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The Cochrane Database of Systematic... Jul 2016Sudden Unexpected Death in Epilepsy (SUDEP) is defined as sudden, unexpected, witnessed or unwitnessed, non-traumatic or non-drowning death of people with epilepsy, with... (Review)
Review
BACKGROUND
Sudden Unexpected Death in Epilepsy (SUDEP) is defined as sudden, unexpected, witnessed or unwitnessed, non-traumatic or non-drowning death of people with epilepsy, with or without evidence of a seizure, excluding documented status epilepticus and in whom postmortem examination does not reveal a structural or toxicological cause for death. SUDEP has a reported incidence of 1 to 2 per 1000 patient years and represents the most common epilepsy-related cause of death. The presence and frequency of generalised tonic-clonic seizures (GTCS), male sex, early age of seizure onset, duration of epilepsy, and polytherapy are all predictors of risk of SUDEP. The exact pathophysiology of SUDEP is currently unknown, although GTCS-induced cardiac, respiratory, and brainstem dysfunction appears likely. Appropriately chosen antiepileptic drug treatment can render around 70% of patients free of all seizures. However, around one-third will remain drug refractory despite polytherapy. Continuing seizures place patients at risk of SUDEP, depression, and reduced quality of life. Preventative strategies for SUDEP include reducing the occurrence of GTCS by timely referral for presurgical evaluation in people with lesional epilepsy and advice on lifestyle measures; detecting cardiorespiratory distress through clinical observation and seizure, respiratory, and heart rate monitoring devices; preventing airway obstruction through nocturnal supervision and safety pillows; reducing central hypoventilation through physical stimulation and enhancing serotonergic mechanisms of respiratory regulation using selective serotonin reuptake inhibitors (SSRIs); reducing adenosine and endogenous opioid-induced brain and brainstem depression.
OBJECTIVES
To assess the effectiveness of interventions in preventing SUDEP in people with epilepsy by synthesising evidence from randomised controlled trials of interventions and cohort and case-control non-randomised studies.
SEARCH METHODS
We searched the following databases: Cochrane Epilepsy Group Specialized Register; Cochrane Central Register of Controlled Trials (CENTRAL, Issue 11, 2015) via the Cochrane Register of Studies Online (CRSO); MEDLINE (Ovid, 1946 onwards); SCOPUS (1823 onwards); PsycINFO (EBSCOhost, 1887 onwards); CINAHL Plus (EBSCOhost, 1937 onwards); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We used no language restrictions. The date of the last search was 12 November 2015. We checked the reference lists of retrieved studies for additional reports of relevant studies and contacted lead study authors for any relevant unpublished material. We identified duplicate studies by screening reports according to title, authors' names, location, and medical institute, omitting any duplicated studies. We identified any grey literature studies published in the last five years by searching: Zetoc database; ISI Proceedings; International Bureau for Epilepsy (IBE) congress proceedings database; International League Against Epilepsy (ILAE) congress proceedings database; abstract books of symposia and congresses, meeting abstracts, and research reports.
SELECTION CRITERIA
We aimed to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs; prospective non-randomised cohort controlled and uncontrolled studies; and case-control studies of adults and children with epilepsy receiving an intervention for the prevention of SUDEP. Types of interventions included: early versus delayed pre-surgical evaluation for lesional epilepsy; educational programmes; seizure-monitoring devices; safety pillows; nocturnal supervision; selective serotonin reuptake inhibitors (SSRIs); opiate antagonists; and adenosine antagonists.
DATA COLLECTION AND ANALYSIS
We aimed to collect data on study design factors and participant demographics for included studies. The primary outcome of interest was the number of deaths from SUDEP. Secondary outcomes included: number of other deaths (unrelated to SUDEP); change in mean depression and anxiety scores (as defined within the study); clinically important change in quality of life, that is any change in quality of life score (average and endpoint) according to validated quality of life scales; and number of hospital attendances for seizures.
MAIN RESULTS
We identified 582 records from the databases and search strategies. We found 10 further records by searching other resources (handsearching). We removed 211 duplicate records and screened 381 records (title and abstract) for inclusion in the review. We excluded 364 records based on the title and abstract and assessed 17 full-text articles. We excluded 15 studies: eight studies did not assess interventions to prevent SUDEP; five studies measured sensitivity of devices to detect GTCS but did not directly measure SUDEP; and two studies assessed risk factors for SUDEP but not interventions for preventing SUDEP. One listed study is awaiting classification.We included one case-control study at serious risk of bias within a qualitative analysis in this review. This study of 154 cases of SUDEP and 616 controls ascertained a protective effect for the presence of nocturnal supervision (unadjusted odds ratio (OR) 0.34, 95% confidence interval (CI) 0.22 to 0.53) and when a supervising person shared the same bedroom or when special precautions, for example a listening device, were used (unadjusted OR 0.41, 95% CI 0.20 to 0.82). This effect was independent of seizure control. Non-SUDEP deaths; changes to anxiety, depression, and quality of life; and number of hospital attendances were not reported.
AUTHORS' CONCLUSIONS
We found very low-quality evidence of a preventative effect for nocturnal supervision against SUDEP. Further research is required to identify the effectiveness of other current interventions, for example seizure detection devices, safety pillows, SSRIs, early surgical evaluation, educational programmes, and opiate and adenosine antagonists in preventing SUDEP in people with epilepsy.
Topics: Adult; Case-Control Studies; Death, Sudden; Epilepsy; Epilepsy, Tonic-Clonic; Female; Humans; Male; Patient Safety; Sleep
PubMed: 27434597
DOI: 10.1002/14651858.CD011792.pub2 -
Advances in Nutrition (Bethesda, Md.) Jul 2016Strategic translational research is designed to address research gaps that answer specific guidance questions. It provides translational value with respect to nutrition... (Review)
Review
Strategic translational research is designed to address research gaps that answer specific guidance questions. It provides translational value with respect to nutrition guidance and regulatory and public policy. The relevance and the quality of evidence both matter in translational research. For example, design decisions regarding population, intervention, comparator, and outcome criteria affect whether or not high-quality studies are considered relevant to specific guidance questions and are therefore included as evidence within the context of systematic review frameworks used by authoritative food and health organizations. The process used in systematic reviews, developed by the USDA for its Nutrition Evidence Library, is described. An eating pattern and cardiovascular disease (CVD) evidence review is provided as an example, and factors that differentiated the studies considered relevant and included in that evidence base from those that were excluded are noted. Case studies on ω-3 (n-3) fatty acids (FAs) and industrial trans-FAs illustrate key factors vital to relevance and translational impact, including choice of a relevant population (e.g., healthy, at risk, or diseased subjects; general population or high-performance soldiers); dose and form of the intervention (e.g., food or supplement); use of relevant comparators (e.g., technically feasible and realistic); and measures for both exposure and outcomes (e.g., inflammatory markers or CVD endpoints). Specific recommendations are provided to help increase the impact of nutrition research on future dietary guidance, policy, and regulatory issues, particularly in the area of lipids.
Topics: Cardiovascular Diseases; Diet; Evidence-Based Medicine; Fatty Acids, Omega-3; Feeding Behavior; Humans; Nutritional Sciences; Recommended Dietary Allowances; Research Design; Review Literature as Topic; Trans Fatty Acids; Translational Research, Biomedical; United States; United States Department of Agriculture
PubMed: 27422509
DOI: 10.3945/an.115.010926 -
BMC Medicine Jun 2016The peer review process is a cornerstone of biomedical research. We aimed to evaluate the impact of interventions to improve the quality of peer review for biomedical... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The peer review process is a cornerstone of biomedical research. We aimed to evaluate the impact of interventions to improve the quality of peer review for biomedical publications.
METHODS
We performed a systematic review and meta-analysis. We searched CENTRAL, MEDLINE (PubMed), Embase, Cochrane Database of Systematic Reviews, and WHO ICTRP databases, for all randomized controlled trials (RCTs) evaluating the impact of interventions to improve the quality of peer review for biomedical publications.
RESULTS
We selected 22 reports of randomized controlled trials, for 25 comparisons evaluating training interventions (n = 5), the addition of a statistical peer reviewer (n = 2), use of a checklist (n = 2), open peer review (i.e., peer reviewers informed that their identity would be revealed; n = 7), blinded peer review (i.e., peer reviewers blinded to author names and affiliation; n = 6) and other interventions to increase the speed of the peer review process (n = 3). Results from only seven RCTs were published since 2004. As compared with the standard peer review process, training did not improve the quality of the peer review report and use of a checklist did not improve the quality of the final manuscript. Adding a statistical peer review improved the quality of the final manuscript (standardized mean difference (SMD), 0.58; 95 % CI, 0.19 to 0.98). Open peer review improved the quality of the peer review report (SMD, 0.14; 95 % CI, 0.05 to 0.24), did not affect the time peer reviewers spent on the peer review (mean difference, 0.18; 95 % CI, -0.06 to 0.43), and decreased the rate of rejection (odds ratio, 0.56; 95 % CI, 0.33 to 0.94). Blinded peer review did not affect the quality of the peer review report or rejection rate. Interventions to increase the speed of the peer review process were too heterogeneous to allow for pooling the results.
CONCLUSION
Despite the essential role of peer review, only a few interventions have been assessed in randomized controlled trials. Evidence-based peer review needs to be developed in biomedical journals.
Topics: Biomedical Research; Checklist; Data Accuracy; Databases, Factual; Humans; Peer Review, Research; Publications; Randomized Controlled Trials as Topic; Research Report
PubMed: 27287500
DOI: 10.1186/s12916-016-0631-5 -
PLoS Neglected Tropical Diseases Feb 2016Neglected Tropical Diseases (NTDs) not only cause health and life expectancy loss, but can also lead to economic consequences including reduced ability to work. This... (Review)
Review
BACKGROUND
Neglected Tropical Diseases (NTDs) not only cause health and life expectancy loss, but can also lead to economic consequences including reduced ability to work. This article describes a systematic literature review of the effect on the economic productivity of individuals affected by one of the five worldwide most prevalent NTDs: lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminths (ascariasis, trichuriasis, and hookworm infection) and trachoma. These diseases are eligible to preventive chemotherapy (PCT).
METHODOLOGY/PRINCIPAL FINDINGS
Eleven bibliographic databases were searched using different names of all NTDs and various keywords relating to productivity. Additional references were identified through reference lists from relevant papers. Of the 5316 unique publications found in the database searches, thirteen papers were identified for lymphatic filariasis, ten for onchocerciasis, eleven for schistosomiasis, six for soil-transmitted helminths and three for trachoma. Besides the scarcity in publications reporting the degree of productivity loss, this review revealed large variation in the estimated productivity loss related to these NTDs.
CONCLUSIONS
It is clear that productivity is affected by NTDs, although the actual impact depends on the type and severity of the NTD as well as on the context where the disease occurs. The largest impact on productivity loss of individuals affected by one of these diseases seems to be due to blindness from onchocerciasis and severe schistosomiasis manifestations; productivity loss due to trachoma-related blindness has never been studied directly. However, productivity loss at an individual level might differ from productivity loss at a population level because of differences in the prevalence of NTDs. Variation in estimated productivity loss between and within diseases is caused by differences in research methods and setting. Publications should provide enough information to enable readers to assess the quality and relevance of the study for their purposes.
Topics: Animals; Chemoprevention; Humans; Neglected Diseases; Tropical Medicine; Work
PubMed: 26890487
DOI: 10.1371/journal.pntd.0004397 -
Parasites & Vectors Jan 2016Soil-transmitted helminth (STH) infections of humans fall within the World Health Organization's (WHO) grouping termed the neglected tropical diseases (NTDs). It is... (Review)
Review
Soil-transmitted helminth (STH) infections of humans fall within the World Health Organization's (WHO) grouping termed the neglected tropical diseases (NTDs). It is estimated that they affect approximately 1.4 billion people worldwide. A significant proportion of these infections are in the population of Southeast Asia. This review analyses published data on STH prevalence and intensity in Southeast Asia over the time period of 1900 to the present to describe age related patterns in these epidemiological measures. This is with a focus on the four major parasite species affecting humans; namely Ascaris lumbricoides, Trichuris trichiura and the hookworms; Necator americanus and Ancylostoma duodenale. Data were also collected on the diagnostic methods used in the published surveys and how the studies were designed to facilitate comparative analyses of recorded patterns and changes therein over time. PubMed, Google Scholar, EMBASE, ISI Web of Science, Cochrane Database of Systematic Reviews and the Global Atlas of Helminth Infections search engines were used to identify studies on STH in Southeast Asia with the search based on the major key words, and variants on, "soil-transmitted helminth" "Ascaris" "Trichuris" "hookworm" and the country name. A total of 280 studies satisfied the inclusion criteria from 11 Southeast Asian countries; Brunei, Cambodia, Indonesia, Lao People's Democratic Republic (Lao PDR), Malaysia, Myanmar, Philippines, Singapore, Thailand, Timor-Leste and Vietnam. It was concluded that the epidemiological patterns of STH infection by age and species mix in Southeast Asia are similar to those reported in other parts of the world. In the published studies there were a large number of different diagnostic methods used with differing sensitivities and specificities, which makes comparison of the results both within and between countries difficult. There is a clear requirement to standardise the methods of both STH diagnosis in faecal material and how the intensity of infection is recorded and reported in future STH research and in monitoring and evaluation (M&E) of the impact of continuing and expanding mass drug administration (MDA) programmes.
Topics: Ancylostoma; Ancylostomatoidea; Animals; Ascariasis; Ascaris lumbricoides; Asia, Southeastern; Feces; Helminthiasis; Helminths; Hookworm Infections; Humans; Prevalence; Research; Soil; Surveys and Questionnaires; Trichuriasis; Trichuris
PubMed: 26813007
DOI: 10.1186/s13071-016-1310-2 -
Iranian Red Crescent Medical Journal Dec 2015This study aimed to explore the effect of the International Organization for Standardization (ISO) ISO 9001 standard and the European foundation for quality management... (Review)
Review
CONTEXT
This study aimed to explore the effect of the International Organization for Standardization (ISO) ISO 9001 standard and the European foundation for quality management (EFQM) model on improving hospital performance.
EVIDENCE ACQUISITION
PubMed, Embase and the Cochrane Library databases were searched. In addition, Elsevier and Springer were searched as main publishers in the field of health sciences. We included empirical studies with any design that had used ISO 9001 or the EFQM model to improve the quality of healthcare. Data were collected and tabulated into a data extraction sheet that was specifically designed for this study. The collected data included authors' names, country, year of publication, intervention, improvement aims, setting, length of program, study design, and outcomes.
RESULTS
Seven out of the 121 studies that were retrieved met the inclusion criteria. Three studies assessed the EFQM model and four studies assessed the ISO 9001 standard. Use of the EFQM model increased the degree of patient satisfaction and the number of hospital admissions and reduced the average length of stay, the delay on the surgical waiting list, and the number of emergency re-admissions. ISO 9001 also increased the degree of patient satisfaction and patient safety, increased cost-effectiveness, improved the hospital admissions process, and reduced the percentage of unscheduled returns to the hospital.
CONCLUSIONS
Generally, there is a lack of robust and high quality empirical evidence regarding the effects of ISO 9001 and the EFQM model on the quality care provided by and the performance of hospitals. However, the limited evidence shows that ISO 9001 and the EFQM model might improve hospital performance.
PubMed: 26756012
DOI: 10.5812/ircmj.23010 -
Health Research Policy and Systems Dec 2015In the past decades, various frameworks, methods, indicators, and tools have been developed to assess the needs as well as to monitor and evaluate (needs assessment,... (Review)
Review
Tools and instruments for needs assessment, monitoring and evaluation of health research capacity development activities at the individual and organizational level: a systematic review.
BACKGROUND
In the past decades, various frameworks, methods, indicators, and tools have been developed to assess the needs as well as to monitor and evaluate (needs assessment, monitoring and evaluation; "NaME") health research capacity development (HRCD) activities. This systematic review gives an overview on NaME activities at the individual and organizational level in the past 10 years with a specific focus on methods, tools and instruments. Insight from this review might support researchers and stakeholders in systemizing future efforts in the HRCD field.
METHODS
A systematic literature search was conducted in PubMed and Google Scholar. Additionally, the personal bibliographies of the authors were scanned. Two researchers independently reviewed the identified abstracts for inclusion according to previously defined eligibility criteria. The included articles were analysed with a focus on both different HRCD activities as well as NaME efforts.
RESULTS
Initially, the search revealed 700 records in PubMed, two additional records in Google Scholar, and 10 abstracts from the personal bibliographies of the authors. Finally, 42 studies were included and analysed in depth. Findings show that the NaME efforts in the field of HRCD are as complex and manifold as the concept of HRCD itself. NaME is predominately focused on outcome evaluation and mainly refers to the individual and team levels.
CONCLUSION
A substantial need for a coherent and transparent taxonomy of HRCD activities to maximize the benefits of future studies in the field was identified. A coherent overview of the tools used to monitor and evaluate HRCD activities is provided to inform further research in the field.
Topics: Capacity Building; Developed Countries; Developing Countries; Health Services Research; Humans; Needs Assessment; Program Evaluation
PubMed: 26691766
DOI: 10.1186/s12961-015-0070-3 -
Journal of Neurology May 2016Mal de debarquement (MdD) is a subjective perception of self-motion after exposure to passive motion, in most cases sea travel, hence the name. Mal de debarquement... (Review)
Review
Mal de debarquement (MdD) is a subjective perception of self-motion after exposure to passive motion, in most cases sea travel, hence the name. Mal de debarquement occurs quite frequently in otherwise healthy individuals for a short period of time (several hours). However, in some people symptoms remain for a longer period of time or even persist and this is then called mal de debarquement syndrome (MdDS). The underlying pathogenesis is poorly understood and therefore, treatment options are limited. In general, limited studies have focused on the topic, but the past few years more and more interest has been attributed to MdDS and its facets, which is reflected by an increasing number of papers. Till date, some interesting reviews on the topic have been published, but a systematic review of the literature is lacking and could help to address the shortcomings and flaws of the current literature. We here present a systematic review of MdD(S) based on a systematic search of medical databases employing predefined criteria, using the terms "mal de debarquement" and "sea legs". Based on this, we suggest a list of criteria that could aid healthcare professionals in the diagnosis of MdDS. Further research needs to address the blank gaps by addressing how prevalent MdD(S) really is, by digging deeper into the underlying pathophysiology and setting up prospective, randomized placebo-controlled studies to evaluate the effectiveness of possible treatment strategies.
Topics: Humans; Motion Sickness; Travel; Travel-Related Illness
PubMed: 26559820
DOI: 10.1007/s00415-015-7962-6 -
Trials Aug 2015Manuscript abstracts represent a critical source of information for oncology practitioners. Practitioners may utilize the information contained in abstracts as a basis... (Review)
Review
BACKGROUND
Manuscript abstracts represent a critical source of information for oncology practitioners. Practitioners may utilize the information contained in abstracts as a basis for treatment decisions particularly when full-text articles are not accessible. In 2007, the Consolidated Standards of Reporting Trials (CONSORT) extension statement for abstracts provided a minimum list of elements that should be included in abstracts. In this study we evaluate the degree of adherence to these recommendations and accessibility of full text publications in oncology publications.
METHODS
A systematic review of abstracts of randomized, controlled, phase III trials in metastatic solid malignancies published between January 2009 and December 2011 in PubMed, Medline, and Embase was completed. Abstracts were assigned a completeness score of 0-18 based on the number of CONSORT-recommended elements. Accessibility through open access was recorded.
RESULTS
174 abstracts with data for 95,956 patients were reviewed. The median completeness score was 9 (range, 3-17). Open access to full text articles was available for 80 % of abstracts. The remaining 20 % (35 out of 174) had a median cost of 38 USD (range: $22-49.95). The least frequently reported elements were: trial design description (20 %), participant allocation method (13 %), blinding (24 %), trial enrollment status (22 %), registration and name of trial (26 %) and funding source (18 %). The most frequently reported elements were eligibility criteria (98 %), study interventions (100 %), and primary endpoint (87 %).
CONCLUSION
There is poor adherence to the CONSORT recommendations for abstract reporting in publications of randomized cancer clinical trials which could negatively impact clinical decision-making. Full-text articles are frequently available through open access.
Topics: Access to Information; Antineoplastic Agents; Clinical Trials, Phase III as Topic; Evidence-Based Medicine; Guideline Adherence; Guidelines as Topic; Humans; Neoplasm Metastasis; Neoplasms; Quality Control; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome
PubMed: 26253548
DOI: 10.1186/s13063-015-0885-9 -
The Cochrane Database of Systematic... Apr 2015Laetrile is the name for a semi-synthetic compound which is chemically related to amygdalin, a cyanogenic glycoside from the kernels of apricots and various other... (Review)
Review
BACKGROUND
Laetrile is the name for a semi-synthetic compound which is chemically related to amygdalin, a cyanogenic glycoside from the kernels of apricots and various other species of the genus Prunus. Laetrile and amygdalin are promoted under various names for the treatment of cancer although there is no evidence for its efficacy. Due to possible cyanide poisoning, laetrile can be dangerous.
OBJECTIVES
To assess the alleged anti-cancer effect and possible adverse effects of laetrile and amygdalin.
SEARCH METHODS
We searched the following databases: CENTRAL (2014, Issue 9); MEDLINE (1951-2014); EMBASE (1980-2014); AMED; Scirus; CINAHL (all from 1982-2015); CAMbase (from 1998-2015); the MetaRegister; the National Research Register; and our own files. We examined reference lists of included studies and review articles and we contacted experts in the field for knowledge of additional studies. We did not impose any restrictions of timer or language.
SELECTION CRITERIA
Randomized controlled trials (RCTs) and quasi-RCTs.
DATA COLLECTION AND ANALYSIS
We searched eight databases and two registers for studies testing laetrile or amygdalin for the treatment of cancer. Two review authors screened and assessed articles for inclusion criteria.
MAIN RESULTS
We located over 200 references, 63 were evaluated in the original review, 6 in the 2011 and none in this update. However, we did not identify any studies that met our inclusion criteria.
AUTHORS' CONCLUSIONS
The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.
Topics: Amygdalin; Antineoplastic Agents, Phytogenic; Humans; Neoplasms
PubMed: 25918920
DOI: 10.1002/14651858.CD005476.pub4