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Artikel: Trial Number and Sample Size Do Not Affect the Accuracy of the I2-Point Estimate for Testing Selection Bias Risk in Meta-Analyses.

Mickenautsch, Steffen / Yengopal, Veerasamy

2024 Band 16, Heft 4, Seite(n) e58961

Abstract: Aim This study aims to establish the test sensitivity and specificity of the ... ...

Abstract	Aim This study aims to establish the test sensitivity and specificity of the I
Sprache	Englisch
Erscheinungsdatum	2024-04-24
Erscheinungsland	United States
Dokumenttyp	Journal Article
ZDB-ID	2747273-5
ISSN	2168-8184
ISSN	2168-8184
DOI	10.7759/cureus.58961
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel: Allocation concealment appraisal of clinical therapy trials using the extended Composite Quality Score (CQS-2)-An empirically based update.

Mickenautsch, Steffen / Yengopal, Veerasamy

Frontiers in medicine

2023 Band 10, Seite(n) 1176219

Abstract: Objectives: The objective of this study was to revise CQS-2/Criterion II concerning allocation concealment appraisal for prospective, controlled clinical therapy trials.: Methods: Meta-analyses of trials with inadequate allocation concealment were ... ...

Abstract	Objectives: The objective of this study was to revise CQS-2/Criterion II concerning allocation concealment appraisal for prospective, controlled clinical therapy trials. Methods: Meta-analyses of trials with inadequate allocation concealment were tested for in-between trial heterogeneity ( Result: One suitable meta-analysis was identified. Two forest plots with data from five and four trials with inadequate/unclear allocation concealment were selected for testing. In addition, a total of five trials with adequate allocation concealment were identified. The meta-analysis test results were positive, and keywords for the judgment of adequate allocation concealment were extracted verbatim from the text of the meta-analysis. The extracted keywords indicated "central allocation" as the main criterion for adequate allocation concealment. Criterion II of the CQS-2 was revised accordingly. Conclusion: Criterion II of the CQS-2 trial appraisal tool was revised. The revised appraisal tool was specified as version CQS-2B.
Sprache	Englisch
Erscheinungsdatum	2023-06-15
Erscheinungsland	Switzerland
Dokumenttyp	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2023.1176219
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Allocation concealment appraisal of clinical therapy trials using the extended Composite Quality Score (CQS-2)—An empirically based update

Steffen Mickenautsch / Veerasamy Yengopal

Frontiers in Medicine, Vol

2023 Band 10

Abstract: ObjectivesThe objective of this study was to revise CQS-2/Criterion II concerning allocation concealment appraisal for prospective, controlled clinical therapy trials.MethodsMeta-analyses of trials with inadequate allocation concealment were tested for ... ...

Abstract	ObjectivesThe objective of this study was to revise CQS-2/Criterion II concerning allocation concealment appraisal for prospective, controlled clinical therapy trials.MethodsMeta-analyses of trials with inadequate allocation concealment were tested for in-between trial heterogeneity (I2 > 0) due to imbalances in baseline variables. Meta-analyses with positive test results were used as a basis to deduce criteria for adequate allocation concealment. The CQS-2/Criterion II was reformulated in line with the findings.ResultOne suitable meta-analysis was identified. Two forest plots with data from five and four trials with inadequate/unclear allocation concealment were selected for testing. In addition, a total of five trials with adequate allocation concealment were identified. The meta-analysis test results were positive, and keywords for the judgment of adequate allocation concealment were extracted verbatim from the text of the meta-analysis. The extracted keywords indicated “central allocation” as the main criterion for adequate allocation concealment. Criterion II of the CQS-2 was revised accordingly.ConclusionCriterion II of the CQS-2 trial appraisal tool was revised. The revised appraisal tool was specified as version CQS-2B.
Schlagwörter	Composite Quality Score ; systematic review ; trial appraisal ; clinical trial ; allocation concealment ; Medicine (General) ; R5-920
Thema/Rubrik (Code)	310
Sprache	Englisch
Erscheinungsdatum	2023-06-01T00:00:00Z
Verlag	Frontiers Media S.A.
Dokumenttyp	Artikel ; Online
Datenquelle	BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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Artikel: Application of the Composite Quality Score (CQS-2B) versus Cochrane's Risk of Bias tool (Version 2) in systematic reviews of clinical trials - an exploratory study.

Mickenautsch, Steffen / Rupf, Stefan / Yengopal, Veerasamy

Frontiers in medicine

2024 Band 11, Seite(n) 1307815

Abstract: Objectives: To explore whether systematic review conclusions generated from Cochrane's second version of its Risk of Bias tool (RoB 2) for trial appraisal differ when the Composite Quality Score, Version 2.B (CQS-2B) is used instead and to develop a ... ...

Abstract	Objectives: To explore whether systematic review conclusions generated from Cochrane's second version of its Risk of Bias tool (RoB 2) for trial appraisal differ when the Composite Quality Score, Version 2.B (CQS-2B) is used instead and to develop a testable hypothesis based on these findings. Methods: PubMed was searched for one single systematic review. From the review's accepted trials, data concerning effect estimates and overall bias risk according to the RoB 2 tool were extracted. All trial reports were appraised again using the CQS-2B. Datasets were stratified according to overall bias risk (RoB 2) or corroboration (C-) level (CQS-2B). The effect estimates from trials with 'low bias risk' (RoB 2) and with highest C-level (CQS-2B) were pooled separately. These pooled effect estimates were statistically and all clinical conclusions qualitatively compared. Results: The pooled effect estimates for trials with 'low bias risk' (RoB 2) were -0.07, 95% CI: -0.10 to -0.04 ( Conclusion: A testable hypothesis was generated suggesting that trial appraisal using the CQS-2B may provide more conservative conclusions based on similar data than with the RoB 2 tool.
Sprache	Englisch
Erscheinungsdatum	2024-05-02
Erscheinungsland	Switzerland
Dokumenttyp	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2024.1307815
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Oral health-related quality of life among people living with HIV and HIV-negative adults in Kigali, Rwanda: a comparative cross-sectional study.

Murererehe, Julienne / Malele-Kolisa, Yolanda / Niragire, François / Yengopal, Veerasamy

BMC oral health

2024 Band 24, Heft 1, Seite(n) 128

Abstract: Background: Assessing health-related quality of life has become integral to people living with HIV (PLHIV) follow-up. However, there is a lack of data regarding the impact of oral health on quality of life, known as Oral health-related quality of life ( ... ...

Abstract	Background: Assessing health-related quality of life has become integral to people living with HIV (PLHIV) follow-up. However, there is a lack of data regarding the impact of oral health on quality of life, known as Oral health-related quality of life (OHRQoL) among PLHIV compared to HIV-negative individuals in Rwanda. Aim: The study aimed to assess OHRQoL among PLHIV compared to HIV-negative counterparts in Kigali, Rwanda. Methods: The Oral Health Impact Profile short version (OHIP-14) questionnaire was interviewer-administered to 200 PLHIV and 200 HIV-negative adults (≥ 18 years old) at an HIV clinic of Kigali Teaching Hospital (CHUK). Socio-demographic characteristics, including age, sex, occupation, and socioeconomic status (SES) of participants, were collected using a survey questionnaire. A 4-point Likert scale was used to assess the frequency of oral impacts for all 14 items within 7 domains of the OHIP tool. The descriptive statistics were used to see frequencies and percentages of OHRQoL among PLHIV and HIV-negative persons, respectively. The Chi-square test was used to determine the association of OHRQoL with caries (DMFT) and periodontal disease (CPITN) among PLHIV compared to HIV-negative individuals. Results: The results revealed a higher prevalence of PLHIV with poor OHRQoL than HIV-negative individuals in 5 domains and almost all items of OHIP-14 except for the OHIP 3 (found it uncomfortable to eat any foods because of problems with teeth or mouth) and OHIP-14 (being totally unable to function because of problems with teeth or mouth). The findings showed statistically significant results (p ≤ 0.05) for the OHIP1 item "trouble pronouncing any word," with a prevalence of 2.5% (n = 11) and 2.25% (n = 9) in PLHIV and HIV-negative, respectively. Also, PLHIV had a significantly higher prevalence, 2.75% (n = 11) for the OHIP 13 item "life not satisfying due to teeth and mouth problems compared to HIV-negative individuals 2% (8) p ≤ 0.05. Moreover, dental caries was significantly associated with poor OHRQoL among PLHIV and HIV-negative adults and for all 14 items of the OHIP tool. Periodontal disease was not significantly associated with OHRQoL among PLHIV and HIV-negative adults. Conclusion: This study revealed poor OHRQoL among PLHIV compared to HIV-negative adults. There is a need for further longitudinal studies to investigate the OHRQoL in Rwanda, especially among PLHIV. It is essential to include oral health care as one of the components of the medical health care programs for PLHIV in Rwanda.
Mesh-Begriff(e)	Adult ; Humans ; Adolescent ; Quality of Life ; Dental Caries/epidemiology ; Dental Caries/complications ; Cross-Sectional Studies ; Rwanda/epidemiology ; Oral Health ; Periodontal Diseases/epidemiology ; Surveys and Questionnaires ; HIV Infections/complications ; HIV Infections/epidemiology
Sprache	Englisch
Erscheinungsdatum	2024-01-25
Erscheinungsland	England
Dokumenttyp	Journal Article
ZDB-ID	2091511-1
ISSN	1472-6831 ; 1472-6831
ISSN (online)	1472-6831
ISSN	1472-6831
DOI	10.1186/s12903-023-03828-9
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: The Composite Quality Score (CQS) as an Appraisal Tool for Prospective, Controlled Clinical Therapy Trials: Rationale and Current Evidence.

Mickenautsch, Steffen / Rupf, Stefan / Miletić, Ivana / Yengopal, Veerasamy

Reviews on recent clinical trials

2023 Band 18, Heft 1, Seite(n) 28–33

Abstract: Background: Current evidence appraisal concepts, such as the Assessment, Development and Evaluation (GRADE) approach and Cochrane's Risk of Bias (RoB) tool, rely on assumptions related to the classic problem of inductive reasoning and may suffer from ... ...

Abstract	Background: Current evidence appraisal concepts, such as the Assessment, Development and Evaluation (GRADE) approach and Cochrane's Risk of Bias (RoB) tool, rely on assumptions related to the classic problem of inductive reasoning and may suffer from insufficient inter-rater reliability. Discussion: The Composite Quality Score (CQS) has emerged as a possible trial appraisal tool that does not rely on inductive assumptions and has been shown to be of potentially very high inter-rater reliability. Conclusion: Although the current CQS concept is still under development, its current evidence is encouraging and justifies further study. This article presents the rationale and currently available research concerning the CQS and shows where further research is required.
Mesh-Begriff(e)	Humans ; Bias ; Problem Solving ; Prospective Studies ; Reproducibility of Results ; Controlled Clinical Trials as Topic
Sprache	Englisch
Erscheinungsdatum	2023-01-30
Erscheinungsland	United Arab Emirates
Dokumenttyp	Journal Article
ZDB-ID	2251879-4
ISSN	1876-1038 ; 1574-8871
ISSN (online)	1876-1038
ISSN	1574-8871
DOI	10.2174/1574887118666230104152245
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel: The composite quality score for the appraisal of prospective controlled clinical therapy trials in systematic reviews and its limits.

Mickenautsch, Steffen / Rupf, Stefan / Yengopal, Veerasamy

Frontiers in medicine

2023 Band 10, Seite(n) 1201951

Abstract: Systematic reviews of prospective controlled clinical therapy trials are one of the most important sources of information in modern medicine. Besides the systematic search for and statistical pooling of current clinical trial data for a particular type ... ...

Abstract	Systematic reviews of prospective controlled clinical therapy trials are one of the most important sources of information in modern medicine. Besides the systematic search for and statistical pooling of current clinical trial data for a particular type of therapy, systematic reviews also have the task of appraising the quality of trial results. The quality of trial results may be diminished by low internal trial validity, due to systematic error (bias). A high risk of bias may likely cause the reported trial results to be diverted from the actual true therapeutic effect and thus render it unsuitable for clinical guidance. According to the Cochrane Collaboration, the risk of bias in clinical therapy trials should be assessed using its Risk of Bias tool, Version 2 (RoB 2). However, the tool has been established to have poor inter-rater reliability, with a limited empirical evidence base and described as complex and demanding. Against this background, the composite quality score (CQS) has been developed as a possible alternative trial appraisal tool, characterised by high epistemic rigour, empirical evidence base, inter-rater reliability and ease of use. This article presents the current evidence of the CQS and its limitations.
Sprache	Englisch
Erscheinungsdatum	2023-06-28
Erscheinungsland	Switzerland
Dokumenttyp	Journal Article ; Review
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2023.1201951
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Correction: Exploring reasons why South African dental therapists are leaving their profession: A theory-informed qualitative study.

Sodo, Pumla Pamella / Malele-Kolisa, Yolanda / Moola, Aneesa / Yengopal, Veerasamy / Nemutandani, Simon / Jewett, Sara

PloS one

2024 Band 19, Heft 3, Seite(n) e0300094

Abstract: This corrects the article DOI: 10.1371/journal.pone.0293039.]. ...

Abstract	[This corrects the article DOI: 10.1371/journal.pone.0293039.].
Sprache	Englisch
Erscheinungsdatum	2024-03-05
Erscheinungsland	United States
Dokumenttyp	Published Erratum
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0300094
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: The composite quality score for the appraisal of prospective controlled clinical therapy trials in systematic reviews and its limits

Steffen Mickenautsch / Stefan Rupf / Veerasamy Yengopal

Frontiers in Medicine, Vol

2023 Band 10

Abstract	Systematic reviews of prospective controlled clinical therapy trials are one of the most important sources of information in modern medicine. Besides the systematic search for and statistical pooling of current clinical trial data for a particular type of therapy, systematic reviews also have the task of appraising the quality of trial results. The quality of trial results may be diminished by low internal trial validity, due to systematic error (bias). A high risk of bias may likely cause the reported trial results to be diverted from the actual true therapeutic effect and thus render it unsuitable for clinical guidance. According to the Cochrane Collaboration, the risk of bias in clinical therapy trials should be assessed using its Risk of Bias tool, Version 2 (RoB 2). However, the tool has been established to have poor inter-rater reliability, with a limited empirical evidence base and described as complex and demanding. Against this background, the composite quality score (CQS) has been developed as a possible alternative trial appraisal tool, characterised by high epistemic rigour, empirical evidence base, inter-rater reliability and ease of use. This article presents the current evidence of the CQS and its limitations.
Schlagwörter	composite quality score ; clincial rial ; trial appraisal ; systematic review ; bias ; Medicine (General) ; R5-920
Thema/Rubrik (Code)	610
Sprache	Englisch
Erscheinungsdatum	2023-06-01T00:00:00Z
Verlag	Frontiers Media S.A.
Dokumenttyp	Artikel ; Online
Datenquelle	BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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Artikel ; Online: Validation of the Child-Oral-Health-Impact-Profile among adolescents in Johannesburg: A cross-sectional study.

Malele-Kolisa, Yolanda / Maposa, Innocent / Yengopal, Veerasamy / Igumbor, Jude

African journal of primary health care & family medicine

2023 Band 15, Heft 1, Seite(n) e1–e8

Abstract: Background: Oral health-related quality of life (OHRQol) is described as the effect of oral conditions on the overall functioning and well-being of individuals.: Aim: This study sought to determine the validity of a modified-child oral health ... ...

Abstract	Background: Oral health-related quality of life (OHRQol) is described as the effect of oral conditions on the overall functioning and well-being of individuals. Aim: This study sought to determine the validity of a modified-child oral health impact profile (M-COHIP) among adolescents living with the human immunodeficiency virus (HIV) infection (ALHIV) and HIV-undiagnosed adolescents and establish the factors influencing OHRQoL among adolescents in central Johannesburg. Setting: Schools and HIV wellness centre in central Johannesburg. Methods: An interviewer-administered questionnaire was applied, followed by an oral examination. Results: A total of 504 adolescents were included in the study. The overall mean decayed teeth for permanent dentition was 1.6 (standard deviation [s.d.]: 1.99) and caries prevalence was 62.2% (n = 309). The tool's Cronbach's alpha was 0.88. The item-rest correlations were from 0.6 to 0.85 for all items. The initial exploratory factor analysis explained 76% of the total variance. The overall M-COHIP score was 59.6 (18.2). The overall modified-COHIP scores for those not in care (schools) were higher [62.88] than those of ALHIV. The poor M-COHIP scores were associated with reporting toothache, having active decay, poor oral health-self-rating, and being selected from the school site (p 0.005). Conclusion: The validation study supports the use of the tool as a reliable and valid measure of OHRQoL. Future research can investigate the extent to which the tool is effective in measuring treatment outcomes and patient satisfaction.Contribution: The validated tool will be beneficial in the African context for programme assessments and overall measure of quality-of-life impacts from oral conditions.
Mesh-Begriff(e)	Humans ; Adolescent ; Quality of Life ; Cross-Sectional Studies ; Reproducibility of Results ; Psychometrics ; South Africa/epidemiology ; Surveys and Questionnaires ; Oral Health ; HIV Infections/epidemiology
Sprache	Englisch
Erscheinungsdatum	2023-10-25
Erscheinungsland	South Africa
Dokumenttyp	Journal Article
ZDB-ID	2526836-3
ISSN	2071-2936 ; 2071-2936
ISSN (online)	2071-2936
ISSN	2071-2936
DOI	10.4102/phcfm.v15i1.3993
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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