scholarly journals A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS)

2015 ◽  
Vol 19 (57) ◽  
pp. 1-210 ◽  
Author(s):  
Fay Crawford ◽  
Genevieve Cezard ◽  
Francesca M Chappell ◽  
Gordon D Murray ◽  
Jacqueline F Price ◽  
...  
Keyword(s):  
Systematic Review ◽  
Risk Assessment ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Data Sets ◽  
Eligibility Criteria ◽  
Foot Ulceration ◽  
History Of ◽  
Meta Analyses ◽  
Assessment Procedures

BackgroundAnnual foot risk assessment of people with diabetes is recommended in national and international clinical guidelines. At present, these are consensus based and use only a proportion of the available evidence.ObjectivesWe undertook a systematic review of individual patient data (IPD) to identify the most highly prognostic factors for foot ulceration (i.e. symptoms, signs, diagnostic tests) in people with diabetes.Data sourcesStudies were identified from searches of MEDLINE and EMBASE.Review methodsThe electronic search strategies for MEDLINE and EMBASE databases created during an aggregate systematic review of predictive factors for foot ulceration in diabetes were updated and rerun to January 2013. One reviewer applied the IPD review eligibility criteria to the full-text articles of the studies identified in our literature search and also to all studies excluded from our aggregate systematic review to ensure that we did not miss eligible IPD. A second reviewer applied the eligibility criteria to a 10% random sample of the abstract search yield to check that no relevant material was missed. This review includes exposure variables (risk factors) only from individuals who were free of foot ulceration at the time of study entry and who had a diagnosis of diabetes mellitus (either type 1 or type 2). The outcome variable was incident ulceration.ResultsOur search identified 16 cohort studies and we obtained anonymised IPD for 10. These data were collected from more than 16,000 people with diabetes worldwide and reanalysed by us. One data set was kept for independent validation. The data sets contributing IPD covered a range of temporal, geographical and clinical settings. We therefore selected random-effects meta-analysis, which assumes not that all the estimates from each study are estimates of the same underlying true value, but rather that the estimates belong to the same distribution. We selected candidate variables for meta-analysis using specific criteria. After univariate meta-analyses, the most clinically important predictors were identified by an international steering committee for inclusion in the primary, multivariable meta-analysis. Age, sex, duration of diabetes, monofilaments and pulses were considered most prognostically important. Meta-analyses based on data from the entire IPD population found that an inability to feel a 10-g monofilament [odds ratio (OR) 3.184, 95% confidence interval (CI) 2.654 to 3.82], at least one absent pedal pulse (OR 1.968, 95% CI 1.624 to 2.386), a longer duration of a diagnosis of diabetes (OR 1.024, 95% CI 1.011 to 1.036) and a previous history of ulceration (OR 6.589, 95% CI 2.488 to 17.45) were all predictive of risk. Female sex was protective (OR 0.743, 95% CI 0.598 to 0.922).LimitationsIt was not possible to perform a meta-analysis using a one-step approach because we were unable to procure copies of one of the data sets and instead accessed data via Safe Haven.ConclusionsThe findings from this review identify risk assessment procedures that can reliably inform national and international diabetes clinical guideline foot risk assessment procedures. The evidence from a large sample of patients in worldwide settings show that the use of a 10-g monofilament or one absent pedal pulse will identify those at moderate or intermediate risk of foot ulceration, and a history of foot ulcers or lower-extremity amputation is sufficient to identify those at high risk. We propose the development of a clinical prediction rule (CPR) from our existing model using the following predictor variables: insensitivity to a 10-g monofilament, absent pedal pulses and a history of ulceration or lower-extremities amputations. This CPR could replace the many tests, signs and symptoms that patients currently have measured using equipment that is either costly or difficult to use.Study registrationThis study is registered as PROSPERO CRD42011001841.FundingThe National Institute for Health Research Health Technology Assessment programme.

scholarly journals Tolerability of statin-based management of patients with a history of statin-associated muscle symptoms: protocol for a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e052341
Author(s):  
Fanny Villoz ◽  
Christina Lyko ◽  
Cinzia Del Giovane ◽  
Nicolas Rodondi ◽  
Manuel R Blum
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Mean Difference ◽  
Control Group ◽  
Cochrane Central Register ◽  
Eligibility Criteria ◽  
Clinical Issue ◽  
Standard Data ◽  
Evaluation Approach ◽  
History Of

IntroductionStatin-associated muscle symptoms (SAMSs) are a major clinical issue in the primary and secondary prevention of cardiovascular events. Current guidelines advise various approaches mainly based on expert opinion. We will lead a systematic review and meta-analysis to explore the tolerability and acceptability and effectiveness of statin-based therapy management of patients with a history of SAMS. We aim to provide evidence on the tolerability and different strategies of statin-based management of patients with a history of SAMS.Methods and analysisWe will conduct a systematic review of randomised controlled trials (RCTs) and non-randomised studies with a control group. We will search in Data sources MEDLINE, EMBASE, Cochrane Central Register of Controlled Clinical Trials, Scopus, Clinicaltrials.gov and Proquest from inception until April 2021. Two independent reviewers will carry out the study selection based on eligibility criteria. We will extract data following a standard data collection form. The reviewers will use the Cochrane Collaboration’s tools and Newcastle-Ottawa Scale to appraise the study risk of bias. Our primary outcome will be tolerability and our secondary outcomes will be acceptability and effectiveness. We will conduct a qualitative analysis of all included studies. In addition, if sufficient and homogeneous data are available, we will conduct quantitative analysis. We will synthesise dichotomous data using OR with 95% CI and continuous outcomes by using mean difference or standardised mean difference (with 95% CI). We will determine heterogeneity visually with forest plots and quantitatively with I2 and Q-test. We will summarise the confidence in the quantitative estimate by using Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationAs a systematic review of literature without collection of new clinical data, there will be no requirement for ethical approval. We will disseminate findings through peer-reviewed publications.PROSPERO registration numberCRD42020202619.

scholarly journals Efficacy and safety of instantaneous wave-free ratio in patients undergoing coronary revascularisation: protocol for a systematic review

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017868
Author(s):  
Joey S.W. Kwong ◽  
Sheyu Li ◽  
Wan-Jie Gu ◽  
Hao Chen ◽  
Chao Zhang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Meta Analysis ◽  
Adverse Outcomes ◽  
Coronary Revascularisation ◽  
Eligibility Criteria ◽  
Registration Number ◽  
Collection Form ◽  
Randomised Controlled ◽  
Meta Analyses

IntroductionEffective selection of coronary lesions for revascularisation is pivotal in the management of symptoms and adverse outcomes in patients with coronary artery disease. Recently, instantaneous ‘wave-free’ ratio (iFR) has been proposed as a new diagnostic index for assessing the severity of coronary stenoses without the need of pharmacological vasodilation. Evidence of the effectiveness of iFR-guided revascularisation is emerging and a systematic review is warranted.Methods and analysisThis is a protocol for a systematic review of randomised controlled trials and controlled observational studies. Electronic sources including MEDLINE via Ovid, Embase, Cochrane databases and ClinicalTrials.gov will be searched for potentially eligible studies investigating the effects of iFR-guided strategy in patients undergoing coronary revascularisation. Studies will be selected against transparent eligibility criteria and data will be extracted using a prestandardised data collection form by two independent authors. Risk of bias in included studies and overall quality of evidence will be assessed using validated methodological tools. Meta-analysis will be performed using the Review Manager software. Our systematic review will be performed according to the guidance from the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.Ethics and disseminationEthics approval is not required. Results of the systematic review will be disseminated as conference proceedings and peer-reviewed journal publication.Trial registration numberThis protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42017065460.

scholarly journals Evaluation of Preeclampsia Results after Use of Metformin in Gestation: Systematic Review and Meta-analysis

2018 ◽  
Vol 40 (11) ◽  
pp. 713-721 ◽  
Author(s):  
Iramar Nascimento ◽  
Guilherme Dienstmann ◽  
Matheus de Souza ◽  
Raquel Fleig ◽  
Carla Hoffmann ◽  
...  
Keyword(s):  
Systematic Review ◽  
Treatment Time ◽  
Meta Analysis ◽  
Cochrane Collaboration ◽  
Eligibility Criteria ◽  
Time Segment ◽  
Meta Analyses ◽  
The Cochrane Collaboration ◽  
Lower Correlation

Objective Does the use of metformin have an influence on the outcomes of preeclampsia (PE)? Sources of Data The descriptors pregnancy, metformin, treatment, and preeclampsia associated with the Boolean operators AND and OR were found in the MEDLINE, LILACS, Embase and Cochrane databases. A flowchart with exclusion criteria and inclusion strategy using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol, and eligibility criteria was used. Data were extracted regarding the type of study, the applied dosage, treatment time, segment, bias risks, and the Patient, Intervention, Comparison and Outcome (PICO) strategy to identify the quality of the study. Selection of Studies Total number of journals in the initial search (n = 824); exclusions from repeated articles on different search engines (n = 253); exclusions after reading the titles, when the title had no correlations with the proposed theme (n = 164); exclusions due to incompatibility with the criteria established in the methodological analysis (n = 185), exclusion of articles with lower correlation with the objective of the present study (n = 187); and final bibliographic selection (n = 35). Data Collection At first, a systematic review of the literature was performed. Subsequently, from the main selection, randomized and non-randomized trials with metformin that presented their results in absolute and relative numbers of PE outcomes were selected. The variables were treated statistically in the meta-analysis with the Review Manager software (RevMan), version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration. Denmark in the Hovedistaden region. Synthesis of Data The study showed that metmorfin presented greater preventive effects for pregnancy-induced hypertension and was less effective for PE. Conclusion Metformin may gain place in preventive treatments for PE, once the dosages, the gestational age, and treatment time are particularly evaluated. A methodological strategy with an improved perspective of innovative and/or carefully progressive dosages during pregnancy to avoid side effects and the possibility of maternal-fetal risks is suggested.

scholarly journals Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sophie Juul ◽  
Emil Eik Nielsen ◽  
Joshua Feinberg ◽  
Faiza Siddiqui ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Individual Patient Data ◽  
Viral Vector ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Serious Adverse Events ◽  
Meta Analyses ◽  
Harmful Effects

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19. Methods/design We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; “active placebo;” no intervention; standard care; an “active” intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately. Discussion COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease. Systematic review registration PROSPERO CRD42020196492

scholarly journals Systematic Reviews and Meta-Analysis in Spine Surgery—How Good Are They in Methodological Quality? A Systematic Review

2020 ◽  
pp. 219256822090681 ◽  
Author(s):  
Muthu Sathish ◽  
Ramakrishnan Eswar
Keyword(s):  
Systematic Review ◽  
Spine Surgery ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Meta Analysis ◽  
Eligibility Criteria ◽  
Cochrane Database ◽  
Critical Flaw ◽  
Meta Analyses

Study Design: Systematic review. Objectives: To assess the methodological quality of systematic reviews and meta-analyses in spine surgery over the past 2 decades. Materials and Methods: We conducted independent and in duplicate systematic review of the published systematic reviews and meta-analyses between 2000 and 2019 from PubMed Central and Cochrane Database pertaining to spine surgery involving surgical intervention. We searched bibliographies to identify additional relevant studies. Methodological quality was evaluated with AMSTAR score and graded with AMSTAR 2 criteria. Results: A total of 96 reviews met the eligibility criteria, with mean AMSTAR score of 7.51 (SD = 1.98). Based on AMSTAR 2 criteria, 13.5% (n = 13) and 18.7% (n = 18) of the studies had high and moderate level of confidence of results, respectively, without any critical flaws. A total of 29.1% (n = 28) of the studies had at least 1 critical flaw and 38.5% (n = 37) of the studies had more than 1 critical flaw, so that their results have low and critically low confidence, respectively. Failure to analyze the conflict of interest of authors of primary studies included in review and lack of list of excluded studies with justification were the most common critical flaw. Regression analysis demonstrated that studies with funding and studies published in recent years were significantly associated with higher methodological quality. Conclusion: Despite improvement in methodological quality of systematic reviews and meta-analyses in spine surgery in current decade, a substantial proportion continue to show critical flaws. With increasing number of review articles in spine surgery, stringent measures must be taken to adhere to methodological quality by following PRISMA and AMSTAR guidelines to attain higher standards of evidence in published literature.

scholarly journals What components of smoking cessation care during pregnancy are implemented by health providers? A systematic review and meta-analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e026037 ◽  
Author(s):  
Gillian Sandra Gould ◽  
Laura Twyman ◽  
Leah Stevenson ◽  
Gabrielle R Gribbin ◽  
Billie Bonevski ◽  
...  
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Data Extraction ◽  
Meta Analysis ◽  
Self Report ◽  
Health Providers ◽  
Eligibility Criteria ◽  
Reporting Practices ◽  
Registration Number ◽  
Meta Analyses

BackgroundPregnancy is an opportunity for health providers to support women to stop smoking.ObjectivesIdentify the pooled prevalence for health providers in providing components of smoking cessation care to women who smoke during pregnancy.DesignA systematic review synthesising original articles that reported on (1) prevalence of health providers’ performing the 5As (‘Ask’, ‘Advise’, ‘Assess’, ‘Assist’, ‘Arrange’), prescribing nicotine replacement therapy (NRT) and (2) factors associated with smoking cessation care.Data sourcesMEDLINE, EMBASE, CINAHL and PsycINFO databases searched using ‘smoking’, ‘pregnancy’ and ‘health provider practices’.Eligibility criteria for selecting studiesStudies included any design except interventions (self-report, audit, observed consultations and women’s reports), in English, with no date restriction, up to June 2017.ParticipantsHealth providers of any profession.Data extraction, appraisal and analysisData were extracted, then appraised with the Hawker tool. Meta-analyses pooled percentages for performing each of the 5As and prescribing NRT, using, for example, ‘often/always’ and ‘always/all’. Meta-regressions were performed of 5As for ‘often/always’.ResultsOf 3933 papers, 54 were included (n=29 225 participants): 33 for meta-analysis. Health providers included general practitioners, obstetricians, midwives and others from 10 countries. Pooled percentages of studies reporting practices ‘often/always’ were: ‘Ask’ (n=9) 91.6% (95% CI 88.2% to 95%); ‘Advise’ (n=7) 90% (95% CI 72.5% to 99.3%), ‘Assess’ (n=3) 79.2% (95% CI 76.5% to 81.8%), ‘Assist (cessation support)’ (n=5) 59.1% (95% CI 56% to 62.2%), ‘Arrange (referral)’ (n=6) 33.3% (95% CI 20.4% to 46.2%) and ‘prescribing NRT’ (n=6) 25.4% (95% CI 12.8% to 38%). Heterogeneity (I2) was 95.9%–99.1%. Meta-regressions for ‘Arrange’ were significant for year (p=0.013) and country (p=0.037).ConclusionsHealth providers ‘Ask’, ‘Advise’ and ‘Assess’ most pregnant women about smoking. ‘Assist’, ‘Arrange’ and ‘prescribing NRT’ are reported at lower rates: strategies to improve these should be considered.PROSPERO registration numberCRD42015029989.

scholarly journals Antioxidants as Adjuvants in Periodontitis Treatment: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 2019 ◽  
pp. 1-24 ◽  
Author(s):  
Micaele Maria Lopes Castro ◽  
Nathallia Neves Duarte ◽  
Priscila Cunha Nascimento ◽  
Marcela Barauna Magno ◽  
Nathalia Carolina Fernandes Fagundes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Conventional Therapy ◽  
Meta Analysis ◽  
Clinical Parameter ◽  
Risk Of Bias ◽  
Eligibility Criteria ◽  
Clinical Attachment Loss ◽  
Nonsurgical Periodontal Therapy ◽  
Significant Difference ◽  
Meta Analyses

This systematic review with meta-analysis aimed to evaluate the effect of antioxidants as an adjuvant in periodontitis treatment. The following databases were consulted: PubMed, Scopus, Web of Science, Cochrane, Lilacs, OpenGrey, and Google Scholar. Based on the PICO strategy, the inclusion criteria comprised interventional studies including periodontitis patients (participants) treated with conventional therapy and antioxidants (intervention) compared to patients treated only with conventional therapy (control) where the periodontal response (outcome) was evaluated. The risk of bias was evaluated using the Cochrane RoB tool (for randomized studies) and ROBINS-I tool (for nonrandomized studies). Quantitative data were analyzed in five random effects meta-analyses considering the following periodontal parameters: clinical attachment loss (CAL), plaque index (PI), gingival index (GI), bleeding on probing (BOP), and probing depth (PD). After all, the level of certainty was measured with the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) tool. Among the 1884 studies identified, only 15 interventional studies were according to the eligibility criteria and they were included in our review. From them, 4 articles presented a high risk of bias. The meta-analysis showed a statistically significant difference for CAL (SMD 0.29 (0.04, 0.55), p=0.03, I2=13%), PI (SMD 0.41 (0.18, 0.64), p=0.0005, I2=47%), and BOP (SMD 0.55 (0.27, 0.83), p=0.0001, I2=0%). The GRADE tool showed a moderate to high certainty in the quality of evidence depending on the clinical parameter and antioxidants used. These results suggest that the use of antioxidants is an adjunct approach to nonsurgical periodontal therapy which may be helpful in controlling the periodontal status.

scholarly journals Predicting future self-harm or suicide in adolescents: a systematic review of risk assessment scales/tools

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029311 ◽  
Author(s):  
Isobel Marion Harris ◽  
Sophie Beese ◽  
David Moore
Keyword(s):  
Systematic Review ◽  
Risk Assessment ◽  
Data Extraction ◽  
Meta Analysis ◽  
Predictive Ability ◽  
Risk Of Bias ◽  
Assessment Tools ◽  
Case Control Studies ◽  
Eligibility Criteria ◽  
Self Harm

ObjectiveThis systematic review aimed to evaluate the ability of risk tools to predict the future episodes of suicide/self-harm in adolescents.DesignSystematic review.Data sourcesMEDLINE, EMBASE, CINAHL and PsycINFO were searched from inception to 3 March 2018.Eligibility criteria for selecting studiesCohort studies, case–control studies and randomised controlled trials of adolescents aged 10–25 who had undergone risk assessment in a clinical setting following an episode of self-harm were included.Data extraction and synthesisTwo independent reviewers extracted data and assessed risk of bias. Data were grouped by tool and narrative synthesis undertaken, with studies appraised using a checklist combining the QUIPS (Quality In Prognosis Studies) and QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies) tools.ResultsOf the 17 137 articles initially identified, 11 studies evaluating 10 separate tools were included. The studies varied in setting, population and outcome measure. The majority of the studies were rated as having an unclear risk of bias, and meta-analysis was not possible due to high variability between studies.The ability of the tools to correctly identify those adolescents going on to make a self-harm/suicide attempt ranged from 27% (95% CI 10.7% to 50.2%) to 95.8% (95% CI 78.9% to 99.9%). A variety of metrics were provided for 1–10 points increases in various tools, for example, odds and HRs.ConclusionsThis systematic review is the first to explore the use of assessment tools in adolescents. The predictive ability of these tools varies greatly. No single tool is suitable for predicting a higher risk of suicide or self-harm in adolescent populations.PROSPERO registration numberCRD42017058686

Prevalence of white spot caries lesions in primary teeth in preschool children: systematic review and meta-analysis

2021 ◽  
Vol 17 ◽  
Author(s):  
Priscila H Campos ◽  
Thais Gimenez ◽  
Rafael S Rocha ◽  
Taciana MF Caneppele ◽  
Renata O Guaré ◽  
...  
Keyword(s):  
Systematic Review ◽  
Preschool Children ◽  
Low Income ◽  
Primary Teeth ◽  
Meta Analysis ◽  
White Spot ◽  
White Spot Lesion ◽  
Eligibility Criteria ◽  
Meta Analyses ◽  
Caries Lesions

Background: The first clinically detectable stage of caries lesion is a non-cavitated white spot lesion (WSL). The detection of early stages of caries lesions allows non-invasive management by fluoride usage, oral hygiene and diet control. There is a lack of information in the literature regarding the prevalence of these caries lesions in preschool children, which is important especially for public health strategies. Objective: The aim of this study was to conduct a systematic review with meta-analysis to verify the WSLs prevalence in primary teeth of preschool children. Methods: A literature search with MEDLINE/PubMed, Scopus, Web of Science, and Open Gray databases was conducted. Included studies fulfilled the eligibility criteria. Meta-analyses were performed using random effects model, for prevalence of pooled WSLs and subgroups analyses. Results: The search strategy identified 4922 potentially relevant articles, with final inclusion of 16 studies. The pooled prevalence of WSLs in primary teeth was 14.0% (95% CI: 8.0-24.0), without publication bias (p=0.2668). For subgroup analyses, an increase in WSLs prevalence for children of low-income economy (24.0%; 95% CI: 20.0-28.0), for age >31 months (22.0%; 95% CI: 12.0-37.0), for validated visual criteria assessment (20.0%; 95% CI: 11.0-33.0), and for tactile assessment with ball-ended probe (26.0%; 95% CI: 11-50.0) were detected. Conclusion: It is suggested that the prevalence of WSLs in primary teeth of preschool children increases in countries with low income economy, with age greater than 31 months as the texture was assessed with visual validated criteria or ball-end probe.

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