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Published in: Health and Quality of Life Outcomes 1/2019

Open Access 01-12-2019 | Tuberculosis | Research

The impact of adverse events on health-related quality of life among patients receiving treatment for drug-resistant tuberculosis in Johannesburg, South Africa

Authors: Tembeka Sineke, Denise Evans, Kathryn Schnippel, Heleen van Aswegen, Rebecca Berhanu, Nozipho Musakwa, Elisabet Lönnmark, Lawrence Long, Sydney Rosen

Published in: Health and Quality of Life Outcomes | Issue 1/2019

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Abstract

Background

Adverse events (AEs) are common during treatment of drug-resistant tuberculosis (DR-TB). Little is known about the health-related quality of life (HRQoL) of patients receiving treatment for DR-TB or the effect of AEs on HRQoL.

Methods

We conducted a cross-sectional study among adult patients with laboratory-confirmed rifampicin resistant tuberculosis (TB) on DR-TB treatment at a public-sector outpatient DR-TB clinic in Johannesburg, South Africa between 02/2015–01/2018. Data on HRQoL using the Medical Outcomes Short Form-36 (SF-36) questionnaire and self-reported AEs were collected by trained interviewers through face-to-face interviews. We report averages for the eight major domains and mental (MCS) and physical health (PCS) component summary scores, stratified by whether AEs were reported in the last four weeks. For comparative purposes, we enrolled two other patient groups and included data on a separate group of healthy adults.

Results

We enrolled 149 DR-TB patients (median age 36 years IQR 29–43, 55% male, 77.9% HIV-positive, 81% on ART, 61.8% on a standard long-course regimen and 44.3% on DR-TB treatment for less than 6 months). 58/149 (38.9%) patients reported a total of 122 AEs in the preceding 4 weeks, of these the most common were joint pain (n = 22), peripheral neuropathy (n = 16), hearing loss (n = 15), nausea and vomiting (n = 12) and dizziness or vertigo (n = 11). SF-36 domains and summary scores (MCS and PCS) were lower in those who reported an AE compared to those who did not, and both were lower than healthy adults. Compared to those who did not report an AE, patients who reported AEs were more likely to have a low MCS (aRR 2.24 95% CI 1.53–3.27) and PCS (aRR 1.52 95% CI 1.07–2.18) summary score. HRQoL was lower among those on DR-TB treatment for 6 months or less.

Conclusion

Results show that DR-TB had a substantial impact on patients’ quality of life, but that AEs during the early months on treatment may be responsible for reducing HRQoL even further. Our findings highlight the negative effects of injectable agents on HRQoL. Patients require an integrative patient-centered approach to deal with DR-TB and HIV and the potential overlapping toxicities which may be worsened by concurrent treatment.
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Literature
1.
go back to reference World Health Organization. Global tuberculosis report 2018. Annex 2: country profiles. Geneva: World Health Organization; 2018. https://wwwwhoint/tb/publications/global_report/gtbr2018_annex2pdf?ua=1. Accessed 08 March 2019CrossRef World Health Organization. Global tuberculosis report 2018. Annex 2: country profiles. Geneva: World Health Organization; 2018. https://​wwwwhoint/​tb/​publications/​global_​report/​gtbr2018_​annex2pdf?​ua=​1.​ Accessed 08 March 2019CrossRef
2.
go back to reference Dela AI, Tank ND, Singh AP, Piparva KG. Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis Centre: a four year retrospective study. Lung India. 2017;34(6):522.CrossRef Dela AI, Tank ND, Singh AP, Piparva KG. Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis Centre: a four year retrospective study. Lung India. 2017;34(6):522.CrossRef
3.
go back to reference Schnippel K, Berhanu RH, Black A, Firnhaber C, Maitisa N, Evans D, Sinanovic E. Severe adverse events during second-line tuberculosis treatment in the context of high HIV co-infection in South Africa: a retrospective cohort study. BMC Infect Dis. 2016;16:593.CrossRef Schnippel K, Berhanu RH, Black A, Firnhaber C, Maitisa N, Evans D, Sinanovic E. Severe adverse events during second-line tuberculosis treatment in the context of high HIV co-infection in South Africa: a retrospective cohort study. BMC Infect Dis. 2016;16:593.CrossRef
4.
go back to reference Brust JC, Shah NS, van der Merwe TL, Bamber S, Ning Y, Heo M, Moll AP, Loveday M, Lalloo UG, Friedland GH, et al. Adverse events in an integrated home-based treatment program for MDR-TB and HIV in KwaZulu-Natal, South Africa. J Acquir Immune Defic Syndr. 2013;62(4):436–40.CrossRef Brust JC, Shah NS, van der Merwe TL, Bamber S, Ning Y, Heo M, Moll AP, Loveday M, Lalloo UG, Friedland GH, et al. Adverse events in an integrated home-based treatment program for MDR-TB and HIV in KwaZulu-Natal, South Africa. J Acquir Immune Defic Syndr. 2013;62(4):436–40.CrossRef
5.
go back to reference Sagwa E, Ruswa N, Musasa JP, Mantel-Teeuwisse AK. Adverse events during treatment of drug-resistant tuberculosis: a comparison between patients with or without human immunodeficiency virus co-infection. Drug Saf. 2013;36(11):1087–96.CrossRef Sagwa E, Ruswa N, Musasa JP, Mantel-Teeuwisse AK. Adverse events during treatment of drug-resistant tuberculosis: a comparison between patients with or without human immunodeficiency virus co-infection. Drug Saf. 2013;36(11):1087–96.CrossRef
6.
go back to reference Schnippel K, Firnhaber C, Berhanu R, Page-Shipp L, Sinanovic E. Adverse drug reactions during drug-resistant TB treatment in high HIV prevalence settings: a systematic review and meta-analysis. J Antimicrob Chemother. 2017;72(7):1871–9.CrossRef Schnippel K, Firnhaber C, Berhanu R, Page-Shipp L, Sinanovic E. Adverse drug reactions during drug-resistant TB treatment in high HIV prevalence settings: a systematic review and meta-analysis. J Antimicrob Chemother. 2017;72(7):1871–9.CrossRef
7.
go back to reference Bloss E, Kuksa L, Holtz TH, Riekstina V, Skripconoka V, Kammerer S, Leimane V. Adverse events related to multidrug-resistant tuberculosis treatment, Latvia, 2000-2004. Int J Tuberc Lung Dis. 2010;14(3):275–81.PubMed Bloss E, Kuksa L, Holtz TH, Riekstina V, Skripconoka V, Kammerer S, Leimane V. Adverse events related to multidrug-resistant tuberculosis treatment, Latvia, 2000-2004. Int J Tuberc Lung Dis. 2010;14(3):275–81.PubMed
8.
go back to reference Nathanson E, Gupta R, Huamani P, Leimane V, Pasechnikov AD, Tupasi TE, Vink K, Jaramillo E, Espinal MA. Adverse events in the treatment of multidrug-resistant tuberculosis: results from the DOTS-plus initiative. The international journal of tuberculosis and lung disease : the official journal of the international union against. Tuberc Lung Dis. 2004;8(11):1382–4. Nathanson E, Gupta R, Huamani P, Leimane V, Pasechnikov AD, Tupasi TE, Vink K, Jaramillo E, Espinal MA. Adverse events in the treatment of multidrug-resistant tuberculosis: results from the DOTS-plus initiative. The international journal of tuberculosis and lung disease : the official journal of the international union against. Tuberc Lung Dis. 2004;8(11):1382–4.
9.
go back to reference Sagwa E, Mantel-Teeuwisse AK, Ruswa N, Musasa JP, Pal S, Dhliwayo P, van Wyk B. The burden of adverse events during treatment of drug-resistant tuberculosis in Namibia. Southern Med Review. 2012;5(1):6–13.PubMedPubMedCentral Sagwa E, Mantel-Teeuwisse AK, Ruswa N, Musasa JP, Pal S, Dhliwayo P, van Wyk B. The burden of adverse events during treatment of drug-resistant tuberculosis in Namibia. Southern Med Review. 2012;5(1):6–13.PubMedPubMedCentral
10.
go back to reference Brown J, Capocci S, Smith C, Morris S, Abubakar I, Lipman M. Health status and quality of life in tuberculosis. Int J Infect Dis. 2015;32:68–75.CrossRef Brown J, Capocci S, Smith C, Morris S, Abubakar I, Lipman M. Health status and quality of life in tuberculosis. Int J Infect Dis. 2015;32:68–75.CrossRef
11.
go back to reference Guo N, Marra CA, Marra F, Moadebi S, Elwood RK, Fitzgerald JM. Health state utilities in latent and active tuberculosis. Value Health. 2008;11(7):1154–61.CrossRef Guo N, Marra CA, Marra F, Moadebi S, Elwood RK, Fitzgerald JM. Health state utilities in latent and active tuberculosis. Value Health. 2008;11(7):1154–61.CrossRef
12.
go back to reference Guo N, Marra F, Marra CA. Measuring health-related quality of life in tuberculosis: a systematic review. Health Qual Life Outcomes. 2009;7:14.CrossRef Guo N, Marra F, Marra CA. Measuring health-related quality of life in tuberculosis: a systematic review. Health Qual Life Outcomes. 2009;7:14.CrossRef
13.
go back to reference Louw J, Peltzer K, Naidoo P, Matseke G, McHunu G, Tutshana B. Quality of life among tuberculosis (TB), TB retreatment and/or TB-HIV co-infected primary public health care patients in three districts in South Africa. Health Qual Life Outcomes. 2012;10:77.CrossRef Louw J, Peltzer K, Naidoo P, Matseke G, McHunu G, Tutshana B. Quality of life among tuberculosis (TB), TB retreatment and/or TB-HIV co-infected primary public health care patients in three districts in South Africa. Health Qual Life Outcomes. 2012;10:77.CrossRef
14.
go back to reference Muniyandi M, Rajeswari R, Balasubramanian R, Nirupa C, Gopi PG, Jaggarajamma K, Sheela F, Narayanan PR. Evaluation of post-treatment health-related quality of life (HRQoL) among tuberculosis patients. Int J Tuberc Lung Dis. 2007;11(8):887–92.PubMed Muniyandi M, Rajeswari R, Balasubramanian R, Nirupa C, Gopi PG, Jaggarajamma K, Sheela F, Narayanan PR. Evaluation of post-treatment health-related quality of life (HRQoL) among tuberculosis patients. Int J Tuberc Lung Dis. 2007;11(8):887–92.PubMed
15.
go back to reference Sharma R, Yadav R, Sharma M, Saini V, Koushal V. Quality of life of multi drug resistant tuberculosis patients: a study of North India. Acta Medica Iranica. 2014;52(6):448–53.PubMed Sharma R, Yadav R, Sharma M, Saini V, Koushal V. Quality of life of multi drug resistant tuberculosis patients: a study of North India. Acta Medica Iranica. 2014;52(6):448–53.PubMed
16.
go back to reference Uchmanowicz B, Chudiak A, Mazur G. The influence of quality of life on the level of adherence to therapeutic recommendations among elderly hypertensive patients. Patient Preference Adherence. 2018;12:2593.CrossRef Uchmanowicz B, Chudiak A, Mazur G. The influence of quality of life on the level of adherence to therapeutic recommendations among elderly hypertensive patients. Patient Preference Adherence. 2018;12:2593.CrossRef
17.
go back to reference Grover GS, Takkar J. Recent advances in multi-drug-resistant tuberculosis and RNTCP. Indian J Community Med. 2008;33(4):219.CrossRef Grover GS, Takkar J. Recent advances in multi-drug-resistant tuberculosis and RNTCP. Indian J Community Med. 2008;33(4):219.CrossRef
18.
go back to reference Kastien-Hilka T, Rosenkranz B, Sinanovic E, Bennett B, Schwenkglenks M. Health-related quality of life in South African patients with pulmonary tuberculosis. PLoS One. 2017;12(4):e0174605.CrossRef Kastien-Hilka T, Rosenkranz B, Sinanovic E, Bennett B, Schwenkglenks M. Health-related quality of life in South African patients with pulmonary tuberculosis. PLoS One. 2017;12(4):e0174605.CrossRef
21.
go back to reference Berhanu R, Schnippel K, Mohr E, Hirasen K, Evans D, Rosen S, Sanne I. Early outcomes of decentralized Care for Rifampicin-Resistant Tuberculosis in Johannesburg, South Africa: an observational cohort study. PLoS One. 2016;11(11):e0164974.CrossRef Berhanu R, Schnippel K, Mohr E, Hirasen K, Evans D, Rosen S, Sanne I. Early outcomes of decentralized Care for Rifampicin-Resistant Tuberculosis in Johannesburg, South Africa: an observational cohort study. PLoS One. 2016;11(11):e0164974.CrossRef
22.
go back to reference van Aswegen H, Myezwa H, Mudzi W, Becker P. Health-related quality of life of survivors of penetrating trunk trauma in Johannesburg, South Africa. Eur J Trauma Emerg. 2011;37(4):419–26.CrossRef van Aswegen H, Myezwa H, Mudzi W, Becker P. Health-related quality of life of survivors of penetrating trunk trauma in Johannesburg, South Africa. Eur J Trauma Emerg. 2011;37(4):419–26.CrossRef
25.
go back to reference Schnippel K, Ndjeka N, Maartens G, Meintjes G, Master I, Ismail N, Hughes J, Ferreira H, Padanilam X, Romero R. Effect of bedaquiline on mortality in south African patients with drug-resistant tuberculosis: a retrospective cohort study. Lancet Respir Med. 2018;6(9):699–706.CrossRef Schnippel K, Ndjeka N, Maartens G, Meintjes G, Master I, Ismail N, Hughes J, Ferreira H, Padanilam X, Romero R. Effect of bedaquiline on mortality in south African patients with drug-resistant tuberculosis: a retrospective cohort study. Lancet Respir Med. 2018;6(9):699–706.CrossRef
28.
go back to reference Hays RD, Shapiro MF. An overview of generic health-related quality of life measures for HIV research. Qual Life Res. 1992;1(2):91–7.CrossRef Hays RD, Shapiro MF. An overview of generic health-related quality of life measures for HIV research. Qual Life Res. 1992;1(2):91–7.CrossRef
29.
go back to reference Stewart AL. Measuring functioning and well-being: the medical outcomes study approach: Duke University Press; 1992. Stewart AL. Measuring functioning and well-being: the medical outcomes study approach: Duke University Press; 1992.
30.
go back to reference 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):473–83.CrossRef 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):473–83.CrossRef
31.
go back to reference de Vries ST, Mol PG, de Zeeuw D, Haaijer-Ruskamp FM, Denig P. Development and initial validation of a patient-reported adverse drug event questionnaire. Drug Saf. 2013;36(9):765–77.CrossRef de Vries ST, Mol PG, de Zeeuw D, Haaijer-Ruskamp FM, Denig P. Development and initial validation of a patient-reported adverse drug event questionnaire. Drug Saf. 2013;36(9):765–77.CrossRef
32.
go back to reference Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ (Clinical research ed). 1992;305(6846):160–4.CrossRef Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ (Clinical research ed). 1992;305(6846):160–4.CrossRef
33.
go back to reference Ruta DA, Abdalla MI, Garratt AM, Coutts A, Russell IT. SF 36 health survey questionnaire: I. reliability in two patient based studies. Qual Health Care ( QHC). 1994;3(4):180–5.CrossRef Ruta DA, Abdalla MI, Garratt AM, Coutts A, Russell IT. SF 36 health survey questionnaire: I. reliability in two patient based studies. Qual Health Care ( QHC). 1994;3(4):180–5.CrossRef
34.
go back to reference Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. Am J Speech Lang Hearing Assoc. 1983;25(7):37–42. Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. Am J Speech Lang Hearing Assoc. 1983;25(7):37–42.
35.
go back to reference Harris PA, RT RT, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) - a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Informatics. 2009;42(2):377–81.CrossRef Harris PA, RT RT, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) - a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Informatics. 2009;42(2):377–81.CrossRef
38.
go back to reference Hagiwara Y, Shiroiwa T, Shimozuma K, Kawahara T, Uemura Y, Watanabe T, Taira N, Fukuda T, Ohashi Y, Mukai H. Impact of adverse events on health utility and health-related quality of life in patients receiving first-line chemotherapy for metastatic breast cancer: results from the SELECT BC study. Pharmacoeconomics. 2018;36(2):215–23.CrossRef Hagiwara Y, Shiroiwa T, Shimozuma K, Kawahara T, Uemura Y, Watanabe T, Taira N, Fukuda T, Ohashi Y, Mukai H. Impact of adverse events on health utility and health-related quality of life in patients receiving first-line chemotherapy for metastatic breast cancer: results from the SELECT BC study. Pharmacoeconomics. 2018;36(2):215–23.CrossRef
39.
go back to reference Tachi T, Teramachi H, Tanaka K, Asano S, Osawa T, Kawashima A, Yasuda M, Mizui T, Nakada T, Noguchi Y, et al. The impact of outpatient chemotherapy-related adverse events on the quality of life of breast cancer patients. PLoS One. 2015;10(4):e0124169.CrossRef Tachi T, Teramachi H, Tanaka K, Asano S, Osawa T, Kawashima A, Yasuda M, Mizui T, Nakada T, Noguchi Y, et al. The impact of outpatient chemotherapy-related adverse events on the quality of life of breast cancer patients. PLoS One. 2015;10(4):e0124169.CrossRef
40.
go back to reference Petersen L, Rogers C. Aminoglycoside-induced hearing deficits – a review of cochlear ototoxicity. S Afr Fam Pract. 2015;57(2):77–82. Petersen L, Rogers C. Aminoglycoside-induced hearing deficits – a review of cochlear ototoxicity. S Afr Fam Pract. 2015;57(2):77–82.
41.
go back to reference Deribew A, Tesfaye M, Hailmichael Y, Negussu N, Daba S, Wogi A, Belachew T, Apers L, Colebunders R. Tuberculosis and HIV co-infection: its impact on quality of life. Health Qual Life Outcomes. 2009;7:105.CrossRef Deribew A, Tesfaye M, Hailmichael Y, Negussu N, Daba S, Wogi A, Belachew T, Apers L, Colebunders R. Tuberculosis and HIV co-infection: its impact on quality of life. Health Qual Life Outcomes. 2009;7:105.CrossRef
42.
go back to reference Basavaraj KH, Navya MA, Rashmi R. Quality of life in HIV/AIDS. Indian J Sexually Transmitted Dis AIDS. 2010;31(2):75–80.CrossRef Basavaraj KH, Navya MA, Rashmi R. Quality of life in HIV/AIDS. Indian J Sexually Transmitted Dis AIDS. 2010;31(2):75–80.CrossRef
43.
go back to reference Sagwa EL, Mantel-Teeuwisse AK, Ruswa NC. Occurrence and clinical management of moderate-to-severe adverse events during drug-resistant tuberculosis treatment: a retrospective cohort study. J Pharm Policy Pract. 2014;7(1):14.CrossRef Sagwa EL, Mantel-Teeuwisse AK, Ruswa NC. Occurrence and clinical management of moderate-to-severe adverse events during drug-resistant tuberculosis treatment: a retrospective cohort study. J Pharm Policy Pract. 2014;7(1):14.CrossRef
44.
go back to reference Dheda K, Cox H, Esmail A, Wasserman S, Chang KC, Lange C. Recent controversies about MDR and XDR-TB: global implementation of the WHO shorter MDR-TB regimen and bedaquiline for all with MDR-TB? Respirology. 2018;23(1):36–45.CrossRef Dheda K, Cox H, Esmail A, Wasserman S, Chang KC, Lange C. Recent controversies about MDR and XDR-TB: global implementation of the WHO shorter MDR-TB regimen and bedaquiline for all with MDR-TB? Respirology. 2018;23(1):36–45.CrossRef
45.
go back to reference Ambaw F, Mayston R, Hanlon C, Medhin G, Alem A. Untreated depression and tuberculosis treatment outcomes, quality of life and disability, Ethiopia. Bull World Health Organ. 2018;96(4):243.CrossRef Ambaw F, Mayston R, Hanlon C, Medhin G, Alem A. Untreated depression and tuberculosis treatment outcomes, quality of life and disability, Ethiopia. Bull World Health Organ. 2018;96(4):243.CrossRef
46.
go back to reference Lee E. Prevalence of depression among active TB and TB/HIV patients in Kisumu County. Independent Study Project(ISP) Collection. 2015:2152. Lee E. Prevalence of depression among active TB and TB/HIV patients in Kisumu County. Independent Study Project(ISP) Collection. 2015:2152.
47.
go back to reference Farivar SS, Cunningham WE, Hays RD. Correlated physical and mental health summary scores for the SF-36 and SF-12 health survey, V.I. Health Qual Life Outcomes. 2007;5:54.CrossRef Farivar SS, Cunningham WE, Hays RD. Correlated physical and mental health summary scores for the SF-36 and SF-12 health survey, V.I. Health Qual Life Outcomes. 2007;5:54.CrossRef
48.
go back to reference Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002;32(6):959–76.CrossRef Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002;32(6):959–76.CrossRef
49.
go back to reference Allen EN, Mushi AK, Massawe IS, Vestergaard LS, Lemnge M, Staedke SG, Mehta U, Barnes KI, Chandler CI. How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials. BMC Med Res Methodol. 2013;13:140.CrossRef Allen EN, Mushi AK, Massawe IS, Vestergaard LS, Lemnge M, Staedke SG, Mehta U, Barnes KI, Chandler CI. How experiences become data: the process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials. BMC Med Res Methodol. 2013;13:140.CrossRef
50.
go back to reference Kelly AM, Smith B, Luo Z, Given B, Wehrwein T, Master I, Farley JE. Discordance between patient and clinician reports of adverse reactions to MDR-TB treatment. Int J Tuberc Lung Dis. 2016;20(4):442–7.CrossRef Kelly AM, Smith B, Luo Z, Given B, Wehrwein T, Master I, Farley JE. Discordance between patient and clinician reports of adverse reactions to MDR-TB treatment. Int J Tuberc Lung Dis. 2016;20(4):442–7.CrossRef
Metadata
Title
The impact of adverse events on health-related quality of life among patients receiving treatment for drug-resistant tuberculosis in Johannesburg, South Africa
Authors
Tembeka Sineke
Denise Evans
Kathryn Schnippel
Heleen van Aswegen
Rebecca Berhanu
Nozipho Musakwa
Elisabet Lönnmark
Lawrence Long
Sydney Rosen
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2019
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-019-1155-4

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