A cross-sectional study on the quality of the randomized controlled trials (RCTs) included in the systematic review in the anti-infection field in the elderly_Chinese Journal of Evidence-Based Medicine

Authors：

CAI Yujia ¹ , FAN Jing ² ,  ZHANG Yonggang ¹ , LIU Xiaobo ² , XUE Chen ² , ZHANG Jiaming ² , ZHAO Jing ² , ZHANG Yue ² , XIA Haisha ² , GOU Xinyun ² , LI Juan ² ,  LI Nian ³

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P.R.China;
2. College of Health Preservation and Rehabilitation, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, P.R.China;
3. West China Hospital, Sichuan University, Chengdu 610041, P.R.China;

Corresponding author：

LI Nian, Email: linian@wchscu.cn

Keywords：

The aged; Anti-infection; Randomized controlled trials; Meta-analysis; Systematic review; Cross-sectional study

DOI：

10.7507/1672-2531.202101141

Video：

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Objective To analyze the quality of the randomized controlled trials (RCTs) included in the systematic review in the anti-infection field in the elderly.Methods A comprehensive and systematic literature search in PubMed, EMbase, CNKI, The Cochrane Library, WanFang Data, VIP and CBM was conducted to collect systematic review or meta-analysis which involoved anti-infection RCTs in the elderly from inception to February 17^th, 2020. The results of Cochrane risk of bias assessment of the included RCTs were analyzed.Results A total of 8 systematic reviews were included, involving 19 RCTs and 6 735 participants. The sample size of the RCTs ranged from 23 to 2538, and the published date were from 1980 to 2020. The included RCTs focused on postoperative infection, urinary tract infection, Clostridium Difficile infection and so on. The included RCTs had methodological quality issues. Among the assessment results of low risk of bias, the domains of selection bias (random sequence generation) and selection bias (allocation hiding) had the lowest proportion (47.3%, 36.8%). Among the assessment results of unclear risk of bias, the domains of selection bias (random sequence generation) and selection bias (allocation hiding) had the highest proportion (42.1%, 52.6%). Among the assessment results of high risk of bias, the domains of measurement bias and performance bias had the highest proportion (21.1%, 21.1%).Conclusions The quality of RCTs in the field of anti-infection in the elderly requires further improvement. High-quality anti-infection RCTs for the elderly should be developed in future to better guide clinical practice.

Citation： CAI Yujia, FAN Jing, ZHANG Yonggang, LIU Xiaobo, XUE Chen, ZHANG Jiaming, ZHAO Jing, ZHANG Yue, XIA Haisha, GOU Xinyun, LI Juan, LI Nian. A cross-sectional study on the quality of the randomized controlled trials (RCTs) included in the systematic review in the anti-infection field in the elderly. Chinese Journal of Evidence-Based Medicine, 2021, 21(4): 457-463. doi: 10.7507/1672-2531.202101141 Copy

1.	韩郸, 郑松柏. 老年人感染研究进展. 中华老年病研究电子杂志, 2014, (11): 39-42.
2.	Maggini S, Pierre A, Calder PC. Immune function and micronutrient requirements change over the life course. Nutrients, 2018, 10(10): 1531.
3.	Wu Y, Yin D, Abbasi K. China's medical research revolution. BMJ, 2018, 360: k547.
4.	张薇, 许吉, 邓宏勇. 国际医学证据分级与推荐体系发展及现状. 中国循证医学杂志, 2019, 19(11): 1373-1378.
5.	Ahmed H, Davies F, Francis N, et al. Long-term antibiotics for prevention of recurrent urinary tract infection in older adults: systematic review and meta-analysis of randomised trials. BMJ Open, 2017, 7(5): e015233.
6.	Cortegiani A, Russotto V, Maggiore A, et al. Antifungal agents for preventing fungal infections in non-neutropenic critically ill patients. Cochrane Database Syst Rev, 2016, (1): CD004920.
7.	Beinortas T, Burr NE, Wilcox MH, et al. Comparative efficacy of treatments for Clostridium difficile infection: a systematic review and network meta-analysis. Lancet Infect Dis, 2018, 18(9): 1035-1044.
8.	Zalmanovici TA, Lador A, Sauerbrun-Cutler MT, et al. Antibiotics for asymptomatic bacteriuria. Cochrane Database Syst Rev, 2015, (4): CD009534.
9.	Alves Galvão MG, Rocha Crispino Santos MA, Alves da Cunha AJ. Amantadine and rimantadine for influenza A in children and the elderly. Cochrane Database Syst Rev, 2014, (11): CD002745.
10.	Vermeij JD, Westendorp WF, Dippel DW, et al. Antibiotic therapy for preventing infections in people with acute stroke. Cochrane Database Syst Rev, 2018, (1): CD008530.
11.	Huang J, Wang X, Chen X, et al. Perioperative antibiotics to prevent acute endophthalmitis after ophthalmic surgery: a systematic review and meta-analysis. PLoS One, 2016, 11(11): e0166141.
12.	Aboulatta L, Sugita H, Wakabayashi H, et al. Comparison of extended versus intermittent infusion of antipseudomonal beta-lactams for the treatment of critically ill patients with respiratory infections: a systematic review and meta-analysis. Int J Infect Dis, 2020, 98: 41-50.
13.	Raz R, Colodner R, Rohana Y, et al. Effectiveness of estriol-containing vaginal pessaries and nitrofurantoin macrocrystal therapy in the prevention of recurrent urinary tract infection in postmenopausal women. Clin Infect Dis, 2003, 36(11): 1362-1368.
14.	Namikawa T, Kitagawa H, Yamatsuji T, et al. Pre-emptive treatment of fungal infection based on plasma β-D-glucan levels after gastric surgery for gastric cancer in elderly patients. J Gastroenterol Hepatol, 2013, 28(9): 1457-1461.
15.	Guery B, Menichetti F, Anttila VJ, et al. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial. Lancet Infect Dis, 2018, 18(3): 296-307.
16.	Abrutyn E, Mossey J, Berlin JA, et al. Does asymptomatic bacteriuria predict mortality and does antimicrobial treatment reduce mortality in elderly ambulatory women? Ann Intern Med, 1994, 120(10): 827-833.
17.	Abrutyn E, Berlin J, Mossey J, et al. Does treatment of asymptomatic bacteriuria in older ambulatory women reduce subsequent symptoms of urinary tract infection? J Am Geriatr Soc, 1996, 44(3): 293-295.
18.	Boscia JA, Kobasa WD, Knight RA, et al. Therapy vs. no therapy for bacteriuria in elderly ambulatory nonhospitalized women. JAMA, 1987, 257(8): 1067-1071.
19.	Giamarellou H, Dontas AS, Zorbas P, et al. Asymptomatic bacteriuria in freely voiding elderly subjects: long-term continuous vs pulse treatment with ofloxacin. Clinical Drug Investigation, 1998, 15: 187-195.
20.	Nicolle LE, Bjornson J, Harding GK, et al. Bacteriuria in elderly institutionalized men. N Engl J Med, 1983, 309(23): 1420-1425.
21.	Nicolle LE, Henderson E, Bjornson J, et al. The association of bacteriuria with resident characteristics and survival in elderly institutionalized men. Ann Intern Med, 1987, 106(5): 682-686.
22.	Gravenstein S, Drinka P, Osterweil D, et al. Inhaled zanamivir versus rimantadine for the control of influenza in a highly vaccinated long-term care population. J Am Med Dir Assoc, 2005, 6(6): 359-366.
23.	Monto AS, Ohmit SE, Hornbuckle K, et al. Safety and efficacy of long-term use of rimantadine for prophylaxis of type A influenza in nursing homes. Antimicrob Agents Chemother, 1995, 39(10): 2224-2228.
24.	Patriarca PA, Kater NA, Kendal AP, et al. Safety of prolonged administration of rimantadine hydrochloride in the prophylaxis of influenza A virus infections in nursing homes. Antimicrob Agents Chemother, 1984, 26(1): 101-103.
25.	Chamorro A, Horcajada JP, Obach V, et al. The early systemic prophylaxis of infection after stroke study: a randomized clinical trial. Stroke, 2005, 36(7): 1495-1500.
26.	Harms H, Prass K, Meisel C, et al. Preventive antibacterial therapy in acute ischemic stroke: a randomized controlled trial. PLoS One, 2008, 3(5): e2158.
27.	Kalra L, Irshad S, Hodsoll J, et al. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet, 2015, 386(10006): 1835-1844.
28.	Schwarz S, Al-Shajlawi F, Sick C, et al. Effects of prophylactic antibiotic therapy with mezlocillin plus sulbactam on the incidence and height of fever after severe acute ischemic stroke: the Mannheim infection in stroke study (MISS). Stroke, 2008, 39(4): 1220-1227.
29.	Westendorp WF, Vermeij JD, Zock E, et al. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet, 2015, 385(9977): 1519-1526.
30.	Inoue Y, Usui M, Ohashi Y, et al. Preoperative disinfection of the conjunctival sac with antibiotics and iodine compounds: a prospective randomized multicenter study. Jpn J Ophthalmol, 2008, 52(3): 151-161.
31.	Lyu Y, Yang Y, Li X, et al. Selection of piperacillin/tazobactam infusion mode guided by SOFA score in cancer patients with hospital-acquired pneumonia: a randomized controlled study. Ther Clin Risk Manag, 2017, 14: 31-37.
32.	韩叙, 王力红, 李小莹, 等. 基于 DRGs 的老年患者医院感染疾病负担评价. 中国医院管理, 2018, 38(10): 51-53.
33.	Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA, 1995, 273(5): 408-412.
34.	闫世艳, 何丽云, 刘保延. 随机对照临床试验中盲法质量评价现状. 中国循证医学杂志, 2014, 14(5): 631-635.
35.	刘波. 药物联合团体整合心理治疗对老年抑郁症患者临床疗效及脱落率研究. 泸州: 西南医科大学, 2018.
36.	衡明莉, 陈丽嫦, 王骏. 临床试验中缺失数据处理方法研究. 中国临床药理学杂志, 2019, 35(22): 2948-2952.
37.	吴泰相, 卞兆祥, 李幼平, 等. 临床试验原始数据透明化与共享: 关于医学研究伦理的哲学命题及其对临床试验的意义. 中国循证医学杂志, 2018, 18(6): 538-542.

1. 韩郸, 郑松柏. 老年人感染研究进展. 中华老年病研究电子杂志, 2014, (11): 39-42.
2. Maggini S, Pierre A, Calder PC. Immune function and micronutrient requirements change over the life course. Nutrients, 2018, 10(10): 1531.
3. Wu Y, Yin D, Abbasi K. China's medical research revolution. BMJ, 2018, 360: k547.
4. 张薇, 许吉, 邓宏勇. 国际医学证据分级与推荐体系发展及现状. 中国循证医学杂志, 2019, 19(11): 1373-1378.
5. Ahmed H, Davies F, Francis N, et al. Long-term antibiotics for prevention of recurrent urinary tract infection in older adults: systematic review and meta-analysis of randomised trials. BMJ Open, 2017, 7(5): e015233.
6. Cortegiani A, Russotto V, Maggiore A, et al. Antifungal agents for preventing fungal infections in non-neutropenic critically ill patients. Cochrane Database Syst Rev, 2016, (1): CD004920.
7. Beinortas T, Burr NE, Wilcox MH, et al. Comparative efficacy of treatments for Clostridium difficile infection: a systematic review and network meta-analysis. Lancet Infect Dis, 2018, 18(9): 1035-1044.
8. Zalmanovici TA, Lador A, Sauerbrun-Cutler MT, et al. Antibiotics for asymptomatic bacteriuria. Cochrane Database Syst Rev, 2015, (4): CD009534.
9. Alves Galvão MG, Rocha Crispino Santos MA, Alves da Cunha AJ. Amantadine and rimantadine for influenza A in children and the elderly. Cochrane Database Syst Rev, 2014, (11): CD002745.
10. Vermeij JD, Westendorp WF, Dippel DW, et al. Antibiotic therapy for preventing infections in people with acute stroke. Cochrane Database Syst Rev, 2018, (1): CD008530.
11. Huang J, Wang X, Chen X, et al. Perioperative antibiotics to prevent acute endophthalmitis after ophthalmic surgery: a systematic review and meta-analysis. PLoS One, 2016, 11(11): e0166141.
12. Aboulatta L, Sugita H, Wakabayashi H, et al. Comparison of extended versus intermittent infusion of antipseudomonal beta-lactams for the treatment of critically ill patients with respiratory infections: a systematic review and meta-analysis. Int J Infect Dis, 2020, 98: 41-50.
13. Raz R, Colodner R, Rohana Y, et al. Effectiveness of estriol-containing vaginal pessaries and nitrofurantoin macrocrystal therapy in the prevention of recurrent urinary tract infection in postmenopausal women. Clin Infect Dis, 2003, 36(11): 1362-1368.
14. Namikawa T, Kitagawa H, Yamatsuji T, et al. Pre-emptive treatment of fungal infection based on plasma β-D-glucan levels after gastric surgery for gastric cancer in elderly patients. J Gastroenterol Hepatol, 2013, 28(9): 1457-1461.
15. Guery B, Menichetti F, Anttila VJ, et al. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial. Lancet Infect Dis, 2018, 18(3): 296-307.
16. Abrutyn E, Mossey J, Berlin JA, et al. Does asymptomatic bacteriuria predict mortality and does antimicrobial treatment reduce mortality in elderly ambulatory women? Ann Intern Med, 1994, 120(10): 827-833.
17. Abrutyn E, Berlin J, Mossey J, et al. Does treatment of asymptomatic bacteriuria in older ambulatory women reduce subsequent symptoms of urinary tract infection? J Am Geriatr Soc, 1996, 44(3): 293-295.
18. Boscia JA, Kobasa WD, Knight RA, et al. Therapy vs. no therapy for bacteriuria in elderly ambulatory nonhospitalized women. JAMA, 1987, 257(8): 1067-1071.
19. Giamarellou H, Dontas AS, Zorbas P, et al. Asymptomatic bacteriuria in freely voiding elderly subjects: long-term continuous vs pulse treatment with ofloxacin. Clinical Drug Investigation, 1998, 15: 187-195.
20. Nicolle LE, Bjornson J, Harding GK, et al. Bacteriuria in elderly institutionalized men. N Engl J Med, 1983, 309(23): 1420-1425.
21. Nicolle LE, Henderson E, Bjornson J, et al. The association of bacteriuria with resident characteristics and survival in elderly institutionalized men. Ann Intern Med, 1987, 106(5): 682-686.
22. Gravenstein S, Drinka P, Osterweil D, et al. Inhaled zanamivir versus rimantadine for the control of influenza in a highly vaccinated long-term care population. J Am Med Dir Assoc, 2005, 6(6): 359-366.
23. Monto AS, Ohmit SE, Hornbuckle K, et al. Safety and efficacy of long-term use of rimantadine for prophylaxis of type A influenza in nursing homes. Antimicrob Agents Chemother, 1995, 39(10): 2224-2228.
24. Patriarca PA, Kater NA, Kendal AP, et al. Safety of prolonged administration of rimantadine hydrochloride in the prophylaxis of influenza A virus infections in nursing homes. Antimicrob Agents Chemother, 1984, 26(1): 101-103.
25. Chamorro A, Horcajada JP, Obach V, et al. The early systemic prophylaxis of infection after stroke study: a randomized clinical trial. Stroke, 2005, 36(7): 1495-1500.
26. Harms H, Prass K, Meisel C, et al. Preventive antibacterial therapy in acute ischemic stroke: a randomized controlled trial. PLoS One, 2008, 3(5): e2158.
27. Kalra L, Irshad S, Hodsoll J, et al. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet, 2015, 386(10006): 1835-1844.
28. Schwarz S, Al-Shajlawi F, Sick C, et al. Effects of prophylactic antibiotic therapy with mezlocillin plus sulbactam on the incidence and height of fever after severe acute ischemic stroke: the Mannheim infection in stroke study (MISS). Stroke, 2008, 39(4): 1220-1227.
29. Westendorp WF, Vermeij JD, Zock E, et al. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet, 2015, 385(9977): 1519-1526.
30. Inoue Y, Usui M, Ohashi Y, et al. Preoperative disinfection of the conjunctival sac with antibiotics and iodine compounds: a prospective randomized multicenter study. Jpn J Ophthalmol, 2008, 52(3): 151-161.
31. Lyu Y, Yang Y, Li X, et al. Selection of piperacillin/tazobactam infusion mode guided by SOFA score in cancer patients with hospital-acquired pneumonia: a randomized controlled study. Ther Clin Risk Manag, 2017, 14: 31-37.
32. 韩叙, 王力红, 李小莹, 等. 基于 DRGs 的老年患者医院感染疾病负担评价. 中国医院管理, 2018, 38(10): 51-53.
33. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA, 1995, 273(5): 408-412.
34. 闫世艳, 何丽云, 刘保延. 随机对照临床试验中盲法质量评价现状. 中国循证医学杂志, 2014, 14(5): 631-635.
35. 刘波. 药物联合团体整合心理治疗对老年抑郁症患者临床疗效及脱落率研究. 泸州: 西南医科大学, 2018.
36. 衡明莉, 陈丽嫦, 王骏. 临床试验中缺失数据处理方法研究. 中国临床药理学杂志, 2019, 35(22): 2948-2952.
37. 吴泰相, 卞兆祥, 李幼平, 等. 临床试验原始数据透明化与共享: 关于医学研究伦理的哲学命题及其对临床试验的意义. 中国循证医学杂志, 2018, 18(6): 538-542.

Chinese Journal of Evidence-Based Medicine

A cross-sectional study on the quality of the randomized controlled trials (RCTs) included in the systematic review in the anti-infection field in the elderly

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