***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: The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care When a r and omized trial ( NMSG 4/90 ) comparing treatment with melphalan/prednisone to melphalan/prednisone + interferon α‐2b in newly diagnosed multiple myeloma was inititated in 1990 , a quality ‐of‐life assessment was integrated into the study . We used the question naire ( QLQ‐C30 ) developed by the European Organization of Research and Treatment of Cancer ( EORTC ) Study Group on Quality of Life . The QLQ‐C30 incorporates five functional scales , three symptom scales , a global health and quality ‐of‐life scale and some single symptom measures . The question naire was completed prior to treatment and after 1 , 6 , 12 , 24 , 36 and 48 months . 524 ( 90.2 % ) of 581 patients enrolled in the NMSG 4/90 completed the first question naire , and 484 ( 83.3 % ) completed all question naires given to them . All but one of the scales met the minimum criteria of reliability ( Cronbach ’s alpha ≥0.70 ) . Validity was shown by ( 1 ) the ability of the scales to discriminate clearly between patients differing in clinical status as defined by pre‐treatment W.H.O. performance index and Durie & Salmon stage , and ( 2 ) the sensitivity to changes in objective disease status ( response and relapse ) . This is the first report of the measurement of health‐related quality of life in a prospect i ve clinical trial in multiple myeloma . The results demonstrate that the QLQ‐C30 is a reliable and valid instrument for the measurement of quality of life in these patients . The data will be used for a cost – utility analysis of the results of the NMSG 4/90 trial Abstract In the MM-015 trial , melphalan – prednisone – lenalidomide followed by lenalidomide maintenance ( MPR-R ) significantly prolonged progression-free survival versus melphalan – prednisone ( MP ) in newly diagnosed patients with multiple myeloma aged ≥ 65 years . Health-related quality of life ( HRQoL ) , a secondary endpoint of MM-015 , was also improved with MPR-R. This sub- analysis evaluated the impact of individual predictive factors on HRQoL. Patients completed HRQoL question naires at baseline , every third cycle and at progressive disease (PD)/treatment discontinuation . In a mixed-effects model female gender , advanced age and PD negatively affected HRQoL while better treatment responses showed positive effects . Compared to PD , HRQoL during MPR-R treatment was statistically significantly better in two of six preselected domains both of which were also clinical ly meaningful . HRQoL scores at end of treatment were all either improved or not statistically significantly different versus baseline . In conclusion , continuous treatment with MPR-R , which delays PD , appears to be associated with clinical ly meaningful improvements in Few studies have evaluated long-term health-related quality of life ( HRQL ) in patients during auto-SCT .  This prospect i ve study examined HRQL in 96 eligible patients before , during and up to 3 years after auto-SCT .  The aim of the study was to make a comprehensive assessment of the frequency and severity of different symptoms in patients undergoing auto-SCT .  The European Organization for Treatment and Research of Cancer Quality of Life Question naire ( EORTC QLQ C-30 ) was administered 13 times . The second week during treatment was the period when patients had the lowest HRQL regarding both total quality of life and function and symptom scales . The patients recovered quickly and just two months after transplantation the baseline values were restored . Three years after transplantation most of the items in the question naire had stabilized , except role function and dyspnea , which had improved . There were significant differences between multiple myeloma ( MM ) and lymphoma patients ’ physical function , quality of life , fatigue and pain during week 2 . At the 3-year follow-up , lymphoma patients indicated a better HRQL than MM patients . The quick recovery of patients after transplantation suggests that treatment is well tolerated ; however , the supportive care could be improved at week 2 , especially for the lymphoma patients BACKGROUND Few effective treatments exist for patients with refractory or relapsed and refractory multiple myeloma not responding to treatment with bortezomib and lenalidomide . Pomalidomide alone has shown limited efficacy in patients with relapsed multiple myeloma , but synergistic effects have been noted when combined with dexamethasone . We compared the efficacy and safety of pomalidomide plus low-dose dexamethasone with high-dose dexamethasone alone in these patients . METHODS This multicentre , open-label , r and omised phase 3 trial was undertaken in Australia , Canada , Europe , Russia , and the USA . Patients were eligible if they had been diagnosed with refractory or relapsed and refractory multiple myeloma , and had failed at least two previous treatments of bortezomib and lenalidomide .  They were assigned in a 2:1 ratio with a vali date d interactive voice and internet response system to either 28 day cycles of pomalidomide ( 4 mg/day on days 1 - 21 , orally ) plus low-dose dexamethasone ( 40 mg/day on days 1 , 8 , 15 , and 22 , orally ) or high-dose dexamethasone ( 40 mg/day on days 1 - 4 , 9 - 12 , and 17 - 20 , orally ) until disease progression or unacceptable toxicity . Stratification factors were age ( ≤75 years vs > 75 years ) , disease population ( refractory vs relapsed and refractory vs bortezomib intolerant ) , and number of previous treatments ( two vs more than two ) . The primary endpoint was progression-free survival ( PFS ) . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT01311687 , and with EudraCT , number 2010 - 019820 - 30 . FINDINGS The accrual for the study has been completed and the analyses are presented . 302 patients were r and omly assigned to receive pomalidomide plus low-dose dexamethasone and 153 high-dose dexamethasone . After a median follow-up of 10·0 months ( IQR 7·2 - 13·2 ) , median PFS with pomalidomide plus low-dose dexamethasone was 4·0 months ( 95 % CI 3·6 - 4·7 ) versus 1·9 months ( 1·9 - 2·2 ) with high-dose dexamethasone ( hazard ratio 0·48 [ 95 % CI 0·39 - 0·60 ] ; p<0·0001 ) . The most common grade 3 - 4 haematological adverse events  in the pomalidomide plus low-dose dexamethasone and high-dose dexamethasone groups were neutropenia ( 143 [ 48 % ] of 300 vs 24 [ 16 % ] of 150 , respectively ) , anaemia ( 99 [ 33 % ] vs 55 [ 37 % ] , respectively ) , and thrombocytopenia ( 67 [ 22 % ] vs 39 [ 26 % ] , respectively ) . Grade 3 - 4 non-haematological adverse events in the pomalidomide plus low-dose dexamethasone and high-dose dexamethasone groups included pneumonia ( 38 [ 13 % ] vs 12 [ 8 % ] , respectively ) , bone pain ( 21 [ 7 % ] vs seven [ 5 % ] , respectively ) , and fatigue ( 16 [ 5 % ] vs nine [ 6 % ] , respectively ) . There were 11 ( 4 % ) treatment-related adverse events leading to death in the pomalidomide plus low-dose dexamethasone group and seven ( 5 % ) in the high-dose dexamethasone group . INTERPRETATION Pomalidomide plus low-dose dexamethasone , an oral regimen , could be considered a new treatment option in patients with refractory or relapsed and refractory multiple myeloma . FUNDING Celgene Corporation BACKGROUND Health-related quality of life ( HRQoL ) is an important element for consideration in treatment decisions in patients with relapsed/refractory multiple myeloma ( RRMM ) . The pivotal MM-003 ( A Phase 3 , Multicenter , R and omized , Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone vs. High-Dose Dexamethasone in Patients With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study [ NIMBUS ] ) r and omized , open-label , multicenter , phase III trial demonstrated improved progression-free survival ( PFS ) and prolonged overall survival ( OS ) with pomalidomide ( POM ) plus low-dose dexamethasone ( POM + LoDEX ) versus high-dose dexamethasone ( HiDEX ) in patients with RRMM in whom lenalidomide ( LEN ) and bortezomib ( BORT ) had failed . MM-003 also investigated HRQoL as a predefined secondary end point . PATIENTS AND METHODS Recruited patients ( n = 455 ) were refractory to their last treatment and had failed LEN and BORT after ≥ 2 consecutive cycles of each ( alone or in combination ) . Eight clinical ly relevant and vali date d HRQoL domains from the European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-C30 , EORTC QLQ-MY20 , and EQ-5D question naires were selected for analysis . Time to symptom worsening based on minimally important differences ( MIDs ) was calculated . RESULTS Clinical ly meaningful improvements in HRQoL as determined by MIDs , regression analyses , and best response analyses were observed more frequently in patients receiving POM + LoDEX than in those receiving HiDEX . POM + LoDEX significantly extended median time to clinical ly meaningful worsening in HRQoL versus HiDEX in 4 HRQoL domains and demonstrated a trend in an additional 3 domains . Patients in the HiDEX arm experienced earlier HRQoL deterioration compared with those in the POM + LoDEX arm in each domain analyzed . CONCLUSION POM + LoDEX offer good clinical outcomes that lead to improved and prolonged HRQoL  compared with HiDEX in patients with RRMM and end-stage disease Purpose Measurement and reporting of health-related quality of life ( HRQL ) data have evolved considerably over the past 10 years . Our goal was to identify the current barriers to , and enablers of , the effective translation of HRQL outcome data from r and omized clinical trials by investigating physician attitudes , knowledge , and education needs . Methods We undertook a mixed qualitative and quantitative study of 33 oncologists ’ attitudes and educational needs around the value , interpretation , and application of  HRQL data from cancer clinical trials . The approach was design ed to identify barriers and enablers relating to the characteristics of the knowledge itself , to the potential users of the knowledge , and to the environment in which the knowledge is used . Results The majority of barriers and enablers identified were “ second order ” , i.e. , related to the underst and ability and generalizability of the data , its presentation , its accessibility within the medical literature , and its relevance to specific patient population s. Conclusions Our results suggest knowledge translation ( KT ) of HRQL results would improve if the clinical trial HRQL data were easily accessible to clinicians , and presented in a comprehensible and clinical ly applicable format , which includes discussion of the relevance of the measurement domains and implication s of the findings . We recommend that st and ards of clinical trial HRQL reporting be implemented in clinical journals Thalidomide with melphalan/prednisone ( MPT ) was defined as st and ard treatment in elderly patients with multiple myeloma ( MM ) based on five r and omized trials . In one of these trials , HOVON49 , a prospect i ve health-related quality -of-life ( HRQoL ) study was initiated in order to assess the impact of thalidomide on QoL. 
    Output:
    
Thus , evidence -based knowledge of HRQoL in patients with MM is compromised .