ArticleQuality & safety in health care2004
When does quality improvement count as research? Human subject protection and theories of knowledge.
Article in Quality & safety in health care, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Bridging the Silos: A Comparative Analysis of Implementation Science and Improvement Science.Frontiers in health services · 2021Pooled it
- A decision tool to guide the ethics review of a challenging breed of emerging genomic projects.European journal of human genetics : EJHG · 2016Review
- Infection prevention and control self-audit: just a tick box exercise?Journal of infection prevention · 2014Article
- Variations in institutional review board approval in the implementation of an improvement research study.Nursing research and practice · 2013Article
- Ethical issues in using data from quality management programs.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2009Review
- Ethics of collecting and using healthcare data.BMJ (Clinical research ed.) · 2007Article
- Innovations in the Ethical Review of Health-Related Quality Improvement and Research: The Alberta Research Ethics Community Consensus Initiative (ARECCI).Healthcare policy = Politiques de sante · 2007Article
- Narrative methods in quality improvement research.Quality & safety in health care · 2005Article
- Research governance: where did it come from, what does it mean?Journal of the Royal Society of Medicine · 2005Review
- Toward stronger evidence on quality improvement. Draft publication guidelines: the beginning of a consensus project.Quality & safety in health care · 2005Article
- Primary care practice-based research networks: working at the interface between research and quality improvement.Annals of family medicineReview
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The publication of insights from a quality improvement project recently precipitated a ruling by the lead federal regulatory agency that regulations providing protection for human subjects of research should apply. The required research review process did not match the rapid changes, small samples, limited documentation, clinician management, and type of information commonly used in quality improvement. Yet quality improvement can risk harm to patients, so some review might be in order. The boundaries and processes are not clear. Efforts have been made to determine what constitutes "research", but this has proved difficult and often yields irrational guidance with regard to protection of patients. Society needs a workable way to separate activities that will improve care, on the one hand, and those that constitute research, on the other. Practitioners who lead both quality improvement and research projects claim that those which rapidly give feedback to the care system that generated the data, aiming to change practices within that system, are "quality improvement" no matter whether the findings are published, whether the project is grant funded, and whether contemporaneous controls do not have the intervention. This criterion has not previously been proposed as a possible demarcation. The quandaries of which projects to put through research review and how to ensure ethical implementation of quality improvement need to be resolved.
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What OpenQuestion holds
Registered trials
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.