Challenges in quantifying the patient-reported burden of herpes zoster and post-herpetic neuralgia in the UK: learnings from the Zoster Quality of Life (ZQOL) study

BMC Research Notes

Azharul Mannan²  Dirk Demuth¹  Fiona Smith¹  Linda Abetz-Webb³  Adam Gater³  Stuart Carroll² 

[1] Adelphi Real World, Cheshire, UK;Sanofi-Pasteur MSD, Berkshire, UK;Adelphi Values, Cheshire, UK

关键词: Burden;    Real-world;    Post-herpetic neuralgia;    Herpes zoster;   

Others  :  1140684
DOI  :  10.1186/1756-0500-6-486

 received in 2013-05-07, accepted in 2013-11-18,  发布年份 2013

【 摘 要 】

Background

Acute presentation of herpes zoster (HZ) and the subsequent development of post-herpetic neuralgia (PHN) can have a significant impact on patients’ lives. To date, evidence regarding the human and economic burden of HZ and PHN in the UK is limited. To address this knowledge gap a national, multicentre, large-scale real-world study was conducted to inform the scientific community and healthcare decision-makers. This paper outlines difficulties encountered and challenges to conducting real-world studies in the UK, methods used to overcome these hurdles and strategies that can be employed to promote and facilitate the conduct of future studies.

Findings

The Zoster Quality of Life (ZQOL) study is the first UK-wide and largest observational study investigating patient burden associated with HZ and PHN. A total of 383 patients (229 HZ; 154 PHN) over the age of 50 years were recruited from 42 primary and secondary/tertiary care centres. Patient-reported outcome (PRO) assessments of pain, quality of life and treatment satisfaction were completed by all participants and supplemented by clinical information from participating physicians.

Key challenges encountered during the conduct of this study can be broadly categorised as follows: 1) identification of centres willing/able to participate in the study: lack of resources and limited research experience were major barriers to recruitment of centres for participation in the study; 2) obtaining local research & development (R&D) approval: lack of clearly defined processes and requirements specific to real-world studies and limited degree of standardisation between R&D departments in approval procedures led to significant variability in submission requirements and lead times for obtaining approval; 3) recruitment of study participants: rates of recruitment were slower than anticipated, meaning it was necessary to extend the study recruitment period and increase the number of participating centres.

Discussion

Initiatives designed to promote and facilitate the conduct of research in the UK are important for real-world studies. The ZQOL study shows that opportunities exist for real-word research. However, streamlining the R&D approval process where possible and further incentivising the participation of primary care centres in such studies would help to further facilitate the generation of real-world evidence to inform healthcare decisions.

【 授权许可】

   
2013 Carroll et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Cohen J, Powderly WG, Berkley SF, Calandra T, Clumeck N, Finch RG: Infectious diseases. 2nd ed. London: Mosby; 2003.
• [2]Brisson M, Edmunds WJ, Law B, Gay NJ, Walld R, Brownell M, Roos L, De SG: Epidemiology of varicella zoster virus infection in Canada and the United Kingdom. Epidemiol Infect 2001, 127(2):305-314.
• [3]Edmunds WJ, Brisson M, Rose JD: The epidemiology of herpes zoster and potential cost-effectiveness of vaccination in England and Wales. Vaccine 2001, 19(23–24):3076-3090.
• [4]Schmader K, Gnann JW, Watson CP: The epidemiological, clinical, and pathological rationale for the herpes zoster vaccine. J Infect Dis 2008, 197(Supplement 2):S207-S215.
• [5]Dworkin RH, Schmader KE: The epidemiology and natural history of herpes zoster and postherpetic neuralgia. Amsterdam: Elsevier; 2001:39-64. [Herpes zoster and postherpetic neuralgia. 2nd ed]
• [6]Drolet M, Brisson M, Schmader KE, Levin MJ, Johnson R, Oxman MN, Patrick D, Blanchette C, Mansi JA: The impact of herpes zoster and postherpetic neuralgia on health-related quality of life: a prospective study. Can Med Assoc J 2010, 182(16):1731-1736.
• [7]Schmader KE, Sloane R, Pieper C, Coplan PM, Nikas A, Saddier P, Chan IS, Choo P, Levin MJ, Johnson G, Williams HM, Oxman MN: The impact of acute herpes zoster pain and discomfort on functional status and quality of life in older adults. Clin J Pain 2007, 23(6):490-496.
• [8]van Seventer R, Sadosky A, Lucero M, Dukes E: A cross-sectional survey of health state impairment and treatment patterns in patients with postherpetic neuralgia. Age Ageing 2006, 35(2):132-137.
• [9]Scott FT, Johnson RW, Leedham-Green M, Davies E, Edmunds WJ, Breuer J: The burden of Herpes Zoster: a prospective population based study. Vaccine 2006, 24(9):1308-1314.
• [10]Oster G, Harding G, Dukes E, Edelsberg J, Cleary PD: Pain, medication Use, and health-related quality of life in older persons with postherpetic neuralgia: results from a population-based survey. J Pain 6(6):356-363. 6-1-2005. http://linkinghub.elsevier.com/retrieve/pii/S1526590005004153?showall=true webcite
• [11]Katz J, Cooper EM, Walther RR, Sweeney EW, Dworkin RH: Acute pain in herpes zoster and its impact on health-related quality of life. Clin Infect Dis 2004, 39(3):342-348.
• [12]Johnson RW, Bouhassira D, Kassianos G, Leplege A, Schmader KE, Weinke T: The impact of herpes zoster and post-herpetic neuralgia on quality-of-life. BMC Med 2010, 8:37. BioMed Central Full Text
• [13]Chidiac C, Bruxelle J, Daures JP, Hoang-Xuan T, Morel P, Leplege A, El Hasnaoui A, De Labareyre C: Characteristics of patients with herpes zoster on presentation to practitioners in France. Pain Pract 2001, 1(4):381.
• [14]Gauthier A, Breuer J, Carrington D, Martin M, Remy V: Epidemiology and cost of herpes zoster and post-herpetic neuralgia in the United Kingdom. Epidemiol Infect 2009, 137(1):38-47.
• [15]Rothberg MB, Virapongse A, Smith KJ: Cost-effectiveness of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. Clin Infect Dis 2007, 44(10):1280-1288.
• [16]Dworkin RH, White R, O’Connor AB, Baser O, Hawkins K: Healthcare costs of acute and chronic pain associated with a diagnosis of herpes zoster. J Am Geriatr Soc 2007, 55(8):1168-1175.
• [17]Yawn BP, Itzler RF, Wollan PC, Pellissier JM, Sy LS, Saddier P: Health care utilization and cost burden of herpes zoster in a community population. Mayo Clin Proc 2009, 84(9):787-794.
• [18]Insinga RP, Itzler RF, Pellissier JM: Acute/subacute herpes zoster: healthcare resource utilisation and costs in a group of US health plans. Pharmacoeconomics 2007, 25(2):155-169.
• [19]Brisson M, Pellissier JM, Camden S, Quach C, De WP: The potential cost-effectiveness of vaccination against herpes zoster and post-herpetic neuralgia. Hum Vaccin 2008, 4(3):238-245.
• [20]Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, Arbeit RD, Simberkoff MS, Gershon AA, Davis LE, Weinberg A, Boardman KD, Williams HM, Zhang JH, Peduzzi PN, Beisel CE, Morrison VA, Guatelli JC, Brooks PA, Kauffman CA, Pachucki CT, Neuzil KM, Betts RF, Wright PF, Griffin MR, Brunell P, Soto NE, Marques AR, Keay SK, Goodman RP, Cotton DJ, Gnann JW Jr, Loutit J, Holodniy M, Keitel WA, Crawford GE, Yeh SS, Lobo Z, Toney JF, Greenberg RN, Keller PM, Harbecke R, Hayward AR, Irwin MR, Kyriakides TC, Chan CY, Chan IS, Wang WW, Annunziato PW, Silber JL: A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 2005, 352(22):2271-2284.
• [21]Department of Health: Equity and excellence: liberating the NHS (White Paper). London: TSO; 2010.
• [22]Moore L, Remy V, Martin M, Beillat M, McGuire A: A health economic model for evaluating a vaccine for the prevention of herpes zoster and post-herpetic neuralgia in the UK. Cost Eff Resour Alloc 2010, 8:7. BioMed Central Full Text
• [23]Joint Committee on Vaccination and Immunisation: Minutes of the meeting held on 14 october 2009. London; 2009.
• [24]Joint Committee on Vaccination and Immunisation Varicellar Subgroup: Minutes of the varicella JCVI subgroup meeting on Monday 9th March. London; 2009.
• [25]Lancaster T, Silagy C, Gray S: Primary care management of acute herpes zoster: systematic review of evidence from randomized controlled trials. Br J Gen Pract 1995, 45(390):39-45.
• [26]Mounsey AL, Matthew LG, Slawson DC: Herpes zoster and postherpetic neuralgia: prevention and management. Am Fam Physician 2005, 72(6):1075-1080.
• [27]Opstelten W, Eekhof J, Neven AK, Verheij T: Treatment of herpes zoster. Can Fam Physician 2008, 54(3):373-377.
• [28]Coplan PM, Schmader K, Nikas A, Chan IS, Choo P, Levin MJ, Johnson G, Bauer M, Williams HM, Kaplan KM, Guess HA, Oxman MN: Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. J Pain 2004, 5(6):344-356.
• [29]Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36) I. Conceptual framework and item selection. Med Care 1992, 30(6):473-483.
• [30]Rabin R, De CF: EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001, 33(5):337-343.
• [31]Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR: Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes 2004, 2(12):12.
• [32]Lydick E, Epstein RS, Himmelberger D, White CJ: Herpes zoster and quality of life: a self-limited disease with severe impact. Neurology 1995, 45(12 Suppl 8):S52-S53.
• [33]Volpi A, Gatti A, Serafini G, Costa B, Suligoi B, Pica F, Marsella LT, Sabato E, Sabato AF: Clinical and psychosocial correlates of acute pain in herpes zoster. J Clin Virol 2007, 38(4):275-279.
• [34]SF-36 v2 US population norms. 1998. http://www.sf-36.org/research/sf98norms.pdf webcite
• [35]Kind P, Hardman G, Macran S: UK population norms for EQ-5D. Centre for Health Economics, University of York; 1999. http://econpapers.repec.org/paper/chyrespap/172chedp.htm webcite
• [36]Bower P, Wilson S, Mathers N: Short report: how often do UK primary care trials face recruitment delays? Fam Pract 2007, 24(6):601-603.
• [37]Murphy E, Spiegal N, Kinmonth AL: ‘Will you help me with my research?’ gaining access to primary care settings and subjects. Br J Gen Pract 1992, 42(357):162-165.
• [38]Hummers-Pradier E, Scheidt-Nave C, Martin H, Heinemann S, Kochen MM, Himmel W: Simply no time? Barriers to GPs’ participation in primary health care research. Fam Pract 2008, 25(2):105-112.
• [39]Department of Health: Governance arrangements for research ethics committees, a harmonized edition. London; 2011.
• [40]Ward HJ, Cousens SN, Smith-Bathgate B, Leitch M, Everington D, Will RG, Smith PG: Obstacles to conducting epidemiological research in the UK general population. BMJ 2004, 329(7460):277-279.
• [41]Jones AM, Bamford B: The other face of research governance. BMJ 2004, 329(7460):280-281.
• [42]Wald DS: Bureaucracy of ethics applications. BMJ 2004, 329(7460):282-284.
• [43]Al-Shahi R: Research ethics committees in the UK–the pressure is now on research and development departments. J R Soc Med 2005, 98(10):444-447.
• [44]Alberti KG: Multicentre research ethics committees: has the cure been worse than the disease? No, but idiosyncracies and obstructions to good research must be removed. BMJ 2000, 320(7243):1157-1158.
• [45]Jamrozik K: Research ethics paperwork: what is the plot we seem to have lost? BMJ 2004, 329(7460):286-287.
• [46]Cohen J: Statistical power analysis for the behaviora sciences. 2nd edition. Hillsdale, NJ: Erlbaum; 1988.
• [47]McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, Snowdon C: What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 2006, 7:9. BioMed Central Full Text
• [48]Rees M, Wells F: Falling research in the NHS. BMJ 2010, 340:c2375.
• [49]ABPI: The vision for real world data - harnessing the opportunities in the UK. London: White Paper; 2011.
• [50]Department of Health: A new value-based approach to the pricing of branded medicines - a consultation. (Available at http://webarchive.nationalarchives.gov.uk/ webcite+/www.dh.gov.uk/en/consultations/liveconsultations/dh_122760 webcite). 2010