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Appropriateness Criteria

Reference Study Type Patients/Events Study Objective(Purpose of Study) Study Results Study Quality
1. Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin 2021;71:209-49. Review/Other-Dx N/A To provide an update on the global cancer burden using the GLOBOCAN 2020 estimates of cancer incidence and mortality produced by the International Agency for Research on Cancer. No results stated in abstract. 4
2. Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res 2014;74:2913-21. Review/Other-Dx N/A To review the projected cancer incidence for thyroid, liver and pancreas cancer. No results stated in abstract. 4
3. Singal AG, Reddy S, Radadiya Aka Patel H, et al. Multicenter Randomized Clinical Trial of a Mailed Outreach Strategy for Hepatocellular Carcinoma Surveillance. Clinical Gastroenterology & Hepatology. 20(12):2818-2825.e1, 2022 12. Observational-Dx 1436 patients To evaluate the effectiveness of mailed HCC surveillance outreach to promote HCC surveillance in patients with cirrhosis. Compared with usual care, the outreach arm had significantly higher semiannual surveillance (35.1% vs 21.9%) and lower no-surveillance (29.8% vs 43.5%) (P < .001), resulting in significant increases in the proportion of time covered by surveillance (41.3% vs 31.0%; P < .001). The intervention increased HCC surveillance across most predefined subgroups; however, there were site-level differences in the intervention effect, with significant increases in semiannual surveillance at the Veterans Affairs and safety net health systems but not at the tertiary care referral center. 3
4. Marrero JA, Kulik LM, Sirlin CB, et al. Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 68(2):723-750, 2018 Aug. Review/Other-Dx N/A To provide a data-supported approach to the diagnosis, staging, and treatment of patients diagnosed with hepatocellular carcinoma (HCC). No abstract available. 4
5. van der Pol CB, Lim CS, Sirlin CB, et al. Accuracy of the Liver Imaging Reporting and Data System in Computed Tomography and Magnetic Resonance Image Analysis of Hepatocellular Carcinoma or Overall Malignancy-A Systematic Review. Gastroenterology. 156(4):976-986, 2019 03. Meta-analysis 17 studies To determine the percentage of observations in each LI-RADS category for computed tomography and magnetic resonance imaging that are HCCs or malignancies. Of 454 studies identified, 17 (all retrospective studies) were included in the final analysis, consisting of 2760 patients, 3556 observations, and 2482 HCCs. The pooled percentages of observations confirmed as HCC and overall malignancy, respectively, were 94% (95% confidence interval [CI] 92%-96%) and 97% (95% CI 95%-99%) for LR-5, 74% (95% CI 67%-80%) and 80% (95% CI 75%-85%) for LR-4, 38% (95% CI 31%-45%) and 40% (95% CI 31%-50%) for LR-3, 13% (95% CI 8%-22%) and 14% (95% CI 9%-21%) for LR-2, 79% (95% CI 63%-89%) and 92% (95% CI 77%-98%) for LR-TIV, and 36% (95% CI 26%-48%) and 93% (95% CI 87%-97%) for LR-M. No malignancies were found in the LR-1 group. The percentage of HCCs and overall malignancies confirmed differed significantly among LR groups 2-5 (P < .00001). Patient selection was the most frequent factor that affected bias risk, because of verification bias and case-control study design. Good
6. Llovet JM, Zucman-Rossi J, Pikarsky E, et al. Hepatocellular carcinoma. Nat Rev Dis Primers 2016;2:16018. Review/Other-Dx N/A To review risk factors and staging classification for hepatocellular carcinoma. No results stated in abstract. 4
7. Polikoff A, Wessner CE, Balasubramanya R, et al. Imaging appearance of residual HCC following incomplete trans-arterial chemoembolization on contrast-enhanced imaging. Abdominal Radiology. 47(1):152-160, 2022 01. Observational-Dx 29 patients To describe changes in contrast agent kinetics in HCC following incomplete trans-arterial chemoembolization (TACE) on contrast-enhanced ultrasound (CEUS) and MRI/CT. Contrast-enhanced imaging data were collected from 29 patients with residual HCC post-TACE. On CEUS, 84.2% of patients with baseline APHE demonstrated APHE post-TACE (p = 0.25). On CE-MRI/CT, 57.1% of patients with baseline APHE later demonstrated APHE (p = 0.004). As for washout, on CEUS 33.3% of patients with baseline washout retained washout post-TACE (p = 0.01), while on CE-MRI/CT only 18.8% of patients with baseline washout later demonstrated washout (p < 0.001). Among CEUS readers, reader agreement was 100% for baseline APHE, 66.7% for baseline washout (K = 0.35), 84.2% for post-TACE APHE (K = 0.35), and 57.9% for post-TACE washout (K = - 0.09). On CE-MRI/CT, reader agreement was 65.5% for baseline APHE (K = 0.19), 55.2% for baseline washout (K = 0.12), 48.3% for post-TACE APHE (K = - 0.07), and 58.6% for post-TACE washout (K = 0.04). 3
8. Kim HA, Kim KA, Choi JI, et al. Comparison of biannual ultrasonography and annual non-contrast liver magnetic resonance imaging as surveillance tools for hepatocellular carcinoma in patients with liver cirrhosis (MAGNUS-HCC): a study protocol. BMC Cancer. 17(1):877, 2017 12 21. Review/Other-Dx N/A To evaluate and compare the feasibility and efficacy of non-contrast magnetic resonance imaging (MRI) with US as a surveillance tool for HCC in patients with liver cirrhosis. No results stated in abstract. 4
9. Kim SY, An J, Lim YS, et al. MRI With Liver-Specific Contrast for Surveillance of Patients With Cirrhosis at High Risk of Hepatocellular Carcinoma. JAMA Oncol. 3(4):456-463, 2017 Apr 01. Observational-Dx 407 patients To compare the HCC detection rate of US and MRI in patients with cirrhosis who are at high risk for HCC. A total of 407 eligible patients received 1100 screenings with paired US and MRI. Hepatocellular carcinomas were diagnosed in 43 patients: 1 detected by US only, 26 by MRI only, 11 by both, and 5 were missed by both. The HCC detection rate of MRI was 86.0% (37/43), significantly higher than the 27.9% (12/43) of US (P < .001). Magnetic resonance imaging showed a significantly lower rate of false-positive findings than US (3.0% vs 5.6%; P = .004). Of the 43 patients with HCC, 32 (74.4%) had very early-stage HCC (a single nodule <2 cm), and 29 (67.4%) received curative treatments. The 3-year survival rate of the patients with HCC (86.0%) was not inferior to those without HCC (94.2%; hazard ratio, 2.26; 95% CI, 0.92-5.56; P = .08). 3
10. Marks RM, Ryan A, Heba ER, et al. Diagnostic per-patient accuracy of an abbreviated hepatobiliary phase gadoxetic acid-enhanced MRI for hepatocellular carcinoma surveillance. AJR Am J Roentgenol. 204(3):527-35, 2015 Mar. Observational-Dx 298 Patients To evaluate the per-patient diagnostic performance of an abbreviated gadoxetic acid-enhanced MRI protocol for hepatocellular carcinoma (HCC) surveillance. Interreader agreement was substantial for both image sets (? = 0.72 for both) and intrareader agreement was excellent (? = 0.97-0.99). Reader performance for image set 1 was sensitivity of 85.7% for reader A and 79.6% for reader B, specificity of 91.2% for reader A and 95.2% for reader B, and negative predictive value of 97.0% for reader A and 96.0% for reader B. Reader performance for image set 2 was nearly identical, with only one of 298 examinations scored differently on image set 2 compared with set 1. 2
11. Demirtas CO, Gunduz F, Tuney D, et al. Annual contrast-enhanced magnetic resonance imaging is highly effective in the surveillance of hepatocellular carcinoma among cirrhotic patients. Eur J Gastroenterol Hepatol. 32(4):517-523, 2020 04. Observational-Dx 35 patients To investigate the effectiveness of a surveillance strategy using annual contrast-enhanced MRI to detect HCCs at early-stage. Thirty-five (11.9%) HCCs were detected with annual surveillance MRI. Of those, 30 (85.8%) were early-stage and 15 (42.9%) were very early-stage. The majority of patients (82.9%) with surveillance detected HCC were high risk at the entry. MRI had sensitivity of 83.3 and 80% with a specificity of 95.4 and 91.4%, for detecting early and very early-stage HCC, respectively. Addition of AFP to MRI displayed similar sensitivity and specificity rates to detect early and very early HCCs. The area under the curve of MRI alone and combination with AFP was not statistically different (Any-HCC: 0.905 vs. 0.924; Early-HCC: 0.853 vs. 0.885; Very early-HCC: 0.838 vs. 0.885, respectively, all P values >0.2). 3
12. Sutherland T, Watts J, Ryan M, et al. Diffusion-weighted MRI for hepatocellular carcinoma screening in chronic liver disease: Direct comparison with ultrasound screening. J Med Imaging Radiat Oncol. 61(1):34-39, 2017 Feb. Observational-Dx 192 patients To compare ultrasound screening with diffusion-weighted (DWI) MRI for detecting HCC. One hundred and ninety-two patients were recruited and HCC was diagnosed in six patients (3%); all of whom were detected at ultrasound screening, and five detected at MRI screening. Ultrasound had false-positive studies 20 times (10%) while DWI MRI had three false-positive examinations (2%) p>/=0.05. The sensitivity, specificity, positive predictive value and negative predictive values for ultrasound are 100%, 90%, 23% and 100%, respectively, while for MRI are 83%, 98%, 63% and 99%. 3
13. Bruix J, Sherman M, Llovet JM, et al. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol 2001;35:421-30. Review/Other-Dx N/A To provide conclusions on the clinical management of hepatocellular carcinoma. No results stated in abstract. 4
14. Zhang BH, Yang BH, Tang ZY. Randomized controlled trial of screening for hepatocellular carcinoma. J Cancer Res Clin Oncol 2004;130:417-22. Experimental-Tx 18,816 subjects To assess the effect of screening on HCC mortality in people at increased risk. The screened group completed 58.2 percent of the screening offered. When the screening group was compared to the control group, the number of HCC was 86 versus 67; subclinical HCC being 52 (60.5%) versus 0; small HCC 39 (45.3%) versus 0; resection achieved 40 (46.5%) versus 5 (7.5%); 1-, 3,-, and 5-year survival rate 65.9%, 52.6%, 46.4% versus 31.2%, 7.2%, 0, respectively. Thirty-two people died from HCC in the screened group versus 54 in the control group, and the HCC mortality rate was significantly lower in the screened group than in controls, being 83.2/100,000 and 131.5/100,000, respectively, with a mortality rate ratio of 0.63 (95%CI 0.41-0.98). 1
15. Moon AM, Weiss NS, Beste LA, et al. No Association Between Screening for Hepatocellular Carcinoma and Reduced Cancer-Related Mortality in Patients With Cirrhosis. Gastroenterology. 155(4):1128-1139.e6, 2018 10. Experimental-Dx 238 To determine whether screening by abdominal ultrasonography (USS) and/or by measuring serum level of a-fetoprotein (AFP) was associated with decreased cancer-related mortality in patients with cirrhosis. There were no significant differences between cases and controls in the proportions of patients who underwent screening USS (52.9% vs 54.2%), screening measurement of serum AFP (74.8% vs 73.5%), screening USS or measurement of serum AFP (81.1% vs 79.4%), or screening USS and measurement of serum AFP (46.6% vs 48.3%) within 4 years before the index date, with or without adjusting for potential confounders. There also was no difference in receipt of these screening tests within 1, 2, or 3 years before the index date. 4
16. Atiq O, Tiro J, Yopp AC, et al. An assessment of benefits and harms of hepatocellular carcinoma surveillance in patients with cirrhosis. Hepatology. 65(4):1196-1205, 2017 04. Observational-Dx 680 patients To characterize prevalence and correlates of surveillance benefits and harms in cirrhosis patients undergoing HCC surveillance. We identified 680 patients with cirrhosis, of whom 78 (11.5%) developed HCC during the 3-year study period. Of the 48 (61.5%) HCCs identified by surveillance, 43.8% were detected by ultrasound, 31.2% by AFP, and 25.0% by both surveillance tests. Surveillance-detected patients had a higher proportion of early HCC (70.2% vs. 40.0%; P = 0.009), with no difference in tumor stage between ultrasound- and AFP-detected tumors (P = 0.53). Surveillance-related physical harms were observed in 187 (27.5%) patients, with a higher proportion of ultrasound-related harm than AFP-related harm (22.8% vs. 11.4%; P < 0.001). Surveillance-related harms were associated with elevated ALT (odds ratio [OR], 1.87; 95% confidence interval [CI], 1.26-2.76), thrombocytopenia (OR, 2.06; 95% CI, 1.26-3.38), and hepatology subspecialty care (OR, 1.63; 95% CI, 1.09-2.42). 3
17. Nguyen SA, Merrill CD, Burrowes DP, Medellin GA, Wilson SR. Hepatocellular Carcinoma in Evolution: Correlation with CEUS LI-RADS. Radiographics. 42(4):1028-1042, 2022 Jul-Aug. Review/Other-Dx N/A To discuss correlation with CEUS LI-RADS for hepatocellular carcinoma. No results stated in abstract. 4
18. Motz VL, White R, Lee R, Vu T, Shin B, McGillen KL. Contrast-enhanced ultrasound for screening hepatocellular carcinoma: an implemented program at a semi-rural academic center. Abdominal Radiology. 46(9):4170-4177, 2021 09. Observational-Dx 100 patients To describe our early experience using a contrast-enhanced ultrasound (CEUS) protocol for surveillance of hepatocellular carcinoma (HCC) at a semi-rural academic medical center. 66 men and 34 women (average age, 59 +/- 13 years) were included. On average, the distance from patient's home to our institution was 39 miles (range 2-179 miles). The majority of our patients were covered under Private insurance (46%) with 43% covered by Medicare. CEUS exams on average took 35 min to complete. Lumason was administered in split doses for an average total of 5 mL per exam. Of the 10 lesions identified, there were five LI-RADS 3, two LI-RADS 4, one LI-RADS 5, two LI-RADS M, and one bland portal vein thrombus. There were no complications reported. 3
19. Tang A, Fowler KJ, Chernyak V, Chapman WC, Sirlin CB. LI-RADS and transplantation for hepatocellular carcinoma. [Review]. Abdominal Radiology. 43(1):193-202, 2018 01. Review/Other-Dx N/A To explain the conversion of LI-RADS observation categories to organ procurement and transplantation network classes, illustrates the radiologic T-staging systems, reviews selection criteria for liver transplant eligibility, and discusses prioritization of liver transplant candidates with HCC. No results stated in abstract. 4
20. Chalaye J, Costentin CE, Luciani A, et al. Positron emission tomography/computed tomography with 18F-fluorocholine improve tumor staging and treatment allocation in patients with hepatocellular carcinoma. J Hepatol. 69(2):336-344, 2018 08. Observational-Dx 177 patients To assess the impact of dual-tracer 18F-fluorocholine and 18F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) on tumor staging and treatment allocation. Patients were primarily men (87.5%) with cirrhosis (71%) due to alcohol?+/-?non-alcoholic steatohepatitis (26%), viral infection (62%) or unknown causes (12%). Among 122 patients with PET/CT performed for staging, BCLC stage based on conventional imaging was 0/A in 61 patients (50%), B in 32 patients (26%) and C in 29 patients (24%). Dual-tracer PET/CT detected new lesions in 26 patients (21%), upgraded BCLC staging in 14 (11%) and modified treatment strategy in 17 (14%). In addition, dual-tracer PET/CT modified the final treatment in 4/9 (44%) patients with unexplained elevation of alpha-fetoprotein (AFP), 10/25 patients (40%) with doubtful lesions on conventional imaging and 3/36 patients (8%) waiting for liver transplantation without active HCC after tumor response following bridging therapy. 3
21. Khan MA, Combs CS, Brunt EM, et al. Positron emission tomography scanning in the evaluation of hepatocellular carcinoma. J Hepatol 2000;32:792-7. Observational-Dx 20 patients To evaluate the role of PET imaging in the diagnosis of hepatocellular carcinoma. Of the 20 patients studied, 11 (55%) had positive PET scans (PET score: 3 or 4) while nine (45%) were negative (PET score: 1 or 2). CT scan was positive in 18 patients (90%) and negative in two (10%). PET, however, revealed metastases in three patients that were not seen on CT. On pathological review, well-differentiated and low-grade tumors had lower PET scores. Comparison of the well-differentiated with the moderately- and poorly-differentiated tumors revealed a statistically significant difference. No statistical significance was observed between the moderately- and poorly-differentiated tumors or between different tumor grades and PET scores 3
22. Au KP, Chok KSH. Multidisciplinary approach for post-liver transplant recurrence of hepatocellular carcinoma: A proposed management algorithm. [Review]. World Journal of Gastroenterology. 24(45):5081-5094, 2018 Dec 07. Review/Other-Dx N/A To propose multi-disciplinary management for post-liver transplant recurrence of hepatocellular carcinoma. No results stated in abstract. 4
23. Roberts LR, Sirlin CB, Zaiem F, et al. Imaging for the diagnosis of hepatocellular carcinoma: A systematic review and meta-analysis. [Review]. Hepatology. 67(1):401-421, 2018 01. Observational-Dx 33 studies To determine if there is a relative diagnostic benefit of multiphasic computed tomography (CT) versus magnetic resonance imaging (MRI), we synthesized evidence regarding the relative performance of CT, extracellular contrast-enhanced MRI, and gadoxetate-enhanced MRI for diagnosis of hepatocellular carcinoma (HCC) in patients with cirrhosis. We also assessed whether liver biopsy versus follow-up with the same versus alternative imaging is best for CT-indeterminate or MRI-indeterminate liver nodules in patients with cirrhosis. Of 33 included studies, 19 were comprehensive, while 14 reported sensitivity only. For all tumor sizes, the 19 comprehensive comparisons showed significantly higher sensitivity (0.82 versus 0.66) and lower negative likelihood ratio (0.20 versus 0.37) for MRI over CT. The specificities of MRI versus CT (0.91 versus 0.92) and the positive likelihood ratios (8.8 versus 8.1) were not different. All three modalities performed better for HCCs =2 cm. Performance was poor for HCCs <1 cm. No studies examined whether adults with cirrhosis and an indeterminate nodule are best evaluated using biopsy, repeated imaging, or alternative imaging. 4
24. Mirdad RS, Madison Hyer J, Diaz A, et al. Postoperative imaging surveillance for hepatocellular carcinoma: How much is enough?. J Surg Oncol. 123(7):1568-1577, 2021 Jun. Observational-Dx 130 patients To define trends in postoperative surveillance imaging following liver-directed treatment of hepatocellular carcinoma (HCC), and characterize the impact of high-intensity surveillance on long-term survival. Utilization of high-intensity surveillance abdominal imaging (>/=6 scans over 2 years) following liver-directed therapy of HCC decreased over time (2004-2007: n = 130, 36.1% vs. 2008-2011: n = 181, 29.5% vs. 2012-2016: n = 111, 24.5%; p(trend) < 0.001). History of chronic viral hepatitis (hepatitis B: odds ratio [OR], 1.98; 95% confidence interval [CI]: 1.15-3.43; hepatitis C: OR, 1.79; 95% CI: 1.32-2.43), presence of regional (vs. local-only) disease (OR, 1.47; 95% CI: 1.09-1.98) and receipt of transplantation (OR, 2.23; 95% CI: 1.57-3.17) were associated with higher odds of high intensity surveillance. Intensity of surveillance imaging was not associated with long-term survival (5-year overall survival: low-intensity, 48.1% vs. high-intensity, 48.9%; hazards ratio, 0.94; 95% CI: 0.78-1.13). 3
25. American College of Radiology Committee on LI-RADS®. Liver Imaging Reporting & Data System (LI-RADS®).  Available at: https://www.acr.org/Clinical-Resources/Reporting-and-Data-Systems/LI-RADS Review/Other-Dx N/A LI-RADS® was created to standardize the reporting and data collection of CT and MR imaging for hepatocellular carcinoma (HCC). No abstract available. 4
26. American College of Radiology. LI-RADS® CEUS Nonradiation TRA. v2024 Core.  Available at: https://edge.sitecorecloud.io/americancoldf5f-acrorgf92a-productioncb02-3650/media/ACR/Files/RADS/LI-RADS/LI-RADS-CEUS-Nonradiation-TRA-v2024-Core.pdf Review/Other-Dx N/A A comprehensive system for standardizing Contrast-Enhanced Ultrasound (CEUS) acquisition, interpretation, reporting, and data collection for HCC and select cases of non-HCC malignancies (iCCA and cHCC-CCA), treated with locoregional  therapy (LRT) or surgical resection. No abstract available. 4
27. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol 2018;69:182-236. Review/Other-Dx N/A To provide clinical practice guidelines for the management of hepatocellular carcinoma. No results stated in abstract. 4
28. Kulik L, Heimbach JK, Zaiem F, et al. Therapies for patients with hepatocellular carcinoma awaiting liver transplantation: A systematic review and meta-analysis. Hepatology 2018;67:381-400. Meta-analysis 15 studies To synthesize evidence regarding the effectiveness of LRT in the management of patients with HCC who were on the LT waitlist. In one series, the rate of dropout from all causes at 6 months in T1 HCC patients who underwent LRT was 5.3%, while in the other series of T1 HCC patients who did not receive LRT, the dropout rate at median follow-up of 2.4 years and the progression rate to T2 HCC were 30% and 88%, respectively. For adults with T2 HCC awaiting LT, transplant with any bridging therapy showed a nonsignificant reduction in the risk of waitlist dropout due to progression (relative risk [RR], 0.32; 95% confidence interval [CI], 0.06-1.85; I(2) = 0%) and of waitlist dropout from all causes (RR, 0.38; 95% CI, 0.060-2.370; I(2) = 85.7%) compared to no therapy based on three comparative studies. The quality of evidence is very low due to high risk of bias, imprecision, and inconsistency. There were five comparative studies which reported on posttransplant survival rates and 10 comparative studies which reported on posttransplant recurrence, and there was no significant difference seen in either of these endpoints. For adults initially with stage T3 HCC who received LRT, there were three studies reporting on transplant with any down-staging therapy versus no downstaging, and this showed a significant increase in 1-year (two studies, RR, 1.11; 95% CI, 1.01-1.23) and 5-year (1 study, RR, 1.17; 95% CI, 1.03-1.32) post-LT survival rates for patients who received LRT. The quality of evidence is very low due to serious risk of bias and imprecision. Good
29. National Academies of Sciences, Engineering, and Medicine; Division of Behavioral and Social Sciences and Education; Committee on National Statistics; Committee on Measuring Sex, Gender Identity, and Sexual Orientation. Measuring Sex, Gender Identity, and Sexual Orientation. In: Becker T, Chin M, Bates N, eds. Measuring Sex, Gender Identity, and Sexual Orientation. Washington (DC): National Academies Press (US) Copyright 2022 by the National Academy of Sciences. All rights reserved.; 2022. Review/Other-Dx N/A Sex and gender are often conflated under the assumptions that they are mutually determined and do not differ from each other; however, the growing visibility of transgender and intersex populations, as well as efforts to improve the measurement of sex and gender across many scientific fields, has demonstrated the need to reconsider how sex, gender, and the relationship between them are conceptualized. No abstract available. 4
30. American College of Radiology. ACR Appropriateness Criteria® Radiation Dose Assessment Introduction. Available at: https://edge.sitecorecloud.io/americancoldf5f-acrorgf92a-productioncb02-3650/media/ACR/Files/Clinical/Appropriateness-Criteria/ACR-Appropriateness-Criteria-Radiation-Dose-Assessment-Introduction.pdf. Review/Other-Dx N/A To provide evidence-based guidelines on exposure of patients to ionizing radiation. No abstract available. 4
No of Rows: 30
Definitions of Study Quality Categories
The study is well-designed and accounts for common biases. The source has all 8 diagnostic study quality elements present. The source has 5 or 6 therapeutic study quality elements
The study is moderately well-designed and accounts for most common biases. The source has 6 or 7 diagnostic study quality elements The source has 3 or 4 therapeutic study quality elements
There are important study design limitations. The source has 3, 4, or 5 diagnostic study quality elements The source has 1 or 2 therapeutic study quality elements
The study is not useful as primary evidence. The article may not be a clinical study or the study design is invalid, or conclusions are based on expert consensus. For example:
  1. The study does not meet the criteria for or is not a hypothesis-based clinical study (e.g., a book chapter or case report or case series description);
  2. The study may synthesize and draw conclusions about several studies such as a literature review article or book chapter but is not primary evidence;
  3. The study is an expert opinion or consensus document.
The source has 0, 1, or 2 diagnostic study quality elements present. The source has zero (0) therapeutic study quality elements.
  • Good quality – the study design, methods, analysis, and results are valid and the conclusion is supported.
  • Inadequate quality – the study design, analysis, and results lack the methodological rigor to be considered a good meta-analysis study.
n/a n/a
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