ELPV Feasibility Study: systemic treatments are better

Page 1 of 22 ELPV Focus Groups Final Version 1.0 Date 19/11/12 This protocol is confidential and the property of the University of Nottingham. No part of it may be transmitted, reproduced, published, or used by others persons without prior written authorisation from the University of Nottingham

ELPV Feasibility Study:

Feasibility Study (Focus Groups) for an RCT to determine whether systemic treatments are better than topical alone in the

management of Vulval Erosive Lichen Planus

Final Version 1.0 19/11/12

Short title: Erosive lichen planus focus groups

Acronym: N/A

NRES reference: 12/EM/0462

Study Sponsor: University of Nottingham

Sponsor reference: 12122

Funding Source: NIHR


STUDY PERSONNEL AND CONTACT DETAILS Sponsor: University of Nottingham Contact name Mr Paul Cartledge Head of Research Grants and Contracts Research and Graduate Services King’s Meadow Campus Lenton Lane Nottingham NG7 2NR Chief investigator: Dr Kim Thomas

Associate Professor and Deputy Director Centre of Evidence Based Dermatology University of Nottingham King’s Meadow Campus Lenton Lane Nottingham NG7 2NR

Phone: 0115 8468630

Email: [email protected] Co-investigators: Dr Rosalind Simpson Dermatology Clinical Research fellow

Centre of Evidence Based Dermatology University of Nottingham King’s Meadow Campus Lenton Lane Nottingham NG7 2NR

Dr Ruth Murphy Consultant Dermatologist Nottingham University Hospitals Queen’s Medical Centre Campus B Floor South Block Queen’s Medical Centre Derby Road Nottingham

NG7 2UH Professor Hywel Williams Professor of Dermato-Epidemiology Centre of Evidence Based Dermatology University of Nottingham King’s Meadow Campus Lenton Lane


Nottingham NG7 2NR

Dr Paul Leighton

The NIHR Research Design Service for the East Midlands (NDL) Nottingham Health Science Partners Room 2104, C Floor South Block Queen's Medical Centre Nottingham NG7 2UH

Study Statistician: Statistician input not required for this study Study Coordinating Centre: Centre of Evidence Based Dermatology

University of Nottingham King’s Meadow Campus Lenton Lane Nottingham NG7 2NR


SYNOPSIS Title Feasibility Study (Focus Groups) for an RCT to determine whether

systemic treatments are better than topical alone in the management of Vulval Erosive Lichen Planus

Acronym N/A

Short title Erosive lichen planus focus groups

Chief Investigator Dr Kim Thomas

Objectives To assist in designing a randomised controlled trial (RCT) of treatments for vulval erosive lichen planus (ELPV) patients.

To determine what are the most appropriate outcome measures for use in a clinical trial of ELPV treatments (i.e. are current existing tools appropriate or do other methods of measuring outcomes need to be devised and validated);

To determine whether the overall design of a provisional RCT protocol is acceptable to patients and assess if they would be willing to take part;

To understand the potential barriers to recruitment and consider ways to overcome these;

To explore factors that will make the trial attractive to participants.

Study Configuration One centre will be involved in identifying patients for focus group work. Two focus group sessions involving the same patient group will take place. Patients will therefore attend two focus group sessions each, which will be approximately 2 weeks apart.

Setting Patients will be identified from a single secondary-care centre which runs a specialist vulval dermatology service. Focus group sessions will occur in a non-clinical environment.

Sample size estimate N/A

Number of participants 6-8 patients will be involved overall.

Eligibility criteria Patients with a diagnosis of vulval erosive lichen planus (made by Specialist Clinician) who are willing to consent to participation in the sessions.

Description of interventions

Focus group session 1 will involve open discussion about i) impact of ELPV on patients’ lives and ii) outcome measure tools that are used to determine response to treatment of vulval skin conditions. Focus group session 2 will discuss a provisional RCT protocol. These sessions will be


moderated by female non-clinical personnel skilled in taking such sessions, who will be guided by a prompt-sheet.

Duration of study Focus groups will be conducted between January and March 2013. Overall duration of the study will therefore be 3 months. Each individual session will last a maximum of 2 hours including refreshment breaks.

Outcome measures This feasibility study is designed to i) obtain information on the proposed RCT design and ii) determine outcome measures that are suitable for use in patients with vulval skin disorders and therefore will be suitable for the proposed RCT. As this is feasibility work and not a trial, there are no outcome measures to be specified. The focus groups will obtain data from using patients’ knowledge, perspectives and attitudes towards items defined in the study objectives

Statistical methods As this is a qualitative research study, transcription of the recording will be made and themes will be coded by the Chief Investigator. Data will be analysed using Framework analysis. Coded data will be stored and managed using NVivo software.


ABBREVIATIONS

AE Adverse Event CI Chief Investigator overall CRF Case Report Form DAP Data Analysis Plan ELP Erosive lichen planus ELPV Erosive lichen planus affecting the vulva GCP Good Clinical Practice ICF Informed Consent Form NHS National Health Service P/GIS Parent / Guardian Information Sheet PI Principal Investigator at a local centre PIS Participant Information Sheet RCT Randomised controlled trial REC Research Ethics Committee R&D Research and Development department


TABLE OF CONTENTS

STUDY PERSONNEL AND CONTACT DETAILS ............................................................ 2

SYNOPSIS ................................................................................................................................. 4

ABBREVIATIONS ................................................................................................................... 6

STUDY BACKGROUND INFORMATION AND RATIONALE ....................................... 9

WHAT IS EROSIVE LICHEN PLANUS? 9 WHAT EVIDENCE IS THERE FOR TREATMENT? 9

WHAT IS THE REASON FOR PERFORMING THIS FEASIBILITY WORK? 9

STUDY OBJECTIVES AND PURPOSE ............................................................................. 10

PURPOSE 10 PRIMARY OBJECTIVE 10

SECONDARY OBJECTIVES 10

STUDY DESIGN .................................................................................................................... 10

STUDY CONFIGURATION 10 STUDY MANAGEMENT 11

DURATION OF THE STUDY AND PARTICIPANT INVOLVEMENT 11

END OF THE STUDY 11 SELECTION AND WITHDRAWAL OF PARTICIPANTS 11

Recruitment 11

Eligibility criteria 12 Inclusion criteria 12 Exclusion criteria 12

Expected duration of participant participation 12 Participant Withdrawal 12

Informed consent 13 STUDY REGIMEN (SEE FIGURE) 13

Compliance 16 Criteria for terminating the study 16

STATISTICS/ ANALYSES ................................................................................................... 16

Methods 16

Sample size and justification 16

ADVERSE EVENTS .............................................................................................................. 16

ETHICAL AND REGULATORY ASPECTS ..................................................................... 16

ETHICS COMMITTEE AND REGULATORY APPROVALS 17 INFORMED CONSENT AND PARTICIPANT INFORMATION 17 RECORDS 17

Study Forms 17 DATA PROTECTION 18

QUALITY ASSURANCE & AUDIT .................................................................................... 18

INSURANCE AND INDEMNITY 18


RECORD RETENTION AND ARCHIVING 18 DISCONTINUATION OF THE STUDY BY THE SPONSOR 18

STATEMENT OF CONFIDENTIALITY 19

PUBLICATION AND DISSEMINATION POLICY .......................................................... 19

USER AND PUBLIC INVOLVEMENT .............................................................................. 19

STUDY FINANCES ............................................................................................................... 19

Funding source 19 Participant stipends and payments 19

SIGNATURE PAGES ............................................................................................................ 21

REFERENCES ....................................................................................................................... 22


STUDY BACKGROUND INFORMATION AND RATIONALE

What is erosive lichen planus?

Erosive lichen planus (ELP) is a chronic skin condition, which can affect any surface lined with squamous epithelium. ELP affecting the vulva (ELPV) is characterized by painful erosions at the vaginal entrance and scarring which causes anatomical destruction with narrowing of the vaginal canal. The incidence has been estimated at 0.01%, but this is probably an underestimate as many cases go undiagnosed for a number of reasons, such as patients failing to present to medical services (Lawton 2006). It is believed to be an autoimmune condition (Cooper 2008) with T-cell mediated damage to basal keratinocytes (Cooper 2005), although at present, the exact pathogenesis remains unclear. ELPV is associated with significant morbidity. It causes difficulty in daily activities such as walking, sitting and sexual function, and leads to a reduction in quality of life (QoL) (Hickey 2010, Simpson 2011). Approximately 25-30% of ELPV cases are reported as refractory to treatment (Cooper 2006; Simpson 2012) but a higher percentage are likely to have inadequate long-term control. Frequent visits to specialist dermatology or gynaecology services in secondary care are required and numerous therapies may be tried without success. Therefore the condition places strain on healthcare resources. Furthermore, there is a 1-3% risk of cancerous change (Lewis 1994, Cooper 2006). It is not known if early aggressive treatment reduces this risk, however, effective therapy does reduce morbidity caused by scarring.

What evidence is there for treatment?

A recently completed Cochrane Systematic Review (Cheng, 2012) has shown that there is no randomised controlled trial (RCT) evidence on which to base treatment for ELPV. It also demonstrated that there are no standardised outcome measures for ELPV. The authors recommended that RCTs on a large scale were needed for the genital ELP population. They also suggested that future studies should have standardised outcome variables that are clinically important to affected individuals. Ideally, future studies should measure a clinical severity score and a participant-rated symptom score using agreed and validated severity scoring tools.

What is the reason for performing this feasibility work?

In order to design an RCT for patients with ELPV a number of steps need to be taken to ensure the trial is pragmatic, answers clinical questions that are important to patients and doctors, and measures clinically relevant outcome measures. Patients and clinicians have already been consulted to ensure the topic is one of priority. With their involvement, data to inform a provisional RCT protocol has been collected. A national multi-centre case note audit with input from ten centres (Simpson 2012) gathered data from 172 patients has provided an insight into current UK practice. This audit provided information on what ‘usual care’ for ELPV entails by collecting data on frequently used outcome measures, patient numbers, follow up periods and treatments used in day-to-day clinical practice. The audit demonstrated inconsistencies in the use of outcome measures and in second-line therapies, with no clear indication of which


are best to use in clinical practice. This most likely reflects the lack of vulval-specific outcome measure tools, and the lack of evidence-based guidelines for clinicians to follow. A set of structured interviews with 25 clinicians across the UK have subsequently been performed to clarify issues that were not clear from the audit and we have gone on to formulate a provisional trial protocol. It is now timely to further engage patients in the planning of the proposed trial by discussing aspects of trial design, in particular, the most appropriate outcome measures to use. As there are no validated outcome measure tools specifically designed for vulval disease, the most promising existing tools will be identified through a systematic review of the literature and discussed during these focus groups. Acceptability of the proposed trial design will also be discussed in the focus groups.

STUDY OBJECTIVES AND PURPOSE

PURPOSE

The purpose of the eventual RCT is to determine whether systemic treatment is better than topical alone for the long-term control of ELPV. Very little research has previously been carried out into treatments for ELPV on which to base our RCT design. It is therefore essential that formal consultation with patients is carried out before performing the full-scale study. The purpose of these focus groups is to help develop the proposed RCT and the focus groups have the following objectives:

PRIMARY OBJECTIVE

To determine what are the most appropriate outcome measures for use in the planned RCT;

SECONDARY OBJECTIVES

To determine whether the overall design of the planned RCT is acceptable to ELPV patients and if they would be willing to take part;

To understand the potential barriers to recruitment and consider ways to overcome these;

To explore factors that will make the RCT attractive to participants including patient information sheet contents, discussing the potential treatments/regimens to be used, willingness to be randomised to a new treatment, follow up timings, monitoring investigations and potential use of patient diaries.

STUDY DESIGN

STUDY CONFIGURATION

The focus groups will involve patients from one centre which runs a specific vulval dermatology clinic. Patients will not be randomised as this is not a clinical trial. Focus groups will occur on two different dates at the same location. They will be approximately two weeks apart. The same moderators will lead both sessions. Moderators will both be female and will consist of the study co-ordinator (RS) and an independent moderator (from UK Dermatology


Clinical Trials network, UK DCTN). Participants will be identified through outpatient clinic lists and enrolled via their usual treating clinician. Sessions will be held in a non-clinical environment to facilitate open discussion.

STUDY MANAGEMENT

The Chief Investigator will be Dr Kim Thomas, Associate Professor and Deputy Director of the Centre of Evidence Based Dermatology. The study management group will consist of Dr Thomas, Dr Rosalind Simpson (Dermatology Clinical Research Fellow), Dr Ruth Murphy (Consultant Dermatologist), Professor Hywel Williams (Professor of Dermato-epidemiology) and Dr Paul Leighton (Research associate). Dr R Simpson will coordinate and manage the day to day running of the project as part of her PhD studies. The Chief Investigator has overall responsibility for the study and shall oversee all study management. The data custodian will be the Chief Investigator.

DURATION OF THE STUDY AND PARTICIPANT INVOLVEMENT

Each participant’s involvement with the study shall be limited to the two focus groups in which they consent to be involved. There will be no ‘run-in’ period, except the provision of material relating to the individual sessions, which will be sent in advance for the participant to familiarise themselves with the format of the day. It is hoped that participants will form an open and free discussion about their experiences of living with ELPV. There will be no active follow-up, although participants will be asked if they are willing to be contacted about future relevant research projects. This study will cease after the two focus group sessions have been completed. Each participant’s involvement will last approximately 2 hours on each date, two weeks apart. Travel costs, refreshments and inconvenience allowances will be provided. Overall length of the study will be approximately three months. This timeframe will include recruitment and running of the actual sessions.

END OF THE STUDY

The endpoint of the study will be after the two focus groups have been performed.

SELECTION AND WITHDRAWAL OF PARTICIPANTS

Recruitment

Due to the chronic and often severe nature of the disease, the majority of ELPV patients in the UK are under the long-term care of a consultant at a secondary/tertiary referral centre. We plan to recruit 6-8 patients in total from Nottingham University Hospital’s specialist vulval dermatology clinic. ELPV usually affects women of post menopausal age, however, younger females may be affected. We would exclude patients under 18 years as they may not have the confidence or maturity to fully participate in these sessions. However, it is unlikely that patients of this age will suffer from the condition. Due to the nature of the discussion, it would not be appropriate to include patients with a poor understanding and poor spoken English language.


Furthermore, due to resources available, consent forms and information sheets will not be available printed in other languages. Patients known to a member of the clinical team will be approached either by letter from their usual managing consultant, or when they present for a routine clinic visit by a member of their normal care team (Figure, Page 14). A full patient information leaflet (PIL) will be enclosed with the invite letter. Patients who are interested in taking part will either return a response slip or contact the co-ordinator by telephone. The coordinator will arrange a follow up telephone call to discuss the PIL in full. During this time the patient will be counselled of all aspects relating to participation in the study and will have the opportunity to ask any questions. Patients will then inform the co-ordinator if they wish to participate in the study, or not. It will be explained to the potential participant that entry into the study is entirely voluntary and that their treatment and care will not be affected by their decision. It will also be explained that they can withdraw at any time but attempts will be made to avoid this occurrence. In the event of their withdrawal it will be explained that their data collected so far cannot be erased and we will seek consent to use the data in the final analyses where appropriate.

Eligibility criteria

Inclusion criteria

Clinical diagnosis of ELPV as made by a Dermatologist

Capability to give informed consent and to attend focus group meetings

Fluent in written and spoken English language

Age >18 years

Exclusion criteria

Age < 18 years

Not willing/ unable to give informed consent/unable to attend focus group meetings

Alternative/unclear clinical diagnosis

Expected duration of participant participation

Study participants will take part in the study for the duration of two focus group sessions only. They will therefore be participating in the study for two weeks.

Participant Withdrawal

Participants may be withdrawn from the study either at their own request or at the discretion of the Investigator. The participants will be made aware that this will not affect their future care. Participants will be made aware (via the information sheet and consent form) that should they withdraw the data collected to date cannot be erased and may still be used in the final analysis.


Informed consent

All participants will provide written informed consent. The Consent Form will be signed and dated by the participant before the focus group session begins. The Investigator will explain the details of the study and provide a Participant Information Sheet (as detailed in the ‘Recruitment’ section), ensuring that the participant has sufficient time to consider participating or not. The Investigator will answer any questions that the participant has concerning study participation.

Informed consent will be collected from each participant before they participate in the focus groups. One copy of this will be kept by the participant and one will be kept by the Investigator.

STUDY REGIMEN (see Figure)

Following agreement to participate in the focus groups, subjects will receive an information pack containing details of the session, an agenda and any relevant background reading material. Patients and moderators will meet at the designated location where the session is to occur. Sessions will be conducted on University of Nottingham premises. At the beginning of Focus Group 1, introductions will take place and the function of the day reiterated. Participants will be asked to sign the consent form prior to starting the recording of the first session. Participants will first be encouraged to discuss their experiences of living with ELPV and the impact it has had on their lives. Following initial open discussion, patients will be asked about outcome measure tools that are commonly used in clinical practice. The concept of an ‘outcome measure’ will be introduced and explained. Patients will be asked to complete several tools/questionnaires (the exact tools will be decided following a systematic review of the literature which is currently taking place). They will then be asked which tools/questionnaires they feel are relevant and accurately provide a reflection of their disease severity. We will also assess whether there are any other aspects of disease (or its treatment) that patients feel should be asked about as an outcome. We will ask their opinion as to which tools should be used in the outpatient clinic and in clinical trials, to measure response to treatment. Focus Group 1 will close after this discussion is complete. Patients will have been introduced to what we aim to achieve from the sessions and why their input is important for the planned future clinical trial. They will subsequently have a 2 week period to reflect upon what we have discussed before attending Focus Group 2. In Focus Group 2 the proposed future RCT protocol will be presented, focusing on aspects of the study that have most impact on patients. Participants will be encouraged to give their opinion on the overall study concept i.e. proposed trial medications, timing of follow up visits, and will be asked to highlight any aspects that would prevent or discourage them from entering the study. Each focus group session will last approximately two hours. This will include a refreshment break. Dialogue/prompts that will be used in both focus group sessions are detailed in the document entitled ‘ELPV Focus Group Prompts’. If the number of participants who are available for focus groups is low and adequate information is unlikely to be obtained, we plan to supplement this research with


questionnaires / semi-structured interviews. The same dialogue and prompts will be used in interviews as with the focus groups to ensure the same points are covered. Any aspects of the RCT design that are identified as problematic will then be reviewed as a result of these discussions. Following the focus group patients will be asked for their consent to be contacted regarding future work, in particular to re-review the amended trial protocol (if necessary), comment upon patient information sheets and to be assessed for eligibility into the RCT. If patients do not wish any further involvement they will not be contacted again and will continue normal care as before. Focus groups will be audio-recorded. The recordings will be transcribed at the earliest possible time point. The recordings and their transcriptions will be stored securely at the coordinating centre and will not contain identifiable patient information.


FIGURE: Flow diagram of steps taken to run focus groups for ELPV patients

Participants receive copy of results once complete

Participants may be contacted re: future participation in

related studies

Patient consents to

further contact

Identify patients through outpatient clinic lists (normal care team)

Invitation letter plus full PIL given to patient by usual treating clinician

(either give to patient in clinic or post)

Patient contacts co-ordinator if wants to discuss further. Appointment for telephone discussion

arranged

Full discussion between co-ordinator and patient to discuss potential participation

Pre-Focus Group information sent out

Focus Group 1 takes place (consent taken at the time of the FG)

Focus Group 2 takes place two weeks later

No further contact made re: participation

No further contact made re: participation

No response

from patient

Patient responds

Willing to participate

Not willing to

participate


Compliance

Participants will attend two focus group sessions, two weeks apart. We do not anticipate compliance will be a problem but will need to keep in contact with participants (by letter and telephone) in between sessions to encourage them to attend both.

Criteria for terminating the study

N/A

STATISTICS/ ANALYSES

Methods

Recordings will be transcribed by an experienced typist as soon as possible after the focus groups. The typist will be a qualified person external to the research team. Dr R Simpson (Study co-ordinator) with the assistance of Dr P Leighton (Qualitative work advisor) will then code the data manually and manage it using NVivo9 software on UoN computers and backed up to the UoN servers. Analysis will be performed using a framework analysis, a qualitative analytic technique.

Sample size and justification

As this is qualitative focus group work, no formal sample size calculation has been required. We will endeavour to recruit 6-8 patients who will participate in both sessions. This is standard for focus group size as too many (i.e. >10) participants make the discussion difficult to manage and too few (i.e. <4) would generate insufficient data. These focus groups have been designed to facilitate patient and public involvement in the development of our proposed future trial, rather than as a means to exhaustively identifying all relevant themes and issues of relevance to the management of ELPV. As such, we feel that two focus groups will be sufficient to capture the key issues for patients.

ADVERSE EVENTS The occurrence of an adverse event as a result of participation within this study is not expected and no adverse event data will be collected.

ETHICAL AND REGULATORY ASPECTS Focus groups will record and transcribe personal information from patients discussing genital disease. Patients will only participate on a voluntary basis once informed consent has been obtained. They will therefore know what to expect from the sessions as a result of taking part. Information from these forums will be anonymised and there will be no identifiable information present in the transcription or published results. Any anonymised but linked data will be stored confidentially at the co-ordinating centre and will be made available only for review by the research team, sponsor and inspection by relevant regulatory authorities.


ETHICS COMMITTEE AND REGULATORY APPROVALS

The study will not be initiated before the protocol, consent forms and participant information sheets have received approval / favourable opinion from the Research Ethics Committee (REC), and the respective National Health Service (NHS) Research & Development (R&D) department. Should a protocol amendment be made that requires REC approval, the changes in the protocol will not be instituted until the amendment and revised informed consent forms and participant information sheets (if appropriate) have been reviewed and received approval / favourable opinion from the REC and R&D departments. A protocol amendment intended to eliminate an apparent immediate hazard to participants may be implemented immediately providing that the REC are notified as soon as possible and an approval is requested. Minor protocol amendments only for logistical or administrative changes may be implemented immediately; and the REC will be informed. The study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, 1996; the principles of Good Clinical Practice, and the Department of Health Research Governance Framework for Health and Social care, 2005.

INFORMED CONSENT AND PARTICIPANT INFORMATION

The process for obtaining participant informed consent will be in accordance with the REC guidance, and Good Clinical Practice (GCP) and any other regulatory requirements that might be introduced. The investigator or their nominee and the participant shall both sign and date the Consent Form before the person can participate in the study. The participant will receive a copy of the signed and dated forms and the original will be retained in the Study records. The decision regarding participation in the study is entirely voluntary. The investigator or their nominee shall emphasize to them that consent regarding study participation may be withdrawn at any time without penalty or affecting the quality or quantity of their future medical care, or loss of benefits to which the participant is otherwise entitled. No study-specific interventions will be done before informed consent has been obtained. The investigator will inform the participant of any relevant information that becomes available during the course of the study, and will discuss with them, whether they wish to continue with the study. If applicable they will be asked to sign revised consent forms. If the Consent Form is amended during the study, the investigator shall follow all applicable regulatory requirements pertaining to approval of the amended Consent Form by the REC and use of the amended form.

RECORDS

Study Forms

Study forms will comprise focus group transcriptions. Each participant will be identified by their initials on the transcription forms. For other study documents and the electronic database, each participant will be assigned a study identity code number. This will ensure confidentiality is maintained. The documents and database will also use their initials (of first and last names separated by a hyphen or a middle name initial when available) and date of birth (dd/mm/yy).


Study forms will be treated as confidential documents and held securely in accordance with regulations. They will be restricted to those personnel approved by the Chief or local Investigator and recorded as such in the study records.

DATA PROTECTION

All study staff and investigators will endeavour to protect the rights of the study’s participants to privacy and informed consent, and will adhere to the Data Protection Act, 1998. The study forms will only collect the minimum required information for the purposes of the study. CRFs will be held securely, in a locked room, or locked cupboard or cabinet. Access to the information will be limited to the study staff and investigators and any relevant regulatory authorities (see above). Computer held data including the study database will be held securely and password protected. All data will be stored on a secure dedicated web server. Access will be restricted by user identifiers and passwords (encrypted using a one way encryption method). Electronic data will be backed up every 24 hours to remote media in encrypted format.

QUALITY ASSURANCE & AUDIT

INSURANCE AND INDEMNITY

Insurance and indemnity for clinical study participants and study staff is covered within the NHS Indemnity Arrangements for clinical negligence claims in the NHS, issued under cover of HSG (96)48. There are no special compensation arrangements, but study participants may have recourse through the NHS complaints procedures. The University of Nottingham as research Sponsor indemnifies its staff, research participants and research protocols with both public liability insurance and clinical trials insurance. These policies include provision for indemnity in the event of a successful litigious claim for proven non-negligent harm.

RECORD RETENTION AND ARCHIVING

In compliance with the ICH/GCP guidelines, regulations and in accordance with the University of Nottingham Code of Research Conduct and Research Ethics, the Chief Investigator will maintain all records and documents regarding the conduct of the study. These will be retained for at least 7 years or for longer if required. If the responsible investigator is no longer able to maintain the study records, a second person will be nominated to take over this responsibility. The study documents held by the Chief Investigator on behalf of the Sponsor shall be finally archived at secure archive facilities at the University of Nottingham. This archive shall include study databases and associated meta-data encryption codes. Audio recordings will be deleted following transcription.

DISCONTINUATION OF THE STUDY BY THE SPONSOR

The Sponsor reserves the right to discontinue this study at any time for failure to meet expected enrolment goals, for safety or any other administrative reasons. The Sponsor shall take advice as appropriate in making this decision.


STATEMENT OF CONFIDENTIALITY

Individual participant medical or personal information obtained as a result of this study are considered confidential and disclosure to third parties is prohibited with the exceptions noted above. Participant confidentiality will be further ensured by utilising identification code numbers to correspond to treatment data in the computer files. If information is disclosed during the study that could pose a risk of harm to the participant or others, the researcher will discuss this with the CI and where appropriate report accordingly. Data generated as a result of this study will be available for inspection on request by the participating physicians, the University of Nottingham representatives, the REC, and the local R&D Departments.

PUBLICATION AND DISSEMINATION POLICY The results of this study will form part of Dr R Simpson’s PhD Thesis and will contribute towards the design and conduct of a later RCT. Participants will receive a report on the study’s findings at the earliest convenience. An internal report will be written and subsequently condensed into manuscript format for submission to a Peer reviewed scientific journal. The work will also be submitted for presentation at a relevant scientific meeting. Identifiable personal data will not be used during publication of the results.

USER AND PUBLIC INVOLVEMENT This study will actively involve patients in identifying clinically relevant outcomes, improving the readability of research proposals (especially the lay summary) and patient information sheets and refining the RCT protocol. It is hoped that through collaboration with patients they will also be able to help to recruit into studies and disseminate of study results.

STUDY FINANCES

Funding source

This study is funded by the National Institute for Health Research (NIHR Doctoral Research Fellowship awarded to Dr Rosalind Simpson, grant ref NIHR-DRF-2012-05-166).

Participant stipends and payments

Participants will not be paid to participate in the study. In line with guidance issued by INVOLVE in the document 'Payment for Involvement' (issued 2010, revised August 2012), the following will be offered to participants in this research project:

Out of pocket expenses e.g. travel and parking will be paid by cash or cheque on receipt of evidence for expenses incurred;


A one-off thank you gift in recognition the time and effort contributed by the participant will be provided. This will be in the form of high street vouchers to the value of £30.


SIGNATURE PAGES Signatories to Protocol: Chief Investigator: (name)__________________________________ Signature:__________________________________ Date: ___________


REFERENCES

Cheng, S., G. Kirtschig, et al. (2012). "Interventions for erosive lichen planus affecting mucosal sites." Cochrane Database Syst Rev 2: CD008092.

Cooper, S. M., I. Ali, et al. (2008). "The association of lichen sclerosus and erosive

lichen planus of the vulva with autoimmune disease: a case-control study." Arch Dermatol 144(11): 1432-1435.

Cooper, S. M., D. Dean, et al. (2005). "Erosive lichen planus of the vulva: weak circulating basement membrane zone antibodies are present." Clin Exp Dermatol 30(5): 551-556.

Cooper, S. M. and F. Wojnarowska (2006). "Influence of treatment of erosive lichen

planus of the vulva on its prognosis." Archives of Dermatology 142(3): 289-294.

Hickey, S. and H. Bell (2010). "Quality of life in the vulvar clinic: a pilot study." J Low

Genit Tract Dis 14(3): 225-229. Lawton, S. and S. Littlewood (2006). "Vulval skin disease: clinical features,

assessment and management." Nurs Stand 20(42): 57-63; quiz 64. Lewis, F. M. and C. I. Harrington (1994). "Squamous cell carcinoma arising in vulval

lichen planus." British Journal of Dermatology 131(5): 703-705. Simpson, R. C., S. M. Littlewood, et al. (2012). "Real-life experience of managing

vulval erosive lichen planus: a case-based review and U.K. multicentre case note audit." Br J Dermatol 167(1): 85-91.

Simpson, R. C. and R. Murphy (2012). "Considerations for Disease Impact and

Outcome Measures in Vulvar Disease." J Low Genit Tract Dis. May 31. [Epub ahead of print]

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ELPV Feasibility Study: systemic treatments are better