FOTROCAN Delphi consensus statement regarding the prevention and treatment of cancer-associated thrombosis in areas of uncertainty and low quality of evidence

Introduction. Decision-making in cancer-related venous thromboembolism (VTE) is often founded on scant lines of evidence and weak recommendations. The aim of this work is to evaluate the percentage of agreement surrounding a series of statements about complex, clinically relevant, and highly uncertain aspects to formulate explicit action guidelines. Materials and methods. Opinions were based on a structured questionnaire with appropriate scores and were agreed upon using a Delphi method. Questions were selected based on a list of recommendations with low evidence from the Spanish Society of Oncology Clinical Guideline for Thrombosis. The questionnaire was completed in two iterations by a multidisciplinary panel of experts in thrombosis. Results. Of the 123 statements analyzed, the panel concurred on 22 (17%) and another 81 (65%) were agreed on by qualified majority, including important aspects of long-term and prolonged anticoagulation, major bleeding and rethrombosis management, treatment in special situations, catheter-related thrombosis and thromboprophylaxis. Among them, the panelists agreed the incidental events should be equated to symptomatic ones, long-term and extended use of full-dose low-molecular weight heparin, and concluded that the Khorana score is not sensitive enough to uphold an effective thromboprophylaxis strategy. Conclusion. Though the level of consensus varied depending on the scenario presented, overall, the iterative process achieved broad agreement as to the general treatment principles of cancer-associated VTE. Clinical validation of these statements in genuine practice conditions would be useful (AU)

No disponible

FOTROCAN Delphi consensus statement regarding the prevention and treatment of cancer-associated thrombosis in areas of uncertainty and low quality of evidence.

INTRODUCTION: Decision-making in cancer-related venous thromboembolism (VTE) is often founded on scant lines of evidence and weak recommendations. The aim of this work is to evaluate the percentage of agreement surrounding a series of statements about complex, clinically relevant, and highly uncertain aspects to formulate explicit action guidelines. MATERIALS AND METHODS: Opinions were based on a structured questionnaire with appropriate scores and were agreed upon using a Delphi method. Questions were selected based on a list of recommendations with low evidence from the Spanish Society of Oncology Clinical Guideline for Thrombosis. The questionnaire was completed in two iterations by a multidisciplinary panel of experts in thrombosis. RESULTS: Of the 123 statements analyzed, the panel concurred on 22 (17%) and another 81 (65%) were agreed on by qualified majority, including important aspects of long-term and prolonged anticoagulation, major bleeding and rethrombosis management, treatment in special situations, catheter-related thrombosis and thromboprophylaxis. Among them, the panelists agreed the incidental events should be equated to symptomatic ones, long-term and extended use of full-dose low-molecular weight heparin, and concluded that the Khorana score is not sensitive enough to uphold an effective thromboprophylaxis strategy. CONCLUSION: Though the level of consensus varied depending on the scenario presented, overall, the iterative process achieved broad agreement as to the general treatment principles of cancer-associated VTE. Clinical validation of these statements in genuine practice conditions would be useful.

[Treatment of scalp psoriasis: review of the evidence and Delphi consensus of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology]. / Tratamiento de la psoriasis del cuero cabelludo. Revisión de la evidencia y Consenso Delphi del Grupo de Psoriasis de la Academia Española de Dermatología y Venereología.

Scalp lesions are common in psoriasis and difficult to treat. Scientific evidence on the topic is scant and fragmentary, especially with respect to long-term treatment. This consensus statement is based on a critical assessment of the results of a MEDLINE search for clinical trials of the efficacy and safety of therapies used to treat scalp psoriasis. The recommendations were developed by an expert panel using the Delphi process to reach a consensus and then ratified by the members of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology. The recommended induction therapy for scalp psoriasis is either a topical corticosteroid or a topical treatment combining calcipotriol and betamethasone. The choice of an appropriate vehicle is crucial in improving effectiveness and patient adherence to treatment. The only formulations that have been studied in the long-term treatment of scalp psoriasis are a combination of calcipotriol and betamethasone in gel and calcipotriol alone in solution.

Tratamiento de la psoriasis del cuero cabelludo. Revisión de la evidencia y Consenso Delphi del Grupo de Psoriasis de la Academia Española de Dermatología y Venereología / Treatment of Scalp Psoriasis: Review of the Evidence and Delphi Consensus of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology

La afectación del cuero cabelludo resulta frecuente y de difícil tratamiento en los pacientes con psoriasis, siendo escasa y poco sistematizada la evidencia científica al respecto, en particular por lo que se refiere al tratamiento a largo plazo. En el presente documento de consenso, basado en una búsqueda (MEDLINE) de los ensayos clínicos publicados sobre la eficacia y seguridad de los diferentes tratamientos para la psoriasis del cuero cabelludo y su evaluación, se establecen unas recomendaciones, partiendo de un consenso Delphi por parte de un panel de expertos, refrendado por los miembros del Grupo de Psoriasis de la Academia Española de Dermatología y Venereología. El tratamiento de inducción recomendado para la psoriasis del cuero cabelludo son los corticoides tópicos y la combinación de calcipotriol/betametasona. La elección de un vehículo apropiado es decisiva para incrementar la eficacia y el cumplimiento del paciente. Únicamente la combinación de calcipotriol/betametasona en gel y el calcipotriol en solución se han estudiado en el tratamiento de la psoriasis del cuero cabelludo a largo plazo (AU)

Scalp lesions are common in psoriasis and difficult to treat. Scientific evidence on the topic is scant and fragmentary, especially with respect to long-term treatment. This consensus statement is based on a critical assessment of the results of a MEDLINE search for clinical trials of the efficacy and safety of therapies used to treat scalp psoriasis. The recommendations were developed by an expert panel using the Delphi process to reach a consensus and then ratified by the members of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology. The recommended induction therapy for scalp psoriasis is either a topical corticosteroid or a topical treatment combining calcipotriol and betamethasone. The choice of an appropriate vehicle is crucial in improving effectiveness and patient adherence to treatment. The only formulations that have been studied in the long-term treatment of scalp psoriasis are a combination of calcipotriol and betamethasone in gel and calcipotriol alone in solution (AU)

Long-term use of different doses of low-molecular-weight heparin versus vitamin K antagonists in the treatment of venous thromboembolism.

BACKGROUND: We evaluated whether the incidence of recurrent venous thromboembolic events (VTEs) during and after therapy differs for patients treated with full or reduced doses of low-molecular-weight heparin (LMWH) used long term compared with vitamin K antagonists (VKAs). METHODS: We identified randomized studies of long-term treatment with LMWH or VKA by searching MEDLINE, EMBASE, BIOSIS, and PASCAL. Seventeen studies were included, with 4,002 patients. RESULTS: In the assessment at 12 months of 1,957 patients without cancer, the recurrence rates of VTE in the LMWH/VKA groups were 8.3%/7.6% in the studies using full doses and 12.3%/12.1% in those using prophylactic doses. However, combined analysis after treatment to 1 year showed a nonsignificant (NS) trend to lower recurrent symptomatic VTE in favor of VKA (RR = 1.46, 95% CI 0.96-2.23). In 1,292 patients with cancer the recurrence rates of VTE in the LMWH/VKA groups were 6.5%/17.9% (p = 0.005) in the studies using full doses, 7.1%/13.4% (p = 0.002) in the studies using intermediate doses, and 14.3%/19.1% (p = NS) in the studies using prophylactic doses. Furthermore, the recurrences of VTE after discontinuation of treatment in the LMWH/VKA groups were 1.6%/9.5% (RR = 0.25, 95% CI 0.06-1.1) in 252 patients with full doses and 12%/7.4% (RR = 1.49, 95% CI 0.3-7.48) in 52 patients with prophylactic doses. In this population with cancer, the full-treatment LMWH regimen did not produce more major bleeding events than intermediate or prophylactic doses (5.1% vs. 6.3% or 8.1%, respectively). CONCLUSION: Full-dose LMWH for 3-6 months is as safe as intermediate and prophylactic doses for the long-term treatment of deep vein thrombosis. In patients with cancer it appears that there is an excess of VTE recurrence after treatment with prophylactic doses that does not occur with full therapeutic doses.

[Update of the topical treatment of psoriasis]. / Revisión actualizada del tratamiento tópico de la psoriasis.

Topical therapy continues to be one of the pillars of psoriasis management. Topical corticosteroids and vitamin D analogs are the drugs of choice during the induction phase, and vitamin D analogs continue to be drugs of choice for maintenance therapy. Tazarotene and dithranol are suitable options in patients with certain, specific characteristics. The calcineurin inhibitors can be considered to be second-line treatment for psoriasis of the face and flexures. The efficacy and safety of the fixed-dose combination of betamethasone and calcipotriol in the induction phase is greater than that of either drug alone. The combination of corticosteroids with salicylic acid achieves better results than corticosteroids in monotherapy. None of the drugs evaluated stands out over the others in all clinical situations, and their use must therefore be individualized in each patient and adjusted according to the course of the disease.

Revisión actualizada del tratamiento tópico de la psoriasis / Update of the topical treatment of psoriasis

La terapia tópica sigue representando un pilar fundamental y de actualidad en el manejo de la psoriasis. Los corticoides tópicos y los análogos de la vitamina D son los principios activos de elección durante la fase de inducción, mientras que estos últimos se mantienen como alternativa de elección en el mantenimiento. El tazaroteno y el ditranol resultan alternativas adecuadas en pacientes con determinadas características. Los inhibidores de la calcineurina pueden considerarse tratamientos de segunda línea en la psoriasis de la cara y las flexuras. La eficacia y la seguridad en la fase de inducción de la combinación en dosis fija de betametasona y calcipotriol es superior a la obtenida por ambos principios activos por separado. La combinación de corticoides con ácido salicílico aporta ventajas con respecto a los corticoides en monoterapia. Ninguno de los principios activos evaluados presenta ventajas sobre el resto en todas las situaciones clínicas, por lo que su empleo debe individualizarse para cada paciente y para cada momento evolutivo de la dermatosis (AU)

Topical therapy continues to be one of the pillars of psoriasis management. Topical corticosteroids and vitamin D analogs are the drugs of choice during the induction phase, and vitamin D analogs continue to be drugs of choice for maintenance therapy. Tazarotene and dithranol are suitable options in patients with certain, specific characteristics. The calcineurin inhibitors can be considered to be second-line treatment for psoriasis of the face and flexures. The efficacy and safety of the fixed-dose combination of betamethasone and calcipotriol in the induction phase is greater than that of either drug alone. The combination of corticosteroids with salicylic acid achieves better results than corticosteroids in monotherapy. None of the drugs evaluated stands out over the others in all clinical situations, and their use must therefore be individualized in each patient and adjusted according to the course of the disease (AU)

A randomised open-label trial comparing long-term sub-cutaneous low-molecular-weight heparin compared with oral-anticoagulant therapy in the treatment of deep venous thrombosis.

OBJECTIVE: To evaluate whether low-molecular-weight heparin (LMWH) could be equally (or more) effective than oral anti-vitamin-K agents (AVK) in the long-term treatment of deep venous thrombosis (DVT). DESIGN: A randomised, open-label trial. MATERIAL AND METHODS: In this trial, 241 patients with symptomatic proximal DVT of the lower limbs confirmed by duplex ultrasound scan were included. After initial LMWH, patients received 6 months of treatment with full therapeutic dosage of tinzaparin or acenocoumarol. The primary outcome was the 12-month incidence of symptomatic recurrent venous thrombo-embolism (VTE). Duplex scans were performed at 6 and 12 months. RESULTS: During the 12-month period, six patients (5%) of 119 who received LMWH and 13 (10.7%) of 122 who received AVK had recurrent VTE (p=0.11). In patients with cancer, recurrent VTE tended to be lower in the LMWH group (two of 36 [5.5%]) vs. seven of 33 [21.2%]; p=0.06). One major bleeding occurred in the LMWH group and three in the AVK group. Venous re-canalisation increased significantly at 6 months (73.1% vs. 47.5%) and at 12 months (91.5% vs. 69.2%) in the LMWH group. CONCLUSIONS: Tinzaparin was more effective than AVK in achieving re-canalisation of leg thrombi. Long-term tinzaparin was at least as efficacious and safe as AVK for preventing recurrent VTE, especially in patients with cancer.

Efficacy of intravenous alfacalcidol in the treatment of secondary hyperparathyroidism in patients on hemodialysis.

BACKGROUND: Secondary hyperparathyroidism remains a serious problem in hemodialysis patients. The therapy of renal osteodystrophy is mainly based on lowering phosphate levels and administering vitamin D(3) metabolites and calcimimetic agents. METHODS: An observational, prospective, multicenter study was made to evaluate the efficacy of alfacalcidol in 185 chronic hemodialysis patients with secondary hyperparathyroidism (i-PTH >150 pg/ml). Patients with a CaxP product >70 were excluded. Intermittent therapy with intravenous alfacalcidol was observed for 6 months. RESULTS: The mean dose of alfacalcidol per week was 3.63 +/- 1.71 microg. Patients previously treated with vitamin D(3) metabolites needed higher doses of alfacalcidol (4.0 +/- 1.7 vs. 3.2 +/- 1.6; p = 0.01). Only 50.8% of the patients had received vitamin D(3) metabolites prior to the start of the study and at baseline they had higher i-PTH levels (600.3 +/- 360.5 vs. 489.9 +/- 292.6, p = 0.02). i-PTH levels decreased from 546 +/- 332.6 to 332.4 +/- 274.5 pg/ml (p < 0.001). 60.5% of the patients had i-PTH < 300 pg/ml at the last observation. Serum calcium increased (9.4 +/- 0.8 to 9.97 +/- 1.0 mg/l, p < 0.001). CONCLUSION: Alfacalcidol reduced the levels of i-PTH and produced a slight increase in serum calcium and phosphate levels. In mild or moderate hyperparathyroidism the doses needed were lower than in severe hyperparathyroidism.

Burden of illness of Crohn's disease in Spain.

OBJECTIVE: To evaluate the burden of Crohn's disease in Spain. DESIGN: Observational, cross-sectional study of patients affected with Crohn's disease who were attended to in hospitals in Spain. METHODS: Three structured questionnaires were used: one completed by the gastroenterologists to obtain demographic, clinical and disease activity data; a phone interview to obtain epidemiological and drug utilisation data; and the Spanish version of the Short-Form Health Survey (SF-36). RESULTS: The annual cost per patient was estimated at Euro 6808-Euro 2104 from direct medical costs and Euro 4704 from indirect costs. Approximate effect sizes for health-related quality of life were as follows: 0.8 for general health, social function, role functioning--physical and vitality; 0.5 for role functioning--emotional, body pain and mental health; and 0.2 for physical function. CONCLUSION: Crohn's disease causes a significant decrease in health-related quality of life for patients and a considerable economic cost to society, mainly due to hospitalisations and loss of productivity. This burden indicates the importance of health programmes and interventions in reducing the heavy impact of the disease on both patients and society.

[Research on drug utilization in primary health care in national journals]. / La investigación sobre la utilización de medicamentos en atención primaria en revistas nacionales.

In order to discover the present state of research into the use of medication (UM) in primary care, articles published in the "Original Articles" sections of Medicina Clínica (MC) (Clinical Medicine) and Atención Primaria (AP) (Primary Care) between 1983 and 1990, were studied. A total of 130 articles that meet the definition of the WHO for studies into the use of Medications (SUM) were identified. The instigator and organiser of the research, the drugs included, the kind of study, the source of the data, the main variables used and the qualitative analysis made, were all studied. In conclusion we were able to point out that the characteristics of UM were met in the majority of the studies; although they are the main objective of the study in only a minority of cases. The people who undertook most of the research were those who themselves prescribed the drugs or dealt with very common pathologies. In general, the studies are only descriptive and have a poor level of assessment of the results.

Evaluation of cefonicid use in a general hospital.

Recently marketed drugs have limited experience in clinical use. Follow-up evaluation is therefore needed, particularly when these drugs are "restricted use" medicines, such as the second-generation cephalosporins. We present a follow-up of the first use of cefonicid, which was carried out after its substitution for cefuroxime in our hospital. The indication for use, dosing, therapeutic effects, and possible adverse reactions were recorded in 210 of the first 319 medical-surgical inpatients who received cefonicid. Cefonicid was administered to patients who could have been treated with free-use antibiotics on at least 128 occasions; these were cases of community-acquired pneumonia without any risk factor, urinary tract infections, acute exacerbations in patients with chronic lung disease, surgical prophylaxis, and intraabdominal infections. One fatal case of Stevens-Johnson syndrome was seen. Other recorded adverse events were two skin reactions, one tachyarrhythmia with evidence of low cardiac output, six episodes of phlebitis, and nine superinfections during treatment with cefonicid. The use of cefonicid instead of cefuroxime was associated with 20 percent cost savings; however, this study shows that optimal antibiotic prescribing may produce much greater savings.