Revista: Plos Medicine
Relaciones financieras entre organizaciones que producen Guías de Práctica Clínica y las empresas Biomédicas
Financial relationships between organizations that produce clinical
practice guidelines and biomedical companies are vulnerable to conflicts of
interest. We sought to determine whether organizations that produce clinical
practice guidelines have financial relationships with biomedical companies and
whether there are associations between organizations’ conflict of interest
policies and recommendations and disclosures provided in guidelines.
Methods and Findings
We conducted a cross-sectional survey and review of websites of 95
national/international medical organizations that produced 290 clinical
practice guidelines published on the National Guideline Clearinghouse website
from January 1 to December 31, 2012. Survey responses were available for 68%
(65/95) of organizations (167/290 guidelines, 58%), and websites were reviewed
for 100% (95/95) of organizations (290/290 guidelines, 100%). In all, 63%
(60/95) of organizations producing clinical practice guidelines reported
receiving funds from a biomedical company; 80% (76/95) of organizations
reported having a policy for managing conflicts of interest. Disclosure
statements (disclosing presence or absence of financial relationships with
biomedical companies) were available in 65% (188/290) of clinical practice guidelines
for direct funding sources to produce the guideline, 51% (147/290) for
financial relationships of the guideline committee members, and 1% (4/290) for
financial relationships of the organizations producing the guidelines. Among
all guidelines, 6% (18/290) disclosed direct funding by biomedical companies,
40% (117/290) disclosed financial relationships between committee members and
biomedical companies (38% of guideline committee members, 773/2,043), and 1%
(4/290) disclosed financial relationships between the organizations producing
the guidelines and biomedical companies. In the survey responses, 60
organizations reported the procedures that they included in their conflict of
interest policies (158 guidelines): guidelines produced by organizations
reporting more comprehensive conflict of interest policies (per additional
procedure, range 5–17) included fewer positive (rate ratio [RR] 0.91, 95% CI
0.86–0.95) and more negative (RR 1.32, 95% CI 1.09–1.60) recommendations
regarding patented biomedical products. The clinical practice guidelines
produced by organizations reporting more comprehensive conflict of interest
policies were also more likely to include disclosure statements for direct
funding sources (odds ratio [OR] 1.31, 95% CI 1.10–1.56) and financial
relationships of guideline committee members (OR 1.36, 95% CI 1.09–1.79), but
not financial relationships of the organizations (0 disclosures). Limitations
of the study include the use of the National Guideline Clearinghouse as the
single source of clinical practice guidelines and the self-report of survey
responses and organizations’ website postings.
Conclusions
Financial relationships between organizations that produce clinical
practice guidelines and biomedical companies are common and infrequently
disclosed in guidelines. Our study highlights the need for an effective policy
to manage organizational conflicts of interest and disclosure of financial
relationships.
Campsall P, Colizza K, Straus S, Stelfox HT (2016) Financial
Relationships between Organizations That Produce Clinical Practice Guidelines
and the Biomedical Industry: A Cross-Sectional Study. PLoS Med 13(5):
e1002029. doi:10.1371/journal.pmed.1002029
Comentario: Cuidado.
Los nuevos medicamentos para el tratamiento de la hepatitis C han demostrado gran eficacia y tolerabilidad... pero son muy caros.
New hepatitis C virus (HCV) medicines have markedly improved treatment
efficacy and regimen tolerability. However, their high prices have limited
access, prompting wide debate about fair and affordable prices. This study
systematically compared the price and affordability of sofosbuvir and
ledipasvir/sofosbuvir across 30 countries to assess affordability to health
systems and patients.
Methods and Findings
Published 2015 ex-factory prices for a 12-wk course of treatment were
provided by the Pharma Price Information (PPI) service of the Austrian public
health institute Gesundheit Österreich GmbH or were obtained from national
government or drug reimbursement authorities and recent press releases, where
necessary. Prices in Organisation for Economic Co-operation and Development
(OECD) member countries and select low- and middle-income countries were
converted to US dollars using period average exchange rates and were adjusted
for purchasing power parity (PPP). We analysed prices compared to national
economic performance and estimated market size and the cost of these drugs in
terms of countries’ annual total pharmaceutical expenditure (TPE) and in terms
of the duration of time an individual would need to work to pay for treatment
out of pocket. Patient affordability was calculated using 2014 OECD average
annual wages, supplemented with International Labour Organization median wage
data where necessary. All data were compiled between 17 July 2015 and 25
January 2016. For the base case analysis, we assumed a 23% rebate/discount on
the published price in all countries, except for countries with special pricing
arrangements or generic licensing agreements.
The median nominal ex-factory price of a 12-wk course of sofosbuvir
across 26 OECD countries was US$42,017, ranging from US$37,729 in Japan to
US$64,680 in the US. Central and Eastern European countries had higher
PPP-adjusted prices than other countries: prices of sofosbuvir in Poland and
Turkey (PPP$101,063 and PPP$70,331) and of ledipasvir/sofosbuvir in Poland
(PPP$118,754) were at least 1.09 and 1.63 times higher, respectively than in
the US (PPP$64,680 and PPP$72,765). Based on PPP-adjusted TPE and without the
cost of ribavirin and other treatment costs, treating the entire HCV viraemic
population with these regimens at the PPP-adjusted prices with a 23% price
reduction would amount to at least one-tenth of current TPE across the
countries included in this study, ranging from 10.5% of TPE in the Netherlands
to 190.5% of TPE in Poland. In 12 countries, the price of a course of
sofosbuvir without other costs was equivalent to 1 y or more of the average
annual wage of individuals, ranging from 0.21 y in Egypt to 5.28 y in Turkey.
This analysis relies on the accuracy of price information and infection prevalence
estimates. It does not include the costs of diagnostic testing, supplementary
treatments, treatment for patients with reinfection or cirrhosis, or associated
health service costs.
Conclusions
Current prices of these medicines are variable and unaffordable
globally. These prices threaten the sustainability of health systems in many
countries and prevent large-scale provision of treatment. Stakeholders should
implement a fairer pricing framework to deliver lower prices that take account
of affordability. Without lower prices, countries are unlikely to be able to
increase investment to minimise the burden of hepatit
Iyengar S, Tay-Teo K, Vogler S, Beyer P, Wiktor S, de Joncheere K, et
al. (2016) Prices, Costs, and Affordability of New Medicines for Hepatitis C in
30 Countries: An Economic Analysis. PLoS Med 13(5): e1002032.
doi:10.1371/journal.pmed.1002032
El cancer, la genomica, utilidad para el diagnóstico ,estratificación de la enfermedad e investigación para los tratamientos.
Abstract
Aging of populations in many countries around the world means that the
incidence of cancer, a disease of ageing, can be expected to increase steadily.
In addition to meeting the growing need for care of oncology patients,
development of new and improved cancer treatments is therefore an important
priority. In this month’s Editorial, we discuss progress in cancer genomics
that promises to inform diagnosis, disease stratification, and research on
targeted cancer therapies. We invite submission of translational and clinical
research studies to PLOS Medicine for a special issue on the topic to be
published in late 2016, for which Drs Elaine Mardis and Marc Ladanyi will serve
as Guest Editors.
Image Credit: NIH, Flickr
Nota. Si eres como yo ,que ya llevo unos años ejerciendo, necesitarás renovar tus conocimientos. Mira aquí:.Edx courses
Acta Pediatrica
Cuidado con la circuncisión, a veces se complica. Es aconsejable llevarla a cabo en hospitales con medios para la reanimación.
Circulatory shock;Infant
circumcision;Medical malpractice;Neonatal complications;Severe bleeding
More than 7000 male circumcisions are performed in Scandinavia every
year. Circumcision is regulated in different ways in Sweden and Denmark and
Norway. This study reviewed and described factors associated with complications
of circumcision in infant boys in Scandinavia over the last two decades and
discussed how these complications could be avoided.
Methods
Data on significant complications following circumcision on boys under
the age of one in Scandinavia over the last 20 years were collected.
Information was retrieved from testimonies of circumcisers, witnesses, medical
records and verdicts. A systematic review was performed of fatal cases in the
literature.
Results
We found that 32 cases had been reported to the health authorities in
the three countries, and we identified a total of 74 complications in these
cases. These included four boys with severe bleeding and circulatory shock,
which ended in the death of one boy. Other less serious complications may have
occurred in other boys, but not been reported.
Conclusion
Complications following male circumcision in Scandinavia were relatively
rare, but serious complications did occur. Based on the analyses of the severe
cases, we argue that circumcision should only be performed at hospitals with
24-hour emergency departments.
Edler, G., Axelsson, I., Barker, G. M., Lie, S. and Naumburg, E. (2016),
Serious complications in male infant circumcisions in Scandinavia indicate that
this always be performed as a hospital-based procedure. Acta Paediatrica,
105: 842–850. doi: 10.1111/apa.13402
Comentario: Este problema si que tiene relevancia aunque llevo muchos años trabajando en Atención Primaria y nunca me he encontrado un caso tan severo. Pero... pueden haber consultado diréctamente con el servicio de urgencias. ¿Porqué es importante? Porque en muchas culturas se practica la circuncisión por razones religiosas, higiénicas o culturales y dado que no ésta cubierta por la Seguridad Social, recurren a Médicos u otros personal que les operan en las casas con el consiguiente riesgo.
Eficacia y seguridad del Propanolol en el Tratamiento de los hemangiomas infantiles
Keywords:
Hypoglycaemia;Hypotension;Infantile haemangiomas;Prednisolone
propranolol
The aim of this study was to explore the efficacy and safety of
propranolol in treating infantile haemangiomas, the most common benign vascular
tumours in children.
Methods
We carried out a retrospective chart review of infantile haemangioma
patients admitted to the Faculty of Medicine, Khon Kaen University, Thailand,
from January 2009 to January 2015.
Results
There were 53 infantile haemangioma cases treated with oral propranolol.
Treatment responses occurred as early as two weeks after propranolol
administration in 91.5% of the follow-up patients, with all 53 cases achieving
the desired treatment responses two months after propranolol was initiated. No
significant differences in treatment responses were found between propranolol
as a mono-therapy or as a combination therapy with prednisolone at the two-week
(p value 0.13) and one-month follow-ups (p value 0.98). Complications were
documented in three cases (5.6%) when the propranolol dose was increased, and
these were asymptomatic hypoglycaemia in two cases and one case of hypotension.
Conclusion
Propranolol was effective in treating infantile haemangiomas, and
combining it with prednisolone achieved no significant differences in treatment
outcome. Cases should be monitored for hypoglycaemia and hypotension. More data
on using propranolol for infantile haemangiomas are needed, including long-term
follow-up studies.
echasatian, L., Komwilaisak, P., Panombualert, S., Uppala, R. and
Jetsrisuparb, C. (2016), Propranolol was effective in treating cutaneous
infantile haemangiomas in Thai children. Acta Paediatrica, 105: e257–e262. doi:
10.1111/apa.13378
Comentario: Otro estudio más que confirma la eficacia del tratamiento con Propanolol en los hemangiomas infantiles (retrospectivo)
Gastroschisis;Impairments;Interdisciplinary;Long-term outcomes;Morbidity
The aims of this Argentinian study were to describe and analyse the
outcomes of a continuous interdisciplinary follow-up programme of patients with
gastroschisis.
Methods
This was a prospective, longitudinal study of babies with gastroschisis
admitted from 1 November 2003 to 31 October 2014, and this paper presents
results at one, three and six years of age. Matched-pairs analyses were carried
out when they were one and six.
Results
We enrolled 62 babies and assessed 52 at one year of age, 34 at three
years and 17 at six years. This showed that 63% had mental health problems and
5% had recurrent wheezing. Normal outcomes at one, three and six years were
growth (80%, 85% and 80%), neurology-psychomotor development index (64%, 50%
and 82%), audiology (100%, 76% and 76%), vision (98%, 94% and 89%) and language
(55%, 62% and 65%). The rehospitalisation rates were 30%, 0.3% and zero, and
the surgical re-intervention rates were 9%, 0.3% and 12%. Matched-pairs
analysis showed no significant differences between outcomes at the ages of one
and six.
Conclusion
Babies born with gastroschisis were at risk for long-term morbidity and
impairments, according to follow-up assessments at the ages of one, three and
six years.
Giúdici, L., Bokser, V. S., Maricic, M. A., Golombek, S. G. and
Ferrario, C. C. (2016), Babies born with gastroschisis and followed up to the
age of six years faced long-term morbidity and impairments. Acta Paediatrica,
105: e275–e280. doi: 10.1111/apa.13374
Comentario: No es fácil afirmar esto desde la Consulta de Atención Primaria por los pocos casos que vemos , pero es un tema que me intrigó hace años dado un caso de un paciente mayor ya (adolescente) con problemas de conducta, que al final fueron "etiquetados" de rasgos Autistas.
¿Existe una relacion lineal (correlación) entre la Procalcitonina y La PCR en las infecciones bacterianas severas?
Keywords:
Bacteraemia;C-reactive
protein;Ketoacidosis;Procalcitonin;Serious bacterial infection
Procalcitonin (PCT) and C-reactive protein (CRP) are biomarkers of
bacterial infection with distinct clinical qualities. This study aimed to
determine the occurrence and significance of discrepancies in plasma PCT and
CRP levels in hospitalised children.
Methods
This was a single centre, retrospective analysis of simultaneous PCT and
CRP measurements. Clinical characteristics, microbiological findings and
diagnoses were compared between cases in which only PCT or CRP levels were
elevated.
Results
We studied 635 pairs of PCT and CRP measurements and found discrepancies
in 29% of these. In the group with increased PCT and low CRP, there were more
children with hypoxia or haemodynamic stress (14 versus 0, p < 0.001) and
more bacteraemic patients (eight versus zero, p = 0.001) than in the group with
low PCT and increased CRP. The latter group was associated with focal bacterial
infections (three versus 18, p = 0.009), inflammatory conditions (one versus
12, p = 0.016) and postoperative setting (one versus 19, p = 0.001). Diabetic
ketoacidosis was associated with a marked elevation of PCT.
Conclusion
Discrepancies in plasma PCT and CRP levels occurred in 29% of acutely
ill children. Both biomarkers can increase in the absence of bacterial
infection, but PCT may offer an advantage over CRP in the diagnosis of
bacteraemia.
Ivaska, L., Elenius, V., Mononen, I., Ruuskanen, O. and Peltola, V.
(2016), Discrepancies between plasma procalcitonin and C-reactive protein
levels are common in acute illness. Acta Paediatrica, 105: 508–513. doi:
10.1111/apa.13293
Comentario: Éste merece un comentario más meditado . Lo dejo para otro Post.
