Regulatory Standards and Guidance for the Use of Health Apps for Self-Management in Sub-Saharan Africa: Scoping Review.

BACKGROUND: Health apps are increasingly recognized as crucial tools for enhancing health care delivery. Many countries, particularly those in sub-Saharan Africa, can substantially benefit from using health apps to support self-management and thus help to achieve universal health coverage and the third sustainable development goal. However, most health apps published in app stores are of unknown or poor quality, which poses a risk to patient safety. Regulatory standards and guidance can help address this risk and promote patient safety. OBJECTIVE: This review aims to assess the regulatory standards and guidance for health apps supporting evidence-based best practices in sub-Saharan Africa with a focus on self-management. METHODS: A methodological framework for scoping reviews was applied. A search strategy was built and applied across the following databases, gray literature sources, and institutional websites: PubMed, Scopus, World Health Organization (WHO) African Index Medicus, OpenGrey, WHO Regional Office for Africa Library, ICTworks, WHO Directory of eHealth policies, HIS Strengthening Resource Center, International Telecommunication Union, Ministry of Health websites, and Google. The search covered the period between January 2005 and January 2024. The findings were analyzed using a deductive descriptive content analysis. The policy analysis framework was adapted and used to organize the findings. The Reporting Items for Stakeholder Analysis tool guided the identification and mapping of key stakeholders based on their roles in regulating health apps for self-management. RESULTS: The study included 49 documents from 31 sub-Saharan African countries. While all the documents were relevant for stakeholder identification and mapping, only 3 regulatory standards and guidance contained relevant information on regulation of health apps. These standards and guidance primarily aimed to build mutual trust; promote integration, inclusion, and equitable access to services; and address implementation issues and poor coordination. They provided guidance on systems quality, software acquisition and maintenance, security measures, data exchange, interoperability and integration, involvement of relevant stakeholders, and equitable access to services. To enhance implementation, the standards highlight that legal authority, coordination of activities, building capacity, and monitoring and evaluation are required. A number of stakeholders, including governments, regulatory bodies, funders, intergovernmental and nongovernmental organizations, academia, and the health care community, were identified to play key roles in regulating health apps. CONCLUSIONS: Health apps have huge potential to support self-management in sub-Saharan Africa, but the lack of regulatory standards and guidance constitutes a major barrier. Hence, for these apps to be safely and effectively integrated into health care, more attention should be given to regulation. Learning from countries with effective regulations can help sub-Saharan Africa build a more robust and responsive regulatory system, ensuring the safe and beneficial use of health apps across the region. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-025714.

Assessment of Clinical Information Quality in Digital Health Technologies: International eDelphi Study.

BACKGROUND: Digital health technologies (DHTs), such as electronic health records and prescribing systems, are transforming health care delivery around the world. The quality of information in DHTs is key to the quality and safety of care. We developed a novel clinical information quality (CLIQ) framework to assess the quality of clinical information in DHTs. OBJECTIVE: This study explored clinicians' perspectives on the relevance, definition, and assessment of information quality dimensions in the CLIQ framework. METHODS: We used a systematic and iterative eDelphi approach to engage clinicians who had information governance roles or personal interest in information governance; the clinicians were recruited through purposive and snowball sampling techniques. Data were collected using semistructured online questionnaires until consensus was reached on the information quality dimensions in the CLIQ framework. Responses on the relevance of the dimensions were summarized to inform decisions on retention of the dimensions according to prespecified rules. Thematic analysis of the free-text responses was used to revise definitions and the assessment of dimensions. RESULTS: Thirty-five clinicians from 10 countries participated in the study, which was concluded after the second round. Consensus was reached on all dimensions and categories in the CLIQ framework: informativeness (accuracy, completeness, interpretability, plausibility, provenance, and relevance), availability (accessibility, portability, security, and timeliness), and usability (conformance, consistency, and maintainability). A new dimension, searchability, was introduced in the availability category to account for the ease of finding needed information in the DHTs. Certain dimensions were renamed, and some definitions were rephrased to improve clarity. CONCLUSIONS: The CLIQ framework reached a high expert consensus and clarity of language relating to the information quality dimensions. The framework can be used by health care managers and institutions as a pragmatic tool for identifying and forestalling information quality problems that could compromise patient safety and quality of care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-057430.

A mixed-method service evaluation of health information exchange in England: technology acceptance and barriers and facilitators to adoption.

BACKGROUND: The need for information exchange and integrated care has stimulated the development of interoperability solutions that bring together patient data across the health and care system to enable effective information sharing. Health Information Exchange (HIE) solutions have been shown to be effective in supporting patient care, however, user adoption often varies among users and care settings. This service evaluation aimed to measure user acceptance of HIE and explore barriers and facilitators to its wider uptake. METHODS: A mixed-method study design was used. A questionnaire was developed using the Unified Theory of Acceptance and Use of Technology and administered to HIE users to assess technology acceptance. Pearson Chi2 tests were used to examine differences in acceptance between user groups and care settings. Web-based, semi-structured interviews were conducted drawing on the Normalisation Process Theory to explore barriers and facilitators to adoption. Interview data were analysed thematically using the Framework Approach. RESULTS: A total of 105 HIE users completed the survey and another 12 participated in the interviews. Significant differences were found in HIE acceptance between users groups and care settings, with high adopters demonstrating higher acceptance and social care users showing lower acceptance. Participants identified several drivers to adoption, including increased information accessibility, better care coordination, informed decision-making, improved patient care, reduced duplication of procedures, and time and cost savings. However, they also highlighted a number of barriers, such as lack of awareness about the solution and its value, suboptimal communication strategies, inadequate training and lack of resources for knowledge dissemination, absence of champions to support the implementation, lack of end-user involvement in the implementation and evaluation of HIE, unclear accountability and responsibility for the overall success of the programme, and patient confidentiality concerns. CONCLUSIONS: Working to better engage stakeholders, considering the needs of users from different care settings, providing users with training resources and support to increase their knowledge and confidence in using the system, developing implementation strategies to seek user feedback and monitor performance, and using communication strategies to increase awareness of the product and its value, can help improve uptake and adoption of HIE.

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.

Adherence of popular smoking cessation mobile applications to evidence-based guidelines.

BACKGROUND: Smoking remains one of the major preventable causes of chronic diseases. Considering the promising evidence on the effectiveness of mobile technology for health behaviour change, along with the increasing adoption of smartphones, this review aims to systematically assess the adherence of popular mobile apps for smoking cessation to evidence-based guidelines. METHODS: The United Kingdom Android and iOS markets were searched in February 2018 to identify smoking cessation apps. After screening, 125 Android and 15 iOS apps were tested independently by two reviewers for adherence to the National Institute of Care and Excellence (NICE) Smoking Cessation Guidelines for Self-Help Materials and the Five A Guidelines for Smoking Cessation. Pearson chi square tests were run to examine differences between the two operating systems. RESULTS: A majority of apps across both operating systems had low adherence (fulfils 1-2 out of 5 guidelines) to the Five A Guidelines (65.7%) and low adherence (fulfils 1-3 out of 9 guidelines) to the NICE Smoking Cessation Guidelines for Self-Help Materials (63.6%). Only 15% of mobile apps provided information about the benefits of nicotine replacement therapy (NRT), and even fewer provided information regarding types of NRT products (7.1%) or how to use them (2.1%). In addition, only a minority of apps arrange follow-up appointments or provide additional support to help smokers quit. CONCLUSION: Similar to previous mobile app reviews dating back to 2014, our findings show that most mobile apps do not follow existing smoking cessation treatment guidelines, indicating little change regarding the availability of evidence-based mobile apps for smoking cessation in the UK market. Smokers seeking to quit, tobacco control policy makers and software developers need to work together to develop apps that are in line with the latest clinical guidelines and strategies to maximise effectiveness.

Training community healthcare workers on the use of information and communication technologies: a randomised controlled trial of traditional versus blended learning in Malawi, Africa.

BACKGROUND: Despite the increasing uptake of information and communication technologies (ICT) within healthcare services across developing countries, community healthcare workers (CHWs) have limited knowledge to fully utilise computerised clinical systems and mobile apps. The 'Introduction to Information and Communication Technology and eHealth' course was developed with the aim to provide CHWs in Malawi, Africa, with basic knowledge and computer skills to use digital solutions in healthcare delivery. The course was delivered using a traditional and a blended learning approach. METHODS: Two questionnaires were developed and tested for face validity and reliability in a pilot course with 20 CHWs. Those were designed to measure CHWs' knowledge of and attitudes towards the use of ICT, before and after each course, as well as their satisfaction with each learning approach. Following validation, a randomised controlled trial was conducted to assess the effectiveness of the two learning approaches. A total of 40 CHWs were recruited, stratified by position, gender and computer experience, and allocated to the traditional or blended learning group using block randomisation. Participants completed the baseline and follow-up questionnaires before and after each course to assess the impact of each learning approach on their knowledge, attitudes, and satisfaction. Per-item, pre-post and between-group, mean differences for each approach were calculated using paired and unpaired t-tests, respectively. Per-item, between-group, satisfaction scores were compared using unpaired t-tests. RESULTS: Scores across all scales improved after attending the traditional and blended learning courses. Self-rated ICT knowledge was significantly improved in both groups with significant differences between groups in seven domains. However, actual ICT knowledge scores were similar across groups. There were no significant differences between groups in attitudinal gains. Satisfaction with the course was generally high in both groups. However, participants in the blended learning group found it more difficult to follow the content of the course. CONCLUSIONS: This study shows that there is no difference between blended and traditional learning in the acquisition of actual ICT knowledge among community healthcare workers in developing countries. Given the human resource constraints in remote resource-poor areas, the blended learning approach may present an advantageous alternative to traditional learning.

Automated telephone communication systems for preventive healthcare and management of long-term conditions.

BACKGROUND: Automated telephone communication systems (ATCS) can deliver voice messages and collect health-related information from patients using either their telephone's touch-tone keypad or voice recognition software. ATCS can supplement or replace telephone contact between health professionals and patients. There are four different types of ATCS: unidirectional (one-way, non-interactive voice communication), interactive voice response (IVR) systems, ATCS with additional functions such as access to an expert to request advice (ATCS Plus) and multimodal ATCS, where the calls are delivered as part of a multicomponent intervention. OBJECTIVES: To assess the effects of ATCS for preventing disease and managing long-term conditions on behavioural change, clinical, process, cognitive, patient-centred and adverse outcomes. SEARCH METHODS: We searched 10 electronic databases (the Cochrane Central Register of Controlled Trials; MEDLINE; Embase; PsycINFO; CINAHL; Global Health; WHOLIS; LILACS; Web of Science; and ASSIA); three grey literature sources (Dissertation Abstracts, Index to Theses, Australasian Digital Theses); and two trial registries (www.controlled-trials.com; www.clinicaltrials.gov) for papers published between 1980 and June 2015. SELECTION CRITERIA: Randomised, cluster- and quasi-randomised trials, interrupted time series and controlled before-and-after studies comparing ATCS interventions, with any control or another ATCS type were eligible for inclusion. Studies in all settings, for all consumers/carers, in any preventive healthcare or long term condition management role were eligible. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods to select and extract data and to appraise eligible studies. MAIN RESULTS: We included 132 trials (N = 4,669,689). Studies spanned across several clinical areas, assessing many comparisons based on evaluation of different ATCS types and variable comparison groups. Forty-one studies evaluated ATCS for delivering preventive healthcare, 84 for managing long-term conditions, and seven studies for appointment reminders. We downgraded our certainty in the evidence primarily because of the risk of bias for many outcomes. We judged the risk of bias arising from allocation processes to be low for just over half the studies and unclear for the remainder. We considered most studies to be at unclear risk of performance or detection bias due to blinding, while only 16% of studies were at low risk. We generally judged the risk of bias due to missing data and selective outcome reporting to be unclear.For preventive healthcare, ATCS (ATCS Plus, IVR, unidirectional) probably increase immunisation uptake in children (risk ratio (RR) 1.25, 95% confidence interval (CI) 1.18 to 1.32; 5 studies, N = 10,454; moderate certainty) and to a lesser extent in adolescents (RR 1.06, 95% CI 1.02 to 1.11; 2 studies, N = 5725; moderate certainty). The effects of ATCS in adults are unclear (RR 2.18, 95% CI 0.53 to 9.02; 2 studies, N = 1743; very low certainty).For screening, multimodal ATCS increase uptake of screening for breast cancer (RR 2.17, 95% CI 1.55 to 3.04; 2 studies, N = 462; high certainty) and colorectal cancer (CRC) (RR 2.19, 95% CI 1.88 to 2.55; 3 studies, N = 1013; high certainty) versus usual care. It may also increase osteoporosis screening. ATCS Plus interventions probably slightly increase cervical cancer screening (moderate certainty), but effects on osteoporosis screening are uncertain. IVR systems probably increase CRC screening at 6 months (RR 1.36, 95% CI 1.25 to 1.48; 2 studies, N = 16,915; moderate certainty) but not at 9 to 12 months, with probably little or no effect of IVR (RR 1.05, 95% CI 0.99, 1.11; 2 studies, 2599 participants; moderate certainty) or unidirectional ATCS on breast cancer screening.Appointment reminders delivered through IVR or unidirectional ATCS may improve attendance rates compared with no calls (low certainty). For long-term management, medication or laboratory test adherence provided the most general evidence across conditions (25 studies, data not combined). Multimodal ATCS versus usual care showed conflicting effects (positive and uncertain) on medication adherence. ATCS Plus probably slightly (versus control; moderate certainty) or probably (versus usual care; moderate certainty) improves medication adherence but may have little effect on adherence to tests (versus control). IVR probably slightly improves medication adherence versus control (moderate certainty). Compared with usual care, IVR probably improves test adherence and slightly increases medication adherence up to six months but has little or no effect at longer time points (moderate certainty). Unidirectional ATCS, compared with control, may have little effect or slightly improve medication adherence (low certainty). The evidence suggested little or no consistent effect of any ATCS type on clinical outcomes (blood pressure control, blood lipids, asthma control, therapeutic coverage) related to adherence, but only a small number of studies contributed clinical outcome data.The above results focus on areas with the most general findings across conditions. In condition-specific areas, the effects of ATCS varied, including by the type of ATCS intervention in use.Multimodal ATCS probably decrease both cancer pain and chronic pain as well as depression (moderate certainty), but other ATCS types were less effective. Depending on the type of intervention, ATCS may have small effects on outcomes for physical activity, weight management, alcohol consumption, and diabetes mellitus. ATCS have little or no effect on outcomes related to heart failure, hypertension, mental health or smoking cessation, and there is insufficient evidence to determine their effects for preventing alcohol/substance misuse or managing illicit drug addiction, asthma, chronic obstructive pulmonary disease, HIV/AIDS, hypercholesterolaemia, obstructive sleep apnoea, spinal cord dysfunction or psychological stress in carers.Only four trials (3%) reported adverse events, and it was unclear whether these were related to the interventions. AUTHORS' CONCLUSIONS: ATCS interventions can change patients' health behaviours, improve clinical outcomes and increase healthcare uptake with positive effects in several important areas including immunisation, screening, appointment attendance, and adherence to medications or tests. The decision to integrate ATCS interventions in routine healthcare delivery should reflect variations in the certainty of the evidence available and the size of effects across different conditions, together with the varied nature of ATCS interventions assessed. Future research should investigate both the content of ATCS interventions and the mode of delivery; users' experiences, particularly with regard to acceptability; and clarify which ATCS types are most effective and cost-effective.

Feasibility and acceptability of TRANSFoRm to improve clinical trial recruitment in primary care.

BACKGROUND: Recruitment of study participants is a challenging process for health professionals and patients. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) clinical trial tools enable automated identification, recruitment and follow-up in clinical trials, potentially saving time, effort and costs for all parties involved. OBJECTIVES: This study evaluates the acceptability and feasibility of TRANSFoRm to improve clinical trial recruitment in primary care. METHODS: A feasibility study was conducted in three general practices in Poland. Participants were physicians and patients with gastro-oesophageal reflux disease. Semi-structured interviews were held to obtain feedback about the usefulness, ease of use and overall experience with the TRANSFoRm tools and to identify potential usability issues. Data were analysed thematically. RESULTS: A total of 5 physicians and 10 patients participated in the study. Physicians were satisfied with the usefulness of the system, as it enabled easier and faster identification, recruitment and follow-up of patients compared with existing methods. Patients found the TRANSFoRm apps easy to use to report patient outcomes. However, they also felt that the apps may not be useful for patients with limited exposure to smartphone and web technologies. Two main usability issues were identified: physicians could not access the result of the randomization at the end of each visit, and participants could not locate the follow-up reminder email. CONCLUSIONS: This study provides new evidence on the acceptability and feasibility of TRANSFoRm to enable automated identification, recruitment and follow-up of study participants in primary care trials. It also helps to better understand and address users' requirements in eHealth-supported clinical research.

Feasibility of extracting data from electronic medical records for research: an international comparative study.

BACKGROUND: Electronic medical records (EMR) offer a major potential for secondary use of data for research which can improve the safety, quality and efficiency of healthcare. They also enable the measurement of disease burden at the population level. However, the extent to which this is feasible in different countries is not well known. This study aimed to: 1) assess information governance procedures for extracting data from EMR in 16 countries; and 2) explore the extent of EMR adoption and the quality and consistency of EMR data in 7 countries, using management of diabetes type 2 patients as an exemplar. METHODS: We included 16 countries from Australia, Asia, the Middle East, and Europe to the Americas. We undertook a multi-method approach including both an online literature review and structured interviews with 59 stakeholders, including 25 physicians, 23 academics, 7 EMR providers, and 4 information commissioners. Data were analysed and synthesised thematically considering the most relevant issues. RESULTS: We found that procedures for information governance, levels of adoption and data quality varied across the countries studied. The required time and ease of obtaining approval also varies widely. While some countries seem ready for secondary uses of data from EMR, in other countries several barriers were found, including limited experience with using EMR data for research, lack of standard policies and procedures, bureaucracy, confidentiality, data security concerns, technical issues and costs. CONCLUSIONS: This is the first international comparative study to shed light on the feasibility of extracting EMR data across a number of countries. The study will inform future discussions and development of policies that aim to accelerate the adoption of EMR systems in high and middle income countries and seize the rich potential for secondary use of data arising from the use of EMR solutions.

Transtheoretical model stages of change for dietary and physical exercise modification in weight loss management for overweight and obese adults.

BACKGROUND: Obesity is a global public health threat. The transtheoretical stages of change (TTM SOC) model has long been considered a useful interventional approach in lifestyle modification programmes, but its effectiveness in producing sustainable weight loss in overweight and obese individuals has been found to vary considerably.  OBJECTIVES: To assess the effectiveness of dietary intervention or physical activity interventions, or both, and other interventions based on the transtheoretical model (TTM) stages of change (SOC) to produce sustainable (one year and longer) weight loss in overweight and obese adults. SEARCH METHODS: Studies were obtained from searches of multiple electronic bibliographic databases. We searched The Cochrane Library, MEDLINE, EMBASE and PsycINFO. The date of the last search, for all databases, was 17 December 2013. SELECTION CRITERIA: Trials were included if they fulfilled the criteria of randomised controlled clinical trials (RCTs) using the TTM SOC as a model, that is a theoretical framework or guideline in designing lifestyle modification strategies, mainly dietary and physical activity interventions, versus a comparison intervention of usual care; one of the outcome measures of the study was weight loss, measured as change in weight or body mass index (BMI); participants were overweight or obese adults only; and the intervention was delivered by healthcare professionals or trained lay people at the hospital and community level, including at home. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data, assessed studies for risk of bias and evaluated overall study quality according to GRADE (Grading of Recommendations Assessment, Development and Evaluation). We resolved disagreements by discussion or consultation with a third party. A narrative, descriptive analysis was conducted for the systematic review. MAIN RESULTS: A total of three studies met the inclusion criteria, allocating 2971 participants to the intervention and control groups. The total number of participants randomised to the intervention groups was 1467, whilst 1504 were randomised to the control groups. The length of intervention was 9, 12 and 24 months in the different trials. The use of TTM SOC in combination with diet or physical activity, or both, and other interventions in the included studies produced inconclusive evidence that TTM SOC interventions led to sustained weight loss (the mean difference between intervention and control groups varied from 2.1 kg to 0.2 kg at 24 months; 2971 participants; 3 trials; low quality evidence). Following application of TTM SOC there were improvements in physical activity and dietary habits, such as increased exercise duration and frequency, reduced dietary fat intake and increased fruit and vegetable consumption (very low quality evidence). Weight gain was reported as an adverse event in one of the included trials. None of the trials reported health-related quality of life, morbidity, or economic costs as outcomes. The small number of studies and their variable methodological quality limit the applicability of the findings to clinical practice. The main limitations include inadequate reporting of outcomes and the methods for allocation, randomisation and blinding; extensive use of self-reported measures to estimate the effects of interventions on a number of outcomes, including weight loss, dietary consumption and physical activity levels; and insufficient assessment of sustainability due to lack of post-intervention assessments. AUTHORS' CONCLUSIONS: The evidence to support the use of TTM SOC in weight loss interventions is limited by risk of bias and imprecision, not allowing firm conclusions to be drawn. When combined with diet or physical activity, or both, and other interventions we found very low quality evidence that it might lead to better dietary and physical activity habits. This systematic review highlights the need for well-designed RCTs that apply the principles of the TTM SOC appropriately to produce conclusive evidence about the effect of TTM SOC lifestyle interventions on weight loss and other health outcomes.

Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease.

OBJECTIVES: This study aimed to assess the impact of on-demand versus continuous prescribing of proton pump inhibitors (PPIs) on symptom burden and health-related quality of life in patients with gastroesophageal reflux disease (GERD) presenting to primary care. METHODS: Thirty-six primary care centres across Europe enrolled adult GERD patients from electronic health records. Participants were randomised to on-demand or continuous PPI prescriptions and were followed for 8 weeks. PPI intake, symptom burden, and quality of life were compared between the two groups using mixed-effect regression analyses. Spearman's correlation was used to assess the association between changes in PPI dose and patient-reported outcomes. RESULTS: A total of 488 patients (median age 51 years, 58% women) completed the initial visit, with 360 attending the follow-up visit. There was no significant difference in PPI use between the continuous and on-demand prescription groups (b=.57, 95%CI:0.40-1.53), although PPI use increased in both groups (b = 1.33, 95%CI:0.65 - 2.01). Advice on prescribing strategy did not significantly affect patient-reported outcomes. Both symptom burden (Reflux Disease Questionnaire, b=-0.61, 95%CI:-0.73 - -0.49) and quality of life (12-item Short Form Survey physical score b = 3.31, 95%CI:2.17 - 4.45) improved from baseline to follow-up in both groups. Increased PPI intake correlated with reduced reflux symptoms (n = 347, ρ=-0.12, p = 0.02) and improved quality of life (n = 217, ρ = 0.16, p = 0.02). CONCLUSION: In real-world settings, both continuous and on-demand PPI prescriptions resulted in similar increases in PPI consumption with no difference in treatment effects. Achieving an adequate PPI dose to alleviate reflux symptom burden improves quality of life in GERD patients. EudraCT number 2014-001314-25.

Continuous and on-demand prescription increase in proton pump inhibitor consumption equally in real-world settings and did not result in different outcomes.Reaching a sufficient dose of proton pump inhibitor to reduce reflux symptom burden improves quality of life in patients with gastroesophageal reflux disease.

Engagement With Gamification Elements in a Smoking Cessation App and Short-term Smoking Abstinence: Quantitative Assessment.

BACKGROUND: Gamification in smoking cessation apps has been found to improve cognitive outcomes associated with higher odds of quitting. Although some research has shown that gamification can also positively impact behavioral outcomes such as smoking cessation, studies have largely focused on physical activity and mental health. Only a few studies have explored the effects of gamification on smoking cessation outcomes, of which the majority have adopted qualitative methodologies and/or assessed engagement with apps using self-report. OBJECTIVE: This study aimed to explore levels of user engagement with gamification features in a smoking cessation app via in-app metrics. Specifically, the objective of this paper was to investigate whether higher engagement with gamification features is associated with the likelihood of quitting in the short term. METHODS: Data from a larger online study that recruited smokers seeking to quit were analyzed to address the objectives presented in this paper. The study took place between June 2019 and July 2020, and participants were primarily recruited via social media posts. Participants who met the eligibility criteria used 1 of 2 mobile apps for smoking cessation. In-app metrics shared by the developer of one of the smoking cessation apps, called Kwit, were used to assess engagement with gamification features. Out of 58 participants who used the Kwit app, 14 were excluded due to missing data or low engagement with the app (ie, not opening the app once a week). For the remaining 44 participants, mean (SD) values were calculated for engagement with the app using in-app metrics. A logistic regression model was used to investigate the association between engagement with gamification and 7-day smoking abstinence. RESULTS: In total, data from 44 participants who used the Kwit app were analyzed. The majority of participants were male, married, and employed. Almost 30% (n=13) of participants self-reported successful 7-day abstinence at the end of the study. On average, the Kwit app was opened almost 31 (SD 39) times during the 4-week study period, with the diary feature used the most often (mean 22.8, SD 49.3). Moreover, it was found that each additional level unlocked was associated with approximately 22% higher odds of achieving 7-day abstinence after controlling for other factors such as age and gender (odds ratio 1.22, 95% CI 1.01-1.47). CONCLUSIONS: This study highlights the likely positive effects of certain gamification elements such as levels and achievements on short-term smoking abstinence. Although more robust research with a larger sample size is needed, this research highlights the important role that gamification features integrated into mobile apps can play in facilitating and supporting health behavior change.

Clinical information quality of digital health technologies: protocol for an international eDelphi study.

INTRODUCTION: Digital health technologies (DHTs) such as electronic health records, clinical decision support systems and electronic prescribing systems are widely used in healthcare. While adoption of DHTs can improve healthcare delivery, information quality (IQ) problems associated with DHTs can compromise quality and safety of care. The clinical information quality (CLIQ) framework for digital health is a novel approach to assessing the quality of clinical information from DHTs. This study aims to appraise the CLIQ framework by exploring clinicians' perspectives on the relevance, definition and assessment of IQ dimensions as defined in the framework. This study will adapt the CLIQ framework to the needs of clinical information users-the clinicians. The contextualised CLIQ framework will offer a pragmatic approach to assessing clinical information from DHTs and may help to forestall IQ problems that can compromise quality and safety of care. METHODS AND ANALYSIS: The electronic Delphi (eDelphi) approach will be used to engage a heterogeneous group of clinicians with patient-facing and/or information governance roles recruited through purposive and snowball sampling techniques. A semi-structured online questionnaire will be used to explore clinicians' perspectives on relevance, definition and assessment of IQ dimensions in the CLIQ framework. Survey responses on the relevance of dimensions will be summarised using descriptive statistics to inform decisions on retention of dimensions and termination of the study, based on pre-specified rules. Analysis of the free-text responses will be used to revise definition and assessment of dimensions. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Imperial College Research Governance and Integrity Team (Imperial College Research Ethics Committee (ICREC) Reference number: 20IC6396). The results of the study will be published in a peer-reviewed journal and presented at scientific conferences.

Regulatory standards and guidance for the use of health applications for self-management in Africa: scoping review protocol.

INTRODUCTION: Despite health applications becoming ubiquitous and with enormous potential to facilitate self-management, regulatory challenges such as poor application quality, breach of data privacy and limited interoperability have impeded their full adoption. While many countries now have digital health-related policies/strategies, there is also a need for regulatory standards and guidance that address key regulatory challenges associated with the use of health applications. Currently, it is unclear the status of countries in Africa regarding regulatory standards and guidance that address the use of health applications.This protocol describes the process of conducting a scoping review which aims to investigate the extent to which regulatory standards and guidance address the use of health applications for self-management within the WHO African Region countries. METHODS: The review will follow the methodological framework for conducting a scoping study by Arksey and O'Malley (2005), and the updated methodological guidance for conducting a Joanna Briggs Institute (JBI) scoping review. Given that regulatory standards and guidance are unlikely to be available in scientific databases, we will search Scopus, Google, OpenGrey, WHO Regional Office for Africa Library (AFROLIB), African Index Medicus (AIM), websites of WHO, ITU and Ministries of Health, repositories for digital health policies. We will also search the reference lists of included documents, and contact key stakeholders in the region. Results will be reported using descriptive qualitative content analysis based on the review objectives. The policy analysis framework by Walt and Gilson (1994) will be used to organise findings. A summary of the key findings will be presented using tables, charts and maps. ETHICS AND DISSEMINATION: The collection of primary data is not anticipated in this study and hence ethical approval will not be required. The review will be published in a peer-reviewed journal while key findings will be shared with relevant organisations and/or presented at conferences.

Self-Efficacy and Motivation to Quit of Smokers Seeking to Quit: Quantitative Assessment of Smoking Cessation Mobile Apps.

BACKGROUND: Decreasing trends in the number of individuals accessing face-to-face support are leaving a significant gap in the treatment options for smokers seeking to quit. Face-to-face behavioral support and other interventions attempt to target psychological factors such as the self-efficacy and motivation to quit of smokers, as these factors are associated with an increased likelihood of making quit attempts and successfully quitting. Although digital interventions, such as smoking cessation mobile apps, could provide a promising avenue to bridge the growing treatment gap, little is known about their impact on psychological factors that are vital for smoking cessation. OBJECTIVE: This study aims to better understand the possible impact of smoking cessation mobile apps on important factors for successful cessation, such as self-efficacy and motivation to quit. Our aim is to assess the self-efficacy and motivation to quit levels of smokers before and after the use of smoking cessation mobile apps. METHODS: Smokers seeking to quit were recruited to participate in a 4-week app-based study. After screening, eligible participants were asked to use a mobile app (Kwit or Quit Genius). The smoking self-efficacy questionnaire and the motivation to stop smoking scale were used to measure the self-efficacy and motivation to quit, respectively. Both were assessed at baseline (before app use), midstudy (2 weeks after app use), and end-study (4 weeks after app use). Paired sample two-tailed t tests were used to investigate whether differences in self-efficacy and motivation between study time points were statistically significant. Linear regression models investigated associations between change in self-efficacy and change in motivation to quit before and after app use with age, gender, and nicotine dependence. RESULTS: A total of 116 participants completed the study, with the majority being male (71/116, 61.2%), employed (76/116, 65.6%), single (77/116, 66.4%), and highly educated (87/116, 75.0%). A large proportion of participants had a low to moderate dependence on nicotine (107/116, 92.2%). A statistically significant increase of 5.09 points (95% CI 1.83-8.34) from 37.38 points at baseline in self-efficacy was found at the end of the study. Statistically significant increases were also found for the subcomponents of self-efficacy (intrinsic and extrinsic self-efficacies). Similarly, a statistically significant increase of 0.38 points (95% CI 0.06-0.70) from 5.94 points at baseline in motivation to quit was found at the end of the study. Gender, age, and nicotine dependence were not statistically significantly associated with changes in self-efficacy and motivation to quit. CONCLUSIONS: The assessed mobile apps positively impacted the self-efficacy and motivation to quit of smokers making quit attempts. This has important implications on the possible future use of digitalized interventions and how they could influence important psychological factors for quitting such as self-efficacy and motivation. However, further research is needed to assess whether digital interventions can supplement or replace traditional forms of therapy.

Impact of Gamification on the Self-Efficacy and Motivation to Quit of Smokers: Observational Study of Two Gamified Smoking Cessation Mobile Apps.

BACKGROUND: The proportion of smokers making quit attempts and the proportion of smokers successfully quitting have been decreasing over the past few years. Previous studies have shown that smokers with high self-efficacy and motivation to quit have an increased likelihood of quitting and staying quit. Consequently, further research on strategies that can improve the self-efficacy and motivation of smokers seeking to quit could lead to substantially higher cessation rates. Some studies have found that gamification can positively impact the cognitive components of behavioral change, including self-efficacy and motivation. However, the impact of gamification in the context of smoking cessation and mobile health has been sparsely investigated. OBJECTIVE: This study aims to examine the association between perceived usefulness, perceived ease of use, and frequency of use of gamification features embedded in smoking cessation apps on self-efficacy and motivation to quit smoking. METHODS: Participants were assigned to use 1 of the 2 mobile apps for a duration of 4 weeks. App-based questionnaires were provided to participants before app use and 2 weeks and 4 weeks after they started using the app. Gamification was quantitatively operationalized based on the Cugelman gamification framework and concepts from the technology acceptance model. The mean values of perceived frequency, ease of use, and usefulness of gamification features were calculated at midstudy and end-study. Two linear regression models were used to investigate the impact of gamification on self-efficacy and motivation to quit. RESULTS: A total of 116 participants completed the study. The mean self-efficacy increased from 37.38 (SD 13.3) to 42.47 (SD 11.5) points and motivation to quit increased from 5.94 (SD 1.4) to 6.32 (SD 1.7) points after app use. Goal setting was perceived to be the most useful gamification feature, whereas sharing was perceived to be the least useful. Participants self-reported that they used the progress dashboards the most often, whereas they used the sharing feature the least often. The average perceived frequency of gamification features was statistically significantly associated with change in self-efficacy (ß=3.35; 95% CI 0.31-6.40) and change in motivation to quit (ß=.54; 95% CI 0.15-0.94) between baseline and end-study. CONCLUSIONS: Gamification embedded in mobile apps can have positive effects on self-efficacy and motivation to quit smoking. The findings of this study can provide important insights for tobacco control policy makers, mobile app developers, and smokers seeking to quit.

Effect of computerised, knowledge-based, clinical decision support systems on patient-reported and clinical outcomes of patients with chronic disease managed in primary care settings: a systematic review.

OBJECTIVES: Chronic diseases are the leading cause of disability globally. Most chronic disease management occurs in primary care with outcomes varying across primary care providers. Computerised clinical decision support systems (CDSS) have been shown to positively affect clinician behaviour by improving adherence to clinical guidelines. This study provides a summary of the available evidence on the effect of CDSS embedded in electronic health records on patient-reported and clinical outcomes of adult patients with chronic disease managed in primary care. DESIGN AND ELIGIBILITY CRITERIA: Systematic review, including randomised controlled trials (RCTs), cluster RCTs, quasi-RCTs, interrupted time series and controlled before-and-after studies, assessing the effect of CDSS (vs usual care) on patient-reported or clinical outcomes of adult patients with selected common chronic diseases (asthma, chronic obstructive pulmonary disease, heart failure, myocardial ischaemia, hypertension, diabetes mellitus, hyperlipidaemia, arthritis and osteoporosis) managed in primary care. DATA SOURCES: Medline, Embase, CENTRAL, Scopus, Health Management Information Consortium and trial register clinicaltrials.gov were searched from inception to 24 June 2020. DATA EXTRACTION AND SYNTHESIS: Screening, data extraction and quality assessment were performed by two reviewers independently. The Cochrane risk of bias tool was used for quality appraisal. RESULTS: From 5430 articles, 8 studies met the inclusion criteria. Studies were heterogeneous in population characteristics, intervention components and outcome measurements and focused on diabetes, asthma, hyperlipidaemia and hypertension. Most outcomes were clinical with one study reporting on patient-reported outcomes. Quality of the evidence was impacted by methodological biases of studies. CONCLUSIONS: There is inconclusive evidence in support of CDSS. A firm inference on the intervention effect was not possible due to methodological biases and study heterogeneity. Further research is needed to provide evidence on the intervention effect and the interplay between healthcare setting features, CDSS characteristics and implementation processes. PROSPERO REGISTRATION NUMBER: CRD42020218184.

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.

Investigation of Cardiovascular Health and Risk Factors Among the Diverse and Contemporary Population in London (the TOGETHER Study): Protocol for Linking Longitudinal Medical Records.

BACKGROUND: Global trends in cardiovascular disease (CVD) exhibit considerable interregional and interethnic differences, which in turn affect long-term CVD risk across diverse populations. An in-depth understanding of the interplay between ethnicity, socioeconomic status, and CVD risk factors and mortality in a contemporaneous population is crucial to informing health policy and resource allocation aimed at mitigating long-term CVD risk. Generating bespoke large-scale and reliable data with sufficient numbers of events is expensive and time-consuming but can be circumvented through utilization and linkage of data routinely collected in electronic health records (EHR). OBJECTIVE: We aimed to characterize the burden of CVD risk factors across different ethnicities, age groups, and socioeconomic groups, and study CVD incidence and mortality by EHR linkage in London. METHODS: The proposed study will initially be a cross-sectional observational study unfolding into prospective CVD ascertainment through longitudinal follow-up involving linked data. The government-funded National Health System (NHS) Health Check program provides an opportunity for the systematic collation of CVD risk factors on a large scale. NHS Health Check data on approximately 200,000 individuals will be extracted from consenting general practices across London that use the Egton Medical Information Systems (EMIS) EHR software. Data will be analyzed using appropriate statistical techniques to (1) determine the cross-sectional burden of CVD risk factors and their prospective association with CVD outcomes, (2) validate existing prediction tools in diverse populations, and (3) develop bespoke risk prediction tools across diverse ethnic groups. RESULTS: Enrollment began in January 2019 and is ongoing with initial results to be published mid-2021. CONCLUSIONS: There is an urgent need for more real-life population health studies based on analyses of routine health data available in EHRs. Findings from our study will help quantify, on a large scale, the contemporaneous burden of CVD risk factors by geography and ethnicity in a large multiethnic urban population. Such detailed understanding (especially interethnic and sociodemographic variations) of the burden of CVD risk and its determinants, including heredity, environment, diet, lifestyle, and socioeconomic factors, in a large population sample, will enable the development of tailored and dynamic (continuously learning from new data) risk prediction tools for diverse ethnic groups, and thereby enable the personalized provision of prevention strategies and care. We anticipate that this systematic approach of linking routinely collected data from EHRs to study CVD can be conducted in other settings as EHRs are being implemented worldwide. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/17548.

Primary care integration of sexual and reproductive health services for chlamydia testing across WHO-Europe: a systematic review.

OBJECTIVE: To identify current uptake of chlamydia testing (UCT) as a sexual and reproductive health service (SRHS) integrated in primary care settings of the WHO European region, with the aim to shape policy and quality of care. DESIGN: Systematic review for studies published from January 2001 to May 2018 in any European language. DATA SOURCES: OVID Medline, EMBASE, Maternal and Infant Care and Global Health. ELIGIBILITY CRITERIA: Published studies, which involved women or men, adolescents or adults, reporting a UCT indicator in a primary care within a WHO European region country. Study designs considered were: randomised control trials (RCTs), quasi-experimental, observational (eg, cohort, case-control, cross-sectional) and mixed-methods studies as well as case reports. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers screened the sources and validated the selection process. The BRIGGS Critical Appraisal Checklist for Analytical Cross-Sectional Studies, the Mixed Methods Appraisal Tool 2011 and Critical Appraisal Skills Programme (CASP) checklists were considered for quality and risk of bias assessment. RESULTS: 24 studies were finally included, of which 15 were cross-sectional, 4 cohort, 2 RCTs, 2 case-control studies and 1 mixed-methods study. A majority of the evidence cites the UK model, followed by the Netherlands, Denmark, Norway and Belgium only. Acceptability if offered test in primary healthcare (PHC) ranged from 55% to 81.4% in women and from 9.5% to 70.6% when both genders were reported together. Men may have a lower UCT compared with women. When both genders were reported together, the lowest acceptability was 9.5% in the Netherlands. Denmark presented the highest percentage of eligible people who tested in a PHC setting (87.3%). CONCLUSIONS: Different health systems may influence UCT in PHC. The regional use of a common testing rate indicator is suggested to homogenise reporting. There is very little evidence on integration of SRHS such as chlamydia testing in PHC and there are gaps between European countries.