Evaluation of patient involvement strategies in health technology assessment in Spain: the viewpoint of HTA researchers.

OBJECTIVE: The Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) defined a patient involvement (PI) framework for health technology assessment (HTA) activities in 2016. The aim of this study is to evaluate the process and impact of those PI initiatives that were implemented in the first year following the publication of this new framework. METHODS: A survey was sent to those HTA researchers who implemented PI in RedETS projects. Responses were reviewed by two authors. An adapted thematic analysis was performed and the results were later discussed by all authors. RESULTS: Six responses from six agencies/units were analyzed. The objectives of PI initiatives were the following: inclusion of patient perspectives, preferences and values; elicitation of important health outcomes measures; and barriers, facilitators, or suggestions for implementation. Different methods were used for PI: surveys, focus groups, in depth interviews, and participation in an expert panel. Five main themes emerged: (i) challenges with the recruitment process, (ii) needs identified, (iii) impact of PI, (iv) lessons learned, and (v) suggestions for the future. CONCLUSIONS: PI initiatives within the RedETS framework were tailored to each HTA project, its specific goals and the individual needs and resources of each HTA agency. The results also pointed out how PI has a relevant impact that has enriched RedETS products providing key information on experiences, values, and preferences of patients, contributions that benefit the HTA and the process of drawing up recommendations. The main challenges were related to recruitment processes and capacity building.

Relationship Between Depression and the Use of Mobile Technologies and Social Media Among Adolescents: Umbrella Review.

BACKGROUND: Despite the relevance of mobile technologies and social media (MTSM) for adolescents, their association with depressive disorders in this population remains unclear. While there are previous reviews that have identified the use of MTSM as a risk factor for developing depression, other reviews have indicated their possible preventive effect. OBJECTIVE: The aim of this review was to synthesize the current evidence on the association between MTSM use and the development or prevention of depressive disorders in adolescents. METHODS: An umbrella review was conducted using information published up to June 2019 from PubMed/MEDLINE, PsycINFO, Web of Science, and The Cochrane Library. Systematic reviews focusing on the adolescent population (up to 20 years old) and depression and its potential relationship with MTSM use were included. Screening of titles, abstracts, and full texts was performed. After selecting the reviews and given the heterogeneity of the outcome variables and exposures, a narrative synthesis of the results was carried out. RESULTS: The search retrieved 338 documents, from which 7 systematic reviews (3 meta-analyses) were selected for data extraction. There were 11-70 studies and 5582-46,015 participants included in the 7 reviews. All reviews included quantitative research, and 2 reviews also included qualitative studies. A statistically significant association between social media and developing depressive symptoms was reported in 2 reviews, while 5 reviews reported mixed results. CONCLUSIONS: Excessive social comparison and personal involvement when using MTSM could be associated with the development of depressive symptomatology. Nevertheless, MTSM might promote social support and even become a point of assistance for people with depression. Due to the mixed results, prospective research could be valuable for providing stronger evidence.

Promoting healthy teenage behaviour across three European countries through the use of a novel smartphone technology platform, PEGASO fit for future: study protocol of a quasi-experimental, controlled, multi-Centre trial.

BACKGROUND: Behaviour change interventions targeting physical activity, diet, sleep and sedentary behaviour of teenagers show promise when delivered through smartphones. However, to date there is no evidence of effectiveness of multicomponent smartphone-based interventions. Utilising a user-centred design approach, we developed a theory-based, multi-dimensional system, PEGASO Fit For Future (PEGASO F4F), which exploits sophisticated game mechanics involving smartphone applications, a smartphone game and activity sensors to motivate teenagers to take an active role in adopting and maintaining a healthy lifestyle. This paper describes the study protocol to assess the feasibility, usability and effectiveness (knowledge/awareness and behavioural change in lifestyle) of the PEGASO system. METHODS: We are conducting a quasi-experimental controlled cluster trial in 4 sites in Spain, Italy, and UK (England, Scotland) over 6 months. We plan to recruit 525, in a 2:1 basis, teenagers aged 13-16 years from secondary schools. The intervention group is provided with the PEGASO system whereas the comparison group continues their usual educational routine. Outcomes include feasibility, acceptance, and usability of the PEGASO system as well as between and within group changes in motivation, self-reported diet, physical activity, sedentary and sleeping behaviour, anthropometric measures and knowledge about a healthy lifestyle. DISCUSSION: PEGASO F4F will provide evidence into the cross-cultural similarities and differences in the feasibility, acceptability and usability of a multi-dimensional smartphone based behaviour change intervention for teenagers. The study will explore facilitating factors, challenges and barriers of engaging teenagers to adapt and maintain a healthy lifestyle when using smartphone technology. Positive results from this ICT based multi component intervention may have significant implications both at clinical level, improving teenagers health and at public health level since it can present an influential tool against the development of chronic disease during adulthood. TRIAL REGISTRATION: https://clinicaltrials.gov Registration number: NCT02930148, registered 4 October 2016.

Towards the centralization of digestive oncologic surgery: changes in activity, techniques and outcome.

AIM: The objective of the present study was to examine changes in the activity, surgical techniques and results from the process of centralization of complex digestive oncologic surgery in 2005-2012 as compared to 1996-2000. MATERIAL AND METHODS: A retrospective cohort study employing the minimum basic data set of hospital discharge (MBDSHD 1996-2012) from public centers in Catalonia (Spain) was performed. The population consisted of individuals aged > 18 who underwent digestive oncologic surgery (esophagus, pancreas, liver, stomach or rectum). Medical centers were divided into low, medium, and high-volume centers (≤ 5, 6-10, and > 10 interventions/year, respectively). The tendency Chi-squared test was used to assess the centralization of patients in high-volume centers and hospital mortality evolution during the study period. Logistic regression was performed to assess the relationship between volume and outcome. RESULTS: A centralization of complex oncologic digestive surgery between 10% (liver) and 46% (esophagus) was obtained by means of a reduction in the number of hospitals that perform these interventions and a significant rise in the number of patients operated in high-volume centers (all types p ≤ 0.0001, except for esophagus). A significant decrease in mortality was observed, especially in esophagus (from 15% in 1996/2000 to 7% in 2009/12, p = 0.003) and pancreas (from 12% in 1996/2000 to 6% in 2009/12, p trend < 0.0001). CONCLUSIONS: A centralization of oncologic digestive surgery in high-volume centers and a reduction of hospital mortality in Catalonia were reported among esophageal and pancreatic cancers. However, no significant changes were found for others cancer types.

Effects of kiwi consumption on plasma lipids, fibrinogen and insulin resistance in the context of a normal diet.

BACKGROUND AND AIMS: Among fruits, kiwi is one of the richest in vitamins and polyphenols and has strong anti-oxidant effects. We aimed to analyze the relationship between the consumption of kiwi and plasma lipid values, fibrinogen, and insulin resistance in adults within the context of a normal diet and physical-activity. METHODS: Cross-sectional study. Participants (N = 1469), who were free of cardiovascular diseases, completed a visit, which included the collection of information concerning the participant's usual diet and kiwi consumption using a previously validated, semi-quantitative, 137-item food-frequency-questionnaire. Fasting laboratory determinations included plasma lipids, fibrinogen and insulin resistance. Regular physical-activity was determined using accelerometry. RESULTS: Consumers of at least 1 kiwi/week presented higher plasma values of HDL-cholesterol (mean difference 4.50 [95% CI: 2.63 to 6.36]) and lower triglyceride values (mean difference -20.03 [95% CI: -6.77 to -33.29]), fibrinogen values (mean difference -13.22 [95% CI: -2.18 to -24.26]) and HOMAir values (mean difference -0.30 [95% CI: -0.09 to -0.50]) (p < 0.05, for all comparisons) than those who consumed less than 1 kiwi per week. In an adjusted logistic regression analysis, this group had a lower odds-ratio for presenting plasmatic fibrinogen concentrations above 400 mg/dL (OR = 0.68, 95% CI 0.49 to 0.95), HDL-Cholesterol plasma values below 45 mg/dL (OR = 0.57, 95% CI 0.36 to 0.91) and a HOMAir above 3 (OR = 0.61, 95% CI 0.37 to 1.00). CONCLUSIONS: Consumption of at least one kiwi/week is associated with lower plasma concentrations of fibrinogen and improved plasma lipid profile in the context of a normal diet and regular exercise.

Information and communication technologies for approaching smokers: a descriptive study in primary healthcare.

BACKGROUND: Common interventions for smoking cessation are based on medical advice and pharmacological aid. Information and communication technologies may be helpful as interventions by themselves or as complementary tools to quit smoking. The objective of the study was to determine the use of information and communication technologies (ICTs) in the smoking population attended in primary care, and describe the major factors associated with its use. METHODS: Descriptive observational study in 84 health centres in Cataluña, Aragon and Salamanca. We included by simple random sampling 1725 primary healthcare smokers (any amount of tobacco) aged 18-85. Through personal interview professionals collected Socio-demographic data and variables related with tobacco consumption and ICTs use were collected through face to face interviews Factors associated with the use of ICTs were analyzed by logistic regression. RESULTS: Users of at least one ICT were predominantly male, young (18-45 years), from most favoured social classes and of higher education. Compared with non-ICTs users, users declared lower consumption of tobacco, younger onset age, and lower nicotine dependence. The percentages of use of email, text messages and web pages were 65.3%, 74.0% and 71.5%, respectively. Factors associated with the use of ICTs were age, social class, educational level and nicotine dependence level. The factor most closely associated with the use of all three ICTs was age; mainly individuals aged 18-24. CONCLUSIONS: The use of ICTs to quit smoking is promising, with the technology of mobile phones having a broader potential. Younger and more educated subjects are good targets for ICTs interventions on smoking cessation.

Effectiveness of a primary care-based intervention to reduce sitting time in overweight and obese patients (SEDESTACTIV): a randomized controlled trial; rationale and study design.

BACKGROUND: There is growing evidence suggesting that prolonged sitting has negative effects on people's weight, chronic diseases and mortality. Interventions to reduce sedentary time can be an effective strategy to increase daily energy expenditure. The purpose of this study is to evaluate the effectiveness of a six-month primary care intervention to reduce daily of sitting time in overweight and mild obese sedentary patients. METHOD/DESIGN: The study is a randomized controlled trial (RCT). Professionals from thirteen primary health care centers (PHC) will randomly invite to participate mild obese or overweight patients of both gender, aged between 25 and 65 years old, who spend 6 hours at least daily sitting. A total of 232 subjects will be randomly allocated to an intervention (IG) and control group (CG) (116 individuals each group). In addition, 50 subjects with fibromyalgia will be included.Primary outcome is: (1) sitting time using the activPAL device and the Marshall questionnaire. The following parameters will be also assessed: (2) sitting time in work place (Occupational Sitting and Physical Activity Questionnaire), (3) health-related quality of life (EQ-5D), (4) evolution of stage of change (Prochaska and DiClemente's Stages of Change Model), (5) physical inactivity (catalan version of Brief Physical Activity Assessment Tool), (6) number of steps walked (pedometer and activPAL), (7) control based on analysis (triglycerides, total cholesterol, HDL, LDL, glycemia and, glycated haemoglobin in diabetic patients) and (8) blood pressure and anthropometric variables. All parameters will be assessed pre and post intervention and there will be a follow up three, six and twelve months after the intervention. A descriptive analysis of all variables and a multivariate analysis to assess differences among groups will be undertaken. Multivariate analysis will be carried out to assess time changes of dependent variables. All the analysis will be done under the intention to treat principle. DISCUSSION: If the SEDESTACTIV intervention shows its effectiveness in reducing sitting time, health professionals would have a low-cost intervention tool for sedentary overweight and obese patients management. TRIAL REGISTRATION: A service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov NCT01729936.

Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study): study protocol for a randomized controlled trial.

BACKGROUND: Intensive interventions on smoking cessation increase abstinence rates. However, few electronic mail (E-mail) based intensive interventions have been tested in smokers and none in primary care (PC) setting. The aim of the present study is to evaluate the effectiveness of an intensive E-mail based intervention in smokers attending PC services. METHODS/DESIGN: Randomized Controlled Multicentric Trial. STUDY POPULATION: 1060 smokers aged between 18-70 years from Catalonia, Salamanca and Aragón (Spain) who have and check regularly an E-mail account. Patients will be randomly assigned to control or intervention group. INTERVENTION: Six phase intensive intervention with two face to face interviews and four automatically created and personal E-mail patients tracking, if needed other E-mail contacts will be made. Control group will receive a brief advice on smoking cessation. OUTCOME MEASURES: Will be measured at 6 and 12 months after intervention: self reported continuous abstinence (confirmed by cooximetry), point prevalence abstinence, tobacco consumption, evolution of stage according to Prochaska and DiClemente's Stages of Change Model, length of visit, costs for the patient to access Primary Care Center. STATISTICAL ANALYSIS: Descriptive and logistic and Poisson regression analysis under the intention to treat basis using SPSS v.17. DISCUSSION: The proposed intervention is an E-mail based intensive intervention in smokers attending primary care. Positive results could be useful to demonstrate a higher percentage of short and long-term abstinence among smokers attended in PC in Spain who regularly use E-mail. Furthermore, this intervention could be helpful in all health services to help smokers to quit. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01494246.

New insights into melatonin/CRH signaling in hamster Leydig cells.

We have previously described that melatonin inhibits androgen production in hamster testes via melatonin subtype 1a (mel1a) receptors and the local corticotrophin-releasing hormone (CRH) system. This study attempted to determine the initial events of the melatonin/CRH signaling pathway. In Leydig cells from reproductively active Syrian hamsters, Western blotting, reverse transcription quantitative polymerase chain reaction (RT-qPCR) and a colorimetric assay demonstrated that melatonin and CRH activate tyrosine phosphatases and subsequently reduce the phosphorylation levels of extracellular signal-regulated kinase (erk) and c-jun N-terminal kinase (jnk), down-regulate the expression of c-jun, c-fos and steroidogenic acute regulatory (StAR), and inhibit the production of testosterone. These effects were prevented by a highly selective CRH antagonist, thus indicating that melatonin does not exert a direct role. Specific mitogen-activated protein kinase kinase (MEK) and jnk blockers inhibited expression of c-jun, c-fos, StAR and the production of testosterone, confirming that these are events triggered downstream of erk and jnk. In Leydig cells from photoperiodically regressed adult hamsters, CRH inhibited the production of androstane-3α,17ß-diol (3α-diol), the main androgen produced, through the same signaling pathway. Testicular melatonin concentration was 3-4-fold higher in reproductively inactive hamsters than that detected in active animals. Since melatonin, CRH, and their receptors are present not only in hamster testes but also in testicular biopsies of infertile men, we can conjecture about the relevance of this previously uncharacterized pathway in human fertility disorders. In summary, our study identifies crucial intracellular events triggered by melatonin/CRH in the testis that lead to a down-regulation of the steroidogenic process.

Codesign and Feasibility Testing of a Tool to Evaluate Overweight and Obesity Apps.

BACKGROUND: Digital health interventions and mobile technologies can help to reduce the rates of obesity and overweight conditions. Although weight management apps are widely used, they usually lack professional content and evaluation, so the quality of these apps cannot be guaranteed. The EVALAPPS project aims to design and validate a tool to assess the safety and effectiveness of health-related apps whose main goal is to manage and prevent obesity and overweight conditions. OBJECTIVE: The aim of this paper is two-fold: (a) to co-create and codesign the EVALAPPS assessment tool and (b) to pilot its feasibility among overweight and obese individuals that use weight control apps. METHODS: A mixed-methods approach was used. A multidisciplinary team (n = 12) participated in a co-creation workshop to provide proposals and inputs about the look and feel of the content, usability aspects, appearance, sections, and main features of the EVALAPPS tool. The tool was tested for its feasibility among 31 overweight and obese individuals, attending the CP Endocrinologia i Nutrició SL Clinic for the first time. Participants were asked to use a specific weight control app [Yazio (YAZIO GmbH, Erfurt, Germany), My FitnessPal (MyFitnessPal, Austin, TX, USA) or MyPlate (MyPlate, Santa Monica, CA, USA)] for two weeks and then evaluate them by using the EVALAPPS (EVALAPPS, David Ganyan, Barcelona, Spain) (June 2020, David Ganyan, Barcelona, Spain) tool. Seven participants were phone interviewed to gain more insight into the use of the EVALAPPS tool. RESULTS: The co-creation workshop allowed conceptualizing the EVALAPPS tool. The feasibility study showed that all criteria from the Usability and Functionality dimensions had valid answers, while Reliability, Security, Privacy, and Health indicators were the dimensions with less valid answers. In all three apps, the dimension with the highest score was Usability/functionality, followed by app purpose. Clinical effectiveness and Development were the dimensions with the lowest scores in all three tested weight control apps. CONCLUSIONS: The participation of the multidisciplinary team and end-users in the conceptualization and testing of a tool to assess health apps was feasible and relevant for the usability of the tool.

Relationships between occupational history and serum concentrations of organochlorine compounds in exocrine pancreatic cancer.

BACKGROUND: Previous studies investigating associations between occupational history and risk of exocrine pancreatic cancer (EPC) did not use biomarkers of exposure. The only two studies that measured internal concentrations of organochlorine compounds (OCs) in EPC did not analyse their relationship with occupation. OBJECTIVE: To analyse the relationship between occupational history and blood concentrations of seven OCs in patients with EPC. METHODS: Incident cases of EPC were prospectively identified, and during hospital admission were interviewed face-to-face on occupational history and life-style factors (n = 135). Occupations were coded according to the International Standard of Occupations 1988. Some occupational exposures were also assessed with the Finnish job-exposure matrix (Finjem). Serum concentrations of OCs were analysed by high-resolution gas chromatography with electron-capture detection. RESULTS: Craftsmen and related trades workers had significantly higher concentrations of polychlorinated biphenyl (PCB) congeners 138, 153 and 180. Years worked in agriculture did not influence concentrations of p,p'-DDT, p,p'-DDE, hexachlorobenzene or ß-hexachlorocyclohexane. Subjects who ever worked in agriculture had lower concentrations of PCBs (all p < 0.05). Occupational exposure to lead, nickel and low frequency magnetic fields was significantly associated with higher concentrations of PCBs. CONCLUSIONS: Certain occupations were associated with higher concentrations of PCBs, suggesting that these compounds may account for some increased risks found in previous studies. The lack of association between work in agriculture and concentrations of OC pesticides is consistent with occupation playing a lesser role than diet in influencing OC concentrations. Occupational studies on the relationships among exposure to industrial agents and EPC risk may need to consider adjusting for exposure to PCBs.

Expression of the TGF-beta1 system in human testicular pathologies.

BACKGROUND: In non-obstructive azoospermia, histological patterns of Sertoli cell-only Syndrome (SCO) and hypospermatogenesis (H) are commonly found. In these pathologies, Leydig cell hyperplasia (LCH) is detected in some patients. Since TGF-ß1 is involved in cellular proliferation/development, the aim of this work was to analyze the expression of TGF-ß1, its receptors TGFBRII, TGFBRI (ALK-1 and ALK-5), and the co-receptor endoglin in human biopsies from patients with idiopathic infertility. METHODS: Specific immunostaining of TGF-ß1, its receptors TGFBRII, TGFBRI (ALK-1 and ALK-5), co-receptor endoglin and Smads proteins, were carried out in testicular biopsies from normal and infertile men with SCO or H. Gene expression of TGF-ß1 system were made in biopsies from infertile patients with semi-quantitative and quantitative PCR. RESULTS: Immunohistochemical studies revealed that TGF-ß1 and its specific receptors are present in Leydig cells in biopsies from normal tissue or patients with SCO or H with or without LCH. Smad proteins, which are involved in TGF-ß1 signaling, are also detected in both their phosphorylated (activated) and dephosphorylated form in all samples TGF-ß1, ALK-1 and endoglin gene expression are stronger in human biopsies with LCH than in those with SCO or H. Neither TGFBRII nor ALK-5 gene expression showed significant differences between pathologies. A significant correlation between ALK-1 and endoglin expression was observed. CONCLUSIONS: In conclusion, the high levels of mRNA and protein expression of the TGF-ß1 system in patients with LCH, particularly ALK1 and its correlation with endoglin, suggest that these proteins acting in concert might be, at least in part, committed actors in the Leydig cell hyperplasia.

Differences in Results and Related Factors Between Hospital-at-Home Modalities in Catalonia: A Cross-Sectional Study.

Hospital-at-home (HaH) is a healthcare modality that provides active treatment by healthcare staff in the patient's home for a condition that would otherwise require hospitalization. The aims were to describe the characteristics of different types of hospital-at-home (HaH), assess their results, and examine which factors could be related to these results. A cross-sectional study based on data from all 2014 HaH contacts from Catalonia was designed. The following HaH modalities were considered-admission avoidance (n = 7,214; 75.1%) and early assisted discharge (n = 2,387; 24.9%). The main outcome indicators were readmission, mortality, and length of stay (days). Multivariable models were fitted to assess the association between explanatory factors and outcomes. Hospital admission avoidance is a scheme in which, instead of being admitted to acute care hospitals, patients are directly treated in their own homes. Early assisted discharge is a scheme in which hospital in-care patients continue their treatment at home. In the hospital avoidance modality, there were 8.3% readmissions, 0.9% mortality, and a mean length of stay (SD) of 9.6 (10.6) days. In the early assisted discharge modality, these figures were 7.9%, 0.5%, and 9.8 (11.1), respectively. In both modalities, readmission and mean length of stay were related to comorbidity and type of hospital, and mortality with age. The results of HaH in Catalonia are similar to those observed in other contexts. The factors related to these results identified might help to improve the effectiveness and efficiency of the different HaH modalities.

Melatonin daily oral supplementation attenuates inflammation and oxidative stress in testes of men with altered spermatogenesis of unknown aetiology.

We have previously shown an inverse correlation between testicular melatonin concentration and inflammation/oxidative stress-related markers levels in infertile men showing unexplained azoospermia. Here, we evaluated the impact of melatonin oral supplementation (daily 3 mg dose used to treat sleep disorders) in the incidence of local inflammation, oxidative stress, and tubular wall fibrosis development in young and middle-aged infertile adult men. Compared with testes without histological alterations, gonads with morphological abnormalities showed lower melatonin concentration along with increased macrophage numbers, TBARS generation, and expression levels of inflammation-related markers and antioxidant enzymes, as well as tubular wall collagen fibers disorganization and thickening. Melatonin oral supplementation not only increased its own testicular levels but also decreased inflammation- and oxidative stress-related markers levels, and improved the tubular wall aspect. Overall, our work provides insights into the potential benefits of melatonin on the inflammatory and oxidative status in testes of patients suffering from unexplained infertility.

Past medical conditions and K-ras mutations in pancreatic ductal adenocarcinoma: a hypothesis-generating study.

BACKGROUND: In pancreatic ductal adenocarcinoma (PDA) evidence on the etiopathogenic role of past medical conditions in the occurrence and persistence of K-ras mutations is scant. METHODS: Incident cases of PDA were interviewed face-to-face about past medical history and other factors. Logistic regression was used to compare PDA cases (n = 120) with wild-type and mutated K-ras tumors (case-case study). RESULTS: Patients with wild-type K-ras tumors were more likely to have a prior diagnosis of pancreatitis (Odds ratio [OR] = 6.11, p = 0.041). Diabetes mellitus (DM) was non-significantly more common among cases with a K-ras wild-type tumor, and the OR for DM of >6 years of duration was 4.54 (p = 0.39). Patients with wild-type K-ras were significantly more likely to have had a surgically treated peptic ulcer (OR = 9.03, p = 0.027). The probability of having a K-ras wild-type tumor increased with the number of medical conditions (p for trend = 0.012); the corresponding OR for two or more medical conditions was 4.46 (95% CI: 1.37-14.50). CONCLUSIONS: Results raise the hypothesis that pancreatitis and possibly peptic ulcer might influence pancreatic carcinogenesis through pathways independent of K-ras mutation, perhaps related to growth factors or mediators of the inflammatory response. Large unselected studies should be conducted to refute or replicate our findings.

ß-adrenergic receptors in the up-regulation of COX2 expression and prostaglandin production in testicular macrophages: Possible relevance to male idiopathic infertility.

Catecholaminergic neuronal elements (CNE) and macrophages (MACs) are increased in testes of patients with idiopathic infertility. Now, we describe an anatomical proximity between CNE and MACs, expression of specific α- and ß-adrenergic receptors (ADRs) subtypes in MACs, and a positive correlation between the number of MACs and cyclooxygenase (COX2) expression - key enzyme in prostaglandin (PG) synthesis and an inflammatory marker - in testes of infertile men. To examine a potential effect of adrenergic input on COX2 expression, we used two additional experimental models: non-testicular human MACs (THP1 cell line) and non-human testicular MACs purified from adult Syrian hamsters. We found that epinephrine and norepinephrine up-regulate COX2 expression and PGD2 production through ß1-and ß2-ADRs. Our results demonstrate the existence of a yet unknown link between CNE and MACs in the human testis that could trigger inflammation and tissue homeostatic dysregulation associated with pathogenesis or maintenance of infertility states.

Availability of specific tools to assess patient reported outcomes in hip arthroplasty in Spain. Identifying the best candidates to incorporate in an arthroplasty register. A systematic review and standardized assessment.

PURPOSE: 1) To systematically review the available scientific literature regarding specific instruments developed and/or tested in a Spanish population, to assess these PROMs in hip arthroplasty; 2) to carry out a standardized assessment of their measurement properties; and 3) to identify the best tools for use in Spain in an arthroplasty registry context. METHODS: A systematic review of PubMed/MEDLINE and EMBASE and CINHAL was done. Furthermore, a standardized assessment of the questionnaires identified using the Evaluating the Measurement of Patient-Reported Outcomes (EMPRO) tool was performed. All developments, validation and studies aiming to assess the measurement properties of PROMs in hip arthroplasty in the Spanish population were included. Data from the questionnaires on metric properties was taken into account to identify the best candidates for inclusion in a register. RESULTS: A total of 853 documents were found. After screening title and abstract, 13 full text documents were reviewed and 8 questionnaires adapted and validated to assess some of the aspects of hip arthroplasty in the Spanish population were identified. After the EMPRO assessment, 4 questionnaires showed suitable properties (WOMAC, OAKHQOL, mini-OAKHQOL and PFH). CONCLUSIONS: In Spain, there are a few suitable hip-specific questionnaires currently available to assess PROMs in hip arthroplasty surgery. Some of the more widely used questionnaires, like the OHS and HOOS, have not been validated in the Spanish population until now. Identified tools are suitable for use in a clinical context, however their use in an arthroplasty register is more questionable due to the lack of validation studies of the widely used tools in other registers.

Evaluation of the effectiveness of hip and knee implant models used in Catalonia: a protocol for a prospective registry-based study.

BACKGROUND: Monitoring results regarding the effectiveness of knee and hip arthroplasties may be useful at the clinical, economic and patient level and help reduce the number of prosthesis revisions. In Spain, and specifically in Catalonia, there is currently no systematic monitoring of the different prosthesis models available on the market. Within this context, the aim of the project presented in this protocol is to evaluate the short- and medium-term effectiveness of knee and hip models implanted in Catalonia and to identify where the results could be better or worse than expected. METHODS: A prospective observational design will be drawn up based on data from a population-based arthroplasty register for hip and knee replacements that includes data from 53 of the 61 public hospitals in Catalonia. The knee and hip prosthesis models used will be identified and classified according to the type of prosthesis, fixation and, in total hip replacements, the bearing surface. For the data analysis, two methodological approaches will be used sequentially: first, an approach based on a survival analysis, followed by an approach based on standardised revision ratios and funnel plots. Following the analyses, a panel of experts will evaluate the results to identify possible sources of bias. Lastly, those models with results better or worse than expected compared to those from the comparison group will be valued, and strengths and difficulties for routine implementation of this methodology within the Catalan Arthroplasty Register will be identified. DISCUSSION: The study presented in this protocol will allow us to identify the hip and knee prosthesis models whose results might be better or worse than expected. This information could have a potential impact at the patient, orthopaedic surgeon, healthcare manager, decision-making and industry levels, both in the short term and in the medium and long term.

Safety and Effectiveness of Shoulder Arthroplasties in Spain: A Systematic Review.

The effectiveness and safety of shoulder arthroplasties in the general context of a Spanish patient population remains unclear. The aim of this study was to ascertain both the effectiveness and safety of primary shoulder arthroplasties and the prosthesis types used in Spain. A systematic review of all the available literature evaluating the effectiveness and safety of primary shoulder arthroplasties in Spain was performed. A narrative synthesis was performed, and evidence tables were created in four dimensions: study design, arthroplasty characteristics, safety, and effectiveness. Orthopaedic Data Evaluation Panel (ODEP) scores were used to evaluate prosthesis types. Twenty-one studies were selected that included a total of 1293 arthroplasties. The most common indication was fractures, while the prosthesis most frequently used was the Delta Xtend (ODEP 10A). The most common complication was scapular notching. Prosthesis revision rate was approximately 6% for follow-ups between 12 and 79 months. In addition, significant improvements were observed in the Constant-Murley test score after the intervention. Currently in Spain, shoulder arthroplasty can be considered a safe and effective procedure with functional recovery and pain reduction for eligible patients with humeral fracture, rotator cuff arthropathy, fracture sequelae and malunion of the proximal humerus, and degenerative disease. Future longitudinal research and population-based studies could serve to confirm these results and identify points of improvement.