In general, there is a need for testing new interventions in large randomized controlled trials. Depending on the research question it may be advantageous to establish multicenter studies as a way of organizing clinical trials in order to increase study power.The object of this study was to investigate the development in the organization of multicenter studies, the distribution of studies within different clinical specialties, across continents, and investigate the differences related to testing various interventions.A literature search was done in MEDLINE for multicenter studies published in 1995, 2000, 2005, and 2010, respectively. Data extraction identified data related to clinical specialties, interventions, participating patients, departments, countries, and continents.The number of multicenter studies increased from 112 in 1995 to 1,273 in 2010, with a larger share of multicenter studies being performed in Europe and North America. The pharmacological interventions were primarily being tested in medical studies followed by the device tests predominantly in surgical studies. The number of included patients as well as the number of participating departments increased during the time span, though the increase in studies was most evident in Europe and North America compared with the rest of the world. In general, results relying on meta-analyses of randomized controlled trials are being regarded as the highest level of evidence When new treatments are introduced without having been tested in high quality randomized controlled trials there seems to be methodological problems in some clinical research areas The above mentioned hypotheses have not been explored in a systematic way uncovering aspects related to obtaining sufficient power in clinical research in multicenter studies. Our hypothesis before initiating the study was that we expected studies originating from the medical specialty would be larger in number than studies reporting results from surgery, psychiatry and general practice. Furthermore, we expected studies testing pharmacological interventions would also be larger in number. The object of this study was therefore to investigate the development in clinical studies organized as multicenter studies from 1995 to 2010. Moreover, we wanted to explore this issue related to the distribution of studies within different clinical specialties, and across continents. Furthermore, we wanted to investigate the differences in numbers of the published papers, and in participants included in the studies, and in relation to the various interventions being tested.We searched for published studies  in MEDLIInclusion criteria were: papers reporting RCTs that were organized as multicenter studies, and testing clinical interventions aimed at humans. Exclusion criteria were non-randomized designs, odontologic studies, protocol abstracts, and studies with less than two participating centers.Data were extracted by one of the authors (CO) from abstracts including the following variables: clinical specialty , medical subspecialties  as well as surgical subspecialties  surgery, vascular surgery, urology, orthopedic surgery, and “others” covering e.g. ophthalmology, gynecology, neurosurgery). Furthermore, we registered continent of origin, number of participating countries, number of participating centers, the tested intervention , and number of included patients if available. If reading the abstracts could not retrieve data on the number of patients, full-text papers were obtained.Data were analyzed using SPSS 19 . We did not do any statistical tests as our data, although large in number, would be better presented descriptively. Data describing number of participants and studies were analyzed as continuous variables, and data describing specialties and subspecialties were handled as categorical variables. Hence, results were presented using mean and standard deviation and median and min-max, and percentages where relevant.The study was exempt from approval with the Danish Ethical Committee as well as the Danish Data Protection Agency, as we did not include any form of biomedical intervention or any personal data related to individual and identifiable humans.The search in the database for relevant studies published in the months of February, June, and November in 1995, 2000, 2005, and 2010, identified 2,602 studies. Based on reading of the abstracts we included 2,567 studies and excluded 35 studies not meeting our inclusion criteria . An examThe results showed a substantial increase in the total number of trials in all specialties organized and published as multicenter studies with 112 reported trials in 1995 and 1,273 trials reported in 2010. When differentiating between the specialties it was evident that more studies in numbers originated from medical specialties compared with other specialties . HoweverWhen exploring the publication trend within the different medical and surgical subspecialties, we found a rise in multicenter publications from 1995 to 2010 within all medical subspecialties . When looking at the surgical subspecialties the development in numbers was equally positive, and all the surgical subspecialties experienced an increasing number of multicenter publications from 1995 to 2010 .The number of studies being organized as multicenter studies across continents pointed at Europe and North America accounting for the largest increase (Europe 48 (year 1995) – 555 (year 2010), North America 52 (year 1995) – 491 (year 2010)). Furthermore, Europe and North America combined covered more than 80% of the multicenter studies published in 2010, and including 89% of the total number of participants.When comparing the total number of patients in all specialties for the total study period, we found a variation between specialties, and not surprisingly we found a rise in total number of participants being included over the period . We discWe found a rise in number of participating countries across the total study period both in total and in the specific specialty . This variable was reported in 97.3% of the included studies.We found an overweight of studies testing pharmaceuticals (in total, pharmaceuticals: n = 1,732, devices: n = 158, observational: n = 295, other: n = 369, with more medical studies reporting results on pharmaceuticals . HoweverAdditionally, we identified that studies testing pharmaceuticals accounted for 69% to 75% of studies being conducted in Europe, Asia, North and South America and Asia, and only 33% of the studies originating from Oceania.In general, we found that the number of multicenter studies increased during the period from 1995 to 2010, with a larger share of multicenter studies been performed in Europe and North America compared with the rest of the world. Furthermore, the distribution between the different specialties showed that the medical specialties had the highest number of studies, but without substantial change in distribution between specialties over the years. When looking at the different interventions being tested in multicenter studies it was obvious that pharmacological interventions were overrepresented and primarily tested in medical studies followed by the testing of devices predominantly in surgical studies. The number of included patients as well as the number of participating departments increased during the time span, though the increase in studies was most evident in Europe and North America.Multicenter studies may be a way of organizing clinical trials in order to increase power of the study, and to conduct studies of high scientific quality. This may establish the safety and efficacy of the tested intervention and produce results with clinical impact Adequately sized randomized controlled trials are regarded as the gold standard in rigorous and robust clinical research. Participants may be recruited across a number of centers on a randomly assigned basis. One of the difficulties when carrying out clinical research is to have a high recruitment rate in order to have sufficient power. One way to overcome some of these difficulties could be to organize trials in multicenter studies.We found that the number of multicenter studies increased during the period from 1995 to 2010. This interesting result hopefully reflects the rising awareness of the ethical issues within clinical decision making, as it should be based on best evidence from adequately sized randomized controlled trials When looking at the number of medical studies testing pharmaceuticals, there might be a need for not only testing a new drug and comparing it to placebo, but preferably to routine medication If pursuing the issue of inclusion, the increase in participating centers should be followed by an increase in included participants, hereby increasing sample size and power. However, we did not examine this relation further in this study, and therefore we cannot generalize that the increase in multi center studies did lead to studies reporting significant and clinically relevant results; both showing p-values and confidence intervals.Some authors have discussed that one of the major concerns when planning and running multicenter studies was the increasing demands on cooperation and communication across departments, regions and countries The medical specialties represented a larger number of studies organized as multicenter studies, as well as a large number of trials testing pharmaceuticals. Hence, it should be considered whether testing of pharmaceuticals may be easier organized in multicenter studies, or if the reason would be more frequent use of CROs to run the studies. A link between the structure and the intervention may be coincidental, but could be due to easier access to administrative and economic resources, or pharmaceuticals being easier to test than for instance surgical procedures The difference between the continents was profound, showing that Europe and North America accounted for over 80% of the published multicenter studies, but probably with an increasing trend from Asia. The increase in Asia might be connected to an ease in establishing multicenter trials, and especially the rise in trials testing pharmaceuticals might be because of possible economic benefits related to for instance phase 3 trials.Additionally, another perspective on the barriers related to research in for instance Africa might cover general aspects of a semi colonial approach to cooperation One of the limitations of this study was that we were not able to include a group for comparison, which means that the total number of trials being conducted the same period and in the same specialty is not scrutinized in our study. Therefore, our findings might reflect the development in clinical trials in general, and not just the development in multicenter organization. However, despite our data especially from some of the smaller clinical specialties were low in numbers, we were able to point at interesting differences in many of our variables. Doing a literature search as a mean of data retrieval was an obvious option for us, as there was no other alternative database where we could access the relevant data. Hence, we cannot be sure that our literature search fully identified all relevant trials for us to explore and examine the object of our study. However, we have retrieved data from published studies over a long period of time covering months that had similar publication rates as the rest of the year.We found an increase in numbers of clinical trials organized as multicenter studies primarily in Europe and North America. Furthermore, data revealed that medical specialties had a higher number of participating departments and number of included patients in multicenter studies compared with other specialties. However, we did not find large differences when comparing the increase in multicenter studies across the different clinical specialties. We also found that testing of pharmaceuticals, followed by testing of devices were the most widely used interventions in multicenter studies, and that pharmaceuticals were most often tested by medical specialties. This raises the question whether the larger proportion of multicenter studies within pharmaceuticals than devices may be related to funding from industry, which could be pursued in other studies.


Current instruments to evaluate the postgraduate medical educational environment lack theoretical frameworks and are relatively long, which may reduce response rates. We aimed to develop and validate a brief instrument that, based on a solid theoretical framework for educational environments, solicits resident feedback to screen the postgraduate medical educational environment quality.Stepwise, we developed a screening instrument, using existing instruments to assess educational environment quality and adopting a theoretical framework that defines three educational environment domains: content, atmosphere and organization. First, items from relevant existing instruments were collected and, after deleting duplicates and items not specifically addressing educational environment, grouped into the three domains. In a Delphi procedure, the item list was reduced to a set of items considered most important and comprehensively covering the three domains. These items were triangulated against the results of semi-structured interviews with 26 residents from three teaching hospitals to achieve face validity. This draft version of the Scan of Postgraduate Educational Environment Domains (SPEED) was administered to residents in a general and university hospital and further reduced and validated based on the data collected.Two hundred twenty-three residents completed the 43-item draft SPEED. We used half of the dataset for item reduction, and the other half for validating the resulting SPEED . Internal consistencies were high. Correlations between domain scores in the draft and brief versions of SPEED were high (>0.85) and highly significant (p<0.001). Domain score variance of the draft instrument was explained for ≥80% by the items representing the domains in the final SPEED.The SPEED comprehensively covers the three educational environment domains defined in the theoretical framework. Because of its validity and brevity, the SPEED is promising as useful and easily applicable tool to regularly screen educational environment quality in postgraduate medical education. In postgraduate medical education (PGME), the quality of the educational environment is important for the effectiveness of clinical teaching programs ,2, for tpersonal development or goal direction dimensions, relationship dimensions and system maintenance and system change dimensions.The central idea behind the general theoretical framework for describing human environments is that each kind of human environment can be characterized in terms of three common sets of dimensions, or in other words: in terms of three broad domains –9. ReseaThe personal development or goal direction domain concerns the basic goals of the environment and comprises the aspects in the environment that are important for personal growth and self-enhancement. For instance, the main aim of educational settings is achieving the learning goals. To achieve these goals, it is important that the educational environment scores high on aspects like clarity about learning objectives, relevance of learning content and providing constructive criticism.The relationship domain concerns the involvement of people in the setting, the extent to which they support each other and to which they feel free to express themselves in an open and spontaneous way. A beneficial relationship domain implies that there is open communication, that people in the setting are friendly toward each other and that they provide social and interpersonal support to each other. In addition, they have a clear sense of cohesion and of group spirit. In educational settings, dimensions relevant to assess positive relationship are, for instance, student involvement,  support, affiliation or bonding, and support by teachers.The system maintenance and system change domain concerns the degree to which there is order in the environment and clarity in expectations, the amount of control in the environment and the environment’s responsiveness to change. In educational settings, typical dimensions to assess this domain are organization, order, rule clarity, teacher control, student influence and innovation. In specific learning environments like workplace-learning settings, some dimensions relevant to work environments may also apply, for instance, work pressure and physical comfort.goal orientation, relationships and organization/regulation [A content analysis of existing instruments to assess the medical educational environment showed that the majority of the items in these instruments could be related to the general framework. In the medical education context, the contents of the three domains could be summarized as gulation . Goal orWe aimed to contribute to the medical education environment field by applying a solid theoretical framework–i.e. a theoretical framework that has been tested repeatedly and that appears to be generally acknowledged . In liteThe purpose of this study was to develop a theoretically sound instrument–suitable for regular use–that solicits resident feedback to screen the quality of the educational environment in postgraduate medical education (PGME) programs. We based the instrument on the aforementioned theoretical framework defining goal orientation, relationships and organization/regulation as the three key domains of the medical educational environment. In addition, we built on prior research by using the contents of previously developed environment instruments and the outcomes of the content analysis described earlier . As a reConsidering our objective to develop an instrument that is suitable for regular use, we aimed to limit its length. Existing instruments assessing the quality of the educational environment in PGME ,3,6 are We developed the SPEED in a stepwise fashion. First, we extracted items from published instruments assessing the educational environment. Building on previous work in which we categorized all the items from eight existing instruments into the three domains goal orientation (content), relationships (atmosphere) and organization/regulation (organization) , we addeThe final draft of the SPEED was sent as a web-based survey to all PGME residents in a general hospital  and in a university hospital  in the Netherlands. Respondents were asked to score their agreement to each item (presented as a statement) on a 4-point Likert scale ranging from 0 (completely disagree) to 3 (completely agree). In addition, respondents were asked to provide an overall rating of the quality of their PGME training program in the three domains  as a numerical score ranging from 1  to 10 . This method of providing an overall rating of performance on a scale ranging from 1 to 10 is the standard way of grading tests and exams in schools and universities in the Netherlands.Item reduction was planned in two stages. First, we calculated correlation coefficients between the mean item score in each domain and the overall numerical score for that domain. If the correlation coefficient between the mean item score and the total numerical score was >0.85, the domain in the abbreviated instrument would be reduced to only the overall numerical score. If this correlation was ≤0.85, item reduction was performed on half of the database (the derivation dataset), and validation of the abbreviated instrument on the other half . As item reduction based on only maximization of internal consistencies may bear the risk of reduced validity due to redundancy in the items and limited coverage of each of the three domains, we followed published recommendations to not limit item reduction to internal consistency alone, but also take item content into account . TherefoUsing the validation dataset, we validated the abbreviated SPEED by calculating the adjusted item-to-total-domain-score correlations of each item (required not to be <0.30) , the corThe study was conducted according to the declaration of Helsinki, and was approved by the ethical review board of the Dutch Society of Medical Education (NERB dossier number 171). All participants provided informed consent.After item extraction and deletion of duplicate items, the first draft of the SPEED consisted of 169 items: 67 in the content domain, 48 in the atmosphere domain, and 54 in the organization domain. After the first Delphi round, these were reduced to 10, 11, and 10 items, respectively. In round 2, 7 items were added . After the interviews with residents, 5 more items were added: 4 to the content and 1 to the organization domain. The final draft SPEED therefore consisted of 43 items see . There wOut of a total of 666 residents who were mailed the final draft instrument, 223 responded (33.5%). After deleting 15 respondents with incomplete responses, 208 completely scored final draft versions of the SPEED were available for analysis . CronbacValidation of the abbreviated 15-item SPEED was performed on the responses of the 104 respondents in the validation dataset. The item-to-total domain score correlations for each of the 15 items in the abbreviated instrument in this validation dataset are presented in The aim of this study was to develop a concise valid instrument based on a solid theoretical framework, suitable for regular assessment of the PGME environment. For this purpose, we integrated a thorough theoretical basis with the content of existing instruments to assess the quality of the (postgraduate) medical educational environment. This approach resulted in an instrument of only 15 items that comprehensively covers the three key elements of the (postgraduate) medical educational environment: content, atmosphere and organization of education. We called this instrument the Scan of Postgraduate Educational Environment Domains (SPEED). Our study, which encompassed several development and validation stages, supports the face and content validity of the SPEED. Therefore, the SPEED is suitable for regular assessment of the PGME environment.The fact that our study resulted in an instrument that is both concise and valid may be attributable to the integrated approach we applied. First, we founded the SPEED on a solid theoretical framework to ensure that it covers the key elements of good PGME quality. Second, we selected relevant content from previously developed instruments. Building on this previous work was not only efficient, but also considered justifiable because of the high quality of these existing instruments: they were developed carefully, published in peer-reviewed journals, the items fit into the theoretical framework that we adopted and were found to cover the educational environment comprehensively . Third, The outcomes of the validation process provided support for the quality of the abbreviated instrument. Its internal consistency was high and the item-to-total domain score correlations were adequate. In addition, the outcomes of the SPEED were strongly representative of the scores obtained with the full draft version, indicating high content validity.Compared to the instruments to evaluate the quality of the PGME environments that have been published previously ,19,20, tCompared to earlier instruments assessing educational environment quality, a third and final advantage of the SPEED is its conciseness, with only 15 items to be scored instead of up to 50 ,20. The The main strength of our study is the thorough and innovative development process of this PGME environment instrument, building on a sound theoretical framework and previous research, involving stakeholders, and basing the item reduction process on recommendations from experts in the field. The main limitation of our study is the relatively low response rate during the validation phase. We would like to emphasize that this was the response to a 43-item questionnaire with item redundancy and that response rates may be higher when using the final, abbreviated SPEED. The sample size was large enough, however, to perform the validation analyses, even those in which only half of the dataset was used. Besides, we did not restrict item reduction to a statistical procedure by basing it entirely on the analyses, but we also took item content into account. In addition, to prevent item reduction on the basis of idiosyncratic characteristics of the data, we validated our item selection using a dataset different from the development dataset. The fact that the outcomes of the SPEED are representative of those obtained with the full draft version is promising and supports our development process as sound and the SPEED as a valid tool to obtain an apt and encompassing picture of the quality of the PGME environment. Using the contents of previously developed environment instruments may pose a second limitation to our study. However, despite the fact that existing instruments in our field lacked theoretical frameworks, we consider their contents as a useful starting point for our work. The existing instruments were developed conscientiously through profound qualitative research methods, in various cases even using more than one  research approach, such as literature review, grounded theory which often involved stakeholders through Delphi panels and/or focus groups, and/or using existing instruments from within or outside the medical educational field. As a result, the instruments appear to contain rich materials, which are considered valid to practice by important stakeholders. Besides, the fact that they were all published in peer-reviewed journals represents an acknowledgment of the quality of the instruments. Also, their wide coverage of environment aspects makes them suitable as an adequate basis for judging the relevance of items for the new instrument to be developed. A third possible limitation is that the final SPEED may provide less diagnostic information than a long questionnaire due to its brevity. As our study shows, however, the items that we selected for inclusion in the final SPEED explained a high percentage of the variance and therefore, it is suitable to indicate problems in (certain domains of) the educational environment. In case of such problems, longer questionnaires might be administered or other kinds of evaluation procedures started, for instance interviews may be held, to explore the problematic aspects in-depth in order to resolve them.Future research might focus on further validation of the SPEED. As explained by Stanton et al.  item comWe succeeded in our aim to develop a concise instrument of only 15 items to assess the quality of the educational environment in PGME, which seems feasible for regular application. In the development process, we followed the suggestions of experts to use a guiding theoretical framework and build upon previous work –13. Our S1 File(SAV)Click here for additional data file.


Acute respiratory distress syndrome (ARDS) has been intensively and continuously studied in various settings, but its mortality is still as high as 30–40 %. For the last 20 years, lung protective strategy has become a standard care for ARDS, but we still do not know the best way to ventilate patients with ARDS. Tidal volume itself does not seem to have an important role to develop ventilator-induced lung injury (VILI), but the driving pressure, which is inspiratory plateau pressure—PEEP, is the most important to predict and affect the outcome of ARDS, though there is no safe limit for the driving pressure. There is so much controversy regarding what the best PEEP is, whether collapsed lung should be recruited, and what parameters should be measured and evaluated to improve the outcome of ARDS. Since the mechanical ventilation for patients with respiratory failure, including ARDS, is a standard care, we need more dynamic and regional information of ventilation and pulmonary circulation in the injured lungs to evaluate the efficacy of new type of treatment strategy. In addition to the CT scanning of the lung as the gold standard of evaluation, the electrical impedance tomography (EIT) of the lung has been clinically available to provide such information non-invasively and at the bedside. Various parameters have been tested to evaluate the homogeneity of regional ventilation, and EIT could provide us with the information of ventilator settings to minimize VILI. Since the introduction of disease entity almost 50 years ago, the mortality has been slightly but consistently improved, but the survival rate is still as low as 70 %.Acute respiratory distress syndrome (ARDS) was first introduced by Dr. Ashbaugh in 1969 and re-defined as Berlin definition in 2012 as acute respiratory failure in terms of acute onset, hypoxia, diffuse infiltrates on chest X-ray, and absence of cardiac failure, or pulmonary edema due to cardiac origin [The reason for such low surviving rate of ARDS might be due to the lack of knowledge and evidence regarding the respiratory anatomy and physiology in normal and ARDS patients as well as the pathological process of ARDS.We have to recognize what we have already elucidated about the physiological changes in ARDS and understand the pathophysiology of ARDS in order to improve its outcome.Until the Berlin definition was established , the defSuch high mortality from ARDS might be associated with various factors other than respiratory failure. Some studies reported that the mortality is more commonly related to the development of sepsis and multiple organ failure (MOF) and others that it is related with severity of respiratory failure. Ferring et al. studied the clinical and biological data to elucidate what makes the mortality from ARDS much worse . Over a In conclusion, almost 50 years after the introduction of ARDS by Ashbaugh, the mortality is still 30 to 40 %, and such high mortality could be associated with the concomitant development of sepsis and MOF. In order to improve the outcome of ARDS, we have to consider the strategy to reduce the incidence of sepsis and MOF.The first report was by Amato and his coworkers that the protective ventilation strategy with small tidal volume in the patients with ARDS resulted in the better outcome, when compared with those with larger tidal volume, published in 1998 . Until n2O significantly reduced the mortality at day 28, hospital mortality, and morbidity [In these studies, it is quite clear that those patients with ARDS had an extremely wide variety of back grounds in terms of tidal volume, PEEP, inspiratory plateau pressure, and concomitant incidence of sepsis or pneumonia. Indeed, the mortality in control group of the studies by Amato and Villar was 71 and 53 %, respectively, and seems extremely higher than the mortality of ordinary care of 30 to 40 %, which is reported elsewhere [orbidity , 17.Eichacker et al. presented a meta-analysis of the first five randomized controlled trials of lung protective strategy –14, and VT), and higher positive end-expiratory pressure (PEEP) can improve survival in patients with ARDS, but the relative importance of each component has not been clear. Each component is closely related with each other. Because respiratory-system compliance (CRS) is strongly related to the volume of aerated remaining lung , they hypothesized that the driving pressure (ΔP = VT/CRS), which is tidal volume normalized in relation to CRS but not by body weight, would be a better predictor of survival than VT or PEEP in patients with ARDS.Amato et al. finally summarized the clinical effects of ventilatory components on the outcome of patients with ARDS . MechaniP as an independent variable associated with survival. As a result, two baseline variables  and two ventilator variables (FIO2 and ΔP) were significantly associated with survival after multivariate adjustment. Higher ΔP predicted lower survival consistently across trials (P = 0.13 for heterogeneity).They analyzed individual data from 3562 patients with ARDS enrolled in nine previously reported randomized trials in order to examine ΔP or higher PEEP, but with different consequences (resampling A vs. B): higher mortality was noted only when higher plateau pressures were observed in patients with higher ΔPs. Similarly, the protective effects of higher PEEP were noted only when there were associated decreases in ΔP (resampling B vs. C). In addition, at constant levels of plateau pressure, VT was a strong predictor of survival when normalized to CRS  but not when normalized to predicted body weight.Figure As mentioned above, the outcome of ARDS is dependent on the involvement of MOF other than respiratory failure. There is evidence that the way of mechanical ventilation has a significant effect on the cause of MOF. Indeed, unfortunately, there are still many who believed that the tidal volume of 6 ml/kg of predicted normal weight is a safe method to ventilate the patient with ARDS, but the essence of lung protective strategy is clearly demonstrated above and is to protect the lesion where the normal lung mechanics is maintained, from overstretch in terms of computed tomography (CT) numbers.In the lungs which suffered from ARDS, the common pathophysiology is systematic inflammation and resultant pulmonary edema. The lungs of ARDS are wet and heavy, and the part of the lungs which seems normal and ready to accept the tidal ventilation is quite limited and probably dependent on the percentage of aeration of the diseased lungs. Mechanical ventilation, which is a standard therapy to maintain adequate gas exchange during ARDS, may lead to the acceleration of inflammatory process and may augment a pulmonary damage (ventilator-induced lung injury (VILI)). Indeed, analysis of CT images of patients with ARDS has demonstrated a non-homogenous distribution of pulmonary changes, such as hyperinflated, normally aerated, poorly aerated, and non-aerated compartments, according to the CT numbers (Hounsfield unit) , 21.2O. And, an insufficient level of PEEP may cause tidal recruitment/derecruitment of the consolidated/poorly aerated region and can expose these regions to shear stress, increasing cytokines from lungs, leading to the MOF in remote organs [Gattinoni and coworkers provided the direct visual and biochemical evidence that the same tidal volume means different in the patients with different lung structures and alterations due to ARDS . The adue organs , 23.VT ~3 m/kg-predicted body weight) using pumpless extracorporeal lung assist (AVECCO2R) and another with ARDSNet strategy (~6 ml/kg) without AVECCO2R [Much smaller tidal volume was challenged by using extracorporeal approach. In severe ARDS, one of the alternative treatments other than mechanical ventilation is extracorporeal membrane oxygenation (ECMO), and its clinical significance has been proven , 25. ButAVECCO2R . There wLung protective strategy and its success are dependent on the amount of aerated area in the ARDS lungs, and normally aerated region is highly variable among the patients and its severity of inflammation. The concept of baby lung was first introduced in middle 1980s , and it In order to understand the management of ARDS, we have to understand the regional differences in ventilation and perfusion of the lung. Indeed, several current textbooks state that gravity has a predominant effect on pulmonary regional blood flow, but in some other textbooks that the recent research has shown that factors such as the basic anatomical structure of the pulmonary vessels and airways may be as important as gravity in determining regional distribution of blood flow and ventilation.2O) in the negative pressure chamber (−10 cm H2O), and pulmonary circulation  was achieved by the arterial blood supply from another animal. The radioactivity of injected Xe was counted to calculate the regional pulmonary blood flow.One of the most popular findings of the effect of gravity on respiratory system was introduced by West in 1964, and his result was that the lung is categorized in three distinctive zones: zones 1–3, dependent on the relationship among pulmonary arterial and venous pressures, and alveolar (airway) pressure . In zoneIn reality, the lungs are inside the thoracic cavity, and its own weight and gravitational effects influence lung structure and its shape. The three zones of lung perfusion by West do not include those physiological and anatomical factors, and cannot be applied to the normal as well as diseased lungs; thus, we have to re-evaluate the gravitational effects on the ARDS-lungs.Various studies have been done, and one of the most interesting studies was done by Petersson and coworkers, using single-photon-emission computed tomography (SPECT) in the healthy volunteers .Their study evaluated the effect of gravity on the pulmonary circulation. To make the gravitational effect more clear, they measured during high gravity condition using centrifugation up to 3G, and Tc-labeled macroaggregates of albumin (MAA) were injected during centrifugation both in supine and prone positions to measure regional blood flow by using SPECT.As shown in Fig. Such mechanism was also demonstrated by Remeika and his coworkers, by using the same technique, SPECT and 99mcTc-MMA injections; the distribution of blood flow was measured before and after the injection of NOS inhibitor (L-NMMA) . It was As mentioned above, the intensive evaluation has been done to look at the gravitational effect on the regional pulmonary blood flow, and regional ventilation, and it has been also evaluated by means of various interventions. One of those was done in the healthy volunteers, who were anesthetized with propofol and mechanically ventilated, and regional ventilation and pulmonary perfusion were evaluated using the same SPECT technique as previous studies . They meThose SPECT studies in healthy volunteers indicate very important findings; the lungs in the thorax is affected by the gravitational effect, the weight of the lung itself would squeeze the regional blood flow from dependent region to non-dependent region, the distribution of blood flow would be adjusted by the production of NO in the dependent region to maintain the homogenous V/Q ratio in the lungs, and V/Q ratio would be more homogenous in prone position than in supine position. Prone position might be more physiologically appropriate than supine in human population.We still do not know whether such adjustment to obtain a more homogenous distribution of regional pulmonary blood flow and ventilation is also true in patients with ARDS, thus, the goal of the lung protective strategy would be better homogeneity of regional ventilation and perfusion in those suffered lungs.There is an important suggestion that the gravity is not the only factor to control the distribution of pulmonary blood flow and ventilation, because the blood flow at the same vertical height (iso-heights) was not uniformly distributed –38. RegiAs mentioned above, the ARDS lung is characterized by the small-aerated region, called baby lung. The damage to the alveolar-capillary membrane leads to high-permeability edema with wash-out or dilution of the surfactant and inactivation of the surfactant by plasma components, such as fibrin, albumin, globulin and hemoglobin, and cell membrane lipids , 43. The2O, periodic sighs, step-wise increase in PEEP, and inspiratory pressure have been attempted. It is all dependent on the amount of aerated region of the lungs to determine the VILI, while the RM might worsen tidal hyperinflation, with over-distension of compliant, or normal, part of the lung tissue, predisposing them to VILI [There have been issues regarding the way of mechanical ventilation of patients with ARDS, and relatively higher PEEP may keep the alveoli open at end-expiration, thus preventing atelectrauma and biotrauma , 46. Var to VILI , 48. Des to VILI –51.One of such approaches was to evaluate the effect of PEEP to recruit the ARDS-model-lungs on the best compromise between mechanical stress and lung aeration in oleic acid-induced lung injury . In thisIn conclusion, PEEP at which the highest respiratory-system compliance occurred, obtained by descending PEEP titration, corresponded to the largest amount of normally aerated areas, with the least amount of collapsed and hyperinflated areas. The institution of higher levels of PEEP reduced both compliance and poorly aerated areas but increased hyperinflated areas. The lower PEEP level consistently enhanced poorly or non-aerated areas as well as tidal re-aeration, with the reduction in compliance. Hence, monitoring respiratory mechanics during a PEEP titration procedure may be a useful adjunct to optimize lung aeration.Thus, the optimal setting of mechanical ventilation has been challenged by means of chest CT scanning , 54, butBy recruiting the collapsed lungs, we try to open up the lungs and keep it open to improve gas exchange and to reduce the stress by mechanical ventilation. The ideal goal is to minimize the mechanical-ventilation-induced stress on the lungs, in order to minimize the part of the lungs with hyperinflation as well as collapse. This is the best compromise of mechanical ventilation, because the airway pressures, such as inspiratory plateau pressure and PEEP level, are common to all the airway and alveoli. It is a common way to assess the appropriateness of ventilation by CT scanning data, since CT is regarded as the gold standard to assess the effect of a recruitment maneuver and PEEP level applied on the aeration of the atelectatic lung , 54. HowOn the other hand, electrical impedance tomography (EIT) is a real-time monitoring device, which has proven to correlate well with CT for assessment of changes in gas volume and tidal volume –57. SeveEIT could provide us with a new type of monitoring the regional distribution of ventilation non-invasively and continuously at the bedside. However, extensive clinical studies are needed to elucidate such information could lead to better outcome in patients with ARDS.The pathophysiology of ARDS has been intensively and continuously studied in both clinical and experimental settings for the last 50 years, but still the mortality rate for ARDS is as high as 30–40 %. The lung protective ventilation has become the standard treatment strategy for the patients with ARDS. It has been clearly demonstrated that the driving pressure could be the ventilatory parameter, which significantly predicts and affects the outcome, based on the pooled data by using a statistical tool known as multilevel mediation analysis. The lower the driving pressure, the better the outcome. It is essential to prove that this statistical finding is true for patients with ARDS in clinical settings. Moreover, although in that article, the level of PEEP does not affect the outcome, we still have to elucidate how to determine the best level of PEEP in order to obtain homogenous gas distribution, thus improving oxygenation and lung injury.Prone positioning seems physiologically correct in terms of better gas exchange, but it should be considered with monitoring the regional distribution of both ventilation and pulmonary perfusion. And gravitational effects on both ventilation and pulmonary perfusion in ARDS should be clarified.Mechanical ventilation could be harmful for the healthy as well as injured lungs by an inappropriate setting of the ventilator, but mechanical ventilation is still and will be a standard care for patients with ARDS even after the introduction of ECMO. For a better outcome of ARDS, there are various questions of mechanical ventilation to be solved, such as management of spontaneous breathing, use of neuromuscular blocking agents, and clinical significance of transpulmonary-pressure, which will provide a new approach to the settings of mechanical ventilation. All the answers to these things are too fascinating to wait for.


Health risk behaviours known to result in poorer outcomes in adulthood are generally established in late childhood and adolescence. These ‘risky’ behaviours include smoking, alcohol and illicit drug use and sexual risk taking. While the role of social capital in the establishment of health risk behaviours in young people has been explored, to date, no attempt has been made to consolidate the evidence in the form of a review. Thus, this integrative review was undertaken to identify and synthesise research findings on the role and impact of family and community social capital on health risk behaviours in young people and provide a consolidated evidence base to inform multi-sectorial policy and practice.Key electronic databases were searched  for relevant studies and this was complemented by hand searching. Inclusion/exclusion criteria were applied and data was extracted from the included studies. Heterogeneity in study design and the outcomes assessed precluded meta-analysis/meta-synthesis; the results are therefore presented in narrative form.Thirty-four papers satisfied the review inclusion criteria; most were cross-sectional surveys. The majority of the studies were conducted in North America (n=25), with three being conducted in the UK. Sample sizes ranged from 61 to 98,340. The synthesised evidence demonstrates that social capital is an important construct for understanding the establishment of health risk behaviours in young people. The different elements of family and community social capital varied in terms of their saliency within each behavioural domain, with positive parent–child relations, parental monitoring, religiosity and school quality being particularly important in reducing risk.This review is the first to systematically synthesise research findings about the association between social capital and health risk behaviours in young people. While providing evidence that may inform the development of interventions framed around social capital, the review also highlights key areas where further research is required to provide a fuller account of the nature and role of social capital in influencing the uptake of health risk behaviours. A significant proportion of premature adult deaths are considered to have their antecedents in late childhood and adolescence . It is dUnderstanding the trajectory and the underlying determinants of health risk behaviours in young people is essential if interventions are to be developed to reduce uptake. The family provides the first context for infants and very young children and families provide a vehicle through which children become part of their local communities; however, it is generally accepted that, as children mature, the wider environment and social interaction take on a larger role -8. This Social capital has been described as a resource for societies -13. WhilTheoretical consideration of social capital as a resource for the health and wellbeing of young people first appeared in the literature in the 1990s ,18,20,21In one of the few attempts to synthesise the literature, Ferguson “explored how social capital had been conceptually and operationally defined as a predictor variable in empirical research on individual and collective wellbeing, especially in relation to children and youth” . AcknowlMore recently, a review undertaken by Vyncke and colleagues  exploredThis integrative review is, therefore, the first attempt to systematically identify and synthesise published empirical literature exploring the role and impact of both family and community social capital on health risk behaviours in young people. Cognisant of the various theoretical traditions and definitions within the social capital literature we adopted an inclusive and pluralistic approach drawing on the work of a broad range of theorists; including, but not limited to, Bourdieu, Coleman and Putnam. Given the focus on young people, however, the concepts of family social capital (FSC) and community social capital (CSC) have been used to frame the presentation of the results.This paper forms part of a larger review, which explored the association between social capital and a range of psychosocial indicators of health and wellbeing . The method for the larger review is published in full in the final report  and thisStudies were included if they were published, peer-reviewed and described primary empirical research that was quantitative, qualitative or had employed mixed methods.Studies were required to have focused on children and/or adolescents. Scoping of the literature revealed inconsistencies in the ways that authors defined children and adolescents so we adopted a pragmatic approach, guided by the WHO’s definition of adolescence . SamplesWe included studies where the data had been collected directly from the young person and where the data about the young person had been reported by a relevant other .As noted above, we adopted a pluralistic approach to the conceptualisation of social capital but we were guided by Ferguson’s findings as a framework for categorising indicators of family and community social capital. Thus, studies were included if they explored the role and impact of social capital at the family and community level. The elements of FSC included: family structure (e.g. number of parents present in the household), the quality of parent–child relations (e.g. parent–child communication), adult interest in the child , parent’s monitoring of the child  and extended family support and exchange (e.g. perceptions of extended family support). The elements of CSC included: social support networks (e.g. peer support), civic engagement in local institutions (e.g. volunteering), trust and safety (e.g. trust in others), religiosity (e.g. attendance at religious services), the quality of the school (e.g. school cohesion and relationship between teachers and pupils) and the quality of neighbourhood . In addition, we included studies that employed a composite measure of FSC and/or CSC and studies where, although the indicator did not fit within the definition above, the author(s) explicitly described their work as FSC (e.g. family cohesion) and/or CSC (e.g. peer role models) and we refer to this as ‘other measure’.Studies were included if they assessed individual-level health risk behaviours, including: alcohol use/misuse; smoking/tobacco use; illicit drug use; sexual health behaviours; and general health risk taking, where a composite health risk behaviour score was calculated to assess risk across a number of different domains . Studies were only included where health risk behaviours were conceptualised and/or measured as outcome variables.In April 2012, nine electronic bibliographic databases were searched for relevant published empirical literature: ASSIA, CINAHL, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews Effects, Embase, Medline, PsycINFO, and Sociological Abstracts.Following the electronic database searches, the reference lists of retrieved articles were examined for further studies. The web-sites of organisations and groups conducting research on the health and wellbeing of children and adolescents, and/or research in the field of social capital, were also searched for published empirical literature (e.g. the Centre for Research on Families and Relationships and the WHO).Scoping of relevant electronic databases helped identify the most appropriate search terms and a single search strategy was developed to capture literature from across the range of psychosocial health and wellbeing outcomes, including health risk behaviour terms. The search strategy included both index terms (i.e. thesaurus and subject headings) and free text keywords. Social capital-relevant search terms were combined with health and wellbeing outcome-relevant search terms. The search strategy was tailored to optimise its sensitivity within each database  and the RefWorks was used to store the results of each of the searches and to identify duplicates.Our searches were limited to literature published between January 1990 and April 2012 and to English language-only. After duplicates were removed, the title and abstract of each retrieved study were screened independently by two members of the research team, rejecting any that did not fit the inclusion criteria described previously. If no abstract was available, or the abstract did not contain sufficient detail, the study was retained for full text review. Again, the full text was reviewed against the inclusion/exclusion criteria by two independent reviewers. At both stages, few discrepancies were identified between the reviewers and any that did arise were resolved through discussion.The full text of articles assessed as meeting the inclusion criteria was sourced for data extraction. A review-specific data extraction tool was developed to enable the extraction of data generated using a range of different research designs . The datConcurrently with data extraction, each reviewer assessed the methodological quality of the studies using a study-specific quality appraisal tool (QAT). The QAT was developed drawing on published guidance  and unpuUpon consensus, each study was awarded one of three quality ratings, studies scoring: 16–22 were awarded a ‘high quality’ rating; 8–15 were awarded a ‘moderate quality’ rating; and, 0–7 were awarded a ‘low quality’ rating. The ratings for each included study are presented in Additional file The results are presented in narrative form. The majority of studies were surveys and the associated design issues (e.g. lack of control groups) and heterogeneity in the outcome measures precluded meta-analysis. Moreover, meta-synthesis was not possible because few qualitative studies met the inclusion criteria.Instead, results are summarised and then synthesised using an approach similar to that originally described by Ramirez et al. . That isIn accordance with the PRISMA  guidelines  Figure 1Descriptive information about each of the individual studies is presented in Additional file The health risk behaviours explored in the 34 studies were ordered into five outcome categories with 12 of the studies reporting on more than one of the outcomes. Eleven studies reported on tobacco use, 14 on alcohol use, nine on illicit drug use and 15 on sexual risk behaviours. Five of the studies reported on general health risk behaviours where the outcome was a composite score of risk across a number of behaviour domains. Six studies included at least one indicator of FSC and nine included at least one indicator of CSC. The remaining 19 studies included indicators of both FSC and CSC  were conducted in the United States, with further studies from Canada (n=3) and the UK (n=3). One was a multi-country study conducted in Europe and Canada and the remaining studies were conducted in China, El Salvador, Ethiopia, Japan and Switzerland. Eleven studies did not report when the data were collected, 14 studies began, and in some instances completed, data collection in the 1990s and nine began data collection after 2000  was associated with delay in first sexual experience [quantity of parent-adolescent conversations about sex, adolescents reporting more frequent conversations were more likely to report having had sex [In terms of the parent-adolescent relationship, there was evidence that the perience ,55 and tperience ,57,59. C had sex . The autUnlike the other risk behaviours, there was evidence that parental monitoring can have a positive impact on sexual health, being associated with increased likelihood of the adolescent reporting sexual abstinence ,60,61 anAt the general level, studies assessing the quality and quantity of adolescents’ social networks reported little association with sexual health behaviours ,59; howeMore frequent attendance at religious services was associated with more positive sexual health behaviours ,55. HoweIn contrast to the other risk behaviours, there is considerable variation in the role and impact of both FSC and CSC across the indicators of this outcome  and across different sub-groups of adolescents. As discussed, it appears that in different contexts different elements of social capital may be more or less salient.Five studies . Sex is a natural part of development for most adolescents and at the various stages of adolescence it may be considered more or less appropriate, by both the adolescent and others around them. This sense of appropriateness will necessarily interact with support structures, including those within the family, that are designed to prevent younger adolescents from engaging in sex and promote safer sex amongst older adolescents. Indeed, some of the studies in this review reported that parental monitoring was only related to reduced sexual risk taking in younger age groups . The ideThe evidence for the role of family structure was limited but suggests that, while young people benefit from living with at least one biological parent, being in a two-parent family was most protective ,57,63-65As with FSC, there were elements of CSC that were more or less salient across the various health risk behaviours. However, CSC also showed evidence of the ‘downside’ of social capital with some associations linking it to increased likelihood of young people engaging in health risk behaviours. Specifically, young people with indicators of wider peer networks were at increased risk of using tobacco ,42. We aFacebook) is recognised as being increasingly important for children and adolescents [Linked to this, our search did not identify any studies that explored the role of social relationships and networks sustained in the online world and health risk behaviour outcomes. This is surprising given that online social networking  , it is aFinally, religiosity was identified as an asset related to better tobacco, alcohol, drug and sexual health outcomes ,55,59,63As with any review, the results need to be considered in relation to the strengths and weaknesses both of the review process itself and the included studies. In relation to the process, a major strength of this review lies in the integrative approach which enabled the capture and synthesis of a large body of evidence generated from across different study designs. That said we are cognisant that, as with any review, relevant literature may not have been captured. For example, publication bias, the tendency for journals to publish studies reporting statistically significant results, may have limited our access to studies that did not find a relationship between social capital and health risk behaviour outcomes. In addition, we were constrained by the adequacy of the indexing within each of the databases and, while we placed no geographic restrictions on the selection of studies, employing an English language-only criterion may have resulted in the exclusion of relevant studies published in other languages. We did, however, employ a number of strategies to broaden the reach of our search, including hand searching relevant references lists and web-sites.In terms of the individual studies, while the synthesised results offer a strong body of evidence demonstrating the association between FSC and CSC and health risk behaviour outcomes, the majority of the included studies were cross-sectional surveys. This design limits our ability to make inferences about the direction of causation in these associations and the mechanisms of action. It might be hypothesised, for example, that social capital acquired in the context of family and community is an asset that helps protect young people from engaging in health risk behaviours ,37. ConvThere was considerable heterogeneity in the definition and measurement of social capital across the studies. While this made synthesising the available evidence challenging, all data were extracted using well defined study-specific inclusion/exclusion criteria and by a minimum of two reviewers. There was also heterogeneity in the individuals asked to report on social capital; data were obtained variously from the young people themselves and adults, such as their parents. While it was not possible within the remit of this review to give full consideration to the impact of the different reporters, it is important to be mindful of this. Previous research exploring the relationship between parenting style and adolescent outcome variables has demonstrated that there can be considerable divergence in the reports of parenting style offered by young people and their parents and these different reports share different relationships with the outcome variables .Finally, in terms of the individual studies, although the purpose of this review was to consider the role and impact of social capital on the health risk behaviour outcomes of young people, all accept one of the studies had adolescent-only samples and the focus was very much on mid- to late-adolescence. Given the nature of the behavioural outcomes, the lack of evidence about pre- and early adolescent years is perhaps understandable; however, it limits our capacity to draw conclusions about these age groups.This is, to the best of our knowledge, the first systematic review to synthesise empirical evidence linking social capital to a range of health risk behaviour outcomes and our findings have important implications for future policy, practice and research. Health risk behaviour interventions targeted at young people have traditionally failed to take account of the importance of social capital but this review demonstrates that both family and community social capital have an important role to play. Moreover, by looking within and across the various health risk behaviours we have been able to identify and highlight the elements of social capital that present as supportive health assets irrespective of the behavioural domain (e.g. positive parent–child relations) and highlight elements of social capital that may in some instances present as a health liability  and thus need careful consideration in the context of intervention development.International policy emphasises the need for early intervention as a means of reducing inequalities and promoting health and wellbeing across the lifespan, and priorities for Europe include the promotion of resilient families and communities . Our finKEM, SK, AM, EM and FC were commissioned to undertake this work by the Glasgow Centre for Population Health. JM and JE commissioned the work on behalf of the Glasgow Centre for Population Health.All authors were involved in developing the scope of the project and in determining the search strategy. The search was conducted by KEM. The study selection process, data extraction and quality appraisal was undertaken by KEM, SK, EM and FC. Data analysis and synthesis was conducted by KEM. All authors contribution to the drafting of the manuscript and read and approved the final version of the manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/13/971/prepubSearch strategy (PsycINFO).Click here for fileDescription of studies included in the review (ordered by outcome).Click here for file


Clinical practice in trauma and critical care is predominantly derived from quantitative observational cohort studies based on data retrospectively collected from medical records. Such data create uncontrolled bias and influence external and internal validity, thereby hindering systematic reviews. Templates or standards for uniform documenting and scientific reporting may result in high quality and internationally standardised data being collected on a regular basis, enhance large international multi-centre studies, and increase the quality of evidence. Templates or standards may be developed using multidisciplinary expert panel consensus methods.We present three consensus processes aimed at developing templates for documenting and scientific reporting. We discuss the advantages, limitations, and possible future improvements of our method.The template preparation was based on expert panel consensus derived through a modified nominal group technique (NGT) method that combined the traditional Delphi method with the traditional NGT method in a four-step process.Standard templates for documenting and scientific reporting were developed for major trauma, pre-hospital advanced airway handling, and physician-staffed pre-hospital EMS. All templates were published in scientific journals.Our modified NGT consensus method can successfully be used to establish templates for reporting trauma and critical care data. When used in a structured manner, the method uses recognised experts to achieve consensus, but based on our experiences, we recommend the consensus process to be followed by feasibility, reliability, and validity testing. Current clinical critical care practice is, to varying degrees, evidence based. Evidence-based practice is commonly derived from reports published in international registries and libraries  , which iThis point is well illustrated by the recently published ERC Guidelines 2010 for cardiopulmonary resuscitation and emergency cardiovascular care, which are substantially based on low-level evidence. Observational studies constitute a significant proportion of the reference list . This prA primary challenge to researchers and clinicians has been to improve the quality of observational data collected in day-to-day practice. One method is to develop templates or standards to uniformly document and report data. A template or standard ensures that the reported variables in specific patient groups, specific emergency medical conditions, and from specific interventions are consistent and reproducible. Such standardised variables with precise definitions may strengthen the quality of routinely collected data and the validity of published reports, thereby facilitating the analysis of reports in producing systematic reviews. High quality, well defined, and internationally standardised data that are collected regularly might enhance large international multi-centre studies and increase the quality of evidence .Templates or standards for documenting and reporting data may be developed using qualitative methods, such as multidisciplinary expert panel consensus methods ,15. TherOne of the first consensus-based templates published for use in critical care was uniform documenting and reporting of data for out-of-hospital cardiac arrest, which was published in 1990 by a task force preceding a conference at Utstein Abbey, Stavanger, Norway . Since tIn this paper, we will present and discuss the modified NGT method, which was used in three of these Utstein processes ,24,25, aThe Delphi method has been widely used in health care research for defining priorities in education, clinical practice, organisation, and planning. It is commonly based on three e-mail rounds in which a large number of experts provide opinions on specific matters. The opinions are grouped and re-circulated for ranking, and again summarised and circulated for a re-ranking based on the individual experts' insights in the group response.The NGT method originates from efforts in large industrial companies aiming for a more structured decision-making tool  The NGT The preparation of the three templates referred to in this paper was based on a modified NGT method that combines the traditional Delphi method with the traditional NGT method. The entire process consisted of four steps. The first part of the consensus process (step one and two) uses the Delphi method approach to allow the experts to identify data variables relevant for the template under development. To fully utilise the clinical and scientific competence of the experts, they are allowed to interact by applying the NGT method (step three and four).In the first step, each expert was supplied with the necessary background documents , which were gathered by a co-ordinating project group. The expert was asked to return (by e-mail) the proposals for inclusion and exclusion criteria, a set maximum number of core data variables in a prioritised order, and optional data variables that were regarded as important for the template preparation. The proposed variables were divided into set variable subgroups. A maximum number of core variables were defined by the co-ordinating project group prior to each process, with the intention of keeping the expert panel focused on the core data.These initial proposals were aggregated and systemised by the co-ordinating project group according to the frequency with which the variable had been proposed by the experts. The collated results were redistributed to the experts for comments and the experts were asked to rank the variables within each subgroup from one to 10. The results from step two formed the basis for the expert panel meeting (step three).The third step consisted of one or two consensus meetings in which the members of the expert panels, in groups and plenary sessions, discussed their views in a structured way and reached their conclusions. The consensus meeting differed significantly in structure from the e-mail rounds. During the meeting, the discussion was open, allowing interactions between the panel members to influence the ranking and conclusions, including novel variables if agreed upon. Exceeding the set maximum number of variables was allowed pending group approval.In the fourth step, based on the conclusions from the consensus meeting(s), the co-ordinating project group edited a final proposal for a template, upon which the experts were allowed to comment by e-mail. To complete the process, a letter of agreement was signed by all the expert panel members to enhance the implementation of the achieved template in the daily documentation of practice.Three international expert panels were selected to participate in these three Utstein processes. Because of the structure of the consensus meeting, a maximum number of twenty experts per process were set. As the experts, we invited senior researchers and clinicians who had contributed substantially to research; the development of guidelines, existing registries, and/or clinical practice; and were considered experts in the specific field of critical care for which the template was developed. The experts were identified by Google and PubMed searches on the subject, through personal networks of the co-ordinating project group, and by recommendations from previously selected members. The expert panel was invited by e-mail and personal contact, and all were asked to include information from their own experience or knowledge in the process. The invited experts who could not attend were asked to suggest a substitute colleague. Three reminders were sent to the non-responders.In the e-mail rounds, the experts were supplied with a spreadsheet that was designed as a template for the proposals. The template was divided into category subgroups of data determined by the purpose of the template, e.g., system variables, patient variables and process variables. Each variable required additional information on the exact data variable definition, the possible data variable categories, and the data variable source .After each round, the experts returned their completed spreadsheets of proposals to the co-ordinating project group.In step three of the modified NGT method, the expert panel gathered at a two-day meeting and agreed on the inclusion and exclusion criteria and a core data set for the template. Two experienced scientists and clinicians who were familiar with the method facilitated the meeting of each of the three Utstein processes. In a first plenary section, the co-ordinating project group presented the proposed variables from step two, and the facilitators presented the set structure for the meeting. The experts were divided into two groups and separately discussed the specific inclusion and exclusion criteria and variables for the proposed dataset. The groups subsequently presented their discussions in plenary sessions, at which all variables were discussed, debated, and agreed upon. On day two, the variables were given precise definitions and categorised in a plenary session. In two of the consensus meetings ,24, the The expert panels achieved consensus during the planned four steps in all three Utstein processes. The structure of each process differed slightly.Twenty-three experts were invited, and 19 accepted the invitation and joined the Utstein process. In 2007, the expert panel was asked to propose inclusion and exclusion criteria, as well as a maximum of 30 core data variables in a prioritised order. The first proposals were summarised and structured by the co-ordinating project group, and the collated results were redistributed in step two for comments and re-prioritisation. In step three, the expert group did not reach consensus on all variables because of extensive discussions and a prolonged decision process. To finalise the process, the expert group decided to conduct a second consensus meeting. During these two consensus meetings, which were held at the Utstein Abbey in May and December 2007, the panellists discussed their views by a structured method and reached consensus.Of the 19 individuals participating in the e-mail process, 18 participated in the first consensus meeting and 16 in the second meeting. No formal communication regarding this process occurred among the experts between the two meetings. After completing the process, the expert panel had agreed upon the inclusion and exclusion criteria, 36 core data variables and four subsidiary variables for the template. The data variables were divided into three groups: ‘Predictive Model’ variables, ‘System Characteristics Descriptors’, and ‘Process Mapping’ variables. Each expert signed a letter of consent (agreement), and the results were published in an international, scientific, open access journal in July 2008. The co-ordinating project group published a data definition catalogue on a dedicated web site with open access.In January 2009, 15 experts accepted invitations to join the Utstein process. The panel was asked to propose 10 core data variables and five optional variables in a prioritised order. The first proposals were summarised and structured by the coordinating project group, and the collated results were redistributed in step two for comments and re-prioritisation.During the consensus meeting at Utstein Abbey in April 2009, the expert panel agreed that any patient receiving advanced airway management, defined as the attempted insertion of an advanced airway adjunct or administration of ventilatory assistance, should meet the inclusion criteria. The expert panel agreed that advanced airway management during inter-hospital transfer should be excluded. The expert panel agreed on 23 core data variables that were divided into three groups: system, patient, and post-intervention. Each expert signed a letter of consent before the results were published, and the results were published in an international, scientific, open access journal in November 2009.In winter 2010, an expert panel was invited and asked to propose inclusion and exclusion criteria, as well as a maximum of 50 core data variables in a prioritised order. Seventeen experts were invited, and 16 accepted the invitation and joined the Utstein process. Their first proposal was summarised and structured by the coordinating project group, and the collated results were redistributed in step two for comments and re-prioritisation. In step three, the expert panel met and decided on the definition of physician staffed pre-hospital EMS, inclusion criteria, and 50 variables that were divided into five subgroups: “fixed system variables”, “event operational descriptors”, “patient descriptors”, “process mapping”, and “outcome measures/quality indicators”.The final core data set was sent to the experts by email after the meeting, and the experts were allowed to make comments to the final data set. A few minor changes, which were mainly related to data definitions, were made at this point. When no more comments were received, the consensus process was formally closed.The results were published in an international, scientific, open access journal in November 2011.Most critical care services document their activities daily, but the documentation is typically based on local data definitions and patient categorisations. The difficulty of comparing trauma and critical care between centres and over time based on locally defined data variables has been illustrated in several recent reports -8,28. OvTraditionally, such templates have been designed using consensus methods. In this paper, we present a modified NGT method used in three consensus processes with the aim of developing templates for reporting from three specific areas of trauma and critical care.We perceived a number of benefits from the use of this modified NGT method to reach consensus. A consensus process derives its credibility, in part, from the composition of the expert panel. In these three consensus processes, the experts were professional authorities who were key stakeholders in their services and respected representatives of their profession. They had significant scientific credibility within their fields of medicine. The initial proposals from the experts were unconfined by the group dynamics. In step two, the individual experts had access to all proposals and could review their suggestions in comparison to those of the other respondents. The processes were controlled, giving authority and rationality to the conclusions made by the expert panels. The conclusions were based on pre-existing knowledge introduced to the process partly by scientific papers and reports identified by the co-ordinating project group prior to the process and partially by the competence and experience of the individual experts. Each proposed variable was thoroughly discussed face to face with the opportunity to include new proposals that were not included in the e-mail round (steps one and two). There is a high likelihood that the structure of the process secured the capture of all the collective knowledge on the subject at hand. Upon reaching consensus, the majority of the experts could, empowered by their position, implement the template in daily documentation of practice.consensus. Methodologically, there is no convention for the exact definition of consensus, but some measure of agreement in the panel was critical. In consensus processes, defining a few elements, such as quality indicators or focused research areas, as a statistical measurement of agreement is feasible. In our process, we aimed to agree upon many different variables  and the data set definitions. Therefore, by applying a voting strategy in our process, the voting would have taken too much time and hindered fruitful discussions amongst the panellists. Thus, we defined consensus as no objection to the final dataset, including definitions, by the expert panel members.A particular challenge during the consensus process was defining the word There are obvious limitations to our method. The choice of experts was partly unstructured and did not fully guarantee a representative selection of experts within all the subfields of the subject at hand. This design potentially leads to the omission of vital competences and the omission of important variables. NGT processes may be vulnerable to collective group ignorance caused by the risk of dominance by expert panel members. We hypothesised that the multi-national selection of experts with fairly detailed and predefined selection criteria reduced the risk of establishing an expert panel with biased opinions.The project group decided to provide the expert panel members with a selection of background literature. The experts were advised to focus on the existing templates. The developed templates are defined and established by experts within the specific field of care and should be acknowledged as relevant. The possibility of this “literature-based” bias appears minimal given the extensive amount of different variables proposed in the first rounds.In contrast to the Delphi method, the NGT method may be more prone to the possibility that strong personalities can dominate the group. The NGT method does not secure anonymity for the participants, as does the Delphi method. Maintaining proposals as anonymous during the expert panel processes may be important to reduce influence of “loud-speaking” experts and to facilitate the influence of their “silent-speaking” peers. The expert panel members were aware of its composition, but anonymity related to the proposals was maintained until stage three.There is no evidence that the implementation of standardised templates for documenting and reporting will lead to appropriate standardized practices, and hence this was not a purpose of these consensus processes. The process does not test or check the true feasibility of the template or the validity and reliability of each variable; instead, it reflects the collective conviction of the expert panel. Expert opinion will fluctuate due to new evidence and knowledge. A template developed by the described technique is only as good as the available evidence, and future revisions may significantly change the recommendations.The experiences from these three consensus processes suggest possible improvements. The recruitment of experts should be structured and formalised. Our recruitment strategy was based on unstructured PubMed and Google searches and personal professional networks. To reduce a potential bias, a recruitment strategy should be based on a defined search strategy and/or pre-defined specific qualification criteria. To ensure that all available evidence is included in the process, it should be preceded by a systematic search for evidence. The quality of evidence of the findings from the search should be graded before use in the consensus process.The development of templates for standardised documenting and reporting is a dynamic process and following the consensus process, feasibility, validity and reliability studies should be performed. This process includes a pre-test or feasibility study of the template to identify problems in applying the template to subjects in the clinical setting. The template should be pre-tested to assess its ease of use and acceptability to its administrators and targeted population . TypicalThere are a number of methods of assessing a template’s validity. Content validity, construct validity, and criterion validity should be tested ,17,18,30The reliability of the proposed data variables should be evaluated by measuring the agreement when applied by different users. This concept is known as inter-rater reliability or inter-observer agreement ,17,30. PReliability places an upper limit on validity  . BecauseThe implementation of consensus developed reporting templates in day-to-day documentation is the major weakness in achieving a common platform for intra- and inter system comparison.With key stakeholders involved, the Utstein Trauma Template was implemented as the standard reporting method by hospitals to the UK Trauma Audit and Research Network, the Trauma Registry of the German Society of Trauma Surgery, and the Italian National Registry of Major Injuries. A number of hospitals and registries in Scandinavia and central and southern Europe implemented the core dataset. This wide usage resulted in more than 500 hospitals implementing the template. In the two remaining consensus processes, we have not achieved the identical degree of implementation despite a number of strong recommendations  and implcomplex intervention containing several separate, but highly interacting components. Scientific studies on this subject are difficult to design and interpret because of tremendous variability in (and insufficient description of) operator experience, technique, and patient case-mix, making it difficult to understand or eliminate confounding factors [Several studies have focused on the intricacy of implementing advanced medical interventions in the pre-hospital setting -36. Adva factors . ContinoIt is hypothesised that standardised data reporting from health care systems could enhance inter- and intra-system comparisons. We conclude that a modified NGT method can successfully be used in consensus processes to establish templates for reporting trauma and critical care data. If used in a structured manner, the modified NGT can achieve consensus among recognised experts, but based on our experiences, we recommend that a consensus process is followed by feasibility, reliability, and validity testing.The authors declare that they have no competing interests.HML, AJK, KGR, SJMS and DJL have made substantial contribution to the conception and design of the presented method, and the analysis and interpretation of data. HML drafted the manuscript, which was finally approved by all authors.