Reporting Quality of Systematic Reviews and Meta-Analyses of Otorhinolaryngologic Articles Based on the PRISMA Statement

Background

Systematic reviews (SRs) and meta-analyses (MAs) provide the highest possible level of evidence. However, poor conduct or reporting of SRs and MAs may reduce their utility. The PRISMA Statement (Preferred Reporting Items for Systematic reviews and Meta-Analyses) was developed to help authors report their SRs and MAs adequately.

Objectives

Our objectives were to (1) evaluate the quality of reporting of SRs and MAs and their abstracts in otorhinolaryngologic literature using the PRISMA and PRISMA for Abstracts checklists, respectively, (2) compare the quality of reporting of SRs and MAs published in Ear Nose Throat (ENT) journals to the quality of SRs and MAs published in the ‘gold standard’ Cochrane Database of Systematic Reviews (CDSR), and (3) formulate recommendations to improve reporting of SRs and MAs in ENT journals.

Methods

On September 3, 2014, we searched the Pubmed database using a combination of filters to retrieve SRs and MAs on otorhinolaryngologic topics published in 2012 and 2013 in the top 5 ENT journals (ISI Web of Knowledge 2013) or CDSR and relevant articles were selected. We assessed how many, and which, PRISMA (for Abstracts) items were reported adequately per journal type.

Results

We identified large differences in the reporting of individual items between the two journal types with room for improvement. In general, SRs and MAs published in ENT journals (n = 31) reported a median of 54.4% of the PRISMA items adequately, whereas the 49 articles published in the CDSR reported a median of 100.0 adequately (difference statistically significant, p < 0.001). For abstracts, medians of 41.7% for ENT journals and 75.0% for the CDSR were found (p < 0.001).

Conclusion

The reporting of SRs and MAs in ENT journals leaves room for improvement and would benefit if the PRISMA Statement were endorsed by these journals.     

Reporting Quality of Systematic Reviews/Meta-Analyses of Acupuncture

Background

The QUOROM and PRISMA statements were published in 1999 and 2009, respectively, to improve the consistency of reporting systematic reviews (SRs)/meta-analyses (MAs) of clinical trials. However, not all SRs/MAs adhere completely to these important standards. In particular, it is not clear how well SRs/MAs of acupuncture studies adhere to reporting standards and which reporting criteria are generally ignored in these analyses.

Objectives

To evaluate reporting quality in SRs/MAs of acupuncture studies.

Methods

We performed a literature search for studies published prior to 2014 using the following public archives: PubMed, EMBASE, Web of Science, the Cochrane Database of Systematic Reviews (CDSR), the Chinese Biomedical Literature Database (CBM), the Traditional Chinese Medicine (TCM) database, the Chinese Journal Full-text Database (CJFD), the Chinese Scientific Journal Full-text Database (CSJD), and the Wanfang database. Data were extracted into pre-prepared Excel data-extraction forms. Reporting quality was assessed based on the PRISMA checklist (27 items).

Results

Of 476 appropriate SRs/MAs identified in our search, 203, 227, and 46 were published in Chinese journals, international journals, and the Cochrane Database, respectively. In 476 SRs/MAs, only 3 reported the information completely. By contrast, approximately 4.93% (1/203), 8.81% (2/227) and 0.00% (0/46) SRs/Mas reported less than 10 items in Chinese journals, international journals and CDSR, respectively. In general, the least frequently reported items (reported≤50%) in SRs/MAs were “protocol and registration”, “risk of bias across studies”, and “additional analyses” in both methods and results sections.

Conclusions

SRs/MAs of acupuncture studies have not comprehensively reported information recommended in the PRISMA statement. Our study underscores that, in addition to focusing on careful study design and performance, attention should be paid to comprehensive reporting standards in SRs/MAs on acupuncture studies.     

Dose-dependence of protection from systemic reactions to venom immunotherapy by omalizumab

Background

Systemic reactions (SR) to venom immunotherapy (VIT) are rare but may occur, with a rate significantly higher for honeybee than for vespid VIT. In patients with repeated SRs to VIT it is difficult to reach the maintenance dose of venom and pre-treatment with omalizumab is indicated, as shown by some studies reporting its preventative capacity, when antihistamines and corticosteroids are ineffective.

Case presentation

We present the case of a 47 years old woman allergic to bee venom who experienced two severe SRs after bee stings and several SRs to VIT with bee venom. Pre-treatment with antihistamines and corticosteroids as well as omalizumab at doses up to 300 mg was unsuccessful, while an omalizumab dose of 450 mg finally achieved in our patient the protection from SRs to VIT with 200 mcg of bee venom.

Conclusions

The search of the dose of omalizumab able to protect a patient with repeated SRs to VIT may be demanding, but this search is warranted by the need to provide to this kind of patient, by an adequate VIT, the protection from potentially life-threatening reactions.

     

Blinded by PRISMA: Are Systematic Reviewers Focusing on PRISMA and Ignoring Other Guidelines?

Background

PRISMA guidelines have been developed to improve the reporting of systematic reviews (SRs). Other reporting guidelines and techniques to assess methodological quality of SRs have been developed. We aimed to assess the frequency of the use of reporting and other guidelines in SRs to assess whether PRISMA is being used inappropriately as a substitute for other relevant guidelines.

Methods

Web of Knowledge was searched to identify articles citing the PRISMA guidelines over a 12-month period. The use of reporting guidelines (including PRISMA and MOOSE) and tools for assessing methodological quality (including QUADAS) was assessed. Factors associated with appropriate use of guidelines including review type, field of publication and involvement of a methodologist were investigated.

Results

Over the 12-month period, 701 SRs were identified. MOOSE guidelines were cited in just 17% of epidemiologic reviews; QUADAS or QUADAS-2 was referred to in just 40% of diagnostic SRs. In the multivariable analysis, medical field of publication and methodologist involvement (OR = 1.97, 95% CI: 1.37, 2.83) were significant predictors of appropriate use of guidelines. Inclusion of a meta-analysis resulted in 73% higher odds of appropriate usage of systematic review guidelines (OR = 1.73, 95% CI: 1.22, 2.35).

Conclusions

Usage of SR reporting guidelines and tools for assessment of methodological quality other than PRISMA may be under-utilized with negative implications both for the reporting and methodological quality of systematic reviews.     

The Assessment of the Quality of Reporting of Systematic Reviews/Meta-Analyses in Diagnostic Tests Published by Authors in China

Background

The quality of reporting in systematic reviews (SRs)/meta-analyses (MAs) of diagnostic tests published by authors in China has not been evaluated. The aims of present study are to evaluate the quality of reporting in diagnostic SRs/MAs using the PRISMA statement and determine the changes in the quality of reporting over time.

Methods

According to the inclusion and exclusion criteria, we searched five databases including Chinese Biomedical Literature Database, PubMed, EMBASE, the Cochrane Library, and Web of knowledge, to identify SRs/MAs on diagnostic tests. The searches were conducted on July 14, 2012 and the cut off for inclusion of the SRs/MAs was December 31^st 2011. The PRISMA statement was used to assess the quality of reporting. Analysis was performed using Excel 2003, RevMan 5.

Results

A total of 312 studies were included. Fifteen diseases systems were covered. According to the PRISMA checklist, there had been serious reporting flaws in following items: structured summary (item 2, 22.4%), objectives (item 4, 18.9%), protocol and registration (item 5, 2.6%), risk of bias across studies (item 15, 26.3%), funding (item 27, 28.8%). The subgroup analysis showed that there had been some statistically significant improvement in total compliance for 9 PRISMA items after the PRISMA was released, 6 items were statistically improved regarding funded articles, 3 items were statistically improved for CSCD articles, and there was a statistically significant increase in the proportion of reviews reporting on 22 items for SCI articles (P<0.050).

Conclusion

The numbers of diagnostic SRs/MAs is increasing annually. The quality of reporting has measurably been improved over the previous years. Unfortunately, there are still many deficiencies in the reporting including protocol and registration, search, risk of bias across studies, and funding. Future Chinese reviewers should address issues on these aspects.     

Risk of bias tool in systematic reviews/meta-analyses of acupuncture in Chinese journals

Background

Use of a risk of bias (ROB) tool has been encouraged and advocated to reviewers writing systematic reviews (SRs) and meta-analyses (MAs). Selective outcome reporting and other sources of bias are included in the Cochrane ROB tool. It is important to know how this specific tool for assessing ROB has been applied since its release. Our objectives were to evaluate whether and to what extent the new Cochrane ROB tool has been used in Chinese journal papers of acupuncture.

Methods

We searched CBM, TCM database, CJFD, CSJD, and the Wanfang Database from inception to March 2011. Two reviewers independently selected SRs that primarily focused on acupuncture and moxibustion, from which the data was extracted and analyzed.

Results

A total of 836 SRs were identified from the search, of which, 105 were included and four are awaiting assessment. Thirty-six of the 105 SRs were published before release of the Cochrane ROB tool (up to 2009). Most used the Cochrane Handbook 4.2 or Jadad''s scale for risk or quality assessment. From 2009 to March 2011 69 SRs were identified. While “risk of bias” was reported for approximately two-thirds of SRs, only two SRs mentioned use of a “risk of bias tool” in their assessment. Only 5.8% (4/69) of reviews reported information on all six domains which are involved in the ROB tool. A risk of bias graph/summary figure was provided in 2.9% (2/69) of reviews. Most SRs gave information about sequence generation, allocation concealment, blindness, and incomplete outcome data, however, few reviews (5.8%; 4/69) described selective reporting or other potential sources of bias.

Conclusions

The Cochrane “risk of bias” tool has not been used in all SRs/MAs of acupuncture published in Chinese Journals after 2008. When the ROB tool was used, reporting of relevant information was often incomplete.     

Costs and benefits of giant sperm and sperm storage organs in Drosophila melanogaster

In Drosophila, long sperm are favoured in sperm competition based on the length of the female's primary sperm storage organ, the seminal receptacle (SR). This sperm–SR interaction, together with a genetic correlation between the traits, suggests that the coevolution of exaggerated sperm and SR lengths may be driven by Fisherian runaway selection. Here, we explore the costs and benefits of long sperm and SR genotypes, both in the sex that carries them and in the sex that does not. We measured male and female fitness in inbred lines of Drosophila melanogaster derived from four populations previously selected for long sperm, short sperm, long SRs or short SRs. We specifically asked: What are the costs and benefits of long sperm in males and long SRs in females? Furthermore, do genotypes that generate long sperm in males or long SRs in females impose a fitness cost on the opposite sex? Answers to these questions will address whether long sperm are an honest indicator of male fitness, male post‐copulatory success is associated with male precopulatory success, female choice benefits females or is costly, and intragenomic conflict could influence evolution of these traits. We found that both sexes have increased longevity in long sperm and long SR genotypes. Males, but not females, from long SR lines had higher fecundity. Our results suggest that sperm–SR coevolution is facilitated by both increased viability and indirect benefits of long sperm and SRs in both sexes.     

Effect of Risk of Bias on the Effect Size of Meta-Analytic Estimates in Randomized Controlled Trials in Periodontology and Implant Dentistry

BackgroundRisk of bias (ROB) may threaten the internal validity of a clinical trial by distorting the magnitude of treatment effect estimates, although some conflicting information on this assumption exists.ObjectiveThe objective of this study was evaluate the effect of ROB on the magnitude of treatment effect estimates in randomized controlled trials (RCTs) in periodontology and implant dentistry.MethodsA search for Cochrane systematic reviews (SRs), including meta-analyses of RCTs published in periodontology and implant dentistry fields, was performed in the Cochrane Library in September 2014. Random-effect meta-analyses were performed by grouping RCTs with different levels of ROBs in three domains (sequence generation, allocation concealment, and blinding of outcome assessment). To increase power and precision, only SRs with meta-analyses including at least 10 RCTs were included. Meta-regression was performed to investigate the association between ROB characteristics and the magnitudes of intervention effects in the meta-analyses.ResultsOf the 24 initially screened SRs, 21 SRs were excluded because they did not include at least 10 RCTs in the meta-analyses. Three SRs (two from periodontology field) generated information for conducting 27 meta-analyses. Meta-regression did not reveal significant differences in the relationship of the ROB level with the size of treatment effect estimates, although a trend for inflated estimates was observed in domains with unclear ROBs.ConclusionIn this sample of RCTs, high and (mainly) unclear risks of selection and detection biases did not seem to influence the size of treatment effect estimates, although several confounders might have influenced the strength of the association.     

Epidemiology, quality and reporting characteristics of systematic reviews of traditional Chinese medicine interventions published in Chinese journals

Background

Systematic reviews (SRs) of TCM have become increasingly popular in China and have been published in large numbers. This review provides the first examination of epidemiological characteristics of these SRs as well as compliance with the PRISMA and AMSTAR guidelines.

Objectives

To examine epidemiological and reporting characteristics as well as methodological quality of SRs of TCM published in Chinese journals.

Methods

Four Chinese databases were searched (CBM, CSJD, CJFD and Wanfang Database) for SRs of TCM, from inception through Dec 2009. Data were extracted into Excel spreadsheets. The PRISMA and AMSTAR checklists were used to assess reporting characteristics and methodological quality, respectively.

Results

A total of 369 SRs were identified, most (97.6%) of which used the terms systematic review or meta-analysis in the title. None of the reviews had been updated. Half (49.8%) were written by clinicians and nearly half (47.7%) were reported in specialty journals. The impact factors of 45.8% of the journals published in were zero. The most commonly treated conditions were diseases of the circulatory and digestive disease. Funding sources were not reported for any reviews. Most (68.8%) reported information about quality assessment, while less than half (43.6%) reported assessing for publication bias. Statistical mistakes appeared in one-third (29.3%) of reviews and most (91.9%) did not report on conflict of interest.

Conclusions

While many SRs of TCM interventions have been published in Chinese journals, the quality of these reviews is troubling. As a potential key source of information for clinicians and researchers, not only were many of these reviews incomplete, some contained mistakes or were misleading. Focusing on improving the quality of SRs of TCM, rather than continuing to publish them in great quantity, is urgently needed in order to increase the value of these studies.     

A review of surface roughness in antifouling coatings illustrating the importance of cutoff length

Abstract

Surface roughness (SR) can affect the hydrodynamic performance of antifouling (AF) coatings and influence the settlement behaviour of fouling larvae, which makes it an important parameter in the evaluation of novel coatings. This paper reviews the causes and consequences of SR in the shipping industry, the methodology used for measuring it, and the importance of measuring and reporting it correctly. SR is a parameter that originates from marine engineering, but has been used extensively by marine scientists to characterise novel coatings and to investigate microtopographies that might inhibit settlement behaviour. One of the integral components of the SR measurement is the use of a cutoff filter. This is a short-pass filter that lets the high wave-number components through and thus separates the waviness from the roughness. Depending on the length of this filter, roughness at different levels of magnification can be investigated. Much of the published work on SR of AF coatings makes no mention of cutoff length, so that the results cannot be compared. It is suggested that an international standard is needed and that if more researchers were aware of the significance of stating cutoff length when reporting SR, more interdisciplinary work between biologists, engineers and material scientists would be possible in this field.     

Mapping Systematic Reviews on Atopic Eczema—An Essential Resource for Dermatology Professionals and Researchers

Background

Many research studies have been published on atopic eczema and these are often summarised in systematic reviews (SRs). Identifying SRs can be time-consuming for health professionals, and researchers. In order to facilitate the identification of important research, we have compiled an on-line resource that includes all relevant eczema reviews published since 2000.

Methods

SRs were searched for in MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Database of Systematic Reviews, DARE and NHS Evidence. Selected SRs were assessed against the pre-defined eligibility criteria and relevant articles were grouped by treatment category for the included interventions. All identified systematic reviews are included in the Global Resource of EczemA Trials (GREAT) database (www.greatdatabase.org.uk) and key clinical messages are summarised here.

Results

A total of 128 SRs reviews were identified, including three clinical guidelines. Of these, 46 (36%) were found in the Cochrane Library. No single database contained all of the SRs found. The number of SRs published per year has increased substantially over the last thirteen years, and reviews were published in a variety of clinical journals. Of the 128 SRs, 1 (1%) was on mechanism, 37 (29%) were on epidemiology, 40 (31%) were on eczema prevention, 29 (23%) were on topical treatments, 31 (24%) were on systemic treatments, and 24 (19%) were on other treatments. All SRs included searches of MEDLINE in their search methods. One hundred six SRs (83%) searched more than one electronic database. There were no language restrictions reported in the search methods of 52 of the SRs (41%).

Conclusions

This mapping of atopic eczema reviews is a valuable resource. It will help healthcare practitioners, guideline writers, information specialists, and researchers to quickly identify relevant up-to-date evidence in the field for improving patient care.     

Financial Conflicts of Interest and Reporting Bias Regarding the Association between Sugar-Sweetened Beverages and Weight Gain: A Systematic Review of Systematic Reviews

Background

Industry sponsors'' financial interests might bias the conclusions of scientific research. We examined whether financial industry funding or the disclosure of potential conflicts of interest influenced the results of published systematic reviews (SRs) conducted in the field of sugar-sweetened beverages (SSBs) and weight gain or obesity.

Methods and Findings

We conducted a search of the PubMed, Cochrane Library, and Scopus databases to identify published SRs from the inception of the databases to August 31, 2013, on the association between SSB consumption and weight gain or obesity. SR conclusions were independently classified by two researchers into two groups: those that found a positive association and those that did not. These two reviewers were blinded with respect to the stated source of funding and the disclosure of conflicts of interest.We identified 17 SRs (with 18 conclusions). In six of the SRs a financial conflict of interest with some food industry was disclosed. Among those reviews without any reported conflict of interest, 83.3% of the conclusions (10/12) were that SSB consumption could be a potential risk factor for weight gain. In contrast, the same percentage of conclusions, 83.3% (5/6), of those SRs disclosing some financial conflict of interest with the food industry were that the scientific evidence was insufficient to support a positive association between SSB consumption and weight gain or obesity. Those reviews with conflicts of interest were five times more likely to present a conclusion of no positive association than those without them (relative risk: 5.0, 95% CI: 1.3–19.3).An important limitation of this study is the impossibility of ruling out the existence of publication bias among those studies not declaring any conflict of interest. However, the best large randomized trials also support a direct association between SSB consumption and weight gain or obesity.

Conclusions

Financial conflicts of interest may bias conclusions from SRs on SSB consumption and weight gain or obesity. Please see later in the article for the Editors'' Summary     

An Assessment of the Methodological Quality of Published Network Meta-Analyses: A Systematic Review

ObjectiveTo assess the methodological quality of published network meta-analysis.DesignSystematic review.MethodsWe searched the medical literature for network meta-analyses of pharmaceuticals. We assessed general study characteristics, study transparency and reproducibility, methodological approach, and reporting of findings. We compared studies published in journals with lower impact factors with those published in journals with higher impact factors, studies published prior to January 1^st, 2013 with those published after that date, and studies supported financially by industry with those supported by non-profit institutions or that received no support.ResultsThe systematic literature search identified 854 citations. Three hundred and eighteen studies met our inclusion criteria. The number of network meta-analyses has grown rapidly, with 48% of studies published since January 2013. The majority of network meta-analyses were supported by a non-profit institution or received no support (68%). We found considerable inconsistencies among reviewed studies. Eighty percent reported search terms, 61% a network diagram, 65% sufficient data to replicate the analysis, and 90% the characteristics of included trials. Seventy percent performed a risk of bias assessment of included trials, 40% an assessment of model fit, and 56% a sensitivity analysis. Among studies with a closed loop, 69% examined the consistency of direct and indirect evidence. Sixty-four percent of studies presented the full matrix of head-to-head treatment comparisons. For Bayesian studies, 41% reported the probability that each treatment was best, 31% reported treatment ranking, and 16% included the model code or referenced publicly-available code. Network meta-analyses published in higher impact factors journals and those that did not receive industry support performed better across the assessment criteria. We found few differences between older and newer studies.ConclusionsThere is substantial variation in the network meta-analysis literature. Consensus among guidelines is needed improve the methodological quality, transparency, and consistency of study conduct and reporting.     

Stratification ratio of soil organic carbon as an indicator of carbon sequestration and soil quality in ecological restoration

The stratified distribution of soil organic carbon (SOC) provides a potential means of eliminating the difference in soil background for understanding its response to ecological processes. We assessed the feasibility of SOC stratification ratio (SR) as an index to estimate the dynamics of SOC sequestration and soil quality during ecological restoration. SOC, total nitrogen, and available nitrogen contents were measured at restored sites containing three vegetation types with different stand ages and slope gradients, also at sites with three kinds of agricultural management on the hilly Loess Plateau, China. SR and SOC density (SOCD) showed a consistently significant trend of linear increase along the revegetation chronosequences. The proportion of the annual increase rates of SR to SOCD were approximately 1:15 and 1:5 for SR₁ (0–5:5–10 cm) and SR₂ (0–5:20–30 cm), indicating that SR of the shallow soil layers (0–10 cm) could estimate SOC accumulation to a depth of 30 cm. SRs significantly increased owing to the ecosystem restorations. Also, SRs could discriminate the difference in SOC sequestration and soil quality between vegetation types. SR, however, could not precisely indicate the variation of SOC sequestration and soil quality under different agricultural management. The study suggested that SR was an efficient indicator of the dynamics of SOC sequestration and soil quality, and an SR₂ (0–5:20–30 cm) >2 indicated a distinct improvement of SOC sequestration and soil quality in ecological restoration on the hilly Loess Plateau.     

Structural organization of the nine spectrin repeats of kalirin

Sequence analysis suggests that KALRN, a Rho GDP/GTP exchange factor genetically linked to schizophrenia, could contain as many as nine tandem spectrin repeats (SRs). We expressed and purified fragments of Kalirin containing from one to five putative SRs to determine whether they formed nested structures that could endow Kalirin with the flexible rodlike properties characteristic of spectrin and dystrophin. Far-UV circular dichroism studies indicated that Kalirin contains nine SRs. On the basis of thermal denaturation, sensitivity to chemical denaturants, and the solubility of pairs of repeats, the nine SRs of Kalirin form nested structures. Modeling studies confirmed this conclusion and identified an exposed loop in SR5; consistent with the modeling, this loop was extremely labile to proteolytic cleavage. Analysis of a direpeat fragment (SR4:5) encompassing the region of Kalirin known to interact with NOS2, DISC-1, PAM, and Arf6 identified this as the least stable region. Analytical ultracentrifugation indicated that SR1:3, SR4:6, and SR7:9 were monomers and adopted an extended conformation. Gel filtration suggested that ΔKal7, a natural isoform that includes SR5:9, was monomeric and was not more extended than SR5:9. Similarly, the nine SRs of Kal7, which was also monomeric, were not more extended than SR5:9. The rigidity and flexibility of the nine SRs of Kal7, which separate its essential N-terminal Sec14p domain from its catalytic domain, play an essential role in its contribution to the formation and function of dendritic spines.     

Saffron (Crocus sativus L.) and health outcomes: a meta-research review of meta-analyses and an evidence mapping study

BackgroundAlthough a number of systematic reviews and meta-analyses of saffron (Crocus sativus L.) have been published, no study has comprehensively summarized the clinical evidence from meta-analyses, or assessed the reporting or methodological quality of these reviews.PurposeThe present meta-research study was designed to fill the gaps in knowledge to inform future studies and allow enhanced clinical decision-making on saffron.MethodsThe PubMed, Cochrane Library, Embase, and CNKI databases were systematically searched from inception to April 3 rd, 2021, for meta-analyses of clinical trials that assessed the efficacy and safety of saffron. PRISMA 2009 and AMSTAR-2 were employed to assess the reporting and methodological quality of meta-analyses identified in the search, respectively. The present study was registered on PROSPERO with registration number CRD42020220274.ResultsNineteen eligible systematic reviews with meta-analyses published in English were identified from 235 records. These meta-analyses were published in 12 peer-reviewed journals from 2013 to 2021. The heterogeneous results indicated that saffron significantly reduced fasting blood glucose, waist circumference, diastolic blood pressure, concentrations of total cholesterol and low-density lipoprotein cholesterol, and improved symptoms of depression, cognitive function and sexual dysfunction compared with controls (mainly placebos). Common side effects of saffron consumption included nausea, dry mouth, poor appetite, and headache, but no serious adverse reactions were reported. Primary analysis and sensitivity analysis confirmed that the reporting and methodological quality of reviews included in the study were highly correlated (p < 0.001). The quality of meta-analyses of saffron requires improvement by including a structured abstract, a prospective protocol and registration, explanation of the study designs within each study that is reviewed, the searches, risk of bias assessment, literature selection, and reporting of funding sources.ConclusionThe available evidence indicates that saffron is a safe plant for administration as a medicine and can improve diverse clinical outcomes, but the scientific quality of the published systematic reviews needs to be improved. Moreover, the clinical effects of saffron need to be confirmed through high-quality randomized trials in multiple countries with large sample sizes.     

Relevance of the College of American Pathologists guideline for validating whole slide imaging for diagnostic purposes to cytopathology

Whole slide imaging (WSI) allows pathologists to view virtual versions of slides on computer monitors. With increasing adoption of digital pathology, laboratories have begun to validate their WSI systems for diagnostic purposes according to reference guidelines. Among these the College of American Pathologists (CAP) guideline includes three strong recommendations (SRs) and nine good practice statements (GPSs). To date, the application of WSI to cytopathology has been beyond the scope of the CAP guideline due to limited evidence. Herein we systematically reviewed the published literature on WSI validation studies in cytology. A systematic search was carried out in PubMed-MEDLINE and Embase databases up to November 2021 to identify all publications regarding validation of WSI in cytology. Each article was reviewed to determine if SRs and/or GPSs recommended by the CAP guideline were adequately satisfied. Of 3963 retrieved articles, 25 were included. Only 4/25 studies (16%) satisfied all three SRs, with only one publication (1/25, 4%) fulfilling all three SRs and nine GPSs. Lack of a suitable validation dataset was the main missing SR (16/25, 64%) and less than a third of the studies reported intra-observer variability data (7/25, 28%). Whilst the CAP guideline for WSI validation in clinical practice helped the widespread adoption of digital pathology, more evidence is required to routinely employ WSI for diagnostic purposes in cytopathology practice. More dedicated validation studies satisfying all SRs and/or GPSs recommended by the CAP are needed to help expedite the use of WSI for primary diagnosis in cytopathology.