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

Mickenautsch, Steffen / Yengopal, Veerasamy

2023 Volume 10, Page(s) 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.
Language	English
Publishing date	2023-06-15
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2023.1176219
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Article ; 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 Volume 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.
Keywords	Composite Quality Score ; systematic review ; trial appraisal ; clinical trial ; allocation concealment ; Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2023-06-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
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Article ; 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 Volume 24, Issue 1, Page(s) 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 term(s)	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
Language	English
Publishing date	2024-01-25
Publishing country	England
Document type	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
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Article: 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 Volume 10, Page(s) 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.
Language	English
Publishing date	2023-06-28
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2023.1201951
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Article ; 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 Volume 18, Issue 1, Page(s) 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 term(s)	Humans ; Bias ; Problem Solving ; Prospective Studies ; Reproducibility of Results ; Controlled Clinical Trials as Topic
Language	English
Publishing date	2023-01-30
Publishing country	United Arab Emirates
Document type	Journal Article
ZDB-ID	2251879-4
ISSN	1876-1038 ; 1574-8871
ISSN (online)	1876-1038
ISSN	1574-8871
DOI	10.2174/1574887118666230104152245
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Article ; 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 Volume 19, Issue 3, Page(s) e0300094

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

Abstract	[This corrects the article DOI: 10.1371/journal.pone.0293039.].
Language	English
Publishing date	2024-03-05
Publishing country	United States
Document type	Published Erratum
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0300094
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Article ; 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 Volume 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.
Keywords	composite quality score ; clincial rial ; trial appraisal ; systematic review ; bias ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2023-06-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
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Article ; 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 Volume 15, Issue 1, Page(s) 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 term(s)	Humans ; Adolescent ; Quality of Life ; Cross-Sectional Studies ; Reproducibility of Results ; Psychometrics ; South Africa/epidemiology ; Surveys and Questionnaires ; Oral Health ; HIV Infections/epidemiology
Language	English
Publishing date	2023-10-25
Publishing country	South Africa
Document type	Journal Article
ZDB-ID	2526836-3
ISSN	2071-2936 ; 2071-2936
ISSN (online)	2071-2936
ISSN	2071-2936
DOI	10.4102/phcfm.v15i1.3993
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Article ; Online: Prevalence of dental caries and associated risk factors among People Living with HIV/AIDS and HIV uninfected adults at an HIV clinic in Kigali, Rwanda.

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

PloS one

2023 Volume 18, Issue 4, Page(s) e0276245

Abstract: Background: Dental caries is among the most frequent oral conditions in People Living with HIV/AIDS (PLWHA). There is a lack of baseline information on dental caries prevalence and associated risk factors among PLWHA in comparison to HIV uninfected ... ...

Abstract	Background: Dental caries is among the most frequent oral conditions in People Living with HIV/AIDS (PLWHA). There is a lack of baseline information on dental caries prevalence and associated risk factors among PLWHA in comparison to HIV uninfected people in Rwanda. Objective: This study was conducted to determine the prevalence of dental caries and associated risk factors among PLWHA and HIV uninfected adults at an HIV clinic of Kigali Teaching Hospital (CHUK) in Kigali, Rwanda. Methods: A comparative cross-sectional study was conducted among 200 PLWHA and 200 HIV uninfected adults aged 18 years and above attending an HIV clinic of CHUK. An oral examination was performed by a calibrated examiner. Dental caries were assessed using the WHO Decayed (D), Missing (M), and Filled Teeth (F) index (DMFT). Descriptive statistics, Chi-square, t-tests, and multiple binary logistic regression were used to analyze data. Results: Overall, a higher prevalence (50.5%) of PLWHA had experienced dental caries (DMFT>0) compared to HIV uninfected counterparts (40.5%) (p = 0.045). The prevalence of Decayed teeth (D) was also higher (23.5%) among PLWHA compared to HIV uninfected persons (13.6%) (p = 0.011). The Mean(SD) DMFT scores among PLWHA and HIV uninfected participants were 2.28 (3.68) and 1.29 (2.21) respectively (p = 0.001). After performing multiple binary logistic regression analysis, the predictors of dental caries in PLWHA were being female (OR = 2.33; 95%CI = 1.14-4.75), frequent dental visits (OR = 4.50; 95% CI = 1.46-13.86) and detectable RNA viral load (OR = 4.50; 95% CI = 1.46-13.86). In HIV uninfected participants, the middle age range (36-45 years), and frequent dental visits were significantly associated with dental caries (OR = 6.61; 95%CI = 2.14-20.37) and (OR = 3.42; 95%CI: 1.337-8.760) respectively. Conclusion: The prevalence of dental caries was higher in PLWHA than in HIV uninfected counterparts. The reported higher prevalence of caries in PLWHA was associated with being female, detectable viral load, and frequent dental visits. Therefore, there is a need for effective oral health interventions specific to PLWHA in Rwanda to raise awareness of the risk of dental caries and provide preventive oral health services among this population. To ensure timely oral health care amongPLWHA, there is a need for an effort from policymakers and other stakeholders to integrate oral health care services within the HIV treatment program in Rwanda.
MeSH term(s)	Middle Aged ; Humans ; Adult ; Female ; Male ; Prevalence ; Cross-Sectional Studies ; Dental Caries/epidemiology ; Dental Caries/complications ; Rwanda/epidemiology ; Risk Factors ; HIV Infections/complications ; HIV Infections/epidemiology ; DMF Index
Language	English
Publishing date	2023-04-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0276245
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Article ; Online: Hall Technique had Better 1-year Clinical Outcomes for Treating Dental Caries in Primary Molars in High-risk Children Compared With Conventional Restoration or Non-restorative Approaches.

Yengopal, Veerasamy

The journal of evidence-based dental practice

2015 Volume 15, Issue 2, Page(s) 80–82

MeSH term(s)	Dental Caries/prevention & control ; Humans ; Molar/pathology ; Tooth, Deciduous/pathology
Language	English
Publishing date	2015-06
Publishing country	United States
Document type	Comment ; Journal Article
ZDB-ID	2056058-8
ISSN	1532-3390 ; 1532-3382
ISSN (online)	1532-3390
ISSN	1532-3382
DOI	10.1016/j.jebdp.2015.03.012
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