PubMed · 11648279
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Maryland. Court of Appeals. 1993-02-02. Mack v. Mack.. https://pubmed.ncbi.nlm.nih.gov/11648279/
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PURPOSE: To measure patient-based minimal clinically important effect sizes (minimal incremental benefit that an individual would require to accept one treatment option over another) for pain relief between two contrasting palliative radiotherapy regimens for painful pelvic recurrences from rectal cancer. METHODS AND MATERIALS: Forty-three patients with a history of cancer pain without prior pelvic radiotherapy participated in decision aid-facilitated trade-off exercises. The clinical scenario and treatment options of a 5-day vs. a 20-day course of radiotherapy were described. The duration of pain relief for the 20-day regimen was increased until the respondents' preferences switched to the 20-day regimen. The exercises were repeated for different probabilities of benefit and pain intensity at the time of decision making. RESULTS: When the probability of pain relief was unchanged, the median switch point for the duration of pain relief was 6.7 and 7.2 months for severe and mild pain, respectively. The cumulative percentage frequency curve for the switch points approximated a sigmoid distribution. CONCLUSION: Determining the minimal clinically important effect sizes for symptom relief for palliative therapies is feasible. This type of information can be used to incorporate patient values into clinical trial designs. Modification of this method can be used to improve our understanding of shared (physician and patient) decision making.
In 1983 a ministerial decree based on Section 18 of the Hospital Provisions Act came into force, under which a number of top clinical centres could only give certain specialised care if they obtained a permit from the minister of Health, Welfare and Sport. Following the Health Council's report 'The Limits of Care' published in 1986, the government instructed the Health Council in 1989 to develop a policy for regularly reporting the status of certain section-18-activities and to put forward proposals for investigative medical research. This led to the Health Council's so-called annual reports, which have played a pivotal role in the balanced introduction and dissemination of special provisions. In 1995 the Health Council stopped issuing its annual report due to the ambiguity which arose concerning the implementation of a number of proposals it had made. In 1997 all top clinical activities were made subject to section 2 of the Specific Medical Procedures Act. This meant that there was no longer a statutory obligation to advise the government. However, under the Specific Medical Procedures Act, the Health Council has been able to continue its important advisory role. For example, the Health Council's advice was taken into consideration when the practice of in-vitro fertilisation was evaluated and during the drafting of the Embryo Act.
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