Protocol

Title of research project: Medicated Sleep and Wakefulness: A Social Scientific Investigation of Stakeholder Interests, Policies and Practices

Contents 

Abstract/Lay summary of study 
	2	
Background to research
	2	
The research team and their responsibilities
	4	
Aims and objectives
	5	
Research design and methods 
	6	
Data analysis
	13	
Ethical considerations 
	13	
Benefits of the study 
	14	
Timeline 
	16	
Resources and costs
	16	
Conflicts of interest
	16	
References	17	

Abstract/Lay summary of study 

Concerns are frequently expressed in scientific, professional and popular culture today about the personal and social costs and consequences of poor sleep. At one and the same time concern also continues to be voiced about the 'appropriate' role and use of pharmaceuticals in the management of sleep problems both inside outside the doctors’ surgery or the sleep clinic. This project therefore provides a timely social scientific investigation of these developments and debates regarding sleep and wakefulness promoting drugs in Britain since 2000, with particular reference to the role of pharmaceuticals in the medical, social and personal management of sleep problems. The project so will examine both 'upstream' issues regarding the development and regulation of sleep and wakefulness promoting drugs since 2000 and 'downstream' issues regarding their meaning and use in medical practice and everyday/night life. These issues will be investigated through a qualitative multi-method study comprising documentary sources, semi-structured interviews, focus groups and detailed case studies with a range of key stakeholders in field -- from sleep scientists, doctors and policy makers to  patients, pressure groups and other key members of the public with a stake or interest in these sleep matters. Results will be communicated and disseminated to both academic and non-academic user groups, including scientists, doctors, patients, pressure groups and policy makers.

Background to research

Sleep deprivation, according to current evidence, is a real and growing problem in contemporary society (Martin 2004, Dement 2000, Coren 1996), whether through (un)diagnosed sleep disorders or the escalating demands of modern life in today’s ‘around-the-clock’, ‘non-stop’, culture in which alertness is prized and ‘busyness’ becomes the norm (Summers-Bremner 2008; Chatzitheochari and Arber 2009). The costs and consequences of poor sleep, it is claimed, include impaired health and quality of life, lost productivity and poor performance at work and at school, accidents on the roads, and other tragedies such as the Exxon Valdez oil spill, the Challenger Space Shuttle disaster and the Chernobyl nuclear meltdown (Moore-Ede 1993). 

Sleep, as this suggests, is not simply an important social scientific topic or problem in its own right but a point of articulation for a wide range of concerns and anxieties in contemporary society (Williams 2005, Williams et al 2009a), including questions of health, risk and public safety, work-time, work-culture, and work-ethics, changing forms and patterns of family life, and associated issues to do with sleep, gender and ageing across the life course. Whilst recent work has begun to address some of these issues, including a recent interdisciplinary ESRC ‘Sleep and Society’ seminar series <http://warwick.ac.uk/go/sleepandsociety> and on-going sociological research on sleep, gender and ageing across the life course <http://www.somnia. surrey.ac.uk> (see Williams et al. 2009a, for a comprehensive review of progress to date), little sustained sociological attention has been paid to current trends surrounding ‘medicated’ sleep and wakefulness in relation to: (i) the medical management of sleep disorders, and (ii) the personal management of sleep problems.
The management of sleep problems of course may take many different forms, including a variety of both medical and non-medical strategies (Williams 2005). Sleeping tablets and other pharmaceuticals indeed may well be a treatment of ‘last resort’ (Hislop and Arber 2003). They remain nonetheless a significant therapeutic option with a sizeable number of prescriptions issued each year (see below)( Abraham, 2009). Previous sociological research on sleeping tablets (Abraham and Sheppard 1999, Gabe, 2001; Gabe and Bury 1996; Gabe and Thorogood, 1986), furthermore, is in need of updating given significant developments in both sleep and wakefulness promoting drugs in the last decade, and associated issues to do with the potential use of these drugs for ‘treatment’ or ‘enhancement’ purposes – the latter denoting the improvement or optimisation of human capacities amongst the ‘healthy’ in ways which some claim make us better than well, better humans or better than human (Miller and Wilsdon 2007).

It is certainly timely to consider the role of sleep medication at this particular juncture, given the aforementioned concerns over sleep or sleepiness as significant public health issues.  Concerns, moreover, continue to be voiced about the appropriateness of pharmaceutical solutions for sleep problems, particularly for the treatment of conditions such as insomnia. Expert bodies such as the UK Committee for the Safety of Medicines (CSM) have long since advised that the use of hypnotics be limited to short courses for acutely distressed patients and should generally be avoided in elderly people, whilst non-pharmacological interventions such as cognitive behaviour therapy (CBT) are now increasingly recognised or recommended within the NHS as a cost effective treatment option (Morgan et al. 2004). Hypnotic prescribing in the NHS nonetheless has shown remarkably little change over the last five years at around 10 million items per year. Although the prescribing of benzodiazepines has decreased, this has been offset by the rise in use of the new Z-drugs – zaleplon, zolpidem, zopiclone – which, in the 12 months to March 2008, stood at 5.2 million items dispensed at a total cost to the NHS of £12.3 million (NICE 2008; DoH 2008). 

Excessive daytime sleepiness (EDS) is also now a potential target for medication through a new class of alertness or wakefulness promoting drugs. Provigil (generic name Modafinil), manufactured by the Pennsylvania-based pharmaceutical company Cephalon, is a eugeroic (meaning ‘good arousal’) designed to offset the effects of excessive daytime sleepiness. Initially approved for the treatment of narcolepsy, it is now also officially licensed to treat excessive sleepiness (ES) associated with obstructive sleep apnoea/hypopnoea syndrome (OSAHS) and ‘shift work sleep disorder’ (SWSD), a circadian sleep rhythm disorder. It is also reportedly used off-label for a variety of other conditions involving sleepiness and fatigue including chronic fatigue syndrome, multiple sclerosis and cancer. There is however a potentially significant ‘lifestyle’ or ‘recreational’ market for this drug, with concerns being voiced in many quarters, amplified through the media (Williams et al 2008, Coveney et al. 2009), about the current or near future non-medical or non-therapeutic uses and abuses of Modafinil as a drug of choice in the so-called ‘24/7’ era, both inside and outside the workplace. 
It is not simply Modafinil’s wakefulness promoting qualities, however, which make it a potential drug of choice in the wider pharmaceutical marketplace. Modafinil has also been shown to enhance memory, mood, concentration and cognitive performance (Turner et al 2005). Modafinil, therefore, is yet another drug in which the boundaries between (medical) treatment and (lifestyle) enhancement are likely to become increasingly blurred (Wolpe 2002), particularly in an era where online access to these drugs is readily available via the Internet at the click of a mouse (Williams et al. 2009b). These issues in turn are now being taken up in broader public and policy debates, including a flurry of recent commentaries and reports (Greely et al 2008, Academy of Medical Sciences 2008, British Medical Association 2007, Department of Trade and Industry 2005) on the social and ethical implications of cognitive enhancement drugs. Despite this, however, robust empirical evidence about demand for drugs of this kind for ‘enhancement’ purposes amongst the healthy has yet to be collected (Williams and Martin 2009).

It is within this context that the present study on medicated sleep and wakefulness is located. The study has been 

The research team and their responsibilities 

All members of the research team have contributed to the design and development of the study and all will be involved in its execution, data analysis and dissemination of findings. 

The research project will be led by Professor Jonathan Gabe (JG), who has expertise in qualitative methods and in the meaning and use of tranquillisers and hypnotics. He will be involved in the design and execution of the project, including elements of data collection, data analysis, report writing and dissemination of project findings through talks and publications, in association with the research fellow. He will have particular responsibility for overseeing the conduct of the focus groups with patients and members of the public and will act as co-facilitator. He will also undertake some of the semi-structured interviews with patient and pressure group representatives and senior representatives of pharmaceutical companies. As CI, Professor Gabe will have overall responsibility for the study, including its day-to-day management and co-ordination of other team members’ inputs to the project. 

Professor Simon Williams (SW) has extensive experience of both quantitative and qualitative social research pertaining to health and medicine, including work in primary care settings and schools.  He will be involved in all stages of the research, including research design, execution of the methodology, analysis, writing up and dissemination. He will undertake some of the interviews with expert stakeholders (non-NHS research sites only). He will also co-convene some of the focus groups (non-NHS research sites only). He will also attend full team meetings and advisory group meetings.

Professor John Abraham (JA) has particular research expertise in the development, testing and regulation of drug safety/efficacy/innovation and the sociology and politics of the pharmaceutical industry worldwide. Professor Abraham will be involved in all stages of the research, design, methodology, analysis, write-up and dissemination. He will oversee the investigations of industry development of sleeping pills and the regulatory responses by government - involving both documentary and interview research. He will design the semi-structured interviews of representatives of industry and the government regulatory agencies. He will also conduct some of those interviews (non-NHS research sites only).

The research fellow, Dr. Catherine Coveney (CC), has experience in the design, conduct and dissemination of qualitative research, specifically related to sleep medications. Her previous research involved interviewing sleep scientists, shift workers and students about their attitudes towards sleep and drugs and the social, cultural and ethical issues raised by the introduction to the UK of pharmaceutical products that are being used medically and non-medically to treat sleep disorders and enhance cognition. CC will contribute to the preparation of ethics and R&D applications, the recruitment of research participants, organise interviews and focus group and collect data under the supervision of JG. She is also experienced in qualitative data analysis, being familiar with a range of tools and techniques, and will carry out data analysis and be involved in dissemination activities. 

We will invite representatives of each stakeholder group to form an advisory group. This will allow discussion of the planned research with representatives of these stakeholder groups, resulting in a greater level of analytical engagement with the issues. The Advisory Group will comprise of at least one sleep expert/specialist (TBC post-recruitment), a local GP (Dr Tim Holt), a social scientist with expertise in sleep research (Dr Robert Meadows), a patient/ representative from the patients association (TBC post-recruitment), a representative from the Mental Health Foundation (TBC post-recruitment), a representative from the Council for Involuntary Tranquilliser Addition (Pam Armstrong) and at least one Union representatives (Hope Daley from Unison). The group will meet at the start of the project and then once a year for the duration of the project. The advisory group will also help disseminate the study findings by circulating the results amongst members of their networks.  Final membership of the group will be confirmed once participant recruitment is complete.

Aims and objectives

The aim of the study is to conduct a social scientific study of stakeholder views on the management of sleep ‘problems’ and the appropriate role of sleep medications in these management policies and practices.

The study will provide qualitative data on:

•	Trends and developments in ‘medicated’ sleep and wakefulness in Britain since 2000, including development and regulation issues and prescription trends over time;
•	The views of key stakeholders in the field  (e.g. sleep scientists, doctors, members of the pharmaceutical industry, patients, workers, pressure groups, policy makers and drug regulators) regarding the management of sleep problems and the medical, social and ethical aspects of sleep and wakefulness promoting drugs;
•	Points of consensus and controversy within and amongst stakeholder groups regarding the role of sleep medications in the management of sleep problems;

To contribute, on the basis of these data, to:

•	Future policy and practice regarding sleep and wakefulness promoting drugs, and to broader debates on the public health and safety aspects of sleep for society.

The study will therefore address both development and regulation issues regarding sleep and wakefulness medications and issues concerning their meaning and use in clinical practice and everyday life.
Research design and methods 

This is a multi-method and multi-site study which includes documentary research, interviews, and focus groups with key stakeholders in the field. Access, sampling, recruitment and data collection issues are detailed below. Table 1 shows the anticipated maximum size of the research sample in each group.

a.	Documentary sources

The first stage of the research will involve the collection of medical, scientific, industry and policy literature on sleep and wakefulness promoting drugs since 2000 (e.g. Sleep, Journal of Sleep Research, British Medical Journal, Lancet, the Pharmaceutical Journal, Psychopharmacology, Scrip – a UK weekly pharmaceutical trade journal); official documents with a bearing on sleep, medicine, health and safety (e.g. Department of Health (DoH), including Prescription Cost Analysis (PCA) data, the Medicines and Health Care Products Regulatory Agency (MHRA) and its relevant expert advisory bodies, National Institute of Health and Clinical Excellent (NICE), Health and Safety Executive, Trade Unions, European Work Time Directive etc.); news/media websites (e.g. BBC, Guardian online) for media coverage of sleep and wakefulness promoting drugs in Britain since 2000. The above sources will be sampled wherever possible via online databases such as PUBMED and internet search engines such as GOOGLE. These documentary sources will also be used to identify: key voices from the sleep science and medicine communities; sleep clinics and research institutes based in the UK; and sleep scientists or clinicians involved in dissemination of sleep research or medicine information via the media. This information will then be used to purposively sample experts in the sleep field in order to interview them.

b.	Semi-structured in-depth qualitative interviews 

In-depth qualitative interviewing is a powerful research tool that can be used to reveal the details of how people think and act in everyday life (Haimes, 2002). It provides the opportunity to explore how the informants themselves define the experiences and practices that are the object of research (Murphy & Dingwall, 2003). Semi-structured interviews are based upon a pre-compiled interview guide that can allow for the interactive flow of information between the interviewer and interviewee within certain limits (Hammersley & Atkinson, 1983). Semi-structured interviews work well when the researcher has already identified specific topics they want to address, as the researcher can decide in advance what to cover while maintaining a degree of flexibility to receive any unexpected information the informant may offer. This flexible approach allows interviewees to discuss information that they think is relevant that could have otherwise been neglected (Green et al, 2002).
A maximum of 54 semi-structured in-depth qualitative interviews will be conducted with key experts in the sleep field. A purposive stratified sample, informed by the previous documentary sources and drawing on existing links, will be drawn from the following key groups:

Sleep scientists (n=6-8) and specialists in sleep medicine (n=6-8); general practitioners (GPs), including senior figures at the Royal College of General Practitioners and The British Medical Association General Practitioners Committee, GP trainers and GPs at practice level  (n=10-12); pharmacists and pharmacologists (n=4-8); senior representatives of pharmaceutical companies (n=4-6); regulators and policy makers (e.g. NICE, MHRA, DoH representatives) (n=4); representatives from other relevant patient and public organisations, pressure groups etc. (e.g. Narcolepsy Association UK, Campaign Against Involuntary Tranquilliser Addiction, Mind, Patients Association, Union representatives) (n=4-8).

The research team have extensive links with these stakeholders, including JA and JG’s contacts within the pharmaceutical industry and SW and CC’s links with members of the sleep science and sleep medicine communities. Informants will be specifically selected on the grounds of their strategic positions and knowledge in the sleep field (e.g. authors of key reports or papers, senior figures or spokespersons in the field etc.), rather than as a representative survey sample. Given these individuals are key actors in the field however their views may be seen as indicative of the leading thinking in the field. 

Prospective informants will be contacted at their place of work via email or letter and invited to take part in an interview.  The exception to this is GPs working within Coventry or Warwickshire Primary Care Trusts, who will be recruited for the study via the local primary care research network (PCRN). GPs and clinicians recruited via the PCRN will be compensated for their time through the PCRN. Each prospective informant will be provided with information about the study and given adequate time to decide if they wish to participate or not. Initial contact will be followed up by a second email or telephone call if no response has been received after a period of two weeks. Those who decide not to participate in the research or who do not respond to a second email will not be contacted again. 

Interviews will last approximately one hour and will take place at either the informant’s place of work or another suitable place of their choosing. Informants will be given further information about the study both verbally and in writing. Interviews will be conducted face-to-face (whenever possible) by a member of the research team and recorded using a digital voice recorder, providing informed consent has been granted. All interviews will cover similar themes, however, due to the qualitative nature of the research design, as outlined above, specific prompt questions will only be asked if/ when appropriate. 

c.	Focus groups 

Focus groups are group discussions that are organised to explore people’s views about, and experiences of, a particular topic or specific set of issues. Focus groups can be distinguished from one-to-one interviews as during a focus group participants are encouraged to engage with one another and this interaction between participants is included as research data (Kitzinger, 1994). This methodology generates data not only about what people think about a certain issue, but also draws out how they think about it and why they think as they do. Using focus groups as a research tool therefore, will enable the research team to: explore how people talk about sleep and the management of sleep problems; to assess how ideas are formed and decisions are made regarding the ‘appropriate’ role of sleep medications in such management strategies; and to compare the accounts given and norms operating both within and between particular social groups.

Up to 20 focus groups (6-8 participants per focus group) will be conducted with key patient and public stakeholders (see: Table 1). The groups will be selected in order to explore diversity in experiences and expectations of sleep problems and sleep/wakefulness promoting drugs rather for representativeness.  The overall sample will include ‘general population’ groups such as University students, members of a retirement complex and two shift worker groups (local cleaners/ catering staff and paramedics working in the West Midlands Ambulance Service). It will also include some groups who might be expected to have particular views about sleep and pharmaceutical use, such as people who have been diagnosed with having a sleep disorder or those who have been prescribed sleep or alertness promoting medications. Each group will be sampled for diversity in terms of age, gender and ethnicity.  Sampling, access and recruitment issues relating to each group are outlined below.

(i)	Patients referred to a specialist sleep clinic
 
Patients with a diagnosis of narcolepsy (two focus groups, each with 6-8 participants) or obstructive sleep apnoea (OSA) (two focus groups, each with 6-8 participants) will be recruited to take part in one of four focus groups at the clinic level. OSA patients will be recruited via the Oxford Sleep Unit, Churchill Hospital (Oxford Radcliffe Hospitals NHS Trust). Narcolepsy patients will be recruited via the Oxford Non-Respiratory Sleep Disorders Clinic, John Radcliffe Hospital (Oxford Radcliffe Hospitals NHS Trust) where they currently treat around 50 patients with narcolepsy. Focus groups will be held at a local hotel. 

Inclusion Criteria: Adults who have been diagnosed with either moderate or severe sleep apnoea or narcolepsy and are currently following a treatment regimen under guidance of the clinic.

Exclusion Criteria: Patients who fail to meet the inclusion criteria; those whose illness is deemed too severe for full focus group participation by their care team; people who are unable to provide informed consent (e.g. suffering from dementia; under 18); those who are unable to speak English.

Recruitment: The recruitment strategy (developed with the clinic) relies on potential participants to be identified and initially approached regarding their participation in the study by an existing member of their clinical care team at the sleep clinic. The clinician will scan through the patient records to identify persons who meet the inclusion criteria for the study. If so, the individual will be provided with a letter of invitation to participate in the study. This will be either sent though the post or past on in person during a routine visit to the clinic during the study period. The invitation letter will also include a project information sheet providing brief information about the research and the contact details of the research team. The individuals contacted will then be given time to decide for themselves whether or not they wish to participate in the research. If they wish to do so, they will be asked to make contact with the research team by phone or email regarding their availability. In addition, posters advertising the study will be displayed in the waiting room of the clinic. Those who decide not to participate in the research will not be contacted again. 

Access: Dr. Zenobia Zaiwalla at the Oxford Non-Respiratory Sleep Disorders Clinic, John Radcliffe Hospital (Oxford Radcliffe Hospitals NHS Trust) and Professor John Stradling at the Oxford Sleep Unit, Churchill Hospital (Oxford Radcliffe Hospitals NHS Trust) have agreed to give the research team access to the aforementioned clinics and assist in the recruitment of patients as outlined above. 

(ii)	Patients in primary care 

Patients who have experience of being prescribed or taking sleeping medications (e.g. benzodiazepines, the Z-drugs, xyrem, modafinil etc.) will be accessed at the primary care level. We will conduct four focus groups (each with 6-8 participants), two with chronic users of sleep medication and two with those who have been prescribed sleeping medications for acute use. Patients will be accessed and recruited in the Coventry/ Warwickshire area from up to four practices in each of the Primary Care Trusts (Coventry PCT and Warwickshire PCT). Focus groups will be held at a local hotel or at Warwick University. 

Inclusion Criteria: 

a.	Chronic use: Adults who are being prescribed hypnotics (on their repeat medication screen) and has been prescribed this medication for at least the last 9 months.

b.	Acute use: Adults who have had one or two prescriptions for in the past 12 months. 

Exclusion Criteria: Patients who fail to meet the inclusion criteria; those considered unfit or unsuitable for full focus group participation by their general practitioner; people who are unable to provide consent (e.g. suffering from dementia; under 18); those who are unable to speak English will not be included in the study.

Recruitment: The recruitment strategy relies on potential participants to be identified and initially approached regarding their participation in the study by their GP practice. PCRN Research Nurses will run electronic searches on the practice database to identify individuals who meet the inclusion criteria for the study. The list will be checked for suitability by a general practitioner. Those selected as suitable will be sent a letter of invitation to participate in the study by the practice and a project information sheet to briefly inform them about the research. The invitation letter will also contain the contact details of the research team. In addition, posters advertising the study will also be put up in the GP surgery during the recruitment period. The individual will then be given time to decide for themselves whether or not they wish to participate in the research. If so, the onus will be on them to make contact with the research team regarding their availability. Those who decide not to participate in the research will not be contacted again.

Access: Patients will be accessed from up to eight practices in the Coventry/ Warwickshire area (Coventry Primary Care Trust and Warwickshire Primary Care Trust).  These practices will be recruited via the PCRN once the project has been adopted. 

(iii)	  Shift workers

Shift workers will be selected for their inclusion in the study based upon their working patterns and occupational role. In order to increase the breadth of data, members of different occupational group will be researched with the view that this will offer more varied data. Paramedics will be accessed via the West Midlands ambulance Service (West Midlands Ambulance NHS Trust) which currently employs over 3500 staff. A second shift worker group (comprised of either cleaners or catering staff) will be accessed via local hotels. Focus groups will be held at either a local hotel or at Warwick University.

Inclusion Criteria: Is working as a paramedic or as a member of the cleaning or catering staff at a local hotel; working hours fall outside of the traditional 9am -5pm working day.

Exclusion Criteria: Fails to meet the inclusion criteria; is unable to provide consent (e.g. suffering from dementia; under 18); is unable to speak English/ fully participate in a focus group discussion.

Recruitment strategy (developed with representatives from The West Midlands Ambulance Service):  Potential participants will be identified and informed about the study via the West Midlands Ambulance NHS Trust.  The study will be advertised within the West Midlands Ambulance Service weekly briefing, a publication communicating important Trust information that is available for staff to down load via the trust intranet and union webpages. It is also reproduced in hard copy and made available on WMAS stations. This will briefly inform potential participants about the research and contain an invitation for individuals to contact the research team if they are interested in participating in the study or would like any further information. In addition, posters advertising the study will be placed on staff notice boards on stations during the recruitment period. The recruitment strategy therefore relies on potential participants to contact the research team regarding their willingness to take part and their availability.

Recruitment strategy (for the second shift worker group recruited via local hotels): Shift workers will be contacted directly at their place of work via letter or email and invited to participate in a focus group. The invitation letter and PIS will inform potential participants about the purpose of the research and provide the contact details of the research team. Individuals will be encouraged to contact the research team via phone or email if they are interested in taking part in the research or would like any further information. In addition, in order to boost knowledge about the research amongst target groups, posters advertising the study will be placed on staff notice boards in common areas during the recruitment period. 

Access: The West Midlands ambulance NHS Trust has agreed to act as a Participant Identification Centre (PIC), subject to the study obtaining ethical and R&D approval. 

(iv)	Other stakeholder groups

We will conduct focus groups with a further two groups, each of whom have been identified in the literature as being key stakeholders in relation to the consumption of sleep/wakefulness medications: students in higher education (up to 4 focus groups drawn from different faculties); and retired persons. 

These groups will be recruited in the Midlands through existing local/national contacts with: Warwick University (for access to students) and community centres/ retirement complexes (for access to retired persons). Again, the recruitment strategy will rely on individuals contacting the research team after exposure to an email/ poster/ letter of invitation. Focus groups will be conducted either at appropriate local community centre or on campus at Warwick University. Letters of support from representatives of some of these groups/sectors/services accompany this protocol. 

Research participants will be asked to take part in one focus group interview which will last approximately 1.5 hours. Focus groups will be held at a local hotel or at Warwick University. Refreshments will be provided. Two researchers will be present during each focus group. One will act as a moderator, leading the discussion, while the other takes observational notes. Participants will be given verbal and written information about the study and focus group procedure. They will be informed of their right to withdraw from the study at any time without need for further explanation, that what they say during the focus group will be confidential and that any indentifying information will be removed from the data prior to its use. Participants will all be asked to sign a consent form if they still wish participate. With the permission of participants, the proceedings will be audio recorded using digital voice recorders. All focus group interviews will cover the same main themes, however, due to qualitative nature of the research design, as outlined above, specific issues will only be raised by the moderator if/ when appropriate.

The focus group discussion may potentially touch upon sensitive or personal issues (e.g. pharmaceutical use, medical diagnoses, aspects of the illness experience, addiction, illegal drug use) which could lead to feelings of discomfort or stigma in a group situation. For this reason, vignettes will be used to stimulate discussion and elicit views about the management of sleep problems instead of asking focus group participants to share their personal accounts or experiences of sleep problems or use of medications. However, there may also be positive benefits afforded to participants through group discussions, for example, gaining recognition, understanding and support from their peers. All focus group participants will be compensated for their time at a standard rate (a gift voucher to the value of £10 will be given to each participant) and reimbursed for any expenses they may have incurred as a result of their participation in the study.  

d.	Case-studies

A maximum of 4 case studies, drawn from participants in the focus groups above, will be selected in order to further embed these findings in the context of people’s everyday/night lives. Focus group participants will be asked if they would like to volunteer as a case study participant and informed about what this will entail. This will involve face-to-face interviews and sleep diaries (written or tape recorded) regarding a typical week in their lives.  Cases cannot be specified in advance, but will again be sampled on the basis of instructive comparisons and contrasts regarding sleep problems and experiences/expectations of sleep/promoting medications in everyday/night life.   

Table 1: Maximum size of research sample
	Max. number of focus groups/ interviews	Max. Number of participants	

A.	Interviews	
Sleep experts
•	Scientists
•	Clinicians
•	GPs
•	Pharmacists
•	Industry representatives
•	Policy advisors
•	Other patient and public organisations	54
8
8
12
8
6
4
8	54
8
8
12
8
6
4
8	
Totals
	54	54	

B.	Focus Groups	
Clinic level
•	Narcolepsy patients
•	Sleep apnoea patients	4
2
2	32
16
16 	
Primary care
•	Patients prescribed sleep medication (Chronic use)
•	Patients prescribed sleep medication (acute use)	4
2
2	32
16
16	
Shift workers
•	Paramedics
•	Catering/ cleaning staff
	6
4
2	48
32
16	
Other stakeholder groups
•	Students
•	Retired persons
	6
4
2
	48
32
16

Totals	
20	
160	

Data Analysis

While our research will be sensitive to historical context, our analysis (for the reasons articulated above) will be primarily concerned with developments in medicated sleep and wakefulness since 2000. The four main data sources (documentary, interview, focus group, case studies) will complement and enhance each other as we attempt to craft a social scientific picture of trends and transformations in medicated sleep and wakefulness in contemporary Britain. A particularly novel feature and strength of the study is the combination or integration of both ‘upstream’ (macro) analysis of the development, regulation and marketing of these drugs (e.g. the Z-drugs, xyrem, modafinil etc.) and ‘downstream’ (micro) analysis of their meaning and use in medical practice and everyday/night life. All data sources (documentary, interview and focus group) will be thematically coded and qualitatively analysed using established qualitative data analysis techniques (Antaki et al, 2003; Hepburn & Potter, 2003) and software packages (e.g. NVIVO) (Charmaz, 2003). Topics will be indexed, collated and cross-referenced in order to organise emerging themes (Coffey & Atkinson, 1996; Dingwall & Murphy, 1998). Thematic coding will occur as an ongoing part of data collection.  Coding frames will be discussed and verified by all researchers in the project team.

Key ethical considerations 

The key ethical issues relevant to the proposed research are:

Informed consent: The information provided for participants will explain the purpose of their participation in the research, what is required of them and how the information they provide might be used. Further information about the study, including some basic background material, ethical considerations and what their participation will involve will be provided in both the initial recruitment email/ letter and outlined in both written form and verbally before each interview takes place. 

Participants will be directed to the project website if they require further information about the study. If anything is still unclear to them, they will be encouraged to contact the research team via email or telephone. They will also be informed of the intended use of the data collected (i.e. quotations to be taken from their answers and reproduced in oral presentations and any subsequent papers derived from the research). Participants will also be asked for their permission for their interview/ focus group to be recorded.  Participants will all be asked to sign a consent form prior to their participation.

Anonymity, confidentiality and privacy: It is not necessary for the research team to have access to personal or identifying data (e.g. participant’s full names, addresses or medical records).  Prior to their involvement in the study, all participants will be informed that their responses will be kept confidential and their identities private. In cases where confidential information might have been disclosed during an interview or focus group, only the research team and the transcriber will have access to the recordings. Any potential identifying information will be removed from the data prior to use and all names and places will be anonymised. Respondents will be assigned pseudonyms and referred to in general terms by their stakeholder group (i.e. sleep scientist, paramedic, student etc). These categorizations serve the purpose of protecting the anonymity of research participants. Participants will also be informed that all communication with the research team is confidential and that information they provide during the study will not be communicated back to their employer, GP or clinical care team. 

Data collection and storage: Interview data will be collected via face to face interviews and telephone interviews. Interviews and focus groups will be recorded using a digital voice recorder with the permission of those interviewed and data will be securely stored both physically and electronically in locked files. 

Freedom to choose, ownership of the data and right to withdraw: It will be made clear to participants in both the invitation letter/email and the participant information sheet that it is their choice whether to participate in the research or not and that non-participation will not impact negatively on them in any way. Individuals contacted and informed about the study will be given adequate time to decide whether or not they would like to participate in the research. The onus will be on the individual to contact the research team if they decide they would like to take part. Those who do not wish to take part will not be contacted again in relation to this research. Participants will be informed of their right to withdraw from the study at any time without giving a reason and be informed that the decision to withdraw from the study will have no negative impacts on their present or future healthcare. Participants will be informed of their right to review a full transcript of the interview/ focus group following transcription and their right to retract any part of it prior to the data being used. 

Benefits of the study 

The study findings will add to current theory and debates in medical sociology and the sociology of sleep surrounding the medicalisation of sleepy bodies and the consumption of pharmaceuticals in everyday life. Findings are also of relevance to scholars interested in sociology of work and organisations (especially insofar as the issue of sleep and wakefulness at work are concerned) and will contribute to theoretical developments in the fields of the sociology of sleep and the sociology of pharmaceuticals.

Potential benefits to taking part in focus group discussions about managing sleep and wakefulness have been identified for focus group participants. These include providing people with the opportunity to meet with other people with the same condition or lifestyle as them and giving them a forum to discuss, with others, how this affects their life on a daily basis. These benefits are particularly relevant for (but not exclusive to) those with rare sleep disorders such as narcolepsy who often would not get the chance to meet others with the disorder. 

A primary aim of the research will be the communication and dissemination of findings from the project to relevant user groups and stakeholders outside the academic research community, including scientists, health care professionals, patients, policy makers, the pharmaceutical industry and the wider public. The project will be fully compliant with the ESRC’s communication policy <http://www.esrctoday.ac.uk/ESRCInfoCentre/Support>.

The project findings will be relevant to a wide range of user groups including: The British Sleep Society; The Royal Society of Medicine (Sleep Medicine section); the British Medical Association, the Association of the British Pharmaceutical Industry; the Mental Health Foundation; the UK Narcolepsy Association, the Sleep Patients Association and other patient support groups in the sleep field; Age Concern; Help the Aged, The National Union of Students, the Trades Union Congress and its affiliates. Findings from study will be disseminated to all relevant user groups via an executive summary. Methods of communication and engagement in the short- to mid-term will include the following:

1.	Talks and presentations at relevant conferences and other events e.g. the British Sleep Society annual conference, the European Sleep Research biannual conference, the UK Narcolepsy Association annual conference, Association of the British Pharmaceutical Industry events, Union events associated with the occupational groups involved in the study (e.g. police, transport, health care). A symposium on ‘medicated sleep and wakefulness’ will also be offered towards the end of the project at the British Sleep Society annual conference.
2.	Project Website: a dedicated project website will be developed for the start of the project. will be regularly updated throughout the project, with an executive summary posted (see below) at the end of the project. See: http://www2.warwick.ac.uk/fac/soc/sociology/staff/academicstaff/williams
3.	Executive summary: an executive summary of project findings and their implication for future policy and practice will be sent to representatives of all key user groups involved in the project.
4.	Dissemination event: A one day dissemination event will be held involving representatives from key users groups regarding the implications of the study for future policy and practice in this area.
5.	Publications: the project will produce at least one article for a medical audience such as the British Medical Journal, Lancet, British Journal of General Practice and at least one article for the wider sleep science community, e.g. Sleep or the Journal of Sleep Research. Results will also be published in relevant professional and patient newsletters such as the British Sleep Society newsletter, CITA newsletter, UKAN etc.
6.	Media: findings from the project will also be disseminated through the media (i.e. press releases via the University Press Office and existing local and national media contacts) in order to reach a wider audience.

The research, through these means, will also inform future policy and practice in these areas, in the mid to long-term. Members of the research team (particularly JA and JG) have extensive experience of work of this kind involving liaison with diverse user groups in the pharmaceutical and health care field. All members of the team therefore, including the research fellow, will be involved in these communication and user engagement plans both during the project and following its completion. Please also see letters of support from user group representatives as further evidence of these communication and engagement plans.

Timeline

Priorities and key milestones are detailed below:

Preparation, study design and recruitment (April- September 2011)
April 2011- July 2011: completion of all preparation and design work including NHS ethical approval 
July- September 2011: finalising data collection strategies and participant recruitment 

Data collection (July 2011- December 2012) and Analysis (August 2011- March 2013) 
July 2011: Commencement of fieldwork or data collection phase of study
August 2011: Commencement of analysis phase of study (substantive phase where research facilities are involved)
December 2012: Completion of fieldwork/ data collection phase of study
March 2013: Completion of analysis phase of study

Writing up the research and dissemination activities (September 2012-September 2013)
September 2012: Commencement of writing-up of the research
September 2012- September 2013: conference papers, publications and public engagement events
September 2013: Completion of writing-up

Resources and costs

This research has secured funding from the Economic and Social Research Council (ESRC). All costs incurred by the project will be covered by this funding (Grant number: RES-062-23-2456, value: £307, 856.50). A letter from the funder detailing allocation of resources and costs is attached to the REC application.

Conflicts of Interest

We do not anticipate there to be any conflicts of interest during the execution of the proposed programme of research.

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