A Systematic Review of Recent Academic Research on Clinically-Relevant Digital Measures (Preprint)

2021 ◽  
Author(s):  
Md Mobashir Hasan Shandhi ◽  
Jennifer C. Goldsack ◽  
Kyle Ryan ◽  
Alexandra Bennion ◽  
Aditya V. Kotla ◽  
...  

BACKGROUND Digital clinical measures, such as smartphones, smartwatches, wearables, ingestibles, and implantables, are increasingly used by individuals and clinicians to capture health outcomes and/or behavioral and physiological characteristics of individuals. Although academia is taking an active role in evaluating digital sensing products, academic contributions to advancing the safe, effective, ethical, and equitable use of digital clinical measures are poorly characterized. OBJECTIVE We performed a systematic review to characterize the nature of academic research on digital clinical measures and to compare and contrast the types of sensors used and the sources of funding support for specific sub-areas of this research. METHODS We conducted a PubMed search using a range of search terms to retrieve peer-reviewed articles reporting US-led academic research on digital clinical measures between January 2019 and February 2021. We screened each publication against specific inclusion and exclusion criteria. We then identified and categorized research studies based on the types of academic research, sensors used, and funding sources. Finally, we compared and contrasted the funding support for these specific sub-areas of research and sensor types. RESULTS The search retrieved 4,240 articles of interest. Following screening, 295 articles remained for data extraction and categorization. The top five research sub-areas included operations research (research analysis) (76%), analytical validation (59%), usability and utility (data visualization) (42%), verification (32%), and clinical validation (28%). The three most underrepresented areas of research into digital clinical measures were ethics (0%), security (0.5%), and data rights and governance (0.5%). Movement and activity trackers were the most commonly studied sensor type, and physiological-mechanical sensors were the least frequently studied. We found that government agencies are providing the most funding for research on digital clinical measures (65% of studies), followed by independent foundations (37%), and industry (19%), with the remaining 12% of these studies completely unfunded. CONCLUSIONS Specific subareas of academic research related to digital clinical measures are not keeping pace with the rapid expansion and adoption of digital sensing products. An integrated and coordinated effort is required across academia, academic partners, and academic funders to establish the field of digital clinical measures as an evidence-based field worthy of our trust.

2019 ◽  
Author(s):  
Shelby Rauh ◽  
Trevor Torgerson ◽  
Austin L. Johnson ◽  
Jonathan Pollard ◽  
Daniel Tritz ◽  
...  

AbstractBackgroundThe objective of this study was to evaluate the nature and extent of reproducible and transparent research practices in neurology research.MethodsThe NLM catalog was used to identify MEDLINE-indexed neurology journals. A PubMed search of these journals was conducted to retrieve publications over a 5-year period from 2014 to 2018. A random sample of publications was extracted. Two authors conducted data extraction in a blinded, duplicate fashion using a pilot-tested Google form. This form prompted data extractors to determine whether publications provided access to items such as study materials, raw data, analysis scripts, and protocols. In addition, we determined if the publication was included in a replication study or systematic review, was preregistered, had a conflict of interest declaration, specified funding sources, and was open access.ResultsOur search identified 223,932 publications meeting the inclusion criteria, from which 300 were randomly sampled. Only 290 articles were accessible, yielding 202 publications with empirical data for analysis. Our results indicate that 8.99% provided access to materials, 9.41% provided access to raw data, 0.50% provided access to the analysis scripts, 0.99% linked the protocol, and 3.47% were preregistered. A third of sampled publications lacked funding or conflict of interest statements. No publications from our sample were included in replication studies, but a fifth were cited in a systematic review or meta-analysis.ConclusionsCurrent research in the field of neurology does not consistently provide information needed for reproducibility. The implications of poor research reporting can both affect patient care and increase research waste. Collaborative intervention by authors, peer reviewers, journals, and funding sources is needed to mitigate this problem.


2012 ◽  
Vol 15 (6) ◽  
pp. 972-981 ◽  
Author(s):  
Helena Carreira ◽  
Marta Pereira ◽  
Ana Azevedo ◽  
Nuno Lunet

AbstractObjectiveLocale-specific data on BMI and overweight/obesity are necessary to understand how the obesity epidemic is evolving in each setting. We aimed to describe the temporal trends of mean BMI and prevalences of overweight/obesity in studies that evaluated Portuguese adults and older people.DesignSystematic review, conducted via a PubMed search up to January 2011 and independent reference screening and data extraction. Twenty-one eligible studies were identified. Data were extracted from the published reports and obtained from the authors of seven of the largest studies. Adjusted ecological estimates of mean BMI and prevalences of overweight/obesity were computed by linear regression.ResultsBetween 1995 and 2005, when using data obtained from anthropometric measurements, overweight prevalence increased by 3·2 % and 3·5 % and obesity prevalence by 7·4 % and 1·3 % among women and men, respectively, while mean BMI did not vary meaningfully. When using self-reported information, mean BMI increased by 0·8 kg/m2 and 0·9 kg/m2, overweight prevalence by 3·5 % and 3·7 % and obesity prevalence by 5·8 % and 5·5 % among women and men, respectively. Results from the 20-year-old conscripts (1960–2000) showed a marked increase in these outcomes in the last decades.ConclusionsOur results show an important increase in overweight/obesity in younger ages. The trends in the indicators derived from self-reported data suggest an increase in awareness of the importance of overweight/obesity among the population.


Biomedicines ◽  
2021 ◽  
Vol 9 (1) ◽  
pp. 54
Author(s):  
Nikolaos Machairiotis ◽  
Sofia Vasilakaki ◽  
Nikolaos Thomakos

Background: pain is one of the main symptoms of endometriosis and it has a deleterious effect on a patients’ personal and social life. To date, the clinical management of pain includes prolonged medication use and, in some cases, surgery, both of which are disruptive events for patients. Hence, there is an urgency for the development of a sufficient non-invasive medical treatment. Inflammation is one of the causative factors of pain in endometriosis. It is well established that inflammatory mediators promote angiogenesis and interact with the sensory neurons inducing the pain signal; the threshold of pain varies and it depends on the state and location of the disease. The inhibition of inflammatory mediators’ synthesis might offer a novel and effective treatment of the pain that is caused by inflammation in endometriosis. Objectives: patients with endometriosis experience chronic pelvic pain, which is moderate to severe in terms of intensity. The objective of this systematic review is to highlight the inflammatory mediators that contribute to the induction of pain in endometriosis and present their biological mechanism of action. In addition, the authors aim to identify new targets for the development of novel treatments for chronic pelvic pain in patients with endometriosis. Data Sources: three databases (PubMed, Scopus, and Europe PMC) were searched in order to retrieve articles with the keywords ‘inflammation, pain, and endometriosis’ between the review period of 1 January 2016 to 31 December 2020. This review has been registered with PROSPERO (registry number: CRD42020171018). Eligibility Criteria: only original articles that presented the regulation of inflammatory mediators and related biological molecules in endometriosis and their contribution in the stimulation of pain signal were included. Data Extraction: two authors independently extracted data from articles, using predefined criteria. Results: the database search yielded 1871 articles, which were narrowed down to 56 relevant articles of interest according to the eligibility criteria. Conclusions: inflammatory factors that promote angiogenesis and neuroangiogenesis are promising targets for the treatment of inflammatory pain in endometriosis. Specifically, CXC chemokine family, chemokine fractalkine, and PGE2 have an active role in the induction of pain. Additionally, IL-1β appears to be the primary interleukin (IL), which stimulates the majority of the inflammatory factors that contribute to neuroangiogenesis along with IL-6. Finally, the role of Ninj1 and BDNF proteins needs further investigation.


2020 ◽  
Author(s):  
Samuel Shepard ◽  
Audrey Wise ◽  
Bradley S. Johnson ◽  
Matt Vassar

Abstract Background Given the increased amount of research being funded in the field of urology, reducing the amount of research waste is vital. Systematic reviews are an essential tool in aiding in reducing waste in research; they are a comprehensive summary of the current data on a clinical question. The aim of this study is to evaluate the use of systematic reviews as justification in conducting randomized clinical trials (RCT) in high impact urology journals. Methods On December 13, 2019, one of us (BJ) conducted a PubMed search for randomized controlled trials published in the top four urology journals according to their Google Scholar h5-index. Using a masked data extraction process each RCT was searched for systematic reviews. Then each review was evaluated for if it was justification for conducting the trial based on the context the systematic review was used.Results Of the 566 articles retrieved 281 were included. Overall 60.5% (170/281) trials cited a systematic review. We found only 47.6% (134/281) studies cited a systematic review as “verbatim” justification for conducting the trial. Regression analysis yielded a finding of statistical significance in showing a correlation of studies over medical devices were more likely to cite a systematic review than other study topics ( adjusted odds ratio 2.01, 95% CI, 1.08 - 3.73) A total of 409 different systematic review citations were recorded in the 281 trials.Conclusion Less than half of clinical trials cited a systematic review as justification for conducting the trial. If clinical trials were required to support their studies with systematic reviews we believe this would greatly reduce the amount of research waste within clinical research.


2019 ◽  
Vol 23 (4) ◽  
pp. 442-454 ◽  
Author(s):  
Rachel Mandela ◽  
Maggie Bellew ◽  
Paul Chumas ◽  
Hannah Nash

OBJECTIVEThere are currently no guidelines for the optimum age for surgical treatment of craniosynostosis. This systematic review summarizes and assesses evidence on whether there is an optimal age for surgery in terms of neurodevelopmental outcomes.METHODSThe databases MEDLINE, PsycINFO, CINAHL, Embase + Embase Classic, and Web of Science were searched between October and November 2016 and searches were repeated in July 2017. According to PICO (participants, intervention, comparison, outcome) criteria, studies were included that focused on: children diagnosed with nonsyndromic craniosynostosis, aged ≤ 5 years at time of surgery; corrective surgery for nonsyndromic craniosynostosis; comparison of age-at-surgery groups; and tests of cognitive and neurodevelopmental postoperative outcomes. Studies that did not compare age-at-surgery groups (e.g., those employing a correlational design alone) were excluded. Data were double-extracted by 2 authors using a modified version of the Cochrane data extraction form.RESULTSTen studies met the specified criteria; 5 found a beneficial effect of earlier surgery, and 5 did not. No study found a beneficial effect of later surgery. No study collected data on length of anesthetic exposure and only 1 study collected data on sociodemographic factors.CONCLUSIONSIt was difficult to draw firm conclusions from the results due to multiple confounding factors. There is some inconclusive evidence that earlier surgery is beneficial for patients with sagittal synostosis. The picture is even more mixed for other subtypes. There is no evidence that later surgery is beneficial. The authors recommend that future research use agreed-upon parameters for: age-at-surgery cut-offs, follow-up times, and outcome measures.


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047283
Author(s):  
Rosalind Gittins ◽  
Louise Missen ◽  
Ian Maidment

IntroductionThere is a growing concern about the misuse of over the counter (OTC) and prescription only medication (POM) because of the impact on physical and mental health, drug interactions, overdoses and drug-related deaths. These medicines include opioid analgesics, anxiolytics such as pregabalin and diazepam and antidepressants. This protocol outlines how a systematic review will be undertaken (during June 2021), which aims to examine the literature on the pattern of OTC and POM misuse among adults who are accessing substance misuse treatment services. It will include the types of medication being taken, prevalence and demographic characteristics of people who access treatment services.Methods and analysisAn electronic search will be conducted on the Cochrane, OVID Medline, Pubmed, Scopus and Web of Science databases as well as grey literature. Two independent reviewers will conduct the initial title and abstract screenings, using predetermined criteria for inclusion and exclusion. If selected for inclusion, full-text data extraction will be conducted using a pilot-tested data extraction form. A third reviewer will resolve disagreements if consensus cannot be reached. Quality and risk of bias assessment will be conducted for all included studies. A qualitative synthesis and summary of the data will be provided. If possible, a meta-analysis with heterogeneity calculation will be conducted; otherwise, Synthesis Without Meta-analysis will be undertaken for quantitative data. The reporting of this protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses.Ethics and disseminationEthical approval is not required. Findings will be peer reviewed, published and shared verbally, electronically and in print, with interested clinicians and policymakers.PROSPERO registration numberCRD42020135216.


Author(s):  
Franziska Köhler ◽  
Anne Hendricks ◽  
Carolin Kastner ◽  
Sophie Müller ◽  
Kevin Boerner ◽  
...  

Abstract Background Over the last years, laparoscopic appendectomy has progressively replaced open appendectomy and become the current gold standard treatment for suspected, uncomplicated appendicitis. At the same time, though, it is an ongoing discussion that antibiotic therapy can be an equivalent treatment for patients with uncomplicated appendicitis. The aim of this systematic review was to determine the safety and efficacy of antibiotic therapy and compare it to the laparoscopic appendectomy for acute, uncomplicated appendicitis. Methods The PubMed database, Embase database, and Cochrane library were scanned for studies comparing laparoscopic appendectomy with antibiotic treatment. Two independent reviewers performed the study selection and data extraction. The primary endpoint was defined as successful treatment of appendicitis. Secondary endpoints were pain intensity, duration of hospitalization, absence from work, and incidence of complications. Results No studies were found that exclusively compared laparoscopic appendectomy with antibiotic treatment for acute, uncomplicated appendicitis. Conclusions To date, there are no studies comparing antibiotic treatment to laparoscopic appendectomy for patients with acute uncomplicated appendicitis, thus emphasizing the lack of evidence and need for further investigation.


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040965
Author(s):  
Sandra Miriam Kawa ◽  
Signe Benzon Larsen ◽  
John Thomas Helgstrand ◽  
Peter Iversen ◽  
Klaus Brasso ◽  
...  

ObjectiveTo investigate the risk of prostate cancer-specific mortality (PCSM) following initial negative systematic transrectal ultrasound-guided (TRUS) prostate biopsies.DesignSystematic review.Data sourcesPubMed and Embase were searched using a string combination with keywords/Medical Subject Headings terms and free text in the search builder. Date of search was 13 April 2020.Study selectionStudies addressing PCSM following initial negative TRUS biopsies. Randomised controlled trials and population-based studies including men with initial negative TRUS biopsies reported in English from 1990 until present were included.Data extractionData extraction was done using a predefined form by two authors independently and compared with confirm data; risk of bias was assessed using the Newcastle–Ottawa Scale for cohort studies when applicable.ResultsFour eligible studies were identified. Outcomes were reported differently in the studies as both cumulative incidence and Kaplan-Meier estimates have been used. Regardless of the study differences, all studies reported low estimated incidence of PCSM of 1.8%–5.2% in men with negative TRUS biopsies during the following 10–20 years. Main limitation in all studies was limited follow-up.ConclusionOnly a few studies have investigated the risk of PCSM following initial negative biopsies and all studies included patients before the era of MRI of the prostate. However, the studies point to the fact that the risk of PCSM is low following initial negative TRUS biopsies, and that the level of prostate-specific antigen before biopsies holds prognostic information. This may be considered when advising patients about the need for further diagnostic evaluation.PROSPERO registration numberCRD42019134548.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040997
Author(s):  
Varo Kirthi ◽  
Paul Nderitu ◽  
Uazman Alam ◽  
Jennifer Evans ◽  
Sarah Nevitt ◽  
...  

IntroductionThere is growing evidence of a higher than expected prevalence of retinopathy in prediabetes. This paper presents the protocol of a systematic review and meta-analysis of retinopathy in prediabetes. The aim of the review is to estimate the prevalence of retinopathy in prediabetes and to summarise the current data.Methods and analysisThis protocol is developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines. A comprehensive electronic bibliographic search will be conducted in MEDLINE, EMBASE, Web of Science, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Google Scholar and the Cochrane Library. Eligible studies will report prevalence data for retinopathy on fundus photography in adults with prediabetes. No time restrictions will be placed on the date of publication. Screening for eligible studies and data extraction will be conducted by two reviewers independently, using predefined inclusion criteria and prepiloted data extraction forms. Disagreements between the reviewers will be resolved by discussion, and if required, a third (senior) reviewer will arbitrate.The primary outcome is the prevalence of any standard features of diabetic retinopathy (DR) on fundus photography, as per International Clinical Diabetic Retinopathy Severity Scale (ICDRSS) classification. Secondary outcomes are the prevalence of (1) any retinal microvascular abnormalities on fundus photography that are not standard features of DR as per ICDRSS classification and (2) any macular microvascular abnormalities on fundus photography, including but not limited to the presence of macular exudates, microaneurysms and haemorrhages. Risk of bias for included studies will be assessed using a validated risk of bias tool for prevalence studies. Pooled estimates for the prespecified outcomes of interest will be calculated using random effects meta-analytic techniques. Heterogeneity will be assessed using the I2 statistic.Ethics and disseminationEthical approval is not required as this is a protocol for a systematic review and no primary data are to be collected. Findings will be disseminated through peer-reviewed publications and presentations at national and international meetings including Diabetes UK, European Association for the Study of Diabetes, American Diabetes Association and International Diabetes Federation conferences.PROSPERO registration numberCRD42020184820.


BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e043122
Author(s):  
Bhageerathy Reshmi ◽  
Bhaskaran Unnikrishnan ◽  
Shradha S Parsekar ◽  
Eti Rajwar ◽  
Ratheebhai Vijayamma ◽  
...  

IntroductionHealth insurance is one of the important approaches that can help in boosting universal healthcare coverage through improved healthcare utilisation and financial protection. This objectives of this review are to identify various interventions implemented in India to promote awareness of health insurance, and to provide evidence for the effectiveness of such interventions on the awareness and uptake of health insurance by the resident Indian population.Methods and analysisA systematic review will be carried out based on the Cochrane handbook for systematic reviews of interventions. The review will include experimental and analytical observational studies that have included adult population (>18 years) in India. We will include any intervention, policy or programme that directly or indirectly affects awareness or uptake of health insurance. The following outcomes will be eligible to be included: awareness or health insurance literacy, attitude such as readiness to buy health insurance or decision making, uptake of health insurance, demand-side and supply-side factors for awareness of health insurance, and awareness as a factor for uptake and re-enrolment in health insurance. Databases such as MEDLINE (PubMed), Web of Science, Scopus, 3ie impact evaluation repository and Social Science Research Network will be searched from January 2010 to 15 July 2020. Additionally, important government websites and references of the included studies will be scanned to identify potential records. Three authors, independently, will carry out screening and data extraction. Studies will be categorised into quantitative and qualitative, and mixed-methods synthesis will be employed to analyse the findings.Ethics and disseminationThis review will be based on published studies and will not recruit human participants directly, therefore, ethical clearance is not applicable. We will disseminate the final review findings in a national or international conference and publish in a peer-reviewed journal.


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