Implement Cessation

Holly Gray MSc, MPH

Email: [email protected]

Holly Gray has worked in Public Health and wellbeing for the past 5 years, after completing a Masters of Public Health at Imperial College, London. Her practice has focussed on health promotion campaigns and developing digital health engagement interventions, targeting healthy behaviours and lifestyles. She has experience in a range of global healthcare systems (US, UK and Asia) in both public and private settings. Recently she began as Head of Health Engagement and Public Affairs, for Bupa Global which operates in over 190 countries. Before this she managed Bupa’s NGO partnerships while being the business adviser for prevention and wellbeing. She has a strong interest in health equality and behaviour change.

Yvonne Olando BA, MSc

Email: [email protected]

Yvonne Olando holds an MSc degree in Clinical Psychology from the University of Nairobi, School of Medicine. She is a trainer at SAPTA Trust. She consults for the national agency for drug control in Kenya (NACADA) and World Health Organization (WHO)-AFRO, as a tobacco cessation trainer. She has had the privilege to train healthcare professionals in different African countries in tobacco cessation. Yvonne has participated in drafting Clinical guidelines for tobacco cessation for 7 countries and also evaluated 7 tobacco cessation clinics in Mauritius. Prior to these, Yvonne worked at a rehabilitation program for Substance dependence clients for 5 years.

Marie Lan Cheong Wah MD, PGD

Email: [email protected]

As Associate Professor at the University of Mauritius, Marie is working on tobacco control, with a focus on smoking cessation services. As investigator within the Mauritian team, she has participated in the International Tobacco Control Policy Evaluation Project and in the African Tobacco Situational Analysis. As tobacco control advocate, Marie is a member of the national steering committee for tobacco control and as medically qualified doctor, she has a Diplôme d’Université en Méthodes et pratique en Epidémiologie from Université de Bordeaux, France and also a post-graduate diploma in public health from Staffordshire University, United Kingdom.

Catriona Jennings RN, PhD

Email: [email protected]

Catriona Jennings has served as the European Research Nurse coordinator in the Department of Cardiovascular Medicine at the International Centre for Circulatory Health, Imperial College London since 2002. She has coordinated both randomised controlled trials (RCT) and surveys. The EUROACTION cluster RCT was conducted in eight countries and 24 centres in Europe between 2002 and 2006. Catriona led the multidisciplinary London team who were responsible for training project staff and developing the health professional and educational materials. Since 2006, she has coordinated the third and fourth EUROASPIRE surveys in 22 and 24 countries respectively in Europe, and the British Cardiovascular Society UK based survey of preventive management in coronary patients and high risk individuals called Aspire-2-Prevent. At the end of 2011 she completed coordination of a second EUROACTION study called EUROACTION plus intensive smoking cessation with varenicline which was implemented in 4 countries including the UK.

She read French for her first degree and subsequently trained as a nurse at Charing Cross Hospital in London. She then specialised in cardiac nursing and finally cardiac rehabilitation, leading a programme at Stoke Mandeville Hospital in Buckinghamshire. Catriona is a senior teaching fellow for the Imperial College MSc in Preventive Cardiology programme where she leads modules on Preventive Cardiology Theory and Practice and smoking cessation. She has completed a PhD on concordance for cardiovascular risk factors and concordance for change in families. Catriona has taken leadership roles in professional societies serving as President of the British Association for Nursing in Cardiovascular Care which is an affiliated group of the British Cardiovascular Society and she is currently the Chair of the European Society’s Council on Cardiovascular Nursing and Allied Professions.

Aswathy Sreedevi MD, PGDAP

Email: [email protected]

Dr. Aswathy is a professor of community medicine at Government Medical College in Palakkad, Kerala. She is closely involved with training graduate and post graduate medical students which involves guiding them in research work. She has been instrumental in developing a rural health training centre in a coastal area of Kerala and capacity building of medical graduates to deliver brief intervention for tobacco cessation.

Katarzyna Zatońska MD, PhD

Email: [email protected]

Dr. Zatonska is head of Social Medicine Department at Medical University of Wroclaw, Poland. She is a lecturer and practicing physician at the Wroclaw Medical University with specialisation in diabetology and endocrinology. Her scientific interests are in areas of public health, health risk behaviors, epidemiology of noncommunicable diseases, education of medical personnel. She is interested in using the research results to enhance local health authorities and education of medical personnel.

She is currently working on the PONS study, “Establishing infrastructure for population study of health in Poland”, Coordinated by Department of Cancer Epidemiology and Prevention, Cancer Center and Institute of Oncology in Warsaw, Poland. and the PURE study, “Prospective Urban Rural Epidemiological Study”, Population Health Research Institute in Hamilton, Canada.

Bidyut Sarkar MD, PhD

Email: [email protected]

Bidyut is a physician (MBBS), public health specialist (MD in Community Medicine) and trained in public health research (PhD in Epidemiology and Public Health from UCL London). He has a passion to identify low cost, scalable interventions to make adult tobacco users quit tobacco use. He has conducted a large cluster randomized trial in low income tobacco users in India of a novel intervention of quit advice and use of yogic breathing exercises to quit tobacco use with positive results. He has multiple publications in international peer reviewed journals like Addiction, Psychopharmacology, Asia-Pacific Journal of Cancer Prevention and journal of Infectious diseases.

He wishes to combine his existing public health experience with newly acquired knowledge and skills in context of cardiovascular research to play a leadership role in reducing the morbidity and mortality from cardiovascular diseases in India and South East Asia.

Kemi Tibazarwa MD, MPH, PhD

Email: [email protected]

Anindo Majumdar MBBS, MD

Email: [email protected]

Anindo is a physician (MBBS) with postgraduate training in public health and primary care. He received M.D. (Community Medicine) degree from All India Institute of Medical Sciences (AIIMS), New Delhi and M. Med. (Family Medicine) from Christian Medical College (CMC), Vellore. Currently, he is working with the Centre for Chronic Disease Control (CCDC), Gurgaon, India as Clinical Investigator Research Fellow, fellowship being supported by CDSA, Department of Biotechnology, Ministry of Science & Technology, Government of India. At CCDC, he is involved in international collaborative projects in alignment with cardiovascular health and the CVD roadmaps, both as investigator and coordinator.

After completing his postgraduation, he served as a senior resident for 3 years in the department of Preventive and Social Medicine at JIPMER, Puducherry (an institution of national importance), where he was involved in teaching and training of MBBS, MPH and MSc (community nursing) students, also mentoring them in their research projects. Apart from administration, management and providing clinical care at the rural and urban health centres, he was actively involved in the delivery, monitoring and supervision of various national health programmes in the field practice area, working closely with the community health workers. He has useful experience of planning and conducting research studies in rural and urban communities of Puducherry (South India) and Haryana (North India). He has 21 research papers in both international and national peer reviewed journals so far, and has reviewed papers for notable international journals. His primary research interests lie in developing and implementing cost-effective strategies for the prevention and control of non-communicable diseases (primarily cardio-metabolic diseases), apart from integration of information technology in health, and child and adolescent health.

The World Health Organisation Global Status Report on NCDs has estimated that 80% of mortality from NCDs occurs in Low and Middle Income Countries (LMICs).¹ Tobacco is a major risk factor for many NCDs including CVD. While prevalence of tobacco use remains higher in higher income countries, its use is rapidly increasing in LMICs.

Accelerating and strengthening tobacco cessation support in LMICs, through effective cessation programmes is the need of the hour. It is critical not only to prevent CVDs and cancers, but also for decreasing premature mortality due to these, and several other chronic health conditions (including COPD, chronic kidney disease, chronic liver disease etc.) for which tobacco is a common risk factor.

Treating nicotine dependence is identified by World Health Organisation (WHO) as a low cost and cost effective, population wide intervention to reduce risk factors. There is an urgent need to provide support at an individual level for quitting tobacco, especially in LMICs. This is reflected in Article 14 of the Global Framework Convention on Tobacco Control (FCTC), Demand reduction measures concerning tobacco dependence and cessation and ‘O’ of the WHO MPOWER initiative, ‘offering help to quit’.^2,3

Several reputed global health organizations like World Health Organization (WHO), World Heart Federation (WHF), The Union, and others have been highly active in supporting national governments in LMICs for design and implementation of key FCTC recommendations, including cessation.^{4, 5, 6} For example, WHF envisages to do this through providing guidance to countries in development and adaptation of WHF tobacco roadmaps.

There are several types of smoking cessation interventions with varying levels of effectiveness.

The following table gives a summary of effectiveness of selected smoking cessation interventions (abstinence for at least six months).⁷

One of the most common evidence based physician brief advice techniques accepted worldwide are the 5As model. The 5As model i.e. ‘Ask’, ‘Advise’, ‘Assess’, ‘Assist’ and ‘Arrange’ for tobacco cessation counselling is an evidence-based approach whose feasibility in primary care has already been proved.⁸ It includes five components: ‘asking’ about tobacco use, ‘advising’ to quit, ‘assessing’ willingness to quit, ‘assisting’ the patient in making a quit attempt, and ‘arranging’ follow-up to prevent relapse [see appendix].⁹

The Ministry of Health and Family Welfare in India issued tobacco treatment guidelines in 2011 which recommends physicians in primary care and other settings identifying and treating every tobacco user seen in healthcare settings. It specifies that all health care providers must provide 5As counselling as a part of routine health care consultations and dedicated tobacco cessation specialists services should also be set up in health care settings.¹⁰

There is currently a gap between the evidence base available and the implementation of the evidence. For example, it was shown that the patients visiting primary health care facilities in India neither receive tobacco cessation counselling, nor referral to tobacco cessation centres.^11,12An earlier quantitative cross-sectional study conducted in India showed that patients who reported that they were ‘advised’ to quit, ‘assessed’ for readiness to quit and offered cessation ‘assistance’ were more satisfied with the counselling services than those who were not (OR 9.6, 2.1 and 2.2 respectively).¹⁰ Also, patients who were satisfied with the counselling services, were five times more likely to have an intention to quit tobacco and four times as likely to recommend counselling to other fellow tobacco users.¹³ It has also been reported that concordance rates between physicians and patients for various components of 5A’s varied from 41.4% for ‘Arrange’ and 76.4% for ‘Ask’. This point towards the wide disparities that exist in terms of what happens in usual clinical practice and what is perceived by patients and healthcare professionals as the actions taken towards tobacco cessation.

One study in India found that there were significantly high (more than double that of counselling group) continuous abstinence rates observed in the medication group as compared to the counselling group alone.¹⁴

In the case of Kenya, the International Tobacco Control Policy Evaluation (ITC) Project, Kenya Survey found that about three-quarters (76%) of tobacco users are in favour of a ban on tobacco products within 10 years if the government provided assistance such as cessation clinics.¹⁵ It was reported from the same survey that tobacco users in Kenya are not well connected to sources of cessation assistance. Only one-fifth (20%) of tobacco users reported that they had consulted a health care professional in the last 6 months. Among smokers who had visited a doctor, only 35% were advised to quit tobacco, which apparently was lower than most of the other ITC LMICs. Of those who were given advice to quit, 82% reported that the advice made them think about quitting tobacco.¹⁵.Naturally one of the key recommendations of the ITC Kenya team was to establish cessation services to support tobacco users who wish to quit.

Kenya signed and ratified the FCTC in June 2004, and the treaty became effective as of February 27, 2005. Kenya’s 2007 Tobacco Control Act came into force in July 2008, providing the legal framework for the implementation of FCTC policies in Kenya.¹⁶ The National Tobacco Control Action Plan (NTCAP) 2010-2015 has listed a range of effective interventions available to motivate and support those attempting to quit including brief advice delivered by health and social care professionals including doctors, dentists, nurses and pharmacists, as well as by allied health professionals, behavioural and support services, pharmacotherapy, as well as counselling and referral by health professionals.¹⁷ Smoking cessation support is available in some hospitals, offices of health professionals, health clinics or primary care facilities, and community centres.¹⁸ Nicotine replacement therapy and bupropion are legally sold in Kenya, but not vareniclin.¹⁸

In one study from Kenya, it was found that 73% of the respondents (health care professionals) correctly identified the 5A’s model as a recommended behavioural intervention and 66.3% of respondents correctly identified advice from a health care provider as a recommended behavioural intervention for smoking cessation.¹⁹ The same study also found that more than half of the respondents did not correctly identify various smoking cessation medications. Nicotine gum was correctly identified by only 41% of the respondents while nicotine patch was correctly identified by a mere 35% of the respondents. Only 18% and 11.5% of the respondents correctly identified nicotine lozenges and bupropion respectively as smoking cessation medications.

Most LMICs lack good quality qualitative data which provide an in-depth understanding of how the health system in LMICs work, particularly with respect to tobacco cessation in terms of care pathways, referral, and coordination of services between health and social care professionals at different levels of care. There is also a dire need of understanding the implementation barriers and facilitators in these countries to providing effective tobacco cessation interventions in healthcare facilities. This issue has to be addressed urgently, given the lack of implementation of cessation support services in LMICs, which is only possible through understanding of the perspectives of various stakeholders like patients, health care professionals, and policy makers. Thus, the present qualitative study has been planned in two LMICs, i.e. India and Kenya with the expectation that the findings would set a platform for advocacy to various stakeholders in these countries and ultimately help drive evidence based policy formulation and implementation of tobacco cessation support services.

Study settings

Two study sites from India and two from Kenya have been selected. In India this will include a site in North India (New Delhi and one district from the state of Haryana TBD) and one in Southern India (Ernakulum district and Thiruvanathapuram district belonging to the state of Kerala). Similarly the study sites in Kenya will be Nairobi County (capital city) and a rural setting in the Western region in Nyanza County. The two countries were selected strategically as Kenya and India are both LMICs and in the first and second stage of the tobacco epidemic. Similarly, the selection of the study sites within the countries was done strategically based on feasibility.

Study design

A qualitative approach utilizing semi-structured interviews was chosen in order to ensure that the beliefs, perceptions, attitudes, and contexts are adequately captured by our study.

Sample size

A maximum of 100 interviews (50 each in India and Kenya) will be conducted. This number has been decided with consideration to time constraints and resource availability.

Sampling

Out of a maximum of 50 interviews each in India and Kenya respectively, around 20-30 will be from North India/Central Kenya and around 20-30 from South India/Western Kenya. Out of these 20-30 interviews in each region, an estimated 8-12 will be patients, another 8-12 Health Care Professionals (HCPs) and the remaining 4-6 will be key informants and policy makers. The participants will be selected using a purposive sampling and snowball sampling technique, depending on local requirements.

Patients will be selected from the healthcare facilities according to their background characteristics, provided from discussions with their consulting physicians. The interviews will be conducted at a location preferred by the patient. Depending on the preference, the place of interview could be the healthcare facility, the patient’s home or the patient’s workplace.

Appointments will be taken through emails, phone calls and personal visits, as required. Appropriate permission from the relevant authorities will be taken prior to the interview. After the initial eligibility assessment and obtaining the informed consent, participants will be interviewed with the help of semi-structured interview schedules. Semi-structured in depth one-to-one interviews will be conducted by staff trained in doing qualitative interviews. The training will be conducted by the investigators who already have experience in conducting qualitative research. The interviews will explore the patient-level, provider-level and health system-level barriers, combined with facilitators which directly or indirectly influence delivery of tobacco cessation interventions during the provision of usual routine clinical care. The interviews will be lasting around 40-45 minutes.

Tools

Interviews will be conducted in country specific local languages or in English as appropriate, depending on the participant’s preference. Three separate interview guides will be developed; one for patients, one for the HCPs and one for key informants and policy makers. Country specific contexts will be incorporated before a pilot to test them separately in India and Kenya. The interview guides will be translated to country specific local language. All the interviews will be audio-recorded. Additional notes and non-verbal cues shall be recorded by the interviewer.

Qualitative data analysis plan

The interviews will be recorded and transcribed in full in their respective languages. Following verbatim transcription in native language, the transcriptions will be translated to English before analysing it with the assistance of QSR International’s qualitative analysis software NVivo 10. Data will be analysed both deductively and inductively. Appropriate codes and sub codes will be generated. Data will be analysed thematically to elicit appropriate themes and subthemes. Interviews in local languages will be transcribed and the analysis will be conducted by researchers fluent in these languages.

A policy brief will be developed based on the study findings. This will be used for dissemination and advocacy to policymakers which is expected to help the ongoing efforts of Indian and Kenyan governments and major organizations like WHF. For instance, the findings could be used to supplement currently running/future WHF roadmap activities for tobacco control in these countries to drive implementation of cessation support services. Also attempts will be made to present these in major conferences and publish in highly reputed journals which are interested in disseminating quality studies pertaining to the tobacco control agenda in LMICs. The dissemination and advocacy activities will be carried out at three sites i.e. at New Delhi and Ernakulum in India and Nairobi in Kenya.

The following are the desired dissemination and advocacy objectives of the current project:

• To increase the awareness of the importance of delivery of evidence-based tobacco cessation interventions among influential groups and the public.
• To promote the effective and equitable implementation of existing policies related to tobacco cessation interventions and services being studied in the current project.
• To maintain the involvement of decision-makers, health care professionals and the public in tobacco cessation services control by disseminating information generated during the qualitative study.

Data collection

Data collection has been completed.

A total of 109 in-depth interviews were conducted in India and Kenya. Out of these, 54 interviews were conducted in India, and 55 interviews were conducted in Kenya.

In India, 24 patients, 22 healthcare providers and 08 policymakers were interviewed.

In Kenya, 19 patients, 25 healthcare providers and 11 policymakers were interviewed.

Analysis

Qualitative analysis has been completed using content analysis for all interviews and a summary has been developed. Nvivo version 10 software was used for data analysis.

Dissemination and advocacy activities

There is a plan to submit papers out of this project in journals for publication.  Oral/poster presentations in conferences including WCC 2018 have also been planned. In addition to these, the following have been carried out/planned.

India

In Kerala,

• A dissemination for the general population attended by about 80-100 people with a press report planned on 28/12/2017.
• A dissemination for school police cadets and teachers from selected schools attended by 60-70 students and teachers.
• A dissemination and sensitisation for urban primary health centre teams (medical Officer and health inspector) – Around 50 healthcare staff expected. This will be done on the last week of December and 1st week of January.

Apart from Kerala, Individual level advocacy was carried out by the project team through personal contacts in the WHF roadmap project meetings and policy dialogues held in Delhi and Chennai.

Kenya

The project team went back to the policy makers and shared with them the observations and feedback on the ground, regarding which they were very receptive. Dissemination of project findings to them has also been planned. So far, as a result, ministry of Health and WHO organized a cessation training for 25 healthcare workers after they received feedback.

Ms Yvonne Olando became part of the technical working group on the national strategic plan 2017-2022 so as to ensure all areas touching on cessation have been captured. She has been requested to support in setting up a tobacco cessation clinic in the leading mental health clinic. She also worked on two proposals on cessation for different NGOs. There is a plan to share findings in several side bars in an upcoming symposium in one of Kenya’s public universities.

Appendix and References