Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial

Objective: The aim of this study is to evaluate the efficacy and safety of a topical formulation containing lidocaine plus diclofenac (CLIFE1) compared to CLIFE2 (lidocaine), to decrease pain in benign anorectal surgery (BARS) to date not evaluated. Background: More than 50% of patients undergoing BARS, especially hemorrhoidectomy, suffer from moderate and severe postoperative pain. This remains an unresolved problem that could be addressed with the new CLIFE1 topical treatment. Methods: A multicenter, randomized double-blind, active-controlled parallel-group superiority trial, was conducted in two Spanish hospitals. Patients undergoing BARS (hemorrhoids, anal fistula and anal fissure) were randomized at the end of surgery at a 1:1 ratio to receive first dose either CLIFE1 (n=60) or CLIFE2 (n=60) anorectal topical treatment, and after every 12 hours for the first three postoperative days and once a day from the fourth to sixth. The primary outcome was average of pain decrease after topical treatment, measured with visual analogue scale (VAS) by the patients themselves, the evening in the surgery day and four times daily for the first three postoperative days. Results: The results of 120 patients included out of 150 selected undergoing BARS show a decrease in pain after CLIFE1 topical treatment (7.47±13.2) greater than with CLIFE2 (4.38±6.75), difference -3.21 (95% CI) -5.75; -0.676; p=0.008), decreasing significantly postoperative pain (≥ 9 mm, VAS) in 35% of patients undergoing benign anorectal surgery, compared to 18.33 % treated with lidocaine. Conclusions: The CLIFE1 topical treatment shows better analgesic efficacy than CLIFE2 in BARS

Pragmatic, open-label, single-center, randomized, phase II clinical trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus in patients with severe pneumonia secondary to COVID-19: the TACROVID trial protocol

Introduction: Some COVID-19 patients evolve to severe lung injury and systemic hyperinflammatory syndrome triggered by both the coronavirus infection and the subsequent host-immune response. Accordingly, the use of immunomodulatory agents has been suggested but still remains controversial. Our working hypothesis is that methylprednisolone pulses and tacrolimus may be an effective and safety drug combination for treating severe COVID-19 patients. Methods: and analysis: TACROVID is a randomized, open-label, single-center, phase II trial to evaluate the ef- ficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) versus SoC alone, in patients at advanced stage of COVID-19 disease with lung injury and systemic hyperinflammatory response. Patients are randomly assigned (1:1) to one of two arms (42 patients in each group). The primary aim is to assess the time to clinical stability after initiating randomization. Clinical stability is defined as body temperature≤37.5 ◦C, and PaO2/FiO2 > 400 and/or SatO2/FiO2 > 300, and respiratory rate ≤24 rpm; for 48 consecutive hours. Discussion: Methylprednisolone and tacrolimus might be beneficial to treat those COVID-19 patients progressing into severe pulmonary failure and systemic hyperinflammatory syndrome. The rationale for its use is the fast effect of methylprednisolone pulses and the ability of tacrolimus to inhibit both the CoV-2 replication and the secondary cytokine storm. Interestingly, both drugs are low-cost and can be manufactured on a large scale; thus, if effective and safe, a large number of patients could be treated in developed and developing countries

Obtenció del consentiment informat en assaigs clínics: procés d'obtenció, comprensió i percepcions dels pacients

Objectius: 1) Descriure el procés d'obtenció del consentiment informat (CI) en pacients inclosos en assaigs clínics (AC) a l'Hospital Universitari Vall d'Hebron. 2) Descriure els coneixements que expressen el pacients inclosos en els AC sobre aspectes clau dels mateixos. 3) Descriure les percepcions dels pacients sobre el procés d'obtenció del CI i la informació rebuda sobre aspectes clau dels mateixos. 4) Descriure la percepció dels investigadors sobre diversos aspectes del procés d'obtenció del CI en els AC. 5) Avaluar la variabilitat i els factors associats als coneixements dels pacients inclosos en AC Material i Mètode: Estudi prospectiu en el qual s'obté la informació a partir d'una entrevista personal als pacients inclosos en AC, i d'una enquesta als investigadors dels AC en els que participen els pacients Resultats: Es fa una entrevista personal a 140 pacients que participen en 40 AC diferents. Es fa l'enquesta a 51 investigadors dels AC. Els resultats indiquen que hi ha poc coneixement per part dels pacients d'alguns aspectes rellevant de l'AC, principalment d'aspectes de seguretat i metodològics de l'AC com l'aleatorització o la possibilitat de rebre un placebo. Els resultats també indiquen que la modificació d'alguns aspectes del procés d'obtenció del CI com són la lectura del full d'informació al pacient o la signatura diferida del CI poden contribuir a millorar el coneixement dels pacients. No obstant, el documenta un elevat grau de satisfacció dels pacients amb la informació rebuda i amb el procés de CI en general. La consideració conjunta de l'entrevista als pacients i l'enquesta als investigadors suggereix la importància de la informació verbal que dóna l'investigador en el coneixement que tenen els pacients atès que els aspectes valorats com a menys important per l'investigador a l'hora d'informar als pacients són també els menys coneguts pels pacients. Conclusions: En el procés d'obtenció del CI en AC es compleix adequadament amb el requisit legals de la signatura, però de manera subòptima amb les recomanacions ètiques i requisits legals de com ha de ser el procés d'obtenció del CI per tal que sigui vàlid. Malgrat es documenta un desconeixement d'aspectes importants de l'AC en una proporció rellevant de pacients, els pacients estan majoritàriament satisfets amb la informació rebuda i perceben tenir suficient informació per decidir. Els resultats de l'estudi suggereixen un impacte de la informació verbal que dóna l'equip investigador al pacient en el coneixement sobre l'estudi en el que participen. Modificar algun aspecte del procés d'obtenció del CI com és la signatura diferida del CI o la lectura del full d'informació al pacient podria afavorir la millora del coneixement dels pacients.Objectives: 1) To describe the process of obtaining informed consent (IC) in patients included in clinical trials (CT) at the Vall d'Hebron University Hospital. 2) Describe the knowledge that express the patients included in the CT on key aspects of them. 3) Describe the perceptions of patients about the process of obtaining the IC and the information received on key aspects of CT. 4) Describe the perception of researchers on various aspects of the process of obtaining the IC in CT. 5) Evaluate the variability and the factors associated with the knowledge of patients included in CT Material and Methods: A prospective study in which information is obtained from a personal interview of patients included in CT, and a survey of the CT investigators. Resultats: Study based on a personal interview of 140 patients participating in 40 different CT and a survey of 51 CT investigators. Results indicate that there is a little understanding by patients of some important aspects of the CT, mainly related to security and methodological aspects of the CT such as randomization or the possibility of receiving a placebo. Results also indicate that the modification of certain aspects of the process of obtaining the CI such as reading the patient information sheet or the deferred signature of the IC can contribute to improve the knowledge of patients. However, it's reported a high degree of patient satisfaction when the information received when the IC is obtained. Considering the interview patients and the researchers survey together, results suggest the importance of verbal information given by the researcher in the knowledge of patients. Aspects rated as less important for the investigator when informing patients are also those less known by patients. Conclusions: The process of obtaining the IC in CT properly fulfill the requirement of legal firm, but appears to be suboptimal when the ethical and legal requirements that should be considered in the process of obtaining the CI to make it valid. Despite of a lack of documented knowledge important aspects of the CT in a significant proportion of patients, they are usually satisfied with the information received and the perceptions is to have enough information to decide. The results of the study suggest an impact of verbal information given by the research team in patient the knowledge and decision when participating in the study. Modification of some aspect of the process of obtaining the CI as deferred signing or reading the patient information sheet could promote improved knowledge of patients