Background Treatment non-adherence is a serious challenge to effective tuberculosis (TB) control in Tibet. In this study we will pilot and evaluate the effectiveness of using new electronic monitors (e-monitors) and a smartphone app to improve treatment adherence among new pulmonary TB patients in Tibet. Methods We will use a multicentre, parallel-group, individually randomised controlled, superiority trial with blinded outcome evaluation and unblinded treatment. We will randomise new pulmonary TB outpatients (aged ≥ 15 years old and free from communication impairment) from Shigatse, Tibet to either the intervention or control arm in a 1:1 ratio at the time of their diagnosis. All patients will be treated according to the World Health Organisation standard 6-month TB treatment regimen and the China National TB programme guidelines. Intervention arm patients will be given their medication via e-monitors that have automatic voice reminders, and record medication adherence data and share it with health staff via Cloud connection. Intervention patients will also be encouraged to receive smartphone-based video-observed treatment if their adherence is problematic. Control arm patients will receive their medication in e-monitors that will collect medication adherence history, but will have their reminder function deactivated and are not linked to the app. The primary outcome is the rate of poor adherence, measured monthly during treatment as a binary indicator where poor adherence means missing ≥ 20% of doses in a month. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, as well as a cost-effectiveness analysis and an analysis of the long-term effects of the intervention on TB control. Discussion Our study is one of the first trials to evaluate the use of e-monitors and smartphone apps for customised treatment support in low- and middle-income countries (LMICs). All intervention activities are designed to be embedded into routine TB care with strong local ownership. Through the trial we intend to understand the feasibility of our intervention, its effectiveness, its cost-effectiveness and its long-term impacts to inform future scale-up in remote areas of China and other LMICs. Trial registration Current Controlled Trials, ID: ISRCTN52132803 . Registered on 9 November 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3364-x) contains supplementary material, which is available to authorized users.
IntroductionThe COVID-19 pandemic has required the rapid development of comprehensive guidelines to direct health service organisation and delivery. However, most guidelines are based on resources found in high-income settings, with fewer examples that can be implemented in resource-constrained settings. This study describes the process of adapting and developing role-specific guidelines for comprehensive COVID-19 infection prevention and control in low-income and middle-income countries (LMICs).MethodsWe used a collaborative autoethnographic approach to explore the process of developing COVID-19 guidelines. In this approach, multiple researchers contributed their reflections, conducted joint analysis through dialogue, reflection and with consideration of experiential knowledge and multidisciplinary perspectives to identify and synthesise enablers, challenges and key lessons learnt.ResultsWe describe the guideline development process in the Philippines and the adaptation process in Sri Lanka. We offer key enablers identified through this work, including flexible leadership that aimed to empower the team to bring their expertise to the process; shared responsibility through equitable ownership; an interdisciplinary team; and collaboration with local experts. We then elaborate on challenges including interpreting other guidelines to the country context; tensions between the ideal compared with the feasible and user-friendly; adapting and updating with evolving information; and coping with pandemic-related challenges. Based on key lessons learnt, we synthesise a novel set of principles for developing guidelines during a public health emergency. The SPRINT principles are grounded in situational awareness, prioritisation and balance, which are responsive to change, created by an interdisciplinary team navigating shared responsibility and transparency.ConclusionsGuideline development during a pandemic requires a robust and time sensitive paradigm. We summarise the learning in the ‘SPRINT principles’ for adapting guidelines in an epidemic context in LMICs. We emphasise that these principles must be grounded in a collaborative or codesign process and add value to existing national responses.
IntroductionIn an increasingly globalised and interconnected world, evidence to evaluate complex interventions may be generated in multiple languages. However, despite its influence in shaping the evidence base, there is little literature explicitly connecting the translation process to the goals and processes of implementation research. This study aims to explore the processes and experience of an international implementation research team conducting a process evaluation of a complex intervention in Tibet Autonomous Region, China.MethodsThis study uses a collaborative autoethnographic approach to explore the translation process from Chinese or Tibetan to English of key stakeholder interview transcripts. In this approach, multiple researchers and translators contributed their reflections, and conducted joint analysis through dialogue, reflection and with consideration of multiple perspectives. Seven researchers involved with the translation process contributed their perspectives through in-depth interviews or written reflections and jointly analysed the resulting data.ResultsWe describe the translation process, synthesise key challenges including developing a ‘voice’ and tone as a translator, conveying the depth of idioms across languages, and distance from the study context. We further offer lessons learnt including the importance of word banks with unified translations of words and phrases created iteratively during the translation process, the need to collaborate between translators and the introspective work necessary for translators to explore their positionality and reflexivity during the work. We then offer a summary of these learnings for other implementation research teams.ConclusionOur findings emphasise that in order to ensure rigour in their work, implementation research teams using qualitative data should make concerted effort to consider both the translation process as well as its outcomes. Given the numerous multinational or multilingual implementation research studies using qualitative methods, there is a need for further consideration and reflection on the translation process.
Background: Treatment non-adherence is a serious challenge to effective tuberculosis (TB) control in Tibet. In this study we will pilot and evaluate the effectiveness of using new electronic monitors (e-monitors) and a smartphone app to improve treatment adherence among new pulmonary TB patients in Tibet. Methods: We will use a multicentre, parallel-group, individually-randomized controlled superiority trial with blinded outcome evaluation and unblinded treatment. We will randomise new pulmonary TB outpatients (aged ≥15 years old and free from communication impairment) from Shigatse, Tibet to either the intervention or control arm in a 1:1 ratio at the time of their diagnosis. All patients will be treated according to the World Health Organisation standard 6-month TB treatment regimen and the China National TB programme guidelines. Intervention arm patients will be given their medication via e-monitors that have automatic voice reminders, and record medication adherence data and share it with health staff via cloud connection. Intervention patients will also be encouraged of receiving smartphone-based video observed treatment if their adherence is problematic. Control arm patients will receive their medication in e-monitors that will collect medication adherence history, but will have their reminder function deactivated and are not linked to the app. The primary outcome is the rate of poor adherence, measured monthly during treatment as a binary indicator where poor adherence means missing ≥20% doses in a month. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, as well as a cost-effectiveness analysis and an analysis of the long-term effects of the intervention on TB control. Discussion: Our study is one of the first trials to evaluate the use of e-monitors and smartphone apps for customised treatment support in low- and middle-income countries (LMICs). All intervention activities are designed to be embedded into routine TB care with strong local ownership. Through the trial we intend to understand the feasibility of our intervention, its effectiveness, its cost-effectiveness and its long-term impacts to inform future scale-up in remote areas of China and other LMICs. Trial registration: Current Controlled Trials ISRCTN52132803, registered on 9 November 2018.
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