Thursday, July 28, 2016

Mis lecturas Julio 2016a

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.







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