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Protocol for the mixed-methods process and context evaluation of the TB & Tobacco randomised controlled trial in Bangladesh and Pakistan: a hybrid effectiveness-implementation study.

ABSTRACT: INTRODUCTION:Tuberculosis (TB) remains a significant public health problem in South Asia. Tobacco use increases the risks of TB infection and TB progression. The TB& Tobacco placebo-controlled randomised trial aims to (1) assess the effectiveness of the tobacco cessation medication cytisine versus placebo when combined with behavioural support and (2) implement tobacco cessation medication and behavioural support as part of general TB care in Bangladesh and Pakistan. This paper summarises the process and context evaluation protocol embedded in the effectiveness-implementation hybrid design. METHODS AND ANALYSIS:We are conducting a mixed-methods process and context evaluation informed by an intervention logic model that draws on the UK Medical Research Council's Process Evaluation Guidance. Our approach includes quantitative and qualitative data collection on context, recruitment, reach, dose delivered, dose received and fidelity. Quantitative data include patient characteristics, reach of recruitment among eligible patients, routine trial data on dose delivered and dose received, and a COM-B ('capability', 'opportunity', 'motivation' and 'behaviour') questionnaire filled in by participating health workers. Qualitative data include semistructured interviews with TB health workers and patients, and with policy-makers at district and central levels in each country. Interviews will be analysed using the framework approach. The behavioural intervention delivery is audio recorded and assessed using a predefined fidelity coding index based on behavioural change technique taxonomy. ETHICS AND DISSEMINATION:The study complies with the guidelines of the Declaration of Helsinki. Ethics approval for the study and process evaluation was granted by the University of Leeds (qualitative components), University of York (trial data and fidelity assessment), Bangladesh Medical Research Council and Bangladesh Drug Administration (trial data and qualitative components) and Pakistan Medical Research Council (trial data and qualitative components). Results of this research will be disseminated through reports to stakeholders and peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:ISRCTN43811467; Pre-results.

SUBMITTER: Boeckmann M

PROVIDER: S-EPMC5887198 | biostudies-other | 2018 Mar

REPOSITORIES: biostudies-other

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Protocol for the mixed-methods process and context evaluation of the <i>TB & Tobacco</i> randomised controlled trial in Bangladesh and Pakistan: a hybrid effectiveness-implementation study.

Boeckmann Melanie M Nohavova Iveta I Dogar Omara O Kralikova Eva E Pankova Alexandra A Zvolska Kamila K Huque Rumana R Fatima Razia R Noor Maryam M Elsey Helen H Sheikh Aziz A Siddiqi Kamran K Kotz Daniel D

BMJ open 20180330 3

<h4>Introduction</h4>Tuberculosis (TB) remains a significant public health problem in South Asia. Tobacco use increases the risks of TB infection and TB progression. The <i>TB& Tobacco</i> placebo-controlled randomised trial aims to (1) assess the effectiveness of the tobacco cessation medication cytisine versus placebo when combined with behavioural support and (2) implement tobacco cessation medication and behavioural support as part of general TB care in Bangladesh and Pakistan. This paper su ...[more]

PMID: 29602847

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Project description:Implementation science's focus on establishing implementation strategy effectiveness has overshadowed the need to understand differential performance of such strategies under various conditions. Methods allowing for assessment between implementation context and process can help address this gap. This paper provides a detailed description of a mixed method procedure for assessing factors related to the implementation context and process intersection, which was developed as part of the pilot study of the Housing First Technical Assistance and Training (HFTAT) Program, a multifaceted strategy designed to support Housing First model implementation. The HFTAT was pilot tested among a sample of three organizations. Our mixed method approach combines two tools often used in implementation research-the Stages of Implementation Completion and the Consolidated Framework for Implementation Research-in a novel way. Several stages to analysis were completed, starting with a separate analysis of data pertaining to each measure and then two levels of mixed method analysis. The approach provided a better understanding of the issues that impacted the implementation guided by the HFTAT, suggesting: (1) individual determinants seemed to have a bigger impact based on the number of SIC phases they affected, (2) implementation context and process were connected through climate-related factors in the inner setting that made the sites more or less responsive to addressing identified barriers, and (3) there is a need to better assess context factors to identify areas where implementation drivers should be better targeted to facilitate change, and this is supported by prior research. Understanding the underlying factors impacting a setting's performance related to a specific implementation strategy has potential to improve decision-making and optimize future implementation efforts. The approach likely be as successful combining the SIC with other determinant frameworks and should be utilized at the onset of an implementation project to maximize its usefulness.

Project description:BackgroundLow- and middle-income countries (LMICs) are disproportionately impacted by interacting epidemics of tuberculosis (TB) and tobacco consumption. Research indicates behavioural support delivered by health workers effectively promotes tobacco cessation. There is, however, a paucity of training to support LMIC health workers deliver effective tobacco cessation behavioural support. The TB and Tobacco Consortium undertook research in South Asia to understand factors affecting TB health workers' delivery of tobacco cessation behavioural support, and subsequently developed a training package for LMICs.MethodsUsing the "capability, opportunity, and motivation as determinants of behaviour" (COM-B) framework to understand any issues facing health worker delivery of behaviour support, we analysed 25 semi-structured interviews and one focus group discussion with TB health workers, facility in-charges, and national tuberculosis control programme (NTP) staff members in each country. Results were integrated with findings of an adapted COM-B questionnaire on health worker confidence in tobacco cessation support delivery, administered to 36 TB health workers. Based on findings, we designed a guide and training programme on tobacco cessation support for health workers.ResultsQualitative results highlighted gaps in the majority of health workers' knowledge on tobacco cessation and TB and tobacco interaction, inadequate training on patient communication, insufficient resources and staff support, and NTPs' non-prioritization of tobacco cessation in all three countries. Questionnaire results reiterated the knowledge deficits and low confidence in patient communication. Participants suggested strengthening knowledge, skills, and competence through training and professional incentives. Based on findings, we developed an interactive two-day training and TB health worker guide adaptable for LMICs, focusing on evidence of best practice on TB and tobacco cessation support, communication, and rapport building with patients.ConclusionsTB health workers are essential in addressing the dual burden of TB and tobacco faced by many LMICs. Factors affecting their delivery of tobacco cessation support can be identified using the COM-B framework, and include issues such as individuals' knowledge and skills, as well as structural barriers like professional support through monitoring and supervision. While structural changes are needed to tackle the latter, we have developed an adaptable and engaging health worker training package to address the former that can be delivered in routine TB care.Trial registrationISRCTN43811467 .

Project description:BackgroundSmokeless tobacco (SLT) use is associated with multiple adverse health effects. It is prominent in Bangladesh, India, and Pakistan, but disparities in use within and across these countries are not well documented or understood. This study assessed the prevalence, patterns, and correlates of SLT use in these three countries.MethodData came from the Global Adult Tobacco Survey, a household survey of adults aged ≥15 years. Data were collected in 2014 (Pakistan), 2017 (Bangladesh), and India (2016-2017). Current SLT use (nasal or oral use) was defined as reported SLT use daily or less than daily at the time of the survey. Prevalence of both overall and specific SLT types were assessed. Multivariate logistic regression was used to assess correlates of SLT use.ResultsOverall, SLT use among adults ≥15 years of age was 20.6% in Bangladesh, 21.4% in India, and 7.7% in Pakistan, corresponding to 22.0 million SLT users in Bangladesh, 199.4 million in India, and 9.6 million in Pakistan. Among current tobacco users overall, the percentage of those who used SLT was 58.4% (CI: 56.0-60.7) in Bangladesh, 74.7% (CI: 73.4-76.0) in India, and 40.3% (CI: 36.2-44.5) in Pakistan. The most commonly used oral SLT product was Zarda (14.5%) in Bangladesh, Khaini (11.2%) in India, and Naswar (5.1%) in Pakistan. Females had greater odds of SLT use than males in Bangladesh, but lower odds of SLT use than males in India and Pakistan. In all three countries, the odds of SLT use was higher among those 25 years and older, lower education, lower wealth index, and greater exposure to SLT marketing.ConclusionAn estimated 231 million adults aged 15 years or older currently use SLT in Bangladesh, India, and Pakistan, comprising 40.3%-74.7% of overall tobacco product use in these countries. Moreover, marked variations in SLT use exist by population groups. Furthermore, exposure to pro-SLT marketing was found to be associated with higher SLT use compared to non-exposed. It is important that tobacco control strategies address all forms of tobacco product use, including SLT.

Project description:BACKGROUND: As a response to a changing operating environment, healthcare administrators are implementing modern management tools in their organizations. The balanced scorecard (BSC) is considered a viable tool in high-income countries to improve hospital performance. The BSC has not been applied to hospital settings in low-income countries nor has the context for implementation been examined. This study explored contextual perspectives in relation to BSC implementation in a Pakistani hospital. METHODS: Four clinical units of this hospital were involved in the BSC implementation based on their willingness to participate. Implementation included sensitization of units towards the BSC, developing specialty specific BSCs and reporting of performance based on the BSC during administrative meetings. Pettigrew and Whipp's context (why), process (how) and content (what) framework of strategic change was used to guide data collection and analysis. Data collection methods included quantitative tools (a validated culture assessment questionnaire) and qualitative approaches including key informant interviews and participant observation. RESULTS: Method triangulation provided common and contrasting results between the four units. A participatory culture, supportive leadership, financial and non-financial incentives, the presentation of clear direction by integrating support for the BSC in policies, resources, and routine activities emerged as desirable attributes for BSC implementation. The two units that lagged behind were more involved in direct inpatient care and carried a considerable clinical workload. Role clarification and consensus about the purpose and benefits of the BSC were noted as key strategies for overcoming implementation challenges in two clinical units that were relatively ahead in BSC implementation. It was noted that, rather than seeking to replace existing information systems, initiatives such as the BSC could be readily adopted if they are built on existing infrastructures and data networks. CONCLUSION: Variable levels of the BSC implementation were observed in this study. Those intending to apply the BSC in other hospital settings need to ensure a participatory culture, clear institutional mandate, appropriate leadership support, proper reward and recognition system, and sensitization to BSC benefits.

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Protocol for the mixed-methods process and context evaluation of the TB & Tobacco randomised controlled trial in Bangladesh and Pakistan: a hybrid effectiveness-implementation study.

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Protocol for the mixed-methods process and context evaluation of the <i>TB & Tobacco</i> randomised controlled trial in Bangladesh and Pakistan: a hybrid effectiveness-implementation study.

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