Dr Ines Rombach

Population Health, School of Medicine and Population Health

Senior Research Fellow/ Statistician

i.rombach@sheffield.ac.uk
+44 114 222 0840

Room 2023, Sheffield Clinical Trials Research Unit (CTRU), Regent Court (ScHARR)

Full contact details

Dr Ines Rombach
Population Health, School of Medicine and Population Health
Room 2023, Sheffield Clinical Trials Research Unit (CTRU)
Regent Court (ScHARR)
30 Regent Street
Sheffield
S1 4DA

Profile

As a statistician within the CTRU in ScHARR, I am involved in all aspects of clinical trials. I contribute statistical expertise to the development of grant applications and to the planning, conduct, analysis and reporting of randomised controlled trials.

I have experience of working on trials in orthopaedics, surgery, and complex interventions.

Research interests: My research interests include the handling and reporting of missing data in randomised clinical trials, the use of patient reported outcomes and surgical trials methodology.

Publications

Journal articles

McLeod G, Seeley J, Wilson M, Hind D, Cole A, Hewson D, Hyslop M, Keetharuth A, MacFarlane A, Wilby M , McKendrick M et al (2024) Development and validation of metrics for assessment of ultrasound-guided fascial block skills☆. British Journal of Anaesthesia.
Watson M, Tillett W, Jadon D, Massa MS, Francis A, Gullick N, Rombach I, Sinomati Y, Tucker L & Coates LC (2024) The protocol of a clinical effectiveness trial comparing standard step-up care, early combination DMARD therapy and early use of TNF inhibitors for the treatment of moderate to severe psoriatic arthritis: the 3-arm parallel group SPEED randomized controlled trial. Therapeutic Advances in Musculoskeletal Disease, 16.
Arshad MF, Walkinshaw E, Solomon AL, Bernjak A, Rombach I, Little SA, Shaw JAM, Heller SR & Iqbal A (2024) Diabetic autonomic neuropathy does not impede improvement in hypoglycaemia awareness in adults: Sub-study results from the HypoCOMPaSS trial. Diabetic Medicine. View this article in WRRO
Bamford E, Berntsson H, Beale S, Desoysa L, Dias J, Hamer-Kiwacz S, Hind D, Johnson N, Loban A, Molloy K , Morvan E et al (2024) Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs. Trials, 25(1). View this article in WRRO
Stafford T, Rombach I, Hind D, Mateen B, Woods HB, Dimario M & Wilsdon J (2023) Where next for partial randomisation of research funding? The feasibility of RCTs and alternatives. Wellcome Open Research, 8. View this article in WRRO
Abhishek A, Peckham N, Pade C, Gibbons JM, Cureton L, Francis A, Barber V, Williams JAE, Appelbe D, Eldridge L , Julier P et al (2023) Effect of a 2-week interruption in methotrexate treatment on COVID-19 vaccine response in people with immune-mediated inflammatory diseases (VROOM study): a randomised, open label, superiority trial. The Lancet Rheumatology.
Dakin H, Rombach I, Dritsaki M, Gray A, Ball C, Lamb SE & Nanchahal J (2022) Cost-effectiveness of adalimumab for early-stage Dupuytren’s disease. Bone & Joint Open, 3(11), 898-906.
UK TAVI Trial Investigators , Toff WD, Hildick-Smith D, Kovac J, Mullen MJ, Wendler O, Mansouri A, Rombach I, Abrams KR, Conroy SP , Flather MD et al (2022) Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis : a randomized clinical trial. Journal of the American Medical Association, 327(19), 1875-1887.
Abhishek A, Boyton RJ, McKnight Á, Coates L, Bluett J, Barber VS, Cureton L, Francis A, Appelbe D, Eldridge L , Julier P et al (2022) Effects of temporarily suspending low-dose methotrexate treatment for 2 weeks after SARS-CoV-2 vaccine booster on vaccine response in immunosuppressed adults with inflammatory conditions: protocol for a multicentre randomised controlled trial and nested mechanistic substudy (Vaccine Response On/Off Methotrexate (VROOM) study). BMJ Open, 12(5).
Nanchahal J, Ball C, Rombach I, Williams L, Kenealy N, Dakin H, O'Connor H, Davidson D, Werker P, Dutton SJ , Feldmann M et al (2022) Anti-tumour necrosis factor therapy for early-stage Dupuytren's disease (RIDD): a phase 2b, randomised, double-blind, placebo-controlled trial. The Lancet Rheumatology, 4(6), E407-E416.
Rombach I, Wang K, Tonner S, Grabey J, Harnden A & Wolstenholme J (2022) Quality of life, healthcare use and costs in ‘at-risk’ children after early antibiotic treatment versus placebo for influenza-like illness : within-trial descriptive economic analyses of the ARCHIE randomised controlled trial. BMJ Open, 12(4).
Brook MO, Hester J, Petchey W, Rombach I, Dutton S, Bottomley MJ, Black J, Abdul-Wahab S, Bushell A, Lombardi G , Wood K et al (2022) Transplantation Without Overimmunosuppression (TWO) study protocol: a phase 2b randomised controlled single-centre trial of regulatory T cell therapy to facilitate immunosuppression reduction in living donor kidney transplant recipients. BMJ Open, 12(4).
Hamilton TW, Knight R, Stokes JR, Rombach I, Cooper C, Davies L, Dutton SJ, Barker KL, Cook J, Lamb SE , Murray DW et al (2022) Efficacy of liposomal bupivacaine and bupivacaine hydrochloride vs bupivacaine hydrochloride alone as a periarticular anesthetic for patients undergoing knee replacement : a randomized clinical trial. JAMA Surgery, 157(6), 481-489.
Sooriakumaran P, Wilson C, Rombach I, Hassanali N, Aning J, D. Lamb A, Cathcart P, Eden C, Ahmad I, Rajan P , Sridhar A et al (2022) Feasibility and safety of radical prostatectomy for oligo‐metastatic prostate cancer: the Testing Radical prostatectomy in men with prostate cancer and oligo‐Metastases to the bone (TRoMbone) trial. BJU International, 130(1), 43-53.
Rombach I, Tucker L, Tillett W, Jadon D, Watson M, Francis A, Sinomati Y, Dutton SJ & Coates LC (2022) Clinical effectiveness of symptomatic therapy compared with standard step-up care for the treatment of low-impact psoriatic oligoarthritis: the two-arm parallel group randomised POISE feasibility study. Therapeutic Advances in Musculoskeletal Disease, 14.
Dean BJF, Collins J, Thurley N, Rombach I & Bennell K (2021) Exercise therapy with or without other physical therapy interventions versus placebo interventions for osteoarthritis - systematic review. Osteoarthritis and Cartilage Open, 3(3).
Turner EL, Platt AC, Gallis JA, Tetreault K, Easter C, McKenzie JE, Nash S, Forbes AB, Hemming K, Adrion C , Akooji N et al (2021) Completeness of reporting and risks of overstating impact in cluster randomised trials: a systematic review. The Lancet Global Health, 9(8), e1163-e1168.
Rombach I, Tillett W, Jadon D, Tucker L, Watson M, Francis A, Sinomati Y, Eldridge L, Dritsaki M, Dutton SJ , Al-Mossawi H et al (2021) Treating to target in psoriatic arthritis: assessing real-world outcomes and optimising therapeutic strategy for adults with psoriatic arthritis—study protocol for the MONITOR-PsA study, a trials within cohorts study design. Trials, 22.
Rombach I, Iftikhar M, Jhuti GS, Gustavsson A, Lecomte P, Belger M, Handels R, Castro Sanchez AY, Kors J, Hopper L , Olde Rikkert M et al (2021) Obtaining EQ-5D-5L utilities from the disease specific quality of life Alzheimer’s disease scale: development and results from a mapping study. Quality of Life Research, 30(3), 867-879.
Rombach I, Knight R, Peckham N, Stokes JR & Cook JA (2020) Current practice in analysing and reporting binary outcome data—a review of randomised controlled trial reports. BMC Medicine, 18.
McMeekin N, Geue C, Briggs A, Rombach I, Li HK, Bejon P, McNally M, Atkins BL, Ferguson J & Scarborough M (2020) Cost-effectiveness of oral versus intravenous antibiotics (OVIVA) in patients with bone and joint infection : evidence from a non-inferiority trial. Wellcome Open Research, 4.
Gwilym S, Sansom L, Rombach I, Dutton SJ, Achten J & Costa ML (2020) Woodcast versus standard casting material for the immobilization of nonoperatively treated distal radial fractures. The Bone & Joint Journal, 102-B(1), 48-54.
Scarborough M, Li HK, Rombach I, Zambellas R, Walker AS, McNally M, Atkins B, Kümin M, Lipsky BA, Hughes H , Bose D et al (2019) Oral versus intravenous antibiotics for bone and joint infections: the OVIVA non-inferiority RCT. Health Technology Assessment, 23(38).
Palmer AJR, Ayyar Gupta V, Fernquest S, Rombach I, Dutton SJ, Mansour R, Wood S, Khanduja V, Pollard TCB, McCaskie AW , Barker KL et al (2019) Arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of symptomatic femoroacetabular impingement: multicentre randomised controlled trial. BMJ: British Medical Journal, 364.
Li H-K, Rombach I, Zambellas R, Walker AS, McNally MA, Atkins BL, Lipsky BA, Hughes HC, Bose D, Kümin M , Scarborough C et al (2019) Oral versus intravenous antibiotics for bone and joint infection. New England Journal of Medicine, 380(5), 425-436.
Rombach I, Merritt N, Shirkey BA, Rees JL, Cook JA, Cooper C, Carr AJ, Beard DJ & Gray AM (2019) Cost-effectiveness analysis of a placebo-controlled randomized trial evaluating the effectiveness of arthroscopic subacromial decompression in patients with subacromial shoulder pain. Bone and Joint Journal, 101-B(1), 55-62.
Rombach I, Gray AM, Jenkinson C, Murray DW & Rivero-Arias O (2018) Multiple imputation for patient reported outcome measures in randomised controlled trials : advantages and disadvantages of imputing at the item, subscale or composite score level. BMC Medical Research Methodology, 18(1).
Jepson M, Elliott D, Conefrey C, Wade J, Rooshenas L, Wilson C, Beard D, Blazeby JM, Birtle A, Halliday A , Stein R et al (2018) An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment. Journal of Clinical Epidemiology, 99, 75-83.
Rombach I, Jenkinson C, Gray A, Murray D & Rivero-Arias O (2018) Comparison of statistical approaches for analyzing incomplete longitudinal patient-reported outcome data in randomized controlled trials. Patient Related Outcome Measures, 9, 197-209.
Beard DJ, Rees JL, Cook JA, Rombach I, Cooper C, Merritt N, Shirkey BA, Donovan JL, Gwilym S, Savulescu J , Moser J et al (2018) Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. The Lancet, 391(10118), 329-338.
Palmer A, Fernquest S, Rombach I, Park D, Pollard T, Broomfield J, Bangerter N, Carr A & Glyn-Jones S (2017) Diagnostic and prognostic value of delayed Gadolinium Enhanced Magnetic Resonance Imaging of Cartilage (dGEMRIC) in early osteoarthritis of the hip. Osteoarthritis and Cartilage, 25(9), 1468-1477.
Wartolowska KA, Feakins BG, Collins GS, Cook J, Judge A, Rombach I, Dean BJF, Smith JA & Carr AJ (2016) The magnitude and temporal changes of response in the placebo arm of surgical randomized controlled trials: a systematic review and meta-analysis. Trials, 17.
Hopewell S, Boutron I, Altman DG, Barbour G, Moher D, Montori V, Schriger D, Cook J, Gerry S, Omar O , Dutton P et al (2016) Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial. BMC Medicine, 14.
Wartolowska K, Collins GS, Hopewell S, Judge A, Dean BJF, Rombach I, Beard DJ & Carr AJ (2016) Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review. BMJ Open, 6(3), e010194-e010194.
Rombach I, Rivero-Arias O, Gray AM, Jenkinson C & Burke Ó (2016) The current practice of handling and reporting missing outcome data in eight widely used PROMs in RCT publications: a review of the current literature. Quality of Life Research, 25(7), 1613-1623.
Palmer AJR, Ayyar-Gupta V, Dutton SJ, Rombach I, Cooper CD, Pollard TC, Hollinghurst D, Taylor A, Barker KL, McNally EG , Beard DJ et al (2014) Protocol for the Femoroacetabular Impingement Trial (FAIT). Bone & Joint Research, 3(11), 321-327.
Kynaston-Pearson F, Ashmore AM, Malak TT, Rombach I, Taylor A, Beard D, Arden NK, Price A, Prieto-Alhambra D, Judge A , Carr AJ et al (2013) Primary hip replacement prostheses and their evidence base: systematic review of literature. BMJ, 347(dec19 2), f6956-f6956.
Palmer AJR, Thomas GER, Pollard TCB, Rombach I, Taylor A, Arden N, Beard DJ, Andrade AJ, Carr AJ & Glyn-Jones S (2013) The feasibility of performing a randomised controlled trial for femoroacetabular impingement surgery. Bone & Joint Research, 2(2), 33-40.
Collinson F, Brown J, McCabe C, Brown J, Tubeuf S, Potrata B, Hewison J, Rombach I, Selby P, Olivier C , Howard H et al (2011) The STAR trial: can quality of life benefit offset any survival detriment?. Trials, 12(S1).
Bada ES, Gardner AC, Ahuja S, Beard DJ, Window P & Foster NE () Lumbar spine fusion surgery versus best conservative care for patients with severe, persistent low back pain. Bone & Joint Open, 5(7), 612-620.
Hamdy FC, Lamb AD, Tullis IDC, Verrill C, Rombach I, Rao SR, Colling R, Barber PR, Volpi D, Barbera-Martin L , Lopez JF et al () First-in-man study of the PSMA Minibody IR800-IAB2M for molecularly targeted intraoperative fluorescence guidance during radical prostatectomy. European Journal of Nuclear Medicine and Molecular Imaging.
Howard A, Woods A, Rombach I, Achten J, Appelbe D, Athwal A, Jones E, Draper K & Gwilym S () SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain. Pilot and Feasibility Studies, 10(1).
Glyn-Jones S, Javaid MK, Beard D, Newton J, Kerslake R, McBryde C, Board T, Dutton SJ, Dritsaki M, Khanduja V , Akanni M et al () Assessing a 12-month course of oral alendronate for adults with avascular necrosis of the hip: MANTIS RCT with internal pilot. Health Technology Assessment, 26(43), 1-58.
McMeekin N, Geue C, Briggs A, Rombach I, Li HK, Bejon P, McNally M, Atkins BL, Ferguson J & Scarborough M () Cost-effectiveness of oral versus intravenous antibiotics (OVIVA) in patients with bone and joint infection: evidence from a non-inferiority trial. Wellcome Open Research, 4, 108-108.
McMeekin N, Geue C, Briggs A, Rombach I, Li HK, Bejon P, McNally M, Atkins BL, Ferguson J & Scarborough M () Cost-effectiveness of oral versus intravenous antibiotics (OVIVA) in patients with bone and joint infection: evidence from a non-inferiority trial. Wellcome Open Research, 4, 108-108.
McMeekin N, Geue C, Briggs A, Rombach I, Li HK, Bejon P, McNally M, Atkins BL, Ferguson J & Scarborough M () Cost-effectiveness of oral versus intravenous antibiotics (OVIVA) in patients with bone and joint infection: evidence from a non-inferiority trial. Wellcome Open Research, 4, 108-108.

Conference proceedings papers

Abhishek A, Peckham N, Pade C, Gibbons J, Cureton L, Francis A, Barber V, Williams J, Appelbe D, Eldridge L , Julier P et al (2023) Two-week Break in Methotrexate Treatment and COVID-19 Vaccine Response. Results of the Vaccine Response on off Methotrexate (VROOM) Study, an Open Label, Prospective, Two-arm Parallel-group, Multi-center, Superiority, Randomized Controlled Trial. ARTHRITIS & RHEUMATOLOGY, Vol. 75 (pp 3331-3333)
Velikova G, Valderas JM, Potter C, Batchelder L, A’Court C, Baker M, Bostock J, Coulter A, Fitzpatrick R, Forder J , Fox D et al (2017) Proceedings of Patient Reported Outcome Measure’s (PROMs) Conference Oxford 2017: Advances in Patient Reported Outcomes Research. Health and Quality of Life Outcomes, Vol. 15(S1)
Croudace T, Brazier J, Gutacker N, Street A, Robotham D, Waterman S, Rose D, Satkunanathan S, Wykes T, Nasr N , Enderby P et al (2016) Proceedings of Patient Reported Outcome Measure’s (PROMs) Conference Sheffield 2016: advances in patient reported outcomes research. Health and Quality of Life Outcomes, Vol. 14(Suppl 1), 9 June 2016 - 9 June 2016.

Other

(2019) Partial Oral Therapy for Osteomyelitis and Endocarditis. New England Journal of Medicine, 381(12), 1182-1184.

Preprints

Bamford E, Berntsson H, Beale S, Desoysa L, Dias J, Hamer-Kiwacz S, Hind D, Johnson N, Loban A, Molloy K , Morvan E et al (2024) Flexor Injury Rehabilitation Splint Trial (FIRST): Protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs, Research Square Platform LLC.

Professional activities and memberships: I am involved in Data Monitoring and Safety Committees as the independent statistician and regularly teach a variety of topics, including aspects of clinical trial design, and statistical concepts.