scholarly journals P656 Epidemiology and outcomes associated with local surgical and intersphincteric ligation procedures for complex cryptoglandular fistulas: A systematic literature review

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S584-S585
Author(s):  
K Iglay ◽  
D Bennett ◽  
M Kappelman ◽  
C Karki ◽  
S Cook

Abstract Background Studies suggest that complex cryptoglandular fistulas (CCF) are difficult to treat, resulting in higher intervention failure rates and functional disability. This systematic literature review (SLR) assessed the epidemiology of cryptoglandular fistula and outcomes associated with local, surgical and intersphincteric ligation procedures for treatment of CCF. Methods PubMed and Embase were searched to identify articles published in the past 5 years (2015–2020) relating to incidence or prevalence of cryptoglandular fistula and outcomes of surgical interventions for CCF (PROSPERO registration number CRD42020177732). Outcomes of interest included fistula closure/healing, recurrence, surgery failure, post-operative pain and faecal incontinence. The interventions included anal flap procedures, fistulectomy, fistulotomy, primary sphincteroplasty, modified Park’s technique, LIFT or BIOLIFT, and TROPIS. Two trained reviewers used pre-specified eligibility criteria to identify studies for inclusion and evaluate risk of bias using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool for observational studies. Data were extracted for a range of variables, including study type and design, population, outcomes and limitations. Results In total, 148 studies were identified that met a priori eligibility criteria for all cryptoglandular fistulas and all intervention types. Of these, two reported incidence or prevalence of cryptoglandular fistulas and 18 reported outcomes for the interventions of interest in CCF. Prevalence of cryptoglandular fistulas was reported as 1.35 per 10 000 patients without Crohn’s disease, and 52.6% of patients without IBD were found to progress from anorectal abscess to fistula over 12 months. Studies examining the clinical outcomes reported primary healing rates of 57.4–100.0%, recurrence rates of 4.9–61.0% and failure rates of 2.8–18.0% of patients. Only five studies reported post-operative pain as a clinical outcome. Overall, these studies suggest patients experience no or minimal longer-term post-operative pain. In studies reporting post-operative faecal incontinence following anal mucosal flap procedures, observed incontinence rates were low, as measured using Wexner or Miller scoring. None of the studies involving fistulectomy measured faecal incontinence. Conclusion This SLR provides a summary of outcomes from a selected group of surgical interventions for CCF. Healing rates vary according to surgery type; however, differences in study design and heterogenous definitions prevent direct comparison. Overall, the published literature indicates low to modest rates of CCF recurrence and limited data on faecal incontinence and longer-term post-operative pain. Sponsor: Takeda Pharmaceuticals USA, Inc.

2017 ◽  
Vol 76 (6) ◽  
pp. 1101-1136 ◽  
Author(s):  
Sofia Ramiro ◽  
Alexandre Sepriano ◽  
Katerina Chatzidionysiou ◽  
Jackie L Nam ◽  
Josef S Smolen ◽  
...  

ObjectivesTo assess the safety of synthetic (s) and biological (b) disease-modifying antirheumatic drugs (DMARDs) for the management of rheumatoid arthritis (RA) to inform the European League Against Rheumatism recommendations for the management of RA.MethodsSystematic literature review (SLR) of observational studies comparing any DMARD with another intervention for the management of patients with RA. All safety outcomes were included. A comparator group was required for the study to be included. Risk of bias was assessed with the Hayden's tool.ResultsTwenty-six observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria (15 on serious infections, 4 on malignancies). Substantial heterogeneity precluded meta-analysis. Together with the evidence from the 2013 SLR, based on 15 studies, 7 at low risk of bias, patients on bDMARDs compared with patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1 to 1.8)—without differences across bDMARDs—a higher risk of tuberculosis (aHR 2.7 to 12.5), but no increased risk of infection by herpes zoster. Patients on bDMARDs did not have an increased risk of malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5).ConclusionsThese findings confirm the known safety pattern of bDMARDs, including both tumour necrosis factor-α inhibitor (TNFi) and non-TNFi, for the treatment of RA.


2021 ◽  
Author(s):  
Kristy Iglay ◽  
Dimitri Bennett ◽  
Michael Kappelman ◽  
Sydney Thai ◽  
Molly Aldridge ◽  
...  

Abstract BackgroundCrohn’s disease (CD)-related rectovaginal fistulas (RVFs) and anovaginal fistulas (AVFs) are rare, debilitating conditions that present a substantial disease and treatment burden for women. This systematic literature review (SLR) assessed the burden of Crohn’s-related RVF and AVF, summarizing evidence from observational studies and highlighting knowledge gaps.MethodsThis SLR identified articles in PubMed and Embase that provide data and insight into the patient experience and disease burden of Crohn’s-related RVF and AVF. Two trained reviewers used pre-specified eligibility criteria to identify studies for inclusion and evaluate risk of bias using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool for observational studies.ResultsOf the 582 records identified, 316 full-text articles were assessed, and 16 studies met a priori eligibility criteria and were included. Few epidemiology studies were identified, with one study estimating the prevalence of RVF to be 2.3% in females with Crohn’s disease. Seven of 12 treatment pattern studies reported that patients had or required additional procedures before and/or after the intervention of interest, demonstrating a substantial treatment burden. Seven of 11 studies assessing clinical outcomes reported fistula healing rates between 50% and 75%, with varying estimates based on population and intervention.ConclusionsThis SLR reports the high disease and treatment burden of Crohn’s-related RVF and AVF and identifies multiple evidence gaps in this field. The literature lacks robust, generalizable data, and demonstrates a compelling need for substantial, novel research into these rare and debilitating sequelae of CD.RegistrationThe PROSPERO registration number for the protocol for this systematic literature review is CRD42020177732.


RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000734 ◽  
Author(s):  
Féline P B Kroon ◽  
Loreto Carmona ◽  
Jan W Schoones ◽  
Margreet Kloppenburg

To update the evidence on efficacy and safety of non-pharmacological, pharmacological and surgical interventions for hand osteoarthritis (OA), a systematic literature review was performed up to June 2017, including (randomised) controlled trials or Cochrane systematic reviews. Main efficacy outcomes were pain, function and hand strength. Risk of bias was assessed. Meta-analysis was performed when advisable. Of 7036 records, 127 references were included, of which 50 studies concerned non-pharmacological, 64 pharmacological and 12 surgical interventions. Many studies had high risk of bias, mainly due to inadequate randomisation or blinding. Beneficial non-pharmacological treatments included hand exercise and prolonged thumb base splinting, while single trials showed positive results for joint protection and using assistive devices. Topical and oral non-steroidal anti-inflammatory drugs (NSAIDs) proved equally effective, while topical NSAIDs led to less adverse events. Single trials demonstrated positive results for chondroitin sulfate and intra-articular glucocorticoid injections in interphalangeal joints. Pharmacological treatments for which no clear beneficial effect was shown include paracetamol, intra-articular thumb base injections of glucocorticoids or hyaluronic acid, low-dose oral glucocorticoids, hydroxychloroquine and anti-tumour necrosis factor. No trials compared surgery to sham or non-operative treatment. No surgical intervention for thumb base OA appeared more effective than another, although in general more complex procedures led to more complications. No interventions slowed radiographic progression. In conclusion, an overview of the evidence on efficacy and safety of treatment options for hand OA was presented and informed the task force for the updated European League Against Rheumatism management recommendations for hand OA.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 328-328
Author(s):  
Simona Kwon ◽  
Deborah Min ◽  
Stella Chong

Abstract Asian Americans are the fastest growing racial and ethnic minority group in the United States, whose population is aging considerably. Previous studies indicate that social isolation and loneliness disproportionately affects older adults and predicts greater physical, mental, and cognitive decline. A systematic literature review using PRISMA guidelines was conducted to address this emerging need to understand the scope of research focused on social isolation and loneliness among the disparity population of older Asian Americans. Four interdisciplinary databases were searched: PubMed, CINAHL, PsycINFO, and AgeLine; search terms included variations on social isolation, loneliness, Asian Americans, and older adults. Articles were reviewed based on six eligibility criteria: (1) research topic relevance, (2) study participants aged >60 years, (3) Asian immigrants as main participants, (4) conducted in the United States, (5) published between 1995-2019, and (6) printed in the English language. The search yielded 799 articles across the four databases and 61 duplicate articles were removed. Abstracts were screened for the 738 remaining studies, 107 of which underwent full-text review. A total of 56 articles met the eligibility criteria. Synthesis of our review indicates that existing research focuses heavily on Chinese and Korean American immigrant communities, despite the heterogeneity of the diverse Asian American population. Studies were largely observational and employed community-based sampling. Critical literature gaps exist surrounding social isolation and loneliness in Asian American older adults, including the lack of studies on South Asian populations. Future studies should prioritize health promotion intervention research and focus on diverse understudied Asian subgroups.


2021 ◽  
pp. 30-48
Author(s):  
Andrei Anatolevich Mudrov ◽  
Aleksandr Yur’evich Titov ◽  
Mariyam Magomedovna Omarova ◽  
Sergei Alekseevich Frolov ◽  
Ivan Vasilevich Kostarev ◽  
...  

Despite the large number of available surgical interventions aimed at the treatment of rectovaginal fistulas, the results of their use remain extremely disappointing, associated with the high recurrence rate of the disease reaching 80 %, as well as the lack of a single tactic to minimize the risk of anal incontinence and the need for colostomy. Objective: to conduct a systematic literature review in order to summarize information related to the rectovaginal fistulas surgery. The systematic review includes the results of an analysis of 97 clinical trials selected from 756 publications found in databases. Inclusion criteria: a full-text article, the presence of at least 5 patients in the study, as well as data on the outcome of surgery. Clinical trials with different surgical treatments were identified and classified into the following categories: elimination of the rectovaginal septal defect with a displaced flap (rectal and vaginal); Martius surgery; gracilis muscle transposition; transperineal procedure; abdominal procedure including endoscopic and laparoscopic methods; use of biological or biocompatible materials. Treatment outcomes vary significantly from 0 % to > 80 %. None of the studies were randomized. Due to the low quality of the identified studies, comparison of results and meta-analysis conduction were not possible. Conclusion: as a result of the systematic review, data for the analysis and development of any strategic and tactical algorithms for the treatment of RVF were not obtained. The most important questions still remain open: what and when surgical method to choose, is it necessary to form a disconnecting stoma?


2018 ◽  
Vol 34 (12) ◽  
Author(s):  
Clovis Wanzinack ◽  
Marcos Claudio Signorelli ◽  
Clóvis Reis

Abstract: Brazil currently has the highest absolute number of homicides in the world, which results from a complex range of factors. This study aimed at understanding the associations between socio-environmental determinants of health (SDH) and homicides in Brazil through a systematic literature review. The review followed PRISMA guidelines, selecting quantitative and qualitative studies published in Portuguese, English, and Spanish carried out between 2002 and 2017, available in the PubMed, MEDLINE, LILACS, SciELO and BVS-BIREME databases. Two trilingual reviewers tracked studies independently by basing on the eligibility criteria. We critically assessed the selected studies with the Critical Appraisal Skills Programme (CASP) or the Checklist for Analytical Cross-Sectional Studies, depending on the study design. We considered 60 studies and grouped their SDH into categories to develop a narrative synthesis about each SDH. These categories were: territory; race/ethnicity; gender; age; social inequalities and economic factors; development; education; work and employment; drugs and trafficking; other SDH. We found some SDH were more associated with homicides, such as being young, black, male, of low education level, and also people who lived in places of high social inequality, such as urban suburbs and agricultural frontiers. Unemployment and drug trafficking, as well as intersections between various SDH were also prominent. Education seems to be a protective factor for homicide. Despite the limited capacity of interpretation due to the high range of methodological approaches, this review shows the importance of considering SDH and their intersections when developing homicide prevention policies.


2020 ◽  
Vol 32 (8) ◽  
pp. 545-557
Author(s):  
Susanne M Maassen ◽  
Anne Marie J W Weggelaar Jansen ◽  
Gerard Brekelmans ◽  
Hester Vermeulen ◽  
Catharina J van Oostveen

Abstract Purpose Research shows that the professional healthcare working environment influences the quality of care, safety climate, productivity, and motivation, happiness, and health of staff. The purpose of this systematic literature review was to assess instruments that provide valid, reliable and succinct measures of health care professionals’ work environment (WE) in hospitals. Data sources Embase, Medline Ovid, Web of Science, Cochrane CENTRAL, CINAHL EBSCOhost and Google Scholar were systematically searched from inception through December 2018. Study selection Pre-defined eligibility criteria (written in English, original work-environment instrument for healthcare professionals and not a translation, describing psychometric properties as construct validity and reliability) were used to detect studies describing instruments developed to measure the working environment. Data extraction After screening 6397 titles and abstracts, we included 37 papers. Two reviewers independently assessed the 37 instruments on content and psychometric quality following the COSMIN guideline. Results of data synthesis Our paper analysis revealed a diversity of items measured. The items were mapped into 48 elements on aspects of the healthcare professional’s WE. Quality assessment also revealed a wide range of methodological flaws in all studies. Conclusions We found a large variety of instruments that measure the professional healthcare environment. Analysis uncovered content diversity and diverse methodological flaws in available instruments. Two succinct, interprofessional instruments scored best on psychometrical quality and are promising for the measurement of the working environment in hospitals. However, further psychometric validation and an evaluation of their content is recommended.


Pain Medicine ◽  
2020 ◽  
Vol 21 (8) ◽  
pp. 1581-1589 ◽  
Author(s):  
Timothy R Deer ◽  
Corey W Hunter ◽  
Pankaj Mehta ◽  
Dawood Sayed ◽  
Jay S Grider ◽  
...  

Abstract Objective To conduct a systematic literature review of dorsal root ganglion (DRG) stimulation for pain. Design Grade the evidence for DRG stimulation. Methods An international, interdisciplinary work group conducted a literature search for DRG stimulation. Abstracts were reviewed to select studies for grading. General inclusion criteria were prospective trials (randomized controlled trials and observational studies) that were not part of a larger or previously reported group. Excluded studies were retrospective, too small, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques–Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria. Results DRG stimulation has Level II evidence (moderate) based upon one high-quality pivotal randomized controlled trial and two lower-quality studies. Conclusions Moderate-level evidence supports DRG stimulation for treating chronic focal neuropathic pain and complex regional pain syndrome.


BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Abril Oliva Ramirez ◽  
Alexander Keenan ◽  
Olivia Kalau ◽  
Evelyn Worthington ◽  
Lucas Cohen ◽  
...  

Abstract Background Multiple sclerosis (MS) is a chronic, demyelinating disease of the central nervous system that results in progressive and irreversible disability. Fatigue is one of the most common MS-related symptoms and is characterized by a persistent lack of energy that impairs daily functioning. The burden of MS-related fatigue is complex and multidimensional, and to our knowledge, no systematic literature review has been conducted on this subject. The purpose of this study was to conduct a systematic literature review on the epidemiology and burden of fatigue in people with multiple sclerosis (pwMS). Methods Systematic searches were conducted in MEDLINE, Embase, and Evidence-Based Medicine Reviews to identify relevant studies of fatigue in pwMS. English-language records published from 2010 to January 2020 that met predefined eligibility criteria were included. We initially selected studies that reported quality of life (QoL) and economic outcomes according to categories of fatigue (e.g., fatigued vs non-fatigued). Studies assessing associations between economic outcomes and fatigue as a continuous measure were later included to supplement the available data. Results The search identified 8147 unique records, 54 of which met the inclusion criteria. Of these, 39 reported epidemiological outcomes, 11 reported QoL, and 9 reported economic outcomes. The supplementary screen for economic studies with fatigue as a continuous measure included an additional 20 records. Fatigue prevalence in pwMS ranged from 36.5 to 78.0%. MS-related fatigue was consistently associated with significantly lower QoL. Results on the economic impact of fatigue were heterogeneous, but most studies reported a significant association between presence or severity of fatigue and employment status, capacity to work, and sick leave. There was a gap in evidence regarding the direct costs of MS-related fatigue and the burden experienced by caregivers of pwMS. Conclusion Fatigue is a prevalent symptom in pwMS and is associated with considerable QoL and economic burden. There are gaps in the evidence related to the direct costs of MS-related fatigue and the burden of fatigue on caregivers. Addressing fatigue over the clinical course of the disease may improve health and economic outcomes for patients with MS.


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