scholarly journals Protocol for a systematic review of guidelines for rigour in the design, conduct and analysis of biomedical experiments involving laboratory animals

2018 ◽  
Vol 2 (1) ◽  
pp. e000004 ◽  
Author(s):  
Jan Vollert ◽  
Esther Schenker ◽  
Malcolm Macleod ◽  
Anton Bespalov ◽  
Hanno Wuerbel ◽  
...  
Keyword(s):  
Systematic Review ◽  
Biomedical Research ◽  
Animal Studies ◽  
English Language ◽  
Internal Validity ◽  
Laboratory Animals ◽  
Validity And Reliability ◽  
Standardized Reporting ◽  
Two Phases ◽  
Google Search

ObjectiveWithin the last years, there has been growing awareness of the negative repercussions of unstandardized planning, conduct and reporting of preclinical and biomedical research. Several initiatives have set the aim of increasing validity and reliability in reporting of studies and publications, and publishers have formed similar groups. Additionally, several groups of experts across the biomedical spectrum have published experience and opinion-based guidelines and guidance on potential standardized reporting. While all these guidelines cover reporting of experiments, an important step prior to this should be rigours planning and conduction of studies. The aim of this systematic review is to identify and harmonize existing experimental design, conduct and analysis guidelines relating to internal validity and reproducibility of preclinical animal research. The review will also identify literature describing risks of bias pertaining to the design, conduct and analysis of preclinical biomedical research.Search strategyPubMed, Embase and Web of Science will be searched systematically to identify guidelines published in English language in peer-reviewed journals before January 2018 (box 1). All articles or systematic reviews in English language that describe or review guidelines on the internal validity and reproducibility of animal studies will be included. Google search for guidelines published on the websites of major funders and professional organisations can be found in (Box 2).Screening and annotationUnique references will be screened in two phases: screening for eligibility based on title and abstract, followed by screening for definitive inclusion based on full text. Screening will be performed in SyRF (http://syrf.org.uk). Each reference will be randomly presented to two independent reviewers. Disagreements between reviewers will be resolved by additional screening of the reference by a third, senior researcher.Data management and reportingAll data, including extracted text and guidelines, will be stored in the SyRF platform. Elements of the included guidelines will be identified using a standardized extraction form. Reporting will follow the PRISMA guidelines as far as applicable.

scholarly journals Systematic review of guidelines for internal validity in the design, conduct and analysis of preclinical biomedical experiments involving laboratory animals

2020 ◽  
Vol 4 (1) ◽  
pp. e100046 ◽  
Author(s):  
Jan Vollert ◽  
Esther Schenker ◽  
Malcolm Macleod ◽  
Anton Bespalov ◽  
Hanno Wuerbel ◽  
...  
Keyword(s):  
Systematic Review ◽  
Animal Studies ◽  
Web Of Science ◽  
Internal Validity ◽  
Relative Effect ◽  
Effect Sizes ◽  
Laboratory Animals ◽  
Preclinical Research ◽  
Sample Size Calculations ◽  
Flow Through

Over the last two decades, awareness of the negative repercussions of flaws in the planning, conduct and reporting of preclinical research involving experimental animals has been growing. Several initiatives have set out to increase transparency and internal validity of preclinical studies, mostly publishing expert consensus and experience. While many of the points raised in these various guidelines are identical or similar, they differ in detail and rigour. Most of them focus on reporting, only few of them cover the planning and conduct of studies. The aim of this systematic review is to identify existing experimental design, conduct, analysis and reporting guidelines relating to preclinical animal research. A systematic search in PubMed, Embase and Web of Science retrieved 13 863 unique results. After screening these on title and abstract, 613 papers entered the full-text assessment stage, from which 60 papers were retained. From these, we extracted unique 58 recommendations on the planning, conduct and reporting of preclinical animal studies. Sample size calculations, adequate statistical methods, concealed and randomised allocation of animals to treatment, blinded outcome assessment and recording of animal flow through the experiment were recommended in more than half of the publications. While we consider these recommendations to be valuable, there is a striking lack of experimental evidence on their importance and relative effect on experiments and effect sizes.

Thrombolytic Salvage of the Frostbitten Upper Extremity: A Systematic Review

Hand ◽  
2020 ◽  
pp. 155894472094006
Author(s):  
James Drinane ◽  
Adee J. Heiman ◽  
Joseph A. Ricci ◽  
Ashit Patel
Keyword(s):  
Systematic Review ◽  
Thrombolytic Therapy ◽  
Upper Extremity ◽  
Animal Studies ◽  
English Language ◽  
Case Series ◽  
Current Data ◽  
Ischemic Tissue ◽  
Promising Treatment ◽  
Salvage Rate

Background Vascular thrombosis secondary to frostbite can lead to ischemic tissue damage in severe cases. Threatened extremities may be salvaged with thrombolytics to restore perfusion; however, current data are limited to single institution case series. The authors performed a systematic review to determine the efficacy of thrombolytic therapy in treating upper extremity frostbite. Methods PubMed, EBSCO, and Google Scholar were queried using the keywords “thrombolytics,” “frostbite,” “fibrinolytics,” and “tPA.” Exclusion criteria were failure to delineate anatomic parts injured, failure to report number of limbs salvaged, animal studies, and non-English language publications. Thrombolytic therapy was defined as intraarterial (IA) or intravenous (IV) administration of tissue plasminogen activator (tPA), alteplase, urokinase, streptokinase, or any tPA derivative. Results A total of 42 studies were identified, with 13 satisfying inclusion criteria. Eight studies reported catheter-directed IA thrombolysis, four reported systemic IV administration, and 1 reported both methods. A total of 157 patients received thrombolytics. In all, 73 upper extremity digits were treated by IA route and 136 digits were treated by IV route. Overall upper extremity digit salvage rate was 59%. There was a significantly higher salvage rate in digits treated by the IA route compared to the IV route. Conclusions Thrombolytics, particularly when administered by the intra-arterial route, are emerging as a promising treatment of severe frostbite of the upper extremity, increasing digit salvage rates.

scholarly journals Reliability and Validity of Commercially Available Wearable Devices for Measuring Steps, Energy Expenditure, and Heart Rate: Systematic Review (Preprint)

2020 ◽  
Author(s):  
Daniel Fuller ◽  
Emily Colwell ◽  
Jonathan Low ◽  
Kassia Orychock ◽  
Melissa Ann Tobin ◽  
...  
Keyword(s):  
Systematic Review ◽  
Heart Rate ◽  
Energy Expenditure ◽  
English Language ◽  
Reliability And Validity ◽  
Wearable Devices ◽  
Validity And Reliability ◽  
Health Related ◽  
Wearable Activity Trackers ◽  
Fitness And Health

BACKGROUND Consumer-wearable activity trackers are small electronic devices that record fitness and health-related measures. OBJECTIVE The purpose of this systematic review was to examine the validity and reliability of commercial wearables in measuring step count, heart rate, and energy expenditure. METHODS We identified devices to be included in the review. Database searches were conducted in PubMed, Embase, and SPORTDiscus, and only articles published in the English language up to May 2019 were considered. Studies were excluded if they did not identify the device used and if they did not examine the validity or reliability of the device. Studies involving the general population and all special populations were included. We operationalized validity as criterion validity (as compared with other measures) and construct validity (degree to which the device is measuring what it claims). Reliability measures focused on intradevice and interdevice reliability. RESULTS We included 158 publications examining nine different commercial wearable device brands. Fitbit was by far the most studied brand. In laboratory-based settings, Fitbit, Apple Watch, and Samsung appeared to measure steps accurately. Heart rate measurement was more variable, with Apple Watch and Garmin being the most accurate and Fitbit tending toward underestimation. For energy expenditure, no brand was accurate. We also examined validity between devices within a specific brand. CONCLUSIONS Commercial wearable devices are accurate for measuring steps and heart rate in laboratory-based settings, but this varies by the manufacturer and device type. Devices are constantly being upgraded and redesigned to new models, suggesting the need for more current reviews and research.

scholarly journals Conundrum of re-positives COVID-19 cases: A Systematic review of Case reports and Case series

2020 ◽  
Author(s):  
Arun Kumar Yadav ◽  
Subhadeep Ghosh ◽  
Sudhir Dubey
Keyword(s):  
Systematic Review ◽  
Animal Studies ◽  
English Language ◽  
Case Reports ◽  
Case Series ◽  
Contact Tracing ◽  
First Episode ◽  
Rt Pcr ◽  
Registration Number ◽  
Age Range

AbstractIntroductionThere have been case reports and case series published for RT PCR positive COVID - 19 cases that became RT PCR negative but subsequently became RT PCR positive after a symptom free interval following a negative RT PCR test. These cases may include re-positive, reactivated and re-infection cases. Hence, the systematic review to summarize and synthesize evidence from all available case series and case reports published was undertaken.MethodologyThe systematic review of case series and case reports was registered with Prospero with registration number CRD42020210446. PRISMA guidelines were followed for conducting the systematic review. Studies published in English language only were considered for the Systematic Review. Inclusion criteria for studies included case reports and case series which have documented cases of positive RT-PCR after a period of improvement or negative RT PCR. Reviews, opinions and animal studies were excluded. Case reports which described clinical presentation or manifestations of COVID-19 cases were also excluded from the studies. Methodological quality was assessed using modified Murad scale.ResultsA total of 30 case reports/case series were included in the study, wherein a total of 219 cases were included. In re-positive cases, the age range varied from 10 months to 91 years. The pooled proportion using random effects was 12% with 95% CI from 09% to 15%. Among the re-positives, a total of 57 cases (26%) of the cases had co-morbidities. A total of 51 (23.3%) and 17 (7.8%) re-positive cases had been treated with antivirals and corticosteroids respectively. Among the symptomatic cases, the disease severity was lesser as compared to the initial episode of illness. Only a few studies have confirmed the presence of antibodies after the first episode. The few studies that had done contact tracing of re-positives did not find any positive cases among those in contact with re-positives.ConclusionThis systematic review presents the review of all the case reports and case series on recurrence of COVID 19 disease. Although limited evidence has been generated due to paucity of such studies and shortcomings in the study designs of case reports and case-series, nonetheless, the evidence generated can still be used in making clinical decisions and framing policy guidelines

scholarly journals Treatment Response of Deferiprone in Infratentorial Superficial Siderosis: a Systematic Review

2021 ◽  
Author(s):  
Andreas Flores Martin ◽  
Priya Shanmugarajah ◽  
Nigel Hoggard ◽  
Marios Hadjivassiliou
Keyword(s):  
Systematic Review ◽  
Animal Studies ◽  
English Language ◽  
Human Subjects ◽  
Therapeutic Option ◽  
Language Translation ◽  
Randomised Clinical Trial ◽  
Superficial Siderosis ◽  
Amyloid Angiopathy ◽  
Mixed Response

AbstractSuperficial siderosis describes haemosiderin deposition on the surface of the brain. When present on infratentorial structures, it can cause ataxia, sensorineural hearing loss and pyramidal signs. There is no proven treatment and patients experience slow progression of symptoms. Iron-chelating agents have been suggested as a therapeutic option and deferiprone is suited as it crosses the blood-brain barrier. However, deferiprone is reported to have a 1–2% risk of agranulocytosis. We performed a systematic review on treatment of infratentorial superficial siderosis with deferiprone based on PRISMA guidelines. Studies were included if in English or an English language translation was available, were about human subjects and referred to patients with ataxia. Studies were excluded if they did not possess an English translation, included animal studies or did not have ataxia. Studies were excluded if they discussed cerebral amyloid angiopathy or siderosis of other regions. Eleven papers were included. We identified 69 patients. Seventeen patients (25%) discontinued the drug. The most encountered adverse effect was anaemia (21.7%). Neutropaenia was observed in 8.7% and agranulocytosis in 5.8% of patients. Clinically, response varied, and stability or improvement was seen across neurological domains in 6 studies while 5 showed a mixed response. On imaging, 13 (28.9%) patients improved, 24 (53.3%) stabilised and 8 (17.8%) deteriorated. A prospective international centralised register of patients should be developed to inform the design and conduct of a multicentre, placebo-controlled, randomised clinical trial to evaluate the efficacy of deferiprone. The evidence from this systematic review is that deferiprone is a promising intervention.

scholarly journals Quality of Reporting in Preclinical Urethral Tissue Engineering Studies: A Systematic Review to Assess Adherence to the ARRIVE Guidelines

Animals ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 2456
Author(s):  
Tariq O. Abbas ◽  
Abubakr Elawad ◽  
Abdul Kareem Pullattayil S. ◽  
Cristian Pablo Pennisi
Keyword(s):  
Systematic Review ◽  
Tissue Engineering ◽  
Animal Studies ◽  
Therapeutic Option ◽  
Laboratory Animals ◽  
Size Estimation ◽  
Ethical Guidelines ◽  
Preclinical Research ◽  
Quality Of Reporting

Preclinical research within the area of urethral tissue engineering has not yet been successfully translated into an efficient therapeutic option for patients. This gap could be attributed, in part, to inadequate design and reporting of the studies employing laboratory animals. In this study, a systematic review was conducted to investigate the quality of reporting in preclinical studies utilizing tissue engineering approaches for urethral repair. The scope was on studies performed in rabbits, published between January 2014 and March 2020. Quality assessment of the data was conducted according to the Animal Research: Reporting of in Vivo Experiments (ARRIVE) guidelines by the scoring of a 38-item checklist in different categories. A total of 28 articles that fulfilled the eligibility criteria were included in the study. The range of ARRIVE score was from 0 to 100, taking into consideration having reported the item in question or not. The mean checklist score was 53%. The items that attained the highest scores included the number of animals utilized, the size of control and experimental groups, and the definition of experimental outcomes. The least frequently reported items included the data regarding the experimental procedure, housing and husbandry, determination and justification of the number of animals, and reporting of adverse events. Surprisingly, full disclosure about ethical guidelines and animal protocol approval was missing in 54% of the studies. No paper stated the sample size estimation. Overall, our study found that a large number of studies display inadequate reporting of fundamental information and that the quality of reporting improved marginally over the study period. We encourage a comprehensive implementation of the ARRIVE guidelines in animal studies exploring tissue engineering for urethral repair, not only to facilitate effective translation of preclinical research findings into clinical therapies, but also to ensure compliance with ethical principles and to minimize unnecessary animal studies.

scholarly journals Reliability and Validity of Commercially Available Wearable Devices for Measuring Steps, Energy Expenditure, and Heart Rate: Systematic Review

10.2196/18694 ◽  
2020 ◽  
Vol 8 (9) ◽  
pp. e18694 ◽  
Author(s):  
Daniel Fuller ◽  
Emily Colwell ◽  
Jonathan Low ◽  
Kassia Orychock ◽  
Melissa Ann Tobin ◽  
...  
Keyword(s):  
Systematic Review ◽  
Heart Rate ◽  
Energy Expenditure ◽  
English Language ◽  
Reliability And Validity ◽  
Wearable Devices ◽  
Validity And Reliability ◽  
Health Related ◽  
Wearable Activity Trackers ◽  
Fitness And Health

Background Consumer-wearable activity trackers are small electronic devices that record fitness and health-related measures. Objective The purpose of this systematic review was to examine the validity and reliability of commercial wearables in measuring step count, heart rate, and energy expenditure. Methods We identified devices to be included in the review. Database searches were conducted in PubMed, Embase, and SPORTDiscus, and only articles published in the English language up to May 2019 were considered. Studies were excluded if they did not identify the device used and if they did not examine the validity or reliability of the device. Studies involving the general population and all special populations were included. We operationalized validity as criterion validity (as compared with other measures) and construct validity (degree to which the device is measuring what it claims). Reliability measures focused on intradevice and interdevice reliability. Results We included 158 publications examining nine different commercial wearable device brands. Fitbit was by far the most studied brand. In laboratory-based settings, Fitbit, Apple Watch, and Samsung appeared to measure steps accurately. Heart rate measurement was more variable, with Apple Watch and Garmin being the most accurate and Fitbit tending toward underestimation. For energy expenditure, no brand was accurate. We also examined validity between devices within a specific brand. Conclusions Commercial wearable devices are accurate for measuring steps and heart rate in laboratory-based settings, but this varies by the manufacturer and device type. Devices are constantly being upgraded and redesigned to new models, suggesting the need for more current reviews and research.

scholarly journals Effect of Premedication on the Success of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis: A Systematic Review of the Literature

2019 ◽  
Vol 2019 ◽  
pp. 1-25 ◽  
Author(s):  
Meric Karapinar-Kazandag ◽  
Jale Tanalp ◽  
Handan Ersev
Keyword(s):  
Systematic Review ◽  
Nerve Block ◽  
English Language ◽  
Data Extraction ◽  
Inferior Alveolar Nerve ◽  
Inferior Alveolar Nerve Block ◽  
Mesh Terms ◽  
Google Search ◽  
The Impact ◽  
Irreversible Pulpitis

Background. Failure in the provision of inferior alveolar nerve block anesthesia (IANB) is a significant problem during endodontic treatment of irreversible pulpitis. Various methodologies have been advocated one of which is administration of premedication prior to anesthesia. Despite the considerable number of reports, the topic yet deserves more clarification. This systematic review was conducted to provide an oversight on the effectiveness of premedication prior to IANB in mandibular teeth. Methods. A PubMed and Cochrane Database search was conducted by using MeSH terms inferior alveolar nerve block + pulpitis and mandibular anesthesia+pulpitis. Two reviewers independently performed the screening, selection of papers, and data extraction. Papers in English language that included randomized clinical studies on the impact of different medications on the success of inferior alveolar block anesthesia in irreversible pulpitis were included. Additionally, relevant supporting literature was also used where necessary. Results. Initially, 118 papers were selected from PubMed and 68 were selected from Cochrane. Five additional articles were retrieved from Google Search. Following the elimination of duplicates and irrelevant articles, 35 studies were selected meeting the criteria. It was observed that there was moderate evidence to suggest that some premedications were partially effective for the enhancement of mandibular anesthetic effect in irreversible pulpitis. Conclusion. Though some medications appear to be promising, further supporting research will help highlight this significant topic which requires further clarification.

Thrombolytic Salvage of Threatened Frostbitten Extremities and Digits: A Systematic Review

2019 ◽  
Vol 40 (5) ◽  
pp. 541-549 ◽  
Author(s):  
James Drinane ◽  
Vasanth S Kotamarti ◽  
Casey O’Connor ◽  
Lakshmi Nair ◽  
Alex Divanyan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Thrombolytic Therapy ◽  
Animal Studies ◽  
English Language ◽  
Case Reports ◽  
Case Series ◽  
Weighted Average ◽  
Tissue Loss ◽  
Ischemic Tissue ◽  
Soft Tissue Loss

Abstract Frostbite is a cold injury that results in soft tissue loss and can lead to amputation. Vascular thrombosis following injury causes ischemic tissue damage. Despite understanding the pathology, its treatment has remained largely unchanged for over 30 years. Threatened extremities may be salvaged with thrombolytics to restore perfusion. The authors performed a systematic review to determine whether thrombolytic therapy is effective and to identify patients who may benefit from this treatment. The Pubmed, EBSCO, and Google Scholar databases were queried using the key words “thrombolytics,” “frostbite,” “fibrinolytics,” and “tPA.” Studies written after 1990 in English met inclusion criteria. Exclusion criteria were failure to delineate anatomic parts injured, failure to report number of limbs salvaged, animal studies, and non-English language publications. Thrombolytic therapy was defined as administration of tPA, alteplase, urokinase, or streptokinase. Forty-two studies were identified and 17 included. Included were 1 randomized trial, 10 retrospective studies, 2 case series, and 4 case reports. One thousand eight hundred and forty-four limbs and digits in 325 patients were studied and 216 patients treated with thrombolytics and 346 amputations performed. The most common means of thrombolysis was intra-arterial tPA. The most common duration of therapy was 48 hours. Limb salvage rates ranged from 0% to 100% with a weighted average of 78.7%. Thrombolytics are a safe and effective treatment of severe frostbite. They represent the first significant advancement in frostbite treatment by preventing otherwise inevitable amputations warranting both greater utilization and further research to clarify the ideal thrombolytic protocol.

scholarly journals Systematic review of prehospital haemostatic dressings

2019 ◽  
Vol 166 (3) ◽  
pp. 194-200 ◽  
Author(s):  
Matthew Welch ◽  
J Barratt ◽  
A Peters ◽  
C Wright
Keyword(s):  
Systematic Review ◽  
Animal Studies ◽  
English Language ◽  
Literature Search ◽  
Clinical Evidence ◽  
Grey Literature ◽  
High Quality ◽  
Exclusion Criteria ◽  
Military Forces ◽  
Language Studies

IntroductionHaemorrhage is one of the leading causes of battlefield and prehospital death. Haemostatic dressings are an effective method of limiting the extent of bleeding and are used by military forces extensively. A systematic review was conducted with the aim of collating the evidence on current haemostatic products and to assess whether one product was more effective than others.MethodsA systematic search and assessment of the literature was conducted using 13 health research databases including MEDLINE and CINAHL, and a grey literature search. Two assessors independently screened the studies for eligibility and quality. English language studies using current-generation haemostatic dressings were included. Surgical studies, studies that did not include survival, initial haemostasis or rebleeding and those investigating products without prehospital potential were excluded.Results232 studies were initially found and, after applying exclusion criteria, 42 were included in the review. These studies included 31 animal studies and 11 clinical studies. The outcomes assessed were subject survival, initial haemostasis and rebleeding. A number of products were shown to be effective in stopping haemorrhage, with Celox, QuikClot Combat Gauze and HemCon being the most commonly used, and with no demonstrable difference in effectiveness.ConclusionsThere was a lack of high-quality clinical evidence with the majority of studies being conducted using a swine haemorrhage model. Iterations of three haemostatic dressings, Celox, HemCon and QuikClot, dominated the studies, probably because of their use by international military forces and all were shown to be effective in the arrest of haemorrhage.

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