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The Cochrane Database of Systematic... Jun 2024Persistent visceral pain is an unpleasant sensation coming from one or more organs within the body. Visceral pain is a common symptom in those with advanced cancer.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Persistent visceral pain is an unpleasant sensation coming from one or more organs within the body. Visceral pain is a common symptom in those with advanced cancer. Interventional procedures, such as neurolytic sympathetic nerve blocks, have been suggested as additional treatments that may play a part in optimising pain management for individuals with this condition.
OBJECTIVES
To evaluate the benefits and harms of neurolytic sympathetic nerve blocks for persistent visceral pain in adults with inoperable abdominopelvic cancer compared to standard care or placebo and comparing single blocks to combination blocks.
SEARCH METHODS
We searched the following databases without language restrictions on 19 October 2022 and ran a top-up search on 31 October 2023: CENTRAL; MEDLINE via Ovid; Embase via Ovid; LILACS. We searched trial registers without language restrictions on 2 November 2022: ClinicalTrials.gov; WHO International Clinical Trials Registry Platform (ICTRP). We searched grey literature, checked reference lists of reviews and retrieved articles for additional studies, and performed citation searches on key articles. We also contacted experts in the field for unpublished and ongoing trials. Our trial protocol was preregistered in the Cochrane Database of Systematic Reviews on 21 October 2022.
SELECTION CRITERIA
We searched for randomised controlled trials (RCTs) comparing any sympathetic nerve block targeting sites commonly used to treat abdominal pelvic pain from inoperable malignancies in adults to standard care or placebo.
DATA COLLECTION AND ANALYSIS
We independently selected trials based on predefined inclusion criteria, resolving any differences via adjudication with a third review author. We used a random-effects model as some heterogeneity was expected between the studies due to differences in the interventions being assessed and malignancy types included in the study population. We chose three primary outcomes and four secondary outcomes of interest. We sought consumer input to refine our review outcomes and assessed extracted data using Cochrane's risk of bias 2 tool (RoB 2). We assessed the certainty of evidence using the GRADE system.
MAIN RESULTS
We included 17 studies with 1025 participants in this review. Fifteen studies with a total of 951 participants contributed to the quantitative analysis. Single block versus standard care Primary outcomes No included studies reported our primary outcome, 'Proportion of participants reporting no worse than mild pain after treatment at 14 days'. The evidence is very uncertain about the effect of sympathetic nerve blocks on reducing pain to no worse than mild pain at 14 days when compared to standard care due to insufficient data (very low-certainty evidence). Sympathetic nerve blocks may provide small to 'little to no' improvement in quality of life (QOL) scores at 14 days after treatment when compared to standard care, but the evidence is very uncertain (standardised mean difference (SMD) -0.73, 95% confidence interval (CI) -1.70 to 0.25; I² = 87%; 4 studies, 150 participants; very low-certainty evidence). The evidence is very uncertain about the risk of serious adverse events as defined in our review as only one study contributed data to this outcome. Sympathetic nerve blocks may have an 'increased risk' to 'no additional risk' of harm compared with standard care (very low-certainty evidence). Secondary outcomes Sympathetic nerve blocks showed a small to 'little to no' effect on participant-reported pain scores at 14 days using a 0 to 10 visual analogue scale (VAS) for pain compared with standard care, but the evidence is very uncertain (mean difference (MD) -0.44, 95% CI -0.98 to 0.11; I² = 56%; 5 studies, 214 participants; very low-certainty evidence). There may be a 'moderate to large' to 'little to no' reduction in daily consumption of opioids postprocedure at 14 days with sympathetic nerve blocks compared with standard care, but the evidence is very uncertain (change in daily consumption of opioids at 14 days as oral milligrams morphine equivalent (MME): MD -41.63 mg, 95% CI -78.54 mg to -4.72 mg; I² = 90%; 4 studies, 130 participants; very low-certainty evidence). The evidence is very uncertain about the effect of sympathetic nerve blocks on participant satisfaction with procedure at 0 to 7 days and time to need for retreatment or treatment effect failure (or both) due to insufficient data. Combination block versus single block Primary outcomes There is no evidence about the effect of combination sympathetic nerve blocks compared with single sympathetic nerve blocks on the proportion of participants reporting no worse than mild pain after treatment at 14 days because no studies reported this outcome. There may be a small to 'little to no' effect on QOL score at 14 days after treatment, but the evidence is very uncertain (very low-certainty evidence). The evidence is very uncertain about the risk of serious adverse events with combination sympathetic nerve blocks compared with single sympathetic nerve blocks due to limited reporting in the included studies (very low-certainty evidence). Secondary outcomes The evidence is very uncertain about the effect of combination sympathetic nerve blocks compared with single sympathetic nerve blocks on participant-reported pain score and change in daily consumption of opioids postprocedure, at 14 days. There may be a small to 'little to no' effect, but the evidence is very uncertain (very low-certainty evidence). There is no evidence about the effect on participant satisfaction with procedure at 0 to 7 days and time to need for retreatment or treatment effect failure (or both) due to these outcomes not being measured by the studies. Risk of bias The risk of bias was predominately high for most outcomes in most studies due to significant concerns regarding adequate blinding. Very few studies were deemed as low risk across all domains for any outcome.
AUTHORS' CONCLUSIONS
There is limited evidence to support or refute the use of sympathetic nerve blocks for persistent abdominopelvic pain due to inoperable malignancy. We are very uncertain about the effect of combination sympathetic nerve blocks compared with single sympathetic nerve blocks. The certainty of the evidence is very low and these findings should be interpreted with caution.
Topics: Humans; Randomized Controlled Trials as Topic; Autonomic Nerve Block; Adult; Bias; Pelvic Neoplasms; Abdominal Neoplasms; Cancer Pain; Abdominal Pain; Pain Management; Nerve Block; Quality of Life
PubMed: 38842054
DOI: 10.1002/14651858.CD015229.pub2 -
Water Research Aug 2024Legionella is an opportunistic waterborne pathogen that causes Legionnaires' disease. It poses a significant public health risk, especially to vulnerable populations in...
Legionella is an opportunistic waterborne pathogen that causes Legionnaires' disease. It poses a significant public health risk, especially to vulnerable populations in health care facilities. It is ubiquitous in manufactured water systems and is transmitted via inhalation or aspiration of aerosols/water droplets generated from water fixtures (e.g., showers and hand basins). As such, the effective management of premise plumbing systems (building water systems) in health care facilities is essential for reducing the risk of Legionnaires' disease. Chemical disinfection is a commonly used control method and chlorine-based disinfectants, including chlorine, chloramine, and chlorine dioxide, have been used for over a century. However, the effectiveness of these disinfectants in premise plumbing systems is affected by various interconnected factors that can make it challenging to maintain effective disinfection. This systematic literature review identifies all studies that have examined the factors impacting the efficacy and decay of chlorine-based disinfectant within premise plumbing systems. A total of 117 field and laboratory-based studies were identified and included in this review. A total of 20 studies directly compared the effectiveness of the different chlorine-based disinfectants. The findings from these studies ranked the typical effectiveness as follows: chloramine > chlorine dioxide > chlorine. A total of 26 factors were identified across 117 studies as influencing the efficacy and decay of disinfectants in premise plumbing systems. These factors were sorted into categories of operational factors that are changed by the operation of water devices and fixtures (such as stagnation, temperature, water velocity), evolving factors which are changed in-directly (such as disinfectant concentration, Legionella disinfectant resistance, Legionella growth, season, biofilm and microbe, protozoa, nitrification, total organic carbon(TOC), pH, dissolved oxygen(DO), hardness, ammonia, and sediment and pipe deposit) and stable factors that are not often changed(such as disinfectant type, pipe material, pipe size, pipe age, water recirculating, softener, corrosion inhibitor, automatic sensor tap, building floor, and construction activity). A factor-effect map of each of these factors and whether they have a positive or negative association with disinfection efficacy against Legionella in premise plumbing systems is presented. It was also found that evaluating the effectiveness of chlorine disinfection as a water risk management strategy is further complicated by varying disinfection resistance of Legionella species and the form of Legionella (culturable/viable but non culturable, free living/biofilm associated, intracellular replication within amoeba hosts). Future research is needed that utilises sensors and other approaches to measure these key factors (such as pH, temperature, stagnation, water age and disinfection residual) in real time throughout premise plumbing systems. This information will support the development of improved models to predict disinfection within premise plumbing systems. The findings from this study will inform the use of chlorine-based disinfection within premise plumbing systems to reduce the risk of Legionnaires disease.
Topics: Disinfectants; Chlorine; Legionella; Disinfection; Chlorine Compounds; Water Microbiology; Chloramines; Water Supply; Oxides; Water Purification
PubMed: 38824796
DOI: 10.1016/j.watres.2024.121794 -
Pharmaceutics May 2024Andrographolide (ADG) has poor aqueous solubility and low bioavailability. This study systematically reviews the use of solid dispersion (SD) techniques to enhance the... (Review)
Review
Andrographolide (ADG) has poor aqueous solubility and low bioavailability. This study systematically reviews the use of solid dispersion (SD) techniques to enhance the solubility and absorption of ADG, with a focus on the methods and polymers utilized. We searched electronic databases including PubMed, Web of Science, Scopus, Embase and ScienceDirect Elsevier up to November 2023 for studies on the solubility or absorption of ADG in SD formulations. Two reviewers independently reviewed the retrieved articles and extracted data using a standardized form and synthesized the data qualitatively. SD significantly improved ADG solubility with up to a 4.7-fold increase and resulted in a decrease in 50% release time (T) to less than 5 min. SD could also improve ADG absorption, as evidenced by higher C and AUC and reduced T. Notably, Soluplus-based SDs showed marked solubility and absorption enhancements. Among the five SD techniques (rotary evaporation, spray drying, hot-melt extrusion, freeze drying and vacuum drying) examined, spray drying emerged as the most effective, enabling a one-step process without the need for post-milling. SD techniques, particularly using Soluplus and spray drying, effectively enhance the solubility and absorption of ADG. This insight is vital for the future development of ADG-SD matrices.
PubMed: 38794350
DOI: 10.3390/pharmaceutics16050688 -
MHealth 2023The Digital Healthcare Act, passed in November 2019, authorizes healthcare providers in Germany to prescribe digital health applications (DiGA) to patients covered by... (Review)
Review
BACKGROUND
The Digital Healthcare Act, passed in November 2019, authorizes healthcare providers in Germany to prescribe digital health applications (DiGA) to patients covered by statutory health insurance. If DiGA meet specific efficacy requirements, they may be listed in a special directory maintained by the German Federal Institute for Drugs and Medical Devices. Due to the lack of well-founded app evaluation tools, the objectives were to assess (I) the evidence quality situation for DiGA in the literature and (II) how DiGA manufacturers deal with this issue, as reflected by the apps available in the aforementioned directory.
METHODS
A systematic review of the literature on DiGA using PubMed, Scopus, and Web of Science was started on February 4, 2023. Papers addressing the evidence for applications listed in the directory were included, while duplicates and mere study protocols not reporting on data were removed. The remaining publications were used to assess the quality of the evidence or potential gaps in this regard. Results were aggregated in tabular form.
RESULTS
The review identified fourteen relevant publications. Six studies suggested inadequate scientific evidence, five mentioned shortcomings of tools for validating DiGA-related evidence, and four publications described a high potential for bias, potentially influencing the validity of the results. Concerns about limited external generalizability were also raised.
CONCLUSIONS
The literature review found evidence-related gaps that must be addressed with adequate measures. Our findings can serve as a basis for a plea for a more detailed examination of the quality of evidence in the DiGA context.
PubMed: 38023782
DOI: 10.21037/mhealth-23-17 -
Journal of Robotic Surgery Dec 2023This study aims to conduct a systematic review of full economic analyses of robotic-assisted surgery (RAS) in adults' thoracic and abdominopelvic indications. Authors... (Review)
Review
This study aims to conduct a systematic review of full economic analyses of robotic-assisted surgery (RAS) in adults' thoracic and abdominopelvic indications. Authors used Medline, EMBASE, and PubMed to conduct a systematic review following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) 2020 guidelines. Fully published economic articles in English were included. Methodology and reporting quality were assessed using standardized tools. Majority of studies (28/33) were on oncology procedures. Radical prostatectomy was the most reported procedure (16/33). Twenty-eight studies used quality-adjusted life years, and five used complication rates as outcomes. Nine used primary and 24 studies used secondary data. All studies used modeling. In 81% of studies (27/33), RAS was cost-effective or potentially cost-effective compared to comparator procedures, including radical prostatectomy, nephrectomy, and cystectomy. Societal perspective, longer-term time-horizon, and larger volumes favored RAS. Cost-drivers were length of stay and equipment cost. From societal and payer perspectives, robotic-assisted surgery is a cost-effective strategy for thoracic and abdominopelvic procedures.Clinical trial registration This study is a systematic review with no intervention, not a clinical trial.
Topics: Male; Humans; Cost-Benefit Analysis; Robotic Surgical Procedures; Prostate; Prostatectomy; Quality-Adjusted Life Years
PubMed: 37843673
DOI: 10.1007/s11701-023-01731-7 -
Towards smart sustainable development through value stream mapping - a systematic literature review.Heliyon May 2023Value Stream Mapping (VSM) is a standard Lean tool for identifying and reducing waste. It is used to create value and improve the performance of any industry. The value... (Review)
Review
Value Stream Mapping (VSM) is a standard Lean tool for identifying and reducing waste. It is used to create value and improve the performance of any industry. The value of the VSM has greatly expanded from conventional to smart over time; hence, researchers and practitioners in this sector are paying more emphasis. Comprehensive review research is needed to understand VSM-based smart, sustainable development from a triple-bottom-line perspective. The primary goal of this research is to look at various insights from the historical literature that can help with the adoption of smart, sustainable development through VSM. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) with a fifteen-year time range (2008-2022) is being considered to study various insights and gaps in value stream mapping. Analysis of the significant outcomes presents an eight-point study agenda: year, national context, research method, sector, wastes, VSM type, applied tools, and analysis indicators. The critical finding implies that empirical qualitative research dominates the research sector. Effective VSM implementation requires balancing the three sustainable dimensions of economic, environmental, and social through digitalization. The circular economy should also bolster research on the intersection of sustainability applications and new digital paradigms such as industry revolution 4.0.
PubMed: 37215771
DOI: 10.1016/j.heliyon.2023.e15852 -
The Cochrane Database of Systematic... Feb 2023The copper intrauterine device (Cu-IUD) is a highly effective method of contraception that can also be used for emergency contraception (EC). It is the most effective...
BACKGROUND
The copper intrauterine device (Cu-IUD) is a highly effective method of contraception that can also be used for emergency contraception (EC). It is the most effective form of EC, and is more effective than other existing oral regimens also used for EC. The Cu-IUD provides the unique benefit of providing ongoing contraception after it is inserted for EC; however, uptake of this intervention has been limited. Progestin IUDs are a popular method of long-acting, reversible contraception. If these devices were also found to be effective for EC, they would provide a critical additional option for women. These IUDs could not only provide EC and ongoing contraception, but additional non-contraceptive benefits, including a reduction in menstrual bleeding, cancer prevention, and pain management.
OBJECTIVES
To examine the safety and effectiveness of progestin-containing IUDs for emergency contraception, compared with copper-containing IUDs, or compared with dedicated oral hormonal methods.
SEARCH METHODS
We considered all randomized controlled trials and non-randomized studies of interventions that compared outcomes for individuals seeking a levonorgestrel IUD (LNG-IUD) for EC to a Cu-IUD or dedicated oral EC method. We considered full-text studies, conference abstracts, and unpublished data. We considered studies irrespective of their publication status and language of publication.
SELECTION CRITERIA
We included studies comparing progestin IUDs with copper-containing IUDs, or oral EC methods for emergency contraception.
DATA COLLECTION AND ANALYSIS
We systematically searched nine medical databases, two trials registries, and one gray literature site. We downloaded all titles and abstracts retrieved by electronic searching to a reference management database, and removed duplicates. Three review authors independently screened titles, abstracts, and full-text reports to determine studies eligible for inclusion. We followed standard Cochrane methodology to assess risk of bias, and analyze and interpret the data. We used GRADE methodology to assess the certainty of the evidence.
MAIN RESULTS
We included only one relevant study (711 women); a randomized, controlled, non-inferiority trial comparing LNG-IUDs to Cu-IUDs for EC, with a one-month follow-up. With one study, the evidence was very uncertain for the difference in pregnancy rates, failed insertion rates, expulsion rates, removal rates and the difference in the acceptability of the IUDs. There was also uncertain evidence suggesting the Cu-IUD may slightly increase rates of cramping and the LNG-IUD may slightly increase bleeding and spotting days. AUTHORS' CONCLUSIONS: This review is limited in its ability to provide definitive evidence regarding the LNG-IUD's equivalence, superiority, or inferiority to the Cu-IUD for EC. Only one study was identified in the review, which had possible risks of bias related to randomization and rare outcomes. Additional studies are needed to provide definitive evidence related to the effectiveness of the LNG-IUD for EC.
Topics: Female; Humans; Pregnancy; Contraception, Postcoital; Copper; Intrauterine Devices; Intrauterine Devices, Copper; Progestins; Randomized Controlled Trials as Topic; Steroids
PubMed: 36847591
DOI: 10.1002/14651858.CD013744.pub2 -
The Cochrane Database of Systematic... Feb 2023Since the previous Cochrane Review on this topic in 2016, debate has continued surrounding a potential role for vitamin D in reducing risk of asthma exacerbation and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Since the previous Cochrane Review on this topic in 2016, debate has continued surrounding a potential role for vitamin D in reducing risk of asthma exacerbation and improving asthma control. We therefore conducted an updated meta-analysis to include data from new trials completed since this date.
OBJECTIVES
To evaluate the effectiveness and safety of administration of vitamin D or its hydroxylated metabolites in reducing the risk of severe asthma exacerbations (defined as those requiring treatment with systemic corticosteroids) and improving asthma symptom control.
SEARCH METHODS
We searched the Cochrane Airways Group Trial Register and reference lists of articles. We contacted the authors of studies in order to identify additional trials. Date of last search: 8 September 2022.
SELECTION CRITERIA
We included double-blind, randomised, placebo-controlled trials of vitamin D in children and adults with asthma evaluating exacerbation risk or asthma symptom control, or both.
DATA COLLECTION AND ANALYSIS
Four review authors independently applied study inclusion criteria, extracted the data, and assessed risk of bias. We obtained missing data from the authors where possible. We reported results with 95% confidence intervals (CIs). The primary outcome was the incidence of severe asthma exacerbations requiring treatment with systemic corticosteroids. Secondary outcomes included the incidence of asthma exacerbations precipitating an emergency department visit or requiring hospital admission, or both, end-study childhood Asthma Control Test (cACT) or Asthma Control Test (ACT) scores, and end-study % predicted forced expiratory volume in one second (FEV1). We performed subgroup analyses to determine whether the effect of vitamin D on risk of asthma exacerbation was modified by baseline vitamin D status, vitamin D dose, frequency of dosing regimen, form of vitamin D given, and age of participants.
MAIN RESULTS
We included 20 studies in this review; 15 trials involving a total of 1155 children and five trials involving a total of 1070 adults contributed data to analyses. Participant ages ranged from 1 to 84 years, with two trials providing data specific to participants under five years (n = 69) and eight trials providing data specific to participants aged 5 to 16 (n = 766). Across the trials, 1245 participants were male and 1229 were female, with two studies not reporting sex distribution. Fifteen trials contributed to the primary outcome analysis of exacerbations requiring systemic corticosteroids. The duration of trials ranged from three to 40 months; all but two investigated effects of administering cholecalciferol (vitamin D3). As in the previous Cochrane Review, the majority of participants had mild to moderate asthma, and profound vitamin D deficiency (25-hydroxyvitamin D (25(OH)D) < 25 nmol/L) at baseline was rare. Administration of vitamin D or its hydroxylated metabolites did not reduce or increase the proportion of participants experiencing one or more asthma exacerbations treated with systemic corticosteroids (odds ratio (OR) 1.04, 95% CI 0.81 to 1.34; I = 0%; 14 studies, 1778 participants; high-quality evidence). This equates to an absolute risk of 226 per 1000 (95% CI 185 to 273) in the pooled vitamin D group, compared to a baseline risk of 219 participants per 1000 in the pooled placebo group. We also found no effect of vitamin D supplementation on the rate of exacerbations requiring systemic corticosteroids (rate ratio 0.86, 95% CI 0.62 to 1.19; I = 60%; 10 studies, 1599 participants; high-quality evidence), or the time to first exacerbation (hazard ratio 0.82, 95% CI 0.59 to 1.15; I = 22%; 3 studies, 850 participants; high-quality evidence). Subgroup analysis did not reveal any evidence of effect modification by baseline vitamin D status, vitamin D dose, frequency of dosing regimen, or age. A single trial investigating administration of calcidiol reported a benefit of the intervention for the primary outcome of asthma control. Vitamin D supplementation did not influence any secondary efficacy outcome meta-analysed, which were all based on moderate- or high-quality evidence. We observed no effect on the incidence of serious adverse events (OR 0.89, 95% CI 0.56 to 1.41; I = 0%; 12 studies, 1556 participants; high-quality evidence). The effect of vitamin D on fatal asthma exacerbations was not estimable, as no such events occurred in any trial. Six studies reported adverse reactions potentially attributable to vitamin D. These occurred across treatment and control arms and included hypercalciuria, hypervitaminosis D, kidney stones, gastrointestinal symptoms and mild itch. In one trial, we could not ascertain the total number of participants with hypercalciuria from the trial report. We assessed three trials as being at high risk of bias in at least one domain; none of these contributed data to the analysis of the outcomes reported above. Sensitivity analyses that excluded these trials from each outcome to which they contributed did not change the null findings.
AUTHORS' CONCLUSIONS
In contrast to findings of our previous Cochrane Review on this topic, this updated review does not find evidence to support a role for vitamin D supplementation or its hydroxylated metabolites to reduce risk of asthma exacerbations or improve asthma control. Participants with severe asthma and those with baseline 25(OH)D concentrations < 25 nmol/L were poorly represented, so further research is warranted here. A single study investigating effects of calcidiol yielded positive results, so further studies investigating effects of this metabolite are needed.
Topics: Adult; Child; Humans; Male; Female; Infant; Child, Preschool; Adolescent; Young Adult; Middle Aged; Aged; Aged, 80 and over; Calcifediol; Hypercalciuria; Disease Progression; Asthma; Vitamins; Adrenal Cortex Hormones; Vitamin D; Cholecalciferol; Anti-Asthmatic Agents; Randomized Controlled Trials as Topic
PubMed: 36744416
DOI: 10.1002/14651858.CD011511.pub3 -
Injury Prevention : Journal of the... Apr 2023Toppling televisions (TVs) are a source of childhood injury but meta-analysis has not assessed the likelihood of TV injuries in children. (Meta-Analysis)
Meta-Analysis
CONTEXT
Toppling televisions (TVs) are a source of childhood injury but meta-analysis has not assessed the likelihood of TV injuries in children.
OBJECTIVE
To present pooled results for injuries, following a systematic review.
DATA SOURCES
MEDLINE, Scopus, Google Scholar and EMBASE databases were searched to 5 December 2022.
STUDY SELECTION
Included studies met the following criteria: (1) assessed toppling TV injuries in paediatric populations; (2) reported point estimates as an OR or enabled its calculation and (3) used a comparison group.
DATA EXTRACTION
A standardised form was used to include information on publication year, study design, population type, country, sample size, mean age, risk factors, point estimates or data used to calculate ORs.
RESULTS
A total of 12 803 TV injuries were identified (five studies). Head and neck injuries (OR: 2.13, 95% CI: 1.21 to 3.75) and hospital admission (OR: 2.28, 95% CI: 1.80 to 2.90) were more likely in children aged under 6 years than over 6 years. Conversely, torso injuries were less likely in younger children (OR: 0.60, 95% CI: 0.51 to 0.70). Children under 6 were two and a half times more likely to die or be admitted to an intensive care unit (ICU) as a result of toppling TVs, although this was not statistically significant. Males did not sustain more TV injuries than females.
CONCLUSIONS
Children aged under 6 years are more likely to die, sustain head injuries and require hospital treatment from toppling TVs. Strategies for injury prevention must go beyond warning labels to include community education, promotion and use of tip restraint devices, mandatory safety standards and a commitment from manufacturers to improve TV sets stability.
Topics: Male; Female; Child; Humans; Adolescent; Craniocerebral Trauma; Hospitalization; Television; Risk Factors; Databases, Factual
PubMed: 36690352
DOI: 10.1136/ip-2022-044773 -
Clinical Infectious Diseases : An... Jun 2023We compared 6 new interferon-γ release assays (IGRAs; hereafter index tests: QFT-Plus, QFT-Plus CLIA, QIAreach, Wantai TB-IGRA, Standard E TB-Feron, and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
We compared 6 new interferon-γ release assays (IGRAs; hereafter index tests: QFT-Plus, QFT-Plus CLIA, QIAreach, Wantai TB-IGRA, Standard E TB-Feron, and T-SPOT.TB/T-Cell Select) with World Health Organization (WHO)-endorsed tests for tuberculosis infection (hereafter reference tests).
METHODS
Data sources (1 January 2007-18 August 2021) were Medline, Embase, Web of Science, Cochrane Database of Systematic Reviews, and manufacturers' data. Cross-sectional and cohort studies comparing the diagnostic performance of index and reference tests were selected. The primary outcomes of interest were the pooled differences in sensitivity and specificity between index and reference tests. The certainty of evidence (CoE) was summarized using the GRADE approach.
RESULTS
Eighty-seven studies were included (44 evaluated the QFT-Plus, 4 QFT-Plus CLIA, 3 QIAreach, 26 TB-IGRA, 10 TB-Feron [1 assessing the QFT-Plus], and 1 T-SPOT.TB/T-Cell Select). Compared to the QFT-GIT, QFT Plus's sensitivity was 0.1 percentage points lower (95% confidence interval [CI], -2.8 to 2.6; CoE: moderate), and its specificity 0.9 percentage points lower (95% CI, -1.0 to -.9; CoE: moderate). Compared to QFT-GIT, TB-IGRA's sensitivity was 3.0 percentage points higher (95% CI, -.2 to 6.2; CoE: very low), and its specificity 2.6 percentage points lower (95% CI, -4.2 to -1.0; CoE: low). Agreement between the QFT-Plus CLIA and QIAreach with QFT-Plus was excellent (pooled κ statistics of 0.86 [95% CI, .78 to .94; CoE: low]; and 0.96 [95% CI, .92 to 1.00; CoE: low], respectively). The pooled κ statistic comparing the TB-Feron and the QFT-Plus or QFT-GIT was 0.85 (95% CI, .79 to .92; CoE: low).
CONCLUSIONS
The QFT-Plus and the TB-IGRA have very similar sensitivity and specificity as WHO-approved IGRAs.
Topics: Humans; Interferon-gamma Release Tests; Cross-Sectional Studies; Tuberculosis; Latent Tuberculosis; Sensitivity and Specificity; Tuberculin Test; Mycobacterium tuberculosis
PubMed: 36688489
DOI: 10.1093/cid/ciad030