believe that this study is safe and do not expect you to suffer any harm or injury because of your participation in it. However, Queen Mary University of London has agreed that if you are harmed as a result of your participation in the study, you will be compensated. In such a situation, you will not have to prove that the harm or injury which affects you is anyone s fault. These special compensation arrangements apply where harm is caused to you that would not have occurred if you had not taken part in the study. These arrangements do not affect your rights to pursue a claim through legal action. Please contact the Service user Advisory Service (PALS) if you have any concerns regarding the care you have received, or as an initial point of contact if you have a complaint. Please ask for the contact details from your pharmacist or GP practice. Thank you! If you wish for further information, or you become worried about the study, you can contact Carol Rivas or Robert Walton to discuss your concerns. Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. They may be contacted at the Centre for Public Health and Primary Care, Queen Mary Barts and the London, telephone number 0207 882 8999 and 020 78822502. This study has been reviewed and passed by the Berkshire B Research Ethics Committee Service user PIL V4 1 st May 2013 REC no. 13/SC/0189 Page 4 of 4 SMOKING CESSATION STUDY SERVICE USER INFORMATION SHEET Information about our research and invitation to take part in our study My name is Carol Rivas. I am a researcher at Queen Mary Barts and the London. I am inviting you to take part in our research study about smoking cessation. This leaflet tells you why the research is being done and what you can expect if you take part. Please read this leaflet carefully, and ask me or Professor Robert Walton, if you have any questions. You can phone us on: 0207 882 8999 or 020 78822502. Your community Stop Smoking advisor will go through this information sheet with you before your first Stop Smoking consultation and answer any questions you may have. Please talk to others about the study if you wish. Below I have given the answers to some questions you may have but if you have others, please ask us. What is the purpose of the study? We want to improve the way that pharmacists and service users communicate about how to stop smoking. The information will be used to develop courses to help pharmacists and their assistants to be more effective in helping people to stop smoking. To do so we want to record some Stop Smoking Programme consultations and interview some people doing the Stop Smoking programme, and I may also sit in on a consultation. Your pharmacist will share with us basic information about you too if you agree. Why have I been asked to take part? You have been asked to take part in this study because you have agreed to take part in the Stop Smoking Programme offered by your community pharmacist. We will be recruiting up to 350 service users for this study who are attending the Stop Smoking programmes at pharmacies in Newham, Hackney and City and Tower Hamlets. Do I have to take part? No. It is entirely up to you whether or not you take part. You can refuse to take part in the entire study or parts of it. If you agree to be audiorecorded you may withdraw from the study or stop any recording at any time. You may also ask for a section of the audio recordings to be edited out of the version that we keep. If you agree to the interview, you may refuse to answer some of our interview questions, and that is fine. And whatever you agree to, you can change your mind at any time. Whatever you sign, you can ask for the recordings to be deleted at any time. If you choose not to take part, or withdraw from Service user PIL V4 1 st May 2013 REC no. 13/SC/0189 Page 1 of 4
the study at any time after saying you will take part, this will not affect your treatment and care. You can continue with the Stop Smoking consultations at your local pharmacy whatever you decide about our study. What is the next step? If you are interested in taking part, your Stop Smoking advisor will meet you just before your first Stop Smoking consultation and go over this information sheet with you and ask if you have any questions. When you think he or she has answered all your questions and if you agree to continue, he or she will ask you to sign two consent forms, which are enclosed so that you can see them in advance. You are free to change your mind at any time. Where will you get information about my smoking related health, habits and treatment from? When taking part in the Stop Smoking programme at your pharmacy, your stop smoking advisor has to collect some basic information about you, such as your age, ethnic group, any smoking related health problems you may have, and the type of treatment you are being given to help you stop smoking. With your consent (and initials on the signed consent form), your pharmacist or Stop Smoking advisor will allow us (the Smoking Cessation research study team) to see the information. We will match it up with the audiorecordings of your consultations and it will help us in our analysis of the Stop Smoking programme and how it can be improved. What happens after that? 1. The saliva sample After you have given your written consent, your Stop Smoking advisor will take a sample of your saliva to measure the level of nicotine in your body. We will compare this with a second sample six months after the quit date you set with the advisor. There is nothing unpleasant or painful about this. It is to see how much nicotine is still in your body. This helps us see the effectiveness of the Stop Smoking Programme and we are not monitoring you. 2. The Stop Smoking consultations You will then have your first Stop Smoking consultation. If you agree, the advisor will audiorecord week one, week two and week five or six. You can ask your advisor to turn the recorder off any time you wish. The advisor will send the recordings to the research team at Queen Mary. After each consultation that is being recorded the advisor will check that you are still happy for us to use the recordings for our research. You may amend your consent if you wish 3. The interview If you have agreed the advisor will give us your contact details so that we may phone to ask you if you will agree to an audio recorded interview with us, in your home or at the pharmacy or anywhere else that you prefer and at any time you say. If you agree to an interview, you will be asked to talk about your views and experiences of taking part in the Stop Smoking Programme and whether you think it could be improved. The interviews will be kept confidential and you will not be named. 4. Observing a session If you have agreed, the researcher may observe a consultation but will not talk during the session or take part in the consultation in any way. They will just be there to look for communication moments that cannot be audio-recorded but that it may be helpful to know about to improve the consultations.. You will be compensated for your time in doing an interview and for returning to the pharmacy for a 6 month saliva sample. This will be with a 10 voucher each time. Expenses will be paid, such as reimbursement of reasonable travel expenses if you wish to take part in the interview away from your home. The Stop Smoking advisor will also get compensation for the extra time they spend on the study. How long will it take? Audio recording the consultations will not take up any extra time or affect your healthcare in any way. The interview will probably take 30-60 minutes, and will take place at a time and place of your choosing. Why do I have to sign consent forms? The forms are designed to ensure that you understand what the study involves, and to give you control over what we do, if you take part in the study. You can use them to limit the ways that we use the recordings and interviews. If you do not sign the forms you cannot take part in the study because we would have no way of knowing exactly what you agree to or disagree with. How will I benefit from the study? You will not be likely to benefit personally from the study but our findings will be used in training and education to improve the Stop Smoking Programme in community pharmacies. What happens once I have taken part? The use of the data consent form that allows us to use your data in different ways has three choices. I) You can refuse consent for anyone except the research team to hear the recordings. II) You can give consent for their use in presentations and education and for us to potentially use brief III) excerpts from some of the consultations and the interview as examples in training courses for pharmacists. You can give consent for us to keep the recordings in a data archive with an associated website so that researchers in future can analyze the data looking at different research questions. These other educators and researchers may use small excerpts in their own research publications and talks. Members of the public may also listen to carefully selected short clips via the website, in a public area of the website, if you have agreed to this. We will ask you to double check the clips before we put them on the website. You can consent to some recordings being used further and others not or give consent for part of a recording or all the recording to be used. Recordings will be destroyed after 5 years unless you have signed to allow them to be in our archive. How will we ensure confidentiality? We have a strict process in place to ensure no-one has access to your data except for your Stop Smoking advisor and the research team. All the information we have about you will be securely stored at Queen Mary University of London. We will only pass on recordings to professionals outside of our current research team if you agree. We will always use a code number or false name when referring to you or your audio recordings and never your real name. What do I do if I want to complain? Queen Mary University of London has a special insurance policy to protect service Compensation users who take part in research. Your wellbeing will always be our priority. We Service user PIL V4 1 st May 2013 REC no. 13/SC/0189 Page 2 of 4 Service user PIL V4 1 st May 2013 REC no. 13/SC/0189 Page 3 of 4
'X' if patient is accompanied - companion must also initial each box and sign beside patients'. Site ID: S Smoker ID: P USE OF DATA Smoking Cessation Study - Service user Consent Form Consent to be taken by Stop Smoking Advisor on behalf of QM smoking cessation This form refers to the data from Stop Smoking consultation recordings, interviews and basic information about you recorded by the pharmacies, which we are collecting for the study. 1. We plan to use the data to write research reports, give talks at conferences and at training workshops. 2. We separately wish to store the data in an education and research archive and make it available for use by carefully selected educators, researchers and other professionals with an interest in smoking cessation or communication between health professionals and healthcare service users. There will be a password protected part and a more limited public open access area. The data may be used by professionals for further analyses and may then be reproduced in research and education materials, lectures, audio resources, reports, presentations and publications. Some material may be translated into other languages. 3. The saliva samples will not be shared outside research teams managed by the chief investigator of the current study and so you do not need to consider them here. Please could you sign one of the boxes below to indicate whether or not you are happy for us to reproduce the data outside of the research team. There are two choices, so you can control how we make use of your data, and you can refuse us permission to use all or part of the data in these ways. The choice you make will not affect your health care or legal rights in any way. You can change your mind later, this will not affect your health care or legal rights either. We won t use any of your data outside the research team without your permission. If you want to discuss these options with us and ask more questions before signing, phone Carol Rivas, 0207 882 8999. PLEASE SIGN ONLY ONE OPTION BELOW: OPTION 1: I DO NOT GIVE CONSENT for any of my data collected for the Smoking Cessation Study to be reproduced. Signed Your data will only be seen by the research team but are still useful and we thank you for taking part in the study. YOU DO NOT HAVE TO SIGN THE OTHER SIDE OF THIS FORM OPTION 2: I GIVE CONSENT for my data to be shared via the archive and reproduced for educational and/or non commercial purposes in research and education materials, lectures, audio resources, reports, presentations and publications connected to the Smoking Cessation Study and on the education and research website. (delete the words in bolder text if you do not want to be on the website) I understand my real names will not be used and the data will be anonymised as much as possible. Please tick here which data can be used: Voice recording of consultations Voice recording of interview Written transcript of consultations Written transcript of interview Signed Thank you for taking part in the study PLEASE NOW READ THE OTHER SIDE OF THIS FORM Signature of Stop Smoking Advisor SIDE TWO Queen Mary Barts & the London Smoking Cessation Study service user use of data form v3 VM /CR 22 nd March 2013 REC no. 13/SC/0189 p 1 of 2 1 copy to service user, 1 copy to advisor, 1 copy to QM research team for files
'X' if patient is accompanied - companion must also initial each box and sign beside patients'. Site ID: S Smoker ID: P Smoking Cessation Study Use of Data - Service user consent form: SIDE 2 for joining ERatabase only Consent to be taken by Stop Smoking Advisor on behalf of QM smoking cessation research team Thank you for taking part in the study Please now put your initials in the boxes of everything you agree to, and sign and date the bottom of the page. I understand that consent includes use of independent service providers to help run and manage the web site. My recordings will not be used for advertising or purely commercial purposes or commercial gain. I understand that access to some parts of the website cannot be restricted. I understand the website, being part of the worldwide web, may be accessed from outside the European Union and that in some countries personal data may not have the same level of legal protection as within the European Union. I understand that if it is decided to put brief clips of my audio recording on the website - and I have agreed to this today - I will be given the clips to listen to and will be asked for permission again at the time that we wish to put them on the website. I understand that at this time I can ask for the sound of my voice to be altered before any clips of it go on the website, if I wish. To enable the full use of my contribution in the archive and on the website, I assign my copyright in my contributions to Queen Mary University of London. In return for my assignment my recordings will only be used in the manner set out above. If I decide that I no longer want my contributions to appear in the archive and on the website, they will be removed, although I accept that it will not be possible to remove all existing copies from circulation. Service user signature Signature of Community Pharmacist or Stop Smoking Advisor Queen Mary Barts & the London Smoking Cessation Study service user use of data form v3 VM /CR 22 nd March 2013 REC no. 13/SC/0189 p 2 of 2 1 copy to service user, 1 copy to advisor, 1 copy to QM research team for files
'X' if patient is accompanied - companion must also initial each box and sign beside patients'. Site ID: S SMOKING CESSATION STUDY SERVICE USER CONSENT FORM Consent to be taken by Stop Smoking Advisor on behalf of QM research team Smoker ID: P We are conducting research at your community pharmacy the Smoking Cessation Study. You do not have to take part. Please read the accompanying information sheet and this consent form before making any decisions. Before your first Stop Smoking consultation someone from the community pharmacy will talk to you and go over the information sheet and this form with you, as well as the accompanying consent form about further use of the study data. You can then tell them whether not you wish to take part. If you do not, you can still take part in the Stop Smoking Programme as normal. Please read the statements below and put your initials in the boxes if you agree. Put an X in any box where you do not agree. Please sign the bottom of the form 1. I have read the information sheet dated 1 st May 2013 and have had the opportunity to consider the information and ask questions and I have had these questions answered satisfactorily. 2. I understand that I am being asked to take part in a research study about the community pharmacy Stop Smoking programme and that this study does not involve any changes to my smoking related health care. 3. I understand that my participation is voluntary and that without giving any reasons I can refuse to take part in all or some parts of the study and that this will not affect the care I receive in any way, or my legal rights. 4. I agree to audio recording of three of my stop smoking consultations. 5. I agree to an audio recorded interview by a member of the research team about my participation in the Stop Smoking Programme at a time and place of my choosing. 6. I agree that any routine information that the community pharmacy Stop Smoking advisor has collected about me can be shared with the research team. 7. I agree that the researcher may sit in on a few consultations without joining in, and that if they do I can ask them to leave at any time. 8. I understand that I can later withdraw from the study or ask for the recordings or interviews or parts of them to be deleted, without giving a reason, and this will not adversely affect my smoking related treatment plan. 9. I agree to let the pharmacist take one or two samples of my saliva to look at my nicotine metabolism and for these samples to be used for other analyses by the study team. 10. I agree that my contact details can be given to the researcher so that they can contact me to arrange an interview. 11. I agree that my contact details can be given to the researcher so that they can contact me to invite me to take part in other smoking-related research 12. I understand my participation in this study is entirely confidential and that my details will all be anonymised. 13. I understand that this study is part of a larger 5 year project so that my data will be kept for at least 5 years (and longer if I specifically agree) to be used in this or other studies directly linked to the 5 year project. 14. I understand that all the information collected about me in this study is securely stored by the Queen Mary Smoking Cessation research team and will be shared within the research team to help with their analyses. 15. I understand that relevant sections of my smoking related health records and data may be looked at by individuals from Queen Mary Barts and the London or the local Public Health dept or regulatory authorities where it is relevant to managing and auditing this study or the website. I give permission for this. 16. I understand that this study has been approved by the Berkshire B National Research Ethics Committee [approval number 13/SC/0189. Service user signature Name of Stop Smoking advisor Stop Smoking Advisor signature Community Pharmacy Smoking Cessation Study Service User Consent form V 3 1 st may 2013 1 copy for service user, I copy for Stop Smoking Advisor, I copy for Queen Mary Smoking Cessation Study research team
Site ID: S Patient Demographic Data Form Smoker ID: P We can fill in this side of the form if allowed access to the NHS database in the consent form and by you or you (the SSA) might prefer to fill it in. Age: Gender: Male Female Ethnicity (tick one) White English / Welsh / Scottish / Northern Irish / British Irish Gypsy or Irish Traveller White Other: Mixed/Multiple Ethnic Groups White and Black Caribbean White and Black African White and Asian Mixed Other: Asian Indian Pakistani Bangladeshi Chinese Asian Other: Black / African / Caribbean / Black British African Caribbean Black Other: Other Ethnic Group Arab Any Other: Client Recommended by: (tick one) GP Pharmacy Advertising Friend/relative Other Health Professional Other: Exempt from Prescription Charge? Yes No Pregnant? Yes No Breast Feeding? Yes No Occupation Code: (tick one) Student Unemployed Retired Home Care Sick/Disabled Managerial/Professional Intermediate Routine Manual Prisoner Unable to Code
HOW CLIENT HEARD ABOUT THE SERVICE (please circle relevant answer) GP Friend/relative Pharmacy Other Health Professional Advertising Other (please specify) AGREED QUIT DATE: DATE OF LAST TOBACCO USE: DATE OF 4-WEEK FOLLOW-UP: TYPE OF INTERVENTION DELIVERED (for the purpose of data capturing, the intervention type is the one chosen at the point the client sets a quit date and consents to treatment) Closed group Open (rolling) group One-to-one support Other (please specify): Telephone support Couple/family Drop-in clinic TYPE OF PHARMACOLOGICAL SUPPORT USED (please tick all relevant boxes. Use 1 or 2 to indicate consecutive use of more than one medication e.g. Champix followed by NRT product) None NRT lozenge NRT microtab Zyban NRT inhalator NRT spray NRT gum NRT patch Champix TREATMENT OUTCOME Not quit Lost to follow-up Quit self-reported Quit CO verified
Check list: pre quit session (initial visit which may also be quit date),,-observed ------- Used Assessing current readiness and ability to quit Informing the client about the treatment programme Assessing current smoking Assessing past quit attempts Assessing nicotine dependence Explaining & conduction carbon monoxide (CO monitoring) D D Explaining the importance of abrupt cessation and the "not a puff rule" Informing the client about withdrawal symptoms Discussi ng medication Setting the quit date Prompting a commitment from the client Discussi ng preparations and providing summary Communications skills used throughout Boost motivation and self-efficacy Build rapport Use reflective listening Provide reassurance NCSCT