scholarly journals Development and Validation of the Study Quality Assessment of Design (SQUAD) Tool for Systematic Reviews

2019 ◽  
Author(s):  
Aaron Tierney ◽  
Marie Haverfield ◽  
Shreyas Bharadwaj ◽  
Donna Zulman

Abstract Background Despite consensus about the need to assess study design quality in systematic reviews, there remains a need for practical tools that can be used for quality assessment across diverse study designs. Methods We developed the Study Quality Assessment of Design (SQUAD) tool by combining and streamlining the Cochrane tool for grading randomized controlled trials and the risk of bias criteria developed for Effective Practice and Organisation of Care (EPOC) reviews. We validated the tool and refined it through a four-iteration pilot. We then used the tool to evaluate the quality of studies in a systematic review of the effects of interpersonal interventions on Quadruple Aim outcomes (i.e., population health, cost, patient and provider experience). Results During a pilot with 12 studies (8 randomized controlled trials and 4 observational studies), the ICC (1,1) improved from 0.41 to 0.89. In the systematic review of 77 studies (68 randomized control trials and 9 observational studies), the ICC (2,1) was 0.72. Conclusions SQUAD is a practical and reliable tool for assessing the quality of studies of various designs when synthesizing findings for systematic reviews. Standardized practices for quality assessment are critical to the reliability of systematic reviews. This pragmatic and standardized tool can facilitate efficient and high-quality assessments for a broad range of studies.

1996 ◽  
Vol 12 (2) ◽  
pp. 195-208 ◽  
Author(s):  
David Moher ◽  
Alejandro R. Jadad ◽  
Peter Tugwell

AbstractAssessing the quality of randomized controlled trials is a relatively new and important development. Three approaches have been developed: component, checklist, and scale assessment. Component approaches evaluate selected aspects of trials, such as masking. Checklists and scales involve lists of items thought to be integral to study quality. Scales, unlike the other methods, provide a summary numeric score of quality, which can be formally incorporated into a systematic review. Most scales to date have not been developed with sufficient rigor, however. Empirical evidence indicates that differences in scale development can lead to important differences in quality assessment. Several methods for including quality scores in systematic reviews have been proposed, but since little empirical evidence supports any given method, results must be interpreted cautiously. Future efforts may be best focused on gathering more empirical evidence to identify trial characteristics directly related to bias in the estimates of intervention effects and on improving the way in which trials are reported.


Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
Melinda C Power ◽  
Jennifer Weuve ◽  
A. R Sharrett ◽  
Deborah Blacker ◽  
Rebecca F Gottesman

Introduction: The recently published American College of Cardiology and American Heart Association guidelines on the management of cholesterol expanded the population recommended to receive statins by approximately 13 million United States adults. Statins are hypothesized to reduce risk of dementia through treatment of hyperlipidemia, through anti-oxidant and anti-inflammatory effects, or through influence on brain amyloid-beta or tau metabolism. However, firm conclusions about whether statin use impacts cognitive decline and dementia remain elusive. Existing reviews have focused solely on trials, did not systematically discuss study quality, or discussed and meta-analyzed all observational studies as a group, which may be inappropriate when differences in study design or analyses yield non-comparable effect estimates. Hypothesis: The purpose of this systematic review is to summarize findings from randomized controlled trials and observational cohort studies, study designs that are most useful for evaluating the putative causal effect of statin use on cognition. We hypothesized that the literature would support a protective effect of statin use on cognitive decline and dementia. METHODS: Following a systematic literature search, we grouped eligible reports by study design and statistical approach, and provide specific commentary on findings, as well as the potential for and direction of bias. RESULTS AND CONCLUSIONS: While observational studies of statin use at or near the time of dementia diagnosis suggest a protective effect, these findings may be attributable to reverse causation. Randomized controlled trials and well-conducted observational studies of baseline statin use and subsequent cognition do not support a causal preventive effect of statin use in late-life on cognitive decline or dementia. This of course does not undermine existing recommendations regarding statin use for preventing cardiovascular disease. Important questions remain unanswered, including questions about the impact of midlife or long-term statin use. Much future human research on statins and cognition will be observational; careful study design and analysis will be required to avoid common sources of bias. We advocate continuing systematic review with attention to study quality and the likelihood of bias; the AlzRisk database entry on this topic, which is currently limited to studies reporting on Alzheimer’s disease, will be available shortly and will be updated over time (see www.alzrisk.org for reviews of 11 other potential non-genetic risk factors for Alzheimer’s disease).


2020 ◽  
Author(s):  
Tian-shu Wang ◽  
Zeng-mian Wang ◽  
Wei-dong Song ◽  
Zhao-chen Tang ◽  
Yu Zhao

Abstract Background The objective of this study is to examine the effectiveness and safety of electroacupuncture (EA) in the treatment of urinary incontinence (UI) in patients with spinal cord injury (SCI). Methods All potential studies will be retrieved from the electronic databases of MEDLINE, EMBASE, Cochrane Library, PsycINFO, Web of Science, CBM, and China National Knowledge Infrastructure from origin of each database up to January 31, 2020. Additionally, we will check other resources, such as Google scholar, dissertations, conference proceedings, and reference lists of included studies. No language and publication date limitations will be considered in the literature resources search. All randomized controlled trials using EA for the treatment of UI in patients with SCI will be included. Two independent investigators will perform study selection, data extraction and study quality assessment. If any conflicts occur, we will invite a third investigator to solve them. Cochrane risk of bias will be used for study quality assessment, and RevMan 5.3 software will be employed for statistical analysis. Discussion This study will summarize the most recent evidence to assess the effectiveness and safety of EA for the treatment of UI in patients with SCI. The results of this study will provide helpful evidence to determine whether EA is effective and safety for the treatment of UI in patients with SCI or not.


2021 ◽  
Vol 12 ◽  
Author(s):  
Dana Abdelrahim ◽  
MoezAlIslam E. Faris ◽  
Mohamed Hassanein ◽  
Ayman Z. Shakir ◽  
Ayesha M. Yusuf ◽  
...  

Ramadan is the 9th month of the lunar calendar during which Muslims abstain from food and drink between dawn and sunset for 30 consecutive days. Ramadan fasting is observed by all healthy Muslim adults, as well many Muslims with type 2 diabetes (T2DM). Hypoglycemic events (HE) are a serious complication associated with diabetes management and are associated with increased cardiovascular disease risk. Conflicting results have been reported concerning the incidence of HE among people with T2DM observing Ramadan fasting. This review summarizes available scientific evidence on the occurrence of HE and the effects of different moderators on the incidence of HE among patients with T2DM during Ramadan. We conducted a systematic review of available observational studies and randomized controlled trials (RCTs) for patients with T2DM who fasted during Ramadan, with HE as the primary outcome. Ten databases were searched for relevant studies from inception until October 31, 2020. In total, 68 studies (35 RCTs and 33 observational studies) met the inclusion criteria. Non-sulfonylureas hypoglycemic medications showed superior effects in lowering the incidence of HE over sulfonylureas hypoglycemic medications. Variable moderators were associated with experiencing HE during Ramadan in both observational studies and RCTs, including sex, geographical location, body anthropometric indicators, season, dietary behaviors, fasting duration, time since diagnosis, and pre-fasting education. This comprehensive systematic review covered the largest number of observational and clinical studies investigating the impact of Ramadan on HE among patients with T2DM. The study highlights the significance of different moderators that influence the effect of Ramadan fasting on HE, including dietary behaviors, fasting time duration, sex, season, country, pre-fasting education, age, and time since diagnosis. The study also highlighted the impact of different hypoglycemic medications on HE and noted the superiority of non-sulfonylureas over sulfonylureas hypoglycemic medications in lowering the risk for hypoglycemia in people with T2DM during Ramadan fasting.


2021 ◽  
Author(s):  
Andres Jung ◽  
Julia Balzer ◽  
Tobias Braun ◽  
Kerstin Luedtke

Abstract Background: Internal and external validity are the most relevant components when critically appraising randomized controlled trials (RCTs) for systematic reviews. However, there is no gold standard to assess external validity. This might be related to the heterogeneity of terminology as well as to unclear evidence of the measurement properties of available tools. The aim of this review was to identify tools to assess the external validity of RCTs in systematic reviews and to evaluate the quality of evidence regarding their measurement properties.Methods: A two-phase systematic literature search was performed in four databases: MEDLINE via PubMed, Scopus, PsycINFO via OVID, and CINAHL via EBSCO. First, tools to assess the external validity of RCTs were identified. Second, studies aiming to investigate the measurement properties of these tools were selected. The measurement properties of each included tool were appraised using an adapted version of the COnsensus based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.Results: 34 publications reporting on the development or validation of 26 included tools were included. For 62% of the included tools, there was no evidence of any measurement property. For the remaining tools, reliability was assessed most frequently. Reliability was judged as “sufficient” for three tools (very low quality of evidence). Content validity was rated as “sufficient” for one tool (moderate quality of evidence).Conclusions: Based on these results, no available tool can be fully recommended to assess the external validity of RCTs in systematic reviews. Several steps are required to overcome the identified difficulties to either adapt and validate available tools or to develop a new one. There is a need for more research for this purpose.Trial registration: Prospective registration at Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/PTG4D


2020 ◽  
Vol 91 ◽  
pp. 104236
Author(s):  
Marcele Stephanie de Souza Buto ◽  
Marcos Paulo Braz de Oliveira ◽  
Cristiano Carvalho ◽  
Verena Vassimon-Barroso ◽  
Anielle Cristhine de Medeiros Takahashi

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