scholarly journals Operationalising a real-time research ethics approach: supporting ethical mindfulness in agriculture-nutrition-health research in Malawi

2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Limbanazo Matandika ◽  
Kate Millar ◽  
Eric Umar ◽  
Edward Joy ◽  
Joseph Mfutso-Bengo
Keyword(s):  
Research Ethics ◽  
Real Time ◽  
Ethical Issues ◽  
Controlled Trial ◽  
Research Work ◽  
Field Work ◽  
Research Experience ◽  
Expert Opinions ◽  
Research Programmes ◽  
Randomised Controlled

Abstract Background There have been notable investments in large multi-partner research programmes across the agriculture-nutrition-health (ANH) nexus. These studies often involve human participants and commonly require research ethics review. These ANH studies are complex and can raise ethical issues that need pre-field work, ethical oversight and also need an embedded process that can identify, characterise and manage ethical issues as the research work develops, as such more embedded and dynamic ethics processes are needed. This work builds on notions of ‘ethics in practice’ by developing an approach to facilitate ethical reflection within large research programmes. This study explores the application of a novel ‘real-time research ethics approach’ (RTREA) and how this can support ethical mindfulness. This involves embedding ethical analysis and decision-making within research implementation, with a continuous dialogue between participants and researchers. The aim is to improve ethical responsiveness and participant experience, which in turn may ethically support adherence and retention. In this case study, a bioethics team (BT) was embedded in a community-based randomised, controlled trial conducted in rural Malawi, titled the ‘Addressing Hidden Hunger with Agronomy’. To identify ethical issues, the researchers conducted ten focus group discussions, fourteen in-depth interviews with key informants, two workshops, observed two sensitisation and three activity meetings conducted by the trial team, and analysed fifteen reports from pre-trial to trial implementation. Results The RTREA facilitated the identification of social and ethical concerns and made researchers aware of participants’ ‘lived research experience’. To address concerns and experiences, the BT worked with researchers to facilitate conversation spaces where social and ethical issues were discussed. Conversation spaces were designed to create partnerships and promote participatory methods to capture trial participants’ (TPs) perspectives and experiences. Conclusions The use of RTREA showed the value of real-time and continuous engagement between TPs and researchers. These real-time processes could be embedded to complement traditional ethical guidance and expert opinions. A deeper engagement appeared to support greater operationalising of principles of inclusion, empowerment, and participant autonomy and supported researchers ‘ethical mindfulness’ which in turn may support instrumental outcomes of high recruitment, retention, and adherence levels.

scholarly journals Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034137 ◽  
Author(s):  
Dimitris Papamargaritis ◽  
Werd Al-Najim ◽  
Jonathan Lim ◽  
James Crane ◽  
Mike Lean ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Real World ◽  
Regulatory Authority ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Stopping Rules ◽  
Open Label ◽  
Randomised Controlled

IntroductionIn the UK and Ireland, severe and complex obesity is managed in specialist weight management services (SWMS), which provide multicomponent lifestyle interventions to support weight loss, and use of medication if available. Liraglutide 3 mg (LIRA 3 mg) is an effective weight-loss medication, but weight loss in individual patients is variable, and its efficacy has not been assessed in SWMS. This study aims to investigate whether a targeted prescribing pathway for LIRA 3 mg with multiple prespecified stopping rules could help people with severe obesity and established complications achieve ≥15% weight loss in order to determine whether this could be considered a clinically effective and cost-effective strategy for managing severe and complex obesity in SWMS.Methods and analysisIn this 2-year, multicentre, open-label, real-world randomised controlled trial, 384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m2plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea) will be randomised via a 2:1 ratio to receive either standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules at 16, 32 and 52 weeks (n=256).The primary outcome is to compare the proportion of participants achieving a weight loss of ≥15% at 52 weeks with a targeted prescribing pathway versus standard care. Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.Ethics and disseminationThe Health Research Authority and the Medicines and Healthcare products Regulatory Authority in UK, the Health Products Regulatory Authority in Ireland, the North West Deanery Research Ethics Committee (UK) and the St Vincent’s University Hospital European Research Ethics Committee (Ireland) have approved the study. The findings of the study will be published in peer-reviewed journals.Trial registration numberClinicalTrials.gov—Identifier:NCT03036800.European Clinical Trials Database—Identifier: EudraCT Number 2017-002998-20.

scholarly journals Salivary and Nasal Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses (BBCovid): A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Florence Carrouel ◽  
Stéphane Viennot ◽  
Martine Valette ◽  
Jean-Marie Cohen ◽  
Claude Dussart ◽  
...  
Keyword(s):  
Viral Load ◽  
Randomised Controlled Trial ◽  
Real Time ◽  
Outcome Measures ◽  
Real Time Pcr ◽  
Controlled Trial ◽  
Full Protocol ◽  
Pcr Assays ◽  
Randomised Controlled ◽  
Hospital Center

Abstract Objectives - To describe the evolution of the SARS-CoV-2 salivary viral load of patients infected with Covid-19, performing 7 days of tri-daily mouthwashes with and without antivirals. - To compare the evolution of the SARS-CoV-2 nasal and salivary viral load according to the presence or absence of antivirals in the mouthwash. Trial design This is a multi-center, randomised controlled trial (RCT) with two parallel arms (1:1 ratio). Participants Inclusion criteria - Age: 18-85 years old - Clinical diagnosis of Covid-19 infection - Clinical signs have been present for less than 8 days - Virological confirmation - Understanding and acceptance of the trial - Written agreement to participate in the trial Exclusion criteria - Pregnancy, breastfeeding, inability to comply with protocol, lack of written agreement - Patients using mouthwash on a regular basis (more than once a week) - Patient at risk of infectious endocarditis - Patients unable to answer questions - Uncooperative patient The clinical trial is being conducted with the collaboration of three French hospital centers: Hospital Center Emile Roux (Le Puy en Velay, France), Clinic of the Protestant Infirmary (Lyon, France) and Intercommunal Hospital Center (Mont de Marsan, France). Intervention and comparator Eligible participants will be allocated to one of the two study groups. Intervention group: patients perform a tri-daily mouthwash with mouthwash containing antivirals (β-cyclodextrin and Citrox®) for a period of 7 days. Control group: patients perform a tri-daily mouthwash with a placebo mouthwash for a period of 7 days. Main outcomes Primary Outcome Measures: Change from Baseline amount of SARS-CoV-2 in salivary samples at 4 and 9 hours, 1, 2, 3, 4, 5 and 6 days. Real-time PCR assays are performed to assess salivary SARS-CoV 2 viral load. Secondary Outcome Measures: Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 6 days. Real-time PCR assays are performed to assess nasal SARS-CoV-2 viral load. Randomisation Participants meeting all eligibility requirements are allocated to one of the two study arms (mouthwash with β-cyclodextrin and Citrox® or mouthwash without β-cyclodextrin and Citrox®) in a 1:1 ratio using simple randomisation with computer generated random numbers. Blinding (masking) Participants, doctors and nurses caring for participants, laboratory technicians and investigators assessing the outcomes will be blinded to group assignment. Numbers to be randomised (sample size) Both the intervention and control groups will be composed of 103 participants, so the study will include a total of 206 participants. Trial Status The current protocol version is 6, August 4th, 2020. Recruitment began on April 6, 2020 and is anticipated to be complete by April 5, 2021. As of October 2, 2020, forty-two participants have been included. Trial registration This trial was registered on 20 April 2020 at www.clinicaltrials.gov with the number NCT04352959. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.” The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).”

scholarly journals Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035648
Author(s):  
Saeed Moradian ◽  
Monika Krzyzanowska ◽  
Roma Maguire ◽  
Vishal Kukreti ◽  
Eitan Amir ◽  
...  
Keyword(s):  
Real Time ◽  
Symptom Management ◽  
Management System ◽  
Controlled Trial ◽  
Open Label ◽  
Symptom Monitoring ◽  
Group Assignment ◽  
Home Based ◽  
Chemotherapy Patients ◽  
Randomised Controlled

IntroductionTechnology is emerging as a solution to develop home-based, proactive ‘real-time’ symptom monitoring and management in cancer care. The Advanced Symptom Monitoring and Management System—Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.Methods and analysisThis study is an open-label, prospective, mixed-method, Phase II, 2-arm parallel group assignment (ASyMS-Can vs usual care) feasibility study in patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre. A total of 114 patients will be recruited in oncology clinics prior to initiation of chemotherapy. Patients in both arms will complete a demographic and a set of questionnaires at enrolment, mid and end of treatment. Patients in intervention arm will be provided with an encrypted, secure, preprogrammed ASyMS phone for symptom reporting daily for the first 14 days of each chemotherapy treatment cycle up to sixth cycle (16 weeks). Feasibility metrics (recruitment, retention and protocol adherence) and outcomes to assess impact of ASyMS—Can include symptom severity, emotional distress, quality of life and acceptability to patients and clinicians.Ethics and disseminationThe study has received ethical and institutional approvals from the University Health Network. Dissemination will include presentations at national/international conferences, and publications in peer-reviewed journals.Trial registration numberNCT03335189.

Confidentiality in participatory research

2014 ◽  
Vol 23 (4) ◽  
pp. 442-454 ◽  
Author(s):  
Elmira Petrova ◽  
Jan Dewing ◽  
Michelle Camilleri
Keyword(s):  
Research Ethics ◽  
Ethical Issues ◽  
Field Work ◽  
Research Process ◽  
Ethics Committee ◽  
Ethical Challenges ◽  
Ethical Guidelines ◽  
Case Study Methodology ◽  
Research Ethics Committee ◽  
Practice Development

Aim: This article presents key ethical challenges that were encountered when conducting a participatory qualitative research project with a very specific, small group of nurses, in this case with practice development nurses in Malta. Background: With the small number of nurses employed in practice development roles in Malta, there are numerous difficulties of maintaining confidentiality. Poorly constructed interventions by the researcher could have resulted in detrimental effects to research participants and the overall trustworthiness of the research. Generally, ethical guidelines for research exist to reinforce validity of research; however, there is not an established consensus on how these strategies can be utilised in some types of qualitative field work. Research design: The researcher used an exploratory case study methodology. The sample consisted of 10 participants who were interviewed twice using face-to-face interviews, over a period of 2 months. Ethical considerations: The study was ethically reviewed by the University Research Ethics Committee and the Faculty Research Ethics Committee, University of Malta. The participants referred to in this article have been given adequate information about the study and their consent has been obtained. Discussion: Numerous strategies for ensuring confidentiality during recruitment of the participants, during data collection, during transcription and data analysis and during dissemination of research results assisted the researcher in responding to potential and actual ethical issues. Conclusion: This article emphasises the main strategies that can be used to respond to ethical challenges when researching with a small easily identifiable group. The learning discussed here may be relevant to or even transferable to other similar research studies or research contexts. These methods fostered a greater credibility throughout the research process and predisposed the participants to greater trust, and thus, they disclosed their experiences and speak more freely, thus enhancing the quality of the study.

scholarly journals Randomised controlled trial protocol for the PROTECT-CS Study: PROTein to Enhance outComes of (pre)frail paTients undergoing Cardiac Surgery

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e037240
Author(s):  
Alexandra V Rose ◽  
Todd Duhamel ◽  
Chris Hyde ◽  
Dave E Kent ◽  
Jonathan Afilalo ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Controlled Trial ◽  
Postoperative Recovery ◽  
Primary Site ◽  
Trial Protocol ◽  
Time Points ◽  
Frail Patients ◽  
Randomised Controlled

IntroductionIn the past 20 years, the increasing burden of heart disease in an ageing population has resulted in cardiac surgery (CS) being offered to more frail and older patients with multiple comorbidities. Frailty and malnutrition are key geriatric syndromes that impact postoperative outcomes, including morbidity, mortality and prolonged hospital length of stay. Enhanced recovery protocols (ERPs), such as prehabilitation, have been associated with a reduction in complications after CS in vulnerable patients. The use of nutritional ERPs may enhance short-term and long-term recovery and mitigate frailty progression while improving patient-reported outcomes.Methods and analysisThis trial is a two-centre, double-blinded, placebo, randomised controlled trial with blinded endpoint assessment and intention-to-treat analysis. One-hundred and fifty CS patients will be randomised to receive either a leucine-rich protein supplement or a placebo with no supplemented protein. Patients will consume their assigned supplement two times per day for approximately 2 weeks pre-procedure, during in-hospital postoperative recovery and for 8 weeks following discharge. The primary outcome will be the Short Physical Performance Battery score. Data collection will occur at four time points including baseline, in-hospital (pre-discharge), 2-month and 6-month time points post-surgery.Ethics and disseminationThe University of Manitoba Biomedical Research Ethics Board (20 March 2018) and the St Boniface Hospital Research Review Committee (28 June 2019) approved the trial protocol for the primary site in Winnipeg, Manitoba, Canada. The second site’s (Montreal, Quebec) ethics has been submitted and pending approval from the Research Ethics and New Technology Development Committee for the Montreal Heart Institute (December 2020). Recruitment for the primary site started February 2020 and the second site will begin January 2021. Data gathered from the PROTein to Enhance outComes of (pre)frail paTients undergoing Cardiac Surgery Study will be published in peer-reviewed journals and presented at national and international conferences. Knowledge translation strategies will be created to share findings with stakeholders who are positioned to implement evidence-informed change.Potential study impactMalnutrition and frailty play a crucial role in post-CS recovery. Nutritional ERPs are increasingly being recognised as a clinically relevant aspect of perioperative care. As such, this trial is to determine if leucine-rich protein supplementation at key intervals can mitigate frailty progression and facilitate enhanced postoperative recovery.Trial registration numberClinicalTrials.gov Registry (NCT04038294).

scholarly journals Impact of a farmers’ market nutrition coupon programme on diet quality and psychosocial well-being among low-income adults: protocol for a randomised controlled trial and a longitudinal qualitative investigation

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035143 ◽  
Author(s):  
Michelle L Aktary ◽  
Stephanie Caron-Roy ◽  
Tolulope Sajobi ◽  
Heather O'Hara ◽  
Peter Leblanc ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Diet Quality ◽  
Low Income ◽  
Controlled Trial ◽  
Well Being ◽  
Farmers Markets ◽  
Post Intervention ◽  
Farmers Market ◽  
Randomised Controlled

IntroductionLow-income populations have poorer diet quality and lower psychosocial well-being than their higher-income counterparts. These inequities increase the burden of chronic disease in low-income populations. Farmers’ market subsidies may improve diet quality and psychosocial well-being among low-income populations. In Canada, the British Columbia (BC) Farmers’ Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers’ markets. This study will assess the impact of the BC FMNCP on the diet quality and psychosocial well-being of low-income adults and explore mechanisms of programme impacts.Methods and analysisIn a parallel group randomised controlled trial, low-income adults will be randomised to an FMNCP intervention (n=132) or a no-intervention control group (n=132). The FMNCP group will receive 16 coupon sheets valued at CAD$21/sheet over 10–15 weeks to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts and herbs at farmers’ markets and will be invited to participate in nutrition skill-building activities. Overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, food insecurity and malnutrition risk (secondary outcomes) will be assessed at baseline, immediately post-intervention and 16 weeks post-intervention. Dietary intake will be assessed using the Automated Self-Administered 24-hour Dietary Recall. Diet quality will be calculated using the Healthy Eating Index-2015. Repeated measures mixed-effect regression will assess differences in outcomes between groups from baseline to 16 weeks post-intervention. Furthermore, 25–30 participants will partake in semi-structured interviews during and 5 weeks after programme completion to explore participants’ experiences with and perceived outcomes from the programme.Ethics and disseminationEthical approval was obtained from the University of Calgary Conjoint Health Research Ethics Board, Rutgers University Ethics and Compliance, and University of Waterloo Office of Research Ethics. Findings will be disseminated through policy briefs, conference presentations and peer-reviewed publications.Trial registration numberNCT03952338.

scholarly journals Use of a patient-centred educational exchange (PCEE) to improve patient’s self-management of medicines after a stroke: a randomised controlled trial study protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e022225 ◽  
Author(s):  
Judith Ann Coombes ◽  
Debra Rowett ◽  
Jennifer A Whitty ◽  
W Neil Cottrell
Keyword(s):  
Randomised Controlled Trial ◽  
Secondary Prevention ◽  
Usual Care ◽  
Research Ethics ◽  
Controlled Trial ◽  
Educational Exchange ◽  
Human Research ◽  
Human Research Ethics ◽  
Prescription Refill ◽  
Randomised Controlled

IntroductionNational and international guidelines make recommendations for secondary prevention of stroke including the use of medications. A strategy which engages patients in a conversation to personalise evidence-based educational material (patient-centred educational exchange; PCEE) may empower patients to better manage their medications.Methods and analysisThis protocol outlines a non-blinded randomised controlled trial. Consenting patients admitted with a diagnosis of stroke or transient ischaemic attack will be randomised 1:1 to receive either a PCEE composed of two sessions, one at the bedside before discharge and one by telephone at least 10 days after discharge from hospital in addition to usual care (intervention) or usual care alone (control). The primary aim of this study is to determine whether a PCEE improves adherence to antithrombotic, antihypertensive and lipid-lowering medications prescribed for secondary prevention of stroke over the 3 months after discharge, measured using prescription-refill data. Secondary aims include investigation of the impact of the PCEE on adherence over 12 months using prescription-refill data, self-reported medication taking behaviour, self-reported clinical outcomes (blood pressure, cholesterol, adverse medication events and readmission), quality of life, the cost utility of the intervention and changes in beliefs towards medicines and illness.Ethics and disseminationCommunication of the trial results will provide evidence to aid clinicians in conversations with patients about medication taking behaviour related to stroke prevention. The targeted audiences will be health practitioners and consumers interested in medication taking behaviour in chronic diseases and in particular those interested in secondary prevention of stroke.The trial has ethics approval from Metro South Human Research Ethics Committee (HREC/15/QPAH/531) and The University of Queensland Institutional Human Research Ethics (2015001612).Trial registration numberACTRN12615000888561; Pre-results.

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