EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Hypofractionated Radiation Therapy for Localized Prostate Cancer: Executive Summary of an ASTRO, ASCO, and AUA Evidence-Based Guideline. Methods for Development of the European Commission Initiative on Breast Cancer Guidelines Guidelines for the diagnosis and treatment of hepatocellular carcinoma (HCC) in adults EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. More Informative Abstracts of Articles Describing Clinical Practice Guidelines Navigating healthcare: a qualitative study exploring prostate cancer patients' and doctors' experience of consultations using a decision-support intervention. Impact of a web-based treatment decision aid for early-stage prostate cancer on shared decision-making and health outcomes: study protocol for a randomized controlled trial A qualitative study evaluating experiences of a lifestyle intervention in men with prostate cancer undergoing androgen suppression therapy Presenting treatment options to men with clinically localized prostate cancer: the acceptability of active surveillance/monitoring. Implementing guidelines for cancer pain management: results of a randomized controlled clinical trial. Physician Communication Regarding Prostate Cancer Screening: Analysis of Unannounced Standardized Patient Visits The effect of using high facilitation when implementing the Gold Standards Framework in Care Homes programme: A cluster randomised controlled trial
CONTEXT The most recent summary of the European Association of Urology ( EAU ) guidelines on prostate cancer ( PCa ) was published in 2011 . OBJECTIVE To present a summary of the 2013 version of the EAU guidelines on screening , diagnosis , and local treatment with curative intent of clinical ly organ-confined PCa . EVIDENCE ACQUISITION A literature review of the new data emerging from 2011 to 2013 has been performed by the EAU PCa guideline group . The guidelines have been up date d , and levels of evidence and grade s of recommendation have been added to the text based on a systematic review of the literature , which included a search of online data bases and bibliographic review s. EVIDENCE SYNTHESIS A full version of the guidelines is available at the EAU office or online ( www.uroweb.org ) . Current evidence is insufficient to warrant widespread population -based screening by prostate-specific antigen ( PSA ) for PCa . Systematic prostate biopsies under ultrasound guidance and local anesthesia are the preferred diagnostic method . Active surveillance represents a viable option in men with low-risk PCa and a long life expectancy . A biopsy progression indicates the need for active intervention , whereas the role of PSA doubling time is controversial . In men with locally advanced PCa for whom local therapy is not m and atory , watchful waiting ( WW ) is a treatment alternative to and rogen-deprivation therapy ( ADT ) , with equivalent oncologic efficacy . Active treatment is recommended mostly for patients with localized disease and a long life expectancy , with radical prostatectomy ( RP ) shown to be superior to WW in prospect i ve r and omized trials . Nerve-sparing RP is the approach of choice in organ-confined disease , while neoadjuvant ADT provides no improvement in outcome variables . Radiation therapy should be performed with ≥ 74 Gy in low-risk PCa and 78 Gy in intermediate- or high-risk PCa . For locally advanced disease , adjuvant ADT for 3 yr results in superior rates for disease-specific and overall survival and is the treatment of choice . Follow-up after local therapy is largely based on PSA and a disease-specific history , with imaging indicated only when symptoms occur . CONCLUSIONS Knowledge in the field of PCa is rapidly changing . These EAU guidelines on PCa summarize the most recent findings and put them into clinical practice . PATIENT SUMMARY A summary is presented of the 2013 EAU guidelines on screening , diagnosis , and local treatment with curative intent of clinical ly organ-confined prostate cancer ( PCa ) . Screening continues to be done on an individual basis , in consultation with a physician . Diagnosis is by prostate biopsy . Active surveillance is an option in low-risk PCa and watchful waiting is an alternative to and rogen-deprivation therapy in locally advanced PCa not requiring immediate local treatment . Radical prostatectomy is the only surgical option . Radiation therapy can be external or delivered by way of prostate implants . Treatment follow-up is based on the PSA level 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 In December 2003 , the European Council identified best practice as key for ensuring development of high- quality cancer-screening programs . To support national policies on cancer control , the European Union institutions progressed several initiatives on cancer . The European Commission ( EC ) Initiative on Breast Cancer ( ECIBC ) is the most recent of these projects and the most implementation driven . Within this initiative , the European Guidelines for Breast Cancer Screening and Diagnosis ( in short , European Breast Guidelines ) are being developed ( http://ecibc.jrc.ec.europa.eu/ ) . Guidelines are approaches to generally improve prevention , diagnosis , treatment , and follow-up of diseases , overcoming inappropriate variations by providing recommendations for best care . The new era of guidelines promises recommendations that are based on the best available evidence summarized in systematic review s while providing the necessary flexibility needed to individualize decisions . The best methods for development of practice guidelines have experienced intense elaboration and attention during the past decades ( 17 ) . The impetus for this attention has been the change from expert- or consensus-based to evidence -based health care recommendations . Although this change in terminology should express the shift from un systematic development of guidelines to systematic and trustworthy recommendations , it is often misunderstood and misconstrued as meaning that experts are now meaningless in the process or as if consensus through discussion is a matter of the past . Neither is correct . Experts from various disciplines and consensus as a result of deliberation remain a mainstay of health care guideline development ( 810 ) . These experts are responsible for prioritization of questions that should be addressed in guidelines ; judgments that result from interpretation of evidence , including the rating of the certainty of the available evidence ; and decisions about how the judgments on the different criteria bear on recommendations . What has changed over time in guideline development are the rules , the structure and explicitness of the process , and the guideline product . Indeed , review s of guideline development methodology and how guidelines can be improved have led to more structured and documented processes that allow a reduction of bias and provide balanced views of appropriately composed guideline panels ( 2 , 5 , 6 ) . Core components for trustworthy guideline development ( 13 , 5 , 7 , 11 ) include that guidelines be developed by a knowledgeable , multidisciplinary panel of experts and representatives from key affected groups ; be based on a systematic review of the existing evidence ; consider important patient subgroups and patient preferences as appropriate ; be based on an explicit and transparent process that minimizes distortions , biases , and conflicts of interest ( 12 ) ; provide a clear explanation of the logical relationships between alternative care options and health outcomes and provide ratings of both the quality of evidence and the strength of the recommendations ( 1316 ) ; and be reconsidered and revised as appropriate when important new evidence warrants modifications . In addition , greater transparency in linking the considered research evidence and the recommendations , as well as the requirement of making structured expert judgments , represents a shift in the guideline development paradigm ( 5 , 11 , 1719 ) . At the same time , developing guidelines for a large number of member states and those that aim to adapt the guidelines poses challenges , such as the feasibility of implementing strategies that may exist in some member countries but not others ( for example , organized population -based screening in Italy but not Greece ) . Addressing these challenges requires considerations that extend beyond strictly clinical efforts in guideline development and mastering the many factors that influence recommendations and their implementation . This article describes the rationale , methods , and processes the ECIBC has adopted to develop the European Breast Guidelines in the context of evolving international st and ards . It also describes an innovative approach to presenting , disseminating , and accelerating implementation of recommendations . Guideline Methodology and Development To adhere to the core requirements for guideline development , the EC has taken several steps . First , it selected , via an open call ( https://ecibc.jrc.ec.europa.eu/ guidelines -team ) , a panel with broad representation of expertise , knowledge , and background , which includes patients , health care professionals , epidemiologists , guideline method ologists , and others ( Appendix ) . These individuals voluntarily participate in the ECIBC and compose the guidelines development group ( GDG ) . Second , it ensured that all recommendations were supported by systematic review s of the evidence conducted by independent scientists from Cochrane Iberoamricathe systematic review team (SRT)following st and ard Cochrane Collaboration methods ( 20 , 21 ) . Third , because this is a women-centered initiative , we included women advocates in the GDG as full voting guideline group members . We separately considered important subgroups of women during recommendation development ( for example , different age groups ) , and we specifically focused on evidence that supports best ways of communicating this information to women to inform their decisions . Fourth , we applied EC conflict of interest rules ( http://ecibc.jrc.ec.europa.eu/rules ) , which are consistent with international recommendations , and used GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) Evidence to Decision ( EtD ) frameworks to minimize the influence of competing interests on the recommendations ( 12 , 17 , 18 ) . These EtD frameworks help guideline panels use evidence in a structured , transparent way to inform decisions with a series of criteria , such as anticipated harms and benefits of the options considered , the certainty of the evidence for those effects , and the costs and feasibility of the options , to help them reach their decision . Fifth , using the GRADE approach to guideline development and its EtD frameworks , we focused our questions and recommendations on outcomes that matter to women and provided a rating of the certainty or quality of evidence and the strength of recommendations that is widely accepted as the reference st and ard ( Figures 1 and 2 ) . Sixth , our evidence review s are up to date when the recommendations are formulated , and we engage in international stakeholder feedback to ensure that recommendations remain timely and relevant to public health and clinical practice . The ECIBC is committed to review ing and updating the recommendations as required when new evidence becomes available . The general process is explained in Figure 3 and is based on the Guidelines International NetworkMcMaster Guideline Development Checklist ( https://hei grade .mcmaster.ca/ guideline -development/using-checklist ) ( 5 ) . Figure 1 . According to GRADE , certainty , quality , strength of evidence , or confidence in the estimate of effect is determined on the basis of a systematic review of the evidence for each outcome ( based on the domains risk of bias , indirectness , imprecision , inconsistency , and publication bias that lower certainty and , usually only for nonr and omized studies , large effects , doseresponse relations and opposing plausible residual confounding that may increase the certainty ) . For recommendations , the overall certainty is determined across outcomes based on the lowest certainty outcome among those critical for decision making for the specific context . The guidelines development group applies the GRADE Evidence -to-Decision frameworks to make recommendations that are made available on the European Commission Web site . ( Reproduced from reference 15 , with permission from Schnemann HJ . ) . GRADE = Grading of Recommendations Assessment , Development and Evaluation . Figure 2 . GRADE EtD frameworks . The GRADE EtD frameworks as available in the GRADE pro software ( www . grade pro.org ) . They help with structuring the entire guideline process into 4 sections and support the conduct of guideline group meetings , presentation , and implementation . They clarify the perspective that is taken by the guideline panel or decision maker and the type of question that is asked in the question section . The section on assessment includes the criteria if the problem is a priority , the balance of health benefits and harms , values and preferences related to the outcomes , cost , re sources and cost-effectiveness , equity , acceptability , and feasibility . Conclusions provide the decision or recommendation with a justification and implementation , as well as research considerations . The presentation function supports the conduct of guideline group meetings and facilitates the output of EtD frameworks to other implementation tools , such as Web sites , h and -held apps , and interactive decision aids . EtD = Evidence to Decision ; GRADE = Grading of Recommendations Assessment , Development and Evaluation ; HTA = health technology assessment ; PICO = population , intervention , comparators , and outcomes . Figure 3 . Approach to guideline development used by the European Commission Initiative on Breast Cancer . The European Commission JRC has oversight of the organization , budgeting , planning , and training . The JRC also manages conflicts of interest , documents all aspects of the work , and manages the membership and group processes . The guideline development group and JRC formulate the questions and work with the systematic review team on identifying and assessing the evidence . The guidelines development group is responsible for developing the recommendations . The JRC is responsible for most other aspects as described in the figure under dissemination , implementation , and updating . JRC = Joint Research Centre ; PICO = population , intervention , comparator , and outcomes . ( Reproduced with adaptation to the JRC process from This document , on the diagnosis and treatment of patients with hepatocellular carcinoma ( HCC ) , was commissioned by the British Society of Gastroenterology as part of a wider initiative to develop guidelines for clinicians in several areas of clinical practice . Cancer care has been the subject of increased scrutiny , with the development of care guidelines forming a major part of the strategy to reduce cancer related mortality in the UK . There is a strong suggestion that HCC is a disease which will be seen more frequently over the next few years , mainly as a result of the hepatitis C virus ( HCV ) epidemic . Previously , HCC has been a relatively rare tumour in the UK and much of the data pertaining to its diagnosis and therapy are derived from studies outside of the UK . Because of the lack of screening programmes and the fact that a significant proportion of HCC presents as symptomatic disease in individuals not known to have liver disease , most non-surgical therapies have been used in patients with advanced disease . There are a significant number of variables known to influence prognosis , with stage of underlying liver disease and tumour size at presentation being the most important . Controlling for these variables is difficult and these factors have contributed to a dearth of r and omised controlled trials of treatment for this tumour . There is however a substantial amount of evidence available which can form the basis of a framework for diagnosis and management . Guidelines are not rigid protocol s and they should not be construed as interfering with local clinical judgement . Hence they do not represent a directive of proscribed routes but a basis on which clinicians can consider the options available more clearly . These guidelines cover two areas of clinical practice relating to HCC : firstly , its diagnosis , including surveillance of high risk individuals ; and OBJECTIVE Our aim was to present a summary of the 2010 version of the European Association of Urology ( EAU ) guidelines on the screening , diagnosis , and treatment of clinical ly localised cancer of the prostate ( PCa ) . METHODS The working panel performed a literature review of the new data emerging from 2007 to 2010 . The guidelines were up date d , and level of evidence and grade of recommendation were added to the text based on a systematic review of the literature , which included a search of online data bases and bibliographic review s. RESULTS A full version is available at the EAU office or Web site ( www.uroweb.org ) . Current evidence is insufficient to warrant widespread population -based screening by prostate-specific antigen ( PSA ) for PCa . A systematic prostate biopsy under ultrasound guidance and local anaesthesia is the preferred diagnostic method . Active surveillance represents a viable option in men with low-risk PCa and a long life expectancy .  PSA doubling time in <3 yr or a biopsy progression indicates the need for active intervention . In men with locally advanced PCa in whom local therapy is not m and atory , watchful waiting ( WW ) is a treatment alternative to and rogen-deprivation therapy ( ADT ) with equivalent oncologic efficacy . Active treatment is mostly recommended for patients with localised disease and a long life expectancy with radical prostatectomy ( RP ) shown to be superior to WW in a prospect i ve r and omised trial . Nerve-sparing RP represents the approach of choice in organ-confined disease ; neoadjuvant and rogen deprivation demonstrates no improvement of outcome variables . Radiation therapy should be performed with at least 74 Gy and 78 Gy in low-risk and intermediate/high-risk PCa , respectively . For locally advanced disease , adjuvant ADT for 3 yr results in superior disease-specific and overall survival rates and represents the treatment of choice . Follow-up after local therapy is largely based on PSA , and a disease-specific history with imaging is indicated only when symptoms occur . CONCLUSIONS The knowledge in the field of PCa is rapidly changing . These EAU guidelines on PCa summarise the most recent findings and put them into clinical practice Patients hope that their doctors will correctly identify health problems , clearly articulate sensible options for managing each problem , wisely interpret the best available evidence about probable outcomes associated with each option , sensitively solicit patient preferences for each outcome , and thereby implement practice s that are likely to achieve the results patients care about . Groups of patients hope that doctors will work to prevent , detect , and treat health problems in a way that maximizes the public good achieved with available health care re sources . To meet these dual expectations , doctors face forbidding tasks of clinical decision making . Improved methods for preparing , appraising , and abstract ing overviews of available evidence about a clinical topic can bring a broader range of high- quality information within the busy practitioner 's grasp [ 1 - 4 ] . However , even well- design ed overviews often do not synthesize information about benefits , harms , and costs of medical practice s in a way that facilitates clinical decision making . Clinical practice guidelines have been defined as systematic ally developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances [ 5 ] . Guidelines that are based on sound scientific evidence , and a trustworthy process for judging the value of alternative practice s , could help physicians deal with the information overload they face . Existing practice guidelines , however , vary widely in their quality , and clinicians should carefully consider the validity and applicability of each guideline they read . We propose a structured format for abstract s of articles describing practice guidelines that is based on emerging principles of guideline development and evaluation [ 6 - 13 ] . The proposal is design ed to help readers obtain the key information needed to assess the applicability , importance , and validity of any guideline . The proposed structure for more informative abstract s of articles describing clinical practice guidelines has been review ed and pilot-tested by guideline developers , evaluators , and implementors and by groups of practicing clinicians . Early versions of the proposal were sent to consultants at the National Library of Medicine , the Institute of Medicine , the American College of Physicians ( ACP ) , and the Agency for Health Care Policy and Research . Subsequent versions of the proposal were pilot tested on various published guidelines and were assessed by selected health care organizations for applicability to guidelines under development . An improved proposal was sent to 82 persons active in guideline development , evaluation , and implementation . The Internal Medicine Center to Advance Research and Education circulated the proposal to volunteer practitioners , and the authors solicited feedback from physician and health administrator participants at three national workshops about practice guidelines . The proposal that follows represents an integration of the collective wisdom of our external review ers . ( A glossary of terms used in articles on clinical practice guidelines is supplied in the Appendix . ) Proposed Structure and Content for Abstract s of Articles Describing Clinical Practice Guidelines The proposed structure for abstract s of papers describing clinical practice guidelines is summarized in Table 1 . Key elements of the guideline development process are captured with statements about the principal objective and target of the guideline , the main practice options and outcomes that were considered , the nature of the evidence and values that were analyzed , the main benefits and harms expected from guideline implementation , the key recommendations , and a statement of whether the recommendations have been tested and by whom they have been endorsed . If details about guideline development methods or supporting evidence are published separately , then the abstract should indicate the existence of supporting documents and the most relevant parts of those should be summarized in the abstract . To be included in their entirety in the online bibliographic data bases of the National Library of Medicine , structured abstract s of clinical practice guidelines should not exceed 4096 characters ( approximately 500 words ) in length . Individual journals may have different requirements . Table 1 . Proposed Format for Structured Abstract s of Clinical Practice Guidelines Objective The abstract should state the objective of the guideline by identifying the targeted health problem , the targeted patients and physicians , and the main reason or reasons for developing new recommendations concerning this problem for this population . For guidelines primarily concerned with the management of health conditions , the stage of illness and intent to prevent , diagnose , treat , or palliate the disorder should be specified . For guidelines primarily concerned with health procedures , an intervention and its role in patient management should be defined . Targeted providers , setting s , and patients should be specified so that readers can tell who should do what , where it should be done , and to whom . A statement of objective also may specify why a new guideline is needed and how it should be used . Practice guidelines may be written to clarify or resolve clinical controversies , to communicate important new findings from clinical studies , or to promote more effective , efficient , or consistent physician practice s at less cost or risk to patients . Guidelines may be used concurrently to help physicians and patients make choices ( for example , clinical algorithms ) , retrospectively to compare physician choices to pre-established criteria ( for example , utilization review ) , or prospect ively to set limits on physician choices ( for example , preprocedure approval ) . Options Clinical practice guidelines pertain to clinical decisions . The nature of those decisions should be made explicit by disclosing the main management options considered . The abstract should list principal alternative preventive , diagnostic , or therapeutic strategies available to targeted clinicians and patients . Outcomes The abstract also should specify which health outcomes , such as death , morbidity , quality of life , economic costs , or changes in the process of health care were considered . Evidence To estimate the probable effect of a health intervention on an outcome , relevant data must be defined , gathered , and appraised . Readers need to know what kind of evidence was considered and what methods were used to select and combine evidence from different sources . Potential sources of evidence about clinical outcomes include the results of clinical studies ( published or unpublished ) , expert opinion , information contained in public or private health data bases , and direct input from patients or providers . Potential sources of evidence about economic outcomes include the results of cost-effectiveness studies , various fee schedules , and information contained in public or private health cl aims data bases . Potential methods of gathering evidence include computerized search es for articles that satisfy predetermined criteria , review s of bibliographies of relevant articles , and surveys of relevant persons or organizations [ 1 ] . The abstract should state whether explicit methods were used to combine results from scientific studies ( for example , meta- analysis ) or opinions of experts ( for example , Delphi technique ) [ 14 , 15 ] . The abstract may also indicate whether specific criteria were used to gauge the quality of information from different sources [ 16 , 17 ] . Scientific evidence regarding the likelihood of certain outcomes is often missing or conflicting . It is desirable for the strength of evidence supporting a guideline to be gauged in some way [ 16 ] . If gaps in the evidence were bridged formally ( for example , through use of decision- analysis models ) or informally ( for example , best guess of clinical experts ) , then major assumptions or areas of uncertainty should be acknowledged [ 11 ] . Because of the extraordinary time required to properly assemble and review evidence and then to achieve consensus about practice recommendations , the abstract of a practice guideline should specify the publication date s of the most recent evidence considered . If a sensitivity analysis was performed , then any major vulnerability of the guideline to weaknesses in the evidence should be acknowledged . These considerations may be summarized by qualifying a guideline as provisional by specifying date s for expiration or review , by listing studies in progress that could affect the guideline , or by identifying key research priorities . Values The declaration of a recommended practice presumes an implicit or explicit process for judging the relative desirability of the health , economic , and process outcomes associated with alternative practice s. These are matters of opinion and value . For example , in developing guidelines for breast cancer screening , it is necessary to weigh the value of preventing a death from breast cancer against the value of avoiding unnecessary harm or anxiety in women who do not have breast cancer . A high value placed on maximizing detection of asymptomatic malignancy may motivate an organization to recommend teaching self-examination of breasts to young women [ 18 ] . A relatively greater value placed on avoiding false-positive results may motivate others to not promote such programs [ 19 ] . Consequently , the principal sources of such values and the method by which judgments were made should be reported in guideline abstract s. At a minimum , the abstract should identify the major groups that participated in the process of assigning values to outcomes ( for example , generalist or specialist physicians , other health care providers , insurers , representatives of health organizations , and special-interest groups ) and whether patient preferences were represented . The abstract may also indicate the method used to synthesize opinions from BACKGROUND Men with prostate cancer face preference-sensitive decisions when choosing among treatments with similar survival outcomes but different procedures , risks and potential complications . A decision-support intervention , ' Decision Navigation ' assists men with prostate cancer to prepare a question list ( consultation plan ) for their doctors and provides them with a consultation summary and audio recording . A r and omised controlled trial of Decision Navigation showed advantages over usual care on quantitative measures including confidence in decision-making and regret . OBJECTIVE The aim of this study was to gain a qualitative underst and ing of patient 's and doctor 's perspectives on Decision Navigation . METHODS Six patients who received Decision Navigation were purposively selected for interview out of 62 r and omised controlled trial participants . All four doctors who consulted Navigated patients were interviewed . Interview data was analysed using framework analysis . RESULTS Patients reported that planning for the consultation helped them to frame their questions , enabling them to participate in consultations and take responsibility for making decisions . They reported feeling more confident in the decisions made , having a written report of the key information and an audio recording . Patients considered routine information relating to side effects was inadequate . Doctors reported that consultation plans made them aware of patients ' concerns and ensured comprehensive responses to questions posed . Doctors also endorsed implementing Decision Navigation as part of routine care . CONCLUSION Results suggest that Decision Navigation facilitated patients ' involvement in treatment decision-making . Prostate patients engaging in preference-sensitive decision-making welcomed this approach to personalised tailored support 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 Background The severe iatrogenic hypogonadal state induced by medical castration used for treatment of prostate cancer is associated with adverse effects including fatigue , increased fracture risk , and a decrease in skeletal muscle function , which negatively impact quality of life . We have previously reported beneficial changes in healthy lifestyle behaviors , physical function and fatigue as a result of a novel combined exercise and dietary advice intervention ( a lifestyle intervention ) in men with prostate cancer on and rogen suppression therapy ( AST ) . The aim of this research was to conduct a qualitative evaluation of the lifestyle intervention in these men with advanced prostate cancer receiving and rogen suppression therapy ( AST ) . Methods Twelve men with prostate cancer on AST took part in three focus groups in a UK higher education institution following the 12 week intervention . Sessions lasted between 45 and 60 minutes in duration . All discussion s were audio-taped and transcribed . A framework analysis approach was applied to the focus group data . An initial coding framework was developed from a priori issues listed in the topic guide and extended and refined following initial familiarization with the focus group transcripts . Line by line indexing of the transcripts was undertaken iteratively to allow for the incorporation of new codes . Coded sections of text were grouped together ( charted ) into themes and subthemes prior to a further process of comparison and interpretation . Results None of the participants involved in the trial were provided with information on how lifestyle changes might be beneficial to men with prostate cancer during the course of their st and ard medical treatment . We present novel findings that this intervention was considered beneficial for reducing anxiety around treatment and fear of disease progression . Men were supportive of the benefits of the intervention over conventional cancer survival discussion group arrangements as it facilitated peer support in addition to physical rehabilitation . Conclusions The benefits of lifestyle changes in men with prostate cancer are not well appreciated by care providers despite a range of benefits becoming apparent . Strategies to implement exercise and dietary interventions in st and ard care should be further evaluated . Trial registration Current Controlled Trials IS RCT Presenting treatment options to men with localized prostate cancer is difficult because of the lack of definitive evidence and the range of treatment options available . Active surveillance and monitoring programs are now a recognized treatment option for men with low-risk localized prostate cancer , but many patients are not fully aware of the details of such programs , and most still opt for immediate radical ( surgery or radiotherapy ) treatment . The provision of high- quality information with decision aids has been shown to increase the acceptability of active surveillance/monitoring programs . This chapter outlines techniques for providing high- quality information about active surveillance/monitoring , based on the findings of a r and omized controlled trial of treatments for localized prostate cancer . The ProtecT ( Prostate testing for cancer and Treatment ) trial has r and omized over 1500 men between active monitoring , radical surgery , and radical radiotherapy by ensuring that information was tailored to men 's existing knowledge and views . Care was taken with the content , order , and enthusiasm of the presentation of treatments by recruitment staff , and clinicians and other health professionals were supported to feel comfortable with being open about the uncertainties in the evidence and helped to rephrase terminology likely to be misinterpreted by patients . These techniques of information provision should be added to the use of decision aids to enable patients diagnosed with clinical ly localized prostate cancer in routine practice to reach well-informed and reasoned decisions about their treatment , including full consideration of active surveillance and monitoring programs PURPOSE  Pain and symptom management  is an integral part of the clinical practice of oncology . A number of guidelines have been developed to assist the clinician in optimizing comfort care . We implemented clinical guidelines for cancer pain management in the community setting and evaluated whether these guidelines improved care . PATIENTS AND METHODS Eighty-one cancer patients , aged 37 to 76 years , were enrolled onto a prospect i ve , longitudinal , r and omized controlled study from the outpatient clinic setting s of 26 western Washington-area medical oncologists . A multilevel treatment algorithm based on the Agency for Health Care Policy and Research Guidelines for Cancer Pain Management was compared with st and ard- practice ( control ) pain and symptom management therapies used by community oncologists . The primary outcome of interest was pain ( Brief Pain Inventory ) ; secondary outcomes of interest were all other symptoms ( Memorial Symptom Assessment Scale ) and quality of life ( Functional Assessment of Cancer Therapy Scale ) . RESULTS Patients r and omized to the pain algorithm group achieved a statistically significant reduction in usual pain intensity , measured as slope scores , when compared with st and ard community practice ( P < .02 ) . Concurrent chemotherapy and patient adherence to treatment were significant mediators of worst pain . There were no significant differences in other symptoms or quality of life between the two treatment groups . CONCLUSION This guideline implementation study supports the use of algorithmic decision making in the management of cancer pain . These findings suggest that comprehensive pain assessment and evidence -based analgesic decision-making processes do enhance usual pain outcomes PURPOSE Prostate cancer screening with prostate-specific antigen ( PSA ) is a controversial issue . The present study aim ed to explore physician behaviors during an unannounced st and ardized patient encounter that was part of a r and omized controlled trial to educate physicians using a  prostate cancer screening , interactive , Web-based module . METHODS Participants included 118 internal medicine and family medicine physicians from 5 health systems in California , in 2007–2008 . Control physicians received usual education about prostate cancer screening ( brochures from the Center for Disease Control and Prevention ) . Intervention physicians participated in the prostate cancer screening module . Within 3 months , all physicians saw unannounced st and ardized patients who prompted prostate cancer screening discussion s in clinic . The encounter was audio-recorded , and the recordings were transcribed . Authors analyzed physician behaviors around screening : ( 1 ) engagement after prompting , ( 2 ) degree of shared decision making , and ( 3 ) final recommendations for prostate cancer screening . RESULTS After prompting , 90 % of physicians discussed prostate cancer screening . In comparison with control physicians , intervention physicians showed somewhat more shared decision making behaviors ( intervention 14 items vs control 11 items , P < .05 ) , were more likely to mention no screening as an option ( intervention 63 % vs control 26 % , P < .05 ) , to encourage patients to consider different screening options ( intervention 62 % vs control 39 % , P < .05 ) and seeking input from others ( intervention 25 % vs control 7 % , P<.05 ) . CONCLUSIONS A brief Web-based interactive educational intervention can improve shared decision making , neutrality in recommendation , and reduce PSA test ordering . Engaging patients in discussion of the uses and limitations of tests with uncertain value can decrease utilization of the tests Background : The provision of quality end-of-life care is increasingly on the national agenda in many countries . In the United Kingdom , the Gold St and ards Framework for Care Homes programme has been promoted as a national framework for improving end-of-life care . While its implementation is recommended , there are no national guidelines for facilitators to follow to undertake this role . Aim : It was hypothesised that action learning alongside high facilitation when implementing the Gold St and ards Framework for Care Homes programme will result in a reduced proportion of hospital deaths for residents and improvement in the care home staff ability to facilitate good end-of-life care . Design : A cluster r and omised controlled trial where 24 nursing homes received high facilitation to enable them to implement the Gold St and ards Framework for Care Homes programme . The managers of 12 nursing homes additionally took part in action learning sets . A third group ( 14 nursing homes ) received the ‘ st and ard ’ Gold St and ards Framework for Care Homes facilitation available in their locality . Setting / participants : In total , 38 nursing homes providing care for frail older people , their deceased residents and their nurse managers . Results : A greater proportion of residents died in those nursing homes receiving high facilitation and action learning but not significantly so . There was a significant association between the level of facilitation and nursing homes completing the Gold St and ards Framework for Care Homes programme through to accreditation . Year-on-year change occurred across all outcome measures . Conclusion : There is a danger that without national guidelines , facilitation of the Gold St and ards Framework for Care Homes programme will vary and consequently so will its implementation . The nurse manager of a care home must be actively engaged when implementing the Gold St and ards Framework for Care Homes programme
Results The AUA ( American Urological Association ) , ASTRO , and SUO ( Society of Urologic Oncology ) formulated an evidence ‐based guideline based on a risk stratified clinical framework for the management of localized prostate cancer .
Purpose This guideline is structured to provide a clinical framework stratified by cancer severity to facilitate care decisions and guide the specifics of implementing the selected management options .
The summary presented represents Part I of the two‐part series dedicated to Clinical ly Localized Prostate Cancer : AUA/ASTRO/SUO Guideline discussing risk stratification and care options by cancer severity .