Establishing Requirements for Technology to Support Clinical Trial Retention: Systematic Scoping Review and Analysis Using Self-determination Theory.

BACKGROUND: Retaining participants in clinical trials is an established challenge. Currently, the industry is moving to a technology-mediated, decentralized model for running trials. The shift presents an opportunity for technology design to aid the participant experience and promote retention; however, there are many open questions regarding how this can be best supported. We advocate the adoption of a stronger theoretical position to improve the quality of design decisions for clinical trial technology to promote participant engagement. OBJECTIVE: This study aimed to identify and analyze the types of retention strategies used in published clinical trials that successfully retain participants. METHODS: A systematic scoping review was carried out on 6 electronic databases for articles published from 1990 to September 2020, namely CINAHL, The Cochrane Library, EBSCO, Embase, PsycINFO, and PubMed, using the concepts "retention," "strategy," "clinal trial," and "clinical research." This was followed by an analysis of the included articles through the lens of self-determination theory, an evidence-based theory of human motivation. RESULTS: A total of 26 articles were included in this review. The motivational strategies identified in the clinical trials in our sample were categorized into 8 themes: autonomy; competence; relatedness; controlled motivation; branding, communication material, and marketing literature; contact, tracking, and scheduling methods and data collection; convenience to contribute to data collection; and organizational competence. The trials used a wide range of motivational strategies. Notably, the trials often relied on controlled motivation interventions and underused strategies to support intrinsic motivation. Moreover, traditional clinical trials relied heavily on human interaction and "relatedness" to support motivation and retention, which may cause problems in the move to technology-led decentralized trials. We found inconsistency in the data-reporting methods and that motivational theory-based approaches were not evident in strategy design. CONCLUSIONS: This study offers direction and a framework to guide digital technology design decisions for future decentralized clinical trials to enhance participant retention during clinical trials. This research defines previous clinical trial retention strategies in terms of participant motivation, identifies motivational strategies, and offers a rationale for selecting strategies that will improve retention. It emphasizes the benefits of using theoretical frameworks to analyze strategic approaches and aid decision-making to improve the quality of technology design decisions.

Mitigating the Impact of the COVID-19 Pandemic on Adult Cancer Patients through Telehealth Adoption: A Systematic Review.

During the first wave of the COVID-19 pandemic, the delivery of life-saving and life-prolonging health services for oncology care and supporting services was delayed and, in some cases, completely halted, as national health services globally shifted their attention and resources towards the pandemic response. Prior to March 2020, telehealth was starting to change access to health services. However, the onset of the global pandemic may mark a tipping point for telehealth adoption in healthcare delivery. We conducted a systematic review of literature published between January 2020 and March 2021 examining the impact of the COVID-19 pandemic on adult cancer patients. The review's inclusion criteria focused on the economic, social, health, and psychological implications of COVID-19 on cancer patients and the availability of telehealth services emerged as a key theme. The studies reviewed revealed that the introduction of new telehealth services or the expansion of existing telehealth occurred to support and enable the continuity of oncology and related services during this extraordinary period. Our analysis points to several strengths and weaknesses associated with telehealth adoption and use amongst this cohort. Evidence indicates that while telehealth is not a panacea, it can offer a "bolstering" solution during a time of disruption to patients' access to essential cancer diagnostic, treatment, and aftercare services. The innovative use of telehealth has created opportunities to reimagine the delivery of healthcare services beyond COVID-19.

Effectiveness of Smartphone-Based Community Case Management on the Urgent Referral, Reconsultation, and Hospitalization of Children Aged Under 5 Years in Malawi: Cluster-Randomized, Stepped-Wedge Trial.

BACKGROUND: Integrated community case management (CCM) has led to reductions in child mortality in Malawi resulting from illnesses such as malaria, pneumonia, and diarrhea. However, adherence to CCM guidelines is often poor, potentially leading to inappropriate clinical decisions and poor outcomes. We determined the impact of an e-CCM app on the referral, reconsultation, and hospitalization rates of children presenting to village clinics in Malawi. OBJECTIVE: We determined the impact of an electronic version of a smartphone-based CCM (e-CCM) app on the referral, reconsultation, and hospitalization rates of children presenting to village clinics in Malawi. METHODS: We used a stepped-wedge, cluster-randomized trial to compare paper-based CCM (control) with and without the use of an e-CCM app on smartphones from November 2016 to February 2017. A total of 102 village clinics from 2 districts in northern Malawi were assigned to 1 of 6 clusters, which were randomized on the sequencing of the crossover from the control phase to the intervention phase as well as the duration of exposure in each phase. Children aged ≥2 months to <5 years who presented with acute illness were enrolled consecutively by health surveillance assistants. The primary outcome of urgent referrals to higher-level facilities was evaluated by using multilevel mixed effects models. A logistic regression model with the random effects of the cluster and the fixed effects for each step was fitted. The adjustment for potential confounders included baseline factors, such as patient age, sex, and the geographical location of the village clinics. Calendar time was adjusted for in the analysis. RESULTS: A total of 6965 children were recruited-49.11% (3421/6965) in the control phase and 50.88% (3544/6965) in the intervention phase. After adjusting for calendar time, children in the intervention phase were more likely to be urgently referred to a higher-level health facility than children in the control phase (odds ratio [OR] 2.02, 95% CI 1.27-3.23; P=.003). Overall, children in the intervention arm had lower odds of attending a repeat health surveillance assistant consultation (OR 0.45, 95% CI 0.34-0.59; P<.001) or being admitted to a hospital (OR 0.75, 95% CI 0.62-0.90; P=.002), but after adjusting for time, these differences were not significant (P=.07 for consultation; P=.30 for hospital admission). CONCLUSIONS: The addition of e-CCM decision support by using smartphones led to a greater proportion of children being referred to higher-level facilities, with no apparent increase in hospital admissions or repeat consultations in village clinics. Our findings provide support for the implementation of e-CCM tools in Malawi and other low- and middle-income countries with a need for ongoing assessments of effectiveness and integration with national digital health strategies. TRIAL REGISTRATION: ClinicalTrials.gov NCT02763345; https://clinicaltrials.gov/ct2/show/NCT02763345.

Reducing drug-use harms among higher education students: MyUSE contextual-behaviour change digital intervention development using the Behaviour Change Wheel.

BACKGROUND: Digital harm-reduction interventions typically focus on people with severe drug-use problems, yet these interventions have moderate effectiveness on drug-users with lower levels of risk of harm. The difference in effectiveness may be explained by differences in behavioural patterns between the two groupings. Harnessing behavioural theories to understand what is at the core of drug-use behaviours and mapping the content of new interventions, may improve upon the effectiveness of interventions for lower-risk drug-users. To the best of our knowledge, this is the first study to systematically apply the Behaviour Change Wheel (BCW) approach to understand the components, influencing capabilities, opportunities, and motivations (COM-B) of higher education students to change their drug-use behaviors. It is also the first study which identifies specific patterns of behaviours that are more responsive to harm reduction practices through the use of the Theoretical Domain Framework (TDF). METHODS: We employed an explanatory sequential mix-method design. We first conducted an on-line survey and a Delphi exercise to understand the factors influencing COM-B components of higher education students to change their drug-use. Subsequently, we mapped all evidence onto the COM-B components and the TDF domains to identify clusters of behaviours to target for change, using a pattern-based discourse analysis. Finally, a series of multidisciplinary group meetings identified the intervention functions-the means by which the intervention change targeted behaviours and the Behavioural Change Techniques (BCTs) involved using the behaviour change technique taxonomy (v.1). RESULTS: Twenty-nine BCTs relevant to harm-reduction practices were identified and mapped across five intervention functions (education, modelling, persuasion, incentivization, and training) and five policy categories (communication/marketing, guidelines, regulation, service provision, and environmental/social planning). These BCTs were distributed across eight identified saturated clusters of behaviours MyUSE intervention attempts to change. CONCLUSIONS: The BCTs, identified, will inform the development of a digitally delivered behaviour change intervention that focuses on increasing mindful decision-making with respect to drug-use and promotes alternatives to drug-use activities. The findings can also inform implementation scientists in applying context-specific harm-reduction practices in higher education. We present examples of how the eight identified clusters of target behaviours are mapped across the COM-B components and the TDF, along with suggestions of implementation practices for harm reduction at student population level.

End-user perspectives of two mHealth decision support tools: Electronic Community Case Management in Northern Malawi.

BACKGROUND: The introduction of a paper-based Community Case Management (CCM) in Malawi has contributed to a reduction of child morbidity and mortality rates. In addition, the introduction of electronic Community Case Management (eCCM) (smartphones with built in CCM apps) may help to reduce the under-five mortality rates even further. PURPOSE: It is not uncommon for Apps with a similar area of interest to develop different features to assist the end users. Such differences between Apps may have a significant role to play in its overall adoption and integration. The purpose of this research was to explore end users perspectives of two eCCM decision support tools developed and implemented by the Supporting LIFE project (SL eCCM App) and D-Tree International's (Mangologic eCCM App)in Northern Malawi. METHODS: A mixed methods approach was applied, involving a survey of 109 users (106 Health Surveillance Assistants (HSAs), and 3 Integrated Management of Childhood Il6lnesses (IMCI) coordinators). This was followed up with semi-structured interviews with 34 respondents (31 HSAs, and 3 IMCI coordinators). Quantitative data was analyzed using SPSS version 20 where descriptive statistics and Chi-Squared tests were generated. Qualitative data were analyzed based on thematic analysis. RESULTS: Participants reported that both Apps could assist the HSAs in the management of childhood illnesses. However, usability differed between the two apps where the Supporting LIFE eCCM App was found to be easier to use (61%) compared to the Mangologic eCCM App (4%). Both Apps were perceived to provide credible and accurate information. CONCLUSION: It is essential that the quality of the data within Mobile Health (mHealth) Apps is high, however even Apps with excellent levels of data quality may not succeed if the overall usability of the App is low. Therefore it is essential that the Apps has high levels of data quality, usability and credibility. The results of this study will help inform mobile Health (mHealth) App designers in developing future eCCM Apps as well as researchers and policy makers when considering the adoption of mHealth solutions in the future in Malawi and other LMICs.

A Digital Substance-Use Harm Reduction Intervention for Students in Higher Education (MyUSE): Protocol for Project Development.

BACKGROUND: Digital interventions have been identified as a possible tool for reducing the harm caused by illicit drug use among students attending higher education (ie, college students). However, the success of interventions in this area has been hampered by a lack of user involvement and behavior change theory in their design. The My Understanding of Substance use Experiences (MyUSE) project combines a rigorous user-centered design (UCD) methodology and a robust behavioral change framework to develop a digitally delivered harm reduction intervention for illicit drug use among students in higher education. OBJECTIVE: This project aims to design and develop a digital intervention that targets drug use-related harm among students in higher education. METHODS: The MyUSE project will take place over 3 phases. The first phase was exploratory in nature, involving 3 systematic reviews, a large survey, and student workshops to gather a comprehensive evidence base to guide the project. The second phase is the development stage of the project, involving the use of the Behavior Change Wheel theoretical framework to determine the behavior change techniques of the intervention and the use of the UCD methodology to guide the development of the digital intervention. The third phase is the evaluation stage, whereby the intervention will undergo a 5-stage evaluation process to comprehensively evaluate its impacts. RESULTS: The exploratory phase 1 of the MyUSE project was completed in December 2018. Phase 2 is currently underway, and phase 3 is due to begin in September 2020. CONCLUSIONS: Higher education institutions (HEIs) are ideally placed to intervene and support students in the area of illicit drug use but are constrained by limited resources. Current digital interventions in this area are sparse and have several weaknesses. The MyUSE project combines a UCD approach with a robust behavior change framework to develop a digitally delivered intervention that is economically viable, effective in changing behavior, usable and acceptable to students, and able to sustain long-term implementation in HEIs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17829.

Are we on the same page? Exploring stakeholders' shared mental models of mobile health in rural Nigeria.

Despite the benefits promised by mobile health, the introduction of these solutions is often met with resistance from various stakeholders. This article adopts a shared mental model approach to unearth the current perceptions, concerns, and mentalities of key stakeholders engaged in the provision of healthcare in Nigeria. These include policy makers, academics, healthcare professionals, and health information systems developers. Interviews and focus groups were used to examine stakeholders' views across three mental models: (1) the technology, (2) processes, and (3) the team. Our investigations reveal disparities in stakeholders' existing mental models and their perceptions of the proposed mobile health solution. We argue that fostering a common understanding of mobile health, as well as elucidating an improved understanding of processes and team behaviours, will mitigate the risk of resistance among stakeholders involved in the design and delivery of community healthcare services and culminate in a positive attitude towards new mobile health solutions among these stakeholders. We highlight the need to enhance communication and training from national to rural levels to promote complementary mental models and positively influence team performance.

Considerations for Improved Mobile Health Evaluation: Retrospective Qualitative Investigation.

BACKGROUND: Mobile phone use and, consequently, mobile health (mHealth) interventions have seen an exponential increase in the last decade. There is an excess of 318,000 health-related apps available free of cost for consumers to download. However, many of these interventions are not evaluated and are lacking appropriate regulations. Randomized controlled trials are often considered the gold standard study design in determining the effectiveness of interventions, but recent literature has identified limitations in the methodology when used to evaluate mHealth. OBJECTIVE: The objective of this study was to investigate the system developers' experiences of evaluating mHealth interventions in the context of a developing country. METHODS: We employed a qualitative exploratory approach, conducting semistructured interviews with multidisciplinary members of an mHealth project consortium. A conventional content analysis approach was used to allow codes and themes to be identified directly from the data. RESULTS: The findings from this study identified the system developers' perceptions of mHealth evaluation, providing an insight into the requirements of an effective mHealth evaluation. This study identified social and technical factors which should be taken into account when evaluating an mHealth intervention. CONCLUSIONS: Contextual issues represented one of the most recurrent challenges of mHealth evaluation in the context of a developing country, highlighting the importance of a mixed method evaluation. There is a myriad of social, technical, and regulatory variables, which may impact the effectiveness of an mHealth intervention. Failure to account for these variables in an evaluation may limit the ability of the intervention to achieve long-term implementation and scale.

Face Masks During the COVID-19 Pandemic: A Simple Protection Tool With Many Meanings.

Wearing face masks is recommended as part of personal protective equipment and as a public health measure to prevent the spread of coronavirus disease 2019 (COVID-19) pandemic. Their use, however, is deeply connected to social and cultural practices and has acquired a variety of personal and social meanings. This article aims to identify the diversity of sociocultural, ethical, and political meanings attributed to face masks, how they might impact public health policies, and how they should be considered in health communication. In May 2020, we involved 29 experts of an interdisciplinary research network on health and society to provide their testimonies on the use of face masks in 20 European and 2 Asian countries (China and South Korea). They reflected on regulations in the corresponding jurisdictions as well as the personal and social aspects of face mask wearing. We analyzed those testimonies thematically, employing the method of qualitative descriptive analysis. The analysis framed the four dimensions of the societal and personal practices of wearing (or not wearing) face masks: individual perceptions of infection risk, personal interpretations of responsibility and solidarity, cultural traditions and religious imprinting, and the need of expressing self-identity. Our study points to the importance for an in-depth understanding of the cultural and sociopolitical considerations around the personal and social meaning of mask wearing in different contexts as a necessary prerequisite for the assessment of the effectiveness of face masks as a public health measure. Improving the personal and collective understanding of citizens' behaviors and attitudes appears essential for designing more effective health communications about COVID-19 pandemic or other global crises in the future.    To wear a face mask or not to wear a face mask?    Nowadays, this question has been analogous    to the famous line from Shakespeare's Hamlet:    "To be or not to be, that is the question."    This is a bit allegorical,    but certainly not far from the current circumstances    where a deadly virus is spreading amongst us... Vanja Kopilas, Croatia.

A systematic review of the effectiveness of digital interventions for illicit substance misuse harm reduction in third-level students.

BACKGROUND: Illicit substance misuse is a growing public health problem, with misuse peaking among 18-25 year-olds, and attendance at third-level education identified as a risk factor. Illicit substance misuse has the potential to harm mental and physical health, social relationships, and impact on academic achievements and future career prospects. Digital interventions have been identified as a vehicle for reaching large student populations and circumventing the limited capacity of student health services for delivering face-to-face interventions. Digital interventions have been developed in the area of alcohol and tobacco harm reduction, reporting some effectiveness, but the evidence for the effectiveness of digital interventions targeting illicit substance misuse is lacking. This review aims to systematically identify and critically appraise studies examining the effectiveness of digital interventions for illicit substance misuse harm reduction in third-level students. METHODS: We systematically searched ten databases in April 2018 using keywords and database specific terms under the pillars of "mHealth," "substance misuse," and "student." To be eligible for inclusion, papers had to present a measure of illicit substance misuse harm reduction. Included articles were critically appraised and included in the qualitative synthesis regardless of quality. RESULTS: A total of eight studies were included in the qualitative synthesis. Studies reported harm reduction in terms of substance misuse or initiation, as consequences or problems associated with substance misuse, or as correction of perceived social norms. Overall, five out of the eight studies reported at least one positive outcome for harm reduction. The critical appraisal indicated that the study quality was generally weak, predominantly due to a lack of blinding of study participants, and the use of self-reported substance misuse measures. However, results suggest that digital interventions may produce a modest reduction in harm from illicit substance misuse. CONCLUSIONS: The results of this review are positive, and support the need for further high-quality research in this area, particularly given the success of digital interventions for alcohol and tobacco harm reduction. However, very few studies focused solely on illicit substances, and those that did targeted only marijuana. This suggests the need for further research on the effectiveness of this type of intervention for other illicit substances. TRIAL REGISTRATION: This review is registered on PROSPERO, ID number: CRD42018097203 .

People Welcomed This Innovation with Two Hands: A Qualitative Report of an mHealth Intervention for Community Case Management in Malawi.

INTRODUCTION: Community Case Management (CCM) aims to improve health outcomes among children under five with malaria, diarrhea, and pneumonia, but its effectiveness in Malawi is limited by inconsistent standards of delivery characteristic of paper-based interventions. This may lead to negative impacts on child health outcomes and inefficient use of health system resources. This study evaluated the acceptability and impact of the Supporting LIFE Community Case Management App (SL eCCM App) by Health Surveillance Assistants (HSAs) and caregivers in two districts of Northern Malawi. METHODS: Data were collected through semi-structured interviews with HSAs and caregivers as part of a nested study within a larger trial. We used deductive and inductive approaches during data analysis. Relevant constructs were identified from the Consolidated Framework for Implementation Research and combined with emerging concepts from the data. The Framework Method was used to chart and explore data, leading to the development of themes. RESULTS: Seventeen HSAs and 28 caregivers were interviewed. Participants were generally enthusiastic about the SL eCCM App. Nearly all HSAs expressed a preference for the App over routine paper-based CCM. Most HSAs claimed the App was more reliable and less error prone, facilitated more accurate diagnoses and treatment recommendations, and enhanced professional confidence and respect in the community. Some HSAs believed additional features would improve usability of the App, others identified mobile network or electricity shortages as barriers. Not all caregivers understood the purpose of the App, but most welcomed it as a health and technological advancement. CONCLUSION: The SL eCCM App is acceptable to both HSAs and caregivers, and in most cases, preferred, as it was believed to foster improvements in CCM delivery. Our findings suggest that mobile health interventions for CCM, such as the SL eCCM App, may have potential to improve the effectiveness and efficiency of care to children under five.

Perceptions of a mobile health intervention for Community Case Management in Malawi: Opportunities and challenges for Health Surveillance Assistants in a community setting.

Background: Improved availability of mobile phones in low- and middle-income countries (LMICs) offer an opportunity to improve delivery of Community Case Management (CCM). Despite enthusiasm for introducing mHealth into healthcare across LMICs, end-user attitudes towards mHealth solutions for CCM are limited. We aimed to explore Health Surveillance Assistants' (HSAs) perceptions of the Supporting LIFE electronic CCM Application (SL eCCM App) and their experiences incorporating it as part of their clinical practice. Methods: This exploratory qualitative study was part of a mixed methods feasibility study investigating whether children under-5 presenting to village clinics could be followed-up to collect patient outcome data. The convenience sample of 12 HSAs enrolled into the feasibility study participated in semi-structured interviews, which were conducted at village clinics after HSAs had field-tested the SL eCCM App over a 10-day period. Interviews explored HSAs perceptions of the SL eCCM App and their experiences in using the App in addition to paper CCM to assess and treat acutely unwell children. Open coding was used to label emerging concepts, which were iteratively defined and developed into six key themes. Results: HSAs' perceived enhanced clinical decision-making, quality of CCM delivery, and work efficiency as opportunities associated with using the SL eCCM App. HSAs believed the inability to retrieve patient records,, cumbersome duplicate assessments/data entry study procedures, and inconsistencies between the SL eCCM App and paper-based CCM guidelines as challenges to implementation. Adding features to the App, such as, permitting communication between colleagues/supervisors, drug stock-out reporting, and community assessments, were identified as potentially supporting HSAs' many roles in the community. Conclusion: This study identified opportunities and challenges associated with using the SL eCCM App in Malawi. This information can be used to inform future development and evaluation of the SL eCCM App, and similar mHealth solutions for CCM in Malawi and other developing countries.

Mobile health solutions in developing countries: a stakeholder perspective.

Infrastructural deficiencies, limited access to medical care, and shortage of health care workers are just a few of the barriers to health care in developing countries. mHealth has the potential to overcome at least some of these challenges. To address this, a stakeholder perspective is adopted and an analysis of existing research is undertaken to look at mHealth delivery in developing countries. This study focuses on four key stakeholder groups i.e., health care workers, patients, system developers, and facilitators. A systematic review identifies 108 peer-reviewed articles, which are analysed to determine the extent these articles investigate the different types of stakeholder interactions, and to identify high-level themes emerging within these interactions. This analysis illustrates two key gaps. First, while interactions involving health care workers and/or patients have received significant attention, little research has looked at the role of patient-to-patient interactions. Second, the interactions between system developers and the other stakeholder groups are strikingly under-represented.

The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial.

BACKGROUND: There is evidence to suggest that frontline community health workers in Malawi are under-referring children to higher-level facilities. Integrating a digitized version of paper-based methods of Community Case Management (CCM) could strengthen delivery, increasing urgent referral rates and preventing unnecessary re-consultations and hospital admissions. This trial aims to evaluate the added value of the Supporting LIFE electronic Community Case Management Application (SL eCCM App) compared to paper-based CCM on urgent referral, re-consultation and hospitalization rates, in two districts in Northern Malawi. METHODS/DESIGN: This is a pragmatic, stepped-wedge cluster-randomized trial assessing the added value of the SL eCCM App on urgent referral, re-consultation and hospitalization rates of children aged 2 months and older to up to 5 years, within 7 days of the index visit. One hundred and two health surveillance assistants (HSAs) were stratified into six clusters based on geographical location, and clusters randomized to the timing of crossover to the intervention using simple, computer-generated randomization. Training workshops were conducted prior to the control (paper-CCM) and intervention (paper-CCM + SL eCCM App) in assigned clusters. Neither participants nor study personnel were blinded to allocation. Outcome measures were determined by abstraction of clinical data from patient records 2 weeks after recruitment. A nested qualitative study explored perceptions of adherence to urgent referral recommendations and a cost evaluation determined the financial and time-related costs to caregivers of subsequent health care utilization. The trial was conducted between July 2016 and February 2017. DISCUSSION: This is the first large-scale trial evaluating the value of adding a mobile application of CCM to the assessment of children aged under 5 years. The trial will generate evidence on the potential use of mobile health for CCM in Malawi, and more widely in other low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02763345 . Registered on 3 May 2016.