Patient safety

Methods and measures for the estimation of patient harm: new working group

Building on a meticulous analysis of the world literature on the subject, a new WHO working group has been created. Its ambition is to help set the research agenda in the field.

As commissioned by WHO, in December 2003 French expert Dr Philippe Michel completed a large-scale literature review on the available methods for assessing patient harm. In his report, the author refers to 262 scientific publications, subdivided into methods based on reporting, routinely collected and existing data, and ad hoc studies based on epidemiological designs.

The articles were screened for effectiveness, reliability of data, suitability for smaller or larger-scale studies, economic costs, effectiveness in influencing policy, effectiveness in influencing hospital and local safety procedures and outcomes, and possible synergies with other domains. As well as publications based on the analysis of medical records, the author considered studies based on interviews, clinical examinations and questionnaires, especially in developing and transitional countries.

In the author’s opinion, decision-makers need data on the effectiveness of methods in influencing action and prevention at national and local levels. But in his view, comparative studies may have poor external validity, since results are likely to depend on local conditions.

The groundbreaking work by Dr Michel led to the creation of a new WHO working group, led by Dr Ross Baker of Toronto University and Dr Bill Runciman of the Australian Patient Safety Foundation. At its first meeting, in December 2006 at WHO Headquarters in Geneva, fourteen international experts decided to focus on methods for acute care settings, community-based care, primary care, evaluation, and new methodologies for data poor environments.

The working group plans to edit a practical guide on methods and measures, and another guide on the effectiveness of patient safety interventions. It will establish a conceptual framework for research on methods and measures and publish two background papers, one for acute care and one for community based care. Specific research methods will then be recommended for a range of patient safety research questions, settings and contexts, with a particular emphasis on developing countries.