MinTankesmie

- Involverer ikke pasientene

Involverer ikke pasientene
tidsskriftet.no 19.11.2010
De som utvikler retningslinjer for behandling tar stort sett ikke med pasienter i arbeidet. – Vi har avdekket stor avstand mellom idealer og virkelighet når det gjelder pasientinvolvering i utviklingen av kliniske retningslinjer i Norge. (...)

(Anm: Deltar pasientene i utviklingen av kliniske retningslinjer i Norge? Tidsskr Nor Legeforen 2010; 130:2236-8 (19.11.2010).)

- De fleste legemiddelannonser fulgte ikke FDAs retningslinjer

Most Drug Ads Did Not Follow FDA Guidelines (De fleste legemiddelannonser fulgte ikke FDAs retningslinjer)
pharmalot.com 29.8.2011
Last year, the FDA acknowledged the difficulty in policing advertisements aimed at healthcare professionals and consumers by creating its ‘Bad Ad’ program, which the agency recently maintained is having a positive effect (read here). But just how bad were pharmaceutical ads before the FDA launched this program?

To gain some clarity, researchers examined 192 pharmaceutical ads that ran in biomedical journals in November 2008 - less than two years before the ‘Bad Ad’ program began - and found that only 18 percent were compliant with FDA guidelines. And more than half failed to quantify serious risks, including death, according to their study, which was published PLoS One.

To be more specific, of those 192 ads, which were promoting 82 unique meds, only 15 fully adhered to all 20 FDA Prescription Drug Advertising Guidelines (read here). Meanwhile, 57.8 percent of the ads did not quantify serious risks, 48.2 percent lacked verifiable references and 28.9 percent failed to present adequate efficacy quantification. (...)

Many advertised drugs in the sample presented potential risks - 31 contain black box warnings and 33 place patients at risk for death or serious morbidity. And 36 ads, by the way, referenced “data on file” and 40 lacked verifiable references, due either to an absence of any references or to the presence of references only to data on file or the product’s package insert, the researchers found.

Which journals qualified for their review? The Journal of the National Cancer Institute; JAMA; Gastroenterology; Annals of Internal Medicine; Archives of General Psychiatry; Blood; Circulation; Hepatology; Journal of the American College of Cardiology; Journal of Clinical Oncology, and The New England Journal of Medicine (n=35). (...)

“The limited resources of the FDA’s Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry’s multi-billion dollar marketing budget,” Deborah Korenstein, lead author of the study and associate professor of Medicine at Mount Sinai School of Medicine, says in a statement (here is the complete study).

(Anm: Legemiddelreklame (legemiddelinformasjon) (mintankesmie.no).)

(Anm: Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing. PLoS ONE 6(8): e23336 (August 17).)

- Psykiatere neglisjerer pasienters fysiske helseproblemer, ifølge studie

Psychiatrists neglect patients’ physical health problems, says study (Psykiatere neglisjerer pasienters fysiske helseproblemer, ifølge studie)
BMJ 2011; 343:d5209 (15 August)
Psychiatrists are failing to carry out physical health checks for metabolic complications common in patients with mental illness, in particular patients taking antipsychotics, a study claims.

In a meta-analysis and systematic review published in Psychological Medicine (doi:10.1017/S003329171100105X) researchers found that only blood pressure and triglycerides were routinely monitored in more than 50% of patients. Most other tests, such as cholesterol, glucose, and weight measurement, were carried out in less than half of patients.

Studies show that people with schizophrenia who are taking antipsychotics often have several related cardiovascular and metabolic risk factors so should be monitored often and provided with the appropriate follow-up medical care. These risk factors include high cholesterol concentrations, hypertriglyceridaemia, glucose abnormalities, hypertension, diabetes, and obesity.

Although guidelines for managing such patients have been published in many countries, it is unclear whether these are being followed, the study says, and most evidence indicates that patients are receiving suboptimal care. This meta-analysis assessed data on screening practices to show the extent of suboptimal monitoring and whether guidelines have made a difference.

The team identified 48 studies looking at a total of more than 290 000 patients taking antipsychotics in five countries over 11 years (2000-11). Over half the studies were of people with schizophrenia. Thirty nine studies focused on routine monitoring before guidelines were issued, and nine reported post-guideline monitoring. Seven of these compared changes in screening practices before and after guideline implementation. (...)

(Anm: Guideline concordant monitoring of metabolic risk in people treated with antipsychotic medication: systematic review and meta-analysis of screening practices. Psychological Medicine 2011 (Published online: 10 August 2011) (PDF).)

- Amerikanske leger beskylder firma for påvirkning av legemiddelpolitikk

XIGRIS (drotrecogin alfa(aktivert)) trekkes fra markedet
legemiddelverket.no 26.10.2011
Xigris (drotrecogin alfa (aktivert)), til behandling av voksne med alvorlig blodforgiftning, trekkes fra verdensmarkedet fordi nye studier viser mangel på effekt. Tilbaketrekkingen trer i kraft umiddelbart og gjennomføres så raskt som mulig.

Xigris ble godkjent i Europa i 2002 til behandling av voksne pasienter med alvorlig sepsis med multiorgansvikt, som tillegg til standardbehandling. (...)

- Statlige leger sier Legemiddelfirmaet Eli Lilly & Co. samordnet medisinske retningslinjer for behandling for en ofte dødelig blodinfeksjon på en snedig måte, med håp om å øke salget av et legemiddel med omstridt nytte. (...)

Federal Doctors Fault Lilly Drug Push (Statlige leger kritiserer Lillys pushing av legemiddel)
abcnews.go.com 18.10.2006
Government Doctors Say Eli Lilly Marketed Blood Infection Drug Through Medical Societies

BOSTON - Several government doctors say drug maker Eli Lilly & Co. subtly orchestrated medical guidelines for treatment of an often lethal blood infection, hoping to boost sales of a drug whose value is being debated. (Statlige leger sier Legemiddelfirmaet Eli Lilly & Co. samordnet medisinske retningslinjer for behandling for en ofte dødelig blodinfeksjon på en snedig måte, med håp om å øke salget av et legemiddel med omstridt nytte.)

Such involvement could open another door to corporate interests trying to shape health care, beyond funding experiments and cozying up to doctors in labs or at luncheons. Guidelines are meant to reflect independent medical opinion.

"This company is trying to insinuate its drug into many aspects of patient care that industry really shouldn't be involved in," said Dr. Naomi O'Grady, a critical care specialist at the National Institutes of Health. (...)

US doctors accuse company of influencing drug policy (Amerikanske leger beskylder firma for påvirkning av legemiddelpolitikk)
reutershealth.com 19.10.2006
WASHINGTON (Reuters) - Eli Lilly and Co. may have improperly influenced guidelines on the treatment of a dangerous infection called sepsis in order to sell more of an expensive new drug, three federal researchers said on Thursday.

Lilly did not deny trying to influence the guidelines by hiring a marketing firm and by paying doctors and ethicists to launch a campaign about choosing which patients to treat in the emergency room.

But the company said its efforts were educational, and had the goal of making sure only the appropriate patients were treated with the drug, called Xigris.
The U.S. Food and Drug Administration's approval of the drug in 2001 was controversial, and half of the members of the advisory committee that considered the new drug had voted against it. (...)

- Forskrivninger av antidepressiva mangler ofte diagnoser

Antidepressant Scripts Often Lack Diagnosis (Forskrivninger av antidepressiva mangler ofte diagnoser)
medpagetoday.com 8.8.2011
Nesten trefjerdedeler av forskrivninger av antidepressiva skrevet av ikke-psykiatere hadde ingen dokumentasjon på psykiatriske diagnoser, ifølge en nylig analyse av forskrivningstrender. (Almost three-quarters of the antidepressant prescriptions written by nonpsychiatrists had no documentation of psychiatric diagnoses, an analysis of recent prescribing trends showed)

Prescriptions without psychiatric diagnoses accounted for a majority of nonpsychiatrists' antidepressant prescriptions from 1996 to 2007, according to an article published online in Health Affairs.

And the proportion of prescriptions without documented psychiatric indications increased from about 60% to almost 73% over the study period. (...)

(Anm: Patients Getting Antidepressants More Often From Nonpsychiatrists Without Psychiatric Diagnoses. Health Aff 2011 (August).)

(Anm: Proportion Of Antidepressants Prescribed Without A Psychiatric Diagnosis Is Growing. Health Aff 2011; 30(8):1434-1442 (August).)

- Studie viser at de fleste som skrev kliniske retningslinjer hadde økonomiske bånd til legemiddelfirmaer

Most Psychiatrists Who Wrote Clinical Guidelines Had Financial Ties to Drug Companies, Study Shows (Studie viser at de fleste som skrev kliniske retningslinjer hadde økonomiske bånd til legemiddelfirmaer)
kaisernetwork.org 3.4.2009
Most of the psychiatrists on the American Psychiatric Association panels who wrote the newest clinical guidelines for how to treat depression, bipolar disorder and schizophrenia had financial ties to drug companies, according to a study by Boston researchers scheduled to be published this month in the journal Psychotherapy and Psychosomatics, the Boston Globe reports.

For the study, Lisa Cosgrove of the University of Massachusetts-Boston and colleagues, including Sheldon Krimsky of Tufts University and Harold Bursztajn of Harvard Medical School, searched publicly accessible databases such as Medline and the records of the federal patent office to identify financial ties. According to the study, 18 of the 20 authors of the guidelines had at least one financial tie to drug companies. Twelve authors had ties in at least three categories, such as consulting, research grants, speaking fees or stock ownership, the study found. In addition, the study found that all of the authors of schizophrenia and bipolar guidelines had relationships with the drug industry, while 60% of the authors of the depression guidelines had such connections. According to the study, more than 75% of the authors received funding for research from drug companies. In addition, one-third of the authors served on the speakers' bureaus of drug companies, the study shows. (...)

(Anm: Interessekonflikter, bestikkelser og korrupsjon (mintankesmie.no).)

- Firmaer med tilkytninger til enkelte leger som bestemmer målsettinger

Firms tied to some MDs who set policy (Firmaer med tilkytninger til enkelte leger som bestemmer målsettinger)
boston.com 2.4.2009
Treatment advice focuses on drugs, researchers find

Virtually all the psychiatrists who wrote the latest clinical guidelines for how to treat depression, bipolar disorder, and schizophrenia had financial ties to drug companies, according to preliminary findings by Boston-based researchers.

Their study is the first to examine potential conflicts of interest in the American Psychiatric Association panels that write the treatment guidelines widely used by practitioners, the paper's authors said.

The guidelines focus heavily on medications and give relatively little attention to nondrug treatments and how and when to phase out drugs prescribed for mentally ill patients, the authors wrote. They said three common diagnoses generate some $25 billion in drug sales per year. (...)

- En solskinns-forordning for Europa

A sunshine act for Europe (En solskinns-forordning for Europa)
Leder
BMJ 2011; 343:d6593 (13 October)
As the days grow shorter in this northern outpost of Europe, we can dream about sunshine, real and metaphorical. Barack Obama’s Sunshine Act comes into force in 2013, requiring drug companies to declare all payments and hospitality they give to doctors. As Andrew Jack explains, the aggressive marketing of drugs in the United States is now being met with an equally aggressive response from government, fuelled by exposés, law suits, and public pressure (doi:10.1136/bmj.d6459).

Jennifer Neuman and colleagues give the bandwagon another shove (doi:10.1136/bmj.d5621). Their review of clinical guidelines in the US and Canada finds that half the panel members had conflicts of interest. These were substantially more common on non-government sponsored guidelines and were especially prevalent on guidelines produced by specialty societies, a fact not lost on Edwin Gale in his linked editorial (doi:10.1136/bmj.d5728). (...)

- Retningslinjer trekkes grunnet interessekonflikter (bias)

French guidelines are withdrawn after court finds potential bias among authors (Franske retningslinjer trekkes tilbake etter at domstol finner mulig bias blant forfatterne)
BMJ 2011; 342:d4007 (24 June)
The highest administrative court in France has ruled that two sets of guidelines issued by the French Health Authority must be withdrawn immediately because of potential bias and undeclared conflicts of interest among the authors. Other guidelines are also being reviewed and will be withdrawn if similar problems emerge, the authority has said.

The French Council of State (Conseil d’Etat) made the ruling on 27 April, two years after doctors with the non-profit organisation Formindep (Formation Indépendante) charged that the guideline development process for the authority’s guidelines on type 2 diabetes and Alzheimer’s disease “contravened national law on conflicts of interests and the agency’s own internal rules.”

In a news release issued on 20 June Formindep stated that it had examined the diabetes and Alzheimer’s disease guidelines “because of the large number of patients affected. However, . . . the group considers that most if not all of [the authority’s] guidelines may not stand up to legal scrutiny for similar reasons.” (...)

- Interessekonflikter hos panelmedlemmer som utarbeider retningslinjer

Interessekonflikter og kliniske retningslinjer
Tidsskr Nor Legeforen 2012; 132:285 (14.2.2012)
Mange av dem som utarbeider kliniske retningslinjer har interessekonflikter og unnlater å rapportere om dem.

Interessekonflikter, særlig økonomiske, er problematiske, både ved studier og ved utarbeiding av retningslinjer for klinisk praksis. Nå har amerikanske forskere kartlagt økonomiske interessekonflikter blant medlemmer av paneler som utarbeider retningslinjer for screening og behandling av hyperlipidemi og diabetes (1).

Retningslinjer publisert av nasjonale organisasjoner i USA og Canada mellom 2000 - 10 ble gjennomgått. Fem av de 14 relevante sett med retningslinjer som ble funnet, inneholdt ingen opplysninger om interessekonflikter for panelmedlemmene. 150 av til sammen 288 panelmedlemmer hadde interessekonflikter, hvorav 138 hadde opplyst om dem, mens 12 ikke hadde opplyst om dem. Av 73 medlemmer som hadde oppgitt at de ikke hadde interessekonflikter, ble slike likevel påvist hos åtte. Halvparten av panellederne hadde økonomiske interessekonflikter.

- Vi har sett det samme problemet i Norge, sier Ole Frithjof Norheim, som er professor i medisinsk etikk ved Universitetet i Bergen. I Helsedirektoratets retningslinjer for primærforbygging av hjerte- og karsykdommer, oppga åtte av faggruppens ti medlemmer mulige interessekonflikter. Det betyr ikke at alle var reelle, men at det kunne oppfattes slik. Selv var jeg overrasket over at så mange hadde mulige bindinger til industrien, sier Norheim, som var leder for faggruppen.

- Vi valgte å gjøre åpent rede for mulige interessekonflikter og gjorde dem kjent for Helsedirektoratets ledelse på forhånd. Åpenhet og transparens er et minimum for å redusere tap av legitimitet, sier Norheim. (...)

(Anm: Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ 2011; 343:d5621 (11 October).)

Conflicts of interest in guideline panel members (Interessekonflikter hos panelmedlemmer som utarbeider retningslinjer)
BMJ 2011; 343:d5728 (11 October)
A change in the culture of medicine is needed; legislation is not enough (En endring av medisinsk kultur er nødvendig; lovgivning er ikke nok)

It has been said that “it is difficult to get a man to understand something when his salary depends upon his not understanding it,”¹ and the medical profession has been slow to understand the importance of conflicts of interest. The linked study by Neuman and colleagues (doi:10.1136/bmj.d5621) reports the prevalence of financial conflicts among guideline panel members in the United States and Canada. Of the 14 guidelines considered, six came from government sponsored organisations, six from specialist or professional organisations, and two from private non-profit organisations; three were from Canada and the remainder from the US. Five (four government sponsored) guidelines provided no conflict of interest statement, but their participants had presumably been screened, because only four of 77 panellists seemed to have a conflict. Six of 12 named chairpersons had a conflict, as did 138 of the 211 panellists who provided a disclosure statement; 12 more failed to disclose an interest, and 10 others received research funding from industry. Only 61 (29%) had no potential financial ties.²

The guidelines in question related to the management of diabetes and hyperlipidaemia, therapeutic areas that accounted for sales of $70.8bn (£44.3bn; €50.4bn) worldwide in 2010, or 8.9% of the worldwide drug market.³ Patent protected agents generate most of the profit, but they enter the market in competition with established treatments that are not only cheaper but have more evidence to support their use. Outcome data are rarely available for a new agent at the time of launch, and unexpected safety concerns may still come to light. (...)

Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study
BMJ 2011; 343:d5621 (11 October)
(...) Objective To determine the prevalence of financial conflicts of interest among members of panels producing clinical practice guidelines on screening, treatment, or both for hyperlipidaemia or diabetes. (...)

Conclusions The prevalence of financial conflicts of interest and their under-reporting by members of panels producing clinical practice guidelines on hyperlipidaemia or diabetes was high, and a relatively high proportion of guidelines did not have public disclosure of conflicts of interest. Organisations that produce guidelines should minimise conflicts of interest among panel members to ensure the credibility and evidence based nature of the guidelines' content. (...)

Financial ties between DSM-IV panel members and the pharmaceutical industry (Finansielle bånd mellom DSM-V-medlemmer og legemiddelindustrien)
Psychother Psychosom. 2006;75(3):154-60.
BACKGROUND: Increasing attention has been given to the transparency of potential conflicts of interest in clinical medicine and biomedical sciences, particularly in journal publishing and science advisory panels. The authors examined the degree and type of financial ties to the pharmaceutical industry of panel members responsible for revisions of the Diagnostic and Statistical Manual of Mental Disorders(DSM).

METHODS: By using multimodal screening techniques the authors investigated the financial ties to the pharmaceutical industry of 170 panel members who contributed to the diagnostic criteria produced for the DSM-IV and the DSM-IV-TR.

RESULTS: Of the 170 DSM panel members 95 (56%) had one or more financial associations with companies in the pharmaceutical industry. One hundred percent of the members of the panels on 'Mood Disorders' and 'Schizophrenia and Other Psychotic Disorders' had financial ties to drug companies. The leading categories of financial interest held by panel members were research funding (42%), consultancies (22%) and speakers bureau (16%).

CONCLUSIONS: Our inquiry into the relationships between DSM panel members and the pharmaceutical industry demonstrates that there are strong financial ties between the industry and those who are responsible for developing and modifying the diagnostic criteria for mental illness. The connections are especially strong in those diagnostic areas where drugs are the first line of treatment for mental disorders. Full disclosure by DSM panel members of their financial relationships with for-profit entities that manufacture drugs used in the treatment of mental illness is recommended. (...)

- Kliniske retningslinjer skal laves af uafhængige læger

PLO: Kliniske retningslinjer skal laves uden industrilæger
Ugeskrift for Læger 2012 (9.1.2012)
Sidder du i et advisory board, er investigator eller konsulent for medicinalindustrien, er du diskvalificeret til at deltage i arbejdet med de kommende nationale kliniske retningslinjer.

Så klar er melding fra de praktiserende lægers formand Henrik Dibbern:

"Der skal ikke sidde nogen læge, der har interessekonflikter eller mulige interessekonflikter med medicinalindustrien, der, hvor de retningslinjer bliver skrevet", fastslår formanden.

Dermed vil førende danske specialister og aktive klinikere i videnskabelige selskaber være frataget muligheden for at sikre en ensartet og evidensbaseret nationalt fastlagt behandling. Alene på grund af deres bånd til industrien.

Alle former for økonomiske mellemværender mellem læge og medicinalindustri er i PLO-formandens optik en ”interessekonflikt”, og både igangværende og nært forestående industrisamarbejde "må udløse en karensperiode", der skal gælde år efter endt samarbejde, siger Henrik Dibbern.

Årsagen til den kontroversielle udmelding er, at PLO-formanden vil sikre, at det alene er faglige hensyn til patienterne, der tæller.

Ingen må kunne beklikke de kommende behandlings-guidelines for at være skjult dikteret af medicinalindustrien.

Også derfor foreslog PLO-formanden før jul, at læger, der sidder i myndighedernes eller ministeriets rådgivende udvalg, ikke må samarbejde med medicinalindustrien samtidig. (...)

(Anm: Praktiserende Lægers Organisation (PLO) (da.wikipedia.org).)

PLO: Kliniske retningslinjer skal laves af uafhængige læger
dagenspharma.dk 10.1.2012
Læger, der samarbejder med medicinalindustrien, må ikke være med til at udarbejde nationale kliniske retningslinjer, mener de praktiserende lægers formand.

PLO-formand Henrik Dibbern mener, at læger, der sidder i et advisory board, er investigator eller konsulent for medicinalindustrien, har diskvalificeret sig selv fra at deltage i arbejdet med de kommende nationale kliniske retningslinjer.

»Der skal ikke sidde nogen læge, der har interessekonflikter eller mulige interessekonflikter med medicinalindustrien, der, hvor de retningslinjer bliver skrevet,« siger han til Ugeskrift for Læger. (...)

- Legemiddelkontroll - Offentliggjøring av relasjoner mellom lege-legemiddelfirma

Drug Regulation
Letting the sunshine in on doctor-pharma relationships (- Legemiddelkontroll - Offentliggjøring av relasjoner mellom lege-legemiddelfirma)
BMJ 2011; 343:d6459 ( 11 October )
Drug companies are increasingly obliged to publish details of payments to doctors. The United States is leading the charge, but are we getting the full story in Europe? Andrew Jack reports

When the drug company Cephalon took 13 British doctors to the European pain congress in Lisbon in September 2009, the expenses it provided did not stop with travel, fees, and accommodation—and its presentations were not limited to a balanced scientific explanation of its products at a day time satellite meeting. An internal feedback document circulated to the sales team at the company (now owned by Teva) described one evening’s festivities that it funded for staff and doctors: “Dinner was fantastic . . . we then went to a few bars and to a club till 3am. All the customers were really looked after and spoke positively about Effentora [fentanyl]—let’s make sure they start Rxg [prescribing] now!” (...)

- Utkast til retningslinjer for retningslinjer

«Retningslinjer for retningslinjer» på høring
kommunal-rapport.no 11.10.2011
Vennesla-rådmann Svein Skisland trodde knapt sine egne øyne da han fikk til høringsuttalelse «Retningslinjer for retningslinjer» fra Helsedirektoratet.

– Lurer på når de innser at det er nok skjemaer, spør Vennesla-rådmann Svein Skisland i Fædrelandsvenn, etter at han fikk det 55 sider lange dokumentet «Utkast til retningslinjer for retningslinjer», veileder for utarbeidelse av kunnskapsbaserte faglige retningslinjer i Helse- og omsorgstjenesten, til uttalelse fra Helsedirektoratet. (...)

Retningslinjene er en revisjon av forrige versjon av dokumentet fra 2002. Ifølge Fædrelandsvennen er dette et av hovedrådene i dokumentet:

«Retningslinjer bør følges opp med effektiv implementering slik at praksis justeres etter retningslinjenes anbefalinger. Implementeringsarbeidet bør tilpasses retningslinjens formål og målgruppe, og er bare summarisk beskrevet i dette dokumentet. Det er videre viktig at faglige retningslinjer evalueres og oppdateres jevnlig.» (...)

(Anm: ”Retningslinjer for retningslinjer” Veileder for utarbeidelse av kunnskapsbaserte faglige retningslinjer i helse- og omsorgstjenesten Eksternt høringsutkast 9/2011 (helsedirektoratet.no).)

Utkast til retningslinjer for retningslinjer
fvn.no 10.10.2011
Sjekk denne: Du tror det ikke før du ser det

– Lurer på når de innser at det er nok skjemaer, spør Vennesla-rådmann Svein Skisland. I dag fant han ”Utkast til retningslinjer for retningslinjer” fra Helsedirektoratet.

Vennesla: – Jeg la den ut på Facebook, og reaksjonene lot ikke vente på seg. Men ærlig talt: Jeg har ventet på dette. Det er faktisk helt ufattelig skjemavelde som etter hvert bygger som opp i dette landet. (...)

Les og lær
For den mer interesserte gjengir vi her innholdet i høringen fra Helsedirektoratet. Du kan jo sjekke om du skjønner det greit:

”Høring: Utkast til «Retningslinjer for retningslinjer» – Veileder for utarbeidelse av kunnskapsbaserte faglige retningslinjer i Helse- og omsorgstjenesten

Retningslinjene er en revisjon av forrige versjon av dokumentet fra 2002.

Arbeidet er initiert av Helsedirektoratet etter oppdrag fra Helse- og omsorgsdepartementet. Bakgrunnen for oppdraget var blant annet behovet for å inkludere aspekter av økonomisk og organisatorisk karakter, i tillegg til generell faglig oppdatering av veilederen. Målgruppen for veilederen er aktører som utarbeider kunnskapsbaserte faglige retningslinjer i helse- og omsorgstjenesten”

Så vet vi det. Kanskje du også har bruk for dette:

”En tverrfaglig arbeidsgruppe oppnevnt av Helsedirektoratet har stått bak revideringen. Kunnskapsbaserte faglige retningslinjer inneholder systematisk utarbeidede råd og anbefalinger knyttet til forebygging, diagnostikk, behandling og/eller oppfølging innenfor helse- og omsorgstjenestene. Rådene og anbefalingene som gis skal være konkrete, de skal hjelpe helsepersonell og pasienter til å ta gode beslutninger og de skal bidra til å redusere uønsket variasjon samt fremme god kvalitet i helse- og omsorgstjenestene.” (...)

- Amerikansk institutt peker på uoverensstemmelser mellom retningslinjer for samme tilstand

US institute points up inconsistencies between guidelines on same condition (Amerikansk institutt peker på uoverensstemmelser mellom retningslinjer for samme tilstand)
BMJ 2011; 342:d1991 (28 March)
Biases and methodological shortcomings often undermine the value of clinical practice guidelines and the foundation of systematic reviews on which they are based. These faults pose various challenges for providers, patients, and policy makers alike, the US Institute of Medicine concludes.

The institute was charged with developing best practice guidance for conducting both types of evaluation. It released its recommendations in a pair of reports on 23 March.

The panel looking at clinical practice guidelines identified more than 3700 guidelines from 39 countries. It often found inconsistencies between guidelines covering the same condition in the same country when they were written from the perspective of different medical specialties.

“These standards are necessary, given that there is little documentation to judge the quality and reliability of many of the existing clinical practice guidelines,” said Sheldon Greenfield, who chaired the panel and directs the Health Policy Research Institute at the University of California, Irvine.

“Practice guidelines provide valuable data and guidance that not only informs individual decisions about care but ultimately could also improve overall health care quality and outcomes,” he added.

The report recommends eight standards for developing trustworthy clinical guidelines. Among them, transparency is paramount. It says that ideally none of the people involved in creating guidelines should have an institutional, financial, or other stake in them. And where that cannot be avoided, those members should be in the minority.

The panel should be multidisciplinary, not limited to a single field or specialty. It should include representatives from the nursing profession, payers, patients, and the public.

The evidence base should be fully examined, individual studies should be rated for quality, and those ratings should be explained as part of the guideline development. That is particularly true when the evidence is of low quality and hence subject to interpretation. (...)

- Interessekonflikter vanlig blant de som skriver retningslinjer for hjerte- og karsykdommer

Conflicts Common Among Heart Guideline Writers (Interessekonflikter vanlig blant de som skriver retningslinjer for hjerte- og karsykdommer)
medpagetoday.com 28.3.2011
More than half of the experts who wrote cardiology clinical practice guidelines reported conflicts of interest, researchers reported.

And more than 80% of the chairs of the writing committees reported at least one conflict, according to James Kirkpatrick, MD, of the University of Pennsylvania in Philadelphia, and colleagues.

On the positive side, there appears to be a "substantial pool" of writers and reviewers without conflicts, Kirkpatrick and colleagues reported in the March 28 issue of Archives of Internal Medicine. (...)

(Anm: Can We Trust Cardiovascular Practice Guidelines? Comment on "Conflicts of Interest in Cardiovascular Clinical Practice Guidelines". Arch Intern Med. 2011;171(6):584-585 (March 28).)

(Anm: Fri tilgang til forskningsresultater? (mintankesmie.no).)

Study looks at ties between firms, heart experts
reuters.com 28.3.2011
(Reuters) - Half of the experts involved in writing recent treatment guidelines for heart patients reported a conflict of interest, U.S. researchers said on Monday, raising worries about whose interests are being served.

Even though the experts are disclosing their ties to companies that produce heart drugs and devices, the phenomenon is important because the guidelines they produce are used to help train new doctors, thus can have long-lasting impact on the way patients are treated.

"Because they are so important, the process for producing them is also important. They need to be above suspicion," said Dr. James Kirkpatrick of the University of Pennsylvania, who worked on the study in the Archives of Internal Medicine. (...)

(Anm: Can We Trust Cardiovascular Practice Guidelines? Comment on "Conflicts of Interest in Cardiovascular Clinical Practice Guidelines". Arch Intern Med. 2011;171(6):584-585 (March 28).)

Diverse artikler

Risk of Autism Is Five Times Higher in Low-Birthweight Babies
healthland.time.com 17.10.2011 (Time)
Low-birthweight babies are at risk for all sorts of motor and cognitive delays, and researchers have just added autism to the list. A new study from the University of Pennsylvania finds that premature babies weighing less than 4.5 lbs. at birth are five times more likely than babies born at a normal weight to have an autism spectrum disorder (ASD). (...)

The conclusions, which are published Monday in the journal Pediatrics, are the results of a study that began more than two decades ago. Researchers initially followed 1,105 children who were born in three New Jersey counties between 1984 and 1987, some of whom weighed just a pound at birth.

MORE: For Siblings of Autistic Kids, Risk Is Far Higher Than Thought

Researchers evaluated the children at ages 2, 6, 9, 16 and 21, looking each time at different outcomes — behavioral, academic and psychiatric, to name a few. At age 16, they screened the children for autism. What they found was surprising: 117 of the 623 children screened positive, while 506 screened negative. (...)

They wound up with a total of 14 cases of ASD, which equates to five times the rate of autism reported in the general population. "CDC data says it's about 1% in 8-year-olds, and we found it to be 5% in 21-year-olds," says Pinto-Martin. (...)

Ultrasound Guidelines May Wrongly Diagnose Miscarriage (Retningslinjer for ultralyd kan feilaktig diagnostisere spontanabort)
healthland.time.com 14.10.2011 (Time)
As if the worry over potential miscarriage weren't stressful enough for newly pregnant women, research released Friday shows that current guidelines for using ultrasound to determine that a pregnancy has ended may not always be accurate.

The four new studies looked at U.K. ultrasound specifications, but when the findings are extrapolated to U.S. guidelines, the researchers suggest 1 in 23 women diagnosed with miscarriage could still have a viable pregnancy.

What that might mean for the future of such incorrectly doomed pregnancies is unclear. Researchers did not analyze whether women in the studies who were told that their pregnancies had ended went on to have surgical procedures to clear out their uterus. (...)

Nasjonale retningslinjer gir flere overlevende
dagensmedisin.no 1.3.2011
Flere pasienter med tykk- og endetarmskreft overlever som et resultat av implementering av nasjonale retningslinjer.

Kirurgisk Avdeling ved Stavanger Universitetssykehus melder dette etter en nylig gjennomført nasjonal kohortstudie.

Sammenlignet overlevelsen
Forsker og kirurg Bjørn Steinar Nedrebø og medarbeidere sammenlignet femårsoverlevelse for pasienter som ble diagnostisert med adenokarsinom i tykk- og endetarm i perioden 1994–2003.

Tall fra Kreftregisteret og Det norske rektalkreftregisteret viste at 31.158 personer fikk dianosen i den angitte perioden.

Bedret ved spredning
19.053 av pasientene gjennomgikk kurativ kirurgi. Femårsoverlevelsen bedret seg signifikant, både for pasientene med tykktarmskreft (73,8 prosent til 78,0 prosent) og endetarmskreft (72,1 prosent til 79,6 prosent).

Den bedrede overlevelsen koblet Nedrebø til bedre utfall for pasientene med spredning til lymfeknuter. (...)

Kids not getting enough exercise at sports practice
cbc.ca 6.12.2010

More than 75 per cent of children in organized sports such as baseball or soccer do not reach the U.S. government's recommended amount of physical activity during their practices, a study suggests.

National guidelines in the U.S. recommend that children and teens perform 60 minutes of moderate to vigorous physical activity each day, but fewer than half of children and 10 per cent of teens meet these guidelines. (...)

Antibiotikabruk til bekymring
Tidsskr Nor Legeforen 2010; 130:2010 (21.10.2010)
Retningslinjer implementerer ikke seg selv. Hva skal til for å få legene til å følge retningslinjene for antibiotikabehandling?

Den medisinske utviklingen går raskt, og det er vanskelig å holde seg orientert om hva som er beste behandling og balansere dette mot den farmasøytiske industris markedsføring. I mange land har myndighetene derfor utgitt retningslinjer for behandling av vanlige sykdommer (1). For å kvalitetssikre slike retningslinjer er det strenge kriterier for utarbeiding av disse (2). (...)

Omtrent 90 % av antibiotikabruken i Norge skjer i allmennpraksis. Til tross for at retningslinjene på området har eksistert i over ti år, øker både den totale antibiotikabruken og bruken av bredspektrede resistensdrivende midler (6). Etter vår mening skyldes dette bl.a. manglende føringer og bevilgninger fra de offentlige myndighetene som utgir retningslinjene. (...)

Børnelæger tæt på medicinalindustrien
berlingske.dk 1.9.2010
Børnelæger, der laver retningslinjer for behandling af børn med ADHD, har tæt forbindelse til medicinalindustrien, som laver medicin til netop børn med ADHD.

Flere af Danmarks førende børnepsykiatere har tætte forbindelser til medicinalindustrien. Men samtidig står de også i spidsen for en arbejdsgruppe, som udarbejder retningslinjer for behandlingen af børn med ADHD - tidligere kaldet damp.

Det skriver fagbladet Børn&Unge torsdag.

Bladet fortæller, hvordan den førende danske overlæge Per Hove Thomsen foruden at være formand for den gruppe læger, der udarbejder retningslinjer for behandling af børn med ADHD i Danmark, er foredragsholder, underviser og konsulent for medicinalvirksomheden Novartis, som fremstiller Ritalin. (...)

(Anm: Salg av sykdom (mintankesmie.no).)

Internists' Antidepressant Guideline Defended
medpagetoday.com 26.11.2008
PALO ALTO, Calif., Nov. 26 -- Responding to criticism from a prominent psychiatrist, the chairman of the committee that developed the American College of Physicians' new practice guideline for second-generation antidepressants offers a rebuttal.

Douglas Owens, M.D., of the VA Medical Center here, said the ACP had no intention of suggesting that anti-depressant drugs are the only depression treatment that primary care physicians need to know about. (...)

Dr. Karasu said guidelines related to complex disorders such as depression should address those complexities. He said it was inappropriate to focus on a single treatment modality.

"The cart is put before the horse here," he said. "It's the worst possible practice to give something like this to general practitioners." (See: Psychiatrists Give Mixed Reviews on ACP Antidepressant Guideline) (...)

Evidence-based guidelines for treating depressive disorders with antidepressants: A revision of the 2000 British Association for Psychopharmacology guidelines
Journal of Psychopharmacology 2008;(4):343-396 (June 1) (British Association for Psychopharmacology)
(…) Concerns about the reasons for the higher venlafaxine fatal toxicity index led to a review in the UK (Medicines and Healthcare Products Regulatory Authority, 2006), which concluded that it is partly, but not completely, attributable to patient characteristics and possible mechanisms include cardiotoxicity, seizures, serotonin syndrome/muscle toxicity and CNS depression, but that the relative importance of these mechanisms could not be assessed. Caution was recommended in vulnerable patients (e.g. high arrhythmia risk, uncontrolled hypertension) and at doses ≥300 mg daily. TCAs are cardiotoxic, mainly due to cardiac sodium channel blockade leading to conduction defects (Thanacoody and Thomas, 2005) and MAOIs are dangerous in overdose and have interactions with tyraminecontaining foodstuffs and a variety of medications; toxic effects including hypertensive crisis, serotonin and noradrenaline toxicity and central nervous system excitation and depression (Bateman, 2003).

This is not a complete review of safety considerations and adverse effects and the prescribing should be done in conjunction with a reference book such as the British National Formulary (BMJ and RPS, 2007); some others are considered in Evidence section 5. (...)

New Guidelines Shed Light on Use of Psychiatric Medications During Pregnancy CME/CE
medscape.com 10.4.2008
April 10, 2008 — The American College of Obstetricians and Gynecologists (ACOG) has issued updated guidelines for the treatment of certain psychiatric illnesses during pregnancy and breast-feeding. The April 2008 Practice Bulletin updates the previous November 2007 bulletin and is based on current evidence of risks and benefits of treatment of psychiatric illnesses during pregnancy. The guidelines are designed to aid clinicians in providing appropriate care. (...)

Guidelines Seek to Reduce Medication Errors
Involving Kids
healthfinder.gov 11.4.2008
A key recommendation is measuring a child's weight in kilograms. (...)

"Sadly, there seems to be a lack of widespread appreciation even among health-care providers that children have unique safety and medication needs," said Dr. Matthew Scanlon, assistant professor of pediatrics-critical care at the Medical College of Wisconsin and a member of the Joint Commission's Sentinel Event Advisory Group. "The issues of having to adapt products -- be it technology or medications -- that were created for adults and apply those to pediatric patients is terribly problematic and really is the source of a great deal of work that has to be performed on a daily basis among pediatric health-care providers."

Added Catherine Tom-Revzon, clinical pharmacy manager at Children's Hospital at Montefiore in New York City: "This is definitely increasing the public awareness that at least something's being done to address the medication errors that occur in children."

The alert follows publication this week of a study that found that medication errors, including accidental overdoses and adverse reactions, affect about one of 15 -- or 7 percent -- of hospitalized children. The study was published in the April issue of the journal Pediatrics. (...)

Behind Antismoking Policy Influence of Drug Industry
wsj.com (12.2.2007)
Companies Featured in This Article: GlaxoSmithKline, Pfizer
Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies.
Conflict of interest? No, says Dr. Fiore, who has consistently declared that doctors ought to use stop-smoking medicine. He says his opinion -- reflected in current federal guidelines -- is based on scientific evidence from hundreds of studies.

Now debate is growing about that evidence, and about who should ... (...)

US clinical guidelines often influenced by industry, NEJM says
BMJ 2007;334:171 (27 January)
Many clinical guidelines for doctors in the United States are influenced by the pharmaceutical industry and special interest groups, said an article in the New England Journal of Medicine last week (2007;356:331-3).

"The quality of guidelines varies considerably," and some are controversial, says a commentary by the journal's national correspondent, Robert Steinbrook.

Meanwhile, the National Institutes of Health (NIH) cancelled a conference that it had planned on guidelines for screening pregnant women for herpes, after it received a protest letter from the Center for Science in the Public Interest. The organisation's letter said that four out of five of the speakers had undisclosed ties to drug firms that made antiviral drugs (BMJ 2007;334:115). (...)

Omstridte retningslinjer
Tidsskr Nor Lægeforen 2005;125:2909 (3.11.2005)
Europeiske retningslinjer for behandling av kardiovaskulær risiko vil berøre flertallet av voksne i befolkningen og ha store etiske, samfunnsmedisinske og ressursmessige konsekvenser.

I 2004 publiserte norske forskere en artikkel som viste at med nye europeiske retningslinjer for kardiovaskulær risikointervensjon blir 90 % av den voksne befolkning over 50 år gjort til potensielle pasienter (1). (...)

Vejledning om antipsykotika til ældre med demens og psykiatriske symptomer
Institut for Rationel Farmakoterapi 9.11.2005

Behandling med psykofarmaka har beskeden terapeutisk effekt, men betydeligt alvorlige bivirkninger.

IRF har derfor udgivet en ny folder om udredning og behandling af psykiatriske symptomer, med fokus på behandling af urolige demente ældre. Titlen på folderen er: ”Ældre med demens, psykiatriske symptomer og urolig adfærd” og er i lommeformat.

Folderen udgives i et samarbejde med Sundhedsstyrelsen og demens-eksperter, og de 12 gode råd er et resultat af en nylig rapport fra Sundhedsstyrelsen. Alle læger får tilsendt et eksemplar.

Læs hele folderen i PDF format (98 KB)

Læs om baggrunden for arbejdet

Læs hele rapporten på Sundhedsstyrelsens hjemmeside (...)

GPs to stop prescribing antidepressants blamed for suicidal feelings in under-18s (Allmennpraktiserende leger stanser forskrivning av antidepressiva klandret for selvmordstanker hos de under 18)
Guardian 28.9.2005
· 40 000 barn stanser gradvis pillebruken (Pills to be phased out for up to 40,000 children)
· Nye behandlinger inkluderer trening og veiledning (New treatments to include exercise and counselling)

Leger ble i går bedt om å slutte å gi barn under 18 år antidepressiva, på grunn av risikoen for at pillen får dem til å føle seg suicidale. (...) (Doctors were yesterday told to stop giving antidepressants to children and people under 18, because of the risks that the pills will make them feel suicidal.)

Dataene viste at 3,4 % av barna erfarte endret sinnsstemning, forsøkte selvskading eller fikk selvmordstanker, sammenliknet med 1,2 % som fikk narrepiller i forsøket. (...) (The data showed that 3.4% of children experienced mood changes, tried to harm themselves or thought of suicide, compared with 1.2% who took a dummy pill in the trials.)