1. Photo: Trym I. Bergsmo

2. Best and worst cases Sameline Grimsgaard MD MPH PhD National research center in complementary and alternative medicine; NAFKAM Norway

3. Norwegian weekly: Allers 1992 Lennart aged 59: –Thyroid cancer diagnosed in 1989 –Metastases April 1990 (liver and bone) –No radiation therapy –Healing x 6 –Regression of tumor on radiological follow-up August 1990

4. Considerations Skepticism: –Cured this week and dead next week? –Incorrect diagnosis? Curiosity: –What happened?

5. Norwegian weekly: Allers 2003 Lennart aged 70: –”I am energetic and healthy! … I had four tumors removed in 1994…medical examinations once yearly have been fine..” Kari Victoria (healer): –” The energy come from some higher powers” Is Lennart a ”best-case”?

6. What is a best and worst case? A clinical course of serious disease that is very different from what was expected based upon medical examinations: –A “best case” could be full or long time recovery of cancer or other disease with a poor prognosis, after CAM-treatment. –A “worst case” could be when use of CAM has serious side effects or contributes to delayed conventional treatment with serious consequences for the disease.

7. Best and worst cases WHY?

8. Study objectives 1.Provide data for CAM-treatment Help patients to choose treatment based on correct information 2.Provide data for CAM-research Seek out therapies, therapists and case characteristics to be focused in further research

9. 1-5-year relative survival of breast cancer stage IV Females, Norway 1992-96 Source: Cancer Registry in Norway Percent surviving

10. Research strategies: Bench to bedside vs. CAM CAM practice Best cases series Worst cases Product / compound Animal testing In vitro studies Clinical trials Established medical practice Mechanistic research Clinical trials

11. Related projects National Cancer Institute, USA: Best-case program Quantitative data, only Quantitative and qualitative data: NAFKAMNAFKAM in collaboration with Scandinavian researchers and patient organizations Collaborating with the NCI Both best and worst cases

12. Best and worst cases- HOW?

13. SPONTANEOUS COMMUNICATIONS SELECTION QUANTITATIVE AND QUALITATIVE DATA INDEPENDENT EXPERT PANEL Independent researchers REGISTER REPORT RESEARCH PROJECTS

14. Spontaneous communications What do we need to know? 1.Full name and date of birth 2.Diagnoses and year of diagnoses 3.CAM and conventional treatment history 4.Effects and side effects of the treatment 5.What do you consider most important for how your disease progressed?

15. Criteria for follow-up 1.Serious and / or life threatening disease 2.General agreement on diagnostic criteria E.g. Cancers, multiple sclerosis, asthma 3.CAM treatment during the course of disease Consider cases who have only conventional treatment during the course of disease?

16. Quantitative data Sociodemographic data Name, age, marital status, level of education… Case history and documentation Medical history Results of pathology reports and medical imaging reports (X- rays, CT-scans etc.) Treatment schedule for both CAM and conventional treatment Adverse reactions /side effects

17. Qualitative data Taped interviews focusing the cases’ experience and reflection on: Disease and illness history Treatment course and life contexts Choice of treatment (conventional and CAM) Motivation, expectations and goals Communication with therapists Concordance and compliance Outcomes related to treatment and life contexts Evaluation of treatment courses

18. Qualitative data Process and context- oriented: 1.Phenomenological “data” The case (informant) describes 2.Hermeneutical “data” The case (informant) interprets The case (informant) interprets in a dialog with the researcher

19. What knowledge? 1.Similarities and uniqueness of: –Individuals who constitute best and worst cases –Clinical pictures of best and worst cases –CAM-therapies –case-therapist cooperation –CAM-therapists 2.Outcomes of combining conventional and CAM -treatment

20. Useful knowledge? Cannot be used to: Estimate incidence of best and worst cases Generalize findings to large groups of patients Can be used to: Generate hypotheses and new research projects Contribute validated information to patients, patient organizations and therapists

21. Ethical considerations Cases must not be ”trapped in CAM” Disclosure of expert panel conclusions? To cases if they ask for it To therapists if cases allow for it No legal actions regarding the law of quackery Approved by: –The regional board of research ethics –The Norwegian data inspectorate –The directorate of Health and Social affairs

22. When is a case a best or worst case? Depends on the disease Use available statistics Use clinical experience Always a matter of judgment

23. Where are we today? Approx. 150 communications More than 80 cases: –40 are evaluated (initial selection) –20 selected for follow-up with collection of additional information 18 potential best cases; 10/18 are cancer cases 2 potential worst cases; side effects of homeopathy

24. Where are we today? International collaboration –National Cancer Institute; best case program Scandinavian collaboration –Researchers: Karolinska Institutet, Sweden Laila Launsø, Denmark –Patient organizations Cancer Asthma and allergy Multiple sclerosis

25. NAFKAMDATABASE Swedish researchers Danish researchers International research; NCI, others Scandinavian patient organizations Patients Therapists Others Finland? Iceland? Norwegian researchers

26. Best and worst cases Photo: Trym I. Bergsmo