Multidisciplinary Rectal Cancer Management: 2nd European Rectal Cancer Consensus Conference (EURECA-CC2). Danish Breast Cancer Cooperative Group – DBCG: History, organization, and status of scientific achievements at 30-year anniversary A cohort analysis to identify eligible patients for intraoperative radiotherapy (IORT) of early breast cancer Patient selection for accelerated partial-breast irradiation (APBI) after breast-conserving surgery: recommendations of the Groupe Européen de Curiethérapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) breast cancer working group based on clinical evidence (2009). Radiation therapy quality assurance in clinical trials--Global Harmonisation Group. The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition Optimization of follow-up timing from study of patterns of first failure after primary treatment. An example from patients with NSCLC: a study of the REACT working group of ESTRO. [Approval procedures for clinical trials in the field of radiation oncology]. Pre-operative evaluation of adults undergoing elective noncardiac surgery: Updated guideline from the European Society of Anaesthesiology. 70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial. Practice guidelines developed by specialty societies: the need for a critical appraisal Clinical outcomes and toxicities of proton radiotherapy for gastrointestinal neoplasms: a systematic review. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13 Preoperative or postoperative therapy for resectable oesophageal cancer: an updated practice guideline. American Society of Clinical Oncology provisional clinical opinion: the integration of palliative care into standard oncology care. Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received. Hypofractionated Radiation Therapy for Localized Prostate Cancer: Executive Summary of an ASTRO, ASCO, and AUA Evidence-Based Guideline. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. Prospective randomized cooperative medulloblastoma trial (MED 84) of the international society of paediatric oncology (SIOP) and of the (German) society of paediatric oncology (GPO) Abstracts of randomized controlled trials presented at the society for pediatric research meeting: an example of publication bias. Stereotactic body radiation therapy for early-stage non-small cell lung cancer: Executive Summary of an ASTRO Evidence-Based Guideline. The Medical Review Article Revisited: Has the Science Improved? Survey of the Quality of Experimental Design, Statistical Analysis and Reporting of Research Using Animals
BACKGROUND AND PURPOSE During the first decade of the 21st century a number of important European r and omized studies were published . In order to help shape clinical practice based on best scientific evidence from the literature , the International Conference on ' Multidisciplinary Rectal Cancer Treatment : Looking for an European Consensus ' ( EURECA-CC2 ) was organized in Italy under the endorsement of European Society of Medical Oncology ( ESMO ) , European Society of Surgical Oncology ( ESSO ) , and European Society of Therapeutic Radiation Oncology ( ESTRO ) . METHODS Consensus was achieved using the Delphi method . The document was available to all Committee members as a web-based document customized for the consensus process . Eight chapters were identified : epidemiology , diagnostics , pathology , surgery , radiotherapy and chemotherapy , treatment toxicity and quality of life , follow-up , and research questions . Each chapter was subdivided by a topic , and a series of statements were developed . Each member commented and voted , sentence by sentence thrice . Sentences upon which an agreement was not reached after voting round # 2 were openly debated during a Consensus Conference in Perugia ( Italy ) from 11 December to 13 December 2008 . A h and -held televoting system collected the opinions of both the Committee members and the audience after each debate . The Executive Committee scored percentage consensus based on three categories : " large consensus " , " moderate consensus " , and " minimum consensus " . RESULTS The total number of the voted sentences was 207 . Of the 207 , 86 % achieved large consensus , 13 % achieved moderate consensus , and only 3 ( 1 % ) result ed in minimum consensus . No statement was disagreed by more than 50 % of the members . All chapters were voted on by at least 75 % of the members , and the majority was voted on by > 85 % . CONCLUSIONS This Consensus Conference represents an expertise opinion process that may help shape future programs , investigational protocol s , and guidelines for staging and treatment of rectal cancer throughout Europe DBCG ( Danish Breast Cancer Cooperative Group ) constitutes a multidisciplinary organization established in 1975 by the Danish Surgical Society . The purpose involves first and foremost a nation-wide st and ardization of breast cancer treatment based on novel therapeutic principles , collaboration between experts h and ling diagnostic work-up , surgery , radiotherapy , medical oncology , and basic research , and , further , complete registration of relevant clinical data in a national data base attached to DBCG . Data are processed by the Secretariat personnel composed of statisticians , data managers , and data secretaries making current analyses of outcome results feasible . DBCG is run by the Executive Committee consisting of expert members appointed by their respective society . From 1978 the DBCG project gained widely accession from participating units , and since then nearly all newly diagnosed breast cancer incident cases are reported and registered in the national data base . Today , the data base includes approximately 80 000 incidents of primary breast cancer . Annually , the Secretariat receives roughly 1.5 million parameters to be entered into the data base . Over time DBCG has generated seven treatment programmes including in situ lesions and primary invasive breast cancer . Prob and s are subdivided into risk groups based on a given risk pattern and allocated to various treatment programmes accordingly . The scientific initiatives are conducted in the form of register- and cohort analysis or r and omized trials in national or international protocol ized setting s. Yearly , about 4 000 new incident cases of primary invasive breast cancer and about 200 in situ lesions enter the national programmes . Further , about 600 women with hereditary disposition of breast cancer are registered and evaluated on a risk scale . The main achievements result ed in a reduction of relative risk of death amounting up to 20 % and increased 5-year overall survival ascending from 60 % to roughly 80 % . This article is partly based on a Danish paper to be published in the Centenary Jubilee book of the Danish Surgical Society , 2008 Background Since the results from the r and omized TARGIT A trial were published , intraoperative radiotherapy ( IORT ) is used more often . IORT can be provided as accelerated partial breast irradiation ( APBI ) or as a boost . The definition of suitable patients for IORT as APBI differs between different national societies ( e.g. ESTRO and ASTRO ) and different inclusion criteria of trials and so does the eligibility of patients . This analysis identifies eligible patients for  IORT according to available consensus statements and inclusion criteria of the ongoing TARGIT trials . Methods Between 01/03 – 12/09 , 1505 breast cancer cases were treated at the breast cancer center at the University Medical Center Mannheim . Complete data sets for age , stage ( T , N , and M ) , histology and hormone receptor status were available in 1108 cases . Parameters to identify eligible patients are as follows : ESTRO : > 50 years , invasive ductal carcinoma/other favorable histology ( IDC ) , T1 - 2 ( ≤3 cm ) , N0 , any hormone receptor status , M0 ; ASTRO : ≥60 years , IDC , T1 , N0 , positive estrogen hormone receptor status , M0 ; TARGIT E “ elderly ” , risk adapted radiotherapy with IORT followed by external beam radiotherapy in case of risk factors in final histopathology , phase II : ≥70 years , IDC , T1 , N0 , any hormone receptor status , M0 ; TARGIT C “ consolidation ” , risk adapted radiotherapy , phase IV : ≥50 years , IDC , T1 , N0 , positive hormone receptor status , M0 ; TARGIT BQR “ boost quality registry ” : every age , every histology , T1 - 2 ( max . 3.5 cm ) , any hormone receptor status , N0/+ , M0/+ . Results Out of the 1108 cases , 379 cases ( 34.2 % ) were suitable for IORT as APBI regarding the ESTRO and 175 ( 15.8 % ) regarding the ASTRO consensus statements . 82 ( 7.4 % ) patients were eligible for the TARGIT E trial , 258 ( 23.3 % ) for the TARGIT C trial and 671 ( 60.6 % ) for the TARGIT BQR registry . According to the consensus statements of ASTRO ( 45.1 % ) and ESTRO ( 41.4 % ) about half of the eligible patients were treated with IORT as APBI . From the eligible patients fulfilling the criteria for IORT boost ( 35 % ) about one third was eventually treated . Conclusions Patient selection for IORT should be restrictive . For IORT as APBI the TARGIT trials are even more restrictive including patients than the ESTRO and ASTRO consensus statements PURPOSE To give recommendations on patient selection criteria for the use of accelerated partial-breast irradiation ( APBI )  based on available clinical evidence complemented by expert opinion . METHODS AND MATERIAL S Overall , 340 articles were identified by a systematic search of the PubMed data base using the keywords  " partial-breast irradiation " and " APBI " . This search was complemented by search es of reference lists of articles and h and search ing of relevant conference abstract s and book chapters . Of these , 3 r and omized and 19 prospect i ve non-r and omized studies with a minimum median follow-up time of 4 years were identified . The authors review ed the published clinical evidence on APBI , complemented by relevant clinical and pathological studies of st and ard breast-conserving therapy and , through a series of personal communications , formulated the recommendations presented in this article . RESULTS The GEC-ESTRO Breast Cancer Working Group recommends three categories guiding patient selection for APBI : ( 1 ) a low-risk group for whom APBI outside the context of a clinical trial is an acceptable treatment option ; including patients ageing at least 50 years with unicentric , unifocal , pT1 - 2 ( < or=30 mm ) pN0 , non-lobular invasive breast cancer without the presence of an extensive intraductal component ( EIC ) and lympho-vascular invasion ( LVI ) and with negative surgical margins of at least 2 mm , ( 2 ) a high-risk group , for whom APBI is considered contraindicated ; including patients ageing < or=40 years ; having positive margins , and /or multicentric or large ( > 30 mm ) tumours , and /or EIC positive or LVI positive tumours , and /or 4 or more positive lymph nodes or unknown axillary status ( pNx ) , and ( 3 ) an intermediate-risk group , for whom APBI  is considered acceptable only in the context of prospect i ve clinical trials . CONCLUSIONS These recommendations will provide a clinical guidance regarding the use of APBI outside the context of a clinical trial before large-scale r and omized clinical trial outcome data become available . Furthermore they should promote further clinical research focusing on controversial issues in the treatment of early-stage breast carcinoma Participation in large multi-centre clinical trials aids establishment of the safety and efficacy of new cancer treatments and methods . Oncology clinical trials have contributed to improved local control , overall survival and quality of life for patients with varying disease types [ 1 ] . Radiation Therapy is indicated in the course of treatment for more than 50 % of all cancer patients [ 2,3 ] and consequently a high percentage of oncology clinical trials include radiotherapy within their treatment schema . Collaboration between global clinical trial groups and organisations has increased the number of patient records available for analysis permitting faster recruitment [ 4 ] , broader acceptance and wider impact of trial results . Global cooperation is also essential in the environment of rare cancers [ 5 ] , in order to be able to create sufficiently large patient data sets within a reasonable recruitment period . A successful example is the EORTC 26981/National Cancer Institute of Canada ( NCIC ) CE3 intergroup trial , where 573 Glioblastoma patients were r and omised within 20 months [ 6 ] , despite the low prevalence of the disease among the general population . Globally , clinical trial groups and organisations have independently implemented their own Radiation Therapy ( RT ) Quality Assurance ( QA ) programs within their corresponding large multicentre clinical trials . Various trial groups have reported that the implementation of RTQA procedures enhanced protocol compliance [ 7–13 ] . In four Radiation Therapy Oncology Group ( RTOG ) studies compliance with the study protocol was enhanced by incorporating pre-treatment review of RT planning [ 8 ] . A Trans-Tasman Radiation Oncology Group ( TROG ) QA audit identified a reduction in unacceptable protocol violations due to three main factors , among which was the QA procedure itself [ 7 ] . More recently , strict RTQA procedures have been shown by TROG to have impacted on both trial protocol compliance as well as general clinical practice in prostate RT [ 9 ] . For several EORTC studies it has been shown that centres which previously participated in a Dummy Run ( DR ) were significantly more likely to be successful at subsequent DR attempts and delivery of protocol -compliant RT [ 10 ] . Additionally , the impact of RTQA on actual clinical trial outcome has been recently demonstrated in the setting of various cancer sites [ 11 ] , stressing its importance and correlation with survival [ 12,13 ] . However , the various approaches as to how RTQA in clinical trials is performed , evaluated and described are diverse , making analysis and inter-trial comparisons of RTQA results challenging . This hampers cooperation between trial groups and impedes the exchange and interpretation of RTQA data . The costs of running an RTQA program have also increased with the introduction of new advanced technologies . This increases the need to make RTQA more efficient and streamline the QA workload dem and ed of clinical centres recruiting into international trials [ 14,15 ] . As shown by Pettersen et al [ 4 ] these RTQA efforts can potentially reduce the number of patients required for trials which could lead to further substantial savings and faster availability of results . The need for a global forum on harmonisation of RTQA within clinical trials thus became apparent . After initial discussion s in Goteborg during ESTRO 27 in 2008 the Global Clinical Trials RTQA Harmonisation Group ( GHG ) was formally established in 2010 . The goals of the GHG are : Collate , homogenise and distribute information regarding the RTQA st and ards of the clinical trial groups , Provide a platform for prospect i ve discussion s on new RTQA procedures , software tools , guidelines and policies of trial groups and Provide a framework to endorse existing and future RTQA procedures and guidelines across various trial groups . Each organisation will have the opportunity to endorse RTQA procedures from other organisations and thus accept them much faster in future collaborative trials . In Table 1 the human re sources and number of intergroup trials of the steering committee members of the GHG are given . Further information about terms of reference and current and future projects can be found on its website : www.RTQAHarmonisation.org . Table 1 RTQA within each of the current GHG steering committee members as of August 2013 . All RTQA groups and organisations participate in international collaborative work to some degree , although there are differences between the USA and all other groups . These differences can be explained by the differences in the funding levels and that most USA RTQA groups only work with NCI funded clinical trials mainly operated in North America [ 16 ] . Recently , the North American RTQA organisations have joined forces in the new Imaging and Radiation Oncology Core ( IROC ) group . The dedicated human re sources also vary significantly , most likely due to differences in the QA philosophy of the funding agencies and their commitment to RTQA , although most of the GHG members have at least one Radiation Oncologist , one Medical Physicist and one Radiation Technologist dedicated full time to RTQA . Until now the GHG has contributed to the harmonisation of naming conventions [ 17 ] , strategies to develop an efficient evidence -based clinical trials RTQA system [ 14 ] and the development of a global model for the international recognition of the activities of national and regional Dosimetry Audit Networks [ 18 ] . Currently , each trial group has defined its own RTQA procedures [ 10,19–24 ] that differ significantly in number , naming conventions and implementation methods [ 22,25–31 ] . The GHG is addressing this by collating all RTQA procedures of each member , comparing them and proposing common , harmonised names and procedures . Although RTQA has been proven to be effective , international differences hamper intergroup collaboration . The Global Clinical Trials RTQA Harmonisation Group has been established to reduce those differences , capitalise on the range of expertise available internationally , increase the power of RT clinical trials , deliver consistency in the reporting of trial quality factors and facilitate the undertaking of effective multi-national trials and data analysis . Although important progress has already been made , many challenges remain to be addressed Background Severe trauma continues to represent a global public health issue and mortality and morbidity in trauma patients remains substantial . A number of initiatives have aim ed to provide guidance on the management of trauma patients . This document focuses on the management of major bleeding and coagulopathy following trauma and encourages adaptation of the guiding principles to each local situation and implementation within each institution . Methods The pan-European , multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004 and included representatives of six relevant European professional societies . The group used a structured , evidence -based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale . Expert opinion and current clinical practice were also considered , particularly in areas in which r and omised clinical trials have not or can not be performed . Existing recommendations were reconsidered and revised based on new scientific evidence and observed shifts in clinical practice ; new recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated . This guideline represents the fourth edition of a document first published in 2007 and up date d in 2010 and 2013 . Results The guideline now recommends that patients be transferred directly to an appropriate trauma treatment centre and encourages use of a restricted volume replacement strategy during initial resuscitation . Best- practice use of blood products during further resuscitation continues to evolve and should be guided by a goal -directed strategy . The identification and management of patients pre-treated with anticoagulant agents  continues to pose a real challenge , despite accumulating experience and awareness . The present guideline should be viewed as an educational aid to improve and st and ardise the care of the bleeding trauma patients across Europe and beyond . This document may also serve as a basis for local implementation . Furthermore , local quality and safety management systems need to be established to specifically assess key measures of bleeding control and outcome . Conclusions A multidisciplinary approach and adherence to evidence -based guidance are key to improving patient outcomes . The implementation of locally adapted treatment algorithms should strive to achieve measureable improvements in patient outcome BACKGROUND AND PURPOSE The European Society for Therapeutic Radiology and Oncology was funded by the EU for a project on Recording providing Education , and Ameliorating the Consequences of Treatment ( REACT ) . An important aim of follow-up ( FU ) after treatment for cancer is to detect various events associated with disease recurrence or metastatic spread or severe treatment-related complications as early as possible . Each tumour type may show a specific pattern and timing of these events related to different prognostic factors . The aim of this study was to propose a way of defining an optimal timing schedule for follow-up after treatment based on the analysis of failure patterns determined from follow-up data from prospect i ve clinical trials . MATERIAL AND METHODS Cox proportional hazards model was used to identify prognostic factors associated with each failure type ( loco-regional recurrence ( LR ) , distant metastasis ( DM ) or side effects ( SE ) ) . Competing risks methods were applied to estimate the cumulative incidence functions ( CIF ) , adjusted on the significant prognostic factors . Equally spaced quantiles of the CIF were then used to estimate the corresponding optimised follow-up times depending on a pre-specified total number of visits . Follow-up data from the CHART bronchus clinical trial were used to analyse the pattern of time to first failure . RESULTS A significantly higher risk of failure was observed for males ( SE ) , stage III ( DM ) and conventional treatment ( LR ) . Overall , patients treated with CHART needed 1 fewer visit in each category of patients compared to the Conventional group . For example , stage III male patients treated with CHART would need 8 visits during the first two years at 7 , 11 , 16 , 24 , 37 , 52 , 64 and 104 weeks rather than the 9 follow-up visits planned in the protocol . Similar patients treated with Conventional radiotherapy  would need 8 visits at 3 , 5 , 7 , 11 , 15 , 24 , 52 and 104 weeks . CONCLUSIONS Use of these methods would allow timing of follow-up visits to be adapted according to tumour site and prognostic factors determined previously from audit or clinical trials . Application of this approach could optimize the timing of follow-up visits by placing them closer to the times when failures are expected to occur . It does not address the wider issues of follow-up such as who should do it or what should be done for which further studies are required BACKGROUND AND PURPOSE Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection ( Bundesamt für Strahlenschutz , BfS ) . For studies in the field of radiation oncology , differentiation between use of radiation for " medical care ( Heilkunde ) " versus " medical research " frequently leads to contradictions . The aim of this article is to provide principle investigators , individuals , and institutions involved in the process , as well as institutional review or ethics committees , with the necessary information for this assessment . Information on the legal frame and the approval procedures are also provided . METHODS A workshop was co-organized by the German Society for Radiation Oncology ( DEGRO ) , the Working Party for Radiation Oncology ( ARO ) of the German Cancer Society ( DKG ) , the German Society for Medical Physics ( DGMP ) , and the German Cancer Consortium ( DKTK ) in October 2013 . This paper summarizes the results of the workshop and the follow-up discussion s between the organizers and the BfS. RESULTS Differentiating between " Heilkunde " which does not need to be approved by the BfS and " medical research " is whether the specific application of radiation ( beam quality , dose , schedule , target volume , etc . ) is a clinical ly established and recognized procedure . This must be answered by the qualified physician(s ) ( " fachkundiger Arzt " according to German radiation protection law ) in charge of the study and the treatments of the patients within the study , taking into consideration of the best available evidence from clinical studies , guidelines and consensus papers . Among the important parameters for assessment are indication , total dose , and fractionation . Radiation treatments applied outside clinical trials do not require approval by the BfS , even if they are applied within a r and omized or nonr and omized clinical trial . The decision-making by the " fachkundigem Arzt " may be supported on request by an opinion given by the DEGRO Expert Committee for clinical trials . CONCLUSION An important aim for promoting clinical research and patient care in radiation oncology is to further professionalize planning and implementation of clinical trials in this field . Correct assessment , at an early stage , whether a trial needs to be approved by the BfS may reduce unnecessary costs and reduce the time needed for the approval procedure for those trials which need to be assessed by the : The purpose of this up date of the European Society of Anaesthesiology ( ESA ) guidelines on the pre-operative evaluation of the adult undergoing noncardiac surgery is to present recommendations based on the available relevant clinical evidence . Well performed r and omised studies on the topic are limited and therefore many recommendations rely to a large extent on expert opinion and may need to be adapted specifically to the healthcare systems of individual countries . This article aims to provide an overview of current knowledge on the subject with an assessment of the quality of the evidence in order to allow anaesthesiologists all over Europe to integrate - wherever possible - this knowledge into daily patient care . The Guidelines Committee of the ESA formed a task force comprising members of the previous task force , members of ESA scientific subcommittees and an open call for volunteers was made to all individual active members of the ESA and national societies . Electronic data bases were search ed from July 2010 ( end of the literature search of the previous ESA guidelines on pre-operative evaluation ) to May 2016 without language restrictions . A total of 34 066 abtracts were screened from which 2536 were included for further analysis . Relevant systematic review s with meta-analyses , r and omised controlled trials , cohort studies , case-control studies and cross-sectional surveys were selected . The Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) system was used to assess the level of evidence and to grade recommendations . The final draft guideline was posted on the ESA website for 4 weeks and the link was sent to all ESA members , individual or national ( thus including most European national anaesthesia societies ) . Comments were collated and the guidelines amended as appropriate . When the final draft was complete , the Guidelines Committee and ESA Board ratified the guidelines PURPOSE To perform a r and omized trial comparing 70 and 80 Gy radiotherapy for prostate cancer . PATIENTS AND METHODS A total of 306 patients with localized prostate cancer were r and omized . No and rogen deprivation was allowed . The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions . Toxicity was grade d using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective , objective , management , analytic scales ( LENT-SOMA ) scales . The patients ' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Question  naire 30-item cancer-specific and 25-item prostate-specific modules . RESULTS The median follow-up was 61 months . According to the 1997-American Society for Therapeutic Radiology and Oncology definition , the 5-year biochemical relapse rate was 39 % and 28 % in the 70- and 80-Gy arms , respectively ( p = .036 ) . Using the Phoenix definition , the 5-year biochemical relapse rate was 32 % and 23.5 % , respectively ( p = .09 ) . The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level > 15 ng/mL. At the last follow-up date , 26 patients had died , 10 of their disease and none of toxicity , with no differences between the two arms . According to the Radiation Therapy Oncology Group scale , the Grade 2 or greater rectal toxicity rate was 14 % and 19.5 % for the 70- and 80-Gy arms ( p = .22 ) , respectively . The Grade 2 or greater urinary toxicity was 10 % at 70 Gy and 17.5 % at 80 Gy ( p = .046 ) . Similar results were observed using the LENT-SOMA scale . Bladder toxicity was more frequent at 80 Gy than at 70 Gy ( p = .039 ) . The quality -of-life question naire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms . CONCLUSION High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity BACKGROUND There is increasing concern about the quality , reliability , and independence of practice guidelines . Because no information is available on the method ological quality of the guidelines developed by specialty societies , we undertook a survey on those published in peer- review ed journals . METHODS Practice guidelines produced by specialty societies and published in English between January , 1988 , and July , 1998 , where identified through MEDLINE . Their quality was assessed in terms of whether they reported : the type of professionals and stakeholders involved in the development process ; the strategy to identify primary evidence ; and an explicit grading of recommendations according to the quality of supporting evidence . FINDINGS Overall , 431 guidelines were eligible for the study . Most did not meet the criteria : 67 % did not report any description of the type of stakeholders , 88 % gave no information on search es for published studies , and 82 % did not give any explicit grading of the strength of recommendations . There was improvement over time for search es ( from 2 % to 18 % , p<0.001 ) and explicit grading of evidence ( from 6 % to 27 % , p<0.001 ) . All three criteria for quality were met in only 22 ( 5 % ) guidelines . INTERPRETATION Despite improvement over time , the quality of practice guidelines developed by specialty societies is unsatisfactory . Explicit method ological criteria for the production of guidelines shared among public agencies , scientific societies , and patients ' associations need to be set up . Common st and ards of reporting , following the same principles that led to the CONSORT statement for r and omised clinical trials , should be promoted BACKGROUND Proton beam radiotherapy ( PBT ) is frequently shown to be dosimetrically superior to photon radiotherapy ( RT ) , though supporting data for clinical benefit are severely limited . Because of the potential for toxicity reduction in gastrointestinal ( GI ) malignancies , we systematic ally review ed the literature on clinical outcomes ( survival/toxicity ) of PBT . METHODS A systematic search of PubMed , EMBASE , abstract s from meetings of the American Society for Radiation Oncology , Particle Therapy Co-Operative Group , and American Society of Clinical Oncology was conducted for publications from 2000 - 2015 . Thirty-eight original investigations were analyzed . RESULTS Although results of PBT are not directly comparable to historical data , outcomes roughly mirror previous data , generally with reduced toxicities  for PBT in some neoplasms . For esophageal cancer , PBT is associated with reduced toxicities , postoperative complications , and hospital stay as compared to photon radiation , while achieving comparable local control ( LC ) and overall survival ( OS ) . In pancreatic cancer , numerical survival for resected/unresected cases is also similar to existing photon data , whereas grade ≥3 nausea/emesis and post-operative complications are numerically lower than those reported with photon RT . The strongest data in support of PBT for HCC comes from phase II trials demonstrating very low toxicities , and a phase III trial of PBT versus transarterial chemoembolization demonstrating trends towards improved LC and progression-free survival ( PFS )  with PBT , along with fewer post-treatment hospitalizations . Survival and toxicity data for cholangiocarcinoma , liver metastases , and retroperitoneal sarcoma are also roughly equivalent to historical photon controls . There are two small reports for gastric cancer and three for anorectal cancer ; these are not addressed further . CONCLUSIONS Limited quality ( and quantity ) of data hamper direct comparisons and conclusions . However , the available data , despite the inherent caveats and limitations , suggest that PBT offers the potential to achieve significant reduction in treatment-related toxicities without compromising survival or LC for multiple GI malignancies . Several r and omized comparative trials are underway that will provide more definitive answers Objective To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe . Design Retrospective cohort study . Setting Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency ( EMA ) from 2009 to 2013 . Main outcome measures Pivotal and postmarketing trials of cancer drugs according to their design features ( r and omisation , crossover , blinding ) , comparators , and endpoints . Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry . Vali date d European Society for Medical Oncology Magnitude of Clinical Benefit Scale ( ESMO-MCBS ) used to assess the clinical value of the reported gains in published studies of cancer drugs . Results From 2009 to 2013 , the EMA approved the use of 48 cancer drugs for 68 indications . Of these , eight indications ( 12 % ) were approved on the basis of a single arm study . At the time of market approval , there was significant prolongation of survival in 24 of the 68 ( 35 % ) . The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months ( median 2.7 months ) . At the time of market approval , there was an improvement in quality of life in seven of 68 indications ( 10 % ) . Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation , in the subsequent postmarketing period there was evidence for extension of life in three ( 7 % ) and reported benefit on quality of life in five ( 11 % ) . Of the 68 cancer indications with EMA approval , and with a median of 5.4 years ’ follow-up ( minimum 3.3 years , maximum 8.1 years ) , only 35 ( 51 % ) had shown a significant improvement in survival or quality of life , while 33 ( 49 % ) remained uncertain . Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool , the benefit was judged to be clinical ly meaningful in less than half ( 11/23 , 48 % ) . Conclusions This systematic evaluation of oncology approvals by the EMA in 2009 - 13 shows that most drugs entered the market without evidence of benefit on survival or quality of life . At a minimum of 3.3 years after market entry , there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications . When there were survival gains over existing treatment options or placebo , they were often marginal AIMS Oesophageal cancer is an aggressive disease and the optimal therapy for patients with resectable tumours remains unclear . A systematic review and companion practice guideline were published in 2004 ; however , new evidence has become available since the publication of the original report . An up date of the literature search and a revision of the recommendations were undertaken to incorporate the new data . The following research question was addressed : should patients with resectable oesophageal cancer receive preoperative or postoperative therapy together with surgery ? The outcomes of interest were survival , adverse effects and quality of life . MATERIAL S AND METHODS The literature search of the original systematic review was up date d to April 2007 . MEDLINE , EMBASE , Cochrane Library and abstract s from the American Society of Clinical Oncology and the American Society for Therapeutic Radiology and Oncology were search ed for reports of r and omised controlled trials and meta-analyses comparing preoperative or postoperative therapy with surgery alone or other preoperative or postoperative therapy . After the completion of the draft systematic review and practice guideline , the report was distributed through a mailed survey to 133 health care providers in Ontario for review and feedback . RESULTS The up date d literature search yielded eight new r and omised controlled trial reports and seven new meta- analysis reports for consideration , together with the evidence review ed in the original review publication . Of the 31 practitioners who responded to the mailed survey , 80 % agreed with the draft recommendations as stated , 83 % agreed that the report should be approved as a practice guideline and 86 % indicated that they would probably use the guideline in their own practice . CONCLUSIONS Preoperative cisplatin-based chemotherapy plus radiotherapy is recommended as the preferred modality for the management of surgically resectable patients with oesophageal cancer .  Preoperative cisplatin-based chemotherapy alone is an alternative choice for the management of these patients PURPOSE An American Society of Clinical Oncology ( ASCO ) provisional clinical opinion ( PCO ) offers timely clinical direction to ASCO 's membership following publication or presentation of potentially practice -changing data from major studies . This PCO addresses the integration of palliative care services into st and ard oncology practice at the time a person is diagnosed with metastatic or advanced cancer . CLINICAL CONTEXT Palliative care is frequently misconstrued as synonymous with end-of-life care . Palliative care is focused on the relief of suffering , in all of its dimensions , throughout the course of a patient 's illness . Although the use of hospice and other palliative care services at the end of life has increased , many patients are enrolled in hospice less than 3 weeks before their death , which limits the benefit they may gain from these services . By potentially improving quality of life ( QOL ) , cost of care , and even survival in patients with metastatic cancer , palliative care has increasing relevance for the care of patients with cancer . Until recently , data from r and omized controlled trials ( RCTs ) demonstrating the benefits of palliative care in patients with metastatic cancer who are also receiving st and ard oncology care have not been available . RECENT DATA Seven published RCTs form the basis of this PCO . PROVISIONAL CLINICAL OPINION Based on strong evidence from a phase III RCT , patients with metastatic non-small-cell lung cancer should be offered concurrent palliative care and st and ard oncologic care at initial diagnosis . While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology setting s , substantial evidence demonstrates that palliative care-when combined with st and ard cancer care or as the main focus of care-leads to better patient and caregiver outcomes . These include improvement in symptoms , QOL , and patient satisfaction , with reduced caregiver burden . Earlier involvement of palliative care also leads to more appropriate referral to and use of hospice , and reduced use of futile intensive care . While evidence clarifying optimal delivery of palliative care to improve patient outcomes is evolving , no trials to date have demonstrated harm to patients and caregivers , or excessive costs , from early involvement of palliative care . Therefore , it is the Panel 's expert consensus that combined st and ard oncology care and palliative care should be considered early in the course of illness for any patient with metastatic cancer and /or high symptom burden . Strategies to optimize concurrent palliative care and st and ard oncology care , with evaluation of its impact on important patient and caregiver outcomes ( eg , QOL , survival , health care services utilization , and costs ) and on society , should be an area of intense research . NOTE ASCO 's provisional clinical opinions ( PCOs ) reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision making and identify questions and setting s for further research . Because of the rapid flow of scientific information in oncology , new evidence may have emerged since the time a PCO was su bmi tted for publication . PCOs are not continually up date d and may not reflect the most recent evidence . PCOs can not account for individual variation among patients and can not be considered inclusive of all proper methods of care or exclusive of other treatments . It is the responsibility of the treating physician or other health care provider , relying on independent experience and knowledge of the patient , to determine the best course of treatment for the patient . Accordingly , adherence to any PCO is voluntary , with the ultimate determination regarding its application to be made by the physician in light of each patient 's individual circumstances . ASCO PCOs describe the use of procedures and therapies in clinical trials and can not be assumed to apply to the use of these interventions in the context of clinical practice . ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO 's PCOs , or for any errors or omissions The mission of American Society of Clinical Oncology ( ASCO ) is to conquer cancer through research , education , and promotion of the highest quality patient care . Toward fulfillment of this goal and at the direction of its board of directors , the ASCOValue in Cancer Care Task Force set out to develop a framework that would enable a physician and patient to assess the value of a particular cancer treatment regimen given the patient ’s individual preferences and circumstances . The rationale that served as the impetus for this initiative is many faceted . Substantial progress has been made in translating our knowledge of the biologic characteristics of cancer into novel therapies . Some of these therapies have led to major improvements in outcomes for specific diseases , and others have produced only modest advances . There is now a wide array of choices for treating many cancer types , and these treatment choices often differ by only small degrees in clinical effectiveness and toxicity . Yet , there is often a wide disparity in cost to patients and payers . Because patients are often confronted with enormous expenses when receiving cancer care , the goal of describing a relationship between the cost of an agent or regimen and the clinical benefits it delivers takes on great importance . As the primary advisor to the patient , the oncologist has an important role in providing a comparative assessment of the various treatment options available ; in the spirit of shared decision making , the patient should have transparent information about the clinical impact that can be expected from the different options presented and their relative financial implication s. The value framework has been constructed as a conceptual model that incorporates the elements of clinical benefit , toxicity , and symptom palliation as derived from a comparative clinical trial and combines these elements into a score termed the net health benefit ( NHB ) . Ultimately , deployment of the framework as a software application is planned , enabling a patient to modify the weight attributed to any of the elements included in the NHB depending on his or her personal preferences and circumstances . The final NHB will therefore reflect the priorities that are most important to the patient and will be arrived at through guidance from the physician . Information on the cost of the regimens will also be presented so the patient can consider the relative financial impact of his or her treatment options . Two versions of the framework have been created : one for advanced disease and the other for potentially curable ( adjuvant therapy ) clinical presentations . The original framework versions are shown in Appendix Tables A1 and A2 ( online only ) . The key elements included in the framework— namely , clinical benefit and toxicity — are also those that are regularly reported in the scientific literature when discussing the outcome of a clinical trial that compares two or more therapies . The importance of relying on high- quality , quantifiable evidence can not be overstated , and this is most often provided by a well- design ed , well-conducted prospect i ve r and omized trial . The task force recognizes that a limitation of this approach is that it does not readily permit cross-trial comparisons . Such analyses are important to patients and remain a goal for future versions of the value framework . The task force is well aware that there are many elements that might be important to individual patients in assessing the relative value of their treatment options that are not taken into account in our model . These include the convenience of receiving therapy , the avoidance of interrupting the flow of activities of daily living , and the impact of a treatment on quality of PURPOSE The aim of this guideline is to present recommendations regarding moderately hypofractionated ( 240 - 340 cGy per fraction ) and ultrahypofractionated ( 500 cGy or more per fraction ) radiation therapy for localized prostate cancer . METHODS AND MATERIAL S The American Society for Radiation Oncology convened a task force to address 8 key questions on appropriate indications and dose-fractionation for moderately and ultrahypofractionated radiation therapy , as well as technical issues , including normal tissue dose constraints , treatment volumes , and use of image guided and intensity modulated radiation therapy . Recommendations were based on a systematic literature review and created using a predefined consensus-building methodology and Society-approved tools for grading evidence quality and recommendation strength . RESULTS Based on high- quality evidence , strong consensus was reached for offering moderate hypofractionation across risk groups to patients choosing external beam radiation therapy . The task force conditionally recommends ultrahypofractionated radiation may be offered for low- and intermediate-risk prostate cancer but strongly encourages treatment of intermediate-risk patients on a clinical trial or multi-institutional registry . For high-risk patients , the task force conditionally recommends against routine use of ultrahypofractionated external beam radiation therapy . With any hypofractionated approach , the task force strongly recommends image guided radiation therapy and avoidance of nonmodulated 3-dimensional conformal techniques . CONCLUSIONS Hypofractionated radiation therapy provides important potential advantages in cost and convenience for patients , and these recommendations are intended to provide guidance on moderate hypofractionation and ultrahypofractionation for localized prostate cancer . The limits in the current evidentiary base-especially for ultrahypofractionation-highlight the imperative to support large-scale r and omized clinical trials and underscore the importance of shared decision making between clinicians and patients PURPOSE To determine whether a dose of 78 Gy improves outcome compared with a conventional dose of 68 Gy for prostate cancer patients treated with three-dimensional conformal radiotherapy .  PATIENTS AND METHODS Between June 1997 and February 2003 , stage T1b-4 prostate cancer patients were enrolled onto a multicenter r and omized trial comparing 68 Gy with 78 Gy . Patients were stratified by institution , age , (neo)adjuvant hormonal therapy ( HT ) , and treatment group . Four treatment groups ( with specific radiation volumes ) were defined based on the probability of seminal vesicle involvement . The primary end point was freedom from failure ( FFF ) . Failure was defined as clinical failure or biochemical failure , according to the American Society of Therapeutic Radiation Oncology definition . Other end points were freedom from clinical failure ( FFCF ) , overall survival ( OS ) , and toxicity . RESULTS Median follow-up time was 51 months . Of the 669 enrolled patients , 664 were included in the analysis . HT was prescribed for 143 patients .  FFF was significantly better in the 78-Gy arm compared with the 68-Gy arm ( 5-year FFF rate , 64 % v 54 % , respectively ) , with an adjusted hazard ratio of 0.74 ( P = .02 ) . No significant differences in FFCF or OS were seen between the treatment arms . There was no difference in late genitourinary toxicity of Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer grade 2 or more and a slightly higher nonsignificant incidence of late gastrointestinal toxicity of grade 2 or more . CONCLUSION This multicenter r and omized trial shows a significantly improved FFF in prostate cancer patients treated with a higher dose of radiotherapy This international , prospect i ve , r and omised therapeutic study is based on previous , separate studies of the two societies . The study asks two principal questions : ( 1 ) Is it possible to improve the results of therapy by inserting , between surgery and post-operative irradiation , an intensive course of chemotherapy consisting of vincristine , procarbazine and methotrexate , followed by citrovorum factor rescue ? ( 2 ) In “ low risk ” patients ( i.e. those with macroscopically “ complete ” resection and absence of metastases at diagnosis ) , can the radiotherapy to CNS areas outside the primary tumour site be reduced by 10 Gy with the aim of reducing late sequelae of irradiation but without compromising survival results ? The study also aims at st and ardising diagnostic methods , neurosurgical procedure and radiotherapeutic technique employed in this tumour . For statistical reasons , results can only be disclosed after the end of the recruitment phase . It is intended to include approximately 350 patients in the study , which is planned to continue until the end of 1988 BACKGROUND Publication bias toward studies that favor new therapies has been known to occur for the past 40 years , yet its implication s are not well studied in child health . The increased interest in meta-analyses has highlighted the need to identify the totality of evidence when addressing treatment questions . OBJECTIVES To measure the percentage of r and omized controlled trials  ( RCTs ) presented at a major pediatric scientific meeting that were subsequently published as full-length articles , to investigate factors associated with publication , and to describe the variables that change from abstract to manuscript form . DESIGN The scientific proceedings from the Society for Pediatric Research were h and search ed for RCTs ( 1992 - 1995 ) . Subsequent publication was ascertained through a search of various electronic data bases . Quality of abstract s and manuscripts was measured , and data were extracted using a structured form . RESULTS A total of 264 ( 59.1 % ) of 447 abstract s were subsequently published . Almost 64 % of RCTs that were subsequently published favored new therapy compared with 43.5 % of studies that were never published ( P<.001 ) . Mean effect size for published vs unpublished RCTs was 0.74 vs 0.05 ( P<.001 ) . Median sample size was larger in published ( n = 45 ) vs unpublished ( n = 34 ) RCTs ( P = .02 ) . Quality was significantly lower for abstract s vs published RCTs ( P<.001 ) . For 5 % of abstract s that were subsequently published , the conclusion regarding treatment efficacy changed . CONCLUSIONS Publication bias is a serious threat to assessing the effectiveness of interventions in child health , as little more than half of RCTs presented at a major scientific meeting are subsequently published . There is a need to institute an international registry of RCTs in children so that the totality of evidence can be accessed when assessing treatment effectiveness PURPOSE This guideline presents evidence -based recommendations for stereotactic body radiation therapy ( SBRT ) in challenging clinical scenarios in early-stage non-small cell lung cancer ( NSCLC ) . METHODS AND MATERIAL S The American Society for Radiation Oncology convened a task force to perform a systematic literature review on 4 key questions addressing : ( 1 ) application of SBRT to operable patients ; ( 2 ) appropriate use of SBRT in tumors that are central ly located , large , multifocal , or unbiopsied ; ( 3 ) individual tailoring of SBRT in " high-risk " clinical scenarios ; and ( 4 ) SBRT as salvage therapy after recurrence . Guideline recommendations were created using a predefined consensus-building methodology supported by American Society for Radiation Oncology-approved tools for grading evidence quality and recommendation strength . RESULTS Although few r and omized trials have been completed for SBRT , strong consensus recommendations based on extensive , consistent publications were generated for several questions , including recommendations for fractionation for central tumors and surgery versus SBRT in st and ard-risk medically operable patients with early-stage NSCLC . Lower quality evidence led to conditional recommendations on use of SBRT for tumors > 5 cm , patients with prior pneumonectomy , T3 tumors with chest wall invasion , synchronous multiple primary lung cancer , and as a salvage therapy after prior radiation therapy . These areas of moderate- and low- quality evidence highlight the importance of clinical trial enrollment as well as the role of prospect i ve data registries . CONCLUSIONS SBRT has an important role to play in treating early-stage NSCLC , particularly for medically inoperable patients with limited other treatment options . Shared decision-making with patients should be performed in all cases to ensure the patient underst and s the risks related to SBRT , the side effects , and the alternative treatments available Review articles are an important element of most medical journals and a popular source of information for clinicians ( 1 ) . Given the increasing volume of medical literature and the limited time for reading that busy clinicians have , reliance on review articles is likely to increase . However , concerns have been raised that narrative , non systematic review articles may produce biased conclusions ( 2 , 3 ) . Mulrow ( 4 ) examined 50 review articles published in four major medical journals ( The New Engl and Journal of Medicine , Annals of Internal Medicine , JAMA , and Archives of Internal Medicine ) in 1985 - 1986 and found that none fulfilled 8 explicit criteria for scientifically sound summaries of the evidence . As a result , she and others ( 5 , 6 ) proposed criteria for conducting and evaluating review articles that would improve their quality ; these criteria are the first 10 listed in the Appendix Table . In a study of 36 review articles done by nine content experts and method ologists , these criteria were shown to yield reliable and valid estimates of the scientific quality of review s ( 7 , 8) . We sought to describe the methods used in recently published review articles and determine whether the attention paid to the method ologic shortcomings of review articles has led to improvements in their scientific quality . Methods By using the Science Citation Index ( 9 ) , we stratified the 12 general medicine journals that are considered core journals for ACP Journal Club ( 10 ) into those with high impact factors ( scores 5 ) and those with lower impact factors . We r and omly selected 3 ( The New Engl and Journal of Medicine , Annals of Internal Medicine , and JAMA ) of the 4 high-impact core journals and 3 ( British Medical Journal , American Journal of Medicine , and Journal of Internal Medicine ) of the 8 core journals with lower impact factors . The sampling frame included 3 of the 4 journals examined in Mulrow 's original study ( 4 ) . All 6 journals were h and - search ed by two of the investigators independently , and review articles published between January and December 1996 were retrieved . Review articles were defined as full-text articles published under the banner review that dealt with disease states ; had the words review , overview , or meta- analysis in the title or abstract ; or indicated in the text that the intention was to review or summarize the literature about a clinical topic . Editorials , correspondence , and conference summaries were excluded . Disagreements on article eligibility ( which occurred in five cases ) were resolved by consensus . After training with a test set of articles , five of the authors used explicit criteria ( Appendix Table ) to rate the identified review articles . So that the raters ' assessment s would be blinded , the articles ' authors , author affiliations , and sources of articles were masked . The first 10 criteria in the Appendix Table ( hereafter referred to as method ologic criteria ) have been previously vali date d ( 7 ) and assess method ologic rigor , whereas the last five criteria were developed for this study to evaluate the scientific basis of treatment recommendations . Because inter-rater agreement was excellent on the test set ( overall agreement , 94 % ) , each rater was assigned a r and om sample of 20 % of the articles . One rater independently evaluated a r and om sample of five articles from each rater to assess inter-rater reliability for the criteria . The mean value was 0.79 , indicating substantial agreement ; overall agreement was 95 % and ranged from 84 % for criteria 1 and 6 to 100 % for criteria 2 , 3 , and 5 . After we determined the number of criteria fulfilled by each article , the number of articles meeting each criterion was ascertained . The proportion of review s from high-impact journals and from lower-impact journals that met each criterion were compared . Only the subset of review s containing treatment recommendations were used for the comparisons for criteria 7 to 15 . The chi-square test was used and 95 % CIs for the observed differences were calculated for all comparisons . In addition , articles identified as meta-analyses , systematic review s , or overviews in their title , abstract , or text were compared with the remaining review articles for each criterion ( again by using the chi-square test and by limiting analysis to those that included treatment recommendations for criteria 7 to 15 ) . Logistic regression analysis was used to adjust for journal of publication . The funding organizations were not involved in the design , conduct , analysis , or reporting of this study . Results A total of 158 review articles were identified : 60 from The New Engl and Journal of Medicine , 33 from Annals of Internal Medicine , 24 from British Medical Journal , 18 from American Journal of Medicine , 13 from JAMA , and 10 from Journal of Internal Medicine . ( A full list of the included articles is available from Dr. McAlister on request . ) Most review s were written by more than one author ( median number of authors , 2 [ range , 1 to 10 authors ] ) , and 111 review s ( 70 % ) made treatment recommendations . Although most articles had sections review ing the relevant pathophysiology and pharmacodynamics , 19 articles ( 12 % ) were largely basic science review s. Only 2 review s met all 10 method ologic criteria ; the median number of criteria fulfilled was one ( Figure ) . Nineteen ( 12 % ) of the review articles were described as meta- analysis , systematic review , or overview in the title or abstract ; 12 of these 19 articles were published in high-impact journals . A higher proportion of these articles met the method ologic criteria ( Appendix Table ) ; the comparisons for all but criterion 6 were statistically significant , even after adjustment for journal of publication ( P<0.005 for all comparisons ) . Although there was significant heterogeneity among journals ( P<0.005 for criteria 1 to 5 , 7 , and 8) , review articles published in high-impact journals did not meet method ologic criteria more frequently than those published in other journals ( Table ) . Exclusion of the review s from one journal with method ologic scores that were significantly lower than the rest ( P<0.001 for all comparisons ) resolved much of the interjournal heterogeneity and revealed that review s published in the remaining high-impact journals more often met some ( but not all ) of the method ologic criteria ( Table ) . Figure . Percentage of 158 review articles published in 1996 that fulfilled specific method ologic criteria . Table . Comparison of Methods Used in 1996 Review Articles , by Journal Impact Factor The 44 articles that described how evidence was located used the following sources ( which were not mutually exclusive ) : MEDLINE ( 42 articles ) , h and search of reference lists from published studies or review articles ( 30 articles ) , other electronic data bases ( 14 articles ) , contact with experts in the field ( 10 articles ) , h and search of relevant journals ( 7 articles ) , and contact with the pharmaceutical industry ( 5 articles ) . Of the 22 review s that included a description of the electronic search strategy , the search was restricted to English- language publications in 11 . Of the 111 review s in which treatment recommendations were made , a median of 3 therapies ( range , 1 to 23 therapies ) were discussed . The 16 meta-analyses that included treatment recommendations were more focused , examining a median of 1 therapy ( range , 1 to 6 therapies ) . The scientific basis of these recommendations is outlined in the last five criteria of the Appendix Table . Discussion In summary , only a minority of the review articles published in six widely read general medical journals specified rigorous , systematic methods of identifying , evaluating , and synthesizing the evidence , thereby raising concerns about the validity of their conclusions and recommendations ( 11 ) . Furthermore , although most review articles made recommendations for therapeutic options , their clinical relevance may be limited : Only one third discussed benefits and harms of the treatment options , only 6 % mentioned the relative or absolute costs of the various options , less than half provided an estimate of the anticipated treatment effect , and very few presented the results in clinical ly relevant formats that would be easily understood by clinicians . Although there is still substantial room for improvement , these results do represent progress from the situation in 1985 - 1986 ( Appendix Table ) . A higher proportion of recently published review s specify how the evidence was identified and synthesized . This same pattern was observed in a recent study of oncology review articles published in a single journal between 1983 and 1995 ( 12 ) . Similarly , our findings for meta-analyses published in these journals in 1996 are consistent with contemporaneous investigations in other fields and represent substantial improvement over the state of affairs in the mid-1980s ( 13 , 14 ) . Our study had several potential limitations . First , the authors of articles in which systematic methods were not specified may have used such methods but not reported them ( or the journal may have removed the details of the methods in prepublication ) . However , preliminary evidence suggests that there is little difference between the conduct of studies and their published methods ( 7 , 15 ) . In other words , if what was done is not reported , there is a good chance that it was not done rigorously ( 7 ) . Second , our finding that meta-analyses are more scientifically rigorous than other review s may be seen as tautological because the criteria used in this study may be used by meta-analysts in performing their studies . However , meta-analysts disagree over some issues of methodology , and published meta-analyses often vary in the quality of their reports ( 13 ) . Third , the practical importance of the method ologic flaws identified in these review s is difficult to ascertain . We lack empirical evidence that review s with explicit , systematic methods yield results closer to the truth , but it is known that non systematic review s are more prone to r and om and For scientific , ethical and economic reasons , experiments involving animals should be appropriately design ed , correctly analysed and transparently reported . This increases the scientific validity of the results , and maximises the knowledge gained from each experiment . A minimum amount of relevant information must be included in scientific publications to ensure that the methods and results of a study can be review ed , analysed and repeated . Omitting essential information can raise scientific and ethical concerns . We report the findings of a systematic survey of reporting , experimental design and statistical analysis in published biomedical research using laboratory animals . Medline and EMBASE were search ed for studies reporting research on live rats , mice and non-human primates carried out in UK and US publicly funded research establishments . Detailed information was collected from 271 publications , about the objective or hypothesis of the study , the number , sex , age and /or weight of animals used , and experimental and statistical methods . Only 59 % of the studies stated the hypothesis or objective of the study and the number and characteristics of the animals used . Appropriate and efficient experimental design is a critical component of high- quality science . Most of the papers surveyed did not use r and omisation ( 87 % ) or blinding ( 86 % ) , to reduce bias in animal selection and outcome assessment . Only 70 % of the publications that used statistical methods described their methods and presented the results with a measure of error or variability . This survey has identified a number of issues that need to be addressed in order to improve experimental design and reporting in publications describing research using animals . Scientific publication is a powerful and important source of information ; the authors of scientific publications therefore have a responsibility to describe their methods and results comprehensively , accurately and transparently , and peer review ers and journal editors share the responsibility to ensure that published studies fulfil these criteria
Both journals are anchored in large scientific societies and serve basically the same medical , physical and biological community and at the same scientific level ; the two journals are in the most recent Impact Factor list ranked almost back to back , indicating an equal importance and contribution to science .
Radiotherapy and Oncology is more than a scientific journal , it also serves other purpose s such as facilitate education through ( educational ) review s and improving the st and ard of care by bringing forward guidelines for conduct of radiotherapy .
Finally , the journal also tries to maintain a communication platform between the science produced by the membership of ESTRO and therefore it brings papers frommembers in the different European countries , sometimes at the expense of ultimate scientific quality , but with the underst and ing that it is important that the entire ESTRO membership gets access and opportunity to publish in a high ranked journal .
ESTRO , the European Society for Therapeutic Radiation Oncology , or with its new name European Society for Radiation Oncology , is a scientific society .
It means that the prime aim of ESTRO is to bring to bring people together on an individual basis who have a common interest in improving the scientific conduct of radiotherapy and cancer treatment in Europe by ensuring that proper radiotherapy is available in the multidisciplinary treatment of cancer and applied with the right indication and with the most optimal technique .
One of the main aims of this endeavour was to create a platform for scientific exchange through meetings and through the establishment of a scientific journal [ 1 ] .
Thus Radiotherapy and Oncology was launched shortly after the foundation of ESTRO and has become the society ’s prime vehicle for scientific communication by serving ESTRO members through almost the entire 30 years of the society ’s existence .
The aim was to create a peer review ed high quality international journal and that aim has indeed been fulfilled . ‘ ‘