Who needs a stapling device for haemorrhoidectomy, if one has the radiofrequency device?

Abstract Background Multiple operations exist to treat haemorrhoids. Although comparisons of conventional excision and other techniques have been performed, there are less comparative outcome data available for stapled haemorrhoidopexy (SH) and radiofrequency haemorrhoidectomy (RFH). Use of a radiofrequency energy device for haemorrhoidectomy is an alternative to standard diathermy, scissors or scalpel. It provides vessel sealing between the jaws of the instrument and aims to minimise wider tissue damage. Objective To systematically review the literature comparing SH and RFH, assessing complications, outcomes, patient experience and costs. Methods A tailored search of medical databases identified literature containing relevant primary and secondary data comparing SH and RFH. Papers were screened for relevance and completeness of published data. Those missing methodological information, outcome data or statistical analysis were subsequently excluded. A narrative review was then performed. Results The primary data in this review originate from six randomised control trials (RCTs) and five meta-analyses. Evidence was conflicting, with a trend towards more early postoperative pain in the RFH vs. the SH group (three RCTs reported increased early pain scores in the RFH group). Significantly higher rates of residual and recurrent haemorrhoids and prolapse in the SH group were observed in two RCTs and four meta-analyses. Bleeding, urinary retention, incontinence and anal stenosis did not significantly differ. No detailed contemporary cost analysis was found. Conclusion The trials are small, with significant heterogeneity in the techniques used and outcome data recorded. However, despite the limited available evidence, RFH appears superior to SH due to significantly lower rates of residual and recurrent haemorrhoids and prolapse.

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Which Data to Meta-Analyze, and How?

Zeitschrift für Psychologie ◽

10.1027/2151-2604/a000357 ◽

2019 ◽

Vol 227 (1) ◽

pp. 64-82 ◽

Cited By ~ 3

Author(s):

Martin Voracek ◽

Michael Kossmeier ◽

Ulrich S. Tran

Keyword(s):

Empirical Research ◽

Meta Analysis ◽

Curve Analysis ◽

Research Progress ◽

Primary Data ◽

Statistical Procedures ◽

Graphical Displays ◽

Primary Data Analysis ◽

Meta Analyses ◽

Data Analytic

Abstract. Which data to analyze, and how, are fundamental questions of all empirical research. As there are always numerous flexibilities in data-analytic decisions (a “garden of forking paths”), this poses perennial problems to all empirical research. Specification-curve analysis and multiverse analysis have recently been proposed as solutions to these issues. Building on the structural analogies between primary data analysis and meta-analysis, we transform and adapt these approaches to the meta-analytic level, in tandem with combinatorial meta-analysis. We explain the rationale of this idea, suggest descriptive and inferential statistical procedures, as well as graphical displays, provide code for meta-analytic practitioners to generate and use these, and present a fully worked real example from digit ratio (2D:4D) research, totaling 1,592 meta-analytic specifications. Specification-curve and multiverse meta-analysis holds promise to resolve conflicting meta-analyses, contested evidence, controversial empirical literatures, and polarized research, and to mitigate the associated detrimental effects of these phenomena on research progress.

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Characteristics and Outcomes Among Hospitalized COVID-19-Positive Patients in a Nonurban Environment

Military Medicine ◽

10.1093/milmed/usab044 ◽

2021 ◽

Author(s):

Robert P Lennon ◽

Theodore J Demetriou ◽

M Fahad Khalid ◽

Lauren Jodi Van Scoy ◽

Erin L Miller ◽

...

Keyword(s):

New York ◽

Medical Center ◽

Academic Medical Center ◽

Military Medicine ◽

Case Series ◽

Outcome Data ◽

Urban Environments ◽

Urban Setting ◽

Published Data ◽

Retrospective Case

ABSTRACT Introduction Virtually all hospitalized coronavirus disease-2019 (COVID-19) outcome data come from urban environments. The extent to which these findings are generalizable to other settings is unknown. Coronavirus disease-2019 data from large, urban settings may be particularly difficult to apply in military medicine, where practice environments are often semi-urban, rural, or austere. The purpose of this study is compare presenting characteristics and outcomes of U.S. patients with COVID-19 in a nonurban setting to similar patients in an urban setting. Materials and Methods This is a retrospective case series of adults with laboratory-confirmed COVID-19 infection who were admitted to Hershey Medical Center (HMC), a 548-bed tertiary academic medical center in central Pennsylvania serving semi-urban and rural populations, from March 23, 2020, to April 20, 2020 (the first month of COVID-19 admissions at HMC). Patients and outcomes of this cohort were compared to published data on a cohort of similar patients from the New York City (NYC) area. Results The cohorts had similar age, gender, comorbidities, need for intensive care or mechanical ventilation, and most vital sign and laboratory studies. The NYC’s cohort had shorter hospital stays (4.1 versus 7.2 days, P < .001) but more African American patients (23% versus 12%, P = .02) and higher prevalence of abnormal alanine (>60U/L; 39.0% versus 5.9%, P < .001) and aspartate (>40U/L; 58.4% versus 42.4%, P = .012) aminotransferase, oxygen saturation <90% (20.4% versus 7.2%, P = .004), and mortality (21% versus 1.4%, P < .001). Conclusions Hospitalists in nonurban environments would be prudent to use caution when considering the generalizability of results from dissimilar regions. Further investigation is needed to explore the possibility of reproducible causative systemic elements that may help improve COVID-19-related outcomes. Broader reports of these relationships across many settings will offer military medical planners greater ability to consider outcomes most relevant to their unique settings when considering COVID-19 planning.

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Single-arm oncology trials and the nature of external controls arms

Journal of Comparative Effectiveness Research ◽

10.2217/cer-2021-0003 ◽

2021 ◽

Author(s):

Mustafa Hashmi ◽

Jeremy Rassen ◽

Sebastian Schneeweiss

Keyword(s):

Secondary Data ◽

Outcome Data ◽

Aggregate Data ◽

Primary Data ◽

External Control ◽

Calendar Time ◽

Convenience Sample ◽

Fda Approval ◽

Baseline Characteristics ◽

Us Fda

Aim: Single-arm trials with external control arms (ECAs) have gained popularity in oncology. ECAs may consist of primary data from previous trials, electronic health records (EHRs) or aggregate data from the literature. We sought to provide a description of how such studies achieve similarity of patients, comparability of data quality and outcome assessment. Materials & methods: In a stratified convenience sample of 15 studies, five used primary data from trials as ECAs, five used secondary data from EHRs and five used aggregate data from the literature. Data were collected from the published literature and public web resources, blinded to the eventual approval decision. Results: Studies using ECAs from primary data and EHR data displayed methods to achieve comparability of information, including matched baseline characteristics. Aggregate data from published studies did not attempt to match covariates. The EHR controls often showed calendar time overlap for collecting information while trial data were mostly historic. Outcome data were not consistently reported across studies. US FDA approval was only seen when primary data from trials or EHR data were used as the ECA, however no ECA in this sample directly contributed to approval. Discussion: In this nonsystematic review of ECAs for single-arm trials, the ECAs derived from primary data collected by other trials or EHRs show patterns of patient comparability, time overlap, and realistic methodological approaches to achieving balance between treatment arms. They are often submitted to regulators while literature-derived aggregate findings as ECA may serve as benchmarks for pipeline decisions.

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Relationship between hospital or surgeon volume and outcomes in joint arthroplasty: protocol for a suite of systematic reviews and dose–response meta-analyses

BMJ Open ◽

10.1136/bmjopen-2018-022797 ◽

2018 ◽

Vol 8 (12) ◽

pp. e022797 ◽

Cited By ~ 2

Author(s):

Xiang-Dong Wu ◽

Meng-Meng Liu ◽

Ya-Ying Sun ◽

Zhi-Hu Zhao ◽

Quan Zhou ◽

...

Keyword(s):

Systematic Reviews ◽

Dose Response ◽

Data Extraction ◽

Meta Analysis ◽

High Volume ◽

Joint Arthroplasty ◽

Surgeon Volume ◽

Published Data ◽

Records Management ◽

Meta Analyses

IntroductionJoint arthroplasty is a particularly complex orthopaedic surgical procedure performed on joints, including the hip, knee, shoulder, ankle, elbow, wrist and even digit joints. Increasing evidence from volume–outcomes research supports the finding that patients undergoing joint arthroplasty in high-volume hospitals or by high-volume surgeons achieve better outcomes, and minimum case load requirements have been established in some areas. However, the relationships between hospital/surgeon volume and outcomes in patients undergoing arthroplasty are not fully understood. Furthermore, whether elective arthroplasty should be restricted to high-volume hospitals or surgeons remains in dispute, and little is known regarding where the thresholds should be set for different types of joint arthroplasties.Methods and analysesThis is a protocol for a suite of systematic reviews and dose–response meta-analyses, which will be amended and updated in conjunction with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Electronic databases, including PubMed and Embase, will be searched for observational studies examining the relationship between the hospital or surgeon volume and clinical outcomes in adult patients undergoing primary or revision of joint arthroplasty. We will use records management software for study selection and a predefined standardised file for data extraction and management. Quality will be assessed using the Newcastle-Ottawa Scale, and the meta-analysis, subgroup analysis and sensitivity analysis will be performed using Stata statistical software. Once the volume–outcome relationships are established, we will examine the potential non-linear relationships between hospital/surgeon volume and outcomes and detect whether thresholds or turning points exist.Ethics and disseminationEthical approval is not required, because these studies are based on aggregated published data. The results of this suite of systematic reviews and meta-analyses will be submitted to peer-reviewed journals for publication.PROSPERO registration numberCRD42017056639.

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Chronic Myeloid Leukemia in India

Journal of Global Oncology ◽

10.1200/jgo.2015.002667 ◽

2017 ◽

Vol 3 (1) ◽

pp. 64-71 ◽

Cited By ~ 8

Author(s):

Prasanth Ganesan ◽

Lalit Kumar

Keyword(s):

Chronic Myeloid Leukemia ◽

Myeloid Leukemia ◽

Population Based ◽

Outcome Data ◽

Published Data ◽

Molecular Monitoring ◽

Quality Of Data ◽

Assistance Programs ◽

First Line Therapy ◽

Line Therapy

Background In the last decade, the use of imatinib has brought a paradigm shift in the management of chronic myeloid leukemia (CML). In India, imatinib has been available for more than a decade and has been made accessible to all segments of the population because of patient assistance programs and cheaper generic versions. Despite improvements in survival, there are unique challenges in the Indian context. Methods We reviewed published data pertaining to CML in India for the period of 1990 to 2016, using PubMed advanced search with the terms chronic myeloid leukemia and India, and included studies that reported on epidemiology, monitoring for therapy, treatment outcomes, and resistance. Additionally, the references in retrieved articles were also reviewed. Results Thirty-seven studies were identified. The incidence of CML may be slightly lower in India than in the West, but there was only a single article reporting population-based data. Indian patients presented with more advanced disease. Most centers have access to imatinib as first-line therapy, but there is limited availability of molecular monitoring and second-line therapy. Most of the outcome data were retrospective but seemed comparable with that reported in Western centers. Drug adherence was impaired in at least one third of patients and contributed to poor survival. Conclusion Focused prospective studies and cooperative studies might improve the quality of data available. Future studies should focus on adherence, its effects on outcomes, and methods to address this problem.

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Efficacy of perioperative immunonutrition in visceral surgery: an umbrella review protocol

BMJ Open ◽

10.1136/bmjopen-2021-053851 ◽

2021 ◽

Vol 11 (9) ◽

pp. e053851

Author(s):

Karem Slim ◽

Flora Badon ◽

Charles-Hervé Vacheron ◽

Chadli Dziri ◽

Thomas Marquillier

Keyword(s):

Systematic Reviews ◽

Surgical Site Infections ◽

Visceral Surgery ◽

Hospital Length Of Stay ◽

Bibliographic Databases ◽

Measurement Tool ◽

Published Data ◽

Umbrella Review ◽

Meta Analyses

IntroductionImmunonutrition (IN) is generally used before major visceral surgery with the intent to reduce postoperative complications, especially infectious ones. However, the conclusions of published meta-analyses are conflicting. The purpose of this review is to synthesise the data of published systematic reviews on the effectiveness of IN.Methods and analysisThis protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols guidelines. This is an umbrella review of systematic reviews comparing IN (delivered orally 5–7 days preoperatively) with normal diet or isocaloric isonitrogenous feeding before visceral surgery performed on any of several viscera (colorectum, stomach, pancreas, liver, oesophagus). We search the systematic reviews included in the main bibliographic databases. To assess the efficacy of IN, several outcomes will be considered: the main outcome is infectious complications (surgical site infections, pulmonary infections or urinary infections) and secondary outcomes are overall morbidity, hospital length of stay and mortality. Identified reviews will be screened by two independent assessors. The methodological quality of relevant included reviews will be assessed using A MeaSurement Tool to Assess systematic Reviews (AMSTAR) instrument. The data extracted from included reviews will be synthesised using the r-Metafor package considering separate groups according to the viscus of interest. Publication bias will be evaluated, and subgroup analyses will be performed according to the quality of studies and preoperative nutritional status.Ethics and disseminationAn umbrella review based on published data from systematic reviews needs no ethical approval. Furthermore, no patient will be involved in the review. Once terminated, the review will be submitted for publication in an open access journal to ensure wide dissemination of the findings.PROSPERO registration numberCRD42021255177.

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Unintended Side Effects of Electronic Cigarettes in Otolaryngology: A Scoping Review

Otolaryngology ◽

10.1177/01945998211069502 ◽

2022 ◽

pp. 019459982110695

Author(s):

Ameen Amanian ◽

Jobanjit Phulka ◽

Amanda C. Hu

Keyword(s):

Side Effects ◽

Electronic Cigarettes ◽

Meta Analysis ◽

Senior Author ◽

Significant Heterogeneity ◽

Recent Emergence ◽

Scoping Reviews ◽

Long Term Impact ◽

Meta Analyses

Objective Electronic cigarettes (E-cigs) are nicotine delivery systems with increasing popularity. The US Food and Drug Administration defines side effects as unwanted or unexpected events or reactions. Our objective was to examine the unintended otolaryngology-related side effects associated with E-cigs. Data Sources Medline, EMBASE, CINAHL, Web of Science, and CENTRAL databases. Review Methods Study selection was independently performed by 2 authors in accordance with the PRISMA-ScR statement (Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews); discrepancies were resolved by the senior author. English studies from database inception to May 1, 2020, with a sample size >5 were included. In vitro, animal, and lower respiratory tract studies were excluded. The main outcome was defined as otolaryngology-related side effects following E-cig use. Levels of evidence per the Oxford Centre for Evidence-Based Medicine were used to determine study quality. Results From 1788 articles, 32 studies were included. The most common unintended side effects were throat irritation (n = 16), cough (n = 16), mouth irritation (n = 11), and oral mucosal lesions (n = 8). A large proportion of participants also reported conventional tobacco use in addition to E-cigs. Eight studies investigated the effectiveness of vaping on smoking cessation. The quality of the literature was level 2 to 4. Given the significant heterogeneity in the studies, meta-analysis was not performed. Conclusion The most reported side effects were throat and mouth irritation, followed by cough. The long-term impact of E-cigs is not known given the recent emergence of this technology. Future studies are warranted.

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Developing, Implementing, and Applying Novel Techniques During Systematic Reviews of Primary Space Medicine Data

Aerospace Medicine and Human Performance ◽

10.3357/amhp.5803.2021 ◽

2021 ◽

Vol 92 (8) ◽

pp. 681-688

Author(s):

Andrew Winnard ◽

Nick Caplan ◽

Claire Bruce-Martin ◽

Patrick Swain ◽

Rochelle Velho ◽

...

Keyword(s):

Systematic Review ◽

Systematic Reviews ◽

Quantitative Methods ◽

Primary Data ◽

Controlled Trials ◽

Synthesis Methods ◽

Space Medicine ◽

Systematic Review Methods ◽

Meta Analyses ◽

Primary Space

BACKGROUND: The Aerospace Medicine Systematic Review Group was set up in 2016 to facilitate high quality and transparent synthesis of primary data to enable evidence-based practice. The group identified many research methods specific to space medicine that need consideration for systematic review methods. The group has developed space medicine specific methods to address this and trialed usage of these methods across seven published systematic reviews. This paper outlines evolution of space medicine synthesis methods and discussion of their initial application.METHODS: Space medicine systematic review guidance has been developed for protocol planning, quantitative and qualitative synthesis, sourcing gray data, and assessing quality and transferability of space medicine human spaceflight simulation study environments.RESULTS: Decision algorithms for guidance and tool usage were created based on usage. Six reviews used quantitative methods in which no meta-analyses were possible due to lack of controlled trials or reporting issues. All reviews scored the quality and transferability of space simulation environments. One review was qualitative. Several research gaps were identified.CONCLUSION: Successful use of the developed methods demonstrates usability and initial validity. The current space medicine evidence base resulting in no meta-analyses being possible shows the need for standardized guidance on how to synthesize data in this field. It also provides evidence to call for increasing use of controlled trials, standardizing outcome measures, and improving minimum reporting standards. Space medicine is a unique field of medical research that requires specific systematic review methods.Winnard A, Caplan N, Bruce-Martin C, Swain P, Velho R, Meroni R, Wotring V, Damann V, Weber T, Evetts S, Laws J. Developing, implementing, and applying novel techniques during systematic reviews of primary space medicine data. Aerosp Med Hum Perform. 2021; 92(8):681688.

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Lack of Oncological Benefit from Bursectomy in Radical Gastrectomy: A Systematic Review

Visceral Medicine ◽

10.1159/000517654 ◽

2021 ◽

pp. 1-10

Author(s):

Pankaj Kumar Garg ◽

Ashish Jakhetiya ◽

Kiran Kalyan Turaga ◽

Rahul Kumar ◽

Andreas Brandl ◽

...

Keyword(s):

Overall Survival ◽

Gastric Adenocarcinoma ◽

Systematic Reviews ◽

Disease Recurrence ◽

Assessment Tools ◽

Published Data ◽

Radical Gastrectomy ◽

Significant Difference ◽

Omental Bursa ◽

Meta Analyses

Background: Resection of the omental bursa has been suggested to reduce peritoneal recurrence and facilitate a complete oncological resection during a gastrectomy. The addition of this procedure increases technical complexity and prolongs the procedure. Published data regarding the oncological benefit of this procedure are conflicting. We hypothesized that a bursectomy during a radical gastrectomy does not improve overall survival. Methods: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline, a comprehensive literature search of 3 electronic databases (PubMed, Scopus, and Embase) was conducted to identify the clinical studies that compared bursectomy with no-bursectomy in radical gastrectomy for gastric adenocarcinoma. Qualitative and quantitative data synthesis was performed using RevMan software. A random-/fixed-effect modeling was used depending upon the heterogeneity. Bias and quality assessment tools were applied. The study was registered with the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42019116556). Results: Of 8 studies assessing the role of bursectomy in gastric adenocarcinoma, 6 (75%) were included – of which 2 (33%) are randomized controlled trials. Of 2,904 patients, 1,273 (%) underwent a bursectomy. There was no statistically significant difference in either overall survival (hazard ratio [HR] = 0.89, 95% CI 0.75–1.06, I2 = 14%) or disease recurrence (HR = 1.01, 95% CI 0.84–1.20, I2 = 22%) in the bursectomy group compared to the no-bursectomy group. Conclusion: There is no additional oncological benefit of adding bursectomy to radical gastrectomy in all patients with gastric adenocarcinoma.

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Clinical course of pain and disability following primary lumbar discectomy: systematic review and meta-analysis

European Spine Journal ◽

10.1007/s00586-019-06272-y ◽

2020 ◽

Vol 29 (7) ◽

pp. 1660-1670 ◽

Cited By ~ 2

Author(s):

A. Rushton ◽

N. R. Heneghan ◽

M. W. Heymans ◽

J. B. Staal ◽

P. Goodwin

Keyword(s):

Back Pain ◽

Clinical Course ◽

Meta Analysis ◽

A Priori ◽

Random Effect ◽

Outcome Data ◽

Lumbar Discectomy ◽

Risk Of Bias ◽

Leg Pain ◽

Meta Analyses

Abstract Purpose To conduct a meta-analysis to describe clinical course of pain and disability in adult patients post-lumbar discectomy (PROSPERO: CRD42015020806). Methods Sensitive topic-based search strategy designed for individual databases was conducted. Patients (> 16 years) following first-time lumbar discectomy for sciatica/radiculopathy with no complications, investigated in inception (point of surgery) prospective cohort studies, were included. Studies including revision surgery or not published in English were excluded. Two reviewers independently searched information sources, assessed eligibility at title/abstract and full-text stages, extracted data, assessed risk of bias (modified QUIPs) and assessed GRADE. Authors were contacted to request raw data where data/variance data were missing. Meta-analyses evaluated outcomes at all available time points using the variance-weighted mean in random-effect meta-analyses. Means and 95% CIs were plotted over time for measurements reported on outcomes of leg pain, back pain and disability. Results A total of 87 studies (n = 31,034) at risk of bias (49 moderate, 38 high) were included. Clinically relevant improvements immediately following surgery (> MCID) for leg pain (0–10, mean before surgery 7.04, 50 studies, n = 14,910 participants) and disability were identified (0–100, mean before surgery 53.33, 48 studies, n = 15,037). Back pain also improved (0–10, mean before surgery 4.72, 53 studies, n = 14,877). Improvement in all outcomes was maintained (to 7 years). Meta-regression analyses to assess the relationship between outcome data and a priori potential covariates found preoperative back pain and disability predictive for outcome. Conclusion Moderate-level evidence supports clinically relevant immediate improvement in leg pain and disability following lumbar discectomy with accompanying improvements in back pain. Graphic abstract These slides can be retrieved under Electronic Supplementary Material.

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