Dose and administration time of indocyanine green in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy (DOTIG): study protocol for a randomised clinical trial.

BACKGROUND: One of the most severe complications in laparoscopic cholecystectomy (LC) is intraoperative bile duct injury (BDI). Despite its low incidence, the medical implications for the patient can be serious. Besides, BDI can also generate significant legal issues in healthcare. Different techniques have been described to reduce the incidence of this complication, and near-infrared fluorescence cholangiography with indocyanine green (NIRFC-ICG) is one of the latest additions. In spite of the great interest aroused by this procedure, there are currently great disparities in the usage or administration protocols of ICG. METHODS AND ANALYSIS: This is a randomised, multicentre, per-protocol analysis, open clinical trial with four arms. The estimated duration of the trial is 12 months. The aim of the study is to analyse whether there are differences between the dose and administration ICG intervals to obtain good-quality NIRFC during LC. The primary outcome is the degree of identification of critical biliary structures during LC. In addition, different factors will be analysed that may have an influence on the results of this technique. ETHICS AND DISSEMINATION: The trial will be conducted according to the recommendations for Clinical Trials in the Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects and the recommendations of the Spanish Agency of Medicines and Medical Devices (AEMPs) for clinical trials. This trial was approved by the local institutional Ethics Committee and the AEMPs. The results of the study will be presented to the scientific community through publications, conferences or other means. EUDRACT NUMBER: 2022-000904-36. PROTOCOL VERSION: V.1.4, 2 June 2022 TRIAL REGISTRATION NUMBER: NCT05419947.

Effect of intravenous pulses of methylprednisolone 250 mg versus dexamethasone 6 mg in hospitalised adults with severe COVID-19 pneumonia: An open-label randomised trial.

BACKGROUND: The efficacy and safety of high versus medium doses of glucocorticoids for the treatment of patients with COVID-19 has shown mixed outcomes in controlled trials and observational studies. We aimed to evaluate the effectiveness of methylprednisolone 250 mg bolus versus dexamethasone 6 mg in patients with severe COVID-19. METHODS: A randomised, open-label, controlled trial was conducted between February and August 2021 at four hospitals in Spain. The trial was suspended after the first interim analysis since the investigators considered that continuing the trial would be futile. Patients were randomly assigned in a 1:1 ratio to receive dexamethasone 6 mg once daily for up to 10 days or methylprednisolone 250 mg once daily for 3 days. RESULTS: Of the 128 randomised patients, 125 were analysed (mean age 60 ± 17 years; 82 males [66%]). Mortality at 28 days was 4.8% in the 250 mg methylprednisolone group versus 4.8% in the 6 mg dexamethasone group (absolute risk difference, 0.1% [95% CI, -8.8 to 9.1%]; p = 0.98). None of the secondary outcomes (admission to the intensive care unit, non-invasive respiratory or high-flow oxygen support, additional immunosuppressive drugs, or length of stay), or prespecified sensitivity analyses were statistically significant. Hyperglycaemia was more frequent in the methylprednisolone group at 27.0 versus 8.1% (absolute risk difference, -18.9% [95% CI, -31.8 to - 5.6%]; p = 0.007). CONCLUSIONS: Among severe but not critical patients with COVID-19, 250 mg/d for 3 days of methylprednisolone compared with 6 mg/d for 10 days of dexamethasone did not result in a decrease in mortality or intubation.

Management of prediabetes from the perspective of Spanish physicians and community pharmacists: Detecta2 study.

INTRODUCTION: Prediabetes is a high-risk state for diabetes. The study aims to describe routine clinical practice and the views of physicians and pharmacists on prediabetes management. MATERIALS AND METHODS: An observational, descriptive, cross-sectional study was conducted using a structured questionnaire. RESULTS: A total of 410 physicians and 393 pharmacists completed the questionnaire. Self-adherence to clinical practice guidelines (CPGs) was reported by 51.5% and 23.2% of physicians and pharmacists, respectively. Less than 60% of participants defined prediabetes according to main CPG. Regarding the use of screening strategies to detect prediabetes (physicians: 96%; pharmacists: 42.1%), reports indicate the opportunistic strategy is widely employed (≥75%) whereas systematic screening is unusual (<20%). Changes in lifestyle were deemed essential by almost all participants (≥95%), but in clinical practice only 58.3% of healthcare centers and 28.0% of pharmacies were found to provide awareness-raising/instruction. The role of pharmacists in the prevention of prediabetes/diabetes was judged useful by most participants. CONCLUSIONS: Use of CPG, systematic prediabetes screening strategies, and specific strategies for patient education are scarce. The support of community pharmacists in prediabetes management was well valued. Therefore, it is crucial that the lines of action followed by both physicians and pharmacists align with each other and with the CPG.

Management of prediabetes from the perspective of Spanish physicians and community pharmacists: Detecta2 study.

INTRODUCTION: Prediabetes is a high-risk state for diabetes. The study aims to describe routine clinical practice and the views of physicians and pharmacists on prediabetes management. MATERIALS AND METHODS: An observational, descriptive, cross-sectional study was conducted using a structured questionnaire. RESULTS: A total of 410 physicians and 393 pharmacists completed the questionnaire. Self-adherence to clinical practice guidelines (CPGs) was reported by 51.5% and 23.2% of physicians and pharmacists, respectively. Less than 60% of participants defined prediabetes according to main CPG. Regarding the use of screening strategies to detect prediabetes (physicians: 96%; pharmacists: 42.1%), reports indicate the opportunistic strategy is widely employed (≥75%) whereas systematic screening is unusual (<20%). Changes in lifestyle were deemed essential by almost all participants (≥95%), but in clinical practice only 58.3% of healthcare centers and 28.0% of pharmacies were found to provide awareness-raising/instruction. The role of pharmacists in the prevention of prediabetes/diabetes was judged useful by most participants. CONCLUSIONS: Use of CPG, systematic prediabetes screening strategies, and specific strategies for patient education are scarce. The support of community pharmacists in prediabetes management was well valued. Therefore, it is crucial that the lines of action followed by both physicians and pharmacists align with each other and with the CPG.

Management of atherogenic dyslipidemia in the primary care setting in Spain.

AIM: To describe the management of atherogenic dyslipidemia (AD) in routine clinical practice in the Primary Care (PC) setting in Spain. METHODS: Observational, descriptive, cross-sectional study based on a structured questionnaire designed for this study and addressed to PC physicians. The questionnaire content was based on a literature review and was validated by 3 experts in AD. RESULTS: A total of 1029 PC physicians participated in the study. 96.99% indicated that AD is determinant for cardiovascular risk, even if LDL-C levels are appropriate. 88.43% evaluated residual cardiovascular risk in their clinical practice, however, only 27.89% of them evaluated it in secondary prevention. Regarding diagnosis, 82.22% reported that TC, TG, HDL-C and non-HDL-C are essential measures when evaluating AD. Almost all physicians reported that they can request fractionated cholesterol to assess HDL-C and LDL-C, however 3.69% could not. Physicians (95.63%) considered that the first step in AD treatment should be diet, regular exercise, smoking cessation and pharmaceutical treatment, if necessary. 19.1% agreed partially or completely that gemfibrozil is the most suitable fibrate to associate with statins. 74.83% completely agreed that fenofibrate is the most suitable fibrate to combine with statins. CONCLUSIONS: Physicians have access to general Spanish guidelines and recommendations associated with AD management, however, it is necessary to continue rising awareness about the importance of early detection and optimal control of AD to reduce patients' cardiovascular risk.

Cross-sectional study about the use of telemedicine for type 2 diabetes mellitus management in Spain: patient's perspective. The EnREDa2 Study.

OBJECTIVES: The usefulness of telemedicine (TM) in type 2 diabetes mellitus (T2DM) has been discussed in recent years. The aim of this study is to describe patients' perceptions about TM and to identify preferences on TM resources, in Spain. DESIGN: An observational, cross-sectional study was conducted using a structured questionnaire. PARTICIPANTS: 1036 patients with T2DM accepted to participate in the study (response rate: 68%). RESULTS: Blood glucose values were recorded by 85.9% of the patients while data such as lifestyle habits were only recorded by 14.4% of the patients. Previous experience in TM was reported by 9.8% of the patients, out of which 70.5% were satisfied with its service and 73.5% considered that the use of TM had optimised their T2DM management. However, most of these patients noted aspects to be improved such as user-friendliness (81.4%), interaction with the medical team (78.4%) and time required for recording/transferring data (78.4%). Experienced patients had better perception about TM usefulness than naïve patients for all listed aspects (p<0.05). Among naïve patients, 38.2% expressed their willingness to participate in TM programmes, but only 4.7% were invited to do so. Patients considered that physicians' (77.5%) and pharmacists' (75.5%) encouragement can boost the use of TM. CONCLUSIONS: In Spain, nearly 10% of patients with T2DM have experience with TM and it is well accepted, especially one based on glucometers. Nevertheless, in order to promote TM use, easier and time-saving programmes for patient-physician interaction should be optimised.

Physicians' and Pharmacists' Clinical Considerations for Elderly Patients with Type 2 Diabetes Mellitus: The IMPLICA2 Study.

BACKGROUND: Management of elderly patients with type 2 diabetes mellitus (T2DM) is complex due to their age-related conditions. Several clinical guidelines provide specific recommendations for management of these patients but little is known about their implementation in clinical practice. OBJECTIVE: To describe physician and community pharmacist perceptions and routine clinical practice in the management of elderly T2DM patients. METHODS: Cross-sectional study. RESULTS: A total of 993 physicians and 999 community pharmacists completed the questionnaire. More physicians than pharmacists agreed on the need to establish more flexible HbA1c targets for elderly (79.4% vs. 30.6%; p < 0.001) and frail (92.6% vs. 31.4%; p < 0.001) patients than for the general diabetic population. HbA1c targets < 7.5% for elderly patients and < 8.5% for frail patients (as recommended by the principle guidelines) were set by 38.9% and 28.7% of physicians, respectively. Furthermore, 62.8% of physicians stated they follow guideline recommendations but, based on their prescription decisions for hypothetical patients, less than 50% were aligned with them. In addition, 73.1% of physicians monitor treatment adherence, mainly by using dispensing control (59.1%). Specific nutritional approaches for elderly patients are provided by 62.9% of physicians and 56.0% of pharmacists, whilst 57.4% and 21.7%, respectively, deliver specific physical exercise programs. CONCLUSIONS: Low adherence to guideline recommendations (i.e. setting more stringent HbA1c targets or delaying treatment intensification) may lead to suboptimal glycaemic control in elderly patients. The standardization of processes, extensive monitoring of patient treatment adherence and providing advice regarding specific personal lifestyle habits may improve the management of elderly T2DM patients.

Anal human papillomavirus genotype distribution in HIV-infected men who have sex with men by geographical origin, age, and cytological status in a Spanish cohort.

Knowledge of human papillomavirus (HPV) type distribution in populations at risk for anal cancer is needed. Here, we describe the anal HPV genotype distribution in a large Spanish cohort (Cohort of the Spanish HIV Research Network HPV [CoRIS-HPV]) of HIV-positive men who have sex with men (MSM) according to geographical origin, age, and cytological status. A cross-sectional analysis of baseline data from 1,439 HIV-infected MSM (2007 to 2012) was performed. Anal HPV genotyping was performed using the Linear Array HPV genotyping test. Descriptive analyses of subject characteristics, prevalences, and 95% confidence intervals (CI) were performed. The global prevalences of HPV, high-risk HPV (HR-HPV), and low-risk HPV (LR-HPV) types were 95.8%, 83.0%, and 72.7%, respectively. Among the HR-HPV types, HPV16 was the most common, followed by HPV59, -39, -51, -18, and -52. The prevalence of multiple HR-HPV infections was 58.5%. There were no differences in the crude analyses between Spanish and Latin-American MSM for most HPV types, and a peak in prevalence for most HPV types was seen in patients in their late thirties. Globally and by specific HPV groups, men with abnormal anal cytologies had a higher prevalence of infection than those with normal cytologies. This study has the largest number of HIV-positive MSM with HPV genotype data analyzed according to cytological status as far as we know. The information gained from this study can help with the design of anal cancer prevention strategies in HIV-positive patients.

The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial.

OBJECTIVES: Anaemia is a frequent complication after cardiopulmonary bypass surgery. Iron therapy has been variably employed by medical centres over the years. In our study we test the clinical effectiveness of intravenous and oral iron supplementation in correcting anaemia, and its impact on blood transfusion requirements, in patients undergoing cardiopulmonary bypass surgery. METHODS: A double-blind, randomized, placebo-controlled clinical trial with three parallel groups of patients. Group I (n = 54): intravenous iron(III)-hydroxide sucrose complex, three doses of 100 mg/24 h during pre- and postoperative hospitalization and 1 pill/24 h of oral placebo in the same period and during 1 month after discharge. Group II (n = 53): oral ferrous fumarate iron 1 pill/24 h pre- and postoperatively and during 1 month after discharge, and intravenous placebo while hospitalized. Group III (n = 52): oral and intravenous placebo pre- and postoperatively, following the same protocol. Data were collected preoperatively, at theatre, at intensive care unit admission, before hospital discharge and 1 month later. RESULTS: (1) Baseline clinical and demographic characteristics and surgical procedures were similar in the three groups; (2) no inter-group differences were found in haemoglobin and haematocrit during the postoperative period; (3) the intravenous iron group showed higher serum ferritin levels at hospital discharge (1321 ± 495 ng/ml; P < 0.001) and 1 month later (610 ± 387; P < 0.001) compared with the other groups and (4) we did not observe statistical differences in blood transfusion requirements between the three groups. CONCLUSIONS: The use of intravenous or oral iron supplementation proved ineffective in correcting anaemia after cardiopulmonary bypass and did not reduce blood transfusion requirements. [Current Controlled Trials number: NCT01078818 (oral and intravenous iron in patients postoperative cardiovascular surgery under EC)].