Cost of Babies Born to Mothers With Diabetes

Eur J Health Econ. 2019; 20(3): 407–417.

Toll-effectiveness of controlling gestational diabetes mellitus: a systematic review

Najmiatul Fitria

ⁱUnit of measurement of Pharmaco-Therapy, -Epidemiology and -Economic science (PTE2), Groningen Inquiry Institute of Chemist's shop, Academy of Groningen, A.Deusinglaan 1, 9713 AV Groningen, Kingdom of the netherlands

²Unit of measurement of Pharmacology and Clinical Pharmacy, Kinesthesia of Pharmacy, Universitas Andalas, Padang, W Sumatra Indonesia

Antoinette D. I. van Asselt

^oneUnit of Pharmaco-Therapy, -Epidemiology and -Economics (PTE2), Groningen Enquiry Institute of Chemist's, Academy of Groningen, A.Deusinglaan one, 9713 AV Groningen, The Netherlands

³Department of Epidemiology, University Medical Heart Groningen, Academy of Groningen, Groningen, Holland

Maarten J. Postma

^oneUnit of Pharmaco-Therapy, -Epidemiology and -Economics (PTE2), Groningen Research Institute of Chemist's, Academy of Groningen, A.Deusinglaan i, 9713 AV Groningen, The Netherlands

⁴Department of Health Sciences, Academy Medical Center Groningen, University of Groningen, Groningen, The Netherlands

Received 2018 Feb nineteen; Accepted 2018 Sep x.

Supplementary Materials

Supplementary fabric i (DOCX fourteen KB)

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Supplementary material two (DOCX 24 KB)

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Supplementary textile 3 (DOCX 16 KB)

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Abstruse

Objective

Timely screening for hyperglycaemia in pregnancy using a unproblematic glucose exam enhances early detection and control of gestational diabetes mellitus (GDM). The aim of this report was to provide an overview of the testify on the cost-effectiveness of identification and/or treatment of GDM.

Methods

Nosotros conducted a systematic review using three electronic databases (PubMed, EMBASE, and Cochrane) of cost-effectiveness studies of GDM screening and treatment published during 2000–2017.

Results

The initial search discovered 287 references (PubMed 86, EMBASE 195, Cochrane library 6) of which six full articles were included in the review. Ii manufactures were model-based assay and the remaining four were trial based. Two studies demonstrated favorable cost-effectiveness of intensified management of mild GDM. In the other included studies, neither screening nor handling of GDM was shown to exist price effective, although results varied with the particular outcome measures used and the assumptions that where applied.

Determination

Neither screening nor treating GDM seems to be convincingly price-effective from the studies reviewed. Notwithstanding, all studies were done in high-income countries with manifestly different wellness systems than low-/heart-income countries (LMIC) have. Since detection of GDM may be relatively poor in LMIC, screening might be more than worthwhile in these countries. Comprehensive enquiry is necessary in LMIC, including the potential outcomes of assessing its cost-effectiveness. Favorable price-effectiveness could help in bridging the need for and access to increased diabetes screening in early pregnancy in these countries.

Electronic supplementary material

The online version of this article (10.1007/s10198-018-1006-y) contains supplementary material, which is available to authorized users.

Keywords: Hyperglycemia in pregnancy, Gestational diabetes mellitus, Price-effectiveness

Introduction

An increased blood glucose level (92–125 mg/dl) first detected at any fourth dimension during pregnancy is classified every bit gestational diabetes mellitus (GDM) as part of hyperglycemia in pregnancy (HIP), which is any kind of increased blood glucose level during pregnancy, including live births in women with known diabetes [i]. The distinction between HIP and GDM has merely recently (2013) been fabricated by the World Health System (WHO) [two]. See supplementary Appendix ane for an overview of the WHO nomenclature.

The International Diabetes Federation (IDF) estimates that 21.4 million (sixteen.8%) of women who gave alive birth in 2013 had some grade of HIP. There are some regional differences in the prevalence of HIP. The Southeast Asian Region had the highest crude incidence of the HIP at 23.1% of live births, followed closely by the Center East and North African Region with 22.three% [3]. A staggering 91.6% of cases of the HIP were in low- and middle-income countries (LMIC). Estimates of GDM by region co-ordinate to the diabetes atlas range from 10.iv to 25.0%, where Due north America-Caribbean is the lowest and Southeast Asia is the highest [i, three]. Awareness of HIP equally a risk factor and admission to maternal care in LMIC are often express.

GDM tin significantly affect the health of both mother and child. A pregnant woman with diabetes can feel pre-eclampsia, infections, obstructed labor, and postpartum hemorrhage compared to women without diabetes [iv–6]. These pregnant women with diabetes are besides at risk of long-term complications associated with diabetes, such as retinopathy, nephropathy, and neuropathy [vii, viii]. For the fetus, GDM is associated with stillbirth, preterm nascence, macrosomia, growth retardation and congenital anomalies [9]. According to the American Diabetes Association, women with GDM should be screened for persistent diabetes at six–12 weeks postpartum, and subsequently every one–3 years [10]. An estimated 30–l% of women with a history of gestational diabetes develops it again in subsequent pregnancies within five–ten years, and half of these women progress into type 2 DM [eleven]. Besides, babies built-in from diabetic pregnancies are at increased chance of developing, for instance, juvenile obesity, metabolic disorders in adolescence and type 2 DM in adulthood [12]. The primary goal of managing all types of GDM is to create and maintain a normal blood glucose level for both the mother and fetus and besides to forbid miscarriages and stillbirths [13–fifteen]. GDM can be managed in many means, for instance, using nutritional direction, insulin treatment, or oral hypoglycemic agents [sixteen–18]. According to the guidelines mentioned higher up, insulin is the start line of pharmacologic therapy.

Published data from IDF depict the majority of GDM screening is conducted in high-income countries (HIC) mainly in Europe and N America and Caribbean [3]. Even so, as the screening methodology used in HIC is more than elaborate than commonly performed in LMIC, the evidence on GDM screening from HIC cannot be extrapolated to LMIC. Therefore, more than data on screening for GDM in LMIC are needed to support the case for universal screening.

Treating the short- and long-term complications of GDM tin be plush. Costs of treatment for perinatal complications in the United States may be up to US$9000 during the first twelvemonth of life [19], and costs of handling for T2DM can average upward to US$3500 per year [20]. All strategies to reduce GDM crave investments up front end, and it should be determined whether these are worthwhile [21]. Price-effectiveness analysis (CEA) compares the price and effects of at to the lowest degree ii strategies or interventions [22]. The issue of a cost-effectiveness assay is often an incremental cost-effectiveness ratio (ICER), which expresses the boosted investments required to gain i boosted unit of outcome. Effects can exist some measure of health such as the number of births at term, perinatal deaths prevented, or increased baby weight. In particular, quality-adjusted life years (QALYs) are ofttimes used [23, 24]. There take been many effectiveness trials just fewer cost-effectiveness studies in GDM. The objective of the present study is to provide, past means of a literature review, an overview of the existing evidence on the cost-effectiveness of identification and/or handling of GDM.

Methods

Written report design and search strategy

We conducted a literature review of cost-effectiveness studies related to gestational diabetes mellitus published between 2000 and 2017, taking into account reporting guidelines of preferred reporting items for systematic reviews and meta-analyses (PRISMA) diagram [25]. We decided to simply include papers published from 2000 onwards as this is the first year later the diagnostic criteria for GDM were formally stated in 1999. We accessed iii electronic databases (PubMed, EMBASE, and Cochrane) in August 2017. Supplementary Appendix 1 shows details of the search terms. We only included studies that were performed in significant women and that were written in English language.

Study selection and data extraction

The search results were downloaded into RefWorks Web-Based Bibliographic Management Software. From the initial search results, duplicates were removed, and title and abstruse were screened. Articles that were not cost-effectiveness studies, not full papers (e.g., conference proceedings), or not on the topic of GDM were excluded. Alongside the data extraction, we converted cost estimates into a single currency (international $) and price year (2016), with the purpose of facilitating comparison of estimates collected from dissimilar studies. This conversion was performed using Arrangement for Economic Co-operation and Development (OECD) Consumer Toll Index and Purchasing Ability Parities (PPPs) [26, 27].

Quality of reporting

The Consolidated Wellness Economical Evaluation Reporting Standards (Thank you) statement was used as a checklist to rate the quality of reporting in the included papers. The Thanks statement of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Health Economic Evaluation Publication Guidelines Good Reporting Practices Job Force is a guideline intended to amend reporting of economic evaluation [28, 29]. Within the CHEERS statement, a 24-item checklist is available to examine the quality of reporting of wellness economic studies.

Risk of bias cess

The recommended approach to assess chance of bias in reviews of cost-effectiveness studies is by means of the Consensus Health Economics Criteria (CHEC)-extended checklist [30, 31]. We chose to utilize a version that was adjusted for specific utilize in diabetes mellitus type 2 (DMT2), equally described in a report by Odnoletkova et al. [32]. This risk of bias arroyo was summarized using the Review Director software.

Results

Systematic search strategy

The database search discovered 287 references (PubMed 86, EMBASE 195, Cochrane library 6), of which 274 were left later deduplication (encounter Fig.1 for a flow diagram). Screening of the championship and the abstruse found that 223 articles had a topic other than GDM, 36 articles were not toll-effectiveness studies, and half dozen manufactures were non written in English. By this screening, 9 articles met the inclusion criteria. Four of these articles were briefing proceedings for which no full papers were available. Therefore, a final set of half dozen publications was included in the written report [33–38].

Flow of search strategy in systematic review

Data extraction

An overview of the main study characteristics of the six included price-effectiveness studies is provided in Table1. Tabular arrayii shows information on categories of included costs, currency and toll year.

Table i

Overview of main study characteristics of the included toll-effectiveness analyses on GDM direction

Study	Study design						Assay
	Method	Perspective	Sample size	Countries	Treatment		Fourth dimension horizon	Discount rate (%)		Sensitivity analysis	ICER/ NMB	ICER/ NMB (2016 I$)	Conclusion
					Intervention	Control		Cost	Outcome
Moss [33]	RCT (trial based)	Healthcare and patients	970	Australia	Dietary advice, monitoring blood glucose	Standard exercise	ix months	5	5	Multi-variate, probabilistic sensitivity analysis	$27,503 per additional serious perinatal complication prevented, $lx,506 per perinatal death prevented, $2988 per life/yr saved	I$xiii,886.39 per additional serious perinatal complication prevented, I$thirty,549.77 per perinatal death prevented, I$1508.65 per life/year saved	The incremental price per extra life-year gained is highly favorable at I$1,508,65
Ohno [34]	Model based	Healthcare	NA	U.s. of America	Nutritional counseling and diet therapy along with insulin (if required)	Usual prenatal care	Maternal plus neonatal lifetime	NM	3%	Univariate and probabilistic sensitivity analysis	$20,412 per QALY	I$23,745 per QALY	Treating mild GDM is cost effective below the cost-effectiveness threshold of I$116,326/QALY, as long as the cost to treat GDM was less than $4135
Oostdam [35]	RCT (trial based)	Societal	425	The Netherlands	Standard care + FitFor2	Standard care	9 months	NM	NM	Multi-variate, FCA and HCM	Fasting glucose: €46.97 per one signal improvement in claret glucose Insulin sensitivity: €162.99 per unit improvement of IS HOMA QALY: junior Nascency weight: inferior	Fasting glucose: I$73.72 per one point improvement in blood glucose Insulin sensitivity: I$255.81 per unit of measurement improvement of IS HOMA QALY: junior Birth weight: junior	For fasting blood glucose and insulin sensitivity, the ICER of Fitfor2 was besides loftier to be considered cost effective. For QALYs and birthweight, FitFor2 was junior to standard care
Kolu [36]	Cluster-randomized trial (trial based)	Healthcare and societal	399	Finland	Insulin + lifestyle counseling	Standard care (insulin)	2 years	NM	NM	Multi-variate, probabilistic sensitivity analysis	€vii for increase in nativity weight avoided (g)	I$ix.27 for increase in birth weight avoided (g)	The intervention was constructive in decreasing neonatal nativity weight, merely not toll effective for nativity weight or quality of life
Kolu [37]	Cluster-randomized trial (trial based)	Healthcare and societal	173	Finland	Insulin + lifestyle counseling	Standard care (insulin)	vii years	NM	NM	Multi-variate, PSA	−€233 per 24-hour interval of absence from work prevented −€5386 per QALY	−I$258 per day of absence from piece of work prevented −I$5974 per QALY	The intervention was not toll effective for QALY gained just may subtract the amount of sickness absence in women with risk of GDM
Farrar [38]	Model based, with four strategies compared	NHS and personal social services	NA	United Kingdom	No screening/testing or handling		three months	3.5	NM	PSA	NMB: −£1184	NMB: −I$1987	No screening/exam or treatment is the least unfavorable among all scenarios at threshold I$33,573
					Screen merely  Screening followed by dietary and lifestyle advice for those who screen positive						NMB: −£1197	NMB: −I$2009
					Universal diagnostic test Diagnostic test followed by dietary and lifestyle advice with pharmacological treatment as required						NMB −£1210	NMB: −I$2031
					Screen and diagnostic test Screening followed by diagnostic test in those who screen positive, with dietary and lifestyle advice and pharmacological treatment as required						NMB: −£1197	NMB: −I$2009

ICER incremental price-effectiveness ratio, NMB net monetary benefit, RCT randomized control trial, NM not mentioned, PSA probabilistic sensitivity analysis, QALY quality-adjusted life year

Table 2

Cost categories which are taken into account in the included cost-effectiveness analysis written report

Written report	Categories of included costs	Currency, year
Moss [33]	Directly costs: antenatal clinic visits, specialist dispensary visits, dietician visits, diabetes educator, blood glucose monitoring equipment, and insulin therapy Indirect costs: charges to the family unit: paid kid care, travel, food exchange, female parent fourth dimension off paid work, and partner time off work	Australian dollars, 2002
Ohno [34]	Directly cost: pharmacotherapy, antenatal visits, coincident diabetes-related visits, and antepartum fetal surveillance	US dollars, 2009
Oostdam [35]	Direct costs: full general practitioner, medical specialist, hospitalization, occupational doctor, mental health care, paramedical, dietician, midwife, obstetrician, delivery, and medications Indirect toll: productivity loss	Euro, 2009
Kolu [36]	Direct costs: laboratory test cost, health care visit cost, insulin/diabetes medication cost, delivery cost, infirmary days cost, neonatal care cost, and costs of healthcare intervention: supplemental public health nurse's contribution Indirect price: Productivity loss	Euro, 2009
Kolu [37]	Direct costs: occupational health care, primary care doctor, special health intendance doctor, registered nurse, motherhood clinic, family planning dispensary, physiotherapist, and inpatient days in special health intendance Indirect cost: productivity loss	EUR, 2015
Farrar [38]	Direct costs: screening and diagnostic testing costs, adverse perinatal outcomes, treatment costs, and intensive lifestyle intervention costs	British Pounds, 2014

Four of the included studies were trial-based economic evaluations and two were model based. All trial-based studies in this review used intention-to-treat analysis. Clinical trials that utilise intention-to-treat assay may be a reliable source for an economic evaluation, equally they approximate real-world clinical practice ameliorate than per-protocol analyses [22]. Moss et al. compared dietary communication, blood glucose monitoring and insulin therapy as needed to routine pregnancy care in a population diagnosed with mild GDM [33]. Kolu et al. investigated the effect of lifestyle counseling compared to standard care amongst women at risk for GDM within 7 years of follow-up [36]. This report continued until vii years of follow-up with half of the participants nonetheless included and the children who were built-in during the initial study [37]. Oostdam et al. also compared lifestyle counseling and scheduled practise (FitFor2) in pregnant women at increased adventure for GDM. Women in the control group were not presented the FitFor2 program and received intendance equally usual [35].

All trial-based studies included reported an ICER for diverse outcome measures, e.chiliad., nascence at term, perinatal complications prevented, reduced birth weight in offspring, and QALYs. Moss et al. reported the ICER to be I$xiii,886 per-astringent perinatal complexity prevented and I$30,549 per perinatal death prevented. Even though fewer babies experienced perinatal complications and death, more than women were induced into labor. Moss et al. also presented a long-term analysis based on simple extrapolation of the perinatal deaths prevented into life years gained. The incremental toll per life year gained was I$1508.65 which was considered to be highly cost effective. Kolu et al. present an ICER of I$9.27 for each additional gram of birth weight avoided. This intervention was effective in reducing nascency weight, but also more expensive compared to usual care. After the 7-year follow-upwards, 70% of total costs in the population were due to absence from piece of work. The intervention was non cost effective in terms of QALYs gained but notwithstanding cost constructive for absence from work with an ICER of −I$258 per 24-hour interval of absenteeism from work prevented, indicating the authority of the intervention equally both costs were saved and absence from work was reduced.

In the study by Oostdam et al., the total cost in the intervention group was college than for standard care considering of prolonged hospitalization and a higher rate of preterm births in this group. This also caused a slight decrease in QALYs in the intervention grouping, implying the intervention was junior, i.e., more costly and less effective, compared to standard care. Oostdam et al. also present an analysis on birth weight, which led to comparable results in the sense that most false price-effectiveness pairs were in the northwest quadrant of the cost-effectiveness (CE) plane, and so Fitfor2 was also considered inferior when information technology concerned reducing nascency weight.

The study by Farrar et al. used a meta-analysis and modeling arroyo for the economic evaluation. They compared four strategies for testing and treating for hyperglycemia in healthy pregnancies. Their main results indicated that for the base instance every bit well equally for all scenarios analyses, the most cost-effective strategy at a £20,000 (I$33,573) threshold was 'no screening/testing or treatment'. It is only with the inclusion of maternal longer term wellness outcomes and at toll-effectiveness thresholds of £24,000 (I$40,288) per QALY that net health benefits were improved by intervening. Ohno et al. likewise reported on a model-based written report, comparing nutritional counseling, diet therapy plus insulin if required with usual prenatal intendance in women diagnosed with balmy GDM [34]. The effect for the economic evaluation was the sum of maternal and neonatal QALYs. Costs were also calculated from both the maternal and neonatal perspective, though simply short-term events, i.east., related to pregnancy and delivery, were taken into account. Results indicated that treating GDM would exist more expensive and more effective with an ICER of $20,412 per additional QALY, which was considered to be well below the threshold.

Quality of reporting assessment

For each study, report on all 24 items in the CHEERS checklist is provided in the supplementary Appendix. Most of the studies reported quite comprehensively in the sense that they provide information on almost all items on the checklist. Moss et al. performed a trial-based economical evaluation and reported to take used bootstrapping to confirm their analysis. At that place is no report of the bootstrapping results, though, while an incremental price-effectiveness airplane or cost-effectiveness acceptability curve would take been informative equally to the uncertainty surrounding outcomes.

Risk of bias

Figuretwo shows the summary data for risk of bias per study. It should be noted that for studies that were trial based, providing a model clarification was not applicable, then the absence of a description does not cause whatever bias. Also, when using a time frame for analyses of less than 1 year, discounting is not needed.

Chance of bias for each detail of the modified CHEC-extended checklist

For trial-based economical analyses in gestational-based analyses, a follow-up from the early pregnancy until delivery that took less than 1 year would non be a trouble in terms of discounting. Although Kolu et al. performed a long-term follow-up, they did non disbelieve costs nor wellness effects. When they would take discounted futurity costs and health, the ICERs might accept been impacted, although it is difficult to say in which direction.

The treatment estimates from Farrar were sourced from pooled RCT data of studies performed in HIC and, therefore, could likely validly be generalized to the Uk obstetric population with GDM. In general, there were no serious structural sources or concerns for bias.

Word

The inclusion criteria that we stated at the beginning of this report resulted in six articles included. The studies included in this review were exclusively located in high-resource countries. This is probably due to the fact that screening for GDM is mutual in these countries, every bit opposed to LMICs where screening programs are in the get-go-up phase, at all-time, and, therefore, economic evaluations are not notwithstanding in question.

In the studies included, several terms were used to describe standard care; standard practice, routine care and standard intendance itself. Their content could exist different according to local guidelines in each infirmary or study site. Differences in how standard care was divers and provided hamper comparing between the cost-effectiveness results of the included studies. The chief outcome of all studies was well divers.

In the countries and settings for which the economic evaluations were performed, maternity services and guidelines on screening and treatment of GDM were already well established. Pregnant women who were considered to be at a certain risk for GDM would take an HbA1c screening at 24–28 weeks of gestation [39]. A study past Jiwani in 2011 showed that more than 80% of countries that practise not provide whatever GDM-related maternity intendance was LMIC [39]. They conclude that many of these countries have limited healthcare services capacity and do not nonetheless accept standardized practices for GDM screening and management.

Taking the prove from all vi papers together, information technology seems that treatment of GDM in itself may be effective, but screening the whole population for GDM and later treat is not probable to be price effective. According to Farrar et al. this is caused by the fact that the wellness benefits gained by handling practice non outweigh the investments needed to screen the whole population of pregnant women [38]. The unfavorable cost to benefit ratio may be a issue of the fact that well-nigh GDM cases would, at a certain signal, already be detected with intendance as usual and agile screening does not significantly add to that. In this case and then 'no screening/testing or handling' is the toll-effective option at the considered range of cost-effectiveness thresholds [38]. Based on the small number of studies and sample sizes, the touch on of screening women for GDM on health outcomes is inconclusive. The virtually commonly observed risk factors are age ≥ thirty years and family history of blazon 2 diabetes mellitus [38, 40]. However, in LMIC, the situation may exist different. In LMIC the regimen of pregnancy checkups is less strict and occasional or regular detection of GDM may, therefore, be an exception. In this kind of state of affairs, the added value of protocolized screening, equally advocated past health authorities, would be college.

One more reason for the somewhat disappointing cost-effectiveness of interventions directed toward GDM management might be that in all trial-based studies in this review, depression compliance and high driblet-out was a trouble. As Oostdam et al. put information technology, 'many women stopped exercising during the period of their pregnancy because of physical (pregnancy-related) limitations' [35]. As it seems that the low compliance is intrinsic to the intervention and the pregnant population, it is unlikely that real-globe toll-effectiveness would be meliorate than reported from these trials.

Drawing conclusions from the included studies was hard because of a number of reasons. Outset, the toll-effectiveness results were not always reported clearly and comprehensively. For instance, in the absenteeism of an incremental price-effectiveness plane, one has to very carefully cheque the results to see whether a negative ICER is the result of negative effects and positive costs, or the other way around, and when the outcome measure is expressed as 'the less the meliorate' this complicates things even more. Furthermore, not all of the articles reviewed presented QALYs. Notably, the toll-effectiveness of screening or treatment is ideally reported in the way Ohno et al. have done [34], i.e., in terms of cost per QALY over the whole lifetime of both mother and child. The broad diverseness of outcome measures used in the included studies, even though perfectly relevant from a clinical point of view, adds to the inconclusiveness.

Strengths and limitations

This is the first review to provide integrated evidence on cost-effectiveness in gestational diabetes. Adjacent to summarizing results according to guidelines for systematic reviews of economic evaluation from van Mastrigt [30], we explicitly reported the risk of bias for all included studies. Combining trial- and model-based studies together in ane table provides one integrated presentation, comparison and interpretation of the cost-effectiveness results. A definite limitation of this review is that some of the interventions investigated in the included studies were not however proven to be clinically effective. Therefore, this review should not exist used to conclude on the clinical effectiveness of therapeutic interventions, just rather be used to illustrate the potential favorable cost-effectiveness of interventions in gestational diabetes.

Future research

While nigh countries tin can afford the investments needed, the poorest nations volition need assistance to accomplish the targets. Even though WHO already provided the new screening approach, a standard estimation is still needed, too as making cost-effectiveness assay more generalizable to the LMIC. Since the sustainable development goals put attending on universal health coverage of reproductive, maternal, new-built-in and child health including service capacity and access, hereafter inquiry on this topic is warranted.

Conclusion

From the included studies, GDM treatment could be considered cost effective nether certain circumstances, but universal screening for GDM does not seem worthwhile. All studies in this review were done in high-income countries. Since regular detection of GDM is potentially poor in LMIC, the findings of this systematic review practice non apply to an LMIC setting, and screening might be worthwhile in these countries. The decision on the best strategy for screening, diagnosis, and management should be made based on cost, availability, and accessibility of the local existing health facilities. Further research is warranted to assess applicability and cost-effectiveness apropos GDM peculiarly in resource-limited countries of the globe.

Electronic supplementary material

Below is the link to the electronic supplementary material.

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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6438940/