Informed Consent Procedures Research Articles

Protocol for the LIFEH project: a prospective observational study to explore lifestyle among people living with HIV experiencing weight gain, looking beyond antiretroviral therapy

IntroductionWeight gain, together with the onset of overweight and obesity, is a relevant emerging health issue among people living with HIV (PLWH). A large body of literature recognises this issue...

Compromised informed consent due to functional health literacy challenges in Chinese hospitals

BackgroundMedical informed consent stands as an ethical and legal requisite preceding any medical intervention. Hospitalized patients face functional health literacy (FHL) challenges when dealing with informed consent forms (ICFs). The legitimacy of ICFs and informed consent procedures in China remains substantially undisclosed. The study’s aim was to investigate if Chinese patients have adequate FHL to be truly informed before providing medical consent.MethodsIn this cross-sectional, structured interview-based study, FHL was assessed within the context of the informed consent scenarios in two teaching hospitals (a 1500-bed general tertiary hospital and a 700-bed cancer hospital) affiliated with Shantou University Medical College. Twenty-seven patients admitted across clinical departments, along with their relatives (n = 59), were enrolled in the study after obtaining informed consent. The participants underwent a three-step assessment with two selected ICFs —teach-back skills, perceived understanding (perception), and informed knowledge (cognizance), with each component carrying a maximum score of 10. Data were analyzed with SPSS (version 22.0) for descriptive and inferential statistics, with consideration of significant P values as < 0.05.ResultsThe median age (IQR and range) of participants was 35.5 (28 – 49 and 13 – 74) years. Most participants had only high school education (24.4%, 21/86) or below high school education (47.7%, 41/86). The median score (IQR) of FHL assessments—teach-back, perception, and cognizance—was 4.0 (2.5, 5.8), 8.0 (6.8, 8.8), and 6.5 (5.5, 8.0) out of 10, respectively. A moderate correlation was observed between the scores of cognizance and teach-back (r = 0.359, P = 0.002) or perception (r = 0.437, P < 0.001). Multivariate linear regression analysis predicted being a patient and having lower education levels as independent risk factors of inadequate FHL (Ps = 0.001). Lack of patient-centeredness in ICFs, time constraints, and poor clinical communication were identified as barriers impeding informed consent.ConclusionsThis study demonstrates inadequacy in personal FHL and impaired organizational HL, resulting in compromised informed consent in Chinese teaching hospitals. As a remedy, we propose improving the quality of ICFs and institutionally mandated outcome-focused training on informed consent for all concerned clinicians to enhance medical ethics, ensure quality health care, address patient values, and mitigate potential medical conflicts.

Developing Informed Consent for Academic Hospital-Based Biobank Modeling: An Experience from Indonesia.

Background: Informed consent (IC) for biobank practice is vital to ensure that sample collection, storage, and utilization are ethical. However, the standard practices in biobanking in upper-middle-income countries such as Indonesia often rely on specific consent, leading to restricted sample use and ethical concerns. This article describes the development of an IC model that meets ethical standards and yet is acceptable for biobanking practice in an Indonesian academic hospital. Method: We conducted a study involving Universitas Gadjah Mada (UGM) Biobank Unit and the UGM Academic Hospital, Yogyakarta, Indonesia, between 2019 and 2021. The IC development process consisted of four stages: (1) conceptualization, (2) preparation, (3) pilot, and (4) evaluation. These activities were part of a more extensive pilot study for an academic hospital-based biobank (Medical Biobank for Research in Indonesia (MBRIO) study). Result: We conceptualized a broad consent model, consisting of an information sheet, comprehension test, agreement sheet, and exit survey. We tested and revised the broad consent document to ensure readability, trained 10 consenting staff (1 surgeon and 9 nurses), and then piloted the IC procedure on 24 patients with elective surgery. The evaluation showed that patients understood the information objectively and subjectively. Consenting staff considered the broad consent model acceptable for the academic hospital setting and suggested improvements to increase the readability of information sheets and have more trained staff for better coordination. Conclusion: The IC development process and model consent are ethically sufficient, acceptable and feasibleto be implemented in academic hospital-based biobanks in Indonesia adjusted to the business processes.

Characteristics, consent patterns, and challenges of randomized trials using the Trials within Cohorts (TwiCs) design - A scoping review

ObjectivesTrials within Cohorts (TwiCs) is a pragmatic design approach that may overcome frequent challenges of traditional randomized trials such as slow recruitment, burdensome consent procedures, or limited external validity. This scoping review aims to identify all randomized controlled trials using the TwiCs design and to summarize their design characteristics, ways to obtain informed consent, output, reported challenges and mitigation strategies. Study Design and SettingSystematic search of Medline, Embase, Cochrane, trial registries and citation tracking up to December 2022. TwiCs were defined as randomized trials embedded in a cohort with postrandomization consent for the intervention group and no specific postrandomization consent for the usual care control group. Information from identified TwiCs was extracted in duplicate from protocols, publications, and registry entries. We analyzed the information descriptively and qualitatively to highlight methodological challenges and solutions related to nonuptake of interventions and informed consent procedure. ResultsWe identified a total of 46 TwiCs conducted between 2005 and 2022 in 14 different countries by a handful of research groups. The most common medical fields were oncology (11/46; 24%), infectious diseases (8/46; 17%), and mental health (7/46; 15%). A typical TwiCs was investigator-initiated (46/46; 100%), publicly funded (36/46; 78%), and recruited outpatients (27/46; 59%). Excluding eight pilot trials, only 16/38 (42%) TwiCs adjusted their calculated sample size for nonuptake of the intervention, anticipating a median nonuptake of 25% (interquartile range 10%-32%) in the experimental arm. Seventeen TwiCs (45%) planned analyses to adjust effect estimates for nonuptake. Regarding informed consent, we observed three patterns: 1) three separate consents for cohort participation, randomization, and intervention (17/46; 37%); 2) combined consent for cohort participation and randomization and a separate intervention consent (10/46; 22%); and 3) consent only for cohort participation and intervention (randomization consent not mentioned; 19/46; 41%). ConclusionExisting TwiCs are globally scattered across a few research groups covering a wide range of medical fields and interventions. Despite the potential advantages, the number of TwiCs remains small. The variability in consent procedures and the possibility of substantial nonuptake of the intervention warrants further research to guide the planning, implementation, and analysis of TwiCs.

Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study.

Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals. We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure. All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses. A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs 876/2254, 38.9%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P=.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA1c], lower C-reactive protein levels) than the nonresponse group. More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.

The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies' Soft Impacts into Account.

Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials.

Enhancing online learning environments through real-time social presence dashboards

Online learning is promoted to play a pivotal role in the future of education, necessitating a focus on student engagement and interactivity as essential components for successful online educational environments. Social presence, as a construct capturing these social aspects, is extensively recognized, and investigated within the realm of education and widely shaping the online learning experience. However, a crucial gap remains in the absence of a real-time measurement of social presence.Drawing from prior research, this study identifies indicators derived from social network analysis as promising metrics for assessing social presence in online learning environments. What remains unclear is the means to effectively convey this information to instructors, enabling them to enhance the educational online experience. To address this gap, we conducted focus groups involving seven experts in online education and pedagogical expertise.Our findings reveal that the development of a social presence dashboard holds immense potential for enriching the online teaching experiences through the utilization of these identified indicators. Furthermore, incorporating additional visualizations and graphical representations with such dashboards can equip online instructors with the necessary insights to foster social interactions and capture real-time social dynamics within online courses.However, the implementation of such dashboards necessitates a careful consideration of important ethical and practical considerations, including informed consent procedures, student monitoring practices, and adherence to ethical standards. This research contributes valuable insights into the ongoing discourse on improving online education by leveraging technology to enhance social presence and pedagogical effectiveness.

A Single-Center Study on Clinico-Radiological Evaluation of Inguino-Scrotal or Labial Swellings Presenting to a Tertiary Care Set-Up in Central India.

Introduction The inguino-scrotal/labial region, anatomically defined as the juncture where the thigh meets the lower abdomen, encompassing the ipsilateral scrotal area in men and the inguino-labial area in women, exhibits a broad spectrum of masses. Traditionally, these swellings were clinically diagnosed with high accuracy, primarily due to the prevalence of simple hernias and hydroceles. However, contemporary observations reveal a surge in complex inguino-scrotal/labial swellings, particularly in referral hospitals, necessitating additional radiological and imaging modalities for precise diagnosis. Our interest in this subject was sparked by the escalating numbers of intricate inguino-scrotal/labial masses encountered in our medical setting, posing challenges for clinical diagnosis in both pediatric and adult populations. Materials and methods A prospective, observational study was conducted over two years (August 2021 to March 2023) involving 210 patients presenting with inguino-scrotal/labial swellings at our institute. Clinical data were meticulously collected using a designed pro forma, following informed consent procedures. Results Among the 210 patients with inguino-scrotal/labial swellings, males predominated (194) compared to females (16). The paediatric age group comprised 84 patients, while 126 were adults. Radiological investigations played a crucial role in diagnosing 40 patients and provided significant additional information in 12 cases. Radiological investigations contributed to the diagnosis in 52 patients (24.76%). The study revealed a spectrum of new entities in the inguino-scrotal/labial region, including malignancies, lymph nodal masses in the groin, and vascular, inflammatory, and congenital lesions, which might have been overlooked if solely relying on clinical parameters for diagnosis. Conclusion Inguino-scrotal/labial swelling patients, especially those facing diagnostic dilemmas or harbouring complex lesions, should undergo radiological assessment as an indispensable criterion, particularly when such facilities are readily accessible.

Informed Consent Procedures in Persons with Mental Disorders: A Juridical Review

No field escapes in the context of law, including, in this case, health, so in the law itself, it is known as health law as a branch of science. Health itself is not only in the physical context but also mental, but what if the person with a mental disorder is physically ill? Of course, it requires a doctor's action consent or informed consent from the person with the mental disorder. In law, proficiency is known as a condition for the validity of an agreement, and people with mental disorders are not included in the clever person. So, in the research article, researchers are interested in analysing and knowing how favourable laws that regulate are related to informed consent in Indonesia and how legal procedures are related to informed consent in laws and regulations in Indonesia for patients with mental disorders. The method that researchers use is the normative method. In this article, it was later found that first, informed consent itself is regulated in Law Number 17 of 2023 concerning Health, which was formed by the omnibus law method, and secondly that the legal procedure of informed consent for patients with mental disorders is regulated in Article 80 paragraphs (2) to paragraph (5), but does not yet have an implementing regulation, so the government must immediately form an implementing regulation.

Factors associated with the delay in informed consent procedures of patients with ST-segment elevation myocardial infarction and its influence on door-to-balloon time: a nationwide retrospective cohort study.

ST-segment elevation myocardial infarction (STEMI) is the deadliest and most time-sensitive acute cardiac event. However, failure to achieve timely informed consent is an important contributor to in-hospital delay in STEMI care in China. We investigated the factors associated with informed consent delay in patients with STEMI undergoing percutaneous coronary intervention (PCI) and the association between the delay and door-to-balloon time. We conducted a nationally representative retrospective cohort study using patient data reported by hospital-based chest pain centers from 1 January 2016 to 31 December 2020. We applied generalized linear mixed models and negative binomial regression to estimate factors independently predicting informed consent delay time. Logistic regressions were fitted to investigate the association of the informed consent delay time and door-to-balloon time, adjusting for patient characteristics. In total, 257, 510 patients were enrolled in the analysis. Mean informed consent delay time was 22.4 min (SD = 24.0), accounting for 39.3% in door-to-balloon time. Older age (≥65 years) was significantly correlated with informed consent delay time (RR: 1.034, P = 0.001). Compared with ethnic Han patients, the minority (RR: 1.146, P < 0.001) had more likelihood to extend consent giving; compared with patients who were single, longer informed consent time was found in married patients (RR: 1.054, P = 0.006). Patients with intermittent chest pain (RR: 1.034, P = 0.011), and chest pain relief (RR: 1.085, P = 0.005) were more likely to delay informed consent. As for transfer modes, EMS (RR: 1.063, P < 0.001), transfer-in (RR: 1.820, P < 0.001), and in-hospital onset (RR: 1.099, P = 0.002) all had positive correlations with informed consent delay time compared to walk-in. Informed consent delay was significantly associated with prolonged door-to-balloon time (OR: 1.002, P < 0.001). Informed consent delay is significantly associated with the door-to-balloon time which plays a crucial role in achieving better outcomes for patients with STEMI. It is essential to shorten the delay time by identifying and intervening modifiable factors that are associated with shortening the informed consent procedure in China and other countries.

Point-of-care testing and treatment of sexually transmitted and genital infections to improve birth outcomes in high-burden, low-resource settings (WANTAIM): a pragmatic cluster randomised crossover trial in Papua New Guinea

Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and bacterial vaginosis have been associated with adverse maternal and perinatal outcomes, but there is conflicting evidence on the benefits of antenatal screening and treatment for these conditions. We aimed to determine the effect of antenatal point-of-care testing and immediate treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis on preterm birth, low birthweight, and other adverse maternal and perinatal outcomes compared with current standard of care, which included symptom-based treatment without laboratory confirmation. In this pragmatic cluster randomised crossover trial, we enrolled women (aged ≥16 years) attending an antenatal clinic at 26 weeks' gestation or earlier (confirmed by obstetric ultrasound), living within approximately 1 h drive of a study clinic, and able to provide reliable contact details at ten primary health facilities and their catchment communities (clusters) in Papua New Guinea. Clusters were randomly allocated 1:1 to receive either the intervention or control (standard care) in the first phase of the trial. Following an interval (washout period) of 2-3 months at the end of the first phase, each cluster crossed over to the other group. Randomisation was stratified by province. Individual participants were informed about trial group allocation only after completing informed consent procedures. The primary outcome was a composite of preterm birth (livebirth before 37 weeks' gestation), low birthweight (<2500 g), or both, analysed according to the intention-to-treat population. This study is registered with ISRCTN Registry, ISRCTN37134032, and is completed. Between July 26, 2017, and Aug 30, 2021, 4526 women were enrolled (2210 [63·3%] of 3492 women in the intervention group and 2316 [62·8%] of 3687 in the control group). Primary outcome data were available for 4297 (94·9%) newborn babies of 4526 women. The proportion of preterm birth, low birthweight, or both, in the intervention group, expressed as the mean of crude proportions across clusters, was 18·8% (SD 4·7%) compared with 17·8% in the control group (risk ratio [RR] 1·06, 95% CI 0·78-1·42; p=0·67). There were 1052 serious adverse events reported (566 in the intervention group and 486 in the control group) among 929 trial participants, and no differences by trial group. Point-of-care testing and treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis did not reduce preterm birth or low birthweight compared with standard care. Within the subgroup of women with N gonorrhoeae, there was a substantial reduction in the primary outcome. UK Department of Health and Social Care; UK Foreign, Commonwealth and Development Office; UK Medical Research Council; the Wellcome Trust; the Australian National Health and Medical Research Council; and Swiss National Science Foundation.

A critical analysis of gender-based violence reporting and evidence building applications (GBVxTech) for capturing memory reports.

Gender-based violence (GBV) is under-reported to the authorities owing to the stigma, shame, and fear of reprisal that surrounds these crimes. To address this, there has been an influx of technologies, including mobile phone and online applications that allow victim-survivors (hereafter, victims) to document and report GBV (hereafter referred to as GBVxTech). We critically analysed the extent to which GBVxTech applications align with the scientific knowledge base on gathering accounts of crimes from victims and witnesses. We identified 41 reporting and evidence building applications from around the world but found many (n = 19) were no longer accessible. A total of 13 applications met the study criteria and were available for download. We evaluated each application on how well its design and features align with established minimum best practice standards for gathering complete and accurate accounts from witnesses and victims, such as the pre-interview instructions (e.g., setting ground rules), questioning approach (e.g., using open-ended questions), and the adequacy of security features (e.g., password protection). We found most applications employ open questions, encourage victims to report information in an independent voice, and seek to elicit information pertinent to a criminal investigation. None of the applications use leading questions. However, most applications do not establish ground rules, and many use forced-choice questions, do not time stamp the information gathered, or document when users change their answers. Many applications have limited security features, potentially compromising users' safety. Further, some applications do not provide information about how to use the app, an informed consent procedure, or data usage information. We discuss the findings and offer recommendations for future GBVxTech development.

Incentivizing Fifth-Grade Students to Pursue Science Education: A Study on Encouraging Enrollment in STEM-Specialized High Schools

“STEM-Up” is a pioneering endeavor led by Grade 12 students from Philippine Science High School – Caraga Region Campus, designed to address the challenge of low enrollment rates from Buhangin Elementary School into the Philippine Science High School (PSHS). Grounded in the imperative to cultivate future scholars from Brgy. Buhangin, Butuan City, this project aims to introduce innovative strategies to augment enrollment figures and foster academic excellence. Drawing inspiration from pertinent literature on educational outreach and student motivation, STEM-Up is structured to empower fifth-grade students by providing tailored lessons geared towards excelling in the National Competitive Examination (NCE). The project also emphasizes the importance of mentorship and guidance in nurturing young talents towards realizing their potential to contribute meaningfully to national development. The methodology employed in STEM-Up encompasses a multifaceted approach, beginning with comprehensive engagement with stakeholders, including local authorities, school administrators, and target student cohorts. Initial phases involved the formulation of informed consent procedures, the selection of participants, and the dissemination of project details to the concerned parties. Leveraging insights from educational psychology and pedagogy, the curriculum design prioritized topics aligned with NCE requirements and tailored instructional methodologies to suit the learning needs of the target demographic. Implementation strategies included regular classroom sessions supplemented by interactive workshops and mentoring sessions aimed at instilling confidence and motivation among participants. Continuous assessment and feedback mechanisms were integrated to gauge student progress and adapt instructional strategies accordingly.

Spotivey: A web application for simplified use of the Spotify application programming interface in online questionnaire studies

Everyday music listening has become an important research topic during the last decades. However, self-reporting through questionnaire surveys, the received approach for studying individual music consumption, presents methodological challenges. The rise of mobile music streaming and open application programming interfaces introduces new opportunities to address these productively. Spotivey is a free research software that integrates music streaming provider API functionalities into online surveys and in this way allows to connect digital behavioral traces with self-reported questionnaire data. The current version effortlessly retrieves comprehensive information about respondents’ past music listening on Spotify while they fill an online survey. Through an informed consent procedure, General Date Protection Regulation compliance for this new form of digital data donation is ensured. Methodical challenges include participant dropout and the need for robust statistical analysis methods. Planned future enhancements encompass expanding application programming interfaces support, enriching retrieved data with information from other music databases, and compatibility with diverse online survey design systems.

The ABOARD Cohort Panel: public involvement in a Dutch Cohort study on a personalized medicine approach for Alzheimer’s disease

AbstractBackgroundABOARD is a Dutch public‐private partnership aiming for a personalized medicine approach for Alzheimer’s disease. Within this project, the ABOARD Cohort is initiated: a national prospective data infrastructure with the objective to study the AD disease trajectory using PROMS and linked clinical data. The ABOARD Cohort Panel has been installed to provide advice on the design, execution, and direction of the study. By incorporating the perspective of potential participants the meaningfulness and accessibility of the ABOARD Cohort is ensured.MethodRecruitment for the panel has been initiated by the Dutch Brain Foundation via social media and newsletters, and approximately 300 people responded with potential interest. To further inform them, we hosted a webinar explaining the ABOARD Cohort Panel. Hereafter, respondents received an official Panel invitation and initial survey (including principles for collaboration), resulting in 59 people signing up as panellists.ResultPanel members are on average 62 years old, 78% is female, 96% has no migration background, and 52% participated in a panel before. Panellists vary in education level and geographic distribution. The majority has a personal interest in dementia (64%) and/or friends/family with dementia (62%). When asked how they would like to be involved, they indicated wanting to be involved in online questionnaires (100%), online focus groups (56%), and in‐person focus groups (36%). The majority preferred monthly questionnaires (50%) with a duration of 10‐20 minutes (52%). In the first months, panellists provided feedback in online surveys on the ABOARD Cohort information letter and informed consent form. They considered these lengthy, too difficult, and raising questions. An in‐depth live session was held with panellists to test subsequent adjustments, resulting in higher agreement rates on the informed consent procedure of the ABOARD Cohort. Panellists also advised on the communication strategy of the national ABOARD Cohort campaign, which is currently being implemented. In the coming months, panel members will test the usability of the ABOARD Cohort portal and an online cognitive test and advice on dissemination and variables that are being collected.ConclusionThe ABOARD Cohort Panel incorporates the perspective of potential participants and aims to ensure the meaningfulness and accessibility of the ABOARD Cohort.

Finding equitable solutions to the land-based sources of marine plastic pollution: Sovereignty as a double-edged sword

Marine litter is a global and transboundary pollution problem. Recent attention has focused on the impact of this issue on areas beyond national jurisdiction. In many cases, marine litter is traced to a coastal State where debris have been released into the sea. Effective and legally-binding commitments at the global level to tackle land-based sources of marine pollution are rare, in large part because of the sensitive nature of territorial sovereignty. When it comes to addressing the marine plastics crisis, sovereignty is a double-edged sword. On the one hand, the international legal regime traditionally addressing marine litter, the United Nations Convention on the Law of the Sea, does not specifically respond to, and is not able to adequately address, the issue of plastics as a land-based source of marine pollution. While it contributes to social equity by recognizing the special position of developing States in terms of capacity and need for economic development, this deference to domestic decisions is not conducive to the adoption of binding and global standards. Since a large majority of plastics in the oceans originate from land, this weakness is a major concern. On the other hand, sovereignty might contribute to a solution within the regime regulating trade in waste products: unilateral actions taken in application of sovereign powers and aimed at reducing trade in plastic waste led to major multilateral actions with the potential to reduce the issue of marine plastic pollution. In recent times, the Basel Convention on the Control of Transboundary Movements of Hazardous Waste and their Disposal has indeed become an important forum to respond to the plastic waste issue, with the potential to contribute to a solution to the marine dimension of this crisis. This regime is not perfect, especially in that its complexity and reliance on enforcement at the customs level leave ample opportunities for criminal activities to flourish. Areas for improvement include addressing the legal uncertainty regarding bilateral, regional, and multilateral agreements as well as certain key definitions; strengthening the prior informed consent procedure and the Mechanism for Promoting Implementation and Compliance; and heavily investing in capacity building and technology transfer. Nonetheless, this regime provides a widely-ratified framework to decrease trade in plastic waste considered hazardous or requiring special consideration – these two categories cover most hard-to-recycle plastics. In that sense, the Basel Convention regime has the potential to reduce mismanaged plastic waste leaking into the oceans and to contribute to social equity between States–if not domestically–by reducing the practice of wealthy countries using developing States as dumping grounds under the pretense of mutually beneficial trade in waste products.

Methodological reflections on conducting online research with people with dementia: The Good, The Bad and the Ugly

Conducting qualitative research with people with dementia (PwD) is inherently challenging due to their fluctuating mental capacity and symptom of forgetfulness. These challenges were compounded during the early phase of the COVID-19 pandemic when social distancing and lock down were enforced. This article critically discusses the researchers’ experiences on conducting online research with PwD on a sensitive topic based on an empirical study that aimed to explore the changing needs of PwD and how that affects their expectations of future. The focus is on: i) moving qualitative research to an online space, ii) the impact of joining online research on participants and iii) the impact on researcher (s). Participants were recruited via the Join Dementia Research platform. Narrative online interviews were conducted with 13 PwD and 4 dyads of PwD and carers.Moving to online interviews removed geographical barriers from researcher and participants thus making the study more accessible. The virtual elements of online interviews created a unique interaction since the researcher was simultaneously co-occupying the space virtually but not physically with participants. Disadvantages included internet connection instability and flexible informed consent procedures were required.The primary researcher's expressed identities positioned him variously as an ‘in-betweener’ which challenged the dualistic concept of researcher insiderness-outsiderness. PwD's familiar environment -their homes-appeared to enable them to take more control in the interview and potentially reduced their forgetfulness. The impact on researchers involved vicarious trauma that occurred during and after the interviews; the distress protocol was revised to include supports for the interviewer.

Significant participation bias and suboptimal cardiovascular risk management in learning healthcare systems due to non-consent

Abstract Background Computer-aided clinical decision support algorithms require continuous adjustments (learning) to account for changes in patient-characteristics, treatment(s), and outcomes, also referred to as a "Learning Healthcare System" (LHS). A LHS’s accuracy depends on adequate reflection of all patients, and participation bias may distort its effectiveness substantially. Therefore, we studied participation bias in a single center cardiovascular cohort study. Methods The cardiovascular cohort was set up as a LHS aiming for guideline-based treatment according to the individual risk profile for all cardiovascular disease patients in routine clinical care. Patients visiting an outpatient clinic for first time evaluation of a cardiovascular disease or risk factor received information on the cardiovascular cohort prior to their visit. During visit, cardiovascular risk management (CVRM) data was collected in the electronic health record (EHR) and informed consent was asked. We studied differences in characteristics between consenting, non-consenting and non-responding patients, and used multivariable logistic regression to identify determinants of non-consent. Multinomial regression was used for exploratory analyses of non-response determinants. A waiver (19/641) was obtained from the institutional review board for this study. Results In total, 2378 patients were consenting, 1907 non-consenting, and 1445 non-responding. In short, non-consent was related to higher cardiovascular risk (e.g., a cardiovascular disease history (OR 1.43, 95%CI 1.23-1.66)) and lower education (OR 0.76, 95%CI 0.60-0.97) than consent (Figure 1). Non-response, in contrast, was associated with higher physical activity (OR 1.04, 95%CI 1.01-1.08) and education level (OR 1.43, 95%CI 1.04-1.98) compared to consent. Non-consent and non-response patients were, respectively, younger and older. Presence of CVRM indicators in the EHR was 5-30% lower in non-consenting and 37-69% lower in non-responding patients compared to consenting patients. Conclusion A traditional informed consent procedure leads to participation bias in a LHS. Furthermore, it affects structured registration of CVRM indicators in the EHR, which is detrimental for the LHS feedback loop, and potentially leads to suboptimal cardiovascular risk management in patients not willing to participate. This study underlines the importance of reassessing the need of a traditional informed consent procedure for the use of routine care data in learning healthcare systems.

Developing a digital informed consent app: opportunities and challenges of a new format to inform and obtain consent in public health research

BackgroundInformed consent procedures for large population-based cohort studies should be comprehensive and easy-to-use. This is particularly challenging when participants from different socio-economic groups and multicultural ethnic backgrounds are involved. Recently, more and more studies have tried to use multimedia in informed consent procedures. We describe the development and testing of a digital informed consent app and elaborate on whether this may contribute to a comprehensive and practical procedure to obtain informed consent for public health research.MethodsIn a sample of parents with young children, we used a mixed method approach to study the user experience of an informed consent app and evaluate whether it can be used to adequately inform people and register their consent. Through semi-structured interviews we investigated participants’ experiences with and opinions about the app, with a special focus on comprehensibility of the content and the usability of the app. Information retention questions were asked to evaluate to what extent participants could recall key aspects of the provided study information.ResultsThe 30 participants in this study used the app between 4 and 15 min to give their consent. Overall, they found the app well-designed, informative and easy to use. To learn more about the study for which informed consent is asked, most of the participants chose to watch the animated film, which was generally found to convey information in a clear manner. The identification process was met with mixed reactions, with some feeling it as a secure way to give consent, while for others it contradicted their view of using data anonymously. Information retention questions showed that while all participants remembered various aspects of the study, fewer than half answered all four questions satisfactorily.ConclusionOur study shows that a well-designed informed consent app can be an effective tool to inform eligible participants and to record consents. Still, some issues remain, including trust barriers towards the identification procedure and lack of information retention in some participants. When implementing consent procedures that incorporate digital formats, it may be beneficial to also invest in a complementary face-to-face recruitment approach.

BREATHLEssness in INDIA (BREATHE-INDIA)-Study protocol for the co-design of a community breathlessness intervention in India using realist methods and intervention mapping.

Breathlessness that persists despite treatment of causal disease(s) is disabling, associated with high therapy-related costs and poor socioeconomic outcomes. Low resource countries bear a disproportionate burden of respiratory problems, often characterised by disabling breathlessness. Low-cost self-management breathlessness-targeted interventions are effective and deliverable in community settings but have been developed in high-income countries. We aim to understand how breathlessness self-management works in 'real life' populations and cultural contexts, to develop programme theory and co-design a prototype intervention to improve persistent breathlessness management in India. Using a Realist approach, Intervention Mapping and the Medical Research Council Complex Intervention Framework we will undertake two phases of work supported by our Expert Group (of respiratory, primary, palliative care physicians) and key stakeholder groups (opinion leader clinicians, community health workers and people with lived experiences of breathlessness). 1) Realist review and evaluation to identify and refine evidence and theory for breathlessness self-management, producing intervention and implementation programme theory. We will identify literature through our Expert Group, scoping searches and systematic searches (Medline, Ebscohost, CINAHL, Scopus, Psychinfo). We will map intervention components to 'what works, for whom, and where.' 2) Intervention development using Intervention Mapping to map intervention and implementation programme theory to intervention components, develop materials to support intervention delivery, and co-design a prototype educational intervention ready for early acceptability and delivery-feasibility testing and evaluation planning in India. Use of stakeholder groups is to allow people with experience of breathlessness and/or its management to contribute their views on content developed by our team based upon review of secondary data sources. Experts and Stakeholders are therefore not research subjects but are included as extended members of the study team and will not follow informed consent procedures. Experts and stakeholders will be acknowledge in outputs arising from our project if they wish to be. Our review conduct will be consistent with RAMESES quality standards. At the conclusion of our study, we will have co-designed a breathlessness intervention for use in the community setting in India ready for further evaluation of: effectiveness, socioeconomic outcomes, acceptability and transferability to other low resource settings.