Sunday, September 27, 2009

Ethical use of data for Clinical Decision Support

Noticed this ethics-related question on LOINC website http://loinc.org/articles/Bonney2009

“Is it appropriate, or ethical , to use health data collected for the purpose of direct patient care to develop computerized predictive decision support tools?”

I do not have access to the complete article, but the question itself triggered some thoughts in my mind. I guess the first question to ask is – does the end justify the means? Since use of CDSS (Clinical Decision Support Systems) has been shown on average to lead to better clinical decision-making for providers and hence impact patient care, is it okay to use patient care data for development of such tools?

I will attempt to answer this question using the ethical framework governing the research on human subjects to see if it may apply to this situation (source of framework: Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283:2701-11. [PMID: 10819955]).

Here is the list of 7 framework requirements and their applicability to CDSS development as assessed by me –

  1. Social or scientific value: Benefits from CDSS should justify the resources spent and risks imposed on patients whose data has been used
  2. Scientific validity: Predictive decision-making methodology used by CDSS should be properly structured to meet its objectives
  3. Fair participant selection: Participant data should be selected to achieve a fair distribution of the burdens and benefits of CDSS.
  4. Favorable risk-benefit ratio: CDSS should be designed to ensure that the risks to an individual human participant are balanced by expected benefits to the same participant
  5. Respect for participants: Privacy of participant should be protected and confidentiality of their data should be maintained. This can be achieved by using de-identified data and obtaining patient consent for collection, use, and sharing of data
  6. Informed consent: Participant consent to include data in development of CDSS must be obtained. The risk to participant should be measured relative to risk associated with receiving care without use of CDSS. This risk should be communicated to the participant when obtaining informed consent.
  7. Independent review: CDSS development should receive independent ethical review that is appropriate to the level of potential risk it poses to participants.

1 comment:

  1. Những biểu hiện đó nếu không kịp thời khám xét và điều trị kịp thời thì có những biến chứng như ung thư dương vật (ở nam giới) hay ung thư cổ tử cung (ở nữ giới) mụn cóc sinh dục nam giới
    Khi có nghi ngờ về dấu hiệu của bệnh mụn cóc sinh dục cần có những điều trị kịp thời. Vậy những hình ảnh bệnh mụn cóc sinh dục như thế nào để bạn dễ nhận biết biểu hiện mụn cóc sinh dục
    Bệnh mụn cóc sinh dục hay còn được gọi là sùi mào gà đến nay vẫn chưa có thuốc điều trị đặc hiệu, người bệnh sẽ phải mang mầm bệnh trong suốt quãng đời còn lại. hình ảnh mụn cóc sinh dục nữ

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