Validation and adaptation to Spanish of the quality-of-life questionnaire in patients with hemorrhoidal disease and anal fissure (HEMO-FISS-CdV).

Haemorrhoidal disease and anal fissure are the two most frequent entities within benign anal pathology, both of which have a negative impact on patients' quality of life. To date, there is no specific questionnaire in Spanish to assess the impact on quality of life in patients suffering from these conditions. The aim of our study is to validate in Spanish a questionnaire for this purpose, adapting it to our daily clinical practice. The HEMO-FISS-CdV is the Spanish version of the original HEMO-FISS-QoL by Abramowitz. The questionnaire consists of 23 items organised in 4 dimensions (physical, psychological, defecation and sexuality). The reliability of the new tool was assessed by determining internal consistency using Cronbach's alpha and Guttman's coefficient. It was also correlated with the quality of life questionnaire SF12 version 2. The Cronbach's alpha obtained for our questionnaire (HEMO-FISS-CdV) was 0.951 (ICC 95% +-0.016), with a range between 0.935 and 0.967. The Guttman two-half coefficient had a value of 0.910. Patients with internal haemorrhoids, anal fissure or both had higher values on the HEMO-FISS-CdV questionnaire than patients without internal haemorrhoids and these differences were significant (p<0.05). Both diseases have a negative impact on patients' quality of life. The HEMO-FISS-CdV questionnaire provides a tool in Spanish that easily and specifically assesses the impact of haemorrhoidal disease and anal fissure on quality of life.

Pilot study: a detailed analysis of the timing of immuno-inflammatory indices in gastric cancer, and their assessment together with TNM as supplementary prognostic factors.

An analysis of the prognostic impact of up to 36 immuno-inflammatory indices at 3 different times during the diagnostic-therapeutic process for gastric cancer. The dependent variable was disease-free survival at 3 years. The independent factors obtained were combined with TNM to provide an improved prognostic model.

Recommendations on the management of severe obesity in patients with inflammatory bowel disease of the Spanish Group on Crohn's Disease and Ulcerative Colitis (GETECCU), Spanish Society of Obesity (SEEDO), Spanish Association of Surgery (AEC) and Spanish Society of Digestive Endoscopy (SEED). / Recomendaciones sobre el manejo de la obesidad grave en pacientes con enfermedad inflamatoria intestinal del Grupo Español de Trabajo en Enfermedad Inflamatoria Intestinal (GETECCU), Sociedad Española de Obesidad (SEEDO), Asociación Española de Cirugía (AEC) y Sociedad Española de Endoscopia Digestiva (SEED).

Obesity is a multifactorial, chronic, progressive and recurrent disease considered a public health issue worldwide and an important determinant of disability and death. In Spain, its current prevalence in the adult population is about 24% and an estimated prevalence in 2035 of 37%. Obesity increases the probability of several diseases linked to higher mortality such as diabetes, cardiovascular disease, hyperlipidemia, arterial hypertension, non-alcoholic fatty liver disease, several types of cancer, or obstructive sleep apnea. On the other hand, although the incidence of inflammatory bowel disease (IBD) is stabilizing in Western countries, its prevalence already exceeds 0.3%. Paralleling to general population, the current prevalence of obesity in adult patients with IBD is estimated at 15-40%. Obesity in patients with IBD could entail, in addition to its already known impact on disability and mortality, a worse evolution of the IBD itself and a worse response to treatments. The aim of this document, performed in collaboration by four scientific societies involved in the clinical care of severe obesity and IBD, is to establish clear and concise recommendations on the therapeutic possibilities of severe or typeIII obesity in patients with IBD. The document establishes general recommendations on dietary, pharmacological, endoscopic, and surgical treatment of severe obesity in patients with IBD, as well as pre- and post-treatment evaluation.

Lymphoepithelioma-like gastric adenocarcinoma. Descriptive case series.

Lymphoepithelioma-like gastric adenocarcinoma is characterised by a large reactive lymphoplasmacytic infiltrate in the stroma and islets of undifferentiated cells, which express intense and widespread Epstein-Barr virus (EBV). This tumour type has higher survival rates than other gastric cancers, a more proximal location and less lymphatic spread. Our aim is to describe the clinical and pathological characteristics of our series of lymphoepithelioma-like gastric adenocarcinoma. We selected patients who underwent surgery for gastric adenocarcinoma lymphoepithelioma-like variant from 2014 onwards. The results of the following variables were collected: age (years), sex, pre-diagnostic clinical time (months), gastric tumour location, endoscopic biopsy histology, surgical technique, in situ hybridisation for EBER region (Epstein-Barr virus-associated non-coding RNA), microsatellite instability, degree of differentiation, level of resection, tumour size (cm), TNM T value, lymphadenopathy/resected node ratio, overall survival (months) and vital status. Our experience in the lymphoepithelioma-like variant presents as an advanced gastric cancer, possibly related to long-standing prediagnostic symptoms. It behaves as a tumour with expansive local growth with little capacity for lymphatic or metastatic involvement, which could be explained by the prominent intratumoral lymphoid stroma that acts as an antimetastatic barrier.

Intra-abdominal abscess caused by Streptococcus constellatus in an immunocompetent patient.

Streptococcus constellatus is a Gram-positive commensal bacterium of the oropharyngeal, gastrointestinal and urogenital flora. It can cause abscesses in different parts of the body, especially in immunocompromised patients. We present the clinical case of a 33-year-old female patient with a previous history of one anastomosis gastric bypass, among others. The patient was hospitalized two years after surgery for peritonitis secondary to a perforation in the biliopancreatic loop, underwent laparoscopic surgery and was hospitalised for two weeks. Fifteen days after being discharged from the hospital, she went to the emergency service for abdominal pain and fever. An abdominal and pelvic computerized tomography (CT) scan showed a multiloculated pelvic collection with thickened and hypercapillary walls.

Importance of immunohistochemistry in the differential diagnosis of gastric mesenchymal tumors.

Although morphology is the key to histological diagnosis, gastric mesenchymal tumors can share very similar growth and cellularity patterns, sometimes being indistinguishable. Therefore, immunohistochemical techniques are going to be crucial in the definitive diagnosis. The objective of this work is to perform an immunohistochemical differential diagnosis of gastric mesenchymal tumors.

Recurrence of gastric schwannoma.

Gastric schwannoma can be malignant in 13.8% of cases. The prognosis of malignant schwannoma is usually poor, characterized by a rapidly progressive disease course and a poor response to chemotherapy. Normally, the recurrence of schwannoma is due to involvement of the surgical resection margin. In turn, recurrence of malignant gastric schwannoma GS is approximately 50%, 25% locoregional and 25% with liver metastases. Even after a complete gastric resection with associated lymphadenectomy, schwannoma may present liver metastases during follow-up.

Surgical indication of type I gastric neuroendocrine tumors.

Gastric neuroendocrine tumors (GNETs) account for less than 2% of gastric neoplasms and type 1 GNETs (GNETs-1), which are associated with chronic atrophic gastritis, account for 70-80% of all GNETs. Treatment of GNETs-1 is usually endoscopic, but surgery also has its indications. The aim of this study is to present five case reports of GNETs-1 treated with surgery and to analyze the surgical indications for this type of tumors.

Times to endovascular treatment following two triage models.

INTRODUCTION: Debate is ongoing regarding the best service model for achieving a prompt recanalization in LVO ischemic stroke with an indication for thrombectomy. We aim to assess differences between two of the existing models within our region. METHODS: We work in a cluster of three public hospitals (one hub and two spokes) forming a single functional neurology service in Madrid (Spain). Upon a LVO case out of regular hours, the interventional neuroradiologist drives to the hub hospital following the drive-the-doctor paradigm (DD). For any of the spokes, the patient is transferred to the nearest endovascular-capable hospital (drip-and-ship-DS) following the Madrid Stroke Plan. We compared times to endovascular procedures between cases managed under each model. RESULTS: Thirty-eight patients in the period April 2014-March 2021 meet the inclusion criteria (DD 27; DS 11). While baseline characteristics are comparable between groups, we observed a notable difference in the time delays favoring those managed under the DD model; with differences between median times of 105 min for hospital arrival-groin puncture (DD 140 [110-181]; DS 245 [222-310], p 0.0004); 122 min for CT-groin puncture (DD 100 [85-144]; DS 222 [200-255], p = 0.0001); and 98 min for hospital arrival-recanalization (DD 180 [140-209]; DS 278 [241-360], p = 0.0014). No differences were observed for NIHSS or mRS on discharge. CONCLUSIONS: Compared to the drip-and-ship, the drive-the-doctor triage model for patients with LVO ischemic stroke in primary centers seems to guarantee a shorter time to the start of the endovascular procedure and to recanalization in our region.

Thio- and selenosemicarbazones as antiprotozoal agents against Trypanosoma cruzi and Trichomonas vaginalis.

Herein, we report the preparation of a panel of Schiff bases analogues as antiprotozoal agents by modification of the stereoelectronic effects of the substituents on N-1 and N-4 and the nature of the chalcogen atom (S, Se). These compounds were evaluated towards Trypanosoma cruzi and Trichomonas vaginalis. Thiosemicarbazide 31 showed the best trypanocidal profile (epimastigotes), similar to benznidazole (BZ): IC50 (31)=28.72 µM (CL-B5 strain) and 33.65 µM (Y strain), IC50 (BZ)=25.31 µM (CL-B5) and 22.73 µM (Y); it lacked toxicity over mammalian cells (CC50 > 256 µM). Thiosemicarbazones 49, 51 and 63 showed remarkable trichomonacidal effects (IC50 =16.39, 14.84 and 14.89 µM) and no unspecific cytotoxicity towards Vero cells (CC50 ≥ 275 µM). Selenoisosters 74 and 75 presented a slightly enhanced activity (IC50=11.10 and 11.02 µM, respectively). Hydrogenosome membrane potential and structural changes were analysed to get more insight into the trichomonacidal mechanism.

Impact of exercise training after bariatric surgery on cardiometabolic risk factors: a systematic review and meta-analysis of controlled trials.

The purpose of this systematic review was to provide updated evidence synthesis of the effectiveness of exercise training in patients with obesity undergoing bariatric surgery to improve cardio-metabolic risk. We systematically searched the MEDLINE, EMBASE, Scopus, Cochrane, and Web of Science databases. The studies selected were those in which an exercise-based intervention was performed after bariatric surgery, a control group was present, and at least one of the following outcomes was investigated: VO2max or VO2peak, resting heart rate (RHR), blood pressure, lipid profile, glucose, and insulin. The study quality was assessed using the PEDro scale and the data were meta-analyzed with a random effects model, comparing control groups to intervention groups using standardized measurements. Twenty articles were included in the systematic review and fourteen (70%) in the meta-analysis. Significant differences were observed between the control and intervention groups (always in favor of exercise) for absolute VO2max / VO2peak (ES = 0.317; 95% CI = 0.065, 0.569; p = 0.014), VO2max / peak relative to body weight (ES = 0.673; 95% CI = 0.287, 1.060; p = 0.001), HDL cholesterol (ES = 0.22; 95% CI = 0.009, 0.430; p = 0.041) and RHR (ES = -0.438; 95% CI = -0.753, -0.022; p = 0.007). No effects were observed for either systolic or diastolic blood pressure. Exercise training for patients undergoing bariatric surgery appears to be effective in improving absolute and relative VO2max / VO2peak, HDL cholesterol and reducing the RHR. More intervention studies using (better) exercise interventions are needed before discarding their effects on other cardiometabolic risk factors. This systematic review and meta-analysis has been registered in Prospero (CRD42020153398).

Sexuality amongst heterosexual women with morbid obesity in a bariatric surgery programme: A qualitative study.

AIMS: The objective of this study is to describe and understand the experiences of sexuality amongst heterosexual women with morbid obesity (MO) who are in a bariatric surgery program. BACKGROUND: Morbid obesity is a chronic, metabolic disease that affects women's physical, psychological and sexual health. MO is associated with anxiety, depression and body image disorders. Bariatric surgery is a reliable method for weight loss in people with MO. DESIGN: A qualitative descriptive study research design was adopted. METHODS: Twenty-one heterosexual women with MO in a bariatric surgery program were recruited through purposive sampling. Data collection included individual semi-structured interviews conducted between November 2018 and May 2019. Interviews were audio recorded, transcribed verbatim and analysed using a computer-assisted qualitative data. FINDINGS: Three main themes emerged from the analysis: (1) trapped in a body that limits my sexuality; (2) between neglect and hope and (3) the partner as a source of support for sexuality in women with MO. CONCLUSION: Women hide a body that they do not accept and ignore their own sexuality, focusing on that of their partner. Although the women have doubts about their partners' desire for them, they share the decision-making process with them whilst waiting for bariatric surgery, on which they place all of their hopes for improved sexuality and quality of life. IMPACT: The findings highlight the importance of exploring the experiences and sexual issues faced by heterosexual women with MO in a bariatric surgery program. Bariatric nurses have a privileged position to assess these women's sexuality, recommend alternatives to sexual intercourse or refer them to sexologists. As part of the multidisciplinary team, nurses can contribute to managing the expectations of women with MO and their partners in relation to the improvement of their sex lives following bariatric surgery.

[Evaluation of treatment with intra-articular injections in osteoarticular pathology of the shoulder in primary care]. / Evaluación del tratamiento con infiltraciones intraarticulares en la patología osteoarticular del hombro en atención primaria.

MAIN OBJECTIVE: To evaluate the clinical response at 24weeks after injection, measured as pain relief and functional recovery, in painful shoulder syndrome (PSS) in primary care (PC). DESIGN: Longitudinal case series with injection treatment in the scapulohumeral joint, describing functionality and pain evolution before and at 24weeks post injection. LOCATION: Non-urban primary care centres. PARTICIPANTS: Patients with osteoarticular shoulder pathology susceptible to injection, failure of pharmacological treatment and rating on the visual analogue scale (VAS) ≥4 or constant score (CS) ≤70. INTERVENTIONS: Intra-articular injection of corticosteroid and local anaesthetic into the scapulohumeral joint, describing its evolution at 1, 4, 12 and 24weeks post injection. MAIN MEASUREMENTS: Infiltration response according to EVA before and after, CS before and after, number of infiltrations, side effects, temporary inability to work (TIL). RESULTS: Sixty-six patients receiving injection, mean age 51.1years (SD 14.7), 57.6% were women and 63.3% were injection in the right shoulder. A 22.7% required TIL and were discharged with a median of 14days (range 7-56days). They required an injection (80.3%) and the most frequent injection pathology was rotator cuff tendinitis (90.9%). They suffered mild side effects (9.4%). We found a decrease in pain from severe to mild and a functional improvement from poor to good. The variables: being retired (OR: 37.82, P=.001) and having an EVA score prior to injection >8 (OR: 15.67, P=.055, almost significant) were associated with poor response. CONCLUSIONS: Intra-articular administration of corticosteroids in PSS reduces pain and provides functional improvement after the first week after injection, and is maintained in the long term. This allows a quick recovery to work after an injection at two weeks reducing recovery time by 50%, with few side effects.

Photodynamic Therapy for the Treatment of Complex Anal Fistula.

BACKGROUND AND OBJECTIVES: To validate and analyze the results of intralesional photodynamic therapy in the treatment of complex anal fistula. STUDY DESIGN/MATERIALS AND METHODS: This prospective multicentric observational study enrolled patients treated for complex anal fistula who underwent intralesional photodynamic therapy (i-PDT). The included patients were treated from January 2016 to December 2018 with a minimum follow-up of 1 year to evaluate recurrence, continence and postoperative morbidity. Intralesional 5-aminolevulinic acid (ALA) gel (2%) was injected directly into the fistula. The internal and external orifices were closed. After an incubation period of 2 hours, the fistula was irradiated using an optical fiber connected to a red laser (Multidiode 630 PDT) operating at 1 W/cm for 3 minutes (180 J). RESULTS: In total, 49 patients were included (61.2% male). The mean age was 48 years, and the mean duration of fistula was 13 months. Of the fistulas included, 75.5% were medium transphincteric, and 24.5% were high transphincteric. The median fistula length was 4 ± 1,14 cm (range: 3-5). A total of 41 patients (83.7%) had a previous history of fistula surgery. Preoperatively, some degree of anal incontinence was found in 5 patients (10.2%). No center reported any other procedure-related complications intraoperatively. Phototoxicity was found in one patient. In the first 48 hours after the procedure, fever was reported in 2 patients (4%). At the end of follow-up, total healing was observed in 32/49 patients (65.3%). No patient reported new incontinence postoperatively. CONCLUSION: i-PDT could be considered a good choice in patients with complex anal fistulas to avoid surgery and its complications. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

Sexuality amongst heterosexual men with morbid obesity in a bariatric surgery programme: A qualitative study.

AIM AND OBJECTIVES: To describe and understand the experiences of sexuality amongst heterosexual men diagnosed with morbid obesity (MO) who are in a bariatric surgery programme. BACKGROUND: Morbid obesity is a chronic metabolic disease that affects men's physical, psychological and sexual health. Evidence suggests that MO could be linked to anxiety, depression, low self-esteem, sexual life and social disorders. Bariatric surgery is a reliable method for weight loss in patients with MO. DESIGN: This is a qualitative study based on Merleau-Ponty's phenomenology, and the COREQ checklist was employed to report on the current study. METHODS: Convenience and purposive sampling was carried out and included 24 in-depth interviews with heterosexual men with MO in a bariatric surgery programme between October 2018-March 2019 in Spain. RESULTS: Two main themes emerged from the analysis: (a) a corporality which is judged and condemned; and (b) adapting sexual practices to bariatric surgery. CONCLUSIONS: Men with MO reject a body that limits their physical, social and sexual life. A negative body image and low self-esteem, which do not respond to the traditional masculine role or new masculinities, reduce men's self-concept. Men with MO feel rejection, stigma and isolation. Support from their partner is fundamental to adapt. RELEVANCE TO CLINICAL PRACTICE: The results of the study draw attention to how heterosexual men with MO experience their sexuality in a bariatric surgery programme and the challenges nurses face. Recognising the problem, helping to develop coping strategies or referring to specialists in sexuality could improve the quality of life in patients and their partners.

Molecular and genetic characterization of the pOV plasmid from Pasteurella multocida and construction of an integration vector for Gallibacterium anatis.

BACKGROUND: The pOV plasmid isolated from the Pasteurella multocida strain PMOV is a new plasmid, and its molecular characterization is important for determining its gene content and its replicative properties in Pasteurellaceae family bacteria. METHODS: Antimicrobial resistance mediated by the pOV plasmid was tested in bacteria. Purified pOV plasmid DNA was used to transform E. coli DH5α and Gallibacterium anatis 12656-12, including the pBluescript II KS(-) plasmid DNA as a control for genetic transformation. The pOV plasmid was digested with EcoRI for cloning fragments into the pBluescript II KS(-) vector to obtain constructs and to determine the full DNA sequence of pOV. RESULTS: The pOV plasmid is 13.5 kb in size; confers sulfonamide, streptomycin and ampicillin resistance to P. multocida PMOV; and can transform E. coli DH5α and G. anatis 12656-12. The pOV plasmid was digested for the preparation of chimeric constructs and used to transform E. coli DH5α, conferring resistance to streptomycin (plasmid pSEP3), ampicillin (pSEP4) and sulfonamide (pSEP5) on the bacteria; however, similar to pBluescript II KS(-), the chimeric plasmids did not transform G. anatis 12656-12. A 1.4 kb fragment of the streptomycin cassette from pSEP3 was amplified by PCR and used to construct pSEP7, which in turn was used to interrupt a chromosomal DNA locus of G. anatis by double homologous recombination, introducing strA-strB into the G. anatis chromosome. CONCLUSION: The pOV plasmid is a wide-range, low-copy-number plasmid that is able to replicate in some gamma-proteobacteria. Part of this plasmid was integrated into the G. anatis 12656-12 chromosome. This construct may prove to be a useful tool for genetic studies of G. anatis.

Supervised exercise following bariatric surgery in morbid obese adults: CERT-based exercise study protocol of the EFIBAR randomised controlled trial.

BACKGROUND: There is increasing evidence of weight regain in patients after bariatric surgery (BS), generally occurring from 12 to 24 months postoperatively. Postoperative exercise has been suggested to ad long-term weight maintenance and to improve physical function in BS patients. However, there are a limited number of intervention studies investigating the possible benefits of exercise in this population. The aim of the current report is to provide a comprehensive CERT (Consensus on Exercise Reporting Template)-based description of the rationale and details of the exercise programme implemented in the EFIBAR Study (Ejercicio FÍsico tras cirugía BARiátrica), a randomised controlled trial investigating the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, physical activity and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery. METHODS: A total of 80 BS patients [60-80% expected women, aged 18 to 60 years, body mass index (BMI) ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbid conditions)] will be enrolled in the EFIBAR Randomized Control Trial (RCT). Participants allocated in the exercise group (n = 40) will undertake a 16-week supervised concurrent (strength and aerobic) exercise programme (three sessions/week, 60 min/session), starting 7 to 14 days after surgery. The rationale of the exercise programme will be described following the CERT criteria detailing the 16 key items. The study has been reviewed and approved by the Ethics Committee of the Torrecárdenas University Hospital (Almería, Spain) (ref. N° 76/2016). DISCUSSION: The present study details the exercise programme of the EFIBAR RCT, which may serve: 1) exercise professionals who would like to implement an evidence-based exercise programme for BS patients, and 2) as an example of the application of the CERT criteria. TRIAL REGISTRATION: The trial was prospectively registered at Clinicaltrials.gov NCT03497546 on April 13, 2018.

Cure in Advanced Renal Cell Cancer: Is It an Achievable Goal?

BACKGROUND: Immunotherapy has historically been of interest in the management of metastatic renal cell cancer (mRCC) because of its relative chemoresistance and the reproducible but low incidence of spontaneous remission in metastatic disease. Recently, targeted immunotherapies in the form of checkpoint inhibitors have shown durable responses in approximately 20%-30% of patients with solid tumors, with a much more acceptable side-effect profile. Anti-programmed death receptor 1 (PD-1)/programmed death receptor ligand 1 antibodies rely on the presence of host T cells in the tumor microenvironment to be stimulated in order to activate an antitumor response. The presence of tumor antigens augments this stimulation. This has led to further research into combination therapy with anti-PD-1 inhibitors and radiotherapy, chemotherapy, or targeted therapy with the aim of increasing the response rate to these agents. MATERIALS AND METHODS: We describe three cases of patients with mRCC treated with anti-PD-1 antibody therapy in combination with targeted therapy (bevacizumab), anti-cytotoxic T lymphocyte antigen 4 therapy (ipilimumab), or radiotherapy. We perform a comprehensive literature review on combination immunotherapy and the scope for the future. RESULTS: Two patients had a complete clinical response within 3 months of commencing treatment. The third patient had a further significant response to radiotherapy outside the field of treatment after initial response to anti-PD-1 therapy, which lasted for over 12 months. CONCLUSION: We are now in the era of immunotherapy with promising results in select patients. However, the number of complete remissions with single agents are low. This report demonstrates the potential for combination therapy in mRCC to produce complete responses and improved survival rates. Whether these results equate to cure in a subset of patients requires longer follow-up. Further evaluation of dosing regimens, sequencing methods, and biomarkers to select patient population is required to advance this treatment strategy. IMPLICATIONS FOR PRACTICE: Multiple phase I-III studies exploring the benefit of combination immunotherapy are currently under way. Further research into predictive biomarkers to identify the cohort of patients who gain this benefit is pertinent. This case series demonstrates that the combination of immunotherapy with other treatments can lead to complete responses, even in patients with initially bulky disease. Combination therapy with immunotherapy seems to cause more durable responses in patients with metastatic renal cell cancer compared with monotherapy. Significantly longer follow-up is necessary to determine whether durable complete response confers a cure in a select group of patients.

Design and Psychometric Evaluation of the Quality of Life in Patients With Anal Fistula Questionnaire.

BACKGROUND: Quality of life is often considered when deciding and evaluating the treatment strategy for patients diagnosed with anal fistula. OBJECTIVE: The purpose of this study was to develop and psychometrically test the Quality of Life in Patients with Anal Fistula Questionnaire. DESIGN: This was an observational cross-sectional study for the development and validation of a psychometric tool. SETTINGS: The study was conducted at a general hospital in the southeast of Spain. PATIENTS: A convenience sample included 54 patients diagnosed with anal fistula. MAIN OUTCOMES MEASURES: The reliability of the tool was assessed through its internal consistency (Cronbach α) and temporal stability (Spearman correlation coefficient (r) between test-retest). The content validity index of the items and the scale was calculated. Correlation analysis and an ordinal regression analysis between the developed tool and the Short Form 12 Health Survey examined its concurrent validity. Principal component analysis and known-group analysis using the Kruskal-Wallis test examined its construct validity. RESULTS: The reliability of the developed questionnaire was very high (α = 0.908; r = 0.861; p < 0.01). Its content validity was excellent (all-item content validity index = 0.79-1.00; scale validity index = 0.92). Evidence of its concurrent validity included strong correlation between the developed tool and Short Form 12 Health Survey (r = 0.734; p < 0.001), and participant scores on the developed tool explained ≈46.2% of the between-subject variation for the participant scores on Short Form 12 Health Survey (Nagelkerke R = 0.462). Confirming its construct validity, principal component analysis revealed that 2 factors explained 81.63% of the total variance found. Known-group analysis evidenced the ability of the questionnaire to detect expected differences in patients presenting with different symptomatology. LIMITATIONS: The major limitations of this study were the use of a small sample of Spanish-speaking patients, not including patients in the initial development of the questionnaire, and developing the scoring system using a summation method. CONCLUSIONS: The Quality of Life in Patients with Anal Fistula Questionnaire has proven to be a valid, reliable, and concise tool that could contribute to the evaluation of quality of life among patients with an anal fistula. See Video Abstract at http://links.lww.com/DCR/A368.

Hepatic safety of maraviroc in HIV-1-infected patients with hepatitis C and/or B co-infection. The Maraviroc Cohort Spanish Group.

INTRODUCTION: Limited data is available regarding the hepatic safety of maraviroc in patients co-infected with HIV and HCV and/or HBV. Our objective was to compare the hepatic safety profile and fibrosis progression in HIV-mono-infected patients and co-infected with HCV and/or HBV treated with maraviroc. METHODS: Retrospective multicentre cohort study of HIV-infected patients receiving treatment with a maraviroc-containing regimen in 27 hospitals in Spain. RESULTS: A total of 667 patients were analyzed, of whom 313 were co-infected with HCV (n=282), HBV (n=14), or both (n=17). Maraviroc main indications were salvage therapy (52%) and drug toxicity (20%). Grade 3-4 hypertransaminasaemia (AST/ALT >5 times ULN) per 100 patient-years of maraviroc exposure, was 5.84 (95% CI, 4.04-8.16) and 1.23 (95% CI, 0.56-2.33) in co-infected and HIV-mono-infected patients, respectively (incidence rate ratio, 4.77; 95% CI, 2.35-10.5). However, the degree of aminotransferase abnormalities remained stable throughout the study in both groups, and no significant between-group differences were seen in the cumulative proportion of patients showing an increase in AST/ALT levels greater than 3.5 times baseline levels. No between-group differences were seen in liver fibrosis over time. With a maraviroc median exposure of 20 months (IQR, 12-41), two patients (0.3%) discontinued maraviroc because of grade 4 hepatitis, and other 2 died due to complications associated to end-stage-liver disease. CONCLUSIONS: Maraviroc-containing regimens showed a low incidence of hepatitis in a large Spanish cohort of HIV-infected patients, including more than 300 patients co-infected with HCV and/or HBV. Co-infection did not influence the maximum liver enzyme level or the fibrosis progression throughout the study.