scholarly journals How to Put It Plainly? Findings From Two Randomized Controlled Studies on Writing Plain Language Summaries for Psychological Meta-Analyses

2021 ◽  
Vol 12 ◽  
Author(s):  
Martin Kerwer ◽  
Marlene Stoll ◽  
Mark Jonas ◽  
Gesa Benz ◽  
Anita Chasiotis

Plain language summaries (PLS) aim to communicate research findings to laypersons in an easily understandable manner. Despite the societal relevance of making psychological research findings available to the public, our empirical knowledge on how to write PLS of psychology studies is still scarce. In this article, we present two experimental studies investigating six characteristics of PLS for psychological meta-analyses. We specifically focused on approaches for (1) handling technical terms, (2) communicating the quality of evidence by explaining the methodological approach of meta-analyses, (3) explaining how synthesized studies operationalized their research questions, (4) handling statistical terms, (5) structuring PLS, and (6) explaining complex meta-analytic designs. To develop empirically validated guidelines on writing PLS, two randomized controlled studies including large samples stratified for education status, age, and gender (NStudy1=2,288 and NStudy2=2,211) were conducted. Eight PLS of meta-analyses from different areas of psychology were investigated as study materials. Main outcome variables were user experience (i.e., perceived accessibility, perceived understanding, and perceived empowerment) and knowledge acquisition, as well as understanding and knowledge of the quality of evidence. Overall, our hypotheses were partially confirmed, with our results underlining, among other things, the importance of explaining or replacing content-related technical terms (i.e., theoretical concepts) and indicating the detrimental effects of providing too many details on statistical concepts on user experience. Drawing on these and further findings, we derive five empirically well-founded rules on the lay-friendly communication of meta-analytic research findings in psychology. Implications for PLS authors and future research on PLS are discussed.

2020 ◽  
Vol 2020 (4) ◽  
Author(s):  
Mariano Mascarenhas ◽  
Theodoros Kalampokas ◽  
Sesh Kamal Sunkara ◽  
Mohan S Kamath

Abstract STUDY QUESTION Are systematic reviews published within a 3-year period on interventions in ART concordant in their conclusions? SUMMARY ANSWER The majority of the systematic reviews published within a 3-year period in the field of assisted reproduction on the same topic had discordant conclusions. WHAT IS KNOWN ALREADY Systematic reviews and meta-analyses have now replaced individual randomized controlled trials (RCTs) at the top of the evidence pyramid. There has been a proliferation of systematic reviews and meta-analyses, many of which suffer from methodological issues and provide varying conclusions. STUDY DESIGN, SIZE, DURATION We assessed nine interventions in women undergoing ART with at least three systematic reviews each, published from January 2015 to December 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS The systematic reviews which included RCTs were considered eligible for inclusion. The primary outcome was extent of concordance between systematic reviews on the same topic. Secondary outcomes included assessment of quality of systematic reviews, differences in included studies in meta-analyses covering the same search period, selective reporting and reporting the quality of evidence. MAIN RESULTS AND THE ROLE OF CHANCE Concordant results and conclusions were found in only one topic, with reviews in the remaining eight topics displaying partial discordance. The AMSTAR grading for the majority of the non-Cochrane reviews was critically low whilst it was categorized as high for all of the Cochrane reviews. For three of the nine topics, none of the included systematic reviews assessed the quality of evidence. We were unable to assess selective reporting as most of the reviews did not have a pre-specified published protocol. LIMITATIONS, REASONS FOR CAUTION We were limited by the high proportion of reviews lacking a pre-specified protocol, which made it impossible to assess for selective reporting. Furthermore, many reviews did not specify primary and secondary outcomes which made it difficult to assess reporting bias. All the authors of this review were Cochrane review authors which may introduce some assessment bias. The categorization of the review’s conclusions as beneficial, harmful or neutral was subjective, depending on the tone and wording of the conclusion section of the review. WIDER IMPLICATIONS OF THE FINDINGS The majority of the systematic reviews published within a 3-year period on the same topic in the field of assisted reproduction revealed discordant conclusions and suffered from serious methodological issues, hindering the process of informed healthcare decision-making. STUDY FUNDING/COMPETING INTEREST(S) All the authors are Cochrane authors. M.S.K. is an editorial board member of Cochrane Gynaecology and Fertility group. No grant from funding agencies in the public, commercial or not-for-profit sectors was obtained.


2020 ◽  
Vol 54 ◽  
Author(s):  
Lia M. Palileo-Villanueva ◽  
Elenore Judy B. Uy

KEY FINDINGS There is insufficient evidence to support the routine use of HCQ or CQ for the treatment of COVID-19. Results from interim analyses of 2 large RCTs, the Recovery and the Solidarity trials, reportedly showed no clinical benefit from HCQ for hospitalized patients with COVID-19. There are 3 randomized controlled trials that investigated the efficacy and safety of HCQ compared to standard therapy. Overall quality of evidence was very low. Meta-analyses from the “COVID-19 Living Data” project suggests that the use of HCQ may increase the incidence of adverse events at day 14 to day 28 (RR 2.49, 95% confidence interval: 1.04 to 5.98, moderate quality of evidence); the most common adverse event across the two trials is diarrhea (n=8). In a statement dated June 5, 2020, the investigators of the Recovery trial announced their decision to halt further enrollment to the HCQ arm of the trial because an interim analysis showed no clinical benefit from the use of HCQ in hospitalized patients with COVID. On June 15, 2020, the US FDA revoked the emergency use authorization for HCQ and CQ as treatment for COVID-19. On June 18, 2020, the WHO announced that recruitment to the HCQ arm of the Solidarity trial has been halted.


Nutrients ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3352 ◽  
Author(s):  
Fatme AlAnouti ◽  
Myriam Abboud ◽  
Dimitrios Papandreou ◽  
Nadine Mahboub ◽  
Suzan Haidar ◽  
...  

Background: Metabolic syndrome (MetS) increases the risk of cardiovascular disease, with atherogenic dyslipidemia being a major contributing factor. Methods: A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement to assess whether vitamin D supplementation (VDS) alleviates dyslipidemia in adults with MetS. Scientific databases (PUBMED, MEDLINE, CINAHL, EMBASE, Cochrane Library, ClinicalTrials.gov, International Clinical Trials Registry Platform) and the gray literature were searched for randomized controlled trials of VDS, reporting on blood lipids. A narrative review, meta-analyses, sensitivity analyses, and appraisal of the risk of bias and overall quality of evidence produced were conducted. Results: Seven studies were included, and four were meta-analyzed. The risk of bias was generally low, and the final quality of evidence was low or very low. VDS, whether in high or low dose, significantly increased endline vitamin D blood levels; did not affect total, low-density, high-density cholesterol levels, and novel lipid-related biomarkers; yet, significantly increased triglycerides (TG) levels compared with placebo (MD: 30.67 (95%CI: 4.89–56.45) mg/dL; p = 0.02 for low-dose VDS; and MD: 27.33 (95%CI: 2.06–52.59) mg/dL; p = 0.03 for high-dose VDS). Pertaining heterogeneity was high (I2 = 86%; and I2 = 51%, respectively), and some included studies had significantly higher baseline TG in the intervention arm. The sensitivity analyses revealed robust results. Conclusion: VDS seems not to affect blood lipids in adults with MetS.


2021 ◽  
Vol 10 (7) ◽  
pp. 1478
Author(s):  
Alexandra Voinescu ◽  
Jie Sui ◽  
Danaë Stanton Fraser

Neurological disorders are a leading cause of death and disability worldwide. Can virtual reality (VR) based intervention, a novel technology-driven change of paradigm in rehabilitation, reduce impairments, activity limitations, and participation restrictions? This question is directly addressed here for the first time using an umbrella review that assessed the effectiveness and quality of evidence of VR interventions in the physical and cognitive rehabilitation of patients with stroke, traumatic brain injury and cerebral palsy, identified factors that can enhance rehabilitation outcomes and addressed safety concerns. Forty-one meta-analyses were included. The data synthesis found mostly low- or very low-quality evidence that supports the effectiveness of VR interventions. Only a limited number of comparisons were rated as having moderate and high quality of evidence, but overall, results highlight potential benefits of VR for improving the ambulation function of children with cerebral palsy, mobility, balance, upper limb function, and body structure/function and activity of people with stroke, and upper limb function of people with acquired brain injury. Customization of VR systems is one important factor linked with improved outcomes. Most studies do not address safety concerns, as only nine reviews reported adverse effects. The results provide critical recommendations for the design and implementation of future VR programs, trials and systematic reviews, including the need for high quality randomized controlled trials to test principles and mechanisms, in primary studies and in meta-analyses, in order to formulate evidence-based guidelines for designing VR-based rehabilitation interventions.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
M Oberndorfer ◽  
I Grabovac ◽  
S Haider ◽  
T E Dorner

Abstract Background Reports of the effectiveness of e-cigarettes (ECs) for smoking cessation vary across different studies making implementation recommendations hard to attain. We performed a systematic review and meta-analysis to synthesise the current evidence regarding the effectiveness of ECs for smoking cessation. Methods PubMed, PsycInfo and Embase databases were searched for randomized controlled trials comparing nicotine ECs with non-nicotine ECs or with established smoking cessation interventions (nicotine replacement therapy (NRT) and or counselling) published between 01/01/2014 and 01/05/2019. Data from eligible studies were extracted and used for random-effects meta-analyses. Results Our literature review yielded 13190 publications with 10 studies being identified as eligible for systematic review, covering 8362 participants, and 8 for meta-analyses (n = 30 - 6006). Using the last follow-up of eligible studies, the proportion of smokers achieving abstinence was 1.67 [95CI:0.99 - 2.81] times higher in nicotine EC users compared to non-nicotine EC users. The proportion of abstinent smokers was 1.69 [95CI:1.25 - 2.27] times higher in EC users compared to participants receiving NRT. EC users showed a 2.70 [95CI:1.15 - 6.30] times higher proportion of abstinent smokers in comparison to participants solely receiving counselling. Conclusions Our analysis showed modest effects of nicotine-ECs compared to non-nicotine ECs. When compared to NRT or counselling, results suggest that nicotine EC may be more effective for smoking cessation. As ECs also help maintaining routinized behaviour and social aspects of smoking, we hypothesise that this may explain their advantage as a tool for smoking cessation. However, given the small number of included studies, different populations, heterogeneous designs, and the overall moderate to low quality of evidence, it is not possible to offer clear recommendations. More comparable data is needed to strengthen confidence in the quality of evidence. Key messages The number of previous studies assessing the effectiveness of ECs for smoking cessation is limited. Further, comparability of these studies is restricted, weakening the quality of evidence. Although current evidence on the effectiveness of ECs for smoking cessation is inconclusive, our meta-analyses suggest that ECs could be a promising alternative tool in attempts to achieve abstinence.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ran Liu ◽  
Kun Zhang ◽  
Qiu-yu Tong ◽  
Guang-wei Cui ◽  
Wen Ma ◽  
...  

Abstract Background Acupuncture for post-stroke depression (PSD) has been evolving, but uncertainty remains. To assess the existing evidence from randomized clinical trials (RCTs) of acupuncture for PSD, we sought to draw conclusions by synthesizing RCTs. Methods An exhaustive literature search was conducted in seven electronic databases from their inception dates to April 19, 2020, to identify systematic reviews (SRs) and meta-analyses (MAs) on this topic. The primary RCTs included in the SRs/MAs were identified. We also conducted a supplementary search for RCTs published from January 1, 2015, to May 12, 2020. Two reviewers extracted data separately and pooled data using RevMan 5.3 software. The quality of evidence was critically appraised with the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system. Results A total of 17 RCTs involving 1402 patients were included. Meta-analysis showed that participants who received a combination of acupuncture and conventional treatments exhibited significantly lower scores on the HAM-D17, HAM-D24 and HAM-D (MD, − 5.08 [95% CI, − 6.48 to − 3.67], I2 = 0%), (MD, − 9.72 [95% CI, − 14.54 to − 4.91], I2 = 65%) and (MD, − 2.72 [95% CI, − 3.61 to − 1.82], respectively) than those who received conventional treatment. However, there was no significant difference in acupuncture versus antidepressants in terms of the 17-item, 24-item and HAM-D scales (MD, − 0.43 [95% CI, − 1.61 to 0.75], I2 = 51%), (MD, − 3.09 [95% CI, − 10.81 to 4.63], I2 = 90%) and (MD, − 1.55 [95% CI, − 4.36 to 1.26], I2 = 95%, respectively). For adverse events, acupuncture was associated with fewer adverse events than antidepressants (RR, 0.16 [95% CI, 0.07 to 0.39], I2 = 35%), but there was no significant difference in the occurrence of adverse events between the combination of acupuncture and conventional treatments versus conventional treatments (RR, 0.63 [95% CI, 0.21 to 1.83], I2 = 38%). The quality of evidence was low to very low due to the substantial heterogeneity among the included studies. Conclusions The current review indicates that acupuncture has greater effect on PSD and better safety profile than antidepressants, but high-quality evidence evaluating acupuncture for PSD is still needed.


2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Sameh M. Zamzam ◽  
Mosaad Abdel-Aziz ◽  
Ahmed Atef ◽  
Usama Abdel-Naseer ◽  
Mostafa Hamoda ◽  
...  

Abstract Background Randomized controlled trials (RCTs) are prospective comparative studies in which study groups are allocated randomly to intervention or serve as controls. RCT is the mainstay to achieve evidence in the literature in clinical research. A RCT is the main research design to study the effect of an intervention and the only way to confirm the value of a new treatment. Main body RCT also gives the way to generate meta-analyses and systematic reviews giving a stronger evidence for clinical practice. Evidence-based medicine (EBM) is crucial for safe, effective, and standardized patient care. Although there is an agreement on the importance of performing RCT, it can be challenging to do it efficiently including different aspects like study design, funding, randomization, blinding, follow-up, data analysis, statistics, generalization of results, and reporting of quality of the studies. Conclusion In this article, we gave a comprehensive review for RCT in otolaryngology discussing their importance, advantages, and drawbacks, types, steps, challenges, reporting their quality and their prevalence in the literature.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Siwanon Rattanakanokchai ◽  
Nuntasiri Eamudomkarn ◽  
Nampet Jampathong ◽  
Bao-Yen Luong-Thanh ◽  
Chumnan Kietpeerakool

AbstractThis systematic review and meta-analysis was conducted to assess associations between changing gloves during cesarean section (CS) and postoperative infection. A literature search was conducted using the major electronic databases MEDLINE, Scopus, ISI Web of Science, PubMed, CINAHL, and CENTRAL from their inception to September 2020. Randomized controlled trials (RCTs) comparing glove change during CS to no glove change were included. Outcomes of interest were endometritis, febrile morbidity, and incisional surgical site infection (SSI). GRADE approach was applied to assess the quality of evidence. Ten reports of six studies involving 1707 participants were included in the analyses. Glove change was associated with a reduction in the risk of incisional SSI following CS (pooled RR 0.49, 95% CI 0.30, 0.78; moderate quality of evidence). Compared to no glove change, glove change during CS did not reduce the risks of endometritis (pooled RR 1.00, 95% CI 0.80, 1.24; low quality of evidence) or febrile morbidity (pooled RR 0.85, 95% CI 0.43, 1.71; very low quality of evidence). Changing gloves during CS was associated with a decreased risk of incisional SSI. The risks of postoperative endometritis and febrile morbidity were not altered by changing gloves.


2021 ◽  
Author(s):  
Alaa Abd-alrazaq ◽  
Dari Alhuwail ◽  
Eiman Al-Jafar ◽  
Arfan Ahmed ◽  
Shuja Mohd Reagu ◽  
...  

BACKGROUND Memory, one of the main cognitive functions, is known to decline by age. Serious games have been used for improving memory among the elderly. The effectiveness of serious games in improving memory has been investigated by several systematic reviews; however, they are limited by design and methodological weaknesses. OBJECTIVE This study aims to assess the effectiveness of serious games in improving memory among the elderly with cognitive impairment. METHODS A systematic review of randomized controlled trials (RCTs) was carried out. The search sources included searching 8 databases, screening reference lists of the included studies and relevant reviews, and checking studies that cited the included studies. Two reviewers independently carried out the study selection, data extraction, risk of bias assessment, and quality of evidence appraisal. Extracted data were synthesized using a narrative approach and a statistical approach (i.e., meta-analysis), as appropriate. RESULTS Out of 466 citations retrieved, 18 studies met the eligibility criteria of this review. Of those, 15 RCTs were eventually included in 10 meta-analyses. We found that serious games are more effective than no or passive interventions in improving non-verbal memory (P=0.002) and working memory (P=0.02), but not verbal memory (P=0.13). The review also showed that serious games are more effective than conventional exercises in improving verbal memory (P=0.004), but not for non-verbal memory (P=0.12) and working memory (P=0.49). Serious games were as effective as conventional cognitive activities in improving verbal memory (P=0.07), non-verbal memory (P=0.94), and working memory (P=0.08) among the elderly with cognitive impairment. Lastly, the effect of adaptive serious games on working memory was comparable to non-adaptive serious games (P=0.08). CONCLUSIONS Serious games have the potential to improve verbal, non-verbal, and working memory among elderly people with cognitive impairment. However, our findings should be interpreted cautiously given that most meta-analyses were based on a few studies (≤3) and judged to have a low quality of evidence. Therefore, serious games should be offered as supplemental to existing proven and safe interventions, rather than a complete substitute until further, more robust evidence is available. Future studies should investigate the short and long-term effects of serious games on memory and other cognitive abilities among people from different age groups with or without cognitive impairment.


Author(s):  
Adrian Hernandez ◽  
John Ingemi III ◽  
Michael Sherman ◽  
Vinay Pasupuleti ◽  
Joshuan Barboza ◽  
...  

IntroductionNo early treatment intervention for COVID-19 has proven effective to date. We systematically reviewed the efficacy of hydroxychloroquine as early treatment for COVID-19.Material and methodsRandomized controlled trials (RCTs) evaluating hydroxychloroquine for early treatment of COVID-19 were searched in five engines and preprint websites until September 14, 2021. Primary outcomes were hospitalization and all-cause mortality. Secondary outcomes included COVID-19 symptom resolution, viral clearance, and adverse events. Inverse variance random-effects meta-analyses were performed and quality of evidence (QoE) per outcome was assessed with GRADE methods.ResultsFive RCTs (n=1848) were included. The comparator was placebo in four RCTs and usual care in one RCT. The RCTs used hydroxychloroquine total doses between 1,600 and 4,400 mg and had follow up times between 14 and 90 days. Compared to the controls, early treatment with hydroxychloroquine did not reduce hospitalizations (RR 0.80, 95%CI 0.47-1.36, I2=2%, 5 RCTs, low QoE), all-cause mortality (RR 0.77, 95%CI 0.16-3.68, I2=0%, 5 RCTs, very low QoE), symptom resolution (RR 0.94, 95%CI 0.77-1.16, I2=71%, 3 RCTs, low QoE) or viral clearance at 14 days (RR 1.02, 95%CI 0.82-1.27, I2=65%, 2 RCTs, low QoE). There was a higher non-significant increase of adverse events with hydroxychloroquine vs. controls (RR 2.17, 95%CI 0.86-5.45, I2=92%, 5 RCTs, very low QoE).ConclusionsHydroxychloroquine was not efficacious as early treatment for COVID-19 infections in RCTs with low to very low quality of evidence for all outcomes. More RCTs are needed to elucidate the efficacy of hydroxychloroquine as early treatment intervention.


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