Protocol for a systematic review of reporting standards of anaesthetic interventions in randomised controlled trials

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Abstract

Introduction

There is significant variation in how anaesthesia is defined and reported in clinical research. This lack of standardisation complicates the interpretation of published evidence and planning of future clinical trials. This systematic review will assess the reporting of anaesthesia as an intervention in randomised controlled trials (RCT) against the Consolidated Standards of Reporting Trials for Non-Pharmacological Treatments (CONSORT-NPT) framework.

Methods and analysis

Online archives of the top six journals ranked by impact factor for anaesthesia and the top three general medicine and general surgery journals will be systematically hand searched over a 42-month time period to identify RCTs describing the use of anaesthetic interventions for any invasive procedure. All modes of anaesthesia and anaesthesia techniques will be included. All study data, including the type of anaesthetic intervention described, will be extracted in keeping with the CONSORT-NPT checklist. Descriptive statistics will be used to summarise general study details including types/modes of anaesthetic interventions, and reporting standards of the trials.

Ethics and dissemination

No ethical approval is required. The results will be used to inform a funding application to formally standardise general, local, regional anaesthesia and sedation for use in clinical research. The systematic review will be disseminated via peer-reviewed manuscript and conferences.

PROSPERO registration number

CRD42019141670.

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Most cited references 9

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Better reporting of randomised controlled trials: the CONSORT statement.

Michael Altman (1996)

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Patient experiences of outcomes of bariatric surgery: a systematic review and qualitative synthesis

Karen Coulman, Fiona MacKichan, Jane Blazeby … (2017)

Summary Although bariatric surgery is the most effective treatment for severe and complex obesity, less is known about its psychosocial impact. This systematic review synthesizes qualitative studies investigating the patient perspective of living with the outcomes of surgery. A total of 2,604 records were screened, and 33 studies were included. Data extraction and thematic synthesis yielded three overarching themes: control, normality and ambivalence. These were evident across eight organizing sub‐themes describing areas of life impacted by surgery: weight, activities of daily living, physical health, psychological health, social relations, sexual life, body image and eating behaviour and relationship with food. Throughout all these areas, patients were striving for control and normality. Many of the changes experienced were positive and led to feeling more in control and ‘normal’. Negative changes were also experienced, as well as changes that were neither positive nor negative but were nonetheless challenging and required adaptation. Thus, participants continued to strive for control and normality in some aspects of their lives for a considerable time, contributing to a sense of ambivalence in accounts of life after surgery. These findings demonstrate the importance of long‐term support, particularly psychological and dietary, to help people negotiate these challenges and maintain positive changes achieved after bariatric surgery.

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What is an invasive procedure? A definition to inform study design, evidence synthesis and research tracking

Sian Cousins, Natalie Blencowe, Jane Blazeby (2019)

Worldwide, there are at least 230 million invasive procedures performed annually and most of us will undergo several in our lifetime. There is therefore a need for high-quality evidence to underpin this clinical area. Currently, however, there is no widely accepted definition of an invasive procedure and the terms ‘surgery’ and ‘interventional procedure’ are characterised inconsistently. We propose a definition for invasive procedures which addresses the limitations of those currently available. Our definition was developed from an analysis of the 3946 papers from the last decade. A preliminary definition was created based on existing definitions and applied to a variety of papers reporting all types of procedures. This definition was continuously updated and applied iteratively to all articles. The definition has three key components: (1) method of access to the body, (2) instrumentation and (3) requirement for operator skill. It therefore encapsulates all types of invasive procedure regardless of the method of access to the body (incision, natural orifice or percutaneous access), and is relevant whatever the clinical discipline (eg, obstetric, cardiac, dental, interventional cardiology or radiology). Crucially, the definition excludes medicinal products, except where their administration occurs within an invasive procedure (and thereby involves operator skill). The application of a universal definition of an invasive procedure will (1) inform the selection of relevant methods for study design, (2) streamline evidence synthesis and (3) improve research tracking, helping to identify evidence gaps and direct research funds.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2020

Publication date (Electronic): 13 January 2020

Volume: 10

Issue: 1

Electronic Location Identifier: e034372

Affiliations

[1 ] departmentCentre for Surgical Research , University of Bristol Medical School , Bristol, UK

[2 ] departmentPopulation Health Sciences , University of Bristol Medical School , Bristol, UK

[3 ] departmentSouthmead Hospital , North Bristol NHS Trust , Bristol, UK

Author notes

[Correspondence to ] Dr Lucy Elliott; lucy.elliott@ 123456nbt.nhs.uk

Author information

Lucy Elliott http://orcid.org/0000-0002-4265-4075

Karen Coulman http://orcid.org/0000-0003-0510-4290

Natalie S Blencowe http://orcid.org/0000-0002-6111-2175

Ronelle Mouton http://orcid.org/0000-0001-9562-8199

Robert J Hinchliffe http://orcid.org/0000-0002-6370-0800

Article

Publisher ID: bmjopen-2019-034372

DOI: 10.1136/bmjopen-2019-034372

PMC ID: 7045251

PubMed ID: 31937656

SO-VID: b25406dc-0381-44d1-94f9-5dece34aa45f

License:

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 22 September 2019

Date revision received : 03 December 2019

Date accepted : 18 December 2019

Funding

Funded by: NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust;

Funded by: FundRef http://dx.doi.org/10.13039/501100000883, University of Bristol;

Funded by: University of Bristol Elizabeth Blackwell Clinical Primer Scheme;

Funded by: Association of Anaesthetists of Great Britain and Ireland (AAGBI)/National Institute of Academic Anaesthesia (NIAA) grant;

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ScienceOpen disciplines: Medicine

Keywords: anaesthetics,surgery,protocols & guidelines

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ScienceOpen disciplines: Medicine

Keywords: anaesthetics, surgery, protocols & guidelines

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A systematic review of reporting quality for anaesthetic interventions in randomised controlled trials
Authors: L. Elliott, K. Coulman, N. Blencowe …

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Protocol for a systematic review of reporting standards of anaesthetic interventions in randomised controlled trials

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

PROSPERO registration number

Related collections

Chinese Journal of General Practice

Most cited references 9

Better reporting of randomised controlled trials: the CONSORT statement.

Patient experiences of outcomes of bariatric surgery: a systematic review and qualitative synthesis

What is an invasive procedure? A definition to inform study design, evidence synthesis and research tracking

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Author notes

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Cited by 1

Most referenced authors 781