The role of brain biopsy in the clinical management of HIV-related focal brain lesions.

OBJECTIVES: Up to 20% of HIV-related focal brain lesion (FBL) diagnoses cannot be determined without invasive procedures. In such cases, brain biopsy is an important step in the evaluation algorithm. The aims of this study were to describe the clinical outcomes of patients with FBL, the proportion of diagnoses confirmed by brain biopsies and their aetiologies, and to analyse the proportion of patients in whom the biopsy motivated a change in therapeutic management. METHODS: A retrospective cohort study was performed. The data from clinical records of patients with HIV-related FBL admitted between January 2005 and December 2015 were reviewed. RESULTS: A total of 137 patients were included in the study. The median age was 39 years [interquartile range (IQR) 33-44.5 years]. The median CD4 count was 54 cells/µL (IQR 21-124 cells/µL). Cerebral brain biopsy was performed in 21.16% of patients (29 of 137); 68.9% of these individuals (20 of 29) were diagnosed by histology, with results of central nervous system (CNS) lymphoma in 20.6% (six of 29), progressive multifocal leucoencephalopathy in 6.8% (two of 29), toxoplasmosis in 6.8% (two of 29), tuberculoma in 6.8% (two of 29), and other diagnoses in 27.6% (eight of 29). In nine patients, the histology was nonspecific. In 75.8% of patients (22 of 29), the result of the biopsy led to a change in the therapeutic management. We did not observe higher rates of mortality related to the procedure. Overall mortality at 30 and 90 days was similar in patients who were and were not biopsied. CONCLUSIONS: In this retrospective cohort study, cerebral biopsy was associated with significant adjustments in therapeutic management for a high percentage of patients.

[Determining factors in the sedation of geriatric and oncology patients treated at home]. / Factores condicionantes de sedación en pacientes geriátricos y oncológicos atendidos en el domicilio.

INTRODUCTION: Sedation, used as a therapeutic measure in the field of Palliative Care, continues to present difficulties for many professionals in its management and indications. Is varied existing literature in this regard, often exclusive cancer patients. Our objective is to analyse the characteristics of patients attended by a Home Care Support Team who required sedation compared to non-sedated patients, for possible determining factors for its use that could help in decision-making. METHOD: A prospective analytical study conducted in Barbastro (Huesca) from September 2007 to February 2011. The study population are patients referred to the Home Care Support Team of Barbastro. MAIN VARIABLES: Age, sex, medical history, symptoms, previous and current Barthel, Karnofsky, primary caregiver, previous drugs, drugs after intervention, sedation yes/no. RESULTS: Required sedation 16.6% (n=106) of the cases (N=638). Sedated patients were younger, with no differences in sex, and the large majority (83%) were oncology patients. The presence of metastases showed no differences in need for sedation. Sedated patients have an increased functional impairment, determined by Barthel index decreased and a worse Karnofsky. Sedated patients showed increased frequency of uncontrolled symptoms, except psychomotor agitation, a fact determined by the medications used pre- and post-intervention. CONCLUSIONS: The presence of neoplastic disease, marked with existence of functional decline, and uncontrolled clinical need for certain medications to control symptoms may determine the need for sedation at the end of the process, above other factors such as patient comorbidity.

A checklist for critical appraisal of indirect comparisons.

The aim of this study was to develop a user-friendly checklist for critical appraisal of indirect comparisons of drugs, considering clinical, methodological/statistical and quality aspects, mainly to be applied in drug evaluation in the decision-making context. After conducting a review of the literature, we used group consensus to establish the key points of the checklist, focusing mainly on indirect comparisons, but including topics related to network meta-analysis or multiple treatment comparisons. The coordinating group elaborated the first draft, which was reviewed by external experts, re-evaluated by the coordinating group and finally assessed by 23 drug evaluation experts trained in indirect comparisons, who applied the checklist to one study. The Kappa index of agreement was calculated and the final checklist was developed by group consensus including the external experts. The checklist has two parts. The first consists of three eliminatory key questions while the second includes 17 items: 5 regarding quality, 5 regarding clinical issues and 7 dealing with methodology/statistics. The median kappa values of the 23 evaluations were 0.83 (range 0.67-0.93), 0.61 (0.54-0.91) and 0.36 (0.22-1) with regard to quality, clinical aspects and methodology/statistics, respectively. A structured checklist was developed to facilitate critical appraisal of key issues in indirect comparisons, including comments for assessing the consequences of its application to drug evaluation in the decision-making context. Agreement between reviewers in clinical and quality items was good, but weaker in methodology/statistics ones.

Control of post-hemorrhoidectomy symptoms and wound healing by Triclosan: a randomized, double-blind, controlled trial.

AIM: Milligan-Morgan hemorrhoidectomy (MM) is still the most common treatment for grades III and IV hemorrhoids despite prolonged post-operative anal pain and wound healing. This multicenter, double blind, randomized, controlled trial was designed to assess the safety and the efficacy of anal wound cleansing with Triclosan (Proctocid®) in the control of symptoms and healing time after MM. METHODS: A total of 113 patients with grades III and IV hemorrhoids, undergoing open hemorroidectomy by diathermy or Ligasure vessel sealing device, were randomly assigned to Triclosan or sodium hypochlorite solution. All patients received analgesics and a fiber-rich diet after hemorrhoidectomy. Postoperative anal pain, bleeding and/or secretion and itch were assessed 7, 14 and 21 days after hemorrhoidectomy by a Visual Analogue Scale (VAS) and the day of complete re-epithelialization of anal wounds was recorded. RESULTS: Fifty-five patients were randomized for Triclosan treatment and 58 for the control drug. The two groups were comparable for demographics, severity of hemorrhoids and technique used for the hemorrhoidectomy. The comparison of days to get complete anal wound healing shows a trend of significance (P=0.05) for the Triclosan group. Bleeding and/or secretion, anal pain and itch were significantly better (P=0.003; P<0.0001 and P=0.01, respectively). CONCLUSION: Triclosan solution for the treatment of post-hemorrhoidectomy wounds is safe and improves the control of post-operative symptoms and wound healing time compared to sodium hypochlorite.

Direct and indirect comparison of the efficacy and safety of adalimumab, etanercept, infliximab and golimumab in psoriatic arthritis.

WHAT IS KNOWN AND OBJECTIVE: Psoriatic arthritis is an autoimmune disease characterized by chronic inflammation of the skin and joints. Anti-TNF drugs reduce the severity of the disease in the long term. This study compares the efficacy and safety of adalimumab, etanercept, infliximab and golimumab in patients with psoriatic arthritis. METHODS: Direct comparison was based on a literature search of drug comparison studies, whereas indirect treatment comparison was based on phase III clinical trials with biological agents, involving similar populations and durations, and with the same outcome. ACR50 was taken as primary outcome for comparison, whereas ACR20 and ACR70 were used as secondary outcomes. Indirect comparisons were made using infliximab as the reference drug and the Bucher method. In calculating δ (the maximum acceptable difference as a clinical criterion of equivalence), use was made of half of the absolute risk reduction obtained in the meta-analysis of the clinical trials included in the indirect comparison (ARR 32%; δ: 16%). The four anti-TNF drugs were also compared in relation to the secondary outcomes and adverse effects. RESULTS AND DISCUSSION: Reported direct and indirect comparisons of the four drugs did not include golimumab, and did not yield conclusive results. Four clinical trials - one for each drug studied - were identified. The estimated differences for the primary outcome, ACR50, between infliximab and the other drugs were adalimumab (ARR 4%, 95% CI -9·5 to 17·5), etanercept (ARR 4%, 95% CI -10·5 to 18·5) and golimumab (ARR 9%, 95% CI -5·4 to 23·4). Likewise, there were no relevant differences between the drugs in relation to the secondary efficacy outcomes, except for etanercept, which was less effective in ACR70 response. For adverse reactions, there were also no significant differences except for injection site, reactions which were more frequent with etanercept, with a mean difference of 26% relative to infliximab. WHAT IS NEW AND CONCLUSION: No significant differences were found in ACR50 responses to the four drugs after 24 weeks. Injection-site reactions were more common with etanercept, but this was insufficient to invalidate the inference that clinically the four drugs can be regarded as clinically equivalent for the treatment of psoriatic arthritis.

[Indirect comparisons in drug assessment reports on the GENESIS group (SEFH) webpage]. / Comparaciones indirectas en los informes de evaluación de medicamentos en la web del grupo GENESIS de la SEFH.

OBJECTIVE: Quantify use of indirect comparisons (IC) in drug evaluation reports published on the GENESIS Group web page for new drug assessment, standardisation, and drug selection research. METHOD: Retrospective study of drug reports written between 2008 and 2009. DATA COLLECTED: presence of an active comparator and details from any direct and indirect comparative studies included. RESULTS: An active comparator was present in 95% of the 337 analysed reports; 50% included a direct comparative study vs comparator. In 114 reports (34%), an IC was used; 69% of the ICs were made by the report author. Most ICs were narrative and none were adjusted. An IC could have been made in an additional 16% of the cases and possibly in 24% more. CONCLUSIONS: Most evaluated drugs have an active comparator but studies comparing them directly are not as common. ICs could be included in more reports along with quality control criteria.

Tratamiento del hiperparatiroidismo primario mediante abordaje mínimamente invasivo / Treatment of the primary hiperparatiroidism by minimally invasive boarding

The unilateral boarding of the primary hiperparatiroidism constitutes a technical option increasingly secondhand and adapted for the characteristics of this surgery. This type of boarding has been possible for the appearance of the Tc sestamibi, of the subspecialization of the surgery and of the determination of the PTH intraoperatory. Later we expose an epidemiological, descriptive and retrospective study from january 2004 to December 2008. During this time there were controlled in the hospital Ramon and Cajal of Madrid a total of 195 patients for primary hiperparatiroidism. Of them, 140 were submitted to unilateral exploration by suspicion of the solitary adenoma. The correlation between the findings of Tc sestamibi and surgical was correct in all the cases (139) except one concerns to right or left side. It failed in 30 cases in which there was detected badly the top and low location. As for the results the adenoma was extirpated correctly in 135 of 140 patients. This way we can say that the combination of the gammagraphy, a surgeon with experience and the support of the PTH intraoperatory they meet a high rate of treatment in case of adenomas in the unilateral boarding on a rate of hipercalcemia appellant or persistently between 3 percent-5 percent, rate similar to the obtained one for expert surgeons on having fulfilled an exploratory cervicotomy (considered "gold standard") but with minor postoperatory morbidity, minor pain and minor surgical time.

El abordaje unilateral del hiperparatiroidismo primario constituye una opción técnica cada vez más usada y apropiada debido a las características de esta cirugía. Este tipo de abordaje ha sido posible por la aparición del Tc sestamibi, de la subespecialización de la cirugía y de la determinación de la PTH intraoperatoria. A continuación exponemos un estudio epidemiológico, descriptivo y retrospectivo desde enero de 2004 a diciembre de 2008. Durante este tiempo fueron intervenidos en el hospital Ramón y Cajal de Madrid un total de 195 enfermos por hiperparatiroidismo primario. De ellos, 140 fueron sometidos a exploración unilateral por sospecha de adenoma único. La correlación entre los hallazgos gammagráficos y quirúrgicos fue correcta en todos los casos (139) menos uno en cuanto a lo que a lateralidad se refiere. Falló en 30 casos en los que se detectó mal la localización superior e inferior. En cuanto a los resultados, se extirpó el adenoma correctamente en 135 de los 140 pacientes. Así podemos decir que la combinación de la gammagrafía, de un cirujano con experiencia y el apoyo de la PTH intraoperatoria proporciona una elevada tasa de curación en el caso de adenomas paratiroideos en el abordaje unilateral con una tasa de hipercalcemia recurrente o persistente entre el 3 por ciento-5 por ciento, tasa similar a la obtenida por cirujanos expertos al realizar una cervicotomía exploradora (considerada gold standard) pero con menor morbilidad postoperatoria, menor dolor y menor tiempo quirúrgico.

Developing a search engine for pharmacotherapeutic information that is not published in biomedical journals.

OBJECTIVE: To identify publishers of pharmacotherapeutic information not found in biomedical journals that focuses on evaluating and providing advice on medicines and to develop a search engine to access this information. METHODS: Compiling web sites that publish information on the rational use of medicines and have no commercial interests. Free-access web sites in Spanish, Galician, Catalan or English. Designing a search engine using the Google "custom search" application. RESULTS: Overall 159 internet addresses were compiled and were classified into 9 labels. We were able to recover the information from the selected sources using a search engine, which is called "AlquimiA" and available from http://www.elcomprimido.com/FARHSD/AlquimiA.htm. CONCLUSIONS: The main sources of pharmacotherapeutic information not published in biomedical journals were identified. The search engine is a useful tool for searching and accessing "grey literature" on the internet.

Pseudoquiste de páncreas con extensión a mediastino / Pancreatic pseudocyst extended to the mediastinum: case report

We report a 53 years old male consulting for chest pain and dyspnea. On physical examination, an epigastric mass was detected. A TC scan showed a collection located in the omental bursa, which protruded over the posterior gastric wall and ascended to the mediastinum. Due to the presence of pancreatic calcifications, a pancreatic pseudocyst was suspected. The mediastinal cyst was drained percutaneously, leaving pig tail drainage in the cavity. Afterwards a cyst excision and Roux en Y gastrostomy was performed. After the surgical procedure the cyst became infected, requiring antimicrobials. After two weeks he was discharged in good conditions.

Los pseudoquistes de páncreas representan el 75 por ciento de las lesiones quísticas del páncreas y generalmente se circunscriben en el abdomen. Se presenta el caso de un paciente con un pseudoquiste de páncreas con extensión transhiatal a mediastino. Estos casos deben sospecharse mediante una historia clínica detallada y preguntando por antecedentes de dolor abdominal previo porque la clínica con la que se suelen manifestar es muy poco específica. El tratamiento de los pseudoquistes con extensión a mediastino debería ser el drenaje definitivo, bien de forma quirúrgica o endoscópica.

[Classification and variability of drug assessment reports on the GENESIS group (SEFH) webpage]. / Caracterización y variabilidad de los informes de evaluación de medicamentos en la página web del grupo GENESIS de la SEFH.

OBJECTIVE: To analyse the assessment reports published on the GENESIS webpage (Group for Innovation, Assessment, Standardisation and Research in the Selection of Drugs) and assess the variability of the group's proposals to include drugs in the Formulary. METHOD: We analysed reports published by hospitals on the GENESIS webpage between 2004 and 2007. Data were collected on drugs and indications, ATC group, open or restricted access publications, hospital, and publication date. We drafted a questionnaire that would measure to what extent to what extent the 9-section model recommended by GENESIS was included in each report. For drugs with two or more reports, we analysed whether the recommendation coincided and the possible cause in the event of conflict. RESULTS: We analysed 416 reports corresponding to 185 different drug indications. 93% included 6 or more of the recommended sections, a number which increased over time. The most frequently included sections were: approved indications (92%), mechanism of action (95%), and references (86%) (percentages from 2007). Sections which had an increasing but lower percentage were: differential characteristics (60%), literature search method (40%) and conclusions with a summary of efficacy, safety and cost data (52%). 73% of which had definite recommendations, which coincided for 42 out of the 67 drugs with more than one recommendation report. CONCLUSIONS: The work carried out by the GENESIS group has enabled Spanish hospitals to share their drug assessment reports and making them more complete, although there are still some aspects that can be improved.

Variability in activity and results from drug assessments by pharmacy and therapeutics committees in Spanish hospitals.

OBJECTIVE: To quantify the Spanish Pharmacy and Therapeutics Committees (P&TC) activity with regard to assessing and selecting drugs and describing variability in decisions made to include them. METHOD: Descriptive, cross-sectional study based on a questionnaire aimed to 513 hospitals with more than 75 beds. We included questions referring to the P&TC resolutions, the therapeutic positioning and assessment reports. Recruitment was carried out between November 2007 and January 2008. Variability among P&TC conclusions were presented in five categories or levels of coincidence. RESULTS: One hundred and seventy-five hospitals participated, with a response rate of 34% (54% of beds). The mean (SD) number of drug-indications assessed per hospital was 10.35 (7.45). The proportion of assessments that conclude with drug inclusion or rejection was 75.3 and 21.4%, respectively. 16.2% concluded with therapeutic equivalence. Conditions for use were established for 64% of them, and 33% were included in a clinical guide. With regard to variability, 81.0% of assessments coincided with the conclusion to include or reject the drug. A contradictory decision was made for 19.0%. CONCLUSIONS: Drug assessment and selection activity in hospitals involve an amount of work. The proportion of drugs approved is similar in different types of hospitals. There is extensive variability as regards deciding upon inclusion and is similar to studies conducted in other countries. They indicate that a standardising methodology would be recommendable.

Flora alergógena urbana y polen atmosférico de Diamante (Argentina) / Allergenic urban flora and airborne pollen in the air of Diamante (Argentina)

El polen del aire produce rinitis, conjuntivitis y asma, lo que lleva a una disminución en la calidad de vida. Las especies más abundantes de la vegetación son en general, las que aportan mayoritariamente al registro atmosférico de polen. Sin embargo, esta relación puede variar dependiendo de la cercanía de las fuentes y de la estrategia reproductiva de las plantas emisoras. En este trabajo realizado en la ciudad de Diamante (Entre Ríos, Argentina), se analizó la vegetación arbórea en cuanto a abundancia, diversidad, distribución territorial, tipo de polinización y potencialidad alergénica, para luego evaluar su relación con el polen que se registró en la atmósfera durante un ciclo anual, utilizando un método aerobiológico volumétrico y continuo bajo estándares internacionales. Se observó que la vegetación analizada presenta una gran diversidad. Los representantes de las familias más abundantes en la vegetación tienen polinización entomófila, como Tabebuia impetiginosa y Tecoma stans. Por otra parte, el 34% de los árboles correspondió a familias de polinización anemófila. Los árboles cercanos al muestreador aerobiológico (dentro de las áreas local y extralocal) son las principales fuentes de polen que contribuyen al espectro atmosférico, especialmente los árboles anemófilos. Entre ellos cabe mencionar: Fraxinus pennsylvanica, Ulmus procera y Broussonetia papyrifera. El polen de especies anemófilas en su mayoría tiene características alergénicas y son potencialmente perjudiciales para la salud. Los resultados obtenidos no sólo son importantes para ajustar el modelo aerobiológico de la ciudad, sino que sirven de fundamento para planificar el arbolado urbano.(AU)

Airborne pollen produces rhinitis, conjunctivitis and asthma, leading to a decreased quality of life. In general, the most abundant vegetation species are also present in greater amounts in the pollen spectrum. However, this relationship can vary depending on the proximity of the sources and the plant reproductive strategy. This work was carried out in Diamante city (Entre Ríos, Argentina). Abundance, diversity, territorial distribution, type of pollination, and allergenic potential of vegetation were analyzed to finally assess the relationship with the pollen recorded in the atmosphere during one annual cycle. A volumetric and continuous aerobiological method under international protocols was used to sample the airborne pollen. It was observed that urban vegetation is diverse. Families more abundant in vegetation have insect-pollinated species as representatives: Tabebuia impetiginosa and Tecoma stans. On the other hand, 34% of the trees corresponded to wind-pollinated families. The trees near the aerobiological sampler (within local and extralocal areas) were the main pollen sources contributing to the atmospheric pollen spectrum, especially those wind-pollinated tree species as Fraxinus pennsylvanica, Ulmus procera and Broussonetia papyrifera. Pollen from wind-pollinated species is most likely to be allergenic and so, potentially harmful to health. The results are important not only to adjust the aerobiological model of the city, but also as a basis to plan urban forest(AU)

[Comparative study of errors in electronic versus manual prescription]. / Estudio comparativo de errores con prescripción electrónica versus prescripción manual.

OBJECTIVE: Electronic prescribing is considered a basic measure for the prevention and reduction of medications errors. The goal of this survey was to assess the incidence of errors occurring with electronic versus standard prescription. METHOD: A prospective, sequential, open-label study to assess errors with electronic prescribing as compared to traditional manual prescribing in two public hospitals in Balearic Islands. Errors regarding medication, diet and/or nursing orders were assesses along four process stages: medical prescription, pharmacy transcription/validation, nursing transcription, and dispensation. RESULTS: With manual prescription 1,576 errors/18,539 therapy orders (8.50%) were identified, whereas with electronic prescription 827 errors/18,885 therapy orders (4.38%) were detected, which represents a relative risk reduction by 48% and an absolute risk reduction by 4.12% (p < 0.0001). Pharmacy transcription/validation errors decreased (1.73 vs. 0.13%, p < 0.0001), as did nursing transcription errors (2.54 vs. 0.81%, p < 0.0001) and dispensation errors (2.13 vs. 0.96%, p < 0.0001); however, the number of prescription errors increased (2.10 vs. 2.40%, p = 0.0401). CONCLUSIONS: Electronic prescription is a powerful tool, and one that in this work was shown to decrease medication-, diet-, and nursing care-related errors in a highly significant way; however, it should be developed and maintained in order to achieve safety and effectiveness as required by drug usage.

Treatment of bladder stones without associated prostate surgery: results of a prospective study.

OBJECTIVES: To assess the effectiveness of noninvasive bladder lithiasis treatment without associated prostate surgery to know whether bladder lithiasis is an absolute indication for prostate surgery. METHODS: Fifty patients with bladder lithiasis were entered in a prospective trial and were treated with extracorporeal shock wave lithotripsy if lithiasis was smaller than 4 cm2. Independent of the presence or absence of bladder outlet obstruction, in no case was prostate surgery associated. The variables studied were the effectiveness of the treatment, changes in the International Prostate Symptom Score (IPSS), and the subsequent need for desobstructive prostate surgery. The statistical study was performed using Student's t test and the proportional hazards model. RESULTS: Bladder lithiasis was successfully eliminated in 93% of the cases (in 77% of them with a single extracorporeal shock wave lithotripsy session). The mean IPSS decreased from 17.7 to 9.7 points (P = 0.0001) after lithiasis elimination. After a mean follow-up of 22 months, a mere 8% of the patients needed subsequent prostate surgery because their IPSS had increased to 20 points or more. The sole prognostic factor for the need for ensuing prostate surgery was the pretreatment IPSS score (P = 0.042). CONCLUSIONS: Noninvasive management of bladder lithiasis with no associated prostate surgery is highly efficient and results in marked symptomatic improvement. Furthermore, the number of patients needing subsequent prostate surgery was very low at mid-term follow-up. Because of all of the above, the existence of bladder lithiasis is not an absolute indication for prostate surgery.

Urodynamic findings before and after noninvasive management of bladder calculi.

OBJECTIVES: To determine the most frequent urodynamic observations associated with bladder calculi, and to assess whether the presence of calculi alters these observations. PATIENTS AND METHODS: Fifty patients with bladder stones were included in a prospective study in which two urodynamic tests were used, one at inclusion and another once the patient was stone- free after treatment by noninvasive methods (mainly extracorporeal shockwave lithotripsy). RESULTS: The results from the urodynamic evaluation with the stone in the bladder were: bladder outlet obstruction in 51%, detrusor overactivity in 68%, detrusor under-activity in 10%, and a normal study in 18%. There were no significant differences between the urodynamic study before or after treatment in maximum flow rate and postvoid residual volume, detrusor overactivity and detrusor pressure at maximum flow. CONCLUSIONS: Conversely to what has been accepted for years, bladder calculi are not always associated with bladder outlet obstruction and the urodynamic results are not influenced by the presence of bladder stones during the urodynamic testing.