Oppdatert 14/8 - 2003

Vi kan eventuelt bidra med å drøfte hvorledes PLA kan brukes til kommunikasjon med deltakerne i randomiserte, kontrollerte forsøk - for eksempel vedr informert samtykke og ved bedømmelse av livskvalitet. Men Fondet for Lokale helseforsøk rekker ikke å ta første initiativ for tiden. Interesserte kan også drøfte faktorielle design med oss siden vi ser slike som avgjørende viktige for rimelig kost/nytte i helhetsperspektiv.

We may take part in discussions about how PLA may be used for communication with the participants in randomised, controlled trials (RCTs). Examples of topics are informed consent and quality of life evaluation. However, at present The Foundation has no capacity to take concrete initiatives. You may also discuss the challenge of factorial designs with us as we consider those as very important (and more feasible than many thinks) for good benefit/cost outcome from a holistic point of view.

Some notes from the travel report from the site editor's study travel in The UK, January 1998:

Dr. David Sackett at the Centre for Evidence-Based Medicine, Univ Oxford told that The Cochrane collaboration also has a group for listening to the patients and might be interested of what PLA may yield. Basically EBM (with its major weight on RCTs = randomized controlled trials) and PLA both rest heavily on direct experience though many - who do not regard this aspect - talk about them as very different extremes. Rightly, the exact problem at hand should decide what methodology should be stressed, see the editorial of Sackett in Brit Med Journal 1997;315(7123):1636: Choosing the best research design for each question. It's time to stop sqabbeling over the best methods. (Thus there are connections with "PBL - problem based learning" S4753 and "problem based methodology" .S4773)

He generously gave us the following books which you also may take out from our library: S4818 Sackett DL et al. Evidence-based medicine. How to practice. Churchill Livingstone 1997. og S4817 Sackett DL. Clinical epidemiology. 2nd ed/5printing, Little, Brown and Co., 1991/1995.

Peter G Smith, London School of Hygiene and Tropical Medicine. His and Morrow's toolbox on Methods for field trials of interventions against tropical diseases (S9962) from 1991 (may be borrowed too) was a great support for the exact trial issue in our model for Local Health Trials (S9950). .. In addition the book very nicely pointed out the importance of community involvement. ... Thus, the very important results of the field trial by Smith's co-workers (S4414) on treatment of STDs for preventing spread of HIV, was surrounded by an information campaign which did not have an apparent effect. [.. what would the effect of the same info-resources have been if they had used still more of the techniques of an appropriate PLA approach??] The "toolbox" (S9962) also contain description of a "stepped-wedge" design (S9727).

Do you know whether/where the issue of this comment are dealt with in the large litterature ? is it perhaps in:

S5075 Kunz R, Oxman A. The unpredictability paradox: review of empirical comparisons of randomized and non-randomised trials. BMJ 1998;317:1185-90.

S5075b. Special issue of RCT 50 years. . BMJ 1998;317:1167-1254+ed

Editorial in BMJ 14/10-00: "longer needles produce fewer local reactions … We fast tracked this paper because a simple change in practice can produce quick benefits. We hope that can skip the five year delay that often occurs between new evidence and a change in practice.…….

…solid ethical guidance is practical too……

…….The revised Declaration of Helsinki calls for new treatments to be tested against the current best treatment rather than placebo. " (Confer S9950)

 I Norge burde mer systematiske – forventningsrette/unbiased - utprøvinger hos enkeltpasienter (som evt. kunne samles til serier) snarest utredes og utprøves i praksis.

Her er en begynnelse: (S4230) Johannessen T. Controlled trials in single subjects. A comparison of the symptomatic effect of cimetidine versus placebo in single patients with dyspepsia. Tapir, Trondheim 1992. 45pp+8 papers.