Comparison of bias adjustment in meta-analysis using data-based and opinion-based methods.

INTRODUCTION: Several methods exist for bias adjustment of meta-analysis results, but there has been no comprehensive comparison with unadjusted methods. We compare 6 bias-adjustment methods with 2 unadjusted methods to examine how these different methods perform. METHODS: We re-analyzed a meta-analysis that included 10 randomized controlled trials. Two data-based methods (Welton's data-based approach and Doi's quality effects model) and 4 opinion-informed methods (opinion-based approach, opinion-based distributions combined statistically with data-based distributions, numerical opinions informed by data-based distributions, and opinions obtained by selecting areas from data-based distributions) were used to incorporate methodological quality information into the meta-analytical estimates. The results of these 6 methods were compared with 2 unadjusted models: the DerSimonian-Laird random effects model and Doi's inverse variance heterogeneity model. RESULTS: The 4 opinion-based methods returned the random effects model estimates with wider uncertainty. The data-based and quality effects methods returned different results and aligned with the inverse variance heterogeneity method with some minor downward bias adjustment. CONCLUSION: Opinion-based methods seem to only add uncertainty rather than bias adjust.

Implementing GRADE in systematic reviews that adhere to JBI methodological conduct.

GRADE is a methodological approach used to establish certainty in a body of evidence and is now widely adopted among the evidence synthesis and guideline development community. JBI is an international evidence-based health care organization that provides guidance for a range of evidence synthesis approaches. The GRADE approach is currently endorsed for use in a subset of JBI systematic reviews; however, there is some uncertainty regarding when (and how) GRADE may be implemented in reviews that follow JBI methodology.

Common tool structures and approaches to risk of bias assessment: implications for systematic reviewers.

There are numerous tools available to assess the risk of bias in individual studies in a systematic review. These tools have different structures, including scales and checklists, which may or may not separate their items by domains. There are also various approaches and guides for the process, scoring, and interpretation of risk of bias assessments, such as value judgments, quality scores, and relative ranks. The objective of this commentary, which is part of the JBI Series on Risk of Bias, is to discuss some of the distinctions among different tool structures and approaches to risk of bias assessment and the implications of these approaches for systematic reviewers.

The revised JBI critical appraisal tool for the assessment of risk of bias for quasi-experimental studies.

Systematic reviews of effectiveness offer a rigorous synthesis of the best evidence available regarding the effects of interventions or treatments. Randomized controlled trials are considered the optimal study design for evaluating the effectiveness of interventions and are the ideal study design for inclusion in a systematic review of effectiveness. In the absence of randomized controlled trials, quasi-experimental studies may be relied on to provide information on treatment or intervention effectiveness. However, such studies are subject to unique considerations regarding their internal validity and, consequently, the assessment of the risk of bias of these studies needs to consider these features of design and conduct. The JBI Effectiveness Methodology Group has recently commenced updating the suite of JBI critical appraisal tools for quantitative study designs to align with the latest advancements in risk of bias assessment. This paper presents the revised critical appraisal tool for risk of bias assessment of quasi-experimental studies; offers practical guidance for its use; provides examples for interpreting the results of risk of bias assessment; and discusses major changes from the previous version, along with the justifications for those changes.

Tools to assess the risk of bias of evidence syntheses: a scoping review protocol.

OBJECTIVE: The aim of this scoping review is to identify and examine risk of bias tools, critical appraisal tools, and/or assessment of methodological quality tools (including their items and domains) developed to assess all types of evidence syntheses. INTRODUCTION: Evidence synthesis is often the basis for policies, procedures, decisions, and evidence-based practice. It is imperative that evidence syntheses are of good quality, reproducible, and reliable. Despite methodological advancements, there remains a substantial risk that bias is present in the conduct of an evidence synthesis project, hindering the validity and reliability of the findings. One way to assess bias is through formal tools and assessments for assessing the risk of bias and/or methodological quality. INCLUSION CRITERIA: Published and unpublished papers presenting a risk of bias, critical appraisal, or methodological quality assessment tool for assessing an evidence synthesis will be included. Individual umbrella reviews proposing a de novo tool or modified tool will be excluded from the review, as will texts that do not present a tool. METHODS: A 3-step search strategy will be conducted to locate both published and unpublished documents. An initial search of PubMed was developed with a librarian, which identified keywords and MeSH terms. A second search of MEDLINE (Ovid), CINAHL (EBSCOhost), Embase (Ovid), Scopus, and Compendex will follow. Websites and databases, including Google, Cochrane, and JBI, will be searched for difficult-to-locate and unpublished literature. Documents will be independently screened, selected, and extracted by 2 researchers, and the data will be presented narratively and in tables. REVIEW REGISTRATION: Open Science Framework osf.io/mjcfy.

How should we handle predatory journals in evidence synthesis? A descriptive survey-based cross-sectional study of evidence synthesis experts.

Synthesizers of evidence are increasingly likely to encounter studies published in predatory journals during the evidence synthesis process. The evidence synthesis discipline is uniquely positioned to encounter novel concerns associated with predatory journals. The objective of this research was to explore the attitudes, opinions, and experiences of experts in the synthesis of evidence regarding predatory journals. Employing a descriptive survey-based cross-sectional study design, these experts were asked a series of questions regarding predatory journals to explore these attitudes, opinions, and experiences. Two hundred and sixty four evidence synthesis experts responded to this survey. Most respondents agreed with the definition of a predatory journal (86%), however several (19%) responded that this definition was difficult to apply practically. Many respondents believed that studies published in predatory journals are still eligible for inclusion into an evidence synthesis project. However, this was only after the study had been determined to be 'high-quality' (39%) or if the results were validated (13%). While many respondents could identify common characteristics of these journals, there was still hesitancy regarding the appropriate methods to follow when considering including these studies into an evidence synthesis project.

JBI series paper 2: tailored evidence synthesis approaches are required to answer diverse questions: a pragmatic evidence synthesis toolkit from JBI.

Evidence synthesis is critical in evidence-based healthcare and is a core program of JBI. JBI evidence synthesis is characterised by a pluralistic view of what constitutes evidence and is underpinned by a pragmatic ethos to facilitate the use of evidence to inform practice and policy. This second paper in this series provides a descriptive overview of the JBI evidence synthesis toolkit with reference to resources for 11 different types of reviews. Unique methodologies such as qualitative syntheses, mixed methods reviews, and scoping reviews are highlighted. Key features include standardised and collaborative processes for development of methodologies and a broad range of tailored resources to facilitate the conduct of a JBI evidence synthesis, including appraisal and data extraction tools, software to support the conduct of a systematic review and an intensive systematic review training program. JBI is one of the leading international protagonists for evidence synthesis, providing those who want to answer health-related questions with a toolkit of resources to synthesize the evidence.

Effectiveness of reduced- versus standard-dose radiotherapy on survival and radiation-associated toxicity in patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma: a systematic review protocol.

OBJECTIVE: The objective of this review is to investigate overall survival in patients with human papillomavirus positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC) comparing standard- versus reduced-dose radiotherapy. INTRODUCTION: The improved survival of patients with HPV+ compared to HPV-negative OPSCC has raised the question of reducing the total radiation treatment dose delivered to patients with HPV+ OPSCC. A de-escalated radiotherapy protocol may provide equal oncological benefit, with reduced adverse events/toxicity. INCLUSION CRITERIA: We will include any adult patients aged 18years or older who have undergone curative intent treatment for HPV+ OPSCC. These patients can be at any stage at the time treatment is initiated. Exclusion criteria are as follows: pre-clinical or animal studies, patients with non-squamous cell carcinoma lesions of the oropharynx, patients with primary lesions in other head and neck sites, or patients receiving palliative treatment. METHODS: A three-step search strategy will be used to identify relevant articles for inclusion through MEDLINE, CINAHL, Embase, Web of Science, Scopus, and gray literature sources. These articles will be assessed against our inclusion and exclusion criteria at the title and abstract level as well as at full-text level. Remaining studies will be critically appraised based on their trial design. Data extraction will occur for all studies and, where possible, will be pooled with statistical meta-analysis. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42021252161.

Methods Used and Application of the Mouse Grimace Scale in Biomedical Research 10 Years on: A Scoping Review.

The Mouse Grimace Scale (MGS) was developed 10 years ago as a method for assessing pain through the characterisation of changes in five facial features or action units. The strength of the technique is that it is proposed to be a measure of spontaneous or non-evoked pain. The time is opportune to map all of the research into the MGS, with a particular focus on the methods used and the technique's utility across a range of mouse models. A comprehensive scoping review of the academic literature was performed. A total of 48 articles met our inclusion criteria and were included in this review. The MGS has been employed mainly in the evaluation of acute pain, particularly in the pain and neuroscience research fields. There has, however, been use of the technique in a wide range of fields, and based on limited study it does appear to have utility for pain assessment across a spectrum of animal models. Use of the method allows the detection of pain of a longer duration, up to a month post initial insult. There has been less use of the technique using real-time methods and this is an area in need of further research.

Promoting healthy lifestyle considerations during pregnancy in Midwifery clinics in China: a best practice implementation project.

OBJECTIVES: The aim of this project was to initiate and promote formal and individualized evidence-based education on healthy lifestyle choices during pregnancy for pregnant women. INTRODUCTION: Evidence suggests that lifestyle choices during pregnancy can have a profound influence on many pregnancy complications and chronic diseases such as preterm birth, diabetes, obesity, fetal growth restriction, breast cancer and hypertensive diseases in both pregnant women and their babies. It is widely accepted that formal, individualized, hospital-directed education about lifestyle choices during pregnancy should commence as early as the first consultation between pregnant women and maternal healthcare workers. METHODS: The methods of this project were audit and feedback. The approach to data collection used the Joanna Briggs Institute (JBI) Practical Application of Clinical Evidence System and implementation planning utilized the Getting Research into Practice component. A baseline audit of 50 observations of midwife-led education on prenatal lifestyle were conducted and measured against seven best practice audit criteria. Targeted strategies were then implemented to improve compliance to best practice. A follow-up audit was conducted over a 6-month period from June 2019 to November 2019. RESULTS: The baseline audit revealed significant deficits between current prenatal education practice and recommended best practice. Zero percent compliance was observed in six out of seven audit criteria, indicating that education provided did not conform to best practice. Total compliance (100%) was observed for one audit criterion at baseline, assessing pregnant women being offered an opportunity to discuss and ask questions regarding the education session or information they had received. Three barriers that prevented midwives from achieving compliance with best practice were identified, and a bundled education strategy was implemented. A follow-up audit indicated 100% compliance of all audit criteria. CONCLUSION: Results demonstrated that formal, individualized, midwife-led prenatal education and provision of relevant evidence-based resources had an immediate positive effect. The project helped to transform care givers' attitudes toward education regarding lifestyle during pregnancy from a passive routine 'must do' task to an active process with focus on healthy lifestyle and engagement of pregnant women. Future strategies such as support from hospital management and social media are planned in conjunction with follow-up clinical audits to ensure sustainability.

The Impact of Common Recovery Blood Sampling Methods, in Mice (Mus Musculus), on Well-Being and Sample Quality: A Systematic Review.

Blood sampling is often performed in laboratory mice. Sampling techniques have the potential to cause pain, distress and impact on lifetime cumulative experience. In spite of institutions commonly providing guidance to researchers on these methods, and the existence of published guidelines, no systematic evaluation of the evidence on this topic exists. A systematic search of Medline, Scopus, and Web of Science was performed, identifying 27 studies on the impact of recovery blood sample techniques on mouse welfare and sample quality. Studies were appraised for quality using the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool. In spite of an acceptable number of studies being located, few studies examined the same pairwise comparisons. Additionally, there was considerable heterogeneity in study design and outcomes, with many studies being at a high risk of bias. Consequently, results were synthesised using the Synthesis Without Meta-analysis (SWiM) reporting guidelines. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was utilised for assessment of certainty in the evidence. Due to the heterogeneity and GRADE findings, it was concluded that there was not enough high-quality evidence to make any recommendations on the optimal method of blood sampling. Future high-quality studies, with standardised outcome measures and large sample sizes, are required.

Rinse-free hand wash for reducing absenteeism among preschool and school children.

BACKGROUND: Illness-related absenteeism is an important problem among preschool and school children for low-, middle- and high- income countries. Appropriate hand hygiene is one commonly investigated and implemented strategy to reduce the spread of illness and subsequently the number of days spent absent. Most hand hygiene strategies involve washing hands with soap and water, however this is associated with a number of factors that act as a barrier to its use, such as requiring running water, and the need to dry hands after cleaning. An alternative method involves washing hands using rinse-free hand wash. This technique has a number of benefits over traditional hand hygiene strategies and may prove to be beneficial in reducing illness-related absenteeism in preschool and school children. OBJECTIVES: 1. To assess the effectiveness of rinse-free hand washing for reducing absenteeism due to illness in preschool and school children compared to no hand washing, conventional hand washing with soap and water or other hand hygiene strategies. 2. To determine which rinse-free hand washing products are the most effective (if head-to-head comparisons exist), and what effect additional strategies in combination with rinse-free hand washing have on the outcomes of interest. SEARCH METHODS: In February 2020 we searched CENTRAL, MEDLINE, Embase, CINAHL, 12 other databases and three clinical trial registries. We also reviewed the reference lists of included studies and made direct contact with lead authors of studies to collect additional information as required. No date or language restrictions were applied. SELECTION CRITERIA: Randomized controlled trials (RCTs), irrespective of publication status, comparing rinse-free hand wash in any form (hand rub, hand sanitizer, gel, foam etc.) with conventional hand washing using soap and water, other hand hygiene programs (such as education alone), or no intervention. The population of interest was children aged between two and 18 years attending preschool (childcare, day care, kindergarten, etc.) or school (primary, secondary, elementary, etc.). Primary outcomes included child or student absenteeism for any reason, absenteeism due to any illness and adverse skin reactions. DATA COLLECTION AND ANALYSIS: Following standard Cochrane methods, two review authors (out of ZM, CT, CL, CS, TB), independently selected studies for inclusion, assessed risk of bias and extracted relevant data. Absences were extracted as the number of student days absent out of total days. This was sometimes reported with the raw numbers and other times as an incidence rate ratio (IRR), which we also extracted. For adverse event data, we calculated effect sizes as risk ratios (RRs) and present these with 95% confidence intervals (CIs). We used standard methodological procedures expected by Cochrane for data analysis and followed the GRADE approach to establish certainty in the findings. MAIN RESULTS: This review includes 19 studies with 30,747 participants. Most studies were conducted in the USA (eight studies), two were conducted in Spain, and one each in China, Colombia, Finland, France, Kenya, Bangladesh, New Zealand, Sweden, and Thailand. Six studies were conducted in preschools or day-care centres (children aged from birth to < five years), with the remaining 13 conducted in elementary or primary schools (children aged five to 14 years). The included studies were judged to be at high risk of bias in several domains, most-notably across the domains of performance and detection bias due to the difficulty to blind those delivering the intervention or those assessing the outcome. Additionally, every outcome of interest was graded as low or very low certainty of evidence, primarily due to high risk of bias, as well as imprecision of the effect estimates and inconsistency between pooled data. For the outcome of absenteeism for any reason, the pooled estimate for rinse-free hand washing was an IRR of 0.91 (95% CI 0.82 to 1.01; 2 studies; very low-certainty evidence), which indicates there may be little to no difference between groups. For absenteeism for any illness, the pooled IRR was 0.82 (95% CI 0.69 to 0.97; 6 studies; very low-certainty evidence), which indicates that rinse-free hand washing may reduce absenteeism (13 days absent per 1000) compared to those in the 'no rinse-free' group (16 days absent per 1000). For the outcome of absenteeism for acute respiratory illness, the pooled IRR was 0.79 (95% CI 0.68 to 0.92; 6 studies; very low-certainty evidence), which indicates that rinse-free hand washing may reduce absenteeism (33 days absent per 1000) compared to those in the 'no rinse-free' group (42 days absent per 1000). When evaluating absenteeism for acute gastrointestinal illness, the pooled estimate found an IRR of 0.79 (95% CI 0.73 to 0.85; 4 studies; low-certainty evidence), which indicates rinse-free hand washing may reduce absenteeism (six days absent per 1000) compared to those in the 'no rinse-free' group (eight days absent per 1000). There may be little to no difference between rinse-free hand washing and 'no rinse-free' group regarding adverse skin reactions with a RR of 1.03 (95% CI 0.8 to 1.32; 3 studies, 4365 participants; very low-certainty evidence). Broadly, compliance with the intervention appeared to range from moderate to high compliance (9 studies, 10,749 participants; very-low certainty evidence); narrativley, no authors reported substantial issues with compliance. Overall, most studies that included data on perception reported that teachers and students perceived rinse-free hand wash positively and were willing to continue its use (3 studies, 1229 participants; very-low certainty evidence). AUTHORS' CONCLUSIONS: The findings of this review may have identified a small yet potentially beneficial effect of rinse-free hand washing regimes on illness-related absenteeism. However, the certainty of the evidence that contributed to this conclusion was low or very low according to the GRADE approach and is therefore uncertain. Further research is required at all levels of schooling to evaluate rinse-free hand washing regimens in order to provide more conclusive, higher-certainty evidence regarding its impact. When considering the use of a rinse-free hand washing program in a local setting, there needs to be consideration of the current rates of illness-related absenteeism and whether the small beneficial effects seen here will translate into a meaningful reduction across their settings.

Specific Nutrient Intake Via Diet and/or Supplementation in Relation to Female Stress: A Cross-Sectional Study.

Background: Women are negatively impacted by psychological stress and despite the prolific use of dietary supplements to manage stress there is little evidence to support their use for such. This study examined the relationship between intake of specific nutrients through diet and/or dietary supplementation and level of perceived stress. Method: In this cross-sectional study of adult Australian women (n = 74), perceived stress was measured using the Perceived Stress Scale, dietary intake was assessed using a validated Food Frequency Questionnaire, and supplement usage was recorded using a Supplement Use Questionnaire. Results: Potentially substantive reductions in stress scores were associated with polyunsaturated fatty acid supplementation: α-linolenic acid (mean difference [MD] = -3.34, 95% confidence interval [CI] = -7.97 to 1.29), linoleic acid (MD = -4.08, 95% CI = -8.97 to 0.82), γ-linolenic acid (MD = -2.23, 95% CI = -7.20 to 2.74), and eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) (MD = -4.05, 95% CI = -8.07 to -0.03). There were negative correlations between intake of vitamin B6 and vitamin C and stress (ρ = -0.50 and -0.35, respectively). Compared with nonsupplementers, stress scores were on average 0.92 units lower among those supplementing with magnesium and vitamin B6 concurrently (95% CI = -3.88 to 2.03). An increase in vitamin B6 through food was related to lower stress scores. For most nutrients, intake from food was positively associated with supplementation status. Conclusion: There is some evidence to suggest potentially meaningful associations between intake of particular nutrients and stress, although CIs were wide and there were no statistically significant relationships observed. Further research is warranted to investigate any potential benefits more precisely using randomized controlled trials or large-scale observational studies.

A Judgement Bias Test to Assess Affective State and Potential Therapeutics in a Rat Model of Chemotherapy-Induced Mucositis.

Chemotherapy-induced mucositis is an extremely painful condition that occurs in 40-60% of patients undergoing chemotherapy. As mucositis currently has no effective treatment, and due to the self-limiting nature of the condition, the major treatment aims are to manage symptoms and limit pain with significance placed on improving patient quality of life. Rodent models are frequently used in mucositis research. These investigations typically assess pathological outcomes, yet fail to include a measure of affective state; the key therapeutic goal. Assessment of cognitive biases is a novel approach to determining the affective state of animals. Consequently, this study aimed to validate a cognitive bias test through a judgement bias paradigm to measure affective state in a rat model of chemotherapy-induced intestinal mucositis. Rats with intestinal mucositis demonstrated a negative affective state, which was partially ameliorated by analgesic administration, whilst healthy rats showed an optimistic response. This study concluded that the judgement bias test was able to evaluate the emotional state of rats with chemotherapy-induced mucositis. These findings provide a foundation for future refinement to the experimental design associated with the animal model that will expedite successful transitioning of novel therapeutics to clinical practice, and also improve humane endpoint implementation.