UK Data Archive Study Number 5829 - Mental Health Trusts: Community Mental Health Service User Survey, 2007 National patient survey programme NHS Community Mental Health Service Users Survey Guidance Manual 2007 Updated 13 th December 2006 1
This document and other documents referenced within are available from the Mental Health surveys website at: www.healthcarecommission.org.uk/mentalhealthsurvey2007 Contacts Kay Renwick and Jo Phillipson Mental Health Surveys Co-ordination Centre Kings House 101-135 Kings Road Brentwood CM14 4LX Tel: 01277 690218 E-mail: CommunityUsersSurvey@natcen.ac.uk Updates Before you start your survey, check that you have the latest version of this document, as there might be some small amendments from time to time. (The date of the last update is on the front page.) In the unlikely event that there are major changes, we will e-mail all Trust contacts directly to inform them of the change. Changes to the procedures outlined in this document It is not permissible to deviate from the agreed protocol as set out in the guidance manual. The terms of the ethical approval do not permit these types of alteration. Furthermore, such alterations might mean that the comparability of the survey would be compromised, and this could affect the calculation of performance indicators. If Trusts want to make any minor changes to the method set out in this guidance, they must first check with the Co-ordination Centre that the proposed change would not compromise comparability. Please direct questions or comments about this guidance to: Kay Renwick, Survey Co-ordinator, Tel: 01277 690218 E-mail: CommunityUsersSurvey@natcen.ac.uk 2
CONTENTS Introduction... 5 The Healthcare Commission and the NHS national patient survey programme... 5 How to use this guide... 6 Basic requirements for national Mental Health Survey 2007... 6 Timetable... 8 What's New for the 2007 Survey... 11 1. Commissioning an Approved Contractor... 12 1.1 Model contract... 15 1.2 Honorary contract... 16 2. Data protection and confidentiality... 17 2.1 Statements of compliance with data protection... 17 In-house surveys... 17 Approved Contractors... 18 2.2 Service users names and addresses... 18 2.3 Confidentiality... 20 2.4 Service user anonymity... 23 In-house surveys... 23 Approved Contractors... 23 2.5 Storing completed questionnaires... 24 3. Ethical issues, ethics committees & research governance... 25 3.1 Ethical approval for the mental health survey... 25 3.2 Research governance requirements... 25 4. Publicising the Survey... 29 5 Compiling a sample of service users for the survey... 30 5.1 Making sure your CPA list is reliable... 30 5.2 Compile a full list of current service users... 31 5.3 Data fields to include in the list of service users... 32 5.4 Instructions for taking a sample of service users... 34 5.5 Check the sample list... 35 5.6 Ask your Chief Executive to sign off the sample... 36 5.7 Additional checks on the sample... 37 5.8 Submit the list to the NHS Strategic Tracing Service (NSTS)... 37 3
5.9 Submit the file to the Co-ordination Centre for checking... 38 5.10 Check the Trust s records for service user deaths... 39 5.11 Organise the service user information into the sample file... 39 5.12 Sharing the service user sample file with an Approved Contractor... 42 5.13 Using the sample file... 42 6. Weekly Progress... 44 6.1 Response rate... 44 6.2 Helpline monitoring... 44 7. Implementing the survey - practicalities... 46 7.1 Materials... 46 7.2 Setting up a FREEPOST address... 47 7.3 IMPORTANT: Setting up a PO Box for mail returned undelivered... 47 7.4 Setting up a FREEPHONE line... 48 7.5 Covering letters... 49 7.6 Multi-language sheet... 50 7.7 Sending out questionnaires... 50 7.8 Booking in questionnaires... 51 7.9 Sending out reminders... 52 7.10 Comparing departments or teams within your Trust... 53 8. Entering and coding questionnaire data... 54 8.1 Checking for errors... 55 8.2 Submitting data to the Co-ordination Centre... 55 8.3 Checklist... 60 9. Additional information... 62 9.1 Involvement of non-english speaking populations... 62 9.2 Copyright 2007 NHS Mental Health Service Users Survey of questionnaire. 64 9.3 Data archive... 64 Appendix 1: Declarations of data protection compliance... 64 Appendix 2: Declarations for additional data analysts... 66 4
Introduction The Healthcare Commission and the NHS national patient survey programme The Healthcare Commission is the health watchdog in England. It's our job to check that healthcare services are meeting standards in a range of areas, including safety, cleanliness and waiting times. We have a statutory duty to assess the performance of healthcare organisations (NHS and independent healthcare), award annual performance ratings for the NHS and co-ordinate reviews of healthcare by others. We aim to equip patients and the public with the best possible information about the provision of healthcare, and to promote improvements in healthcare in England. We have created an entirely new approach to assessing and reporting on the performance of healthcare organisations - the annual health check - which examines a much broader range of factors, so we can focus on what really matters to patients and the public. The information from the survey of community mental health service users will provide performance indicators for the annual health check. In addition, the survey's results are used as a data source by the Department of Health for reporting to Parliament, by the Healthcare Commission for screening self-assessment declarations in the annual health check and to inform local improvement activity. 5
How to use this guide This guide outlines the requirements and procedures for carrying out the 2007 community mental health service users survey. By ensuring that organisations carry out these surveys in a consistent and systematic way it is possible to build up a national picture of people's experience and, with care, to compare the performance of different organisations, change over time, and variations between different patient groups. As detailed in Section 1, Trusts have the option of conducting the survey in house or by using an Approved Contractor. Whichever you choose, you will need to address the guidance in Sections 1 to 5 of this guide. Sections 6, 7 and 8 cover the practicalities of mailing out the survey, following-up responses and processing the data and submitting them to the Co-ordination Centre. These sections will be most relevant to Approved Contractors, or Trusts undertaking the surveys themselves. Basic requirements for national Mental Health Survey 2007 For comparisons between and within Trusts to be accurate and fair, the surveys must be carried out using standard procedures in all Trusts. Those standards are set out in detail later in this document. In summary, they are as follows: Tell the Co-ordination Centre who is carrying out your survey (i.e. whether it will be carried out by an Approved Contractor or in-house) by 8 th January 2007. Give the Co-ordination Centre contact details of two people in your Trust who will be responsible for the survey s progress by 8 th January. Email: CommunityUsersSurvey@natcen.ac.uk Follow the sampling procedure set out in this guidance. Work closely with the person in the information department who draws the sample, and check carefully that this guidance is followed exactly. This process can be started as of 13 th December and the sample should be available to your Chief Executive for signing off by 17 th January 2007 at the latest. See Section 5 - Compiling a sample of service users for the survey. Your Chief Executive must sign off the sample before it is submitted to the Coordination centre for checking, and you must send a signed declaration that the sample has been signed off. The signed declaration must reach the Co-ordination Centre by 19 th January 2007. 6
Send the NSTS checked sample to the Co-ordination Centre by 1 st February 2007 Send questionnaires to a random sample of 850 adults aged 16 and over on the Trust s Care Programme Approach (CPA) register. Use the standard 8-page Mental Health Questionnaire 2007 downloaded from the Mental Health surveys website at: www.healthcarecommission.org.uk/mentalhealthsurvey2007. Use only the standard covering letters downloaded from the Mental Health surveys website at: www.healthcarecommission.org.uk/mentalhealthsurvey2007. Send two reminders to non-responders, even if a 40% response rate is already achieved Check the data carefully for errors before submitting it to the Co-ordination Centre. See Section 8.1 A clean, checked data set, must be submitted to the Co-ordination Centre in the form outlined in Section 8.2Submitting data to the Co-ordination Centre - by 5pm on 20 th April 2007. This deadline is determined by the requirement for data from the survey for the annual health check. Two copies of each of the paper documents you used, (questionnaire and covering letters for each mailing) must be submitted to the Co-ordination Centre in the form outlined in 8.2- Submitting data to the Co-ordination Centre - by 5pm on 20 th April 2007. Keep paper copies (or scanned pictures of all of the pages of the questionnaires, including the front and back pages) of all returned questionnaires until 31 st August 2007 but do not send these to the Co-ordination Centre. 7
Timetable The timetable below sets out important dates for the 2007 survey. If you commission an Approved Contractor, most of the work will be done by them, but all Trusts have to be involved in some of the stages of the process. Section numbers need thorough checking Latest date to complete Task 13/12/2006 Guidance and all documents available for download from the Healthcare Commission's Mental Health website 08/01/2007 Inform Co-ordination Centre who is carrying out the survey (in-house or Approved Contractor) and send contact details of 2 Trust personnel See Section 10/01/2007 Draw sample of service users (latest) 8 17/01/2007 Ask Chief Executive to sign off sample, submit declaration to Co-ordination Centre (to be received by 19/01/2007) 18/01/2007 Submit checked service user sample list to NSTS to check 5.8 for deceased service users 31/01/2007 Reduce sample size to 850 (if required) 5.9 01/02/2007 Submit the service user sample list to Co-ordination Centre 5.9 for checking 02/02/2007 Set up P.O. Box (if carrying out survey in-house or if using 7.2 the Approved Contractor non-honorary contract model) 02/02/2007 Set up FREEPOST address and FREEPHONE line (inhouse 7.3 &7.4 model) 02/02/2007 Print questionnaires & covering letters. Ensure you have 7.1 &7.5 enough headed paper, envelopes, return envelopes and labels (in-house model) 02/02/2007 If using an Approved Contractor, supply them with Trust 7.5 headed paper, signature of senior executive and (if appropriate) signed honorary contract 08/02/2007 Co-ordination Centre return checked sample to Trusts 5.9 09/02/2007 Establish system for responding to telephone enquiries 7.4 09/02/2007 Establish system for booking in questionnaires (in-house 7.8 5.6 8
model) 09/02/2007 If using honorary contract model, supply Approved 5.12 Contractor with sample 14/02/2007 Send first weekly progress and helpline monitoring sheet to 6 the Co-ordination Centre 15/02/2007 Stick labels on pre-packed numbered questionnaires 7.7 supplied by Approved Contractor (if non-honorary contract model) 15/02/2007 Check your own Trust s records again for service user 5.10 deaths and notify Approved Contractor (honorary contract model) 16/02/2007 Send out first questionnaires 7.7 Feb-Mar 2007 Book in returned questionnaires 7.8 Feb-Mar 2007 Enter questionnaire data 8 Feb-Mar 2007 Respond to telephone enquiries 7.4 01/03/2007 Check your own Trust s records again for service user 7.9 deaths and notify Approved Contractor (honorary contract model) 02/03/2007 Send out first reminders to non-responders 7.9 15/03/2007 Check your own Trust s records again for service user 7.9 deaths and notify Approved Contractor (honorary contract model) 16/03/2007 Send out second reminders to non-responders 7.9 10/04/2007 Complete data entry 16/04/2007 Very Important: check data for errors 8.1 20/04/2007 Send data, paper documents and checklist to Co-ordination Centre 8.2 9
January February March April Week commenc ing 1/1/2007 8/1/2007 15/1/2007 22/1/2007 29/1/2007 5/2/2007 12/2/2007 19/2/2007 26/2/2007 5/3/2007 12/3/2007 19/3/2007 26/3/2007 2/4/2007 9/4/2007 16/4/2007 Trusts notify Coordination Centre of survey contacts Trusts notify Coordination Centre if working inhouse or with Approved Contractor Draw Sample Submit data to NSTS Submit data for checking by Coordination Centre Sample to Approved Contractor (if using) First mailing (by) Second mailing (by) Third mailing (by) Data entry complete Submit data and documentation to Co-ordination Centre 10
What's New for the 2007 Survey Coaching for new Approved Contractors The Co-ordination Centre is offering new Approved Contractors the opportunity to visit NatCen and discuss how to administer the survey. Extra data item - Local Authority of sampled service user In order to enable analysis of the survey data by Local Authority, you will be required to provide this information for each sampled service user as part of your dataset. This is referred to in this Guidance and more detailed information will be circulated separately. Extra sample checking After your sample has been to NSTS for tracing of deceased service users, and before the first mailing of questionnaires, the sample should be submitted to the Co-ordination Centre for final checking. For more information about this please see section 5.9 Submission of weekly progress information Information about the progress of your survey including helpline queries should be submitted to the Co-ordination Centre on a weekly basis beginning 14 th February 2007. For more information about this please see section 6. Data protection guidance The guidelines on data protection, which are designed to prevent the disclosure of patient information, have been revised for all surveys in the NHS Patient Survey Programme. For more information please see section 2 11
1. Commissioning an Approved Contractor The framework agreement set up by the Department of Health covers the core survey process. Approved Contractors are expected to: Provide support to Trusts on sampling Print questionnaires, covering letters and reminders and provide consumables Handle returned questionnaires, liaise with Trusts on reminders Offer support to ensure good response rates. e.g. offer FREEPHONE line Complete data entry and submit data to the Co-ordination Centre by the deadline Prepare reports for Trusts Twelve organisations have been approved by the Healthcare Commission to carry out patient and service user surveys. Trusts may commission one of these contractors without further tendering for the survey work. Before committing to a contractor, you are advised to check exactly what is covered within the cost quoted. Further information about each of these organisations, can be found on the Mental Health surveys website at www.healthcarecommission.org.uk/mentalhealthsurvey2007. List of Approved Contractors The following contractors have approved status for work on the national patient experience surveys programme: BMG Research Contacts: Dawn Hands Holt Court Heneage Street West Aston Science Park BIRMINGHAM B7 4AX 12
Tel: 0121 333 6006 Fax: 0121 333 6800 E-mail: dawn.hands@bmgresearch.co.uk Website: www.bmgresearch.co.uk GFK NOP Contact: Sarah McHugh, Joy Mhonda and Lisa Endersbee GFK NOP Ludgate House 245 Blackfriars Road London SE1 9UL Tel: 0207 890 9000 (Switchboard) Fax: 0207 890 9744 E-mail: sarah.mchugh@gfk.com, joy.mhonda@gfk.com, lisa.endersbee@gfk.com Website: www.gfknop.co.uk Ipsos MORI Contact: Jessica Elgood Ipsos MORI 79-81 Borough Road London SE1 1FY Tel: 0207 347 3000 Fax: 0207 347 3800 E-mail: Jessica.elgood@ipsos-mori.com Website: www.mori.com Marketing Sciences Contact: Eileen Sutherland Marketing Sciences 8 Clement Street Winchester Hampshire SO23 9DR Tel: 01962 842211 Fax: 01962 840486 E-mail: esutherland@marketing-sciences.com Website: www.marketing-sciences.com/ MSB Ltd Contact: Don Porter MSB Ltd Winslow House Ashurst Park Church Lane Sunninghill Ascot Berkshire SL5 7ED Tel: 01344 876 300 Fax: 01344 873 677 E-mail: Don@msbconsultancy.com Website: www.msbconsultancy.com 13
The Contacts: Marian Bolden Kings House 103-135 Kings Road Brentwood Essex CM14 4LX Tel: 01277 690101 Fax: 01277 226844 E-mail: M.Bolden@natcen.ac.uk Website: www.natcen.ac.uk NHS Partners Contact: Cheryl Kershaw NHS Partners 30 Victoria Ave Harrogate North Yorkshire HG1 5PR Tel: 01423 720212 Fax: E-mail: Cheryl.kershaw@nhspartners.org.uk Website: www.nhspartners.org.uk Patient Dynamics Contacts: Andrew Smith and Delia Knox PatientDynamics Riverside House 5 Nutfield Lane High Wycombe Buckinghamshire HP11 2ND Tel: 01494 536346 Fax: 01494 536146 E-mail: andrew@patientdynamics.org.uk; delia@patientdynamics.org.uk Website: www.patientdynamics.org.uk Patient Perspective Contact: Stephen Bruster 25 Grove St Oxford OX2 7JT Tel: 01865 420027 Fax: 01865 426831 E-mail: Stephen.bruster@PatientPerspective.org Website: www.patientperspective.org 14
Picker Institute Europe Contacts: Tim Markham, Bridget Hopwood, Sheena MacCormick, or Nick Richards Picker Institute Europe King s Mead House Oxpens Road Oxford OX1 1RX Tel: 01865 208100 Fax: 01865 208101 E-mail: surveys@pickereurope.ac.uk Website: www.pickereurope.org Quality Health Contacts: Dr Reg Race and Kerry Hibberd Quality Health Sutton Manor Palterton Lane Sutton Scarsdale Chesterfield Derbyshire S44 5UT Tel: 01246 856263 Fax: 01246 851143 Email: Reg.Race@Quality-Health.co.uk; kerry.hibberd@quality-health.co.uk Website: www.quality-health.co.uk SNAP surveys Contact: Amy Lawrence SNAP Surveys Mead Court Cooper Road Thornbury Bristol BS35 3UW Tel: 01454 280860 Fax: 01454 281216 Email: alawrence@snapsurveys.com Website: www.snapsurveys.com 1.1 Model contract A model contract has been drawn up by the Healthcare Commission for Trusts to use. By signing it, the survey contractor is obliged to keep the information confidential at all times, and to comply with the Data Protection Act 1998. The model contract also ensures that survey contractor staff members sign and abide by the honorary contract. The honorary contract is set up between the Trust and those members of the survey contractor staff who will have access to service users information. The honorary contract describes how service users personal data will be sent to the survey contractor, and how the data can be used. It also ensures that only those members of staff named in the contract will have access to the data. 15
The model contract in Word format is available on the Mental Health surveys website. 1.2 Honorary contract The Honorary Contract is set out in Schedule 3 to the Model Contract. This is to be entered into by the trust and those members of the survey contractor staff who will have access to patients information. The Honorary Contract sets out the basis on which that personal data is provided to and can be used by such staff. The Honorary Contract also makes it clear that it does not constitute a contract of employment between the trust and the survey contractor staff. Honorary Contracts will need to be entered into by the trust with each member of the survey contractor s staff who will have access to patients information. Where it is envisaged that only one such member of the survey contractor s staff will have access, the Healthcare Commission recommends that Honorary Contracts are established with at least two members of staff from the survey contractor in any event (to ensure continuity of progress in the event of one member of staff being away from work, working on other projects, etc). 16
2. Data protection and confidentiality When carrying out your survey, you will need to ensure that you comply with the Data Protection Act 1998, and ensure that all responses are kept confidential. You will also need to comply with the NHS Code of Practice on Confidentiality (2003), which incorporates the Caldicott principles.(see section 2.1) It is your legal responsibility to ensure that you meet any guarantees of anonymity or confidentiality made in covering letters and on the questionnaire form. It will also be necessary to establish appropriate contractual arrangements with any contractors. Your Trust s Caldicott Guardian and legal advisors will be able to advise you on these matters. New guidelines on the use and security of the data collected have been agreed by the Healthcare Commission and the Co-ordination Centres for the national NHS staff and patient survey programmes. These guidelines will help to ensure that data are handled in a manner most in keeping with the spirit of the Data Protection Act 1998 and the Market Research Society s Guidelines for social research (2005). They have implications for Approved Contractors and for NHS Trusts conducting surveys inhouse. This website below has further information: http://www.dh.gov.uk/policyandguidance/informationpolicy/patientconfidentialityan dcaldicottguardians/accesshealthrecordsarticle/fs/en Further information about the Data Protection Act 1998 can be found at http://www.ico.gov.uk Further guidance can be found in the Market Research Society document at http://www.mrs.org.uk/standards/downloads/revised/legal/data_protection_social.pdf 2.1 Statements of compliance with data protection In-house surveys Each NHS Trust has a Caldicott Guardian responsible for overseeing proper use of patient data. If you are conducting the survey in-house, before drawing the sample, you must submit a formal declaration (see Appendix 1), signed by the Caldicott Guardian and survey lead(s) for the Trust, to the community mental health survey Coordination Centre. This declaration will certify that data shall only be displayed, reported, or disseminated in compliance with the new guidelines. Templates for these declarations are available on the website containing the survey guidance (www.healthcarecommission.org.uk/mentalhealthsurvey2007). You must wait for confirmation of receipt from the Co-ordination Centre before you draw your sample. 17
Caldicott Principles Each NHS Trust has a Caldicott Guardian who is responsible for overseeing proper use of patient data. They have to ensure that any use of patient data conforms to the following principles: Principle 1 - Individuals, departments and organisations must justify the purpose(s) for which information is required Principle 2 - Don t use patient-identifiable information unless it is absolutely necessary Principle 3 Use the minimum necessary patient-identifiable information Principle 4 - Access to patient-identifiable information should be on a strict need-to-know basis Principle 5 Everyone should be aware of their responsibilities Principle 6 - Understand and comply with the law You should take particular care to ensure that your use of patient data in carrying out the survey, complies with these 6 principles. In particular, you should be aware of the flows of patient data, and the issues which these present. The Caldicott guidance and principles were incorporated into the NHS code of practice on confidentiality. If the Caldicott Guardian is unable to make such a declaration, then the Trust must use an Approved Contractor to ensure that appropriate standards of confidentiality data protection are maintained. Approved Contractors The framework agreement between the Approved Contractors and the Healthcare Commission contains clauses stating that the Approved Contractor will comply with the Data Protection Act so no declaration is required if a Trust appoints a contractor from the approved list. 2.2 Service users names and addresses In order to comply with the Data Protection Act 1998 and common law duty of confidence, NHS Trusts should not release the names, addresses or any other personal details of service users to anyone who is not employed by the Trust, unless consent has been obtained from each service user. This includes releasing names and addresses for the purpose of mailing survey questionnaires to patients. The honorary contract 18
allows Approved Contractor staff to view this information without infringing the Data Protection Act 1998. Please note that under the new data protection guidelines for patient surveys, the following principles must be followed: All of the Caldicott principles must be satisfied The personal data should be sent to the Approved Contractor in the form of a password protected database or sent to the contractor using a Healthcare Commission approved secure uplink. The password should be verbally given to a named individual at the Approved Contractor. The Trust should save the database onto a CD-ROM or diskette, placed in a single sealed envelope or other container, annotated "Addressee Only", and send this to the Approved Contractor by recorded delivery through the Royal Mail or through a courier service. Names and addresses may be sent by Trusts to contractors over the Internet using an encrypted session. Trusts/contractors must gain prior approval from the Healthcare Commission for their particular methods and choice of products, and must undertake to keep their products up to date to ensure that security is effective. If the Transport Layer Security (TLS) or Secure Sockets Layer (SSL) protocol (for example as with HTTPS or SFTP) is to be used, a key size of 256 bits should be used whenever possible. A key size of at least 128 bits must be used. This procedure is in accordance with the guidelines for sharing restricted information as set out in the Healthcare Commission's handbook for staff: Handling information at the Healthcare Commission. Remember: if the data contains patient names and addresses, this can only be sent to the contractor by CD-ROM or diskette, or via a Healthcare Commission approved encrypted method. If you commission an Approved Contractor to carry out the survey, there are two common methods currently being practised by Trusts and contractors, as advised by the Healthcare Commission: Method 1 1. The Trust allocates serial numbers to their list of sampled service users. 2. The contractor delivers pre-packed serial-numbered questionnaire packs to the Trust. 19
3. The Trust attaches number-matched address labels to the envelopes and posts them out. 4. Completed questionnaires are returned directly to the contractor and the contractor checks off the Record Numbers on returned questionnaires. 5. When the reminders are ready to be sent out, the contractor sends pre-packed serial-numbered questionnaire packs to the Trust for those service users who have not yet returned questionnaires or opted out. This process is described in more detail in Sections 5 and 7 Method 2 With the agreement of the Trust s Caldicott Guardian, an honorary contract is set up between the Trust and two people who are already employed by the contractor. The contractor staff thus become unpaid employees of the Trust (while continuing to be employees of the contractor) during the period in which the survey is carried out. It is then permissible for the contracted employee to be given service user contact details for the purposes of sending out questionnaires and reminders to service users, and sticking address labels on to envelopes. The external contractor must be registered under the Data Protection Act and appropriate steps must be taken to protect service user confidentiality. The Healthcare Commission has developed a set of honorary contracts for Trusts and survey contractors carrying out the surveys. This is to ensure that the transfer of patient data is done in a way that does not compromise patient confidentiality, and to avoid the need for each Trust to develop its own arrangements. A Healthcare Commission sample honorary contract can be found on the Mental Health surveys website at: www.healthcarecommission.org.uk/mentalhealthsurvey2007 2.3 Confidentiality 20
Any service user survey must respect confidentiality and this confidentiality must be given high priority. That is, service users must be given reliable assurances that doctors, nurses, social workers and other Trust staff will not be able to identify any individual s responses. At Trust Level If data are to be presented to trust staff who have not signed the declarations of compliance with the Data Protection Act, only the aggregated totals for each question should be provided. If analysis by subgroup is carried out, the results for any group consisting of fewer than 20 respondents should be suppressed. The data should be presented as shown in the example in Figure 1. In this case responses for the Mixed and Asian ethnic groups are suppressed because there are fewer than 20 service users in each of these sub-groups (though sub-group totals are shown). Figure 1 Example of presentation of aggregated data Ethnic group Yes No Total responses % % n White 81 19 261 Mixed - - 8 Asian - - 18 Black 79 21 52 Chinese or other 85 15 26 Furthermore, do not present response information (including verbatim comments) in a form that allows individuals to be identified by the group receiving the information. If you are presenting the results of a small number of patients, make sure that it will not be possible for staff to identify individual patients from their responses, and pay particular attention to the patients free text comments in this context. For example, if a service user is known to be under the care of a particular team, and his or her year of birth, sex and ethnic group are known from their survey responses, it might be possible to use this information to identify them. Approved Contractors 1) Approved Contractors must not provide raw data to the Trust as a matter of 21
course. 2) If the Trust has a particular need for the raw data from the survey from the Approved Contractor, the contractor may provide an abridged version of this dataset to the Trust upon request, providing that the steps below are undertaken first: a. The contractor must delete the two variables pertaining to ethnicity (e.g. both sample and response variables). b. The contractor must band year of birth into five age groups (16-35, 36-50, 51-65,66-80, 80+). This process should be repeated separately for both sample and response variables. The original year of birth variables (e.g. those specifying an exact year rather than the age group) must then be deleted. c. Additional information specific to a survey that can be used to identify individual patients must also be removed. For example, day month and year of last contact must be removed. d. Verbatim comments that could lead to any staff identifying respondents must be removed, e.g. those mentioning patient, staff, ward or unit names 1 e. Receive confirmation from the Trust that they have destroyed the names and addresses of the sampled patients, otherwise they will be able to identify individual service users by matching up the patient record number/serial numbers on the name and address list to those in the raw data file. These steps MUST be followed before supplying raw data to Trusts. This is to prevent the disclosure of a service user s identity by specific demographic factors. Different arrangements govern the supply of raw data to the Co-ordination Centres. The response data will be anonymous when passed to the Mental Health Survey Coordination Centre and Healthcare Commission. If data are to be presented to Trust staff, only the aggregated totals for each question should be provided. If analysis by subgroup is carried out, the results for any group consisting of fewer than 20 respondents should be suppressed. Furthermore, do not present response information (including comments) in a form that allows an individual service user to be identified by the group receiving the 1 Please be aware that there are exemptions allowing disclosure, such as the prevention of crime exemption which might allow disclosure of free text describing criminal matters actual or threatened. Neither the Healthcare Commission nor the Co-ordination Centre can offer legal advice on these matters; the contractor or trust must seek its own independent legal advice before disclosing patients' comments to Trusts. 22
information. For example, if you are presenting the results of a small number of service users, make sure that it will not be possible for the reader/audience to identify individual service users from their responses, and pay particular attention to the service users free text comments in this context. The electronic file containing the patients names and addresses should be stored securely (i.e. password protected). Access to the file should be given only to those individuals from the PCT or Approved Contractor who have signed honorary contracts with the practices. The electronic file containing the patients names and addresses should be stored securely (i.e. password protected). Access to the file should be given only to those individuals from the PCT or Approved Contractor who have signed honorary contracts with the practices. Sharing of survey data between contractors If a Trust is using a different Approved Contractor than in the last survey year, contractors are permitted to transfer an unabridged version of the data set if there is a clear need to use the data from the previous year s surveys to allow year-on-year comparison. 2.4 Service user anonymity In-house surveys It is important to ensure that any claims you make about anonymity are accurate. The raw data set should not be provided to any staff at the Trust other than the Caldicott Guardian and survey leads recorded on the declaration of compliance with the Data Protection Act 1998 for Trusts using in-house survey teams (Appendix 1). In most cases where a survey is carried out in-house, it is not accurate to tell service users that their responses will be anonymous. The person who receives the completed questionnaires is usually able to match these responses to service user names and addresses. If additional data analysts or staff join the in-house survey team, the declaration of compliance with the Data Protection Act (additional data analysts) must be submitted to the Coordination Centre (Appendix 2). An additional data analyst cannot view the raw data until approval has been received from the Coordination Centre. Approved Contractors Anonymity can sometimes be achieved if there is a clear separation between the information seen by an Approved Contractor and the information held by the Trust. 23
Service users names and addresses should be seen by Trust staff only, while individual responses should be seen by contractor staff only. As long as the response data supplied to Trusts do not include Service User Record Numbers and are not provided to Trusts in a way that allows individuals to be identified, it can reasonably be claimed that responses are anonymous. 2.5 Storing completed questionnaires Completed questionnaires must be stored in a separate location to lists of service users names. Similarly, the electronic file containing the service users names and addresses should be stored separately to that containing the survey data. Any mailing lists of service users names and addresses should be destroyed when the mailing process is complete. 24
3. Ethical issues, ethics committees & research governance 3.1 Ethical approval for the mental health survey The Co-ordination Centre has obtained Multi-Centre Research Ethics Committee (MREC) approval for the standard Mental Health Questionnaire, the covering letters and reminder letters. You do not, therefore, need to seek ethical approval for this survey. Further information on the ethical approval process can be found at www.corec.org.uk. The MREC letters can be downloaded from the mental health surveys website. www.healthcarecommission.org.uk/mentalhealthsurvey2007 To comply with the ethical approval, the survey must be carried out according to the guidelines set out in this document. 3.2 Research governance requirements The Healthcare Commission, as sponsor of this national survey, has taken steps to ensure that principles of research governance and ethics are followed thoroughly. The development of the survey methods, the questionnaire and covering letters to service users, have all been approved by an MREC. The questionnaire and guidance notes on how to conduct the survey are produced by the Mental Health Surveys Co-ordination Centre and approved by the Healthcare Commission. The Department of Health has confirmed to the Healthcare Commission that it would be inappropriate for individual Trusts to follow the same local research governance processes as they would if the survey were a study sponsored by the Trust. As this national service user survey has MREC approval and the Healthcare Commission takes responsibility for it as sponsor, this would duplicate work and delay implementation unnecessarily. 25
Trusts are invited to give permission for the surveys to go ahead after confirming they have the local research governance arrangements to support this study. The following table has been prepared by the Healthcare Commission. It is based on Section 3.10 of the Research Governance Framework for Health and social care (2 nd Edition, 2005, amended April 2006), available at http://www.dh.gov.uk/assetroot/04/12/24/27/04122427.pdf ). The left-hand column sets out the responsibilities of organisations providing care and the right-hand columns sets out the arrangements made by the Healthcare Commission for this survey. If you are required to seek approval from your research governance lead, you are advised to present this information to your R&D Manager in support of your request. Responsibilities of organisations providing care Research Governance Framework Retain responsibility for the quality of all aspects of participants care whether or not some aspects of care are part of a research study. Be aware and maintain a record of all research undertaken through or within the organisation, including research undertaken by students as part of their training. Healthcare Commission patient and service user surveys The survey is carried out on the experiences of service users after they have received the care so this does not apply. All Chief Executives are informed of the proposals of the survey. Ensure patients or users and carers are provided with information on research that may affect their care. Be aware of current legislation relating to research and ensure that it is implemented effectively within the organisation. The survey does not affect the care of the service users. Anonymised results are used for performance rating and local quality improvement initiatives. Detailed guidance is issued to survey leads regarding the publicity of the results and its impact on care. This requirement is not specific to this survey. 26
Ensure that all research involving participants for whom they are responsible has ethical approval and that someone with the authority to do so has given written permission on behalf of the care organisation before each study begins. Ensure that no research with human participants, their organs, tissue or data, begins until an identified sponsor, who understands and accepts the duties set out in this framework, has confirmed it accepts responsibility for that research. Ensure that written agreements are in place regarding responsibilities for all research involving an external partner, funder and/or sponsor, including agreement with the University or other employer in relation to student supervision. Maintain the necessary links with clinical governance and/or best value processes. Ensure that, whenever they are to interact with individuals in a way, which has a direct bearing on the quality of their care, non-nhs employed researchers hold honorary NHS contracts and there is clear accountability and understanding of responsibilities. The Healthcare Commission as sponsors of the study have sought ethics approval from MREC. There is a designated lead for each survey who is appointed by the Chief Executive. The Healthcare Commission as sponsors have undertaken steps to ensure that all the duties of the sponsors listed in section 3.8 of the Research Governance Framework are followed thoroughly. A detailed guidance is issued to all the Trusts, which spells out the responsibilities of all parties involved in the survey. The guidance notes very strongly recommend the Trusts to maintain these links and follow best practice evidence. In situations where Trusts opt to use the services of an external contractor to draw the sample for the survey, the contractor is required to enter into an honorary contract with the Trust. These procedures are specifically detailed in the guidance notes. 27
Put and keep in place systems to identify and learn from errors and failures. Put and keep in place systems to process, address and learn lessons from complaints arising from any research work being undertaken through or within the organisation. Ensure that significant lessons learnt from complaints and from internal enquiries are communicated to funders, sponsors and other partners. Ensure that any research-related adverse events are included in reports to the National Patient Safety Agency in line with the standard procedures of the organisation; or to the systems for adverse events reporting in social care. Permit and assist with any monitoring, auditing or inspection required by relevant authorities. The Healthcare Commission also undertakes consultations with the Trusts in order to ensure that the errors and failures are reported back to the Healthcare Commission. The survey programme is constantly evaluated and reviewed in the light of these. This requirement is not specific to this survey. The Healthcare Commission maintains a helpline facility, which can be used by service users or Trusts to report any complaints. Similar arrangements are in place with the NHS Patient Survey Coordination Centre who are commissioned by the Healthcare Commission to coordinate the patient and service user surveys. Not applicable to the service user survey. Patient safety is not compromised, this being a postal survey. The results of the surveys are used for performance monitoring and national star rating mechanisms 1 When universities and hospitals employ staff on joint or dual contracts, they are expected to make joint arrangements for accountability and management. See A Review of Appraisal, Disciplinary and Reporting Arrangements for Senior NHS and University Staff with Academic and Clinical Duties, a report to the Secretary of State for Education and Skills by Professor Sir Brian Follett and Michael Paulson-Ellis, September 2001 (The Follett Report). 28
4. Publicising the Survey You can heighten awareness of the survey and show the importance your Trust places on service user feedback through the following channels: posters in outpatients departments direct communications with service users before admission or at discharge community newsletters a press release in the local media Service users might ask clinical staff, patient liaison officers, or the Chief Executive's office about the survey, even though your covering letters give contact details for the survey managers and the dedicated helpline. Notify front line staff and executive offices that a survey is being conducted, and give them the name and number of a contact person. Survey managers should be prepared to respond to these calls quickly. Template staff briefings and information for use in press releases can be downloaded from the Mental Health surveys website. 29
5 Compiling a sample of service users for the survey This section explains how to draw the sample of service users. This task will need to be carried out by a member of staff at the NHS Trust. N.B. It is essential that the person who draws the sample understands the importance of following these instructions carefully. Also, that person s line manager must give them the time and support they need to do the task properly. An incorrectly drawn sample can delay the start of the survey or can result in the questionnaires being sent to the wrong service users. Please read all of this section before you start to compile your service user list. 5.1 Making sure your CPA list is reliable The sample for this survey is selected from service users on both Enhanced and Standard CPA. For reliable comparisons to be made between Trusts, it is essential that the definitions of Enhanced and Standard CPA are applied consistently across Trusts in terms of: Levels of need To target resources effectively, and promote a consistent national approach, services are required to deliver the Care Programme Approach according to two levels of need: Standard; and Enhanced. The characteristics of people on Standard CPA will include some of the following: they require the support or intervention of one agency or discipline or they require only low key support from more than one agency or discipline; they are more able to self-manage their mental health problems; 30
they have an active informal support network; they pose little danger to themselves or others; they are more likely to maintain appropriate contact with services. People on Enhanced CPA are likely to have some of the following characteristics: they have multiple care needs, including housing, employment etc, requiring interagency co-ordination; they are only willing to co-operate with one professional or agency but they have multiple care needs; they may be in contact with a number of agencies (including the Criminal Justice System), Account may also need to be taken of the definition of the levels given on page 53 of the National Service Framework for Mental Health (NSF). 5.2 Compile a full list of current service users If you are in any doubt about these sampling instructions, please call the Coordination Centre on 01277 690218. Compile a full list of all service users on either standard or enhanced CPA who were seen between 1 st September 2006 and 30 th November 2006. Make sure that you take out any duplicated names. Include all teams covered by your Trust. If your Trust does not already have all service users on one electronic list, you will need to combine all the separate lists so that you have one complete list and then select as outlined below. If some service users details are not held electronically, it will be necessary to type in their details, so that all service users details are held electronically. Remember to include service users on both Standard and Enhanced CPA. 31
If you do not have an adequate CPA list: Call the Co-ordination Centre on 01277 690218. If your trust has recently merged with another trust and you are unable to amalgamate your databases: Call the Co-ordination Centre on 01277 690218 for further sampling advice If you do not have adequate information on date of last contact: Include all service users who have had a care review in the last 12 months including on-going care in psychiatric outpatients, with a clinical psychologist, social worker or with another mental health professional. Who to leave out The following service users should be removed from the list: Anyone seen only once for an assessment (For example, those who were seen by a psychiatrist for a single assessment.) Any children who are under 16 on the date the sample was drawn Any service users who are known to be current inpatients Service users who are known to have died Service users who do not have a known UK address Service users who did not have contact with Mental Health Services during the sample period of 1 st September 2006 to 30 th November 2006 Any duplicated names Any alias names where the person s real name is already included in the list. 5.3 Data fields to include in the list of service users The following information should be kept in a file in Microsoft Excel or Access: 32
Service User Record Number - This is a series of sequential numbers (for example, 1001 through to 1850). It will be included on address labels and on questionnaires Title (Mr, Mrs, Ms, etc.) - Initials (or First name) Surname Address Fields - The address should be held as separate fields (e.g. street, area, town, county). This should be consistent with the address format required by the NSTS. Postcode - this will be used to apply a Local Authority code needed at the end of the survey Year of birth Gender Ethnic group - This field should be included wherever possible. This data is required in order to evaluate non-response from different ethnic groups. This is in keeping with the aims of the Healthcare Commission and Department of Health to be more responsive to all ethnic groups and provide services that take account of their individual requirements. Day of the month of last contact (1 or 2 digits; e.g. 2 or 30) - Date fields must be supplied in separate columns. Month of last contact (1 or 2 digits; e.g. 9 or 10) Year of last contact (4 digits; e.g. 2006) Whether the service user is on Enhanced or Standard CPA Any other details required by the NHS Strategic Tracing Service (NSTS). Wherever possible, this should include the NHS number. - The NHS number can give more accurate matching, especially if addresses are incomplete. It is advisable to liaise with the registered NSTS batch trace user (if this is not the same person who creates the sample list) to ensure that all the required fields are included in the list of service users (see Section 5.8 for more details on using the NSTS). Unit or team - Include this if you plan to compare units within your Trust. See Section 7.10 for further details 33
5.4 Instructions for taking a sample of service users It is likely that your full list will include thousands of service users, but you will need to send questionnaires to only 850 service users. Taking a sample can only take place once you have compiled the full list of eligible service users as described in Section 5.2. Although the aim is to send questionnaires to 850 service users, you need to select more than 850 users initially. This is because your list of selected service users is likely to contain duplicate names or service users who are ineligible for the survey (see Section 5.5 for details) and some may have died. We have estimated that around 50 users will need to be removed from the initial list, so you need to take a simple random sample of 900 service users from your full list. This means that each eligible service user in the full list (the population) has an equal chance of being included in the sample. The procedure for doing this is as follows: 1. Put the list of service users into a Microsoft Excel file. The first row of this file should be headings (such as name, year of birth, CPA level, etc). There should be one row for each service user below that. 2. Put the cursor in cell A1 and insert a blank column (Click Insert, then Columns). Give this column a heading: Random. 3. In cell A2, type =Rand() When you press Enter, a random number between 0 and 1 will be generated in that cell. 4. Copy the formula from Cell A2 to all the other cells in that column, so that each service user has a random number. To copy the formula, hover the cursor over the bottom righthand corner of cell A2 so that the cursor becomes a black cross +, press and hold down the left mouse button and drag down column A. 5. You are now ready to sort the list of service users. Before you do this, it is essential that you select all columns in your list, including the header row. The simplest way of ensuring this it to click on the blank square above and to the left of Cell A1. This selects all cells in the worksheet. If you do not select all cells in your list, you could mix up service users details, or you could fail to sort some of the service users in the list. 6. Once you have highlighted all the cells, click Data, then Sort. At the bottom of the Sort dialogue box which appears on the screen, ensure that <My data has Header row> is selected. At the top of that dialogue box, use the drop-down box under Sort by to select Random and click OK. 34