Process evaluation of a pragmatic feasibility trial on smokeless tobacco cessation intervention delivered in dental hospitals.

BACKGROUND: Article 14 of the WHO 'Framework Convention on Tobacco Control' recommends, that all oral healthcare providers provide support for tobacco cessation, to all patients. Despite evidence on the effectiveness of tobacco cessation interventions in dental settings, implementation remains low in most high-burden countries like Pakistan. A pragmatic pilot trial of a dentist-delivered behavioural support intervention for smokeless tobacco (ST) cessation, was conducted in dental hospitals in Pakistan. This paper presents the findings of the process evaluation of the trial. METHODS: A mixed-method process evaluation of a multi-centre randomised control pilot trial of dentist-delivered behavioural support intervention ST cessation was conducted. The intervention included three sessions namely: pre-quit, quit and post-quit sessions. The process evaluation involved: semi-structured interviews with trial participants (n = 26, of which dental patients were n = 13 and participating dentists were n = 13 conducted from June-August 2022); and fidelity assessment of audio recordings of the intervention sessions (n = 29). The framework approach was used to thematically analyse the interview data. RESULTS: Overall the trial procedures were well accepted, however, young patients expressed uneasiness over revealing their ST use status. The intervention was received positively by dentists and patients. Dentists identified some challenges in delivering behavioural support to their patients. Of these, some were related to the contents of the intervention whereas, others were related to the logistics of delivering the intervention in a clinical setting (such as workload and space). Acceptability of the intervention resources was overall low amongst young patients as they did not take the intervention resources home due to fear of their family members finding out about their ST use. The intervention was successful in achieving the intended impact (in those who engaged with the intervention), i.e., change in the patients' ST use behaviour. Giving up ST with the aid of behavioural support also had an unintended negative effect i.e., the use of harmful substances (cannabis, cigarettes) to give up ST use. Patients' satisfaction with their dental treatment seemed to influence the intervention outcome. CONCLUSION: While there are many variables to consider, but for the participants of this study, behavioural support for abstinence delivered through dentists during routine dental care, appears to be an acceptable and practical approach in helping patients give up ST use, in a country like Pakistan, where negligible support is offered to ST users.

Smokeless Tobacco Cessation Support in Dental Hospitals in Pakistan: Dentists and Dental Patients' Perspectives on Current Practices, Support Needed, and Opportunities Available.

INTRODUCTION: Despite evidence on the effectiveness of tobacco cessation interventions in dental settings, the implementation remains low, especially for smokeless tobacco (ST). The purpose of this study was to develop an understanding of the influences governing the implementation of ST cessation support in dental hospitals. AIMS AND METHODS: A multicenter qualitative study was conducted at two tertiary-care dental hospitals, in Pakistan. Semi-structured interview guide, guided by the Capability-Opportunity-Motivation-Behavior (COM-B) model, were used to capture the views of dentists (n = 12) and dental patients (n = 12), regarding ST cessation support in dental hospitals. Framework approach was used to thematically analyze the data. RESULTS: Screening of ST users in routine dental practice was seldom practiced and the cessation support offered was brief advice. Barriers identified by dentists included: Fear of offending and stereotyping patients; lack of knowledge and skills; lack of privacy; lack of belief in the effectiveness of behavioral support; lack of time and workload pressure; ST use amongst dentists; lack of referral systems and; the absence of a mandatory requirement of offering ST cessation support. Facilitators included: Delivering support through junior dentists and the length of interaction between the dentist and the patient. Naswar was the most common ST product used by dental patients. Patients reported receiving negligible cessation support from any healthcare provider. CONCLUSIONS: A range of influences governing the implementation of ST cessation support in dental hospitals were identified. These findings can inform the implementation of behavioral interventions for ST cessation in dental and other clinical settings, in low and middle-income countries. IMPLICATIONS: Smokeless tobacco control considerably lags, in comparison to the control of combustible tobacco. This is the first study that qualitatively explores the implementation of ST cessation support in dental settings in Pakistan. Utilizing the "Capability-Opportunity-Motivation-Behavior" model, it provides an in-depth understanding of the inability of dentists in implementing effective behavioral interventions for ST cessation support in routine dental practice. Highlighting the striking discrepancy between the patient's need for and receptivity towards cessation support and the dentists' concerns over their patients' receptivity towards cessation support, it calls for the need for effective implementation strategies to optimize dentist-led tobacco cessation interventions in low-resource settings.

No action is without its side effects: Adverse drug reactions and missed doses of antituberculosis therapy, a scoping review.

AIMS: A key reason for the failure of antituberculosis (anti-TB) treatment is missed doses (instances where medication is not taken). Adverse drug reactions (ADRs) are 1 cause of missed doses, but the global evidence, their relative contribution to missed doses vs. other causes, the patterns of missed doses due to ADRs and the specific ADRs associated with missed doses have not been appraised. We sought to address these questions through a scoping review. METHODS: MEDLINE, Embase and Web of Science were searched on 3 November 2021 using terms around active TB, missed doses and treatment challenges. Studies reporting both ADR and missed dose data were examined (PROSPERO: CRD42022295209). RESULTS: Searches identified 108 eligible studies: 88/108 (81%) studies associated ADRs with an increase in missed doses; 33/61 (54%) studies documenting the reasons for missed doses gave ADRs as a primary reason. No studies examined patterns of missed doses due to ADRs; 41/108 (38%) studies examined associations between 68 types of ADR (across 15 organ systems) and missed doses. Nuance around ADR-missed doses relations regarding drug susceptibility testing profile and whether the missed doses originated from the patient, healthcare professionals, or both were found. CONCLUSION: There is extensive evidence that ADRs are a key driver for missed doses of anti-TB treatment. Some papers examined specific ADRs and none evaluated the patterns of missed doses due to ADRs, demonstrating a knowledge deficit. Knowing why doses both are and are not missed is essential in providing targeted interventions to improve treatment outcomes.

Behaviour Change Intervention for Smokeless Tobacco (ST) Cessation Delivered through Dentists in Dental Settings: A pragmatic pilot trial.

INTRODUCTION: Evidence on smokeless tobacco (ST) cessation interventions is scarce. The South Asian (SA) region which shares more than 90% of the burden of ST use, is grossly underrepresented in research on ST cessation. This study aimed to assess the feasibility of delivering and investigating a behavioural support intervention for ST cessation in dental settings in Pakistan. METHODS: A multi-centre, pilot, 2-armed parallel group, individually randomised control trial, with a 1:1 allocation ratio, was conducted at two dental hospitals. Eligibility criteria included: being a ST user; seeking dental treatment and; not currently accessing cessation support. All participants were provided written self-help, ST cessation material. The intervention group also received a dentist-delivered, bespoke behavioural support intervention for ST cessation developed for users of SA origin. Participants were followed up telephonically at three and six months. Self-reported six month abstinence was verified by salivary cotinine. Analysis was descriptive, with 95% confidence intervals presented where appropriate. RESULTS: 100 participants were successfully recruited from the selected hospitals. Of these 78% continued to engage throughout the study duration and provided primary outcome data, whereas, 63% completed all hospital visits. The outcome measures were successfully collected. Biochemically verified six-month abstinence in the intervention and control group was 10% and 4%. CONCLUSIONS: It was feasible to deliver and evaluate a dentist-delivered behavioural support intervention for ST cessation in Pakistan. The data suggested that the intervention may improve ST quit rates. The findings of this study will be useful in informing the design of future definitive studies. IMPLICATIONS: To our knowledge this is the first pragmatic pilot trial on ST cessation in dental settings in Pakistan and the first trial on dentist-delivered structured behavioural support intervention for ST cessation. It adds to the scarce, trial evidence base on ST cessation interventions. Findings suggest behavioural support intervention for ST cessation may improve quit rates. The trial was conducted in a country with poor ST control measures, where ST products are not taxed, the products are sold openly to and by minors and the users are offered negligible cessation support. The findings may therefore be generalisable to LMICs and particularly South Asian countries, with similar policy backgrounds.

Behaviour change intervention for smokeless tobacco (ST) cessation delivered through dentists within a dental setting: a feasibility study protocol.

OBJECTIVES/AIM: To adapt a structured behavioural support intervention for smokeless tobacco (ST) cessation and to assess the feasibility and acceptability of delivering the intervention via dentists within dental settings in Pakistan. MATERIAL AND METHODS: The study will have 3 phases: (1) Adapt a previously developed intervention to make it suitable for delivery in a clinical/dental setting through qualitative interviews with dental patients and dentists; (2) A multi-centre, pilot randomised control trial in two teaching dental hospitals in Pakistan. Participants (dental patients) will be randomly assigned to intervention or control group in a 1:1 allocation ratio to receive either a structured behavioural support intervention involving face to face counselling or self-help material plus usual care. Each participant will be in the study for approximately 6 months and the overall study is expected to run for 12 months; (3) An embedded qualitative process evaluation. All trial participants will be followed up at 3 and 6 months to assess self-reported ST use. Outcome measures will include: rates of eligibility, recruitment and retention, randomisation group cross-over rates, the provision of data on ST use behaviour, fidelity to the intervention and qualitative assessment of acceptability and feasibility. DISCUSSION: Despite the high use of ST in Pakistan, users are offered negligible cessation support. The findings of this multi-centre, mixed-method feasibility study will inform the scope for a larger trial on ST cessation delivered through the existing dental health system.