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Associate Professor Pollyanna Hardy BSc, MSc

Director of NPEU Clinical Trials Unit pollyanna.hardy@npeu.ox.ac.uk

Biography

Pollyanna Hardy is Clinical Trialist and Director of the National Perinatal Epidemiology Unit Clinical Trials Unit (NPEU CTU).

Polly graduated from the University of Sussex in 1990 with a BSc in Mathematics and European Studies, and obtained an MSc in Statistics from University of Sheffield in 1994. She has previously worked as a medical statistician at the London School of Hygiene and Tropical Medicine and the Murdoch Children's Research Institute in Melbourne, Australia. Polly joined the NPEU CTU as a Senior Statistician in 2010. In 2017 she then took up a post as a Statistics Lead at the Birmingham Clinical Trials Unit, University of Birmingham, where she spent four years working on a diverse portfolio of Randomised Controlled Trials (RCT), including perinatology, global surgery, mental health and health services delivery. She then returned to the NPEU in 2021 as Director of the CTU.

Polly has extensive experience in the design, conduct, analysis and reporting of RCTs, with a keen interest in complex RCT design methodology, and has particular expertise in RCTs in the field of obstetrics and neonatology. She is the statistics lead for the National Institute for Health Research Global Health Research Unit on Global Surgery RCT portfolio, and a member of a national Steering Group to develop a set of principles for handling end of follow-up events in clinical trials research (PeRSEVERE). She also currently sits on the NIHR Health Technology Assessment Commissioning Board.

Publications

  • Biro MA, Sutherland GA, Yelland JS, Hardy P, Brown SJ. In-Hospital Formula Supplementation of Breastfed Babies: A Population-Based Survey. Birth. 2011;38(4):302-10.
    http://dx.doi.org/10.1111/j.1523-536X.2011.00485.x
  • Birthplace in England Collaborative Group, Brocklehurst P, Hardy P, Hollowell J, Linsell L, Macfarlane A, McCourt C, Marlow N, Miller A, Newburn M, Petrou S, Puddicombe D, Redshaw M, Rowe R, Sandall J, Silverton L, Stewart M. Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study. British Medical Journal. 2011;343.
    http://www.bmj.com/content/343/bmj.d7400
  • Hollowell J, Puddicombe D, Rowe R, Linsell L, Hardy P, Stewart M, Redshaw M, Newburn M, McCourt C, Sandall J, Macfarlane A, Silverton L, Brocklehurst P, Birthplace in England Collaborative Group obo. The Birthplace national prospective cohort study: perinatal and maternal outcomes by planned place of birth. Birthplace in England research programme. Final report part 4: NIHR Service Delivery and Organisation programme. 2011.
    http://www.netscc.ac.uk/hsdr/files/project/SDO_FR4_08-1604-140_V03.pdf
  • Group CC, Abalos E, Oyarzun E, Addo V, Sharma JB, Matthews J, Oyieke J, Masood SN, El Sheikh MA, Brocklehurst P, Farrell B, Gray S, Hardy P, Jamieson N, Juszczak E, Spark P. CORONIS - International study of caesarean section surgical techniques: the follow-up study. BMC Pregnancy Childbirth. 2013;13:215.
    http://www.ncbi.nlm.nih.gov/pubmed/24261693
  • The CORONIS Collaborative Group, Ablos E, Addo V, Brocklehurst P, El Sheikh M, Farrell B, Gray S, Hardy P, Juszczak E, Mathews JE, Masood SN, Oyarzun E, Oyieke J, Sharma JB, Spark P. Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial. The Lancet. 2013;382(9888):234-48.
    http://www.ncbi.nlm.nih.gov/pubmed/23721753
  • Brocklehurst P, Abalos E, Farrell B, Hardy P. The CORONIS trial on caesarean section - Authors reply. The Lancet. 2016;388(10052):1373-4.
    http://dx.doi.org/10.1016/S0140-6736(16)31654-3
  • Costeloe K, Hardy P, Juszczak E, Wilks M, Millar MR, Probiotics in Preterm Infants Study Collaborative G. Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial. Lancet. 2016;387(10019):649-60.
    http://www.ncbi.nlm.nih.gov/pubmed/26628328
  • Costeloe KL, Bowler U, Brocklehurst P, Hardy P, Heal P, Juszczak E, King A, Panton N, Stacey F, Whiley A, Wilks M, Millar MR. A randomised controlled trial of the probiotic Bifidobacterium breve BBG-001 in preterm babies to prevent sepsis, necrotising enterocolitis and death: the Probiotics in Preterm infants (PiPS) trial. Health Technol Assess. 2016;20(66).
    http://journalslibrary.nihr.ac.uk/hta/hta20660
  • Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. The Lancet. 2016;387(10015):239-50.
    http://www.ncbi.nlm.nih.gov/pubmed/26507180
  • Hardy P, Bell JL, Brocklehurst P. Evaluation of the effects of an offer of a monetary incentive on the rate of questionnaire return during follow-up of a clinical trial: a randomised study within a trial. BMC Medical Research Methodology. [journal article]. 2016;16(1):82.
    http://dx.doi.org/10.1186/s12874-016-0180-9
  • Edwards AD, Redshaw ME, Kennea N, Rivero-Arias O, Gonzales-Cinca N, Nongena P, Ederies M, Falconer S, Chew A, Omar O, Hardy P, Harvey ME, Eddama O, Hayward N, Wurie J, Azzopardi D, Rutherford MA, Counsell S. Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation. Archives of Disease in Childhood - Fetal and Neonatal Edition. 2017;103(1):F15-F21.
    https://www.ncbi.nlm.nih.gov/pubmed/28988160
  • Millar M, Seale J, Greenland M, Hardy P, Juszczak E, Wilks M, Panton N, Costeloe K, Wade WG. The Microbiome of Infants Recruited to a Randomised Placebo-controlled Probiotic Trial (PiPS Trial). EBioMedicine. 2017;20:255-62.
    https://www.ncbi.nlm.nih.gov/pubmed/28571671
  • Bick D, Briley A, Brocklehurst P, Hardy P, Juszczak E, Lynch L, MacArthur C, Moore P, Nolan M, Rivero-Arias O, Sanders J, Shennan A, Wilson M. A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: clinical effectiveness and an economic evaluation (BUMPES). 2017 Contract No.: 65.
    https://www.ncbi.nlm.nih.gov/pubmed/29110753
  • Chappell LC, Chambers J, Dixon PH, Dorling J, Hunter R, Bell JL, Bowler U, Hardy P, Juszczak E, Linsell L, Rounding C, Smith A, Williamson C, Thornton JG. Ursodeoxycholic acid versus placebo in the treatment of women with intrahepatic cholestasis of pregnancy (ICP) to improve perinatal outcomes: protocol for a randomised controlled trial (PITCHES). Trials. [journal article]. 2018;19(1):657.
    https://doi.org/10.1186/s13063-018-3018-4
  • Chappell LC, Brocklehurst P, Green ME, Hunter R, Hardy P, Juszczak E, Linsell L, Chiocchia V, Greenland M, Placzek A, Townend J, Marlow N, Sandall J, Shennan A, Group PS. Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial. Lancet. 2019;394(10204):1181-90.
    https://www.ncbi.nlm.nih.gov/pubmed/31472930
  • Chappell LC, Green M, Marlow N, Sandall J, Hunter R, Robson S, Bowler U, Chiocchia V, Hardy P, Juszczak E, Linsell L, Placzek A, Brocklehurst P, Shennan A. Planned delivery or expectant management for late preterm pre-eclampsia: study protocol for a randomised controlled trial (PHOENIX trial). Trials. 2019;20(1):85.
    https://doi.org/10.1186/s13063-018-3150-1
  • Maheshwari A, Bhattacharya S, Bowler U, Brison D, Child T, Cole C, Coomarasamy A, Cutting R, Harbottle S, Hardy P, Juszczak E, Khalaf Y, Kurinczuk JJ, Lavery S, Lewis-Jones C, Macklon N, Raine-Fenning NJ, Rajkohwa M, Scotland G, Troup S. Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation. Reproductive Health. [journal article]. 2019;16(1):81.
    https://doi.org/10.1186/s12978-019-0737-2
  • Yates H, Chiocchia V, Linsell L, Orsi N, Juszczak E, Johnson K, Chetcuti P, Illingworth C, Hardy P, Monk V, Newell S, Turner M. Very low-dose dexamethasone to facilitate extubation of preterm babies at risk of bronchopulmonary dysplasia: the MINIDEX feasibility RCT. Southampton (UK): NIHR Journals Library, Efficacy and Mechanism Evaluation. 2019 Contract No.: 8.
    https://www.ncbi.nlm.nih.gov/books/NBK545805/ doi: 10.3310/eme06080
  • Bell JL, Hardy P, Greenland M, Juszczak E, Cole C, Maheshwari A, Bhattacharya S, Linsell L. E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan. Trials. 2020;21(1):596.
    https://pubmed.ncbi.nlm.nih.gov/32605633/
  • Bell JL, Gupta S, Juszczak E, Hardy P, Linsell L. Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes. Trials. 2021;22:368.
    https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05324-3
  • Bell JL, Gupta S, Juszczak E, Hardy P, Linsell L. Correction to: Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies-a statistical analysis plan for short-term outcomes. Trials. 2021;22(1):609.
    https://pubmed.ncbi.nlm.nih.gov/34503560/
  • Fleming P, Wilks M, Eaton S, Panton N, Hutchinson R, Akyempon A, Hardy P, Millar MR, Costeloe K. Bifidobacterium breve BBG-001 and intestinal barrier function in preterm babies: Exploratory Studies from the PiPS Trial. Pediatr Res. 2021;89(7):1818-24.
    https://pubmed.ncbi.nlm.nih.gov/32947603/
  • Gupta S, Juszczak E, Hardy P, Subhedar N, Wyllie J, Kelsall W, Sinha S, Johnson S, Roberts T, Hutchison E, Pepperell J, Linsell L, Bell JL, Stanbury K, Laube M, Edwards C, Field D. Correction to: Study protocol: baby-OSCAR Trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial. BMC Pediatr. 2021;21(1):326.
    https://pubmed.ncbi.nlm.nih.gov/34315421/
  • Gupta S, Juszczak E, Hardy P, Subhedar N, Wyllie J, Kelsall W, Sinha S, Johnson S, Roberts T, Hutchison E, Pepperell J, Linsell L, Bell JL, Stanbury K, Laube M, Edwards C, Field D, on behalf of the The Baby Oscar Collaborative Group. Study protocol: baby-OSCAR trial: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies, a multicentre, masked, randomised placebo-controlled parallel group trial. BMC Pediatrics. 2021;21(1):100.
    https://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-021-02558-7
  • Devall A, Chu J, Beeson L, Hardy P, Cheed V, Sun Y, Roberts T, Ogwulu CO, Williams E, Jones L, Papadopoulos JF, Bender-Atik R, Brewin J, Hinshaw K, Choudhary M, Ahmed A, Naftalin J, Nunes N, Oliver A, Izzat F, Bhatia K, Hassan I, Jeve Y, Hamilton J, Deb S, Bottomley C, Ross J, Watkins L, Underwood M, Cheong Y, Kumar C, Gupta P, Small R, Pringle S, Hodge F, Shahid A, Gallos I, Horne A, Quenby S, Coomarasamy A. Mifepristone and misoprostol versus placebo and misoprostol for resolution of miscarriage in women diagnosed with missed miscarriage: the MifeMiso RCT. Health Technol Assess. 2021;25(68):1-114.
    https://pubmed.ncbi.nlm.nih.gov/34821547/
  • Adams R, Jordan R, Adab P, Barrett T, Bevan S, Cooper L, DuRand I, Hardy P, Heneghan N, Jolly K, Jowett S, Marshall T, O'Hara M, Rai K, Rickards H, Riley R, Sadhra S, Tearne S, Walters G, Sapey E. Enhancing the health of NHS staff: eTHOS - protocol for a randomised controlled pilot trial of an employee health screening clinic for NHS staff to reduce absenteeism and presenteeism, compared with usual care. Pilot Feasibility Stud. 2022;8(1):155.
    https://pubmed.ncbi.nlm.nih.gov/35897113/
  • Ashworth D, Battersby C, Green M, Hardy P, McManus RJ, Cluver C, Chappell LC. Which antihypertensive treatment is better for mild to moderate hypertension in pregnancy? BMJ. 2022;376:e066333.
    https://pubmed.ncbi.nlm.nih.gov/35042721/
  • Beardmore-Gray A, Greenland M, Linsell L, Juszczak E, Hardy P, Placzek A, Hunter R, Sparkes J, Green M, Shennan A, Marlow N, Chappell LC. Two-year follow-up of infant and maternal outcomes after planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial. BJOG : an international journal of obstetrics and gynaecology. 2022;129(10):1654-63.
    https://pubmed.ncbi.nlm.nih.gov/35362666/
  • Evans K, Battersby C, Boardman JP, Boyle EM, Carroll WD, Dinwiddy K, Dorling J, Gallagher K, Hardy P, Johnston E, Mactier H, Marcroft C, Webbe J, Gale C. National priority setting partnership using a Delphi consensus process to develop neonatal research questions suitable for practice-changing randomised trials in the United Kingdom. BMJ Open. 2022;12(9):e061330.
    https://pubmed.ncbi.nlm.nih.gov/36171048/
  • Gupta JK, Maher A, Stubbs C, Brocklehurst P, Daniels JP, Hardy P. A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert. Am J Obstet Gynecol MFM. 2022;4(4):100628.
    https://pubmed.ncbi.nlm.nih.gov/35358740/
  • Gupta JK, Maher A, Stubbs C, Brocklehurst P, Daniels JP, Hardy P. Corrigendum to A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert American Journal of Obstetrics & Gynecology MFM Volume 4, Issue 4, July 2022, 100628. Am J Obstet Gynecol MFM. 2022;10.1016/j.ajogmf.2022.100702:100702.
    https://pubmed.ncbi.nlm.nih.gov/35961850/
  • Hunter R, Beardmore-Gray A, Greenland M, Linsell L, Juszczak E, Hardy P, Placzek A, Shennan A, Marlow N, Chappell LC. Cost-Utility Analysis of Planned Early Delivery or Expectant Management for Late Preterm Pre-eclampsia (PHOENIX). Pharmacoecon Open. 2022;10.1007/s41669-022-00355-1.
    https://pubmed.ncbi.nlm.nih.gov/35861912/
  • Maheshwari A, Bell JL, Bhide P, Brison D, Child T, Chong HY, Cheong Y, Cole C, Coomarasamy A, Cutting R, Hardy P, Hamoda H, Juszczak E, Khalaf Y, Kurinczuk JJ, Lavery S, Linsell L, Macklon N, Mathur R, Pundir J, Raine-Fenning N, Rajkohwa M, Scotland G, Stanbury K, Troup S, Bhattacharya S. Elective freezing of embryos versus fresh embryo transfer in IVF: a multicentre randomized controlled trial in the UK (E-Freeze). Human Reproduction. 2022;37(3):476-87.
    https://pubmed.ncbi.nlm.nih.gov/34999830/
  • Wang R, McLernon D, Lai S, Showell MG, Chen Z, Wei D, Legro RS, Wang Z, Sun Y, Wu K, Vuong LN, Hardy P, Pinborg A, Stormlund S, Santamaría X, Simón C, Blockeel C, Mol F, Ferraretti AP, Shapiro BS, Garner FC, Li R, Venetis CA, Mol BW, Bhattacharya S, Maheshwari A. Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol BMJ Open. 2022;12(7):e062578.
    https://pubmed.ncbi.nlm.nih.gov/35851030/
  • Chappell LC, Brocklehurst P, Green M, Hardy P, Hunter R, Beardmore-Gray A, Bowler U, Brockbank A, Chiocchia V, Cox A, Duhig K, Fleminger J, Gill C, Greenland M, Hendy E, Kennedy A, Leeson P, Linsell L, McCarthy FP, O’Driscoll J, Placzek A, Poston L, Robson S, Rushby P, Sandall J, Scholtz L, Seed PT, Sparkes J, Stanbury K, Tohill S, Thilaganathan B, Townend J, Juszczak E, Marlow N, Shennan A. Planned delivery for pre-eclampsia between 34 and 37 weeks of gestation: the PHOENIX RCT. Health Technol Assess. 2022;10.3310/CWWH0622.
    https://doi.org/10.3310/CWWH0622
  • Maheshwari A, Bari V, Bell J L, Bhattacharya S, Bhide P, Bowler U, Brison D, Child T, Chong HY, Cheong Y, Cole C, Coomarasamy A, Cutting R, Goodgame F, Hardy P, Hamoda H, Juszczak E, Khalaf Y, King A, Kurinczuk JJ, Lavery S, Lewis-Jones C, Linsell L, Macklon N, Mathur R, Murray D, Pundir J, Raine-Fenning N, Rajkohwa M, Robinson L, Scotland G, Stanbury K, Troup S. Transfer of thawed frozen embryo versus fresh embryo to improve the healthy baby rate in women undergoing IVF: the E-Freeze RCT. Health Technology Assessment. 2022;26(25):1-142.
    https://www.journalslibrary.nihr.ac.uk/hta/AEFU1104/#/abstract
  • Ashworth D, Battersby C, Bick D, Green M, Hardy P, Leighton L, Magee LA, Maher A, McManus RJ, Moakes C, Morris RK, Nelson-Piercy C, Sparkes J, Rivero-Arias O, Webb A, Wilson H, Myers J, Chappell LC. A treatment strategy with nifedipine versus labetalol for women with pregnancy hypertension: study protocol for a randomised controlled trial (Giant PANDA). Trials. 2023;24(1):584.
    https://pubmed.ncbi.nlm.nih.gov/37700365/
  • Byng R, Creanor S, Jones B, Hosking J, Plappert H, Bevan S, Britten N, Clark M, Davies L, Frost J, Gask L, Gibbons B, Gibson J, Hardy P, Hobson-Merrett C, Huxley P, Jeffery A, Marwaha S, Rawcliffe T, Reilly S, Richards D, Sayers R, Williams L, Pinfold V, Birchwood M. The effectiveness of a primary care-based collaborative care model to improve quality of life in people with severe mental illness: PARTNERS2 cluster randomised controlled trial. Br J Psychiatry. 2023;10.1192/bjp.2023.28:1-11.
    https://pubmed.ncbi.nlm.nih.gov/37078520/
  • Evans K, Battersby C, Boardman JP, Boyle E, Carroll W, Dinwiddy K, Dorling J, Gallagher K, Hardy P, Johnston E, Mactier H, Marcroft C, Webbe JWH, Gale C. National priority setting partnership using a Delphi consensus process to develop neonatal research questions suitable for practice-changing randomised trials in the UK. Arch Dis Child Fetal Neonatal Ed. 2023;10.1136/archdischild-2023-325504.
    https://pubmed.ncbi.nlm.nih.gov/37094919/
  • Marshall ASJ, Scrivens A, Bell JL, Linsell L, Hardy P, Yong J, Williams R, Adams E, Sadarangani M, Juszczak E, Roehr CC. Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2 × 2 factorial, randomised, controlled trial. The Lancet Child & Adolescent Health. 2023;7(2):91-100.
    https://www.sciencedirect.com/science/article/pii/S2352464222003431
  • Mitchell TK, Hall NJ, Yardley I, Cole C, Hardy P, King A, Murray D, Nuthall E, Roehr CC, Stanbury K, Williams R, Pearce J, Woolfall K. Mixed-methods feasibility study to inform a randomised controlled trial of proton pump inhibitors to reduce strictures following neonatal surgery for oesophageal atresia. BMJ Open. 2023;13(4):e066070.
    https://pubmed.ncbi.nlm.nih.gov/37080617/
  • Knight M, Ramakrishnan R, Ratushnyak S, Rivero-Arias O, Bell J, Bowler U, Buchanan P, Carter C, Cole C, Hewer O, Hurd M, King A, Juszczak E, Linsell L, Long AM, Mottram L, Murray D, Oddie S, Quigley M, Stalker V, Stanbury K, Welsh R, Hardy P, on behalf of the FROSTTIE Trial Collaborative Group. Frenotomy with breastfeeding support versus breastfeeding support alone for infants with tongue-tie and breastfeeding difficulties: the FROSTTIE RCT. Health Technol Assess. 2023;27(11).
    https://doi.org/10.3310/WBBW2302
  • Marshall ASJ, Scrivens A, Bell JL, Linsell L, Hardy P, Yong J. Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2x2 factorial, randomised, controlled trial. 2023;7:91.
  • Gupta S, Subhedar NV, Bell JL, Field D, Bowler U, Hutchison E, Johnson S, Kelsall W, Pepperell J, Roberts T, Sinha S, Stanbury K, Wyllie J, Hardy P, Juszczak E. Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen. N Engl J Med. 2024;390(4):314-25.