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The UNITI project has received funding from the European Union's Horizon 2020 Research and Innovation Program (grant agreement number 848261)., Background: Tinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, presumable due to the heterogeneity of tinnitus with its wide variety of etiologies and tinnitus phenotypes. Hence, most treatment studies merely demonstrated improvement in a subgroup of tinnitus patients. The majority of studies are characterized by small sample sizes, unstandardized treatments and assessments, or applications of interventions targeting only a single organ level. Combinatory treatment approaches, potentially targeting multiple systems as well as treatment personalization, might provide remedy and enhance treatment responses. The aim of the present study is to systematically examine established tinnitus therapies both alone and in combination in a large sample of tinnitus patients. Further, it wants to provide the basis for personalized treatment approaches by evaluating a specific decision support system developed as part of an EU-funded collaborative project (Unification of treatments and interventions for tinnitus patients; UNITI project). Methods/study design: This is a multi-center parallel-arm randomized clinical trial conducted at five different clinical sites over the EU. The effect of four different tinnitus therapy approaches (sound therapy, structured counseling, hearing aids, cognitive behavioral therapy) applied over a time period of 12 weeks as a single or rather a combinatory treatment in a total number of 500 chronic tinnitus patients will be investigated. Assessments and interventions are harmonized over the involved clinical sites. The primary outcome measure focuses on the domain tinnitus distress assessed via the Tinnitus Handicap Inventory. Discussion: Results and conclusions from the current study might not only provide an essential contribution to combinatory and personalized treatment approaches in tinnitus but could also provide more profound insights in the heterogeneity of tinnitus, representing an important step towards a cure for tinnitus., European Union's Horizon 2020 Research and Innovation Program 848261

Background: The aim of this systematic review and meta-analysis was to evaluate the global postural re-education (GPR) program’s effectiveness compared to other exercise programs in subjects with persistent chronic low back pain. Methods: A systematic review and meta-analysis were carried out using PRISMA2020. An electronic search of scientific databases was performed from their inception to January 2021. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. Four meta-analyses were performed. The outcomes analyzed were disability due to back pain and pain. The risk of bias and quality of evidence were evaluated. The final search was conducted in March. Results: Seven trials were included, totaling 334 patients. The results showed improvement in pain measured by Visual Analogue Scale (VAS) (Standardised Mean Difference (SMD) = −0.69; 95% Confidence Interval (CI), −1.01 to −0.37; p < 0.0001), Numerical Pain Scale (NRS) (SMD = −0.40; 95% CI, −0.87 to 0.06); p = 0.022), VAS + NRS (SMD = −1.32; 95% CI, −1.87 to −0.77; p < 0.0001) and function (Roland Morris Disability Questionnaire (RMDQ)) (SMD = −0.55; 95% CI, −0.83 to −0.27; p < 0.0001) after GPR treatment. Conclusion: This meta-analysis provides reliable evidence that GPR may be an effective method for treating LBP by decreasing pain and improving function, with strong evidence. Yes

[Introduction] Stroke is a serious public health problem, given it is a major cause of disability worldwide despite the spread of recanalisation therapies. Enhancement of brain plasticity with stem cell administration is a promising innovative therapy to reduce sequelae in these patients., [Methods and analysis] We have developed a phase IIb, multicentre, randomised, double-blind, placebo-controlled clinical trial protocol to evaluate the safety and efficacy of intravenous administration of allogeneic adipose tissue-derived mesenchymal stem cells (AD-MSCs) in patients with acute ischaemic stroke, concurrently with conventional stroke treatment. Thirty patients will be randomised on a 1:1 basis to receive either intravenous placebo or allogeneic AD-MSCs as soon as possible within the first 4 days from stroke symptom onset. Patients will be followed up to 24 months after randomisation. The primary objective is the safety assessment of early intravenous administration of allogeneic AD-MSCs by reporting all adverse events and neurological or systemic complications in both treatment groups. Secondary objectives assess efficacy of early intravenous AD-MSC treatment in acute ischaemic stroke by evaluating changes in the modified Rankin Scale and the National Institutes of Health Stroke Scale throughout the follow-up period. In addition, brain repair biomarkers will be measured at various visits., [Ethics and dissemination] This clinical trial has been approved by the Clinical Research Ethics Committee of La Paz University Hospital (Madrid, Spain) and by the Spanish Agency of Medication and Health Products and has been registered in Eudra CT (2019-001724-35) and ClinicalTrials.gov (NCT04280003). Study results will be disseminated through peer-reviewed publications in Open Access format and at conference presentations., This clinical trial has been promoted by the La Paz University Hospital Institute for Health Research—IdiPAZ (La Paz University Hospital—Universidad Autónoma de Madrid) and sponsored from a competitive grant from the Carlos III Health Institute Healthcare Research Fund, and cofunded by the European Regional Development Fund (ERDF) 'A way to make Europe'/'Investing in your future' (PIC18/00016). This clinical trial has been supported by Plataforma Española de Investigación Clínica y Ensayos Clínicos, SCReN (Spanish Clinical Research Network), funded by Carlos III Health Institute-General Subdirection for Evaluation and Promotion of Research, research PT17/0017/0013; State Plan for Scientific Investigation, Technology and Innovation (2017–2020) and cofunded by European Regional Development Fund/European Social fund 'A way to make Europe'/'Investing in your future' (grant ID PT17/0017/0013).

Abstract Having access to parenting interventions in the early years is key to improve the developmental outcomes of children with neurodevelopmental problems. The Incredible Years® (IY) Parent Program is a group intervention that has demonstrated efficacy in terms of reducing stress in parents, as well as improving behavioral, emotional, and social outcomes in children. The program has been recently adapted for families of children with autism or language delays (IY-ASLD®). This intervention has not yet been implemented in the Spanish Public Health System, where there is a scarcity of evidence-based interventions being offered to families with young children presenting neurodevelopmental problems. The main aims of this study are to determine the feasibility of implementing the IY-ASLD® program within Spanish Child Mental Health Services and to examine parents’ acceptability and satisfaction with the intervention. As a secondary objective, we aim to evaluate its preliminary effectiveness in terms of reducing parental stress and behavioral difficulties in their children. The FIRST STEPS study is a multicenter, pilot randomized controlled trial comparing the IY-ASLD® program with a treatment-as-usual (TAU) condition. Approximately 70 families of children with autism spectrum disorder (ASD) and preterm children with communication and/or socialization difficulties (aged 2–5 years) will be recruited. Families will be assessed prior to randomization and after the intervention. Due to the COVID-19 pandemic, the intervention will consist of 22 weekly online sessions (approximately 6 months). The FIRST STEPS pilot trial will demonstrate the feasibility and acceptability of reliably implementing the IY-ASLD® program within the Spanish Public Health System. The results of this study could represent the first step to inform policymakers in Spain when designing evidence-based healthcare pathways for families of children presenting ASD symptoms or neurodevelopmental difficulties at early stages. Trial registration ClinicalTrials.gov NCT04358484. Registered on 04 April 2020

Background/Objective Brief transdiagnostic psychotherapies are a possible treatment for emotional disorders. We aimed to determine their efficacy on mild/moderate emotional disorders compared with treatment as usual (TAU) based on pharmacological interventions. Method: This study was a single-blinded randomized controlled trial with parallel design of three groups. Patients (N = 102) were assigned to brief individual psychotherapy (n = 34), brief group psychotherapy (n = 34) or TAU (n = 34). Participants were assessed before and after the interventions with the following measures: PHQ-15, PHQ-9, PHQ-PD, GAD-7, STAI, BDI-II, BSI-18, and SCID. We conducted per protocol and intention-to-treat analyses. Results: Brief psychotherapies were more effective than TAU for the reduction of emotional disorders symptoms and diagnoses with moderate/high effect sizes. TAU was only effectivein reducing depressive symptoms. Conclusions: Brief transdiagnostic psychotherapies might be the treatment of choice for mild/moderate emotional disorders and they seem suitable to be implemented within health care systems. Yes Antecedentes/Objetivo: Las psicoterapias breves son un posible tratamiento para los trastornos emocionales. Nuestro propósito fue determinar su eficacia en los trastornos emocionales leves/moderados en comparación con el tratamiento habitual basado en intervenciones farmacológicas. Método: Este estudio fue un ensayo clínico aleatorizado simple ciego con diseño paralelo de tres grupos. Los pacientes (N = 102) fueron asignados a psicoterapia breve individual (n = 34), psicoterapia breve grupal (n = 34) o tratamiento habitual (n = 34). Los participantes fueron evaluados antes y después del tratamiento con los siguientes instrumentos: PHQ-15, PHQ9, PHQ-PD, GAD-7, STAI, BDI-II, BSI-18 y SCID. Se realizaron análisis por protocolo y por intención de tratar. Resultados: Las psicoterapias breves fueron más efectivas que el tratamiento habitual para la reducción de síntomas y diagnósticos de los trastornos emocionales. El tratamiento habitual solo fue efectivo en reducir los síntomas depresivos. Conclusiones: Las psicoterapias breves pueden ser el tratamiento de elección para los trastornos emocionales leves/moderados y podrían implementarse en los sistemas de salud.

Introduction Perinatal depression is one of the most common complications during pregnancy and one year following childbirth. A negative impact on the mental and physical health of women, their children, partners, or significant others has been associated with this disease. Web-based and Mobile-based psychological interventions can reduce the burden of the disease through prevention of new cases of depression. It is crucial to know the effectiveness of these interventions to implement them around the globe. This systematic review and meta-analysis aims to assess the effectiveness of Web-based and Mobile-based psychological interventions to prevent depression during the perinatal period. Method and analysis A systematic review and meta-analysis will adhere to the PRISMA guidelines. Studies will be identified through MEDLINE, PsycINFO, Web of Science, Scopus, CINAHL, CENTRAL, Opengrey, Australian New Zealand Clinical Trial Registry, National Institute for Mental Health Research at the Australian National University, clinicaltrial.gov, beacon.anu.edu.au, and evidencebasedpsychotherapies.org from inception until 31 March 2021. We will also search the reference lists provided in relevant studies and reviews. The selection criteria will be as follows: 1) pregnant women or women who have given birth in the last 12 months and who were non-depressive at baseline; 2) Web-based and Mobile-Based psychological interventions; 3) comparators will be usual care, attention control, waiting list or no intervention; 4) outcomes will be the incidence of new cases of perinatal depression and/or the reduction of depressive symptoms as measured by validated instruments; and 5) the design of the studies will be randomized controlled trials. No restrictions regarding the year or language of publication will be considered. Pooled standardized mean differences and 95% confidence intervals will be calculated. The risk of bias of the studies will be assessed through the Cochrane Collaboration risk of bias 2.0 tool. Heterogeneity and publication bias will be estimated. Sensitivity and sub-group analyses will also be conducted. Random effects meta-regression will be performed. Ethics and dissemination As a systematic review, ethical approval is not required. The results from this study will be presented at international conferences and disseminated through peer-reviewed publications. Patients and the public will be involved in the dissemination plans. PROSPERO registration number 230,089 (submitted)., Highlights • This will be the first study to assess the effectiveness of Web-based and Mobile-based interventions in preventing perinatal depression • This systematic review and meta-analysis will include results on depression throughout the entire perinatal period. • This study will include only randomized control trials. • Only randomized control trials that excluded at baseline depressed women at baseline will be included.

Despite the existence of global recommendations for physical activity and lifestyle to avoid childhood obesity, there are no specific recommendations for school-age children. The aim of this meta-analysis was to measure the effects of current interventions with a physical activity component on body mass index (BMI) Z-score and on the moderate and vigorous physical activity (MVPA) time, measured by accelerometry, and focused on children with obesity. Randomized controlled trial studies (RCTs) based on physical activity interventions focused on children with obesity (6 to 12 years old) from January 1991 to August 2018 were included. The post-intervention mean and standard deviation of the BMI Z-score and MVPA engaged time were extracted to calculate the results using random effects models. Of a total of 229 studies considered potentially eligible, only 10 RCTs met the inclusion criteria. There were improvements in the BMI Z-score for physical activity intervention groups, compared with non-intervention children in addition to a significant increase in time engaged in MVPA. In conclusion, interventions with a physical activity component in school-children with obesity seem to be effective at reducing BMI and producing an increase in time spent engaged in physical activity. Therefore, interventions based on physical activity should be considered one of the main strategies in treating childhood obesity. Yes

Background: Neurological dysfunction due to stroke affects not only the extremities and trunk muscles but also the respiratory muscles. Aim: to synthesise the evidence available about the effectiveness of respiratory muscle training (RMT) to improve respiratory function parameters and functional capacity in poststroke patients. Methods: a systematic electronic search was performed in the MEDLINE, EMBASE, SPORTDiscus, PEDro and Web of Science databases, from inception to May 2020. Study selection and data extraction: randomised controlled trials (RCTs) that examined the effects of RMT versus non-RMT or sham RMT in poststroke patients. We extracted data about respiratory function, respiratory muscle strength and functional capacity (walking ability, dyspnea, balance, activities of daily life), characteristics of studies and features of RMT interventions (a type of RMT exercise, frequency, intensity and duration). Two reviewers performed study selection and data extraction independently. Results: nineteen RCTs met the study criteria. RMT improved the first second forced expiratory volume (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), maximal expiratory pressure (MEP), maximal inspiratory pressure (MIP) and walking ability (6 min walking test), but not Barthel index, Berg balance scale, and dyspnea. Conclusions: RMT interventions are effective to improve respiratory function and walking ability in poststroke patients. Yes

Obesity is a growing health threat worldwide. Administration of probiotics in obesity has also parallelly increased but without any protocolization. We conducted a systematic review exploring the administration pattern of probiotic strains and effective doses for obesity-related disorders according to their capacity of positively modulating key biomarkers and microbiota dysbiosis. Manuscripts targeting probiotic strains and doses administered for obesity-related disorders in clinical studies were sought. MEDLINE, Scopus, Web of Science, and Cochrane Library databases were searched using keywords during the last fifteen years up to April 2020. Two independent reviewers screened titles, abstracts, and then full-text papers against inclusion criteria according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. From 549 interventional reports identified, we filtered 171 eligible studies, from which 24 full-text assays were used for calculating intervention total doses (ITD) of specific species and strains administered. Nine of these reports were excluded in the second-step because no specific data on gut microbiota modulation was found. Six clinical trials (CT) and 9 animal clinical studies were retained for analysis of complete outcome prioritized (body mass index (BMI), adiposity parameters, glucose, and plasma lipid biomarkers, and gut hormones). Lactobacillus spp. administered were double compared to Bifidobacterium spp.; Lactobacillus as single or multispecies formulations whereas most Bifidobacteria only through multispecies supplementations. Differential factors were estimated from obese populations' vs. obesity-induced animals: ITD ratio of 2 × 106 CFU and patterns of administrations of 11.3 weeks to 5.5 weeks, respectively. Estimation of overall probiotics impact from selected CT was performed through a random-effects model to pool effect sizes. Comparisons showed a positive association between the probiotics group vs. placebo on the reduction of BMI, total cholesterol, leptin, and adiponectin. Moreover, negative estimation appeared for glucose (FPG) and CRP. While clinical trials including data for positive modulatory microbiota capacities suggested that high doses of common single and multispecies of Lactobacillus and Bifidobacterium ameliorated key obesity-related parameters, the major limitation was the high variability between studies and lack of standardized protocols. Efforts in solving this problem and searching for next-generation probiotics for obesity-related diseases would highly improve the rational use of probiotics. Yes

Objectives: • Primary objective: to evaluate the effect of intravenous melatonin (IVM) on mortality in adult patients admitted to the intensive care unit (ICU) with COVID-19. • Secondary objectives: ◦ To evaluate the effect of IVM on ICU length of stay. ◦ To evaluate the effect of IVM on the length of mechanical ventilation (MV). ◦ To evaluate if the use of IVM is associated with an increase in the number of ventilator-free days. ◦ To evaluate if the use of IVM is associated with a reduced number of failing organs as determined by the sequential organ failure assessment (SOFA) scale. ◦ To evaluate if the use of IVM is associated with a reduction of the frequency and severity of COVID-19-associated thromboembolic phenomena. ◦ To evaluate if the use of IVM is associated with a decreased systemic inflammatory response assessed by plasma levels of ferritin, D-dimer, C-reactive protein, procalcitonin and interleukin-6. ◦ To evaluate if the use of IVM is associated with an improvement in hematologic parameters. ◦ To evaluate if the use of IVM is associated with an improvement in biochemical parameters. ◦ To evaluate if the use of IVM is associated with an improvement in blood gas analysis parameters. ◦ To evaluate adverse events during the 28 day study period., Start-up Pharmamel LTD

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system with a degenerative component, leading to irreversible disability. Mesenchymal stem cells (MSC) have been shown to prevent inflammation and neurodegeneration in animal models of MS, but no large phase II clinical trials have yet assessed the exploratory efficacy of MSC for MS. This is an academic, investigator-initiated, randomized, double-blind, placebo-compared phase I/II clinical trial with autologous, bone-marrow derived MSC in MS. Enrolled subjects will receive autologous MSC at either baseline or at week 24, through a cross-over design. Primary co-objectives are to test safety and efficacy of MSC treatment compared to placebo at 6 months. Secondary objectives will evaluate the efficacy of MSC at clinical and MRI levels. In order to overcome funding constraints, the MEsenchymal StEm cells for Multiple Sclerosis (MESEMS) study has been designed to merge partially independent clinical trials, following harmonized protocols and sharing some key centralized procedures, including data collection and analyses. Results will provide patients and the scientific community with data on the safety and efficacy of MSC for MS. The innovative approach utilized to obtain funds to support the MESEMS trial could represent a new model to circumvent limitation of funds encountered by academic trials. Andalusia: NCT01745783 , registered on Dec 10, 2012. Badalona: NCT02035514 EudraCT, 2010–024081–21. Registered on 2012. Canada: ClinicalTrials.gov, NCT02239393 . Registered on September 12, 2014. Copenhagen: EudraCT, 2012–000518-13 . Registered on June 21, 2012. Italy: EudraCT, 2011–001295-19, and ClinicalTrials.gov, NCT01854957 . Retrospectively registered on May 16, 2013. London: Eudra CT 2012–002357-35, and ClinicalTrials.gov, NCT01606215 . Registered on May 25, 2012. Salzburg: EudraCT, 2015–000137-78 . Registered on September 15, 2015. Stockholm: ClinicalTrials.gov, NCT01730547 . Registered on November 21, 2012. Toulouse: ClinicalTrials.gov, NCT02403947 . Registered on March 31, 2015.

Background: Frozen shoulder (FS) is a musculoskeletal condition of poorly understood etiology that results in shoulder pain and large mobility deficits. Despite some physical therapy interventions, such as joint mobilization and exercise, having shown therapeutic benefit, a definitive treatment does not currently exist. The aim of this study will be to compare the effectiveness of a central nervous system (CNS)-directed treatment program versus a standard medical and physical therapy care program on outcomes in participants with FS. Methods/design: The study is a two-group, randomized clinical trial with blinding of participants and assessors. Participants will be recruited via referrals from orthopedic surgeons and physical therapists, community-based advertisements, private care practices and hospitals. Participants will be randomized to receive either a CNS-focused treatment program or standard medical and physical therapy care. The Shoulder Pain And Disability Index (SPADI) will be the primary outcome, while the Numeric Pain Rating Scale (NPRS), shoulder range of movement (ROM), The Patient Specific Functional Scale, two-point discrimination threshold and laterality judgement accuracy will be the secondary outcomes. Assessment will occur at baseline, at the end of the treatment program (week 10), and at 3 and 6 months’ follow-up. Discussion: Preliminary data suggest that treatments that target CNS function are a promising approach to the treatment of people with shoulder pain including patients with FS. In the context of modest effects from most available physical therapy treatments for FS, this CNS-focused approach may lead to improved clinical outcomes. The trial should determine if the CNS-directed program is more effective than traditional interventions at reducing pain intensity and improving function in a FS cohort and will follow up participants for 6 months, providing important information on the persistence of any treatment effects., This work is funded by the Conselleria de Educación, Investigación, Cultura y Deporte de la Generalitat Valenciana, Spain (GV/2016).

BackgroundThe World Health Organization (WHO) has included comorbidity between depression and a chronic disease among the 10 leading global health priorities. Although there is a high prevalence of multimorbidity, health care systems are mainly designed for the management of individual diseases. Given the difficulty in delivering face-to-face psychological treatments, alternative models of treatment delivery have been proposed, emphasizing the role of technologies such as the Internet. The aim of this study is to assess the efficacy in Primary Care (PC) of a blended low-intensity psychological intervention applied using information and communication technologies (ICTs) for the treatment of multimorbidity in PC (depression and type 2 diabetes/low back pain) by means of a randomized controlled trial (RCT). Our main hypothesis is that improved usual care combined with psychological therapy applied using ICTs will be more efficacious for improvement in the symptomatology of multimorbidity, compared to a group with only improved treatment as usual six months after the end of treatment.MethodsA protocol has been designed combining a face-to-face intervention with a supporting online programme that will be tested by an RCT conducted in three different regions (Andalusia, Aragon and the Balearic Islands). The RCT will evaluate three hundred participants diagnosed with depression and type 2 diabetes/low back pain. Four highly experienced research groups specializing in clinical psychology are involved in this trial, and there will be ample possibilities for translation and transfer to usual clinical practice.DiscussionThis clinical trial will lead to improvement in financial sustainability, maximizing the use of resources and responding to principles of efficiency and effectiveness. Furthermore, based on the evaluation of the feasibility of implementing this intervention in primary care facilities, we expect to be able to suggest the intervention for incorporation into public policy. In conclusion, positive results of this study could have a significant impact on one of the most important health-related problems, multimorbidity.Trial registrationClinicalTrials.gov, NCT03426709. Registered retrospectively on 08 February 2018., The first two authors have a FI predoctoral contract awarded by the Institute of Health Carlos III (ISCIII; FI17/00180) and the Ministry of Education, Culture and Sports (Spain) (FPU014/04987) at the Institute of Health Research of Aragon (IIS) of Zaragoza.

The objective of this review was to analyze trends in outcomes and in the quality of phase III randomized controlled trials on advanced NSCLC published between 2000 and 2012, selecting 76 trials from a total of 122 retrieved in a structured search. Over the study period, the number of randomized patients per trial increased by 14 per year (P = 0.178). The sample size significantly increased between 2000 and 2012 in trials of targeted agents (460.1 vs. 740.8 patients, P = 0.009), trials of >1 drug (360.4 vs. 584.8, P = 0.014), and those including patients with good performance status (675.3 vs. 425.6; P = 0.003). Quality of life was assessed in 46 trials (60.5%), and significant improvements were reported in 10 of these (21.7%). Platinum-based regimens were the most frequently investigated (86.8% of trials). Molecular-targeted agents were studied in 25.0% of chemotherapy arms, and the percentage of trials including these agents increased each year. The median (interquartile range) overall survival (MOS) was 9.90 (3.5) months with an increase of 0.384 months per year of publication (P 1 drug (360.4 vs. 584.8, P = 0.014), and those including patients with good performance status (675.3 vs. 425.6; P = 0.003). Quality of life was assessed in 46 trials (60.5%), and significant improvements were reported in 10 of these (21.7%). Platinum-based regimens were the most frequently investigated (86.8% of trials). Molecular-targeted agents were studied in 25.0% of chemotherapy arms, and the percentage of trials including these agents increased each year. The median (interquartile range) overall survival (MOS) was 9.90 (3.5) months with an increase of 0.384 months per year of publication (P 0.05). There has been a continuous but modest improvement in the survival of patients with advanced NSCLC over the past 12 years. Nevertheless, the quality of clinical trials and the benefit in outcomes should be carefully considered before the incorporation of novel approaches into clinical practice.

Introductory Journal Article; The Recommendations for Specialized Nutritional Support in Critically-Ill patients were drafted by the Metabolism and Nutrition Working Group of the Spanish Society of Intensive Care Medicine and Coronary Units (SEMICYUC) in 2005. Given the time elapsed since then, these recommendations have been reviewed and updated as a Consensus Document in collaboration with the Spanish Society of Parenteral and Enteral Nutrition (SENPE). The primary aim of these Recommendations was to evaluate the best available scientific evidence for the indications of specialized nutritional and metabolic support in critically-ill patients. The Recommendations have been formulated by an expert panel with broad experience in nutritional and metabolic support in critically-ill patients and were drafted between October 2009 and March 2011. The studies analyzed encompassed metaanalyses, randomized clinical trials, observational studies, systematic reviews and updates relating to critically-ill adults in MEDLINE from 1966 to 2010, EMBASE reviews from 1991 to 2010 and the Cochrane Database of Systematic Reviews up to 2010. The methodological criteria selected were those established in the Scottish Intercollegiate Guidelines Network and the Agency for Health Care policy and Research, as well as those of the Jadad Quality Scale. Adjustment for the level of evidence and grade of recommendation was performed following the proposal of the GRADE group (Grading of Recommendations Assessment, Development and Evaluation Working Group). Sixteen pathological scenarios were selected and each of them was developed by groups of three experts. A feedback system was established with the five members of the Editorial Committee and with the entire Working Group. All discrepancies were discussed and consensus was reached over several meetings, with special emphasis placed on reviewing the levels of evidence and grades of recommendation. The Editorial Committee made the final adjustments before the document was approved by all the members of the Working Group. Finally, the document was submitted to the Scientific Committees of the two Societies participating in the Consensus for final approval. The present Recommendations aim to serve as a guide for clinicians involved in the management and treatment of critically-ill patients and for any specialists interested in the nutritional treatment of hospitalized patients. Yes El Grupo de trabajo de Metabolismo y Nutrición de la Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC) elaboró en 2005 unas recomendaciones para el soporte nutricional especializado del paciente crítico. Dado el tiempo transcurrido se consideró oportuno la revisión y actualización de dichas recomendaciones, planificándolas como un documento de consenso con la Sociedad Española de Nutrición parenteral y Enteral (SENpE). El objetivo primario planteado para el establecimiento de las recomendaciones fue evaluar la mejor evidencia científica disponible para las indicaciones del soporte nutricional y metabólico especializado en el paciente crí- tico. Las recomendaciones se han realizado por un panel de expertos con amplia experiencia en el soporte nutricional y metabólico de los pacientes en situación crítica y se han llevado a cabo entre octubre de 2009 y marzo de 2011. Se analizaron metaanálisis, estudios clínicos aleatorizados y observacionales, revisiones sistemáticas y puestas al día referentes a pacientes críticos en edad adulta en MEDLINE de 1966 a 2010, EMBASE reviews de 1991 a 2010 y Cochrane Database of Systematic Reviews hasta 2010. Se seleccionaron los criterios metodológicos establecidos en la Scottish Intercollegiate Guidelines Network y los de la Agency for Health Care policy and Research, además de la escala de valoración de la calidad de Jadad, ajustando la gradación de la evidencia y la potencia de las recomendaciones siguiendo la propuesta del Grupo GRADE (Grading of Recommendations Assessment, Development and Evaluation Working Group). Se seleccionaron 16 situaciones patológicas que fueron desarrolladas, cada una, por grupos de 3 expertos, estableciéndose un sistema de feedback con los 5 miembros del Comité de Redacción y con la totalidad del Grupo de trabajo. En diferentes reuniones se discutieron y consensuaron todas las discrepancias, poniéndose especial énfasis en el repaso de los niveles de evidencia y grados de recomendación establecidos. El Comité de Redacción procedió al ajuste final para su presentación y aproba ción definitiva por todos los miembros del Grupo de trabajo. Finalmente el documento se presentó a los comités científicos de las dos sociedades participantes del consenso para su aprobación definitiva. Las presentes recomendaciones pretenden servir de guía para los clínicos con responsabilidades en el manejo y tratamiento de los pacientes críticos y para todos los especialistas interesados en el tratamiento nutricional del paciente hospitalizado.

Background Non cephalic presentation in childbirth involves various risks to both the mother and the foetus. The incidence in Spain is 3.8% of all full-term pregnancies. The most common technique used to end the gestation in cases of non cephalic presentation is that of caesarian section, and although it provokes a lower rate of morbi-mortality than does vaginal delivery in such situations, there remains the possibility of traumatic injury to the foetal head and neck, while maternal morbidity is also increased. The application of heat (moxibustion) to an acupuncture point, in order to correct non cephalic presentation, has been practised in China since ancient times, but as yet there is insufficient evidence of its real effectiveness. Methods/Design The experimental design consists of a multi-centre randomised controlled trial with three parallel arms, used to compare real moxibustion, sham moxibustion and the natural course of events, among pregnant women with a non cephalic presentation and a gestational duration of 33–35 weeks (estimated by echography). The participants in the trial will be blinded to both interventions. The results obtained will be analyzed by professionals, blinded with respect to the allocation to the different types of intervention. In addition, we intend to carry out a economic analysis. Discussion This trial will contribute to the development of evidence concerning moxibustion in the correction of non cephalic presentations. The primary outcome variable is the proportion of cephalic presentations at term. As secondary outcomes, we will evaluate the proportion of cephalic presentations at week 38 of gestation, determined by echography, together with the safety of the technique, the specificity of moxibustion and the control of the blinding process. This study has been funded by the Health Ministry of the Andalusian Regional Government. Trial registration Current Controlled Trials ISRCTN10634508.

Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA) Scale; as secondary variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS), nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs) taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat. Discussion The discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis.

Comparative Study; Journal Article; Research Support, Non-U.S. Gov't; Study Protocol BACKGROUND Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60-70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis. METHODS/DESIGN Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points), placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study. In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI) at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results. DISCUSSION This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain and to isolate the specific and non-specific effects of the treatment. Yes