LF‐LAM‐ Lateral flow urine lipoarabinomannan assay for diagnosing active tuberculosis in people living with HIV Data form | ||
I. STUDY IDENTIFICATION | ||
1 | First author | |
2 | Corresponding author and email | |
3 | Title of study | |
4 | Year of publication | |
5 | Year of study start | |
6 | Language if other than English | |
II. STUDY DETAILS | ||
7 | Population | 1.Adults (15 years of age) 2.Children and adolescents 3.Both adults, children and adolescents 4.Other If other, describe |
8 | In which country or countries was the study conducted? | List all countries: |
9 | Country World Bank Classification (income) (World Bank 2018) | 1.Low income 2.Lower‐middle income 3.Upper‐middle‐income 4.High income 7. Other combination 9.Unknown/Not reported If other, describe: |
10 | Country WHO classification for high TB burden country (WHO Global Tuberculosis Report 2018) | 1.Yes, part of the High TB/HIV burden list 2.No, not part of the High TB/HIV burden list |
11 | Study design | 1.Randomized controlled trial 2.Cross‐sectional 3.Cohort 7.Other, specify 9.Could not tell If other, describe: |
12 | Was a case‐control design avoided? | 1.Yes 2.No 9.Unclear |
III. PATIENT SELECTION | ||
13 | What was the manner of participant selection into the study? | 1.Consecutive 2.Random 3.Convenience 7.Other, specify 9.Unknown/Not Reported/Unclear If other, describe: |
14 | Direction of study data collection | 1.Prospective 2.Retrospective 9.Unknown/Not reported |
15 | Please select the statement that best describes the selection of participants into the study. | 1.HIV‐positive participants with signs or symptoms suggestive of active tuberculosis were tested using LF‐LAM. Please provide study definition of ‘signs and symptoms’: 2.A preAlered target population of HIV‐positive individuals, irrespective of signs and symptoms of tuberculosis, were tested using LF‐LAM. Please specify target population: 3.Both 1 and 2 4.Neither 1 nor 2. This is what was done: |
16 | Sample size | 1._____ 9.Unknown/Not reported |
17 | Did the study avoid inappropriate exclusions? | 1.Yes 2.No 9.Unknown/Not reported/Unclear |
17a | Could the selection of patients have introduced bias? | 1.High risk 2.Low risk 9.Unclear risk |
18 | NOTES ON PATIENT SELECTION | |
IV. PATIENT CHARACTERISTICS AND SETTING | ||
19 | Presenting signs and symptoms | List |
20 | Age (years) | __________
If age is reported in median indicate IQR If age is reported in mean indicate SD |
21 | Age of all study participants, Range | Upper Lower |
22 | HIV infection (%) | |
23 | Participants included of female sex (%) | |
24 | CD4 | _________
If CD4 is reported in median indicate IQR If CD4 is reported in mean indicate SD |
25 | Number (percent) of tuberculosis cases in the study (%): | |
26 | What was the target condition? | 1.Pulmonary tuberculosis 2.Extra pulmonary tuberculosis 3.Mycobacteraemia 4.Both 1 and 2 5.Any of 1,2,3 7.Other, specify |
27 | Did the study include patients with prior tuberculosis history? | 1.Yes 2.No 9.Unknown/Not reported If yes, what is the % _____ Specify the numerator/denominator _____/_____ |
28 | What was the clinical setting of the study? | 1.Outpatient 2.Inpatient 3.Both out‐patient and in‐patient 7.Other, describe: 9.Unknown/Not reported |
29 | How would you describe the health facility where the study took place? | 1.Primary care clinic, stand alone 2.Primary care clinic, connected to a referral hospital 3.Referral hospital 7.Other, describe: 9.Unknown/Not reported |
30 | Are there concerns that the included patients and setting do not match the review question? | 1.High concern 2.Low concern 9.Unclear concern |
31 | NOTES ON CHARACTERISTICS | |
V. INDEX TEST | ||
32 | Was a LF‐LAM threshold used to define positivity that was pre‐specified in the primary analysis? | 1.Yes, Grade 1/5 2.Yes, Grade 2/5 3.Yes, Grade 1/4 4.Yes, Grade 2/4 5.No 7.Other, specify: |
33 | What LF‐LAM threshold was used to define positivity for data extraction? | 1.Grade 2/5 2.Grade 1/4 7. Other, specify |
34 | Are their concerns about index test conduct or interpretation differing from review question? | 1.High concern 2.Low concern 9.Unclear concern |
35 | Was LF‐LAM performed on fresh or stored urine? | 1.Fresh 2.Stored, specify type of storage (e.g. frozen) 3.Both fresh and stored 9.Unknown/Not reported |
36 | Was LF‐LAM result interpreted without knowledge of the result of the reference standard result? | 1.Yes 2.No 9.Unknown/Not reported/Unclear |
37 | Were there any LF‐LAM results that were invalid (no bar in control window)? | 1.Yes a.Specify number of invalid tests: _____ b.Were invalid tests repeated (yes/no): _____ 2.No 9. Unknown/Not reported |
38 | Could the conduct or interpretation of the index test have introduced bias? | 1.High risk 2.Low risk 9.Unclear risk |
39 | NOTES ON INDEX TEST | |
VI. REFERENCE STANDARD | ||
40 | For the diagnosis of pulmonary tuberculosis, what reference standard was used to identify tuberculosis and not tuberculosis? | 1.Sputum: solid culture 2.Sputum: liquid culture 3.Sputum: both solid and liquid culture 4.Nucleic acid amplification test, specify 5.Any of culture or nucleic amplification test, specify 7.Other, specify |
41 | Was sputum induction performed for individuals unable to produce expectorated sputum? | 1.Yes Specify N/% requiring sputum induction ____ 2.No |
42 | Were patients without sputum specimens (for example, no expectorated, no induced sputum) included in this study? | 1.Yes Specify N/% included without sputum ____ 2.No Specify N/% excluded due to lack of sputum____ |
43 | Were non‐pulmonary specimens evaluated to allow diagnosis of extrapulmonary tuberculosis? | 1.All participants received testing of non‐pulmonary specimens, please specify sites/fluids: 2.Some participants received testing of non‐pulmonary specimens, please specify which patients were tested, and sites/fluids: 3.Extrapulmonary tuberculosis was not evaluated 7.Other, please specify: |
44 | For the diagnosis of extrapulmonary tuberculosis, what tests were used to identify tuberculosis and not tuberculosis (circle all that apply)? | 1.Solid culture 2.Liquid culture 3.Both solid and liquid culture 4.Nucleic acid amplification test, specify 7.Other, specify: __________________________ 8.Not applicable, extrapulmonary tuberculosis was not evaluated |
45 | Did the study speciate mycobacteria isolated in culture? | 1.Yes 2.No 9.Unknown/Not reported |
46 | Was the reference standard likely to correctly classify the target condition | 1.Yes 2.No 9. Unclear |
47 | Was the reference standard result interpreted without knowledge of the result of LF‐LAM? | 1.Yes 2.No 9.Unclear |
48 | How many sputum specimens were obtained in order to detect pulmonary tuberculosis? | 1. Single 2. Multiple 8.Not applicable |
49 | How many specimens from fluid (sites) other than sputum were obtained to detect extrapulmonary tuberculosis? | 1. Single 2. Multiple 8.Not applicable |
50 | Could the reference standard, its conduct, or its interpretation have introduced bias? | 1.High risk 2.Low risk 9.Unclear risk |
51 | Are there concerns that the target condition as defined by the reference standard does not match the question? | 1.High concern 2.Low concern 9.Unclear concern |
52 | NOTES ON REFERENCE STANDARD | |
VII. FLOW AND TIMING | ||
53 | Was there appropriate interval between index test and reference standard | 1.Yes, specimens collected at the same time. 2.No, specimens collected greater than 7 days apart 9.Unclear |
54 | Did all patients receive a reference standard? | 1.Yes 2.No 9.Unclear |
55 | Did all patients receive the same reference standard? | 1.Yes 2.No (answer no if clinicians chose sample types, or other differences in reference standards between patients) 9.Unclear |
56 | Were all participants included in the analysis? | 1.Yes 2.No 9.Unclear |
57 | Could the patient flow have introduced bias? | 1.High risk 2.Low risk 9.Unclear risk |
58 | NOTES ON FLOW AND TIMING |