Patient and family co-developed participant information to improve recruitment rates, retention, and patient understanding in the Rehabilitation Strategies Following Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial: Protocol for a study within a trial (SWAT)

Background: Whilst the potential benefits of exercise rehabilitation in cancer survivorship are plentiful, recruitment to survivorship rehabilitation trials remains suboptimal. There is growing evidence that Public and Patient Involvement (PPI) initiatives can increase the rate of recruitment to research. This study within a trial (SWAT) will examine if participant information co-developed by patients and their families can lead to greater recruitment rates, retention and understanding of the Rehabilitation Strategies in Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial when compared to standard participant information. Methods: This SWAT will be carried out over two phases. Phase I will utilise qualitative methods to develop (Phase Ia) and refine (Phase Ib) the new participant information. Phase Ia will recruit up to 20 survivors of upper gastrointestinal or hepatopancreaticobiliary cancer, or their family members, to take part in a focus group or interview to develop the new participant information. Focus groups/interviews will be recorded, transcribed verbatim and analysed thematically. In Phase Ib, participants will return for a second focus group/interview to refine the participant information. Once finalised, the participant information will be submitted to ethics for approval. In Phase II, potential participants for the ReStOre II trial will be randomly assigned to receive either the standard or patient and family co-developed participant information. The two forms of participant information will be compared by recruitment and retention rates, and participant understanding of the trial (Decision-Making Questionnaire). Discussion: We anticipate that engaging with patients and their families to develop participant information will help to increase patient understanding of the ReStOre II trial and therefore recruitment and retention rates. The results of this SWAT will indicate the usefulness of this strategy for optimising recruitment to exercise rehabilitation trials in cancer survivorship. Registration: SWAT: Northern Ireland Hub for Trials Methodology Research SWAT Repository Store (SWAT-100). ReStOre II: ClinicalTrials.gov (NCT03958019).

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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

HRB Open Research ◽

10.12688/hrbopenres.12981.1 ◽

2020 ◽

Vol 3 ◽

pp. 4 ◽

Cited By ~ 1

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.

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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

HRB Open Research ◽

10.12688/hrbopenres.12981.2 ◽

2020 ◽

Vol 3 ◽

pp. 4 ◽

Cited By ~ 1

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.

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The effectiveness of digital multimedia presentation of trial information on recruitment and retention of patients: Protocol for a study within a trial (SWAT).

HRB Open Research ◽

10.12688/hrbopenres.12994.1 ◽

2020 ◽

Vol 3 ◽

pp. 10

Author(s):

Sinead Duane ◽

Akke Vellinga ◽

Valerie Smith ◽

Marie Tierney ◽

Claire Beecher ◽

...

Keyword(s):

Controlled Trial ◽

Multimedia Presentation ◽

Digital Information ◽

Information Leaflet ◽

Eligibility Criteria ◽

Recruitment And Retention ◽

Digital Multimedia ◽

Study Within A Trial ◽

Randomised Controlled ◽

Participant Information

Background: Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing trialists. Failure to meet recruitment targets can result in delays and underpowered studies. This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. Methods: This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT) (ISRCTN12838042) designed within a host trial - the SATIN trial (ISRCTN88111427), a RCT designed for implementation in the Irish primary care setting. The SWAT eligibility criteria was determined by the host trial. General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator). Outcomes are recruitment and retention to the host SATIN trial and participant’s quality of decision-making. Discussion: Although designed to be implemented in a host trial, the host trial, was suspended and therefore this SWAT was not implemented. The protocol and the lessons learnt whilst developing it offer guidance to researchers who wish to answer similar research questions in the future in a similar context or setting. Trial registration: ISRCTN Registry ISRCTN12838042 (11/10/2017)

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Near-falls in Singapore community-dwelling older adults: a feasibility study

Pilot and Feasibility Studies ◽

10.1186/s40814-020-00748-1 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Shawn Leng-Hsien Soh ◽

Chee-Wee Tan ◽

Judith Lane ◽

Ting-Ting Yeh ◽

Benjamin Soon

Keyword(s):

Older Adults ◽

Retention Rate ◽

Community Dwelling ◽

Retention Rates ◽

Reach To Grasp ◽

Balance Recovery ◽

Recruitment And Retention ◽

Body Regions ◽

Near Falls ◽

Community Dwelling Older Adults

Abstract Background A near-fall is defined as a loss of balance that would result in a fall if sufficient balance recovery manoeuvres are not executed. Compared to falls, near-falls and its associated balance recovery manoeuvres have been understudied. Older adults may not recognise a near-fall or identify the use of their balance recovery manoeuvres to prevent a fall. The consensus on the methods to collect near-fall data is lacking. The primary objective of this study was to determine the feasibility of recruitment and retention. Secondary objectives were to establish evidence that Singapore community-dwelling older adults can identify near-falls and associated balance recovery manoeuvres. Texting and calling methods were explored as reporting methods. Methods This study took place in Singapore (September to October 2019). Participants were healthy, community-dwelling adults aged 65 or older. Recruitment was done through poster advertisement, and all participants gave informed consent. Participants attended a briefing session and reported their near-fall or fall incidence over 21 days using either daily texting or calling. The primary outcome measures were the recruitment rate, retention rate, preferred modes for data reporting and ability to report near-falls or falls. Secondary outcomes included the self-reported incidence of falls and near-falls. Results Thirty older adults were recruited in 5 weeks. All participants completed the study. They understood near-fall concepts and were able to report the occurrence and relevant balance recovery manoeuvres used to prevent a fall. 87% (26/30) chose to text while 13% (4/30) selected calling as their reporting method. One actual fall (0.16%) out of 630 responses was reported. Thirty-six incidents (5.7%) of near-falls were recorded. Sixteen participants (53.3%) experienced near-falls and half of this group experienced two or more near-falls. The use of reach-to-grasp strategy (36%), compensatory stepping (52.8%), and other body regions (11.2%) were used to prevent the fall. Conclusions The study provided evidence that studying near-falls in Singapore community-dwelling older adults is feasible and can be applied to a large-scale study. Recruitment and retention rates were good. Older adults were able to identify near-falls and balance recovery manoeuvres. Both texting and calling were feasible reporting methods, but texting was preferred. Trial registration ClinicalTrials identifier: NCT04087551. Registered on September 12, 2019

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Effects of efpeglenatide versus liraglutide on gastric emptying, glucose metabolism and beta-cell function in people with type 2 diabetes: an exploratory, randomized phase Ib study

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2021-002208 ◽

2021 ◽

Vol 9 (1) ◽

pp. e002208

Author(s):

Marcus Hompesch ◽

Jahoon Kang ◽

OakPil Han ◽

Michael E Trautmann ◽

Christopher H Sorli ◽

...

Keyword(s):

Type 2 Diabetes ◽

Gastric Emptying ◽

Glucose Metabolism ◽

Beta Cell ◽

Beta Cell Function ◽

Cell Function ◽

Phase Ib ◽

Link Type ◽

Drug Concentrations

IntroductionTo evaluate the effects of efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA), on gastric emptying, glucose metabolism, and islet beta-cell function versus liraglutide and placebo in people with type 2 diabetes.Research design and methodsThis phase Ib study (ClinicalTrials.gov identifier: NCT02059564) randomized participants (n=47) to three cohorts. Within the first two cohorts, participants were randomized to placebo, efpeglenatide 6 mg weekly (QW; first cohort), or efpeglenatide 16 mg monthly (QM; second cohort). The third cohort received liraglutide 1.8 mg daily (QD). Gastric emptying was assessed through the pharmacokinetic (PK) profile of acetaminophen at baseline and steady state. Glucose metabolism and beta-cell function were assessed based on mixed-meal tolerance testing and a graded glucose infusion procedure.ResultsTreatment duration was approximately 3 months for efpeglenatide 16 mg QM and 1 month for efpeglenatide 6 mg QW and liraglutide. At peak drug concentrations, efpeglenatide 6 mg QW was non-inferior to liraglutide 1.8 mg QD in delaying gastric emptying, as assessed by acetaminophen PK (lower bound of 90% CI for the efpeglenatide:liraglutide ratio >0.8 for area under the curve (AUC)0–120, AUC0–180, AUC0–360 and maximum concentration (Cmax)). Efpeglenatide 16 mg QM did not decrease the rate of gastric emptying to as great an extent as liraglutide (ie, non-inferiority was not shown). Compared with liraglutide, both efpeglenatide dosing regimens demonstrated comparable or more favorable glucometabolic effects and improved beta-cell function. All gastrointestinal adverse events reported with efpeglenatide were mild or moderate in severity and transient over treatment and follow-up.ConclusionsThe glucometabolic effects of efpeglenatide 6 mg QW and 16 mg QM were comparable to liraglutide. Additional studies are necessary to further examine these benefits of efpeglenatide.Trial registration numberNCT02059564.

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Project PIX (Post Intensive care eXercise): impact on physical fitness and focus group analysis of quality of life following exercise rehabilitation

Critical Care ◽

10.1186/cc12472 ◽

2013 ◽

Vol 17 (S2) ◽

Author(s):

J Goodman ◽

W Walker ◽

J Wright ◽

G Danjoux ◽

S Howell ◽

...

Keyword(s):

Quality Of Life ◽

Intensive Care ◽

Focus Group ◽

Physical Fitness ◽

Group Analysis ◽

Exercise Rehabilitation

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Feasibility Study of the Enhancing Parenting Skills Programme

Journal of Child and Family Studies ◽

10.1007/s10826-019-01581-8 ◽

2019 ◽

Vol 29 (3) ◽

pp. 686-698

Author(s):

Margiad E. Williams ◽

Zoe Hoare ◽

Dawn A. Owen ◽

Judy Hutchings

Keyword(s):

Mental Health ◽

Parent Report ◽

Child Behaviour ◽

Retention Rates ◽

Behaviour Problems ◽

Parenting Skills ◽

Parental Mental Health ◽

Treatment As Usual ◽

Recruitment And Retention ◽

The Uk

Abstract Objectives This study reports on the feasibility and initial effectiveness of an individually delivered parent programme for parents of young children with behaviour problems. Whilst parenting programmes are known to be effective in reducing behaviour problems, numerous barriers can prevent families from accessing programmes. Individually delivered parent programmes may be more accessible. In the UK, health visitors provide support to all families with a child under 5 years of age and are ideally placed to deliver interventions for child behaviour problems. Methods Fifty-eight parents reporting children with behaviour problems were recruited from four areas to intervention (n = 29) and treatment as usual, wait-list control (n = 29) conditions. Feasibility outcomes included recruitment, retention, programme delivery, and satisfaction. Baseline and six-month post-randomisation follow-up measures were collected in parents’ homes and included parent-report measures of child behaviour, parenting skills, and parental mental health as well as an observation of parenting behaviour during a parent-child play task. Results Significant changes in child behaviour, lax parenting, and parental mental health were found for the whole sample but there were no significant differences between conditions. Recruitment and retention rates were lower than expected questioning the feasibility of delivering the parent programme as it is in existing services. Conclusions This paper provides limited evidence for the feasibility of the Enhancing Parenting Skills programme delivered in existing health services. Further feasibility work, particularly for recruitment and retention, would be needed before conducting a larger study to examine the effectiveness of the programme.

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Developing a Preliminary Definition and Domains of Flare in Knee and Hip Osteoarthritis (OA): Consensus Building of the Flare-in-OA OMERACT Group

The Journal of Rheumatology ◽

10.3899/jrheum.181085 ◽

2019 ◽

Vol 46 (9) ◽

pp. 1188-1191 ◽

Cited By ~ 4

Author(s):

Francis Guillemin ◽

Camille Ricatte ◽

Annica Barcenilla-Wong ◽

Amandine Schoumacker ◽

Marita Cross ◽

...

Keyword(s):

Content Analysis ◽

Focus Group ◽

Health Professionals ◽

Hip Osteoarthritis ◽

Consensus Building ◽

Delphi Consensus ◽

Focus Group Interviews ◽

Link Type ◽

Group Interviews ◽

Definition Of

Flare in knee and hip osteoarthritis (OA) is more than just an exacerbation of pain. Unstructured, semistructured, and focus group interviews followed by Delphi surveys with patients and health professionals (HP) generated candidate domains of an OA flare. Content analysis of interviews with 29 patients and 16 HP extracted 180 statements, which were grouped into 9 clusters. Delphi consensus with 50 patients (Australia, Canada, and France) and 116 HP (17 countries on 4 continents) identified 5 flare domains: pain, swelling, stiffness, psychological aspects, and effect of symptoms. Elements for a preliminary definition of an OA flare are proposed. Registered at clinicaltrials.govNCT02892058.

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A randomised controlled pilot trial evaluating feasibility and acceptability of a computer-based tool to identify and reduce harmful and hazardous drinking among adolescents with alcohol-related presentations in Canadian pediatric emergency departments

BMJ Open ◽

10.1136/bmjopen-2016-015423 ◽

2017 ◽

Vol 7 (8) ◽

pp. e015423 ◽

Cited By ~ 1

Author(s):

Amanda S Newton ◽

Nadia Dow ◽

Kathryn Dong ◽

Eleanor Fitzpatrick ◽

T Cameron Wild ◽

...

Keyword(s):

Alcohol Consumption ◽

Social Services ◽

Retention Rates ◽

Post Intervention ◽

Research Staff ◽

Recruitment And Retention ◽

Health And Social Services ◽

Intervention Acceptability ◽

Computer Based ◽

Randomised Controlled

ObjectiveThis study piloted procedures and obtained data on intervention acceptability to determine the feasibility of a definitive randomised controlled trial (RCT) of the effectiveness of a computer-based brief intervention in the emergency department (ED).DesignTwo-arm, multi-site, pilot RCT.Setting and participantsAdolescents aged 12–17 years presenting to three Canadian pediatric EDs from July 2010 to January 2013 for an alcohol-related complaint.InterventionsStandard medical care plus computer-based screening and personalised assessment feedback (experimental group) or standard care plus computer-based sham (control group). ED and research staff, and adolescents were blinded to allocation.OutcomesMain: change in alcohol consumption from baseline to 1- and 3 months post-intervention. Secondary: recruitment and retention rates, intervention acceptability and feasibility, perception of group allocation among ED and research staff, and change in health and social services utilisation.ResultsOf the 340 adolescents screened, 117 adolescents were eligible and 44 participated in the study (37.6% recruitment rate). Adolescents allocated to the intervention found it easy, quick and informative, but were divided on the credibility of the feedback provided (agreed it was credible: 44.4%, disagreed: 16.7%, unsure: 16.7%, no response: 22.2%). We found no evidence of a statistically significant relationship between which interventions adolescents were allocated to and which interventions staff thought they received. Alcohol consumption, and health and social services data were largely incomplete due to modest study retention rates of 47.7% and 40.9% at 1- and 3 months post-intervention, respectively.ConclusionsA computer-based intervention was acceptable to adolescents and delivery was feasible in the ED in terms of time to use and ease of use. However, adjustments are needed to the intervention to improve its credibility. A definitive RCT will be feasible if protocol adjustments are made to improve recruitment and retention rates; and increase the number of study sites and research staff.Trial registrationclinicaltrials.govNCT01146665

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