***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: This study aim ed to evaluate the effectiveness of the  Norton score  in predicting the likely occurrence of  pressure sores  compared to the Waterlow scale in Hong Kong . Two elderly care wards ( one male and one female ) were chosen , the sample size was 185 and the mean age of subjects was 80.4 . Each newly admitted patient was assessed using both the Norton calculation and the Waterlow calculation . At the end of the research , there were eight patients who had sore formation . The results indicated that the  Norton score  identified six out of the eight patients while the Waterlow identified seven of them . The Waterlow calculation , however , seems to have misidentified 72 patients as being in the ' at risk group ' . In view of a fear of the misdirection of re sources the  Norton score  was found to be the better of the two and its use in the elderly care units in this study should be continued until a better scoring system is found It is now well known that st and ard statistical procedures become invali date d when applied to cluster r and omized trials in which the unit of inference is the individual . A result ing consequence is that research ers conducting such trials are faced with a multitude of design choices , including selection of the primary unit of inference , the degree to which clusters should be matched or stratified by prognostic factors at baseline , and decisions related to cluster subsampling . Moreover , application of ethical principles developed for individually r and omized trials may also require modification . We discuss several topics related to these issues , with emphasis on the choices that must be made in the planning stages of a trial and on some potential pitfalls to be avoided This study investigated the influence on the number of pressure sores developing in patients nursed in a hospice when three levels of pressure support were used in association with a risk assessment tool . The study was design ed as phase one of an epidemiological study examining the use of a modified Norton scoring system . This was followed by a second phase of the study , when patients were allocated to pressure sore support systems according to their risk assessment score . A total of 327 patients entered , 223 in phase one and 104 in phase two . A significant reduction in the development of pressure sores was observed in the second phase of the study The presence of pressure ulcers imposes a huge burden on the older person 's quality of life and significantly increases their risk of dying . The objective of this study was to determine patient characteristics associated with the presence of pressure ulcers and to evaluate the risk factors associated with mortality among older patients with pressure ulcers . A prospect i ve observational study was performed between Oct 2012 and May 2013 . Patients with preexisting pressure ulcers on admission and those with hospital acquired pressure ulcers were recruited into the study . Information on patient demographics , functional status , nutritional level , stages of pressure ulcer and their complications were obtained . Cox proportional hazard analysis was used to assess the risk of death in all patients . 76/684 ( 11.1 % ) patients had pre-existing pressure ulcers on admission and 30/684 ( 4.4 % ) developed pressure ulcers in hospital . There were 68 ( 66 % ) deaths by the end of the median follow-up period of 12 ( IQR 2.5 - 14 ) weeks . Our Cox regression model revealed that nursing home residence ( Hazard Ratio , HR=2.33 , 95 % confidence interval , CI=1.30 , 4.17 ; p=0.005 ) , infected deep pressure ulcers ( HR=2.21 , 95 % CI=1.26 , 3.87 ; p=0.006 ) and neutrophilia ( HR=1.76 ; 95 % CI 1.05 , 2.94 ; p=0.031 ) were independent predictors of mortality in our elderly patients with pressure ulcers . The prevalence of pressure ulcers in our setting is comparable to previously reported figures in Europe and North America . Mortality in patients with pressure ulcer was high , and was predicted by institutionalization , concurrent infection and high neutrophil counts Objectives : To study the components of two risk assessment scales for decubitus ulcer risk , Waterlow and Braden , and of the Chailey score for the same purpose . Design : Experimental study of patients at risk of developing decubitus ulcers . Setting : The West Midl and s and Yorkshire . Subjects : One hundred and fifty wheelchair users from the West Midl and s and 9022 patients from a District General Hospital in York , the latter consisting of all admissions to the hospital in a four-month period . Interventions :  Braden , Chailey scores  ( wheelchair users ) and Waterlow scores  ( all subjects ) measured . Main outcome measures : Development of a pressure sore , receiver operating characteristic ( ROC ) curves . Results :  Waterlow  outperformed Braden for classification of wheelchair patients with respect to decubitus ulcer . The  Chailey score  performed r and omly in this group . The sensitivity and specificity as seen in ROC curves was different for  Waterlow scores for wheelchair users and general patients , the latter being much better classified . Only three items out of 11 in the  Waterlow score appeared to have any classification ability in the wheelchair group . Conclusions : Risk indicators used for general patients are probably poorly suited for wheelchair users . There is a need for large-scale predictive studies of wheelchair users and other groups to allow regression analysis of the subscales of risk indicators . From the provisional data of this study it appears that splitting patients by gender and into full and part-time wheelchair users classifies almost as well the much more complicated risk assessment tools currently available A report of a r and omized , controlled trial ( RCT ) should convey to the reader , in a transparent manner , why the study was undertaken and how it was conducted and analyzed . For example , a lack of adequately reported r and omization has been associated with bias in estimating the effectiveness of interventions ( 1 , 2 ) . To assess the strengths and limitations of an RCT , readers need and deserve to know the quality of its methods . Despite several decades of educational efforts , RCTs still are not being reported adequately ( 3 - 6 ) . For example , a review of 122 recently published RCTs that evaluated the effectiveness of selective serotonin-reuptake inhibitors as first-line management strategy for depression found that only 1 ( 0.8 % ) paper described r and omization adequately ( 5 ) . Inadequate reporting makes the interpretation of RCT results difficult if not impossible . Moreover , inadequate reporting borders on unethical practice when biased results receive false credibility . History of CONSORT In the mid-1990s , two independent initiatives to improve the quality of reports of RCTs led to the publication of the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement ( 7 ) , which was developed by an international group of clinical trialists , statisticians , epidemiologists , and biomedical editors . CONSORT has been supported by a growing number of medical and health care journals ( 8 - 11 ) and editorial groups , including the International Committee of Medical Journal Editors ( ICMJE , also known as the Vancouver Group ) ( 12 ) , the Council of Science Editors ( CSE ) , and the World Association of Medical Editors ( WAME ) . CONSORT is also published in Dutch , English , French , German , Japanese , and Spanish . It can be accessed on the Internet , along with other information about the CONSORT group ( 13 ) . The CONSORT statement comprises a checklist and flow diagram for reporting an RCT . For convenience , the checklist and diagram together are called simply CONSORT . They are primarily intended for use in writing , review ing , or evaluating reports of simple two-group , parallel RCTs . Preliminary data indicate that the use of CONSORT does indeed help to improve the quality of reports of RCTs ( 14 , 15 ) . In an evaluation ( 14 ) of 71 RCTs published in three journals in 1994 , allocation concealment was not clearly reported in 43 ( 61 % ) of the RCTs . Four years later , after these three journals required that authors reporting an RCT use CONSORT , the proportion of papers in which allocation concealment was not clearly reported had dropped to 39 % ( 30 of 77 ; mean difference , 22 % [ 95 % CI of the difference , 38 % to 6 % ] ) . The usefulness of CONSORT is enhanced by continuous monitoring of the biomedical literature ; this monitoring allows CONSORT to be modified depending on the merits of maintaining or dropping current items and including new items . For example , when Meinert ( 16 ) observed that the flow diagram did not provide important information about the number of participants who entered each phase of an RCT ( enrollment , treatment allocation , follow-up , and data analysis ) , the diagram could be modified to accommo date the information . The checklist is similarly flexible . This iterative process makes the CONSORT statement a continually evolving instrument . While participants in the CONSORT group and their degree of involvement vary over time , members meet regularly to review the need to refine CONSORT . At the 1999 meeting , the participants decided to revise the original statement . This report reflects changes determined by consensus of the CONSORT group , partly in response to emerging evidence on the importance of various elements of RCTs . Revision of the CONSORT Statement Thirteen members of the CONSORT group met in May 1999 with the primary objective of revising the original CONSORT checklist and flow diagram , as needed . The group discussed the merits of including each item in the light of current evidence . As in developing the original CONSORT statement , our intention was to keep only those items deemed fundamental to reporting st and ards for an RCT . Some items not considered essential may well be highly desirable and should still be included in an RCT report even though they are not included in CONSORT . Such items include approval of an institutional ethical review board , sources of funding for the trial , and a trial registry number ( as , for example , the International St and ard R and omized Controlled Trial Number [ IS RCT N ] used to register an RCT at its inception [ 17 ] ) . Shortly after the meeting , a revised version of the checklist was circulated to the group for additional comments and feedback . Revisions to the flow diagram were similarly made . All these changes were discussed when CONSORT participants met in May 2000 , and the revised statement was finalized shortly afterward . The revised CONSORT statement includes a 22-item checklist ( Table ) and a flow diagram ( Figure ) . Its primary aim is to help authors improve the quality of reports of simple two-group , parallel RCTs . However , the basic philosophy underlying the development of the statement can be applied to any design . In this regard , additional statements for other design s will be forthcoming from the group ( 13 ) . CONSORT can also be used by peer review ers and editors to identify reports with inadequate description of trials and those with potentially biased results ( 1 , 2 ) . Table . Checklist of Items To Include When Reporting a R and omized Trial Figure . Flow diagram of the progress through the phases of a r and omized trial ( enrollment , intervention allocation , follow-up , and data analysis ) . During the 1999 meeting , the group also discussed the benefits of developing an explanatory document to enhance the use and dissemination of CONSORT . The document is patterned on reporting of statistical aspects of clinical research ( 18 ) , which was developed to help facilitate the recommendations of the ICMJE 's Uniform Requirements for Manuscripts Su bmi tted to Biomedical Journals . Three members of the CONSORT group , with assistance from members on some checklist items , drafted an explanation and elaboration document . That document ( 19 ) was circulated to the group for additions and revisions and was last revised after review at the latest CONSORT group meeting . Changes to CONSORT 1 . In the revised checklist , a new column for Paper Section and Topic integrates information from the Subheading column that was contained in the original statement . 2 . The Was It Reported ? column has been integrated into a Reported on Page Number column , as requested by some journals . 3 . Each item of the checklist is now numbered , and the syntax and order have been revised to improve the flow of information . 4 . Title and Abstract are now combined in the first item . 5 . While the content of the revised checklist is similar to that of the original one , some items that previously were combined are now separate . For example , authors had been asked to describe primary and secondary outcome ( s ) measure(s ) and the minimum important difference(s ) , and indicate how the target sample size was projected . In the new version , issues pertaining to outcomes ( item 6 ) and sample size ( item 7 ) are separate , enabling authors to be more explicit about each . Moreover , some items request additional information . For example , for outcomes ( item 6 ) authors are asked to report any methods used to enhance the quality of measurements , such as multiple observations . 6 . The item asking for the unit of r and omization ( for example , cluster ) has been dropped because specific checklists have been developed for reporting cluster RCTs ( 20 ) and other design types ( 13 ) since publication of the original checklist . 7 . Whenever possible , new evidence is incorporated into the revised checklist . For example , authors are asked to be explicit about whether the analysis reported is by intention to treat ( item 16 ) . This request is based in part on the observations ( 21 ) that authors do not adequately describe and apply intention-to-treat analysis and that reports not providing this information are less likely to provide other relevant information , such as losses to follow-up ( 22 ) . 8 . The revised flow diagram depicts information from four stages of a trial ( enrollment , intervention allocation , follow-up , and analysis ) . The revised diagram explicitly includes the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers lets the reader know whether the authors have performed an intention-to-treat analysis ( 21 - 23 ) . Because some of the information may not always be known and to accommo date other information , the structure of the flow diagram may need to be modified for a particular trial . Inclusion of the participant flow diagram in the report is strongly recommended but may be unnecessary for simple trials , such as those without any participant withdrawals or dropouts . Discussion Specifically developed to guide authors about how to improve the quality of reporting of simple two-group , parallel RCTs , CONSORT encourages transparency with reporting of the methods and results so that reports of RCTs can be interpreted both readily 
    Output:
    
There is no reliable evidence to suggest that the use of structured , systematic pressure ulcer risk assessment tools reduces the incidence of pressure ulcers