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Topic 9 ethical considerations
1. Topic 9: Are there any ethical
considerations to be made?
Ethical considerations in collecting
the data... (bias in the data)
2. What is Bias?
“...a systematic deviation of a study’s result from a
true value that is usually introduced during the
design or implementation of a study and cannot
be corrected after the fact.”
(The Joint Commission, 2009, p. 87).
3. “data from poor tools can be misleading and
dangerous.”
Expressing concern about data collection
methods, John Boyce, M.D., section chief of
Infectious Diseases and director of the Hand
Hygiene Resource Center at the Hospital of Saint
Raphael in New Haven, Connecticut.
4. “ a tool used as a standard for hand hygiene
monitoring but providing inaccurate data could
produce a false sense of security among health
care workers and, therefore, could be
counterproductive.”
Professor Didier Pittet, M.D., M.S., director,
Infection Control Program, University of Geneva
Hospitals and Faculty of Medicine, Geneva,
Switzerland, and leader, WHO First Global
Patient Safety Challenge.
6. Observer Bias...
• “...the extent to which the observer inaccurately
identifies or measures a phenomenon”
(The Joint Commission, 2009, p. 87).
7. Data is gathered by more than one
researcher...
• Bias could take the form of the position of the
data collector
• employed by the organisation or not
• amount of effort put into the data collection
8. Staffing issues...
• Use of infection preventionists, quality
improvement staff, and other health care
workers
• Time management
• Whether it is worth the effort?
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9. Use of outside staff
• Recommended by the Joint Commission’s report
• Funding will need to be found
• Time consuming
10. Use of technology to eliminate bias
• Unobtrusive
• Less selection bias
• Range of cameras often limited
• Can be expensive and time consuming
• Privacy of the patients and staff
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11. Privacy Considerations
• WHO’s Manual for Observers:“Observation
does not justify infringing the principle of
patient privacy. This means observers show
discretion regarding where they place
themselves and their movements.”
• Ontario’s hand hygiene program’s instructions
for observers state, “The observer must conduct
observations openly, without interfering with the
ongoing work, and keep the identity of the
healthcare providers confidential.”
12. WHO “Clean care is safer care”
5-part multimodal hand hygiene improvement
strategy:
• Structural system changes, such as making
alcohol based hand rub available at the point of
care
• Training and education
• Observation of hand hygiene performance and
feedback
• Reminders in the workplace
• Creation of a safety culture
13. WHO recommended observation tool
• Included in the WHO “Guide for
Implementation” toolkit
• Collects data at the level of each hand hygiene
opportunity
• Used as a model in more than 25 countries
including Australia, Canada and the UK.
Notas do Editor
Vandenbroucke J.P., Von Elm, E.,Altman, D.G.,Gøtzsche, P.C., Mulrow, C.D.,Pocock, S.J., Poole, C.,Schlesselman, J.J., & Egger, M.Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and elaboration. Ann Intern Med 147:W163–W194, Oct. 16, 2007. As quoted in: The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlSo what is bias? According to Vandenbroucke et al as quoted by the Joint Commission report – Bias is “...a systematic deviation of a study’s result from a true value that is usually introduced during the design or implementation of a study and cannot be corrected after the fact.” This systematic deviation can take the form of incorrect reporting of numbers, falsifying numbers and results and failing to publish the true data results.
The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlExpressing concern about data collection methods, John Boyce,section chief of Infectious Diseases and director of the Hand Hygiene Resource Center at the Hospital of Saint Raphael in New Haven, Connecticut, commented that “data from poor tools can be misleading and dangerous.”
The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlAnd according toProfessor Didier Pittet, director of the Infection Control Program, the University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland, and leader of the WHO First Global Patient Safety Challenge, “a tool used as a standard for hand hygiene monitoring but providing inaccurate data could produce a false sense of security among health care workers and, therefore, could be counterproductive.”
Orb, A., Eisenhauer, L., & Wynaden, D. (2000). Ethics in Qualitative Research. Journal of Nursing Scholarship, 33 (1).Capron (1989) as quoted in Orb et al stated that any kind of research should be guided by the principles of respect for people, beneficence and justice. He considered that respect for people is the recognition of participants’ rights, including the right to be informed about the study, the right to freely decide whether to participate in a study, and the right to withdraw at any time without penalty. Autonomy is honoured in studies through informed consent.Beneficence means doing good for others and preventing harm. This includes informing participants of the data that will be published, protecting their identity, personal information and their rights. And justice refers to fairness and equality which can be applied in the reporting and recording of the data.
The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlObserver bias is “...the extent to which the observer inaccurately identifies or measures a phenomenon” Observer bias, according to many research studies is a very difficult phenomena to reduce. This form of bias is mainly considered unintentional, but occurs due to the observer’s knowledge of the study and their want to see it succeed or fail. Many studies I read found that in order to reduce this type of bias you would need to ensure that a protocol or steps are followed, two data collectors are put in the same location to average the data, and ensure that external observers are employed.
The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlBias could take the form of the position of the data collector – if they are employed by the organisation or not, as this could make a difference to the amount of effort put into the data collection, the results and staff compliance.
The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlMonitoring of aprogram is often resource intensive, with the need for the involvement of the infection preventionists, quality improvement staff, and other health care workers (nurses, pharmacists, physicians...). Consideration needs to be taken of whether the use of such people and the taking up of their time from their already heavy work loads is worth it. Hand hygiene and PPE compliance is an important issue and needs to be monitored to ensure its success and ensure that patient safety is maintained, however the use of staff at the hospital/organisation and their time needs to be taken into account.
The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlThe use of outside staff to record the data required is recommended by the Joint Commission’s report to ensure that bias is minimised. The use of outside staff ensures that bias is minimised, however the funding will need to be found for external employees and this also consumes more time and resources. The use of external staff may eliminate bias in the data collection as they have no known history with the organisation or hospital and the people working in that microsystem. However this may also add another level of bias – as the staff member is not part of the community or the organisation and may not care about the data results and the impact the data may have on patient safety.
The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlUse of technology is considered as one way to eliminate bias, as it is unobtrusive, and less selection bias occurs – however the amount and use of the cameras can add to the selection bias, and cameras may not be able to gain a clear view of all dispensers. Purchasing and installing the equipment can be expensive, and someone will need to review the stored data and interpret and record what they see. Cameras can also interfere with the privacy of the patients and the staff being monitored. Staff and patients would need to be made aware of the cameras, their purpose and information about the study. Consent would also need to be gained, and this could be very time consuming.
The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlThe WHO notes in its Manual for Observers (for data collection regarding hand hygiene monitoring)the importance of patient privacy. The manual states that, “Observation does not justify infringing the principle of patient privacy. This means observers show discretion regarding where they place themselves and their movements.”Ontario’s hand hygiene program instructions for observers states that, “The observer must conduct observations openly, without interfering with the ongoing work, and keep the identity of the healthcare providers confidential.”
The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlThe use of the WHO models saves a lot of time, money and resources, as the models have been tested and studied by various organisations and deemed appropriate and ethically safe.As part of the “Clean Care is Safer Care” initiative, the WHO developed guidelines for hand hygiene that include a five-part multimodal hand hygiene improvement strategy for organizations to implement. The improvement strategy includes the following:• Structural system changes, such as making alcohol based hand rub available at the point of care• Training and education• Observation of hand hygiene performance and Feedback Reminders in the workplace• Creation of a safety culture
The Joint Commission. (2009). Measuring hand hygiene adherence: Overcoming the challenges. Retrieved from: http://www.cdc.gov/handhygiene/Measurement.htmlThe observation tool “Manual for Observers,” is included in the WHO “Guide for Implementation” toolkit, • It collects data at the level of each hand hygiene opportunity.• For each opportunity, you can record the hand hygiene indication associated with the five moments, what the action was (wash, rub, or missed), and the professional category of the person observed.• It has been used and validated extensively and translated into several languages.• It has been used as a model for instrument development for nationwide hand hygiene promotion campaigns in more than 25 countries, including Australia, Canada, and the United Kingdom.
