Evidence map›Paper›PMID 40475115›Full record

ArticleCochrane evidence synthesis and methods2024

Systematic reviews of clinical laboratory studies: Pilot risk of bias tool developed by consensus.

Tilly Fox, Beverley J Hunt, Robert A S Ariens, Greg J Towers, Robert Lever, Paul Garner, Rebecca Kuehn

Abstract read
In one paragraph

Article in Cochrane evidence synthesis and methods, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Proposed Risk of Bias Assessment Tool forPathogens (Basel, Switzerland) · 2026
    Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Tilly FoxDepartment of Clinical Sciences Liverpool School of Tropical Medicine Liverpool UK.ORCID 0000-0003-3627-1016
Beverley J HuntKing's Healthcare Partners London UK.
Robert A S AriensLeeds Institute of Cardiovascular and Metabolic Medicine University of Leeds Leeds UK.
Greg J TowersDivision of Infection and Immunity University College London London UK.
Robert LeverImperial College London NHS Trust London UK.
Paul GarnerDepartment of Clinical Sciences Liverpool School of Tropical Medicine Liverpool UK.
Rebecca KuehnDepartment of Clinical Sciences Liverpool School of Tropical Medicine Liverpool UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Some research studies aim to elucidate pathophysiology by examining blood or tissue markers in relation to clinical findings. In COVID-19, this has led specialists to promote treatment options based on single studies without systematic appraisal and critical summaries of the data. As we could not identify any published tools for this purpose, we developed a pilot risk of bias tool by consensus, and report here on our approach. Methods: Using an expert consultative consensus process, a panel of five topic experts were guided through a set of iterative steps to develop questions intended to elicit information about the study methods and reporting in clinical laboratory studies. The team piloted the tool in three clinical laboratory studies, and then applied it formally as a component in assessing a hypothesis about mechanisms in the post-COVID-19 condition as part of a Cochrane review. Results: The pilot tool assessed study quality and bias across three domains applicable to comparative and single-arm clinical laboratory studies: collection and handling of samples, experimental methods, and reporting of the results. In the Cochrane review, the tool identified substantive risk of bias in the included clinical laboratory studies. Conclusion: The plethora of COVID-19 research has highlighted the need for formal methods to systematically appraise clinical laboratory studies related to disease pathology. This tool provides a systematic approach to appraise the validity of these studies. Our process may guide others in the development of appraisal tools in areas where they are needed. Given the relationship between clinical laboratory studies and the development of medical treatments, further development of this risk of bias tool is important for evidence-based healthcare and research.

Indexed as

clinical laboratoryCOVID‐19 pathophysiologycritical appraisalpost‐COVID‐19 conditionrisk of biassystematic reviewvalidity assessment

Identifiers

PMID40475115
PMCPMC11795900

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.