase 3 trial. Williams, L. J., Kunkler, I., Taylor, K., Dunlop, J., Piper, T., Caldwell, J., Jack, W., Loane, J., Elder, K., Bartlett, J., Dixon, M. & Cameron, D. A., 7 Aug 2024, (E-pub ahead of print) In: The Lancet Oncology. 9 p.

Ethical Considerations in Public Engagement: Developing Tools for Assessing the Boundaries of Research and Involvement. Garcia Iglesias, J., Beange, I., Davidson, D. J., Goopy, S., Huang, H., Murray, F., Porteous, C., Stevenson, E., Rhodes, S., Watson, F. & Fletcher-Watson, S., 7 Aug 2024, In: Research Involvement and Engagement. 10, 8 p., 83.

Reporting of surrogate endpoints in randomised controlled trial protocols: The SPIRIT-Surrogate extension checklist with explanation and elaborationManyara, A. M., Davies, P., Stewart, D., Weir, C. J., Young, A. E., Blazeby, J. M., Butcher, N. J., Bujkiewicz, S., Chan, A-W., Dawoud, D., Offringa, M., Ouwens, M., Hróbjartssson, A., Amstutz, A., Bertolaccini, L., Bruno, V. D., Devane, D., Faria, C. DCM., Gilbert, P. B., Harris, R., & 16 others, 9 Jul 2024, In: British Medical Journal (BMJ). 386, 19 p., e078525.

Reporting of surrogate endpoints in randomised controlled trial reports: the CONSORT-Surrogate extension checklist with explanation and elaborationManyara, A. M., Davies, P., Stewart, D., Weir, C. J., Young, A. E., Blazeby, J. M., Butcher, N. J., Bujkiewicz, S., Chan, A-W., Dawoud, D., Offringa, M., Ouwens, M., Hróbjartssson, A., Amstutz, A., Bertolaccini, L., Bruno, V. D., Devane, D., Faria, C. DCM., Gilbert, P. B., Harris, R., & 16 others, 9 Jul 2024, In: British Medical Journal (BMJ). 386, 18 p., e078524.

REALITIES in health disparities: Researching evidence-based alternatives in living, imaginative, traumatised, integrated, embodied systemsDe Andrade, M. & The REALITIES Consortium, 19 Jun 2024, In: Frontiers in public health. p. 1-19 19 p.

Rodriguez A, Lewis SC, Eldridge S, Jackson T, Weir CJ. A survey on UK researchers’ views regarding their experiences with the de-identification, anonymisation, release methods and re-identification risk estimation for clinical trial datasets. Clinical Trials 2024

Link: A survey on UK researchers’ views regarding their experiences with the de-identification, anonymisation, release methods and re-identification risk estimation for clinical trial datasets 

Effectiveness of an extended-role general practitioner clinic for patients with persistent physical symptoms: the Multiple Symptoms Study 3 randomised controlled trial.Burton, C., Mooney, C., Sutton, L., White, D., Dawson, J., Neilson, A., Rowlands, G., Thomas, S., Horspool, M., Fryer, K., Greco, M., Sanders, T., Thom, R. E., Cooper, C., Turton, E., Waheed, W., Woodward, J., Mallender, E. & Deary, V., 15 Jun 2024, In: The Lancet. 403, 10444, p. 2619-2629 11 p.

Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial. Burton, C., Mooney, C., Sutton, L., White, D., Dawson, J., Neilson, A. R., Rowlands, G., Thomas, S., Horspool, M., Fryer, K., Greco, M., Sanders, T., Thomas, R. E., Cooper, C., Turton, E., Waheed, W., Woodward, J., Mallender, E. & Deary, V., 15 Jun 2024, In: Lancet (London, England). 403, 10444, p. 2619-2629 11 p.

Measuring the impact of maternal critical care admission on short- and longer-term maternal and birth outcomesMasterson, J., Adamestam, I., Beatty, M., Boardman, J. P., Chislett, L., Johnston, P., Joss, J., Lawrence, H., Litchfield, K., Plummer, N., Rhode, S., Walsh, T. S., Wise, A., Wood, R., Weir, C. J. & Lone, N. I., 7 Jun 2024, In: Intensive Care Medicine. 50, p. 890-900 11 p.

Is rapid acute coronary syndrome evaluation with high-sensitivity cardiac troponin less costly? An economic evaluation. Danagoulian, S., Miller, J., Cook, B., Gunaga, S., Fadel, R., Gandolfo, C., Mills, N. L., Modi, S., Mahler, S., Levy, P., Parikh, S., Krupp, S., Abdul-Nour, K., Klausner, H., Rockoff, S., Gindi, R., Lewandowski, A., Hudson, M., Perrotta, G., Zweig, B., & 9 others, 2 Apr 2024, In: Journal of the American College of Emergency Physicians Open. 5, 2, 8 p., e13140.

Comparison of neurodevelopmental, educational and adulthood socioeconomic outcomes in offspring of women with and without epilepsy: A systematic review and meta-analysisMazzone, P., Hogg, K. M., Weir, C. J., Stephen, J., Bhattacharya, S., Richer, S. & Chin, R. F. M., Apr 2024, In: Seizure - European Journal of Epilepsy. 117, p. 213-221

Socioeconomic Status in Adulthood of Children With and Without a history of seizures: A Retrospective Cohort Study. Mazzone, P., Weir, C. J., Stephen, J., Bhattacharya, S. & Chin, R., Apr 2024, In: Epilepsy & Behavior. 153, 109705.

Uniform or Sex-Specific Cardiac Troponin Thresholds to Rule-out Myocardial Infarction at Presentation. Li, Z., Wereski, R., Anand, A., Lowry, M. TH., Doudesis, D., Mcdermott, M., Ferry, A. V., Tuck, C., Chapman, A. R., Lee, K. K., Shah, A. SV., Mills, N. L., Kimenai, D. M., Akinlade, O. M., Barker, S., Blades, J., Boeddinghaus, J., Bularga, A., De Bakker, M., Chapman, A. R., & 163 others, 25 Mar 2024, In: Journal of the American College of Cardiology.

Efficacy of oral corticosteroids for acute preschool wheeze: a systematic review and individual participant data meta-analysis of randomised clinical trials. Lee, B., Turner, S., Borland, M., Csonka, P., Grigg, J., Guilbert, T., Jartti, T., Oommen, A., Twynam-Perkins, J., Lewis, S. C. & Cunningham, S., 22 Mar 2024, In: The Lancet Respiratory Medicine.

Assessing catastrophic health expenditure and impoverishment in adult asthma care: a cross-sectional study of patients attending six public health clinics in Klang District, Malaysia. Hussein, N., Ng, C., Ramli, R., Su May, L., Hanafi, N. S., Lee, P. Y., Cheong, A. T., Ghazali, S. S., Pinnock, H., Stoddart, A., Schwarze, J. & Khoo, E. M., 12 Mar 2024, In: BMC Health Services Research. 24, 9 p., 327.

The Rise of Adaptive Platform Trials in Critical Care. PRACTICAL, PANTHER, TRAITS, INCEPT, and REMAP-CAP investigators, Bos, L. D. J., Calfee, C., Castellvi-Font, A., Cornelius, V., Derde, L. PG., Docherty, A. B., Fan, E., Ferguson, N., Goligher, E., Gordon, A. C., Granholm, A., Harhay, M. O., Heath, A., Norregaard Kjaer, M-B., Lawler, P. R., Lone, N. I., McAuley, D. F., Møller, M. H., Munshi, L., & 11 others, 1 Mar 2024, In: American Journal of Respiratory and Critical Care Medicine. 209, 5, p. 491-496 6 p.

Three-year cost utility analysis of mini versus standard slings: A trial based economic evaluation. Kilonzo M, Boyers D, Cooper D, Davidson T, Bhal K, N'Dow J, MacLennan G, Norrie J, Abdel-Fattah M. BJUI Compass. 2023 Nov 13;5(2):230-239. doi: 10.1002/bco2.303. eCollection 2024 Mar.

[Methodology] Cook, J.A., Parker, R.A. Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials. Trials 25, 161 (2024).

Link: Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials 

[Methodology] Stocken DD, Mossop H, Armstrong E, Lewis S, Dutton SJ, Peckitt C, Gamble C, Brown J. Good Statistical Practice – development of tailored Good Clinical Practice training for Statisticians. Trials 2024;25(113). 

Link: Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians 

[PhD Student] Mazzone P, Weir CJ, Stephen J, Bhattacharya S, Chin R. Socioeconomic Status in Adulthood of Children With and Without a history of seizures: A Retrospective Cohort Study. Epilepsy & Behavior 2024;153:109705.

[PhD Student] Krasauskaite J, Conway B, Weir C, Huang Z, Price J. Exploration of metabolomic markers associated with declining kidney function in people with type 2 diabetes mellitus. Journal of the Endocrine Society. 2024;8:bvad166.

Forbes S, Halpin A, Lam A, Grynoch D, Parker R, Hidalgo L, Bigam D, Anderson B, Dajani K, Kin T, O'Gorman D. 

Islet transplantation outcomes in type 1 diabetes and transplantation of HLA-DQ8/DR4: results of a single-centre retrospective cohort in Canada. EClinicalMedicine. 2024 Jan 1;67.

Primary care transformation in Scotland: qualitative evaluation of the views of general practitioners and multidisciplinary team staff membersDonaghy, E., Huang, H., Henderson, D., Wang, H., Guthrie, B. & Mercer, S. W., 1 Jan 2024, In: British Journal of General Practice Open (BJGP Open). 74, 738, p. e1-e8 8 p.

2023

[Stand-up for Health] Sivaramakrishnan D, Baker G, Parker RA, Manner J, Lloyd S, Jepson R (2023) A mixed method evaluation of a theory based intervention to reduce sedentary behaviour in contact centres- the stand up for health stepped wedge feasibility study. PLoS ONE 18(12): e0293602. https://doi.org/10.1371/journal.pone.0293602

[CCBOC] Rabbi Chowdhury F, Shaw S, Abu Sayeed A, Roy S, Rahman AS, Zafrin N, Tarafder P, Rashid MH, Ghose A, Chakraborty SR, Rahman MK. Effectiveness of calcium channel blockade for organophosphorus and carbamate pesticide poisoning–study protocol for an open label, pragmatic, 3-arm RCT repurposing two widely available medicines. Toxicology Communications. 2023 Dec 31;7(1):2272073.

[Methodology] Parker RA. The unblinding of statisticians in clinical trials: commentary on Iflaifel et al., Trials 2023. Trials. 2023 Sep 11;24(1):579.

[Methodology] Parker RA, Cook JA. The importance of clinical importance when determining the target difference in sample size calculations. Trials. 2023 Aug 4;24(1):495.

[MND-SMART] Parker RA, Weir CJ, Pham TM, White IR, Stallard N, Parmar MK, Swingler RJ, Dakin RS, Pal S, Chandran S. Statistical analysis plan for the motor neuron disease systematic multi-arm adaptive randomised trial (MND-SMART). Trials. 2023 Dec;24(1):1-5.

[MS-SMART] John NA, Solanky BS, De Angelis F, Parker RA, Weir CJ, Stutters J, Carrasco FP, Schneider T, Doshi A, Calvi A, Williams T. Longitudinal metabolite changes in progressive multiple sclerosis: a study of 3 potential neuroprotective treatments. Journal of Magnetic Resonance Imaging. 2023 Oct 3.

Thokala P, Goodacre S, Oatey K, et al Cost-effectiveness of rapid assessment of potential ischaemic heart disease with CT coronary angiography Heart Published Online First: 26 January 2023. doi: 10.1136/heartjnl-2022-321211

Current definitions of advanced multimorbidity: a protocol for a scoping review Bowers, S. P., Black, P., Mccheyne, L., Wilson, D., Mills, S. E. E., Agrawal, U., Williams, L., Quirk, F. & Bowden, J., 30 Nov 2023, In: BMJ Open. 13, 11, 5 p., e076903.

Evaluation of the association of area-level socioeconomic deprivation and breast cancer recurrence by oestrogen receptor subtypes in Scotland. Dunlop, H. M., Williams, L. J., Hall, P. S., Barber, M., Dodds, C. & Figueroa, J. D., 3 Oct 2023, In: Breast Cancer Research. 25, 1, 13 p., 106.

[A2B] Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK. Walsh TS, Aitken LM, McKenzie CA, Boyd J, Macdonald A, Giddings A, Hope D, Norrie J, Weir C, Parker RA, Lone NI, Emerson L, Kydonaki K, Creagh-Brown B, Morris S, McAuley DF, Dark P, Wise MP, Gordon AC, Perkins G, Reade M, Blackwood B, MacLullich A, Glen R, Page VJ. BMJ Open. 2023 Dec 10;13(12):e078645. doi: 10.1136/bmjopen-2023-078645. PMID: 38072483

[ASPIRED] Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study. Matthew J Reed, Neil Grubb, Chris Lang, Steve Goodacre, Rachel O’Brien, Christopher J Weir, Praveen Thokala, Nicola Freeman, Caroline Blackstock, Lynn Dinsmore, Julia Boyd, Imad Adamestam, Pam Macrae, Robert Hannigan, Trudie Lobban. BMJ Open: Reed MJ, et al. BMJ Open Feb 2023;13:e069530. doi:10.1136/bmjopen-2022-069530

[CARDIAC CARE] Henriksen PA, Hall P, Macpherson IR, Joshi SS, Singh T, Maclean M, Lewis S, Rodriguez A, Fletcher A, Everett RJ, Stavert H, Broom A, Eddie L, Primrose L, McVicars H, McKay P, Borley A, Rowntree C, Lord S, Collins G, Radford J, Guppy A, Williams MC, Japp A, Payne J, Newby D, Mills N, Oikonomidou O, Lang N. Multicenter prospective randomized controlled trial of high-sensitivity cardiac troponin I-guided combination angiotensin receptor blockade and beta-blocker therapy to prevent anthracycline cardiotoxicity: the Cardiac CARE trial. Circulation 2023

Link: Multicenter, Prospective, Randomized Controlled Trial of High-Sensitivity Cardiac Troponin I–Guided Combination Angiotensin Receptor Blockade and Beta-Blocker Therapy to Prevent Anthracycline Cardiotoxicity: The Cardiac CARE Trial 

[CARE] Loan JMJ, Bacon A, van Beijnum J, Bhatt P, Bjornson A, Broomes N, Bullen A, Bulters D, Cahill J, Chavredakis E, Colombo F, Danciut M, Digpal R, Edwards RJ, Ferguson L, Forsyth L, Fouyas I, Ganesan V, Grover P, Gurusinghe N, Hall PS, Harkness K, Harris LS, Hayton T, Helmy A, Holsgrove D, Hutchinson PJ, Israni A, Kinsella E, Lewis S, Majeed S, Mallucci C, Mukerji N, Nair R, Neilson AR, Papadopoulos MC, Radatz M, Rossdeutsch A, Raza-Knight S, Stephen J, Stoddart A, Teo M, Turner C, Wade J, Walsh D, White D, White P, Wildman J, Wroe Wright O, Uff C, Ushewokunze S, Vindlacheruvu R, Kitchen N, Al-Shahi Salman R. Feasibility of comparing medical management and surgery (with neurosurgery or stereotactic radiosurgery) with medical management alone in people with symptomatic brain cavernoma – protocol for the Cavernomas: A Randomised Effectiveness (CARE) pilot trial. BMJ Open Aug 2023, 13 (8) e075187; DOI: 10.1136/bmjopen-2023-075187

[COBIN] The importance of long-term follow-up in clinical trials. Norrie J.  Lancet Glob Health. 2023 Jul;11(7):e995-e996. doi: 10.1016/S2214-109X(23)00244-9. PMID: 37349045 No abstract available.

Link: The importance of long-term follow-up in clinical trials

[COCROACH] Salman R, Stephen J, Tierney JF, Lewis SC, Newby DE, Parry-Jones AR et al. Effects of oral anticoagulation in people with atrial fibrillation after spontaneous intracranial haemorrhage (COCROACH): prospective, individual participant data meta-analysis of randomised trials. The Lancet Neurology 2023 DOI https://doi.org/10.1016/S1474-4422(23)00315-0

[ESPRIT2] Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial. Mackenzie SC, Stephen J, Williams L, Daniels J, Norrie J, Becker CM, Byrne D, Cheong Y, Clark TJ, Cooper KG, Cox E, Doust AM, Fernandez P, Hawe J, Holland T, Hummelshoj L, Jackson LJ, King K, Maheshwari A, Martin DC, Sutherland L, Thornton J, Vincent K, Vyas S, Horne AW, Whitaker LHR.  Trials. 2023 Jun 22;24(1):425. doi: 10.1186/s13063-023-07386-x. PMID: 37349849 Free PMC article.

Link: Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial

[Methodology] Definitions, acceptability, limitations, and guidance in the use and reporting of surrogate endpoints in trials: A scoping review. 

Manyara AM, Davies P, Stewart D, Weir CJ, Young AE, Wells V, Blazeby J, Butcher NJ, Bujkiewicz S, Chan AW, Collins GS, Dawoud D, Offringa M, Ouwens M, Ross JS, Taylor RS, Ciani O.

J Clin Epidemiol. 2023 Jun 26:S0895-4356(23)00160-9. doi: 10.1016/j.jclinepi.2023.06.013. Online ahead of print.

PMID: 37380118 Review.

[Methodology] Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study. Solovyeva O, Dimairo M, Weir CJ, Hee SW, Espinasse A, Ursino M, Patel D, Kightley A, Hughes S, Jaki T, Mander A, Evans TRJ, Lee S, Hopewell S, Rantell KR, Chan AW, Bedding A, Stephens R, Richards D, Roberts L, Kirkpatrick J, de Bono J, Yap C. BMC Med. 2023 Jul 5;21(1):246. doi: 10.1186/s12916-023-02937-0.

PMID: 37408015 Free PMC article. Review.

[Methodology] Gamble C, Lewis S, Stocken D, Juszczak E, Bradburn M, Doré C, Kean S. Determining a risk-proportionate approach to the validation of statistical programming for clinical trials. Clinical Trials. 2023. doi:10.1177/17407745231204036

[PIONEER] Interventions for Perceptual Disorders in Stroke: A Systematic Review

Hazelton C, Thomson K, Todhunter-Brown A, Campbell P, Chung CSY, Dorris L, Gillespie DC, Hunter SM, Mcgill K, Nicolson DJ, Williams LJ, Brady MC, 6 Apr 2023, In: Stroke.

[PREFFIR] Moss A, Daghem M, Tzolos E, Meah MN, Wang K-L, Bularga A, Adamson PD, Kwiecinski J, Fletcher A, Dawson D, Arumugam P, Sabharwal N, Greenwood JP, Townend J, Calvert PA, Rudd JHF, Berman D, Verjans J, Slomka P, Dey D, Forsyth L, Murdoch L, Lee RJ, Lewis S, Mills NL, van Beek EJR, Williams MC, Dweck MR, Newby DE on behalf of the PRE18FFIR Investigators. Coronary Atherosclerotic Plaque Activity and Future Coronary Events. JAMA Cardiol. Published online June 28, 2023. doi:10.1001/jamacardio.2023.1729

[PREPARE] In-hospital mortality risk stratification in children aged under 5 years with pneumonia with or without pulse oximetry: A secondary analysis of the Pneumonia REsearch Partnership to Assess WHO REcommendations (PREPARE) dataset

Pneumonia REsearch Partnership to Assess WHO REcommendations (PREPARE) study group, Hooli, S., King, C., McCollum, E. D., Colbourn, T., Lufesi, N., Mwansambo, C., Gregory, C. J., Thamthitiwat, S., Cutland, C., Madhi, S. A., Nunes, M. C., Gessner, B. D., Hazir, T., Mathew, J. L., Addo-Yobo, E., Chisaka, N., Hassan, M., Hibberd, P. L., Jeena, P., & 53 others, 1 Apr 2023, In: International Journal of Infectious Diseases. 129, p. 240-250 11 p.

[PRIME2] Kunkler IH, Williams LJ, Jack WJL, Cameron DA, Dixon JM. Breast-Conserving Surgery with or without Irradiation in Early Breast Cancer. NEJM 2023; 388: 585-594. DOI 10.1056/NEJMoa2207586

[ZIPP] Philips J, Subedi D, Lewis SC, Keerie C, Cronin O, Porteous M, Moore D, Cetnarskyj R, Ranganath L, Selby PL, Turgut T, Hampson G, Chandra R, Ho S, Tobias J, Young-Min S, McKenna M, Crowley RK, Fraser WD, Tang JCY, Gennari L, Nuti R, Brandi ML, Del Pino-Montes J, Devogelaer JP, Durnez A, Isaia GC, Di Stefano M, Guanabens N, Rubio JB, Seibel MJ, Walsh JP, Rea S, Kotowicz MA, Nicholson GCC, Duncan EL, Major G, Horne A, Gilchrist N, Ralston SH. Randomised trial of genetic testing and targeted intervention to prevent the development and progression of Paget’s disease of bone. In press Annals of Rheumatic Diseases 2023 doi:10.1136/ard-2023-2249902024.

[LACI-2] Wardlaw JM, Woodhouse LJ, Mhlanga II, Oatey K, Heye AK, Bamford J, Cvoro V, Doubal FN, England T, Hassan A, Montgomery A, O'Brien JT, Roffe C, Sprigg N, Werring DJ, Bath PM; Lacunar Intervention Trial-2 (LACI-2) Investigator Group. Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease: The Lacunar Intervention Trial-2 (LACI-2) Randomized Clinical Trial. JAMA Neurol. 2023 Jul 1;80(7):682-692. doi: 10.1001/jamaneurol.2023.1526. PMID: 37222252; PMCID: PMC10209826.

[ePAMS+] Trotter NE, Slight SP, Karimi R, Bates DW, Sheikh A, Weir CJ, Tolley CL. The effect of digital antimicrobial stewardship programmes on antimicrobial usage, length of stay, mortality and cost. Informatics in Medicine Unlocked 2023;37:101183.

[ePAMS+] Weir CJ, Adamestam I, Sharp R, Ennis H, Heed A, Williams R, Cresswell KM, Dogar O, Pontefract SK, Coleman JJ, Lilford RJ, Watson N, Slee A, Chuter A, Beggs J, Slight S, Mason J, Yardley L, Sheikh A. A complex ePrescribing-based Anti-Microbial Stewardship (ePAMS+) intervention for hospitals combining technological and behavioural components: protocol for a feasibility trial. Pilot and Feasibility Studies 2023;9:18.

[Methodology] Espinasse A, Solovyeva O, Dimairo M, Weir CJ, Jaki T, Mander A, Kightley A, Evans J, Lee SM, Bedding A, Hopewell S, Rantell K, Liu R, Chan A-W, de Bono J, Yap C. SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: the DEFINE (DosE FIndiNg Extensions) study protocol. BMJ Open 2023;13:e068173.

[PhD Student] Mazzone P, Hogg KM, Weir CJ, Stephen J, Bhattacharya S, Chin R. Comparison of perinatal outcomes for women with and without epilepsy: A systematic review and meta-analysis JAMA Neurology 2023;80:484-494.

[ePAMS+] Cresswell KM, Anderson S, Montgomery C, Weir CJ, Atter M, Williams R. Evaluation of digitalisation in healthcare and the quantification of the “unmeasurable”.

Journal of General Internal Medicine. 2023.

[Methodology] Yap C, Rekowski J, Ursino M, Solovyeva O, Patel D, Dimairo M, Weir CJ, Chan A-W, Jaki T, Mander A, Evans TRJ, Peck R, Hayward KS, Calvert M, Rantell KR, Lee S, Kightley A, Hopewell S, Ashby D, Garrett-Mayer E, Isaacs J, Golub R, Kholmanskikh O, Richards DP, Boix O, Matcham J, Seymour L, Ivy SP, Marshall LV, Hommais A, Liu R, Tanaka Y, Berlin J, Espinasse A, de Bono J. Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance. BMJ 2023;383:e076386.

[Methodology] Yap C, Solovyeva O, de Bono J, Rekowski J, Patel D, Jaki T, Mander A, Evans TRJ, Peck R, Hayward KS, Hopewell S, Ursino M, Rantell KR, Calvert M, Lee S, Kightley A, Ashby D, Chan A-W, Garrett-Mayer E, Isaacs JD, Golub R, Kholmanskikh O, Richards D, Boix O, Matcham J, Seymour L, Ivy SP, Marshall LV, Hommais A, Liu R, Tanaka Y, Berlin J, Espinasse A, Dimairo M, Weir CJ. Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance. BMJ 2023;383:e076387.

[Methodology] Ciani O, Manyara AM, Davies P, Stewart D, Weir CJ, Young AE, Blazeby J, Butcher NJ, Bujkiewicz S, Chan A-W, Dawoud D, Offringa M, Ouwens M, Hróbjartssson A, Amstutz A, Bertolaccini L, Bruno VD, Devane D, Faria CDCM, Gilbert PB, Harris R, Lassere M, Marinelli L, Markham S, Powers JH, Rezaei Y, Richert L, Schwendicke F, Tereshchenko LG, Thoma A, Turan A, Worrall A, Christensen R, Collins GS, Ross JS, Taylor RS. A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials. EClinicalMedicine 2023;65:102283.

[TOPaZ] Hald JD, Keerie C, Weir CJ, Javaid MK, Lam W, Osborne P, Walsh J, Langdahl BL, Ralston SH. Protocol of a randomised trial of teriparatide followed by zoledronic acid to reduce fracture risk in adults with osteogenesis imperfecta. BMJ Open 2023;13:e078164.