scholarly journals ReIMAGINE: a prostate cancer research consortium with added value through its patient and public involvement and engagement

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
S. Green ◽  
S. Tuck ◽  
J. Long ◽  
T. Green ◽  
A. Green ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Stratification ◽  
Public Involvement ◽  
Specific Antigen ◽  
Patient And Public Involvement ◽  
Imaging Biomarkers ◽  
List Type ◽  
The Public ◽  
Research Engagement ◽  
The Impact

Abstract Background ReIMAGINE aims to improve the current prostate specific antigen (PSA)/biopsy risk stratification for prostate cancer (PCa) and develop a new image-based method (with biomarkers) for diagnosing high/low risk PCa in men. ReIMAGINE’s varied patient and public involvement (PPI) and engagement (PE) strategy maximises the impact of its scientific output by informing and shaping the different stages of research. Aims Through including the voice of patients and the public, the ReIMAGINE Consortium aims to translate these different perspectives into the design and implementation process. This will improve the overall quality of the research by: reflecting the needs and priorities of patients and the public, ensuring methods and procedures are feasible and appropriate ensuring information is relevant and accessible to those being recruited to the study identifying dissemination channels relevant to patients/the public and developing outputs that are accessible to a lay audience With support from our patient/user groups, the ReIMAGINE Consortium aims to improve our ability to derive prognostic information and allocate men to the most appropriate and effective therapies, using a novel image-based risk stratification with investigation of non-imaging biomarkers. Findings We have been working with patients and the public from initiation of the project to ensure that the research is relevant to men and their families. Our PPI Sub-Committee, led by a PCa patient, has been involved in our dissemination strategy, outreach activities, and study design recommendations. For example, the sub-committee have developed a variety of informative videos relevant and accessible to those being recruited, and organised multiple online research engagement events that are accessible to a lay audience. As quoted by one of the study participants, “the more we present the benefits and opportunities to patients and the public, the more research commitment we obtain, and the sooner critical clinical questions such as PCa diagnostics will be addressed”.

scholarly journals Evaluation of a patient and public involvement training programme for researchers at a large biomedical research centre in the UK

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e047995
Author(s):  
Rosamund Yu ◽  
Bec Hanley ◽  
Simon Denegri ◽  
Jaber Ahmed ◽  
Nicholas J McNally
Keyword(s):  
Biomedical Research ◽  
Public Involvement ◽  
Good Practice ◽  
Training Programme ◽  
Patient And Public Involvement ◽  
Research Centre ◽  
Major Research ◽  
The Public ◽  
The Uk ◽  
The Impact

ObjectivesTo design, deliver and evaluate a programme of training workshops for biomedical researchers aimed at building confidence and skills in actively involving patients and the public (PPI) in research.DesignA bespoke programme of training workshops in PPI aimed at researchers.SettingA large National Institute for Health Research Biomedical Research Centre in London and several partner organisations.Participants721 scientists, clinicians and research managers attending dedicated training in PPI at a major London NHS (National Health Service)–university partnership.InterventionsA programme of 72 training workshops, designed to build practical skills and confidence for researchers working with patients and the public in research, was delivered at a major research-active NHS:university partnership. An iterative approach was taken to the programme, with the content of the workshops continually reviewed and refreshed to respond to the needs of researchers. Surveys before, immediately following and 6 months after training investigated the impact on researchers’ confidence and skills in PPI work, and the kind of PPI they subsequently carried out.ResultsTraining brought about immediate marked increases in researchers’ self-reported confidence to carry out PPI activities within their research, and in their knowledge of good practice. The evaluation indicates that workshop attendees were more likely to involve patients in their research following training. Researchers tended to involve patients and the public in a range of areas, including input to study design and patient information, in particular.ConclusionsWhen positioned within a broader organisational strategy for PPI in research, such training has an important role to play in progressing PPI in a major research partnership. Training appeared to provide the confidence needed to carry out PPI which enabled further development of confidence and skills. Involving researchers who have attended the training in the ongoing development of the programme and bringing in patients to the training programme are key next steps.

Patient and Public Involvement in Clinical Practice Guidelines

2011 ◽  
Vol 31 (6) ◽  
pp. E45-E74 ◽  
Author(s):  
France Légaré ◽  
Antoine Boivin ◽  
Trudy van der Weijden ◽  
Christine Pakenham ◽  
Jako Burgers ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Literature Review ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Public Involvement ◽  
The United States ◽  
Patient And Public Involvement ◽  
Bibliographic Databases ◽  
The Public ◽  
The Impact

Background. The role of patient and public involvement programs (PPIPs) in developing and implementing clinical practice guidelines (CPGs) has generated great interest. Purpose. The authors sought to identify key components of PPIPs used in developing and implementing CPGs. Data sources. The authors searched bibliographic databases and contacted relevant organizations. Study selection. In total, 2161 articles and reports were retrieved on PPIPs in the development and implementation of CPGs. Of these, 71 qualified for inclusion in the review. Data extraction. Reviewers independently extracted data on key components of PPIPs and barriers and facilitators to their operation. Data synthesis. Over half of the studies were published after 2002, and more than half originated from the United States, the United Kingdom, Australia, and Germany. CPGs that involved patients and the public addressed a variety of health problems, especially mental health and cancer. The most frequently cited objective for using PPIPs in developing CPGs was to incorporate patients’ values or perspectives in CPG recommendations. Patients and their families and caregivers were the parties most often involved. Methods used to recruit PPIP participants included soliciting through patient/public organizations, sending invitations, and receiving referrals and recruits from clinicians. Patients and the public most often participated by taking part in a CPG working group, workshop, meeting, seminar, literature review, or consultation such as a focus group, individual interview, or survey. Patients and the public principally helped formulate recommendations and revise drafts. Limitations. The authors did not contact the authors of the studies. Conclusion. This literature review provides an extensive knowledge base for making PPIPs more effective when developing and implementing CPGs. More research is needed to assess the impact of PPIPs and resources they require.

VP02 Involving Patients In HTA Beyond 2020: A Thematic Review

2019 ◽  
Vol 35 (S1) ◽  
pp. 75-76
Author(s):  
Heidi Livingstone ◽  
Xia Li ◽  
Gillian Leng ◽  
Victoria Thomas
Keyword(s):  
Qualitative Data ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Feedback Mechanism ◽  
The Public ◽  
Positive Attitudes ◽  
Thematic Review ◽  
The Impact ◽  
Stock Of Knowledge ◽  
And Training

IntroductionInvolving patients and the public in the health technology assessment (HTA) is crucial and a key part of the NICE patient and public involvement (PPI) policy. To advance the development of our PPI policy in HTA and build capacity for 2020 and beyond, we took stock of knowledge on stakeholders’ views of involving this cohort in HTA.MethodsWe carried out a thematic review of the existing evidence on the involvement of patients and the public in HTA, including: technology appraisals consultation 2017 (110 comments): technology appraisals consultation 2018 (205 comments); and PIP review consultation 2017 with a CHTE focus (162 comments). We used Thomas and Harden's (2008) thematic synthesis to code the data ‘line-by-line’, to develop ‘descriptive themes’, and then to generate ‘analytical themes’. This was followed by using Patton's (1999) triangulation of qualitative data sources to further challenge and refine the emergent themes.ResultsWe identified three themes, namely (i) earlier and full engagement, (ii) simpler and easier engagement, and (iii) patient evidence. Respondents emphasised the significance of involving patients earlier and throughout the process of developing every appraisal to enable them to gain a greater sense of participation and ownership. Respondents also expressed a strong view of making it simpler and easier for patients to engage in the process through various methods, e.g., standardising the approaches, and support and training. Finally, respondents expressed their positive attitudes toward using patient evidence in HTA, clarifying how patient evidence is captured and used, and offering a clear feedback mechanism to the impact of patient evidence on decision-making.ConclusionsThis review highlighted the significance of earlier and full engagement with people, making it simpler and easier for people to work with us, and being clearer about how we use patient evidence with a clearer feedback mechanism as to the impact of their input on the final decisions.

scholarly journals Tissue-Based Biomarkers for the Risk Stratification of Men With Clinically Localized Prostate Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Spyridon P. Basourakos ◽  
Michael Tzeng ◽  
Patrick J. Lewicki ◽  
Krishnan Patel ◽  
Bashir Al Hussein Al Awamlh ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Stratification ◽  
Care Pathway ◽  
Clinical Stage ◽  
Specific Antigen ◽  
Localized Prostate Cancer ◽  
Oncologic Outcomes ◽  
Prognostic Information ◽  
Grade Group ◽  
The Impact

Risk stratification of men with clinically localized prostate cancer has historically relied on basic clinicopathologic parameters such as prostate specific antigen level, grade group, and clinical stage. However, prostate cancer often behaves in ways that cannot be accurately predicted by these parameters. Thus, recent efforts have focused on developing tissue-based genomic tests that provide greater insights into the risk of a given patient’s disease. Multiple tests are now commercially available and provide additional prognostic information at various stages of the care pathway for prostate cancer. Indeed, early evidence suggests that these assays may have a significant impact on patient and physician decision-making. However, the impact of these tests on oncologic outcomes remains less clear. In this review, we highlight recent advances in the use of tissue-based biomarkers in the treatment of prostate cancer and identify the existing evidence supporting their clinical use.

scholarly journals Prognostic role of docetaxel-induced suppression of free testosterone serum levels in metastatic prostate cancer patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Paula Kappler ◽  
Michael A. Morgan ◽  
Philipp Ivanyi ◽  
Stefan J. Brunotte ◽  
Arnold Ganser ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Metastatic Prostate Cancer ◽  
Cox Regression ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Serum Levels ◽  
Biologically Active ◽  
Free Form ◽  
Total Testosterone ◽  
The Impact

AbstractTo date, only few data concerning the biologically active, free form of testosterone (FT) are available in metastatic prostate cancer (mPC) and the impact of FT on disease, therapy and outcome is largely unknown. We retrospectively studied the effect of docetaxel on FT and total testosterone (TT) serum levels in 67 mPC patients monitored between April 2008 and November 2020. FT and TT levels were measured before and weekly during therapy. The primary endpoint was overall survival (OS). Secondary endpoints were prostate-specific antigen response and radiographic response (PSAR, RR), progression-free survival (PFS), FT/TT levels and safety. Median FT and TT serum levels were completely suppressed to below the detection limit during docetaxel treatment (FT: from 0.32 to < 0.18 pg/mL and TT: from 0.12 to < 0.05 ng/mL, respectively). Multivariate Cox regression analyses identified requirement of non-narcotics, PSAR, complete FT suppression and FT nadir values < 0.18 pg/mL as independent parameters for PFS. Prior androgen-receptor targeted therapy (ART), soft tissue metastasis and complete FT suppression were independent prognostic factors for OS. FT was not predictive for treatment outcome in mPC patients with a history of ART.

scholarly journals Clinical use of the SelectMDx urinary-biomarker test with or without mpMRI in prostate cancer diagnosis: a prospective, multicenter study in biopsy-naïve men

2021 ◽  
Author(s):  
Rianne J. Hendriks ◽  
Marloes M. G. van der Leest ◽  
Bas Israël ◽  
Gerjon Hannink ◽  
Anglita YantiSetiasti ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Stratification ◽  
Specific Antigen ◽  
Low Grade ◽  
Diagnostic Study ◽  
High Grade ◽  
Net Benefit ◽  
Conditional Strategy ◽  
Detection Rates ◽  
Guided Biopsy

Abstract Background Risk stratification in men with suspicion of prostate cancer (PCa) requires reliable diagnostic tests, not only to identify high-grade PCa, also to minimize the overdetection of low-grade PCa, and reduction of “unnecessary” prostate MRIs and biopsies. This study aimed to evaluate the SelectMDx test to detect high-grade PCa in biopsy-naïve men. Subsequently, to assess combinations of SelectMDx test and multi-parametric (mp) MRI and its potential impact on patient selection for prostate biopsy. Methods This prospective multicenter diagnostic study included 599 biopsy-naïve patients with prostate-specific antigen level ≥3 ng/ml. All patients underwent a SelectMDx test and mpMRI before systematic transrectal ultrasound-guided biopsy (TRUSGB). Patients with a suspicious mpMRI also had an in-bore MR-guided biopsy (MRGB). Histopathologic outcome of TRUSGB and MRGB was used as reference standard. High-grade PCa was defined as ISUP Grade Group (GG) ≥ 2. The primary outcome was the detection rates of low- and high-grade PCa and number of biopsies avoided in four strategies, i.e., (1) SelectMDx test-only, (2) mpMRI-only, (3) SelectMDx test followed by mpMRI when SelectMDx test was positive (conditional strategy), and (4) SelectMDx test and mpMRI in all (joint strategy). A positive SelectMDx test outcome was a risk score of ≥−2.8. Decision curve analysis (DCA) was performed to assess clinical utility. Results Prevalence of high-grade PCa was 31% (183/599). Thirty-eight percent (227/599) of patients had negative SelectMDx test in whom biopsy could be avoided. Low-grade PCa was not detected in 35% (48/138) with missing 10% (18/183) high-grade PCa. Yet, mpMRI-only could avoid 49% of biopsies, not detecting 4.9% (9/183) of high-grade PCa. The conditional strategy reduces the number of mpMRIs by 38% (227/599), avoiding biopsy in 60% (357/599) and missing 13% (24/183) high-grade PCa. Low-grade PCa was not detected in 58% (80/138). DCA showed the highest net benefit for the mpMRI-only strategy, followed by the conditional strategy at-risk thresholds >10%. Conclusions SelectMDx test as a risk stratification tool for biopsy-naïve men avoids unnecessary biopsies in 38%, minimizes low-grade PCa detection, and misses only 10% high-grade PCa. Yet, using mpMRI in all patients had the highest net benefit, avoiding biopsy in 49% and missing 4.9% of high-risk PCa. However, if mpMRI availability is limited or expensive, using mpMRI-only in SelectMDx test positive patients is a good alternative strategy.

scholarly journals ‘Give Us The Tools!’: development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046450
Author(s):  
Samantha Cruz Rivera ◽  
Richard Stephens ◽  
Rebecca Mercieca-Bebber ◽  
Ameeta Retzer ◽  
Claudia Rutherford ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Patient Reported Outcome ◽  
Flow Diagram ◽  
Additional Patient ◽  
The Public ◽  
Patient Reported ◽  
Trial Protocols ◽  
User Friendly

Objectives(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.DesignA 1-day patient and public involvement session.ParticipantsSeven patient partners.MethodsA patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.ResultsTwo user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.ConclusionsThese tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.

scholarly journals Reaching consensus on reporting patient and public involvement (PPI) in research: methods and lessons learned from the development of reporting guidelines

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e016948 ◽  
Author(s):  
Jo Brett ◽  
Sophie Staniszewska ◽  
Iveta Simera ◽  
Kate Seers ◽  
Carole Mockford ◽  
...  
Keyword(s):  
Public Involvement ◽  
Evidence Base ◽  
Patient And Public Involvement ◽  
Lessons Learned ◽  
Reporting Guidelines ◽  
Consensus Development ◽  
Face To Face ◽  
Three Phase ◽  
Health And Social Care ◽  
The Impact

IntroductionPatient and public involvement (PPI) is inconsistently reported in health and social care research. Improving the quality of how PPI is reported is critical in developing a higher quality evidence base to gain a better insight into the methods and impact of PPI. This paper describes the methods used to develop and gain consensus on guidelines for reporting PPI in research studies (updated version of the Guidance for Reporting Patient and Public Involvement (GRIPP2)).MethodsThere were three key stages in the development of GRIPP2: identification of key items for the guideline from systematic review evidence of the impact of PPI on health research and health services, a three-phase online Delphi survey with a diverse sample of experts in PPI to gain consensus on included items and a face-to-face consensus meeting to finalise and reach definitive agreement on GRIPP2. Challenges and lessons learnt during the development of the reporting guidelines are reported.DiscussionThe process of reaching consensus is vital within the development of guidelines and policy directions, although debate around how best to reach consensus is still needed. This paper discusses the critical stages of consensus development as applied to the development of consensus for GRIPP2 and discusses the benefits and challenges of consensus development.

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