***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: Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials BACKGROUND The alpha-emitter radium-223 ( (223)Ra ) is a bone-seeking radionuclide studied as a new treatment for patients with bone metastases from hormone-refractory prostate cancer . We aim ed to study mature outcomes from a r and omised , multicentre , phase II study of (223)Ra . METHODS Patients with hormone-refractory prostate cancer and bone pain needing external-beam radiotherapy  were assigned to four intravenous injections of (223)Ra ( 50 kBq/kg , 33 patients ) or placebo ( 31 patients ) , given every 4 weeks . Primary endpoints were change in bone-alkaline phosphatase ( ALP ) concentration and time to skeletal-related events ( SREs ) . Secondary endpoints included toxic effects , time to prostate-specific-antigen ( PSA ) progression , and overall survival . All tests were done at a 5 % significance level , based on intention to treat . FINDINGS Median relative change in bone-ALP during treatment was -65.6 % ( 95 % CI -69.5 to -57.7 ) and 9.3 % ( 3.8 - 60.9 ) in the (223)Ra group and placebo groups , respectively ( p<0.0001 , Wilcoxon ranked-sums test ) . Hazard ratio for time to first SRE , adjusted for baseline covariates , was 1.75 ( 0.96 - 3.19 , p=0.065 , Cox regression ) . Haematological toxic effects did not differ significantly between two groups . No patient discontinued (223)Ra because of treatment toxicity . Median time to PSA progression was 26 weeks ( 16 - 39 ) versus 8 weeks ( 4 - 12 ; p=0.048 ) for (223)Ra versus placebo , respectively . Median overall survival was 65.3 weeks ( 48.7-infinity ) for (223)Ra and 46.4 weeks ( 32.1 - 77.4 ) for placebo ( p=0.066 , log rank ) . The hazard ratio for overall survival , adjusted for baseline covariates was 2.12 ( 1.13 - 3.98 , p=0.020 , Cox regression ) . INTERPRETATION (223)Ra was well tolerated with minimum myelotoxicity , and had a significant effect on bone-ALP concentrations . Larger clinical trials are warranted to study (223)Ra on the prevention of SREs and on overall survival in patients with hormone-refractory prostate cancer . Bone-targeting properties of (223)Ra could also potentially be used for treating skeletal metastasis from other primary cancers 
    Output:
    
It has been concluded that there is limited clinical evidence supporting the clinical effect of radionuclides in relieving pain from bone metastasis in breast cancer .