***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: BACKGROUND The comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen ( PSA ) testing remains uncertain . METHODS We compared active monitoring , radical prostatectomy , and external-beam radiotherapy for the treatment of clinical ly localized prostate cancer . Between 1999 and 2009 , a total of 82,429 men 50 to 69 years of age received a PSA test ; 2664 received a diagnosis of localized prostate cancer , and 1643 agreed to undergo r and omization to active monitoring ( 545 men ) , surgery ( 553 ) , or radiotherapy ( 545 ) . The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up . Secondary outcomes included the rates of disease progression , metastases , and all-cause deaths . RESULTS There were 17 prostate-cancer-specific deaths overall : 8 in the active-monitoring group ( 1.5 deaths per 1000 person-years ; 95 % confidence interval [ CI ] , 0.7 to 3.0 ) , 5 in the surgery group ( 0.9 per 1000 person-years ; 95 % CI , 0.4 to 2.2 ) , and 4 in the radiotherapy group ( 0.7 per 1000 person-years ; 95 % CI , 0.3 to 2.0 ) ; the difference among the groups was not significant ( P=0.48 for the overall comparison ) . In addition , no significant difference was seen among the groups in the number of deaths from any cause ( 169 deaths overall ; P=0.87 for the comparison among the three groups ) . Metastases developed in more men in the active-monitoring group ( 33 men ; 6.3 events per 1000 person-years ; 95 % CI , 4.5 to 8.8 ) than in the surgery group ( 13 men ; 2.4 per 1000 person-years ; 95 % CI , 1.4 to 4.2 ) or the radiotherapy group ( 16 men ; 3.0 per 1000 person-years ; 95 % CI , 1.9 to 4.9 ) ( P=0.004 for the overall comparison ) . Higher rates of disease progression were seen in the active-monitoring group ( 112 men ; 22.9 events per 1000 person-years ; 95 % CI , 19.0 to 27.5 ) than in the surgery group ( 46 men ; 8.9 events per 1000 person-years ; 95 % CI , 6.7 to 11.9 ) or the radiotherapy group ( 46 men ; 9.0 events per 1000 person-years ; 95 % CI , 6.7 to 12.0 ) ( P<0.001 for the overall comparison ) . CONCLUSIONS At a median of 10 years , prostate-cancer-specific mortality was low irrespective of the treatment assigned , with no significant difference among treatments . Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring . ( Funded by the National Institute for Health Research ; ProtecT Current Controlled Trials number , IS RCT N20141297 ; Clinical Trials.gov number , NCT02044172 . ) Background At an early stage , prostate cancer patients are often eligible for more than one treatment option , or may choose to defer curative treatment . Without a pre-existing superior option , a patient has to weigh his personal preferences against the risks and benefits of each alternative to select the most appropriate treatment . Given this context , in prostate cancer treatment decision-making , it is particularly suitable to follow the principles of shared decision-making ( SDM ) , especially with the support of specific instruments like decision aids ( DAs ) . Although several alternatives are available , present tools are not sufficiently compatible with routine clinical practice . To overcome existing barriers and to stimulate structural implementation of DAs and SDM in clinical practice , a web-based prostate cancer treatment DA was developed to fit clinical workflow . Following the structure of an existing DA , Dutch content was developed , and values clarification methods ( VCMs ) were added . The aim of this study is to investigate the effect of this DA on ( shared ) treatment choice and patient-reported outcomes . Methods / design Nineteen Dutch hospitals are included in a pragmatic , cluster r and omized controlled trial , with an intervention and a control arm . In the intervention group , the DA will be offered after diagnosis , and a summary of the patients ’ preferences , which were identified with the DA , can be discussed by the patient and his clinician during later consultation . Patients in the control group will receive information and decisional support as usual . Results from both groups on decisional conflict , treatment choice and the experience with involvement in the decision-making process are compared . Patients are requested to fill in question naires after treatment decision-making but before treatment is started , and 6 and 12 months later . This will allow the development of treatment satisfaction , decisional regret , and quality of life to be monitored . Clinicians from both groups will evaluate their practice of information provision and decisional support . Discussion This study will describe a web-based prostate cancer treatment DA with VCMs . The effect of this DA on the decision-making process and subsequent patient reported outcomes will be evaluated . Trial registration The Netherl and s National Trial Register : NTR4554 , registration date 1 May 2014 Objectives To describe the development , validation and inter-rater reliability of an instrument to measure the  quality of patient decision support technologies ( decision aids ) . Design Scale development study , involving construct , item and scale development , validation and reliability testing . Setting There has been increasing use of decision support technologies – adjuncts to the discussion s clinicians have with patients about difficult decisions . A global interest in developing these interventions exists among both for-profit and not-for-profit organisations . It is therefore essential to have internationally accepted st and ards to assess the quality of their development , process , content , potential bias and method of field testing and evaluation . Methods Scale development study , involving construct , item and scale development , validation and reliability testing . Participants Twenty-five research er-members of the International Patient Decision Aid St and ards Collaboration worked together to develop the instrument ( IPDASi ) . In the fourth Stage ( reliability study ) , eight raters assessed thirty r and omly selected decision support technologies . Results IPDASi measures quality in 10 dimensions , using 47 items , and provides an overall quality score ( scaled from 0 to 100 ) for each intervention . Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sample d ( n = 30 ) , enabling discrimination . The inter-rater intraclass correlation for the overall quality score was 0.80 . Correlations of dimension scores with the overall score were all positive ( 0.31 to 0.68 ) . Cronbach 's alpha values for the 8 raters ranged from 0.72 to 0.93 . Cronbach 's alphas based on the dimension means ranged from 0.50 to 0.81 , indicating that the dimensions , although well correlated , measure different aspects of decision support technology quality . A short version ( 19 items ) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 ( CI 0.79 to 0.92 ) . Conclusions This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies . The existing IPDASi provides an assessment of the quality of a DST 's components and will be used as a tool to provide formative advice to DSTs developers and summative assessment s for those who want to compare their tools against an existing benchmark OBJECTIVE The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate , vs. usual education alone , on conflict associated with decision making , plus explore time-to-treatment , and treatment choice . METHODS A r and omized , multi-center clinical trial was conducted with measures at baseline , 1- , and 6 months . Men with newly diagnosed localized prostate cancer ( CaP ) who sought consultation at urology , radiation oncology , or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited . Intervention group participants used the Personal Patient Profile-Prostate , a decision support system comprised of customized text and video coaching regarding potential outcomes , influential factors , and communication with care providers . The primary outcome , patient-reported decisional conflict , was evaluated over time using generalized estimating equations to fit generalized linear models . Additional outcomes , time-to-treatment , treatment choice , and program acceptability/usefulness , were explored . RESULTS A total of 494 eligible men were r and omized ( 266 intervention ; 228 control ) . The intervention reduced adjusted decisional conflict over time compared with the control group , for the uncertainty score ( estimate -3.61 ; ( confidence interval , -7.01 , 0.22 ) , and values clarity ( estimate -3.57 ; confidence interval ( -5.85,-1.30 ) . Borderline effect was seen for the total decisional conflict score ( estimate -1.75 ; confidence interval ( -3.61,0.11 ) . Time-to-treatment was comparable between groups , while undecided men in the intervention group chose brachytherapy more often than in the control group . Acceptability and usefulness were highly rated . CONCLUSION The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences Purpose To determine if particular values clarification exercises included in a patient decision aid had discernible impact on postdecisional regret in patients with early-stage prostate cancer . Methods A multicenter r and omized controlled trial compared 2 versions of a computerized patient decision aid : only structured information compared to the structured information plus values clarification exercises . Assessment s were conducted during the decision aid visit ; telephone follow-up interviews were conducted when patients made their decisions with their physician , 3 months after completing treatment , and > 1 year later ( per a mailing ) . Outcome measures included the Decisional Conflict Scale , the Preparation for Decision Making Scale , and the Decision Regret Scale . Results A total of 156 patients participated , 75 provided information only and 81 provided information plus values clarification exercises . The groups did not differ significantly on any outcome evaluated at the decision aid visit ; in both groups , decisional conflict decreased immediately after using the decision aid . Between-group differences emerged after the decision was actually made . The values clarification exercises group reported higher Preparation for Decision Making Scale scores at the decision follow-up and at the > 1-year follow-up . Regret did not differ significantly between groups at the 3-month follow-up but was lower for the values clarification exercises group than for the information group at the > 1-year follow-up . Conclusion The results suggest that the values clarification exercises led to better preparation for decision making and to less regret . The impact , however , only emerged after the decision was made Introduction Patient decision aids ( PDAs ) have been developed to help patients make an informed choice for a treatment option . Despite proven benefits , structural implementation falls short of expectations . The present study aims to assess the effectiveness and cost-utility of the PDA  among newly diagnosed patients with localised prostate cancer and their partners , alongside implementation of the PDA in routine care . Methods / analysis A stepped-wedge cluster r and omised trial will be conducted . The PDA will be sequentially implemented in 18 hospitals in the Netherl and s , over a period of 24 months . Every 3 or 6 months , a new cluster of hospitals will switch from usual care to care including a PDA . The primary outcome measure is decisional conflict experienced by the patient . Secondary outcomes comprise the patient ’s quality of life , treatment preferences , role in the decision making , expectations of treatment , knowledge , need for supportive care and decision regret . Furthermore , societal cost-utility will be valued . Other outcome measures considered are the partner ’s treatment preferences , experienced participation to decision making , quality of life , communication between patient , partner and health care professional , and the effect of prostate cancer on the relationship , social contacts and their role as caregiver .  Patients and partners receiving the PDA  will also be asked about their satisfaction with the  PDA .  Baseline assessment takes place after the treatment choice and before the start of a treatment , with follow-up assessment s at 3 , 6 and 12 months following the end of treatment or the day after deciding on active surveillance . Outcome measures on implementation include the implementation rate ( defined as the proportion of all eligible patients who will receive a PDA ) and a question naire for health care professionals on determinants of implementing an innovation . Ethics and dissemination This study will be conducted in accordance with local laws and regulations of the Medical Ethics Committee of VU University Medical Center , Amsterdam , The Netherl and s. The results from this stepped-wedge trial will be presented at scientific meetings and published in peer- review ed journals . Trial registration Nederl and s Trial Register NTR TC5177 , registration date : May 28th 2015.Pre- results Men diagnosed with early stage prostate cancer face multiple treatment options , each with distinctive side effects that have significant implication s for post-treatment quality of life .  Healing Choices for Men with Prostate Cancer is a multimedia educational and decision aid program . This nation-wide r and omized controlled trial evaluated the impact of Healing Choices on reducing decisional conflict and distress .  Eligible prostate cancer patients who called the National Cancer Institute 's Cancer Information Service ( CIS ) were invited to participate . After a baseline interview , participants were r and omized to usual personalized consultation with a CIS specialist ( comparison condition ) or CIS personalized consultation plus the Healing Choices program ( intervention condition ) . The Decision Conflict Scale and Impact of Event Scale assessed decisional conflict about pro 
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Crucially , substantial variations in use of CAs by DAs were identified : ( 1 ) few DAs used visual aids to communicate statistical information , ( 2 ) none were personalized in terms of outcome probabilities or mode of communication , ( 3 ) a minority used interactive methods to elicit patients ' values and preferences , ( 4 ) most included biased cross tables to compare treatment options , and ( 5 ) issues were observed in suitability and accessibility that could hinder implementation in clinical practice .
Our review suggests that DAs for LPC treatment could be further improved by adding CAs such as personalized outcome predictions and interaction methods to the DAs .