• The NHS Research Governance Framework sets out the standards by which research is conducted, including the monitoring of protocols and procedures to make sure that these are followed.
• Any research we carry out must meet recognised ethical standards and respect the dignity, rights, safety and well-being of the people who take part.
• These standards must be assessed and approved by an independent Research Ethics Committee (REC)

Links to further information on clinical research

• National Institute for Health Research (NIHR)
• Health Research Authority (HRA)
• Medicines & Healthcare Products Regulatory Agency (MHRA)
• Involve

Patient Information and health and care research

https://www.hra.nhs.uk/information-about-patients/

Please see below sample of published research results from some of the studies that the Royal Cornwall Hospitals Trust have been involved in. We are aiming to increase the number available on this webpage in the future.

Please note there is often a significant time lag between the end of patient participation in a study and the availability of the results.

Anaesthesia

PROBESE- Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial

Cardiology

HPS2-THRIVE randomized placebo-controlled trial in 25 673 high-risk patients of ER niacin/ laropiprant: trial design, pre-specified muscle and liver outcomes, and reasons for stopping study treatment.

Rehabilitation Enablement in Chronic Heart Failure (REACH-HF)

COVID

REMAP-CAP- A Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia.
https://www.sciencedirect.com/science/article/pii/S0140673620305377

Critical Care

Risk Adjustment In Neurocritical care (RAIN)–prospective validation of risk prediction models for adult patients with acute traumatic brain injury to use to evaluate the optimum location and comparative costs of neurocritical care: a cohort study.

POPPI– A nurse-led, preventive, psychological intervention to reduce Post Traumatic Stress Disorder symptom severity in critically ill patients.

Dermatology

Effect of Topical Imiquimod as Primary Treatment for Lentigo Maligna: The LIMIT-1 Study

Diabetes

ALTITUDE: ALiskiren Trail in T2 Diabetes using cardiorenal endpoints

ADDRESS 2- Relationship between islet autoantibody status and the clinical characteristics of children and adults with incident type 1 diabetes in a UK cohort

Emergency Medicine

CRASH 3: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32233-0/fulltext

Randomised Evaluation of modified Valsalva Effectiveness in Re-entrant Tachycardias (REVERT) study.

Gastroenterology

PANTS Personalised anti-TNF therapy in Crohn’s disease study

Haematology

Targeting of Antithrombin in Hemophilia A or B with RNAi Therapy

CHOP versus GEM-P in previously untreated patients with peripheral T-cell lymphoma (CHEMO-T): a phase 2, multicentre, randomised, open-label trial

Hepatology

Hepatitis E virus in patients with decompensated chronic liver disease: a prospective UK/French study.

Steroids or Pentoxifylline for Alcoholic Hepatitis (STOPAH) trial

Neurology- Multiple Sclerosis

The Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial: a randomised double-blind placebo-controlled parallel-group multicentre trial and economic evaluation of cannabinoids to slow progression in multiple sclerosis.

Towards a better understanding of MS pain: a systematic review of potentially modifiable psychosocial factors.

Oncology

Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial

FAST-Forward: Randomised clinical trial testing a 1 week course of curative whole breast radiotherapy against a standard 3 week schedule in terms of local cancer control and late adverse effects in patients with early breast cancer.

The POUT trial: PeriOperative chemotherapy or sUrveillance in upper Tract urothelial cancer

The PAKT Trial: Capivasertib Plus Paclitaxel Versus Placebo Plus Paclitaxel As First-Line Therapy for Metastatic Triple-Negative Breast Cancer

Neoadjuvant/Adjuvant Phase 3 KEYNOTE-522 (Early-Stage Triple-Negative Breast Cancer Trial)

Trial of intraoperative cell salvage versus transfusion in ovarian cancer (TIC TOC): protocol for a randomised controlled feasibility study.

Body mass index and sexual function in women with gynaecological cancer

AspECT A Phase III randomised study of aspirin and esomeprazole chemoprevention in Bareett’s metaplasia

Randomized Phase II Study Evaluating Palbociclib in Addition to Letrozole as Neoadjuvant Therapy in Estrogen Receptor–Positive Early Breast Cancer: PALLET Trial.

Esomeprazole and aspirin in Barrett’s oesophagus (AspECT): a randomised factorial trial

Intermittent chemotherapy plus either intermittent or continuous cetuximab for first-line treatment of patients with KRAS wild-type advanced colorectal cancer (COIN-B): a randomised phase 2 trial

Intermittent versus continuous oxaliplatin and fluoropyrimidine combination chemotherapy for first-line treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial

3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial

Orthopaedics

Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome (UK FASHIoN): a multicentre randomised controlled trial

HEALTH – Total Hip Arthroplasty or Hemiarthroplasty for Hip Fracture

Paediatrics

MAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children

Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-blind, randomised, equivalence trial

Adjunctive rifampicin for Staphylococcus aureus bacteraemia (ARREST): a multicentre, randomised, double-blind, placebo-controlled trial

Early or Delayed Enteral Feeding for Preterm Growth-Restricted Infants: A Randomised Trial ADEPT

Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-blind, randomised, equivalence trial

Oxygen Saturation and Outcomes in Preterm Infants (BOOST II)

Renal Medicine

SPEAK study (Surveying People Experiencing young Adult Kidney failure)

PIVOTAL Intravenous Iron in Patients Undergoing Maintenance Hemodialysis

Rheumatology

A Survey of Psychological Support Provision for People with Inflammatory Arthritis in Secondary Care in England- PSYSCOPE

Stroke

REstart or STop Antithrombotics Randomised Trial

Antiplatelet treatment compared with anticoagulation treatment for cervical artery dissection (CADISS): a randomised trial

Efficacy of nitric oxide, with or without continuing antihypertensive treatment, for management of high blood pressure in acute stroke (ENOS): a partial-factorial randomised controlled trial

TWIST: Does the Use of Nintendo Wii SportsTM Improve Arm Function? Trial of WiiTM in Stroke: A Randomized Controlled Trial and Economics Analysis

Urology

Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): a randomised controlled trial
https://www.sciencedirect.com/science/article/pii/S0140673620305377

Women’s Health & Obstetrics

VUE- Surgical interventions for uterine prolapse and for vault prolapse

Prednisolone in Nephrotic Syndrome: The PREDNOS Study

Intraoperative cell salvaged blood as part of a blood conservation strategy in Caesarean section: is fetal red cell contamination important?

Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial

Upright versus lying down position in second stage of labour in nulliparous women with low dose epidural: BUMPES randomised controlled trial

• Performance in Delivery
• Performance in Initiating

To enable us to do this, we hold an annual, snapshot experience survey as well as welcoming feedback through Care Opinion. https://www.careopinion.org.uk/ Care Opinion allows people to anonymously share their experiences, good and bad, of healthcare services across the country. Stories are then passed to department representatives who will review and respond via the website.

Current vacancies for the Royal Cornwall Hospitals, Research & Development Department can be found at NHS jobs.

Links to useful information:

• National Institute for Health Research
• e-research in Cornwall
• NHS Health Research Authority
• National Institute for Health Research – South West Peninsula