ISB Now

President’s Blog – July 2010

Posted on July 14, 2010

Accreditation of gait analysis laboratories, should this be compulsory around the world? Earlier this month a message was posted on Biomch-L to alert “Biomechers” about an Australian news story related to a gait analysis service (http://www.abc.net.au/news/stories/2010/06/09/2922273.htm).  Given that biomechanics doesn’t traditionally attract media interest “Down Under”, I was quickly drawn to the article.

In brief, the article described ethical and clinical concerns that have been raised about a Motion Analysis Service located within a well-respected Australian university.  The Motion Analysis Service in question conducted gait analyses, particularly pre-operative assessment of children with cerebral palsy for hospital clinicians.  However, the Service was closed in 2009 due to “a breakdown in the relationship between the …hospital and the university, who jointly ran it”.  The article claimed that ongoing concerns had been previously raised about “risks to the health of the children who were measured there and the ethical use of the data on the children”.  In response to complaints received, the hospital and university who jointly ran the facility commissioned an independent review of the service.

It is reported that this review identified data errors, which contributed to a lack of trust in the data and “unexplained and unrecorded manipulation of the data” or “errors in the technical aspects of the analysis”.  A second media report (http://www.smh.com.au/nsw/what-problem-nsw-health-begs-to-differ-with-doctors-20100609-xwyc.html) claimed that a software error had resulted in incorrect foot alignment measurement of a number of children.  Interestingly, it was reported that this software error “had absolutely no impact on clinical care and was not linked in any way to the clinical decision making process”.

These claims, which were publicly repeated in a series of subsequent articles in the main press, raise several points for serious consideration by the biomechanics community, particularly those involved in clinical gait analysis.  Firstly, the statement that the “erroneous data has had no influence on clinical decision making” is a great concern; does this imply that gait analysis has no role or value in determining surgical plans or treatment strategies?  If so, why are patients, particularly young children, subjected to the burden of such complex procedures?  It is not my intention to undermine the extremely valuable work done by well established and professionally run gait analysis facilities that have improved the mobility of individuals who have difficulty walking.  For example, the positive work achieved by groups such as the Centre for Clinical Research Excellence in Clinical Gait Analysis and Gait Rehabilitation are well documented in detailed reports available on their website (http://www.mcri.edu.au/pages/gait-ccre/default.asp).  It is also acknowledged that clinical gait analysis is only part of a suite of tools used in the clinical decision-making process and is not the definitive answer to determining surgery.

Personally, however, I believe that the problems identified in the Motion Analysis Service raise the question about the need for independent accreditation against standard criteria of facilities offering clinical gait analysis and other forms of human motion that potentially affect health outcomes.  Most allied health professions require compulsory accreditation to be eligible to practice.  However, a search of the web revealed few references worldwide to such accreditation of individuals or laboratories offering clinical gait analysis and, where it was offered, it was voluntary (e.g. http://www.cmlainc.org/index.html).  Independent accreditation could ensure that appropriate checks are made to minimise the potential for errors in motion analysis data that is used as part of the clinical decision making process.  Furthermore, although an international accreditation body currently does not exist, those involved in clinical gait analysis should at least regularly use some form of independent peer-review of their processes and procedures to ensure their validity and reliability.

A second major concern raised in the Motion Analysis Service media reports related to a “governance failure which saw the medical records of disabled children used in student research without their parents’ consent or approval from either institution” (http://www.smh.com.au/nsw/hospital-uni-in-blame-game-over-research-breach-20100610-y0mq.html).  It is claimed that researchers at the University used information from the database of children's records from the service, which was established for treatment purposes, for research, without explicit ethical approval to do so.  It was reported that the forms were “somewhat lax”, failing to disclose full details of how the data would be used and by whom.  This example again emphasizes the need for all researchers, whether based in a university or clinical facility, to ensure all ethical requirements and authorizations have been obtained and adhered to throughout the research process.  The issue of access to patient data is another consideration that needs to be addressed by all universities that conduct clinical gait analysis, and any other clinical research, for hospitals.  Who owns the data and who controls access to it needs careful consideration and documentation before any research commences.

In the words of Chris Kirtley, who posted the message:
“I guess this had to happen at some time.  As far as I know it's the first time gait data has been questioned in this way?”

I welcome and encourage further discussion on these issues in forthcoming newsletters, and elsewhere in the biomechanics community so that we can be proactive in responding to potentially negative media reports in our discipline.

Warmest regards
Julie

PS ISB wishes Andrea Hemmerich and her husband best wishes for the impending birth of their first child! Andrea has been instrumental in drafting the new EDC web page (while waiting for “bubbie” to arrive).

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