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PharmacoEconomics - Open Mar 2024Hereditary hemochromatosis (HH) is an autosomal recessive disorder that leads to iron overload and multiorgan failure.
BACKGROUND
Hereditary hemochromatosis (HH) is an autosomal recessive disorder that leads to iron overload and multiorgan failure.
OBJECTIVES
The aim of this systematic review was to provide up-to-date evidence of all the current data on the costs and cost effectiveness of screening and treatment for HH.
METHODS
We searched PubMed, Cochrane Library, National Health Service Economic Evaluation Database (NHSEED), Cost-Effectiveness Analysis Registry (CEA Registry), Health Technology Assessment Database (HTAD), Centre for Reviews and Dissemination (CRD), and Econlit until April 2023 with no date restrictions. Articles that reported cost-utility, cost-description, cost-minimization, cost-effectiveness, or cost-benefit analyses for any kind of management (drugs, screening, etc.) were included in the study. Patients with HH, their siblings, or individuals suspected of having HH were included in the study. All screening and treatment strategies were included. Two authors assessed the quality of evidence related to screening (either phenotype or genotype screening) and treatment (phlebotomy and electrophoresis). Narrative synthesis was used to analyse the similarities and differences between the respective studies.
RESULTS
Thirty-nine papers were included in this study. The majority of the studies reported both the cost of phenotype screening, including transferrin saturation (TS), serum ferritin, and liver biopsy, and the cost of genotype screening (HFE screening, C282Y mutation). Few studies reported the cost for phlebotomy and erythrocytapheresis treatment. Data revealed that either phenotype or genotype screening were cost effective compared with no screening. Treatment studies concluded that erythrocytapheresis might be a cost-effective therapy compared with phlebotomy.
CONCLUSIONS
Economic studies on either the screening, or treatment strategy for HH patients should be performed in more countries. We suggest that cost-effectiveness studies on the role of deferasirox in HH should be carried out as an alternative therapy to phlebotomy.
PubMed: 38279979
DOI: 10.1007/s41669-023-00463-6 -
BMJ Open Dec 2023To assess whether acoustic stimulations relieve venipuncture pain and determine which stimulation is the most effective type. (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To assess whether acoustic stimulations relieve venipuncture pain and determine which stimulation is the most effective type.
DESIGN
Systematic review and network meta-analysis.
DATA SOURCES
PubMed, Cochrane Central Register of Controlled Trials, Excerpta Medica dataBASE, Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov and the International Clinical Trials Registry Platform databases were systematically searched in September 2023.
STUDY SELECTION
Randomised controlled trials evaluating the efficacy of acoustic stimulations on patients undergoing venipuncture were eligible. Acoustic stimulations were classified into seven categories: five types of acoustic stimulations (music medicine (researcher selected), music medicine (patient selected), music therapy, sounds with linguistic meaning and sounds without linguistic meaning) and two controls (only wearing headphones and no treatment).
PRIMARY AND SECONDARY OUTCOME MEASURES
Primary outcomes included self-reported pain intensity assessed during venipuncture and treatment cost, and secondary outcomes were self-reported mental distress and adverse events.
RESULTS
Of 6406 citations, this network meta-analysis included 27 studies including 3416 participants; the mean age was 31.5 years, and 57% were men. Among the five types of acoustic stimulations, only musical interventions, such as music medicine (patient selected) (standardised mean difference (SMD) -0.44 (95% CI: -0.84 to -0.03); low confidence), music medicine (researcher selected) (SMD -0.76 (95% CI: -1.10 to -0.42); low confidence) and music therapy (SMD -0.79 (95% CI: -1.44 to -0.14); low confidence), were associated with improved pain relief during venipuncture compared with no treatment. No significant differences existed between the types of acoustic stimulations. Free-of-charge acoustic stimulations were provided to patients, and no specific adverse events were reported. In many studies, the risk of bias was rated high because of the difficulty of blinding the intervention to the participants and the self-reported pain outcome.
CONCLUSIONS
Music interventions were associated with reduced venipuncture pain. Comparisons between types of acoustic stimulations revealed no significant differences. Therefore, music intervention could be a safe and inexpensive pain relief method for venipuncture.
PROSPERO REGISTRATION NUMBER
CRD42022303852.
Topics: Male; Humans; Adult; Female; Phlebotomy; Acoustic Stimulation; Network Meta-Analysis; Pain; Music Therapy
PubMed: 38135307
DOI: 10.1136/bmjopen-2023-077343 -
Frontiers in Public Health 2023The use of reusable tourniquets is widespread around the world, and reports suggest they may be overused. Several studies have shown that reusable tourniquets can affect...
INTRODUCTION
The use of reusable tourniquets is widespread around the world, and reports suggest they may be overused. Several studies have shown that reusable tourniquets can affect the spread of pathogens between patients. Based on available studies, this review aims to analyse the indirect transmission of antimicrobial-resistant pathogens present on blood collection tourniquets, which may spread infectious diseases between patients in daily clinical practice.
METHODS
A systematic review of the literature was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) protocol guidelines. The contents of PubMed, EBSCO (electronic databases), and Scopus were screened. Keywords used in the search included: "tourniquet," "cross infection," "nosocomial infection," "," "MRO," "pathogen," "infectious disease," "anti-microbial," or a combination of these using AND or OR operators. Finally, 13 publications were included. Data were analysed both descriptively and quantitatively by calculating a balanced average for specific synthesized data.
RESULTS
The proportional observation based on the number sampled median was 77. The genus MRSA was the type of bacteria most commonly found: on 12% of all tested tourniquets. The amount of MRSA found on tourniquets was mean ± SD 14.6 ± 45.89. A review of studies also revealed the presence of , grew and .
CONCLUSION
Patient safety may be at risk due to elevated contamination rates of reusable tourniquets. The microorganisms responsible for this contamination include a variety of species, the most common being the genus . For this reason, we recommend the use of disposable tourniquets.
Topics: Humans; Tourniquets; Equipment Contamination; Phlebotomy; Cross Infection; Staphylococcal Infections
PubMed: 38026360
DOI: 10.3389/fpubh.2023.1258692 -
Journal For Healthcare Quality :...A systematic literature review was performed to understand the prevalence, advantages, and disadvantages of blood collection using different approaches (direct...
BACKGROUND
A systematic literature review was performed to understand the prevalence, advantages, and disadvantages of blood collection using different approaches (direct venipuncture or vascular access devices), and interventions used to mitigate the disadvantages.
METHODS
The review included a broad range of study designs and outcomes. Database searches (Embase, MEDLINE, Cochrane library, and Centre for Reviews and Dissemination) were conducted in March 2021 and supplemented by hand searching.
RESULTS
One hundred forty-one publications were included. The data indicate that blood sampling from vascular access devices is common in emergency departments, trauma centers, and intensive care units. Studies showed that hemolysis and sample contamination place a considerable economic burden on hospitals. Significant cost savings could be made through enforcing strict aseptic technique, or using the initial specimen diversion technique.
CONCLUSIONS
Hemolysis and sample contamination are far from inevitable in vascular access device-collected or venipuncture samples; both can be reduced through adherence to strict blood sampling protocols and utilization of the initial specimen diversion technique. Needle-free blood collection devices offer further hope for reducing hemolysis. No publication focused on the difficult venous access population; insertion success rates are likely to be lower (and the benefits of vascular access devices higher) in these patients.
Topics: Humans; Hemolysis; Phlebotomy; Cost-Benefit Analysis
PubMed: 37788441
DOI: 10.1097/JHQ.0000000000000399 -
PloS One 2023The aim was to evaluate the effectiveness and safety of the vapocoolants for vascular puncture in children and adults. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The aim was to evaluate the effectiveness and safety of the vapocoolants for vascular puncture in children and adults.
METHOD
The search was carried out in PubMed, Web of Science, Embase and The Cochrane Library, from inception to March 2022. Randomized controlled trials comparing vapocoolants to control conditions for participants received intravenous cannulation or arterial puncture were included. Two reviewers independently performed selection of studies, data extraction, and assessment of risk of bias. The analysis was performed using fixed or random-effects model with mean differences or standardized mean difference and risk ratios.
RESULTS
A total of 25 studies involving 3143 participants were included. Compared with control conditions, vapocoolants may not decrease the pain of patients with arterial puncture (SMD = -0.36, 95% CI = -0.92 to -0.19, P = 0.20), but may more effectively relieve pain for adults received vein puncture (SMD = -0.65, 95% CI = -0.85 to -0.45, P < 0.00001). The application of vapocoolant increased the procedural difficulty of medical personnel (RR = 2.49, 95% CI = 1.62 to 3.84, P<0.000 1) and participants were more willing to use the spray in the future (RR = 1.88, 95% CI = 1.34 to 2.64, P = 0.0002). There was no significant difference for the first attempt success rate of the procedure and the occurrence of adverse events.
CONCLUSIONS
Vapocoolant spray may relieve pain in adults received vein puncture and cannot cause severe side effects, but is ineffective in children. It also had no effect on patients with arterial puncture. In addition, the application of spray increases procedural difficulties for medical professionals, but does not decrease first attempt success rate, and many patients would like to use the spray again for pain relief in the future. Thus, more rigorous and large-scale studies are needed to determine its effectiveness in vascular access.
Topics: Humans; Adult; Child; Pain; Punctures; Catheterization; Pain Management; Phlebotomy
PubMed: 36780438
DOI: 10.1371/journal.pone.0279463 -
Neonatology 2023The noninvasive hemoglobin (NHb) devices are recently evaluated as an alternative to laboratory hemoglobin (LHb) in neonates. This systematic review explores the... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND OBJECTIVE
The noninvasive hemoglobin (NHb) devices are recently evaluated as an alternative to laboratory hemoglobin (LHb) in neonates. This systematic review explores the diagnostic accuracy of NHb devices for neonatal hemoglobin measurement.
METHODS
Literature related to the comparison of NHb device with LHb in neonates was searched from Medline, PubMed Central, PubMed, Web of Science, Google Scholar, and Scopus databases after PROSPERO registration. The quality of included publications was assessed by QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). The pooled correlation coefficient and bias (precision) in Bland-Altman difference plots were used for summary statistics using MetaXL 5.0 software.
RESULTS
A total of 1,477 paired NHb-LHb observations were analyzed from 1,047 neonates in 10 studies. Massimo radical-pulse co-oximetry (8 studies) and Mediscan-2000 (2 studies) were used for NHb estimation. The pooled correlation coefficient between NHb and LHb was r = 0.94 (95% CI: 0.83-0.98, p < 0.001), and the pooled bias (precision) was -0.013 (1.4) gm/dL between NHb and LHb measurements in Bland-Altman analysis. NHb device had better precision in stable neonates (0.91gm/dL) over sick neonates (1.66 gm/dL).
CONCLUSIONS
Hemoglobin measurement by NHb is excellently correlated with LHb measurement with a minimal average difference. It may be used as a screening tool for hemoglobin measurement in neonates to avoid frequent phlebotomy.
Topics: Infant, Newborn; Humans; Hemoglobins; Oximetry; Data Collection
PubMed: 36450265
DOI: 10.1159/000526100 -
The Cochrane Database of Systematic... Sep 2022Sickle cell disease (SCD) is one of the most common inherited diseases worldwide. It is associated with lifelong morbidity and a reduced life expectancy. Hydroxyurea... (Review)
Review
BACKGROUND
Sickle cell disease (SCD) is one of the most common inherited diseases worldwide. It is associated with lifelong morbidity and a reduced life expectancy. Hydroxyurea (hydroxycarbamide), an oral chemotherapeutic drug, ameliorates some of the clinical problems of SCD, in particular that of pain, by raising foetal haemoglobin (HbF). This is an update of a previously published Cochrane Review.
OBJECTIVES
The aims of this review are to determine through a review of randomised or quasi-randomised studies whether the use of hydroxyurea in people with SCD alters the pattern of acute events, including pain; prevents, delays or reverses organ dysfunction; alters mortality and quality of life; or is associated with adverse effects. In addition, we hoped to assess whether the response to hydroxyurea in SCD varies with the type of SCD, age of the individual, duration and dose of treatment, and healthcare setting.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched online trial registries. The date of the most recent search was 17 February 2022.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials (RCTs and quasi-RCTs), of one month or longer, comparing hydroxyurea with placebo or standard therapy in people with SCD.
DATA COLLECTION AND ANALYSIS
Authors independently assessed studies for inclusion, carried out data extraction, assessed the risk of bias and assessed the quality of the evidence using GRADE.
MAIN RESULTS
We included nine RCTs recruiting 1104 adults and children with SCD (haemoglobin SS (HbSS), haemoglobin SC (HbSC) or haemoglobin Sβºthalassaemia (HbSβºthal) genotypes). Studies lasted from six to 30 months. We judged the quality of the evidence for the first two comparisons below as moderate to low as the studies contributing to these comparisons were mostly large and well-designed (and at low risk of bias); however, the evidence was limited and imprecise for some outcomes such as quality of life, deaths during the studies and adverse events, and the results are applicable only to individuals with HbSS and HbSβºthal genotypes. We judged the quality of the evidence for the third and fourth comparisons to be very low due to the limited number of participants, the lack of statistical power (both studies were terminated early with approximately only 20% of their target sample size recruited) and the lack of applicability to all age groups and genotypes. Hydroxyurea versus placebo Five studies (784 adults and children with HbSS or HbSβºthal) compared hydroxyurea to placebo; four recruited individuals with only severe disease and one recruited individuals with all disease severities. Hydroxyurea probably improves pain alteration (using measures such as pain crisis frequency, duration, intensity, hospital admissions and opoid use) and life-threatening illness, but we found no difference in death rates (10 deaths occurred during the studies, but the rates did not differ by treatment group) (all moderate-quality evidence). Hydroxyurea may improve measures of HbF (low-quality evidence) and probably decreases neutrophil counts (moderate-quality evidence). There were no consistent differences in terms of quality of life and adverse events (including serious or life-threatening events) (low-quality evidence). There were fewer occurrences of acute chest syndrome and blood transfusions in the hydroxyurea groups. Hydroxyurea and phlebotomy versus transfusion and chelation Two studies (254 children with HbSS or HbSβºthal also with risk of primary or secondary stroke) contributed to this comparison. There were no consistent differences in terms of pain alteration, death or adverse events (low-quality evidence) or life-threatening illness (moderate-quality evidence). Hydroxyurea with phlebotomy probably increased HbF and decreased neutrophil counts (moderate-quality evidence), but there were more occurrences of acute chest syndrome and infections. Quality of life was not reported. In the primary prevention study, no strokes occurred in either treatment group but in the secondary prevention study, seven strokes occurred in the hydroxyurea and phlebotomy group (none in the transfusion and chelation group) and the study was terminated early. Hydroxyurea versus observation One study (22 children with HbSS or HbSβºthal also at risk of stoke) compared hydroxyurea to observation. Pain alteration and quality of life were not reported. There were no differences in life-threatening illness, death (no deaths reported in either group) or adverse events (very low-quality evidence). We are uncertain if hydroxyurea improves HbF or decreases neutrophil counts (very low-quality evidence). Treatment regimens with and without hydroxyurea One study (44 adults and children with HbSC) compared treatment regimens with and without hydroxyurea. Pain alteration, life-threatening illness and quality of life were not reported. There were no differences in death rates (no deaths reported in either group), adverse events or neutrophil levels (very low-quality evidence). We are uncertain if hydroxyurea improves HbF (very low-quality evidence).
AUTHORS' CONCLUSIONS
There is evidence to suggest that hydroxyurea may be effective in decreasing the frequency of pain episodes and other acute complications in adults and children with sickle cell anaemia of HbSS or HbSβºthal genotypes and in preventing life-threatening neurological events in those with sickle cell anaemia at risk of primary stroke by maintaining transcranial Doppler velocities. However, there is still insufficient evidence on the long-term benefits of hydroxyurea, particularly with regard to preventing chronic complications of SCD, or recommending a standard dose or dose escalation to maximum tolerated dose. There is also insufficient evidence about the long-term risks of hydroxyurea, including its effects on fertility and reproduction. Evidence is also limited on the effects of hydroxyurea on individuals with the HbSC genotype. Future studies should be designed to address such uncertainties.
Topics: Acute Chest Syndrome; Adult; Anemia, Sickle Cell; Antisickling Agents; Child; Hemoglobin, Sickle; Humans; Hydroxyurea; Pain; Stroke
PubMed: 36047926
DOI: 10.1002/14651858.CD002202.pub3 -
Annals of Palliative Medicine Nov 2021Vascular punctures are widely used in clinical applications; however, clinical trials have identified complications and poor prognosis for patients undergoing common... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vascular punctures are widely used in clinical applications; however, clinical trials have identified complications and poor prognosis for patients undergoing common peripheral vein puncture as compared to ultrasound-guided peripheral venipuncture and catheterization. Ultrasound-guided peripheral venipuncture and catheterization is accurate, simple, has fewer associated complications, and will gradually take the place of common peripheral vein puncture.
METHODS
To study the safety of ultrasound-guided peripheral venous catheterization, a meta-analysis was conducted of relevant articles dating from establishment date of the database (such as PubMed, MEDLINE and EMBASE) to March 2021, with the search keywords being peripheral venipuncture, ultrasound guidance, vascular injury rate, and hematoma formation rate. A total of 8 trials were used to determine accuracy indicators, which included puncture failure rate, arterial injury rate, hematoma formation rate, pneumothorax incidence rate, and hemothorax incidence rate.
RESULTS
There were statistically significant differences between the two methods for peripheral venipuncture and catheterization in terms of puncture failure rate [odds ratio (OR) =0.08; 95% CI: 0.04-0.16; P<0.00001], incidence of vascular injury (OR =0.15; 95% CI: 0.07-0.32; P<0.00001), probability of hematoma formation during the puncture process (OR =0.24; 95% CI: 0.08-0.69; P=0.008), and probability of pneumothorax during puncture (OR =0.10; 95% CI: 0.02-0.55; P=0.008).
DISCUSSION
Eight articles were included for meta-analysis. Ultrasound-guided peripheral venipuncture and catheterization is a commonly used puncture method for patients needing rapid fluid infusion with pressure or a pressure pump, repeated transfusion of blood product, or multiple daily venous blood drawing test. The results were very clear, and the puncture failure rate and other complications of ultrasound-guided peripheral venipuncture catheterization were low.
Topics: Catheterization, Central Venous; Clinical Trials as Topic; Humans; Incidence; Phlebotomy; Ultrasonography; Ultrasonography, Interventional
PubMed: 34872297
DOI: 10.21037/apm-21-3163 -
International Journal of Environmental... Feb 2021Blood collection is one of the most common nursing procedures and is not devoid of complications. The order of draw during blood collection is a controversial theme. We... (Review)
Review
Blood collection is one of the most common nursing procedures and is not devoid of complications. The order of draw during blood collection is a controversial theme. We aimed to define the efficacy of the order of draw during blood collection to guarantee an exact biochemical result. We carried out a systematic literature review on PubMed, Scopus, Web of Science, CINAHL, Embase, Joanna Briggs Institute, Cochrane Library, and Google Scholar. Articles written in English and published from 2000 to 2020 were considered suitable. The analysis of the 11 articles included highlighted different opinions; however, the most recent evidence declares that the cross-contamination caused by the incorrect order of draw is a trait only in the open system of drawing. The most recent evidence affirms the negligible effect of the order of draw during blood collection when using the closed blood collection system, while it is recommended when using the open collection system.
PubMed: 33562241
DOI: 10.3390/ijerph18041568 -
Health Technology Assessment... Feb 2021Rheumatoid arthritis is a chronic autoimmune disease that primarily causes inflammation, pain and stiffness in the joints. People with severe disease may be treated with...
Enzyme-linked immunosorbent assays for monitoring TNF-alpha inhibitors and antibody levels in people with rheumatoid arthritis: a systematic review and economic evaluation.
BACKGROUND
Rheumatoid arthritis is a chronic autoimmune disease that primarily causes inflammation, pain and stiffness in the joints. People with severe disease may be treated with biological disease-modifying anti-rheumatic drugs, including tumour necrosis factor-α inhibitors, but the efficacy of these drugs is hampered by the presence of anti-drug antibodies. Monitoring the response to these treatments typically involves clinical assessment using response criteria, such as Disease Activity Score in 28 joints or European League Against Rheumatism. Enzyme-linked immunosorbent assays can also be used to measure drug and antibody levels in the blood. These tests may inform whether or not adjustments to treatment are required or help clinicians to understand the reasons for treatment non-response or a loss of response.
METHODS
Systematic reviews were conducted to identify studies reporting on the clinical effectiveness and cost-effectiveness of using enzyme-linked immunosorbent assays to measure drug and anti-drug antibody levels to monitor the response to tumour necrosis factor-α inhibitors [adalimumab (Humira; AbbVie, Inc., North Chicago, IL, USA), etanercept (Enbrel; Pfizer, Inc., New York, NY, USA), infliximab (Remicade, Merck Sharp & Dohme Limited, Hoddesdon, UK), certolizumab pegol (Cimzia; UCB Pharma Limited, Slough, UK) and golimumab (Simponi; Merck Sharp & Dohme Limited)] in people with rheumatoid arthritis who had either achieved treatment target (remission or low disease activity) or shown primary or secondary non-response to treatment. A range of bibliographic databases, including MEDLINE, EMBASE and CENTRAL (Cochrane Central Register of Controlled Trials), were searched from inception to November 2018. The risk of bias was assessed using the Cochrane ROBINS-1 (Risk Of Bias In Non-randomised Studies - of Interventions) tool for non-randomised studies, with adaptations as appropriate. Threshold and cost-utility analyses that were based on a decision tree model were conducted to estimate the economic outcomes of adding therapeutic drug monitoring to standard care. The costs and resource use were considered from the perspective of the NHS and Personal Social Services. No discounting was applied to the costs and effects owing to the short-term time horizon of 18 months that was adopted in the economic analysis. The impact on the results of variations in testing and treatment strategies was explored in numerous clinically plausible sensitivity analyses.
RESULTS
Two studies were identified: (1) a non-randomised controlled trial, INGEBIO, that compared standard care with therapeutic drug monitoring using Promonitor assays [Progenika Biopharma SA (a Grifols-Progenika company), Derio, Spain] in Spanish patients receiving adalimumab who had achieved remission or low disease activity; and (2) a historical control study. The economic analyses were informed by INGEBIO. Different outcomes from INGEBIO produced inconsistent results in both threshold and cost-utility analyses. The cost-effectiveness of therapeutic drug monitoring varied, from the intervention being dominant to the incremental cost-effectiveness ratio of £164,009 per quality-adjusted life-year gained. However, when the frequency of testing was assumed to be once per year and the cost of phlebotomy appointments was excluded, therapeutic drug monitoring dominated standard care.
LIMITATIONS
There is limited relevant research evidence and much uncertainty about the clinical effectiveness and cost-effectiveness of using enzyme-linked immunosorbent assay-based testing for therapeutic drug monitoring in rheumatoid arthritis patients. INGEBIO had serious limitations in relation to the National Institute for Health and Care Excellence scope: only one-third of participants had rheumatoid arthritis, the analyses were mostly not by intention to treat and the follow-up was 18 months only. Moreover, the outcomes might not be generalisable to the NHS.
CONCLUSIONS
Based on the available evidence, no firm conclusions could be made about the cost-effectiveness of therapeutic drug monitoring in England and Wales.
FUTURE WORK
Further controlled trials are required to assess the impact of using enzyme-linked immunosorbent assays for monitoring the anti-tumour necrosis factors in people with rheumatoid arthritis.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42018105195.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 8. See the NIHR Journals Library website for further project information.
Topics: Arthritis, Rheumatoid; Controlled Clinical Trials as Topic; Cost-Benefit Analysis; Enzyme-Linked Immunosorbent Assay; Humans; Tumor Necrosis Factor Inhibitors; Tumor Necrosis Factor-alpha
PubMed: 33555998
DOI: 10.3310/hta25080