scholarly journals How to make study documents clear and relevant: the impact of patient involvement

BJPsych Open ◽  
2021 ◽  
Vol 7 (6) ◽  
Author(s):  
Sagar Jilka ◽  
Georgie Hudson ◽  
Sonja M. Jansli ◽  
Esther Negbenose ◽  
Emma Wilson ◽  
...  
Keyword(s):  
Public Involvement ◽  
Patient And Public Involvement ◽  
Mixed Methods Design ◽  
Information Sheet ◽  
Participant Information Sheet ◽  
Before And After ◽  
Research Document ◽  
The Impact ◽  
Participant Information ◽  
Over Time

Background Patient and public involvement can improve study outcomes, but little data have been collected on why this might be. We investigated the impact of the Feasibility and Support to Timely Recruitment for Research (FAST-R) service, made up of trained patients and carers who review research documents at the beginning of the research pipeline. Aims To investigate the impact of the FAST-R service, and to provide researchers with guidelines to improve study documents. Method A mixed-methods design assessing changes and suggestions in documents submitted to the FAST-R service from 2011 to 2020. Quantitative measures were readability, word count, jargon words before and after review, the effects over time and if changes were implemented. We also asked eight reviewers to blindly select a pre- or post-review participant information sheet as their preferred version. Reviewers’ comments were analysed qualitatively via thematic analysis. Results After review, documents were longer and contained less jargon, but did not improve readability. Jargon and the number of suggested changes increased over time. Participant information sheets had the most suggested changes. Reviewers wanted clarity, better presentation and felt that documents lacked key information such as remuneration, risks involved and data management. Six out of eight reviewers preferred the post-review participant information sheet. FAST-R reviewers provided jargon words and phrases with alternatives for researchers to use. Conclusions Longer documents are acceptable if they are clear, with jargon explained or substituted. The highlighted barriers to true informed consent are not decreasing, although this study has suggestions for improving research document accessibility.

scholarly journals An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding: Protocol for a study-within-a-trial

2020 ◽  
Vol 3 ◽  
pp. 4 ◽  
Author(s):  
Christopher P. Dwyer ◽  
Robert A. Joyce ◽  
Eimear M. Bane ◽  
Anusha Moses ◽  
Alberto Alvarez-Iglesias ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Information Sheet ◽  
Double Blind ◽  
Link Type ◽  
Participant Information Sheet ◽  
Study Within A Trial ◽  
Trials Methodology ◽  
Participant Information

Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets.  Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.

scholarly journals An examination of the effects of a patient-designed-and-informed participant information sheet in comparison with a standard, researcher-designed information sheet on recruitment, retention and understanding: Protocol for a study-within-a-trial

2020 ◽  
Vol 3 ◽  
pp. 4 ◽  
Author(s):  
Christopher P. Dwyer ◽  
Robert A. Joyce ◽  
Eimear M. Bane ◽  
Anusha Moses ◽  
Alberto Alvarez-Iglesias ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Information Sheet ◽  
Double Blind ◽  
Link Type ◽  
Participant Information Sheet ◽  
Study Within A Trial ◽  
Trials Methodology ◽  
Participant Information

Background: This protocol describes a double-blind, randomised non-inferiority study-within-a-trial (SWAT), comparing the effects of a patient-designed-and-informed participant information sheet with a standard, researcher-designed participant information sheet on recruitment, retention, decision certainty, participant information sheet understanding and likeability. The SWAT is part of a larger trial that aims to evaluate the feasibility and preliminary efficacy of a cognitive occupation-based programme for people with MS (COB-MS) on cognitive and daily functioning for people with multiple sclerosis. Methods: During the study, 120 people with multiple sclerosis will be randomly allocated to one of the two groups, where they will either receive a standard participant information sheet or a patient-designed participant information sheet. Recruitment and retention will be analysed, as well as decision certainty, likability and understanding. Discussion: Results will provide recommendations for recruitment, consent and retention for future trials, as well as shed some light on the factors influencing the understanding and likeability of a trial’s participant information sheet. Recommendations will also be made regarding patient and public involvement in developing and/or aiding the development of participant information sheets.  Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT105). COB-MS trial: ISRCTN11462710.

scholarly journals PARE0007 PATIENT AND PUBLIC INVOLVEMENT IN CLINICAL TRIAL DESIGN

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1289.1-1290
Author(s):  
S. De Souza ◽  
R. Williams ◽  
E. Johansson ◽  
C. Zabalan ◽  
T. Esterine ◽  
...  
Keyword(s):  
At Risk ◽  
Lived Experience ◽  
Public Involvement ◽  
Clinical Trial Design ◽  
Patient And Public Involvement ◽  
Face To Face ◽  
Before And After ◽  
Extensive Consultation ◽  
New Perspective ◽  
The Eu

Background:Patient and public involvement (PPI) is gaining increasing recognition as important in ensuring research is relevant and acceptable to participants. Rheuma Tolerance for Cure (RTCure) is a 5 year international collaboration between academia and industry; focusing on earlier detection and prevention of rheumatoid arthritis (RA) through the use of immune-tolerising treatments.Objectives:To bring lived experience and insight into scientific discussions; and to evolve collaboration between lay representatives and academia/industry.Methods:9 Patient Research Partners (PRPs) from 5 European countries were recruited via the EULAR PARE Network and institutions within the RTCure Consortium (8 PRPs with RA and 1 ‘at risk’). They were asked to enter into a legal agreement with the Consortium. PRPs participated in teleconferences (TCs) and were invited to attend face-to-face (F2F) meetings at least annually. Requests for input/feedback were sent from researchers to PRPs via the project’s Patient Engagement Expert [SK].Results:PRP involvement has given researchers and industry partners a new perspective on patient priorities, and focused thought on the ethics of recruitment for and participation in clinical trials of people ‘at risk’ of developing RA. PRPs have helped define the target populations, given their thoughts on what types of treatments are acceptable to people ‘at risk’ and have aided the development of a survey (sent to EULAR PARE members) regarding the use of animal models in biomedical research. Positive informal feedback has been received from researchers and industry regarding the contribution of PRPs to the ongoing project (formal evaluation of PPI in RTCure will be carried out in 2020 and at the project end in 2022).Challenges:Legal agreements- Many PRPs refused to sign the Consortium’s complex PRP Agreement; feeling it unnecessary, incomprehensible and inequitable. After extensive consultation with various parties (including EULAR and the Innovative Medicines Initiative) no similar contract was found. Views for its requirement even varied between legal experts. After 2 years of intense discussion, a simple non-disclosure agreement was agreed upon. Ideally any contract, if required, should be approved prior to project onset.Meeting logistics- Other improvements identified were to locate the meeting venue and accommodation on the same site to minimise travel, and to make it easier for PRPs to take breaks when required. This also facilitates informal discussions and patient inclusivity. We now have agreed a policy to fund PRPs extra nights before and after meetings, and to bring a carer if needed.Enabling understanding– Future annual meetings will start with a F2F meeting between PRPs and Work Package Leads. Researchers will be encouraged to start presentations with a summary slide in lay language. Additionally, an RTCure Glossary is in development.Enabling participation– SK will provide monthly project updates and PRP TCs will be held in the evening (as some PRPs remain employed). PRPs will be invited to all project TCs and F2F meetings. Recruitment is underway to increase the number of ‘at risk’ PRPs as their viewpoint is vital to this study.Conclusion:Currently PPI in RTCure is an ongoing mutual learning process. Universal guidance regarding what types of contracts are needed for PPI would be useful. Communication, trust and fruitful discussions have evolved through F2F meetings (both formal and informal) between PRPs, academia and industry. It is important that all parties can be open with each other in order to make PPI more meaningful.Acknowledgments:This work has received support from the EU/EFPIA Innovative Medicines Initiative 2 Joint Undertaking RTCure grant number 777357.Disclosure of Interests:Savia de Souza: None declared, Ruth Williams: None declared, Eva Johansson: None declared, Codruta Zabalan: None declared, Tom Esterine: None declared, Margôt Bakkers: None declared, Wolfgang Roth: None declared, Neil Mc Carthy: None declared, Meryll Blake: None declared, Susanne Karlfeldt: None declared, Martina Johannesson: None declared, Karim Raza Grant/research support from: KR has received research funding from AbbVie and Pfizer, Consultant of: KR has received honoraria and/or consultancy fees from AbbVie, Sanofi, Lilly, Bristol-Myers Squibb, UCB, Pfizer, Janssen and Roche Chugai, Speakers bureau: KR has received honoraria and/or consultancy fees from AbbVie, Sanofi, Lilly, Bristol-Myers Squibb, UCB, Pfizer, Janssen and Roche Chugai

scholarly journals Land Policy and Food Prices: Evidence from a Land Consolidation Program in Rwanda

2021 ◽  
Vol 19 (1) ◽  
pp. 63-73
Author(s):  
Aimable Nsabimana ◽  
Fidele Niyitanga ◽  
Dave D. Weatherspoon ◽  
Anwar Naseem
Keyword(s):  
Food Prices ◽  
Land Policy ◽  
Land Consolidation ◽  
Easy Access ◽  
Food Crops ◽  
White Potato ◽  
Before And After ◽  
Price Differences ◽  
The Impact ◽  
Over Time

Abstract Rwanda’s “Crop Intensification Program (CIP)” is primarily a land consolidation program aimed at improving agricultural productivity and food security. The program, which began in 2007, focuses on monocropping and commercialization of six priority crops: maize, wheat, rice, white potato, beans, and cassava. CIP has facilitated easy access to improved seed stocks, fertilizer, extension services, and postharvest handling and storage services. Although studies have documented the impact of CIP on changes in farm yield, incomes, and productivity, less is known about its impact on food prices. In this study, we examine the crop-food price differences in intensive monocropped CIP and non-intensive monocropped CIP zones in Rwanda. Specifically, the study evaluates price variations of beans and maize along with complementary food crops in intensive and non-intensive monocropped zones before and after the introduction of the CIP policy. We find that the CIP policy is not associated with differences in CIP crop prices between the intensive and non-intensive monocropped zones. Over time, prices increased for CIP crops but generally, the crop prices in the two zones were cointegrated. Prices for non-CIP crops in the two different zones did show price differentials prior to the implementation of CIP, with the prices in intensive monocropped zones being greater than in the non-intensive monocropped zones. Moreover, the prices in intensive areas are cointegrated with prices in non-intensive areas for maize and beans and these prices are converging. This indicates that farmers who intensively produced one CIP crop were able to go to the market and purchase other food crops and that price differences between zones have decreased over time, potentially making the CIP intensive farmers better off.

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.

scholarly journals Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis

BMJ ◽  
2018 ◽  
pp. k4738 ◽  
Author(s):  
Joanna C Crocker ◽  
Ignacio Ricci-Cabello ◽  
Adwoa Parker ◽  
Jennifer A Hirst ◽  
Alan Chant ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Lived Experience ◽  
Odds Ratio ◽  
Public Involvement ◽  
Meta Analysis ◽  
Patient And Public Involvement ◽  
Retention Rates ◽  
The Impact

AbstractObjectiveTo investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.DesignSystematic review and meta-analysis.Data sourcesTen electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteriaExperimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysisTwo independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14v1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis).ConclusionsThese findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registrationPROSPERO CRD42016043808.

Involving older people in the design and conduct of clinical trials

2015 ◽  
Author(s):  
Kate Wilde ◽  
Zena Jones
Keyword(s):  
Personal Experience ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Power Struggle ◽  
Research Strategies ◽  
Academic Knowledge ◽  
Key Points ◽  
The Uk ◽  
New Treatments ◽  
The Impact

Key points• There are strong policy drivers in the UK to involve patients not only as participants in research, but also as members of the research team.• Patient and public involvement (PPI) can have significant benefits to the patient as well as to the research project.• Many research funders require PPI explicitly described and evaluated in research proposals.• Researchers need increased awareness of PPI, guidance, and a framework of how best to implement PPI within their research strategies.• There is a risk of ‘tokenistic’ involvement of service users.• There is the potential for a power struggle between the PPI representative with personal experience and the lead researcher with academic knowledge of the condition studied.• There is a need to formally evaluate the impact of PPI on the effectiveness of research to bring new treatments to patients.

scholarly journals Popular Piety and Devotion to Parish Patrons in Poland and Spain, 1948–98

Religions ◽  
2020 ◽  
Vol 11 (12) ◽  
pp. 658 ◽  
Author(s):  
Piotr Roszak ◽  
Sławomir Tykarski
Keyword(s):  
Religious Life ◽  
Second Vatican Council ◽  
Popular Piety ◽  
Vatican Council ◽  
Form Part ◽  
Before And After ◽  
Cultural Expressions ◽  
The Impact ◽  
Over Time ◽  
Written Sources

This paper will show the dynamics of change in the celebration of the parish patron’s day at the turn of several decades (before and after the Second Vatican Council) at a Marian shrine in Poland and the cult of Cross from Monjardin in Spain. It will refer to various forms of ritual which are manifestations of popular piety: cultural expressions, services, prayers and songs which form part of the veneration of Our Lady of Sorrows, Chełmno and the Cross in Villamayor de Monjardin. The article will also examine the different ways in which these feasts were celebrated during the period and the impact they had on the religious life of pilgrims. The study will be based on written sources: memories, diaries, newspaper clippings, and historical studies which are instrumental in demonstrating the transformation of how the parish patron’s day was celebrated over time.

scholarly journals The impact of patient and public involvement on UK NHS health care: a systematic review

2011 ◽  
Vol 24 (1) ◽  
pp. 28-38 ◽  
Author(s):  
C. Mockford ◽  
S. Staniszewska ◽  
F. Griffiths ◽  
S. Herron-Marx
Keyword(s):  
Systematic Review ◽  
Health Care ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
The Impact
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