Photo: Trym I. Bergsmo

Best and worst cases

Sameline Grimsgaard

MD MPH PhD

National research center in complementary and alternative medicine;

NAFKAM

Norway

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

Considerations

Skepticism: – Cured this week and dead next week?– Incorrect diagnosis?

Curiosity:– What happened?

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”?

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.

Best and worst cases WHY?

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

1-5-year relative survival of breast cancer stage IVFemales, Norway 1992-96

0

20

40

60

80

100

Diagnosis 1. year 2. year 3. year 4. year 5. year

% o

vere

lven

de

Source: Cancer Registry in Norway

Per

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Research strategies: Bench to bedside vs. CAM

CAM practice

Best cases seriesBest cases series Worst casesWorst cases

Product / compound

Animal testing

In vitro studies

Clinical trials

Established medical practice

Mechanistic research Clinical trials

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

Best and worst cases-HOW?

SPONTANEOUS COMMUNICATIONSSPONTANEOUS COMMUNICATIONS

SELECTION

QUANTITATIVE AND QUALITATIVE DATA

INDEPENDENT EXPERT PANEL

Independent researchersREGISTER

REPORT RESEARCH PROJECTS

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?

Criteria for follow-up

1. Serious and / or life threatening disease

2. General agreement on diagnostic criteriaE.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?

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

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 contextsEvaluation of treatment courses

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

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

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

Ethical considerations

Cases must not be ”trapped in CAM”Disclosure of expert panel conclusions?

To cases if they ask for itTo therapists if cases allow for it

No legal actions regarding the law of quackeryApproved by:

– The regional board of research ethics– The Norwegian data inspectorate– The directorate of Health and Social affairs

When is a case a best or worst case?

Depends on the disease

Use available statistics

Use clinical experience

Always a matter of judgment

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

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

NAFKAMNAFKAM

DATABASEDATABASE

Swedish researchers

Danish researchers

International research; International research; NCI, othersNCI, others

Scandinavian patient

organizations

Patients

Therapists

Others

Finland?

Iceland?

Norwegian researchers

Best and worst cases

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