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Critical Care and Peri-operative Medicine Research Group
  1. Critical Care & Peri-operative Medicine Research Group
  2. SOPs & SAPs
  3. Statistical Analysis Plans (SAPs)

Statistical Analysis Plans (SAPs)

Our SAPs are divided into two categories:

  • Critical Care
  • Perioperative Medicine

This section is regularly updated with the latest SAPs produced by the researchers of the Group. Several of the SAPs are also available on the QMUL repository.

A directed acyclic graph

Image (above): 'Directed acyclic graph for COVID-19 phenotypes'

Critical Care SAPs

Biochemical estimation of muscle mass and unbiased assessment of kidney function using serum creatinine and cystatin-C: A prognostic validation study within UK Biobank

COVID-19 Associated Acute Kidney Injury: Long Term Outcomes (Statistical Analysis Plan)

  • Authors: Barton, J; Bien, Z; Prowle, J; Wan, Y.
  • Version: 1.0
  • Description of data: Statistical Analysis Plan – This prospective analysis of retrospectively collected data as detailed within the EthICAL study will focus on the long-term renal function and mortality associated with acute kidney injury within COVID-19 patients admitted to five acute hospitals within East London during the pandemic. It will also examine the incidence, risk factors, and outcomes associated with acute kidney injury within COVID-19 patients admitted to five acute hospitals within East London during the second wave of the pandemic.
  • URl: https://qmro.qmul.ac.uk/xmlui/handle/123456789/84562
  • DOI: https://doi.org/10.17636/10184562
  • Access SAP: COVID-19 Associated Acute Kidney Injury: Long Term Outcomes SAP [PDF 478KB]

Vagal Augmentation with Transcutaneous Stimulation: a phase II, explanatory, randomised controlled trial

Comorbid disease and ethnicity in emergency hospital admissions in east London

  • Authors: Wan, YI; Puthucheary, ZA; Prowle, JR
  • Version: 1.1
  • Description of data: Statistical analysis plan - The aim of this comparative study is to determine in a cohort of non-COVID emergency hospital admissions within the same representative population in east London, whether there is a difference in outcomes in patients of different ethnicities. It will test the hypothesis that patients of Black, Asian and other ethnicities have poorer outcomes defined using mortality and length of stay. Data generated has the potential to influence and shape relevant policy and practice to improve health outcomes in BAME communities.
  • URI: https://qmro.qmul.ac.uk/xmlui/handle/123456789/69988
  • DOI: https://doi.org/10.17636/10169988 
  • Access SAP: Ethnicity SAP v1.1 [PDF 149KB]

Acute Kidney Injury in COVID-19: secondary analysis of prospective data from the EthICAL study

  • Authors: Wan, YI; Bien, Z; Prowle, JR
  • Version: 1.1
  • Description of data: Statistical analysis plan - This secondary analysis of the EthICAL study will focus on the incidence, risk factors and outcomes associated with AKI within COVID-19 patients admitted to five acute hospitals in East London. We will also examine follow-up data to investigate what proportion of COVID-19 patients who developed an AKI never recovered their renal function and progressed to chronic kidney disease (CKD).
  • URI: https://qmro.qmul.ac.uk/xmlui/handle/123456789/69987
  • DOI: https://doi.org/10.17636/10169987  
  • Access SAP: EthICAL AKI SAP v1.1 [PDF 425KB]

Trends in hospital admissions associated with an Acute Kidney Injury in England 1998-2020: Statistical Analysis Proposal

  • Authors: Bien, Z;  Fowler, AJ; Robbins, AJ; Pearse, RM; Prowle, JR; Wan, YI
  • Version: 1.0
  • Description of data: A statistical analysis proposal to use aggregate hospital admission data from 1998-2020 to investigate trends in admission to NHS England hospitals associated with an Acute Kidney Injury.
  • Access SAP: HES AKI SAP v1.0 [PDF 112KB]

Validity of ROX index for Nasal High Flow Therapy in Critical Care Patients, including those with hypercapnic respiratory failure

Urea-to-creatinine ratio trajectories in multi-organ failure: a reanalysis of the REDOXS trial statistical analysis plan

Ethical: Ethnic Disparities in COVID-19 Admissions in east London

  • Authors: Wan, YI; Apea, V; Dhairyawan, R; Orkin, C; Pearse, RM; Prowle, JR
  • Version: 1.1
  • Description of data: A statistical analysis plan to assess whether there is a difference in age and sex adjusted outcomes in different ethnicities of patients with confirmed COVID 19 admitted to Barts Health. The study will test the hypothesis that there is an association between health outcomes; in terms of need for ITU admission and mortality; and ethnicity in COVID-19 positive patients admitted to Barts Health; with patients of Black, Asian and other Minority Ethnicities having poorer outcomes as compared to patients of White ethnicity.
  • URI: https://qmro.qmul.ac.uk/xmlui/handle/123456789/64155
  • DOI: 10.17636/10164155
  • Access SAP:  Ethnic Disparities In COVID-19 Admissions in east London SAP [PDF 232KB]

Emergency hospital admissions associated with Non-Communicable Diseases 1998-2019: An Ecological Study 

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Perioperative Medicine SAPs

Perioperative management of renin-angiotensin aldosterone-system inhibitors in patients undergoing elective major non-cardiac surgery: A mixed model investigation of systematic review, meta-analysis, multicentre service evaluation and national survey.

  • Authors: Giannas, E; Patel, A; Dias, P; Abbott, T; Biccard, B; Ackland, G; Pearse, R; Janssen, H
  • Version: 1.0
  • Description of data: The risk and benefits of stopping/continuing renin-angiotensin system (RAS) inhibitors during and after major non-cardiac surgery remain uncertain. We report the findings of a systematic review, national audit, and clinician survey exploring the potential impact of a large clinical trial of perioperative RAS-inhibitor use.
  • DOI: To follow
  • Access SAP: RAS meta analysis.manuscript draft.v1 [PDF 1,916KB]

GlucoVITAL-1: Perioperative CGM measurement standards

  • Authors: Ackland, G; Oliver, N; Jhanji, S, Janssen, H; Dias, P
  • Version: 1.0
  • Description of data: Statistical analysis plan
  • Access SAP: GlucoVITAL-1 SAP v1.0 [DOC 393KB]

Stopping Perioperative Angiotensin II Converting Enzyme inhibitors and/or receptor blockers in major non-cardiac surgery (SPACE): a phase II, explanatory, randomised controlled trial

Activation of the Renin–Angiotensin system and myocardial injury in noncardiac surgery: pre-specified analysis of a phase-II, randomised controlled multi-centre trial (SPACE-AXIS)

Volume of surgery during the COVID-19 pandemic in England and Wales: comparative analysis using routinely collected population level data

The age profile of surgical patients in England during the COVID-19 pandemic

Contemporary use of antimicrobial prophylaxis for surgical patients: a mixed methods study

  • Authors: Dias, P; Patel, A; Rook, W; , Edwards, M; Pearse, RM; Abbott, TEF
  • Version: 1.0
  • Access SAP: SAPPHIRE SAP [PDF 444KB]

The environmental impact of commonly used anaesthetic agents

Chronic disease within the NHS surgical population: An epidemiological study

Estimated surgical requirements in England after COVID-19: a modelling study using hospital episode statistics

  • Authors: Fowler, AJ; Dobbs, T; Wan, YI; Laloo, R; Hui, S; Nepogodiev, D; Pearse, RM; Abbott, TEF ​
  • Version: 1.0
  • Description of data: A statistical analysis plan using aggregated, publicly available data from NHS Digital and NHS England to model disruption to, and resources associated with re-establishing, surgical care during the COVID-19 pandemic.
  • URI: https://qmro.qmul.ac.uk/xmlui/handle/123456789/64678
  • DOI: https://doi.org/10.17636/64678    
  • Access SAP: COVID-19 modelling SAP [PDF 106KB]

International Surgical Outcomes Study (ISOS) sub-study: post-operative infection 

  • Authors: Wan, YI; Patel, A; Achary, C; Hewson, R; Phull, M; Pearse, RM
  • Version: 1.1
  • Description of data: This study will is a pre-specified secondary analysis of the International's Surgical Outcomes Study (ISOS). The aims of this analysis is to describe the prevalence of post-operative infection in an international sample of surgical patients. We will also investigate risk factors for the development of infection and the association between infection and morbidity and mortality following elective surgery.
  • URI: https://qmro.qmul.ac.uk/xmlui/handle/123456789/65489
  • DOI: 10.17636/10165489
  • Access SAP: ISOS post-operative infection SAP [PDF 675KB]

Socioeconomic deprivation and surgical outcomes: ISOS and VISION-UK sub-study

Process Evaluation of the PRISM and OPTIMISE II trials: Study Protocol

  • Authors: Stephens, T; Abbott, TEF; Pearse RM
  • Version: 1.0
  • Description: Protocol for mixed-methods process evaluation of two major trials of perioperative care interventions. The PRISM trial evaluation was completed in early 2020.
  • Access protocol: Process Evaluation - PRISM and OPTIMISE II [PDF 352KB]

Describing the high-risk surgical population: A national epidemiological study in England, Scotland, and Wales.

  • Authors: David Cromwell; Alex Fowler; Michael Gillies; Ewen Harrison; Rupert Pearse; John Prowle
  • Version: 1.0
  • Description of data: At present, long-term survival and healthcare need following surgical procedures performed in the NHS is unknown. The aim of this study is to provide a robust description of the high-risk surgical population, including the size and characteristics of these groups at an epidemiological level in the UK.
  • Access SAP: Describing the high-risk surgical population SAP v1.0 [PDF 632KB]
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