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PROTOCOL
COMPARING HEALTH OUTCOMES IN PEOPLE LIVING WITH CHRONIC HEADACHES (QUESTIONNAIRE STUDY) SUBSTUDY of CHESS
ISRCTN Number:TBCSponsor:University of Warwick Funding Body:University of Warwick Ethics Approval date: TBC
Version Number:1.2Date:26.02.2019Stage:Final
contact NAMES and numbers
Chief InvestigatorProfessor Martin Underwood
Warwick Clinical Trials Unit (WCTU)
The University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
Tel: 02476 574664
Fax: 02476 151136
Email: HYPERLINK "mailto:m.underwood@warwick.ac.uk" m.underwood@warwick.ac.ukContactsDr Felix Achana
Warwick Clinical Trials Unit (WCTU)
The University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
Tel: 02476 575265
Email: HYPERLINK "mailto:F.Achana@warwick.ac.uk" F.Achana@warwick.ac.uk
Kimberley White (Trial Manager)
Warwick Clinical Trials Unit (WCTU)
The University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
Tel: 02476 151634
Email: HYPERLINK "mailto:Kimberley.White@warwick.ac.uk" Kimberley.White@warwick.ac.uk
Chloe Norman (Trial Coordinator)
Warwick Clinical Trials Unit (WCTU)
The University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
Tel: 02476 151634
Email: HYPERLINK "mailto:Chloe.Norman@warwick.ac.uk" Chloe.Norman@warwick.ac.uk Department of Health Disclaimer:The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health.
Table of Contents Page
TOC \o "1-3" \h \z \u HYPERLINK \l "_Toc486500508" list of abbreviations/GLOSSARY PAGEREF _Toc486500508 \h 4
HYPERLINK \l "_Toc486500509" 1. Background PAGEREF _Toc486500509 \h 5
HYPERLINK \l "_Toc486500510" 2. Methods PAGEREF _Toc486500510 \h 6
HYPERLINK \l "_Toc486500511" 2.1 Aims PAGEREF _Toc486500511 \h 6
HYPERLINK \l "_Toc486500512" 2.2 Objectives PAGEREF _Toc486500512 \h 6
HYPERLINK \l "_Toc486500513" 2.3 Outcome measures PAGEREF _Toc486500513 \h 6
HYPERLINK \l "_Toc486500514" 2.4 Eligibility criteria PAGEREF _Toc486500514 \h 7
HYPERLINK \l "_Toc486500515" 2.4.1 Inclusion criteria: PAGEREF _Toc486500515 \h 7
HYPERLINK \l "_Toc486500516" 2.4.2 Exclusion criteria PAGEREF _Toc486500516 \h 8
HYPERLINK \l "_Toc486500517" 2.5 Recruitment and consent of participants PAGEREF _Toc486500517 \h 8
HYPERLINK \l "_Toc486500518" 2.6 Ethical considerations PAGEREF _Toc486500518 \h 8
HYPERLINK \l "_Toc486500519" 2.7 Adverse event management PAGEREF _Toc486500519 \h 9
HYPERLINK \l "_Toc486500520" 2.8 End of study PAGEREF _Toc486500520 \h 9
HYPERLINK \l "_Toc486500521" 3. Data management PAGEREF _Toc486500521 \h 10
HYPERLINK \l "_Toc486500522" 3.1 Data collection and management PAGEREF _Toc486500522 \h 10
HYPERLINK \l "_Toc486500523" 3.2 Data storage PAGEREF _Toc486500523 \h 10
HYPERLINK \l "_Toc486500524" 3.3 Data access and quality assurance PAGEREF _Toc486500524 \h 10
HYPERLINK \l "_Toc486500525" 3.4 Archiving PAGEREF _Toc486500525 \h 11
HYPERLINK \l "_Toc486500526" 4. Statistical analysis PAGEREF _Toc486500526 \h 11
HYPERLINK \l "_Toc486500527" 4.1 Study timetable and milestones PAGEREF _Toc486500527 \h 12
HYPERLINK \l "_Toc486500528" 5. References PAGEREF _Toc486500528 \h 13
list of abbreviations/GLOSSARY
Abbreviation ExplanationAEAdverse Event AESAdvanced Encryption Standard APPApplicationCIConfidence intervalCONSORTConsolidated Standards of Reporting TrialsCRFCase Report FormCTUClinical Trials UnitDCMDefinite Chronic Migraine DMCData Monitoring CommitteeGCPGood Clinical PracticeGPGeneral Practitioner ICHInternational Council for Harmonisation IRAS Integrated Research Application System ISRCTNInternational Standard Randomised Controlled Trial NumberMOHMedication Overuse Headache MRCMedical Research CouncilNHSNational Health Service NICEThe National Institute for Health Care Excellence NMCNational Migraine Centre PCMProbable Chronic Migraine PGPPretty Good Privacy (encryption)PISPatient Information SheetQoLQuality of LifeRCTRandomised Controlled TrialR&DResearch and DevelopmentSAESerious Adverse Event SMART Specific Measurable Attainable Realistic Time-based (goals)SOPStandard Operating ProcedureTMGTrial Management Group TTH Tension Type Headache WCTUWarwick Clinical Trials UnitBackground
Economic evaluations conducted alongside randomised controlled trials such as the CHESS (REC: 16/NW/0890) study require health-related quality of life data (commonly referred to as health utilities) in order to express the outcome of treatment in Quality Adjusted Life-Years (QALYs). QALYs provide a common currency to compare clinical and cost-effectiveness of interventions across different disease areas, hence are appealing to decision making bodies such as National Institute for Care and Clinical Excellence (NICE), the All Wales Medicines Strategy Group (AWMSG), and the Scottish Medicines Consortium (SMC). Chronic headache is a major cause of pain and disability; estimating health utilities in this patient population for use in economic evaluation is challenging. Patients may only be affected on some days, when their health state may be classed as very poor perhaps for a few hours only. Standard measures of health utility, such as the EuroQoL EQ-5D ADDIN EN.CITE Herdman20111119[1]1119111917Herdman, M.Gudex, C.Lloyd, A.Janssen, M. F.Kind, P.Parkin, D.Bonsel, G.Badia, X.Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)Quality of Life ResearchQuality of Life Research1727-17362010201104/09
03/24/acceptedDordrechtSpringer Netherlands0962-9343
1573-2649PMC3220807http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3220807/10.1007/s11136-011-9903-xPMC[ HYPERLINK \l "_ENREF_1" \o "Herdman, 2011 #1119" 1] questionnaire that assess health status on the day of completion, may not provide adequate data in this context. Health utilities derived from headache-specific measures may be preferable as they are likely to be responsive to headache symptoms and their impact on patients health and health-related quality of life. We are aware of only two economic evaluations of headache treatments in which health outcomes are expressed in QALY terms; these were both for studies of acupuncture ADDIN EN.CITE Witt20081237[2, 3]1237123717Witt, C. M.Reinhold, T.Jena, S.Brinkhaus, B.Willich, S. N.Cost-Effectiveness of Acupuncture Treatment in Patients With HeadacheCephalalgiaCephalalgia334-34528420082008/04/01SAGE Publications0333-1024http://dx.doi.org/10.1111/j.1468-2982.2007.01504.x10.1111/j.1468-2982.2007.01504.x2017/01/19Wonderling200412381238123817Wonderling, DavidVickers, Andrew JGrieve, RichardMcCarney, RobCost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary careBMJBMJ7473287442200410.1136/bmj.38033.896505.EB[ HYPERLINK \l "_ENREF_2" \o "Witt, 2008 #1237" 2, HYPERLINK \l "_ENREF_3" \o "Wonderling, 2004 #1238" 3]. Both studies used a published algorithm to derive a single index of health utility from the 12-Item Short Form Survey (SF-12) ADDIN EN.CITE Brazier20021099[4]1099109913Brazier, J.Roberts, J.Deverill, M.The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002;21(2):27192. 14262445502002[ HYPERLINK \l "_ENREF_4" \o "Brazier, 2002 #1099" 4]. However, the economic evaluation of the CHESS intervention will be informed by health utilities generated from EQ-5D questionnaire as recommended by NICE ADDIN EN.CITE National Istitute for Health and Care Excellence2013817[5]81781727National Istitute for Health and Care Excellence,Guide to the methods of technology appraisal 2013. Avaialable from http://publications.nice.org.uk/pmg92013[ HYPERLINK \l "_ENREF_5" \o "National Istitute for Health and Care Excellence, 2013 #817" 5]. Further work is needed to help define the best approach to measuring health utilities in headache studies and to develop algorithms that can be used to generate EQ-5D health utilities from more response headache-specific questionnaires.
This mapping study of health outcomes in people living with chronic headaches will contribute to our understanding of outcome measurement in this population and help inform selection of outcome measures in future headache studies. In this study we aim to develop methods to predict health utilities based on responses from two headache-specific questionnaires - the Headache Impact Test (HIT-6) and the Chronic Headache Quality of Life Questionnaire (CHQLQ). These headache-specific questionnaires are more likely to be responsive to improvement or worsening in headache-related symptoms than more generic health-related quality of life measures such as the EQ-5D and SF-12. The mapping study will enable us develop methods to predict the 5L version of the EQ-5D (EQ-5D-5L) and version 2 of the SF-12 (SF-12v2) scores from the more responsive headache-specific measures. This process of generating health utilities based on the responses to a disease-specific outcome measure is often termed mapping or cross-walking in the measurement of health outcomes literature ADDIN EN.CITE ADDIN EN.CITE.DATA [ HYPERLINK \l "_ENREF_6" \o "Dakin, 2013 #1084" 6-8]. The evidence generated from the mapping study will contribute to developing best practice approaches to measuring health utilities in headache studies.
To develop the mapping algorithms, a cross-sectional cohort of people living with chronic headaches will be recruited from among patients attending headache clinics within NHS hospital outpatient departments. Data will be collected using the two headache-specific measures (HIT-6 and CHQLQ) and the generic health-related quality of life measures (EQ-5D-5L and SF-12 version 2). The EQ-5D-5L and SF-12 are the most widely used quality of life measures in clinical research. Both cover full range of different recall periods ranging from 1 to 4 weeks and have UK population preference values ADDIN EN.CITE ADDIN EN.CITE.DATA [ HYPERLINK \l "_ENREF_9" \o "Brooks, 1996 #707" 9, HYPERLINK \l "_ENREF_10" \o "Brazier, 2002 #348" 10]. In addition, the EQ-5D is the recommended questionnaire for generating health utilities to inform appraisal of health technologies by NICE ADDIN EN.CITE National Istitute for Health and Care Excellence2013817[5]81781727National Istitute for Health and Care Excellence,Guide to the methods of technology appraisal 2013. Avaialable from http://publications.nice.org.uk/pmg92013[ HYPERLINK \l "_ENREF_5" \o "National Istitute for Health and Care Excellence, 2013 #817" 5]. We will use data from the CHESS main study to externally validate and assess the generalisability of the mapping methods and algorithms. The study will be conducted in accordance with recently published good practice guidelines conducting mappings to estimate health utilities from nonpreference-based outcome measures ADDIN EN.CITE Wal20111284[8]1284128417Willem M. van der WalRonald B. Geskusipw: An R Package for Inverse Probability WeightingJournal of Statistical SoftwareJournal of Statistical Softwareinverse probability weightingmarginal structural modelscausal inferenceR2011http://www.jstatsoft.org/v43/i13/paper[ HYPERLINK \l "_ENREF_8" \o "Wal, 2011 #1284" 8].
Methods
Aims
To develop mapping methods for predicting EQ-5D-5L and SF-12 version 2 responses and health utilities from two headache-specific questionnaires: the HIT-6 and the CHQLQ for different types of chronic headaches and migraines.
Objectives
To develop mapping algorithms to predict health utilities from two headache-specific outcome measures for people living with different types of chronic headaches.
Externally validate and assess the generalisability of the algorithms using data from the CHESS main study.
Make the algorithms publicly available for use in other headache studies by including them in the Oxford database of mappings between health outcomes ADDIN EN.CITE Dakin20131084[6]1084108417Dakin, H.Review of studies mapping from quality of life or clinical measures to EQ-5D: an online databaseHealth Qual Life Outcomes.Health Qual Life Outcomes.112013http://dx.doi.org/10.1186/1477-7525-11-15110.1186/1477-7525-11-151[ HYPERLINK \l "_ENREF_6" \o "Dakin, 2013 #1084" 6].
Outcome measures
We aim to collect data on headache-specific symptoms and their impact on activities of daily living, general health and health-related quality of life. We will include two headache-specific measures:
The Headache Impact Test (HIT-6)
The Chronic Headache Quality of Life Questionnaire (CHQLQ)
We will include two generic health-related quality of life measures:
The EQ-5D-5L
The SF-12 version 2) ADDIN EN.CITE Ware19931243[11]1243124327Ware, J.E.Snow, K.K.Kolinski, M.et al. SF-36 Health Survey Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Centre, B oston.1993[ HYPERLINK \l "_ENREF_11" \o "Ware, 1993 #1243" 11],
and the Hospital Anxiety and Depression (HADS) scale ADDIN EN.CITE Zigmond19831293[12]1293129317Zigmond, A. S.Snaith, R. P.The Hospital Anxiety and Depression ScaleActa Psychiatrica ScandinavicaActa Psychiatrica Scandinavica361-370676Psychiatric status rating scalesanxiety disordersdepressive disorders1983Blackwell Publishing Ltd1600-0447http://dx.doi.org/10.1111/j.1600-0447.1983.tb09716.x10.1111/j.1600-0447.1983.tb09716.x[ HYPERLINK \l "_ENREF_12" \o "Zigmond, 1983 #1293" 12] as a measure of mental health and well-being.
The HIT-6 is a validated headache-specific measure, whilst the CHQLQ was adapted from the Migraine Specific Quality of Life Questionnaire V2.1 ADDIN EN.CITE Jhingran19981242[13]1242124217Jhingran, PritiOsterhaus, Jane T.Miller, David W.Lee, Jeffrey T.Kirchdoerfer, LeonardDevelopment and Validation of the Migraine-Specific Quality of Life QuestionnaireHeadache: The Journal of Head and Face PainHeadache: The Journal of Head and Face Pain295-302384migrainequality of lifehealth-related quality of lifeMigraine-Specific Quality of Life QuestionnaireMSQpsychometric analysis1998American Association for the Study of Headache/Blackwell Science Ltd1526-4610http://dx.doi.org/10.1046/j.1526-4610.1998.3804295.x10.1046/j.1526-4610.1998.3804295.x[ HYPERLINK \l "_ENREF_13" \o "Jhingran, 1998 #1242" 13]. The CHQLQ suitability as an outcome measure in studies that recruit people living with chronic headache was evaluated in the CHESS feasibility study. Preliminary analysis of the feasibility data (unpublished) suggests the CHQLQ had good measurement properties in this population and is well received by headache patients. The EQ-5D-5L and the SF-12 are the most widely used health-related quality of life questionnaires in clinical research. They are preference-based measures which means that they can be converted to health-utilities using established methods ADDIN EN.CITE Brazier20021099[4, 14]1099109913Brazier, J.Roberts, J.Deverill, M.The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002;21(2):27192. 14262445502002Kind199885485485417Kind, PDolan, PGudex, CWilliams, AVariations in population health status: results from a United Kingdom national questionnaire surveyBritish Medical JournalBritish Medical JournalBrit Med J736 - 74131671331998doi:10.1136/bmj.316.7133.736[ HYPERLINK \l "_ENREF_4" \o "Brazier, 2002 #1099" 4, HYPERLINK \l "_ENREF_14" \o "Kind, 1998 #854" 14]. The EQ-5D is also the recommended questionnaire for generating health utilities to inform appraisal of health technologies by NICE ADDIN EN.CITE National Istitute for Health and Care Excellence2013817[5]81781727National Istitute for Health and Care Excellence,Guide to the methods of technology appraisal 2013. Avaialable from http://publications.nice.org.uk/pmg92013[ HYPERLINK \l "_ENREF_5" \o "National Istitute for Health and Care Excellence, 2013 #817" 5].
To characterise the different types of chronic headaches, we will collect data on socio-demographic and clinical characteristics of patients. Finally, we will use Hospital Anxiety and Depression Scale (HADS) ADDIN EN.CITE ADDIN EN.CITE.DATA [ HYPERLINK \l "_ENREF_12" \o "Zigmond, 1983 #1293" 12, HYPERLINK \l "_ENREF_15" \o "Snaith, 2003 #1260" 15] to collect data on mental health. Psychological distress is extremely common in people living with chronic pain. HADs has been used in many previous studies of chronic pain; including the COPERS study ADDIN EN.CITE Carnes20131261[16]1261126117Carnes, DawnTaylor, Stephanie JCHomer, KateEldridge, SandraBremner, StephenPincus, TamarRahman, AnisurUnderwood, MartinEffectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS)BMJ OpenBMJ Open31201310.1136/bmjopen-2012-002492[ HYPERLINK \l "_ENREF_16" \o "Carnes, 2013 #1261" 16] where the intervention achieved positive effects on both anxiety and depression. We will combine all the study questions and outcome measures into one study questionnaire booklet. An optional section is included at end of the questionnaire for contact details of those happy to be contacted again at a future date to see how they are getting on and inform them of future headache research.
We anticipate completion of the questionnaire booklet will take between 15-20 minutes. Overall the study booklet will include the following outcome measures:
Demographic and clinical characteristics of study participants
Headache-specific measures: HIT-6 and CHQLQ
Generic quality of life measures: EQ-5D-5L and SF-12.
Mental health: HADS.
Eligibility criteria
Inclusion criteria:
Aged 18 or over attending an outpatient headache clinic for treatment and or management of headache symptoms. Patients have to have headache symptoms for 15 of more days of the month for at least three consecutive months to be classified as chronic headache.
Able and willing to comply with the study procedures and give informed consent.
Able to understand English and complete the questionnaire booklet.
Exclusion criteria
Unable to understand or complete questionnaire booklet in English.
Have an underlying serious mental illness that may impair their ability to understand and complete the study questionnaire.
Recruitment and consent of participants
We will aim to recruit between 400 and 500 patients (see section 4) from NHS headache clinics to for a separate mapping sub-study. Data from this study will be used to develop the mapping algorithms. Adults aged 18 years and over and attending outpatient headache clinics during the study period will be screened for eligibility and appropriateness to approach by the research nurse or the treating physician. To enable us to describe the population from which the study sample was recruited from, a log of all those screened and their age and gender will be kept in a study folder. Whilst waiting to be seen by their doctor, those meeting the eligibility criteria will be informed about the study and given the study information sheet and a consent form. To ensure that informed consent is obtained, patients will be given time to read the information sheet and ask questions before deciding whether to take part in the study. Those consenting after reading the patient information sheet and returning the signed consent form will be given a study questionnaire booklet. Each questionnaire booklet will be assigned a unique study identification number comprising of an alphabet unique to the participating clinic followed by a three digit number. Potential participants will be asked to complete and return the questionnaire booklet before leaving the clinic. For those who are unable to complete the questionnaire in clinic, prepaid envelopes addressed to the study team will be provided so that participants can complete the questionnaire at home and return it to the study team at the University of Warwick using the prepaid envelopes provided. Completed questionnaire booklets handed over at the clinic will be returned to the study coordinating team at the Clinical Trials Unit, University of Warwick by freepost envelopes provided. Contact details of the study team will be included in the study information sheet and at the back of the questionnaire booklet.
Ethical considerations
The study will be run according to the principles of the Declaration of Helsinki and to Medical Research Council Good Clinical Practice guidelines. It will also comply with all applicable UK legislation and Warwick CTUs Standard Operating Procedures. All data will be stored securely and held in accordance with Data Protection Act 2018. We will ensure that all identifiable data are anonymised and treated as confidential. Participants will be informed verbally and in the participant information leaflet that they are free to withdraw at any time during the study. We will only recruit patients who are fluent in spoken and written English as we will only use questionnaires that have been validated for an English speaking population. Recruiting people fluent in English would also ensure that patients understand the questions being asked of them and hopefully provide valid responses. Psychological distress is common in people living with chronic pain. It is possible that some study participants may find some questions distressing and become upset whilst completing the questionnaire. Participants will be offered the opportunity to discuss with the research nurse or a member of the clinical team responsible for their care in the headache clinic, issues they find upsetting during completion of the study questions. Contact details of the study team will also be provided in the information sheets and at back of the questionnaire booklets should participants have any queries regarding the study or completion of the study questionnaire booklet. Should there be the need to disclose confidential information given by a participant which indicates an issue which may jeopardise the safety of the participant or another person, the Chief Investigator will be notified in the first instance and CTU standard operating procedures will be followed.
Adverse event management
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant and which does not necessarily have a causal relationship with this treatment/intervention. If any of the study participants becomes upset or emotionally distressed during completion of the study questionnaire, they will be offered support from the research nurse or a member of the clinical team responsible for their care in the headache clinic. Details of adverse event that occur whilst the patient is still in the clinic will be recorded on the adverse event form by the research nurse or a member of the team and forwarded to the study team at the University of Warwick together with the completed study questionnaire. Any adverse event reported to the study team via the contact details provided at the end of the study questionnaire will be recorded on an adverse event form. All adverse events records will be entered into the study database for storage in accordance with the University of Warwick SOPs.
End of study
The study will end if the required number of participants have been recruited.
The study will be stopped prematurely if:
Mandated by the Ethics Committee.
Funding for the CHESS programme of work ceases.
The Research Ethics Committee will be notified in writing if the study has been concluded or terminated early.
Data management
Personal data collected during the study will be handled and stored in accordance with the 2018 Data Protection Act. Completed consent forms, contact details and personal details of participants will be stored in a locked cabinet (separate from completed study questionnaire) in WCTU, University of Warwick. Participants will only be identified using a unique identification number assigned to them when they were initially approached for inclusion in the study. This identification will comprise of a code to identify the clinic followed by a three digit number. This information will be stored separately to the study questionnaire booklet. Participants unique identification number, name and telephone number will be stored on a secure database. All data returned to Warwick Clinical Trials Unit (CTU) will be dealt with in accordance with CTU standard operating procedures and only accessed by authorised personnel.
Data collection and management
All data will be collected using one booklet containing the study questionnaires. The questionnaire booklets will be returned to the study team on completion. A member of the team will check the data and input into an encrypted spreadsheet (Microsoft Excel) database created specifically for the study. If there are missing data, this will be followed up with the participant who completed the form, as soon as possible. We will phone the participant and enter the missing information onto the form, this will be initialled and dated. A second phone call will be made if no response to the first phone call. If there is still no response, a message will be left on the answer phone advising the patient to contact the study team should they wish to do so. If they do not reply, no further attempts to contact will be made. After all the data has been entered onto the database, the original of the study questionnaire booklet will be securely stored in archiving facilities approved and overseen by the unit quality assurance manager.
Data storage
All essential documentation and study records will be stored by WCTU in conformance with the applicable regulatory requirements and access to stored information will be restricted to authorised personnel.
Data access and quality assurance
Data will be stored on University secure servers. Any data transfer would be in accordance with Warwick CTU standard operating procedures and require data sharing agreements to be in place. Study related documents will be made available for internal monitoring and audit activities. Access to the datasets will be restricted to authorised personnel only.
Archiving
Study documentation and data will be archived for at least ten years after completion of the study.
Statistical analysis
The methodology around sample size calculations for mapping studies of the kind we are proposing are still being developed and there currently no clear guidelines. Thus our sample size estimates are based around sample sizes reported in published mapping studies that are similar in design to our proposed study ADDIN EN.CITE ADDIN EN.CITE.DATA [ HYPERLINK \l "_ENREF_17" \o "Dakin, 2011 #682" 17]. Descriptive statistics of the demographic and clinical characteristics of participants will be reported. We will follow a plan broadly similar to that described in Khan et al. ADDIN EN.CITE Khan20141110[18]1110111017Khan, Kamran A.Madan, JasonPetrou, StavrosLamb, Sarah E.Mapping between the Roland Morris Questionnaire and Generic Preference-Based MeasuresValue in HealthValue in Health686-6951762014Elsevier1098-3015http://dx.doi.org/10.1016/j.jval.2014.07.00110.1016/j.jval.2014.07.0012016/01/25[ HYPERLINK \l "_ENREF_18" \o "Khan, 2014 #1110" 18] and make use of direct and response mapping approaches to estimate utility scores based on the headache specific measures. In the direct mapping approach, regression equations will be used to predict summary utility weights for the EQ-5D-5L and the SF-6D (generated via responses to the SF-12 version 2) based on individual responses to the headache-specific measures (i.e. HIT-6 and the CHQLQ v1.0). The response mapping approach makes use of regression based methods to predict dimensions of the EQ-5D-5L and the SF-6D rather than summary utility scores. Several models will be specified and the best fitting model to the data chosen for each approach on the bases of model fit statistics. The results will be validated using an external validation sample derived from the CHESS main trial population. We will also develop algorithms parameterised as structural equations models ADDIN EN.CITE ADDIN EN.CITE.DATA [ HYPERLINK \l "_ENREF_19" \o "Ades, 2013 #1230" 19, HYPERLINK \l "_ENREF_20" \o "Lu, 2013 #1229" 20] and use these to estimate mapping coefficients between the headache-specific and generic quality of life measures. This approach has the advantage that it can produce mapping coefficients that are invertible, transitive, and invariance to linear transformation, conditions necessary for a mapping to be logically coherent according to Lu, Brazier et al. ADDIN EN.CITE Lu20131229[20]1229122917Lu, GuobingBrazier, J. E.Ades, A. E.Mapping from Disease-Specific to Generic Health-Related Quality-of-Life Scales: A Common Factor ModelValue in HealthValue in Health177-1841612013Elsevier1098-3015http://dx.doi.org/10.1016/j.jval.2012.07.00310.1016/j.jval.2012.07.0032017/01/10[ HYPERLINK \l "_ENREF_20" \o "Lu, 2013 #1229" 20]. All analyses will be performed using the R statistical software ADDIN EN.CITE R Core Team20171121[21]112111219R Core Team,R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL http://www.R-project.org/.2017[ HYPERLINK \l "_ENREF_21" \o "R Core Team, 2017 #1121" 21].
Study timetable and milestones
Year 1 2018Year 2
2019Year 3
2020Phase 1: Study set upProtocol development Ethics approval for phase 1Set-up and governance approvalPublication of study protocolPhase 2: Recruitment of participants Identify and recruit headache clinicsSend out study folder with study documentation Recruitment of study participantsPhase 3: Analyses and write-up Data entry and cleaningAnalysesWrite up of analyses methods and resultsPublication and dissemination of study results in peer-reviewed journals and conference meetings
References
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IRAS ID: 233448
Protocol
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IRAS ID: 233448
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