Can evidence drive health equity in the COVID-19 pandemic and beyond?

Using scoping review methods, we systematically searched multiple online databases for publications in the first year of the pandemic that proposed pragmatic population or health system-level solutions to health inequities. We found 77 publications with proposed solutions to pandemic-related health inequities. Most were commentaries, letters, or editorials from the USA, offering untested solutions, and no robust evidence on effectiveness. Some of the proposed solutions could unintentionally exacerbate health inequities. We call on health policymakers to co-create, co-design, and co-produce equity-focussed, evidence-based interventions with communities, focussing on those most at risk to protect the population as a whole. Epidemiologists collaborating with people from other relevant disciplines may provide methodological expertise for these processes. As epidemiologists, we must interrogate our own methods to avoid propagating any unscientific biases we may hold. Epidemiology must be used to address, and never exacerbate, health inequities-in the pandemic and beyond.

Acceptability of a Hypothetical Reduction in Routinely Scheduled Clinic Visits Among Patients With History of a Localized Melanoma (MEL-SELF): Pilot Randomized Clinical Trial.

BACKGROUND: After treatment for a localized melanoma, patients attend routinely scheduled clinics to monitor for new primary or recurrent melanoma. Patient-led surveillance (skin self-examination with patient-performed teledermoscopy) is an alternative model of follow-up that could replace some routinely scheduled visits. OBJECTIVE: This study aims to assess the acceptability of a hypothetical reduction in routinely scheduled visits among participants of the Melanoma Self Surveillance (MEL-SELF) pilot randomized clinical trial of patient-led surveillance (intervention) versus usual care (control). METHODS: Patients previously treated for localized melanoma in New South Wales who were participating in the MEL-SELF pilot randomized clinical trial were asked to respond to a web-based questionnaire at baseline and after 6 months on trial. We used mixed methods to analyze the data. The main outcome of interest was the acceptability of a hypothetical reduction in routinely scheduled visits for melanoma surveillance. RESULTS: Of 100 randomized participants, 87 answered the questionnaire at baseline, 66 answered the questionnaire at 6 months, and 79 provided a free-text explanation at either time point. At 6 months, 33% (17/51) of the control group and 35% (17/49) of the intervention group indicated that a hypothetical reduction in routinely scheduled visits with all melanoma doctors was at least slightly acceptable (difference in proportions -1%, 95% CI -20% to 17%; P=.89). Participants suggested that prerequisites for a reduction in routinely scheduled visits would include that sufficient time had elapsed since the previous diagnosis without a new primary melanoma or recurrence, an unscheduled appointment could be made at short notice if the patient noticed something concerning, their melanoma doctor had suggested reducing their clinic visit frequency, and patients had confidence that patient-led surveillance was a safe and effective alternative. Participants suggested that a reduction in routinely scheduled visits would not be acceptable where they perceived a very high risk of new or recurrent melanoma, low self-efficacy in skin self-examination and in the use of technologies for the patient-led surveillance intervention, and where they had a preference for clinician-led surveillance. Some patients said that a partial reduction to once a year may be acceptable. CONCLUSIONS: Some patients may be receptive to a reduction in routinely scheduled visits if they are assured that patient-led surveillance is safe and effective. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616001716459; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371865&isReview=true; ClinicalTrials.gov NCT03581188; https://clinicaltrials.gov/ct2/show/NCT03581188. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1001/jamadermatol.2021.4704.

Strategies to Improve Adherence to Skin Self-examination and Other Self-management Practices in People at High Risk of Melanoma: A Scoping Review of Randomized Clinical Trials.

Importance: Adherence, both in research trials and in clinical practice, is crucial to the success of interventions. There is limited guidance on strategies to increase adherence and the measurement and reporting of adherence in trials of melanoma self-management practices. Objective: This scoping review aimed to describe (1) strategies to improve adherence to self-management practices in randomized clinical trials of people at high risk of melanoma and (2) measurement and reporting of adherence data in these trials. Evidence Review: Four databases, including MEDLINE, Embase, CENTRAL, and CINAHL, were searched from inception to July 2022. Eligible studies were randomized clinical trials of self-monitoring interventions for early detection of melanoma in people at increased risk due to personal history (eg, melanoma, transplant, dysplastic naevus syndrome), family history of melanoma, or as determined by a risk assessment tool or clinical judgment. Findings: From 939 records screened, 18 eligible randomized clinical trials were identified, ranging in size from 40 to 724 participants, using a range of adherence strategies but with sparse evidence on effectiveness of the strategies. Strategies were classified as trial design (n = 15); social and economic support (n = 5); intervention design (n = 18); intervention and condition support (n = 10); and participant support (n = 18). No strategies were reported for supporting underserved groups (eg, people who are socioeconomically disadvantaged, have low health literacy, non-English speakers, or older adults) to adhere to self-monitoring practices, and few trials targeted provider (referring to both clinicians and researchers) adherence (n = 5). Behavioral support tools included reminders (n = 8), priority-setting guidance (n = 5), and clinician feedback (n = 5). Measurement of adherence was usually by participant report of skin self-examination practice with some recent trials of digital interventions also directly measuring adherence to the intervention through website or application analytic data. Reporting of adherence data was limited, and fewer than half of all reports mentioned adherence in their discussion. Conclusions and Relevance: Using an adaptation of the World Health Organization framework for clinical adherence, this scoping review of randomized clinical trials identified key concepts as well as gaps in the way adherence is approached in design, conduct, and reporting of trials for skin self-examination and other self-management practices in people at high risk of melanoma. These findings may usefully guide future trials and clinical practice; evaluation of adherence strategies may be possible using a Study Within A Trial (SWAT) framework within host trials.

Establishing therapeutic and supportive relationships throughout delivery of a school-based group parenting program via telehealth: Exploring causal pathways.

Background: Access to specialised early intervention mental health services for children, including group counselling for parents/carers, is still a challenge in non-metropolitan areas of Australia. Aim: To gain understanding of the acceptability of a school-based targeted parenting group program delivered via telehealth by exploring the experiences of parents/carers, clinicians and school staff, and asking what works, how, why and in what circumstances. Methods: Caregivers, clinicians and school staff involved in the delivery of a mental health program via telehealth into primary schools in two rural Local Health Districts (LHDs) in southern New South Wales (NSW) were invited to participate in interviews and/or focus group discussions. Thematic analysis of the data was conducted with reference to realist theory. Findings: We conducted semi-structured interviews with 12 caregivers, five semi-structured interviews and two focus group discussions with school staff from six participating schools, and three focus groups with seven clinicians who delivered the intervention. We found that the intervention and micro contexts interacted to influence acceptability by initiating or enhancing cohesion among caregivers, establishing channels of communication between caregivers and teachers, and connection between caregivers and clinicians despite geographic distance. Several adaptations were made to strengthen the therapeutic alliance between caregivers and clinicians. Conclusion: Relationships crucial to the success of delivering psychological group counselling were established. Regional community contexts can facilitate acceptability of parenting group counselling delivered into schools via telehealth. Implementation of the program was flexible enough to allow clinicians to adjust their approach and materials to better suit the telehealth modality.

Inappropriate supply of antibiotics for common viral infections by community pharmacies in Vietnam: A standardised patient survey.

Background: This study aimed to evaluate the appropriateness of antibiotic dispensing of private pharmacies in Vietnam. Methods: Standardised patient surveys were conducted in randomly selected community pharmacies across 40 districts in Vietnam. Four clinical scenarios were represented by patient actors: (a) an adult requesting treatment for a sibling with a viral upper respiratory tract infection (URTI), (b) a parent requesting treatment for a child with acute diarrhoea, (c) an adult making a direct antibiotic request, and (d) an adult presenting with an antibiotic prescription. We calculated the proportion of interactions that resulted in inappropriate supply of antibiotics and patient advice. Predictors of inappropriate antibiotic supply were assessed. Findings: Patient actors attended 949 pharmacies, resulting in 1266 clinical interactions. Antibiotics were inappropriately supplied to 92% (291/316) of adults requesting treatment for URTI symptoms, 43% (135/316) for children with acute diarrhoea symptoms and to 84% (267/317) of direct request for antibiotics. Only 49% of pharmacies advised patients regarding their antibiotic use. Female actors were more likely to be given antibiotics than male actors for URTI (aOR 2·71, 1·12-6·60) but not for diarrhoeal disease. Pharmacies in northern Vietnam were more likely than those in southern Vietnam to supply antibiotics without a prescription: for adult URTI (aOR=5·8, 95% CI: 2·2-14·9) and childhood diarrhoea (aOR=3·5, 95% CI: 2·0-6·0) symptoms, but less likely to dispense for direct antibiotics request. Interpretation: Inappropriate antibiotic supply was common in Vietnamese private pharmacies. Multifaceted measures are urgently needed to achieve WHO's global action plan for the optimal use of antimicrobials. Funding: This study was funded by a grant from the Australian Department of Foreign Affairs and Trade.

Self-reliance or social accountability? The raison d'être of community health committees in Nigeria.

Social justice requires that communities demand social accountability. We conducted this study to inform ongoing efforts to facilitate social accountability through community health committees in Nigeria. We theorised that committees may see themselves in two ways - as outwardly-facing ('social accountability') and/or as inwardly-facing ('self-reliance'). We analysed the minutes of their meetings, alongside interviews and group discussions with committee members, community members, health workers, and health managers in four states across Nigeria. The committees' raison d'être reflects a bias for self-reliance in three ways. First, seen as a platform for the community to co-finance health services, members tend to be the local elite who can make financial contributions. Second, in a one-sided relationship, they function more to achieve the goals of governments (e.g. to improve the uptake of services), than of the community (e.g. rights-based demands for government support). Third, their activities in the community reflect greater concern to ensure that their community makes the most of what the government has already provided (e.g. helping to drive the uptake of existing services) than asking for more. Optimising the committees for social accountability may require support by actors who do not have conflicts of interests in ensuring that they have the necessary information and strategies to demand social accountability.

Experiences of Patient-Led Surveillance, Including Patient-Performed Teledermoscopy, in the MEL-SELF Pilot Randomized Controlled Trial: Qualitative Interview Study.

BACKGROUND: Current clinician-led melanoma surveillance models require frequent routinely scheduled clinic visits, with associated travel, cost, and time burden for patients. Patient-led surveillance is a new model of follow-up care that could reduce health care use such as clinic visits and medical procedures and their associated costs, increase access to care, and promote early diagnosis of a subsequent new melanoma after treatment of a primary melanoma. Understanding patient experiences may allow improvements in implementation. OBJECTIVE: This study aims to explore patients' experiences and perceptions of patient-led surveillance during the 6 months of participation in the MEL-SELF pilot randomized controlled trial. Patient-led surveillance comprised regular skin self-examination, use of a mobile dermatoscope to image lesions of concern, and a smartphone app to track and send images to a teledermatologist for review, in addition to usual care. METHODS: Semistructured interviews were conducted with patients previously treated for melanoma localized to the skin in New South Wales, Australia, who were randomized to the patient-led surveillance (intervention group) in the trial. Thematic analysis was used to analyze the data with reference to the technology acceptance model. RESULTS: We interviewed 20 patients (n=8, 40% women and n=12, 60% men; median age 62 years). Patients who were more adherent experienced benefits such as increased awareness of their skin and improved skin self-examination practice, early detection of melanomas, and opportunities to be proactive in managing their clinical follow-up. Most participants experienced difficulty in obtaining clear images and technical problems with the app. These barriers were overcome or persevered by participants with previous experience with digital technology and with effective help from a skin check partner (such as a spouse, sibling, or friend). Having too many or too few moles decreased perceived usefulness. CONCLUSIONS: Patients with melanoma are receptive to and experience benefits from patient-led surveillance using teledermoscopy. Increased provision of training and technical support to patients and their skin check partners may help to realize the full potential benefits of this new model of melanoma surveillance.

Perspectives and Experiences of Patient-Led Melanoma Surveillance Using Digital Technologies From Clinicians Involved in the MEL-SELF Pilot Randomized Controlled Trial: Qualitative Interview Study.

BACKGROUND: The growing number of melanoma patients who need long-term surveillance increasingly exceeds the capacity of the dermatology workforce, particularly outside of metropolitan areas. Digital technologies that enable patients to perform skin self-examination and send dermoscopic images of lesions of concern to a dermatologist (mobile teledermoscopy) are a potential solution. If these technologies and the remote delivery of melanoma surveillance are to be incorporated into routine clinical practice, they need to be accepted by clinicians providing melanoma care, such as dermatologists and general practitioners (GPs). OBJECTIVE: This study aimed to explore perceptions of potential benefits and harms of mobile teledermoscopy, as well as experiences with this technology, among clinicians participating in a pilot randomized controlled trial (RCT) of patient-led melanoma surveillance. METHODS: This qualitative study was nested within a pilot RCT conducted at dermatologist and skin specialist GP-led melanoma clinics in New South Wales, Australia. We conducted semistructured interviews with 8 of the total 11 clinicians who were involved in the trial, including 4 dermatologists (3 provided teledermatology, 2 were treating clinicians), 1 surgical oncologist, and 3 GPs with qualifications in skin cancer screening (the remaining 3 GPs declined an interview). Thematic analysis was used to analyze the data with reference to the concepts of "medical overuse" and "high-value care." RESULTS: Clinicians identified several potential benefits, including increased access to dermatology services, earlier detection of melanomas, reassurance for patients between scheduled visits, and a reduction in unnecessary clinic visits. However, they also identified some potential concerns regarding the use of the technology and remote monitoring that could result in diagnostic uncertainty. These included poor image quality, difficulty making assessments from a 2D digital image (even if good quality), insufficient clinical history provided, and concern that suspicious lesions may have been missed by the patient. Clinicians thought that uncertainty arising from these concerns, together with perceived potential medicolegal consequences from missing a diagnosis, might lead to increases in unnecessary clinic visits and procedures. Strategies suggested for achieving high-value care included managing clinical uncertainty to decrease the potential for medical overuse and ensuring optimal placement of patient-led teledermoscopy within existing clinical care pathways to increase the potential for benefits. CONCLUSIONS: Clinicians were enthusiastic about the potential and experienced benefits of mobile teledermoscopy; however, managing clinical uncertainty will be necessary to achieve these benefits in clinical care outside of trial contexts and minimize potential harms from medical overuse. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12616001716459; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371865.

Assessing the Potential for Patient-led Surveillance After Treatment of Localized Melanoma (MEL-SELF): A Pilot Randomized Clinical Trial.

IMPORTANCE: Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma. OBJECTIVE: To determine whether patient-led surveillance in patients with prior localized primary cutaneous melanoma is as safe, feasible, and acceptable as clinician-led surveillance. DESIGN, SETTING, AND PARTICIPANTS: This was a pilot for a randomized clinical trial at 2 specialist-led clinics in metropolitan Sydney, Australia, and a primary care skin cancer clinic managed by general practitioners in metropolitan Newcastle, Australia. The participants were 100 patients who had been treated for localized melanoma, owned a smartphone, had a partner to assist with skin self-examination (SSE), and had been routinely attending scheduled follow-up visits. The study was conducted from November 1, 2018, to January 17, 2020, with analysis performed from September 1, 2020, to November 15, 2020. INTERVENTION: Participants were randomized (1:1) to 6 months of patient-led surveillance (the intervention comprised usual care plus reminders to perform SSE, patient-performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (the control was usual care). MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of eligible and contacted patients who were randomized. Secondary outcomes included patient-reported outcomes (eg, SSE knowledge, attitudes, and practices, psychological outcomes, other health care use) and clinical outcomes (eg, clinic visits, skin surgeries, subsequent new primary or recurrent melanoma). RESULTS: Of 326 patients who were eligible and contacted, 100 (31%) patients (mean [SD] age, 58.7 [12.0] years; 53 [53%] men) were randomized to patient-led (n = 49) or clinician-led (n = 51) surveillance. Data were available on patient-reported outcomes for 66 participants and on clinical outcomes for 100 participants. Compared with clinician-led surveillance, patient-led surveillance was associated with increased SSE frequency (odds ratio [OR], 3.5; 95% CI, 0.9 to 14.0) and thoroughness (OR, 2.2; 95% CI, 0.8 to 5.7), had no detectable adverse effect on psychological outcomes (fear of cancer recurrence subscale score; mean difference, -1.3; 95% CI, -3.1 to 0.5), and increased clinic visits (risk ratio [RR], 1.5; 95% CI, 1.1 to 2.1), skin lesion excisions (RR, 1.1; 95% CI, 0.6 to 2.0), and subsequent melanoma diagnoses and subsequent melanoma diagnoses (risk difference, 10%; 95% CI, -2% to 23%). New primary melanomas and 1 local recurrence were diagnosed in 8 (16%) of the participants in the intervention group, including 5 (10%) ahead of routinely scheduled visits; and in 3 (6%) of the participants in the control group, with none (0%) ahead of routinely scheduled visits (risk difference, 10%; 95% CI, 2% to 19%). CONCLUSIONS AND RELEVANCE: This pilot of a randomized clinical trial found that patient-led surveillance after treatment of localized melanoma appears to be safe, feasible, and acceptable. Experiences from this pilot study have prompted improvements to the trial processes for the larger trial of the same intervention. TRIAL REGISTRATION: http://anzctr.org.au Identifier: ACTRN12616001716459.

How community participation in water and sanitation interventions impacts human health, WASH infrastructure and service longevity in low-income and middle-income countries: a realist review.

OBJECTIVE: To understand how, and under what circumstances community participation in water and sanitation interventions impacts the availability of safe water and sanitation, a change in health status or behaviour and the longevity of water, sanitation and hygiene (WASH) resources and services. DESIGN: Realist review. DATA SOURCES: PubMed, Web of Science and Scopus databases were used to identify papers from low-income and middle-income countries from 2010 to 2020. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Criteria were developed for papers to be included. The contribution of each paper was assessed based on its relevance and rigour (eg, can it contribute to context, mechanism or outcome, and is the method used to generate that information credible). ANALYSIS: Inductive and deductive coding was used to generate context-mechanism-outcome configurations. RESULTS: 73 studies conducted in 29 countries were included. We identified five mechanisms that explained the availability, change and longevity outcomes: (1) accountability (policies and procedures to hold communities responsible for their actions and outcomes of an intervention), (2) diffusion (spread of an idea or behaviour by innovators over time through communication among members of a community), (3) market (the interplay between demand and supply of a WASH service or resource), (4) ownership (a sense of possession and control of the WASH service or resource) and (5) shame (a feeling of disgust in one's behaviour or actions). Contextual elements identified included community leadership and communication, technical skills and knowledge, resource access and dependency, committee activity such as the rules and management plans, location and the level of community participation. CONCLUSIONS: The findings highlight five key mechanisms impacted by 19 contextual factors that explain the outcomes of community water and sanitation interventions. Policymakers, programme implementers and institutions should consider community dynamics, location, resources, committee activity and practices and nature of community participation, before introducing community water and sanitation interventions.

Drivers of antibiotic use in Vietnam: implications for designing community interventions.

INTRODUCTION: Antimicrobial resistance is a global challenge that threatens our ability to prevent and treat common infectious diseases. Vietnam is affected by high rates of antimicrobial resistant infections, driven by the overuse of antibiotics and the Vietnamese government has recognised antimicrobial resistance as a health security priority. This study aimed to understand how people in Vietnam use antibiotics in community settings, and the factors that impact their practices and decision-making regarding antibiotics. METHODS: We conducted 43 qualitative in-depth interviews with 50 community members in two urban and two rural sites in Vietnam. We conducted iterative, inductive thematic analysis alongside data collection through a process of systematic debriefings based on detailed interview summaries. Through this process, we developed a coding framework that was then applied to transcribed interview data. RESULTS: Frequent and indiscriminate use of antibiotics was driven by the powerful appeal that antibiotics held for many Vietnamese consumers. Consumers were discerning in making decisions in their purchase and use of antibiotics. Consumers' decisions were affected by perceptions of what constitutes high-quality medicine (effective, strong, accessible and affordable); privileging symptom control over diagnosis; social constructions of antibiotics as a trusted remedy with embodied evidence of prior efficacy, which is reinforced by advice from trusted sources in their community; and varied, generally incomplete, understanding of the concept of antibiotic resistance and its implications for individuals and for public health. CONCLUSION: Antibiotic use at the community and primary care level in Vietnam is driven by community members' social and economic response to what constitutes effective healthcare, rather than biomedical logic. Community-based interventions to reduce unnecessary antibiotic use need to engage with the entangled socio-structural factors that 'resist' current public health efforts to ration antibiotic use, alongside biomedical drivers. This study has informed the design of a community-based trial to reduce unnecessary antibiotic use.

Can patient-led surveillance detect subsequent new primary or recurrent melanomas and reduce the need for routinely scheduled follow-up? A protocol for the MEL-SELF randomised controlled trial.

BACKGROUND: Most subsequent new primary or recurrent melanomas might be self-detected if patients are trained to systematically self-examine their skin and have access to timely medical review (patient-led surveillance). Routinely scheduled clinic visits (clinician-led surveillance) is resource-intensive and has not been shown to improve health outcomes; fewer visits may be possible if patient-led surveillance is shown to be safe and effective. The MEL-SELF trial is a randomised controlled trial comparing patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma. METHODS: Stage 0/I/II melanoma patients (n = 600) from dermatology, surgical, or general practice clinics in NSW Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n = 300) or control (usual care, n = 300). Patients in the intervention will undergo a second randomisation 1:1 to polarised (n = 150) or non-polarised (n = 150) dermatoscope. Patient-led surveillance comprises an educational booklet, skin self-examination (SSE) instructional videos; 3-monthly email/SMS reminders to perform SSE; patient-performed dermoscopy with teledermatologist feedback; clinical review of positive teledermoscopy through fast-tracked unscheduled clinic visits; and routinely scheduled clinic visits following each clinician's usual practice. Clinician-led surveillance comprises an educational booklet and routinely scheduled clinic visits following each clinician's usual practice. The primary outcome, measured at 12 months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma at an unscheduled clinic visit. Secondary outcomes include time from randomisation to diagnosis (of a subsequent new primary or recurrent melanoma and of a new keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), psychological outcomes, and healthcare use. A nested qualitative study will include interviews with patients and clinicians, and a costing study we will compare costs from a societal perspective. We will compare the technical performance of two different models of dermatoscope (polarised vs non-polarised). DISCUSSION: The findings from this study may inform guidance on evidence-based follow-up care, that maximises early detection of subsequent new primary or recurrent melanoma and patient wellbeing, while minimising costs to patients, health systems, and society. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864 . Registered on 18 February 2021.

Implementation of Medication Event Reminder Monitors among patients diagnosed with drug susceptible tuberculosis in rural Viet Nam: A qualitative study.

BACKGROUND: Despite the criticality of adherence to tuberculosis treatment, there is paucity of rigorous experimental research exploring the efficacy of interventions to promote adherence and a greater lack of inquiry addressing the integral role of adherence behaviour. The aim of this formative study was to examine the way in which the Wisepill evriMED Medication Event Reminder Monitor (MERM) was used among outpatients with drug susceptible pulmonary tuberculosis. METHODS: In depth interviews were conducted with 20 outpatients receiving treatment from two public healthcare facilities in Thanh Hoa, a rural province in northern Viet Nam. Patients had been enrolled in a randomized controlled trial evaluating the effect of using the MERM device upon adherence for between 1-3 months. The control group used the device without an alert, while the intervention group used the device with a daily alert and scheduled dosing history review. FINDINGS: All 20 patients interviewed were supportive of using the MERM device. Those able to be at home at the time that their treatment was due (50%) used the device as intended. Patients who worked all reported separating the time when the box was opened from the time at which they ingested their medication. Patients expressed fidelity to the prescribed medication taking time and concerns regarding the portability of the device. Limitations of the study surround the inclusion of a small sample population that did not experience factors that further compromise adherence. CONCLUSIONS: Data recorded by the box did not always accurately reflect usage patterns. The alert in the intervention arm was able to support adherence only in patients who did not work while completing their treatment. MERM implementation can be improved by better aligning prescriber instructions with patients' daily routines, and increasing the use of adherence data to guide adherence support practices. Healthcare staff need to be aware of potential barriers to optimal use of MERM devices. A rigorous qualitative approach to formative assessment is essential to inform the scale up of new digital technologies.