Research advances of real world study in the field of chronic wound

Chen Lingxi; Jia Chiyu; He Yan

doi:10.3760/cma.j.cn501120-20210121-00031

Volume 38 Issue 3

Mar. 2022

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Article Navigation > CHINESE JOURNAL OF BURNS AND WOUNDS > 2022 > 38(3): 291-295

Chen LX,Jia CY,He Y.Research advances of real world study in the field of chronic wound[J].Chin J Burns Wounds,2022,38(3):291-295.DOI: 10.3760/cma.j.cn501120-20210121-00031.

Citation:

Chen LX,Jia CY,He Y.Research advances of real world study in the field of chronic wound[J].Chin J Burns Wounds,2022,38(3):291-295.DOI: 10.3760/cma.j.cn501120-20210121-00031.

Citation:

Chen LX,Jia CY,He Y.Research advances of real world study in the field of chronic wound[J].Chin J Burns Wounds,2022,38(3):291-295.DOI: 10.3760/cma.j.cn501120-20210121-00031.

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Research advances of real world study in the field of chronic wound

doi: 10.3760/cma.j.cn501120-20210121-00031

Department of Burns and Plastic & Wound Repair Surgery, Xiang'an Hospital of Xiamen University, Xiamen 361102, China

Funds:

Natural Science Foundation of Fujian Province of China 2019J01011

Starting Package of Xiang'an Hospital of Xiamen University PM201809170010

More Information

Corresponding author: Jia Chiyu, Email: jiachiyu@qq.com
Received Date: 2021-01-21

Abstract

Abstract

In recent years, as a powerful supplement to the randomized controlled trial (RCT), real world study (RWS) has received more and more attention. However, in the field of chronic wounds, most of the patients have complex condition, and the strict inclusion and exclusion criteria of RCT were lack of practical application values. The RWS provides data closer to the real medical environment in clinical medical practice, drug and medical device supervision, and health technology evaluation. However, RWS has some problems that need to be resolved, such as inconsistent diagnostic criteria and unclear research endpoints. In addition, RWS in chronic wound research in China seems to have not really started yet, and institutions at all levels need to work together to promote the development of RWS.
- Wound healing,
- Chronic wounds,
- Real world study,
- Real world data,
- Real world evidence

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References(34)

References

[1]	ShermanRE,AndersonSA,Dal PanGJ,et al.Real-world evidence-what is it and what can it tell us?[J].N Engl J Med,2016,375(23):2293-2297.DOI: 10.1056/NEJMsb1609216.
[2]	NashP,KirkhamB,OkadaM,et al.Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial[J].Lancet,2017,389(10086):2317-2327.DOI: 10.1016/S0140-6736(17)31429-0.
[3]	EichlerHG,Bloechl-DaumB,BroichK,et al.Data rich, information poor: can we use electronic health records to create a learning healthcare system for pharmaceuticals?[J].Clin Pharmacol Ther,2019,105(4):912-922.DOI: 10.1002/cpt.1226.
[4]	MielkeD,RohdeV.Randomized controlled trials-a critical re-appraisal[J].Neurosurg Rev,2021,44(4):2085-2089.DOI: 10.1007/s10143-020-01401-4.
[5]	EvansK.Real world evidence: can we really expect it to have much influence?[J].Drugs Real World Outcomes,2019,6(2):43-45.DOI: 10.1007/s40801-019-0155-3.
[6]	BlondeL, KhuntiK, HarrisSB, et al. Interpretation and impact of real-world clinical data for the practicing clinician[J]. Adv Ther, 2018;35(11):1763-1774. DOI: 10.1007/s12325-018-0805-y.
[7]	NazhaB, YangJC, OwonikokoTK. Benefits and limitations of real-world evidence: lessons from EGFR mutation-positive non-small-cell lung cancer[J]. Future Oncol, 2021, 17(8): 965-977. DOI: 10.2217/fon-2020-0951.
[8]	SenCK,GordilloGM,RoyS,et al.Human skin wounds: a major and snowballing threat to public health and the economy[J].Wound Repair Regen,2009,17(6):763-771.DOI: 10.1111/j.1524-475X.2009.00543.x.
[9]	HornSD,FifeCE,SmoutRJ,et al.Development of a wound healing index for patients with chronic wounds[J].Wound Repair Regen,2013,21(6):823-832.DOI: 10.1111/wrr.12107.
[10]	DarlingJD,McCallumJC,SodenPA,et al.Predictive ability of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system after first-time lower extremity revascularizations[J].J Vasc Surg,2017,65(3):695-704.DOI: 10.1016/j.jvs.2016.09.055.
[11]	RaspovicKM,WukichDK,NaimanDQ,et al.Effectiveness of viable cryopreserved placental membranes for management of diabetic foot ulcers in a real world setting[J].Wound Repair Regen,2018,26(2):213-220.DOI: 10.1111/wrr.12635.
[12]	LaveryLA,FulmerJ,ShebetkaKA,et al.The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial[J].Int Wound J,2014,11(5):554-560.DOI: 10.1111/iwj.12329.
[13]	ShohamY,KriegerY,TamirE,et al.Bromelain-based enzymatic debridement of chronic wounds: a preliminary report[J].Int Wound J,2018,15(5):769-775.DOI: 10.1111/iwj.12925.
[14]	GrayTA,RhodesS,AtkinsonRA,et al.Opportunities for better value wound care: a multiservice, cross-sectional survey of complex wounds and their care in a UK community population[J].BMJ Open,2018,8(3):e019440.DOI: 10.1136/bmjopen-2017-019440.
[15]	YdeniusV, LarsenR, SteinvallI, et al. Impact of hospital type on risk-adjusted, traffic-related 30-day mortality: a population- based registry study[J/OL]. Burns Trauma, 2021,9:tkaa051 [2021-01-21]. https://pubmed.ncbi.nlm.nih.gov/33732745/.DOI: 10.1093/burnst/tkaa051.
[16]	HamburgMA.Advancing regulatory science[J].Science,2011,331(6020):987.DOI: 10.1126/science.1204432.
[17]	Corrigan-CurayJ,SacksL,WoodcockJ.Real-world evidence and real-world data for evaluating drug safety and effectiveness[J].JAMA,2018,320(9):867-868.DOI: 10.1001/jama.2018.10136.
[18]	LuCY.Uncertainties in real-world decisions on medical technologies[J].Int J Clin Pract,2014,68(8):936-940.DOI: 10.1111/ijcp.12434.
[19]	BrainD,TullenersR,LeeX,et al.Cost-effectiveness analysis of an innovative model of care for chronic wounds patients[J].PLoS One,2019,14(3):e0212366.DOI: 10.1371/journal.pone.0212366.
[20]	GuestJF, AyoubN, McIlwraithT, et al. Health economic burden that wounds impose on the National Health Service in the UK[J]. BMJ Open, 2015, 5(12): e009283. DOI: 10.1136/bmjopen-2015-009283.
[21]	GuestJF, AyoubN, McIlwraithT, et al. Health economic burden that different wound types impose on the UK's National Health Service[J]. Int Wound J, 2017, 14(2): 322-330. DOI: 10.1111/iwj.12603.
[22]	GouldL,LiWW.Defining complete wound closure: closing the gap in clinical trials and practice[J].Wound Repair Regen,2019,27(3):201-224.DOI: 10.1111/wrr.12707.
[23]	GilliganAM.Health economics and outcomes research of wound care: overview of methodology[J].Adv Wound Care (New Rochelle),2018,7(11):380-386.DOI: 10.1089/wound.2018.0817.
[24]	WilliamsR,KontopantelisE,BuchanI,et al.Clinical code set engineering for reusing EHR data for research: a review[J].J Biomed Inform,2017,70:1-13.DOI: 10.1016/j.jbi.2017.04.010.
[25]	McDonaldL,LambrelliD,WasiakR,et al.Real-world data in the United Kingdom: opportunities and challenges[J].BMC Med,2016,14(1):97.DOI: 10.1186/s12916-016-0647-x.
[26]	王弘恺,朱耀,米尔夏提·阿不都热西提,等.泌尿肿瘤基因突变检测结果单中心真实世界研究[J].中华外科杂志,2019,57(6):457-459.DOI: 10.3760/cma.j.issn.0529-5815.2019.06.012.
[27]	孙梦媛, 赵慧, 王玉兰, 等. 甲状腺乳头状癌术后复发相关因素的真实世界研究 [J]. 临床医学进展, 2021, 11(1): 357-365. DOI: 10.12677/ACM.2021.111051.
[28]	CarterMJ,FifeCE,WalkerD,et al.Estimating the applicability of wound care randomized controlled trials to general wound-care populations by estimating the percentage of individuals excluded from a typical wound-care population in such trials[J].Adv Skin Wound Care,2009,22(7):316-324.DOI: 10.1097/01.ASW.0000305486.06358.e0.
[29]	van RijswijkL,M.EvidenceGray, research, and practiceclinical: a patient-centered framework for progress in wound care[J].J Wound Ostomy Continence Nurs,2012,39(1):35-44.DOI: 10.1097/WON.0b013e3182383f31.
[30]	任燕,梁远波,刘密密,等.构建博鳌乐城创新药械真实世界数据研究体系:基于我国首个使用境内真实世界数据获批上市的医疗器械研究的探讨[J].中国循证医学杂志,2020,20(10):1117-1123.DOI: 10.7507/1672-2531.202007133.
[31]	孙鑫,谭婧,王雯,等.建立真实世界数据与研究技术规范,促进中国真实世界证据的生产与使用[J].中国循证医学杂志,2019,19(7):755-762.
[32]	李雪迎,沙若琪,姚晨,等.面向真实世界数据的临床研究数据治理模式选择[J].中国循证医学杂志,2020,20(10):1150-1156.DOI: 10.7507/1672-2531.202003122.
[33]	OlsenLA, AisnerD, McGinnisJMichael.The learning healthcare system[M].Washington (DC): National Academies Press (US), 2007.
[34]	SerenaTE,FifeCE,EckertKA,et al.A new approach to clinical research: integrating clinical care, quality reporting, and research using a wound care network-based learning healthcare system[J].Wound Repair Regen,2017,25(3):354-365.DOI: 10.1111/wrr.12538.

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Research advances of real world study in the field of chronic wound

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