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Downs, S. The feasibility of creating a checklist for the assessment of the methodological quality both of randomized and non-randomized studies of health care interventions.

What is the risk of bias assessment and different tools used to assess systematic review?

Thank you for visiting nature. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser or turn off compatibility mode in Internet Explorer. In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript. The primary aims of this study were to evaluate the methodological quality of exercise intervention studies in adults with spinal cord injuries SCIs ; and to classify the reported outcome measures according to the International Classification of Functioning, Disability and Health ICF.

Selected studies were evaluated for methodological quality using the Downs and Black checklist. Outcome measures were extracted and linked to categories of the ICF using standardized linking rules. Two-hundred forty abstracts were retrieved, 57 studies met eligibility criteria. The mean methodological quality score was Three-hundred seventy four outcome measures were extracted with concepts linked to 35 second-level ICF categories across the four components. Studies of exercise interventions for adults with SCI included in this review are generally low in methodological quality, primarily reporting outcomes related to the Body Functions and Body Structures components of the ICF.

It is recommended that studies employ more vigorous methodological designs to reduce bias and confounding, and include outcome measures targeting more categories in the Activities and Participation component so as to reflect the potential benefits of exercise on health and functioning in this population.

Spinal cord injuries SCIs lead to impairment or loss of function below the level of injury. Impairment or loss of function may ultimately lead to activity limitations, restricted participation in a variety of activities and limitations in community involvement due to restricted mobility. Studies have shown increasing physical activity may be beneficial for individuals with SCI.

Linking outcome measures from exercise intervention studies to the ICF is helpful, as it provides a knowledge base about which ICF categories, domains and components have been most frequently targeted, and which areas need to be addressed further in future studies. Another issue related to studies on exercise interventions in adults with SCI is methodological quality.

This information is beneficial when designing studies to avoid those pitfalls and improve scientific quality. Although randomized controlled trials RCTs are typically viewed as the highest quality of study, 14 poorly designed RCTs will not provide evidence that is superior to other study designs.

The purpose of this systematic review was to 1 assess the methodological quality of prospective studies on exercise interventions in adults with SCI and 2 classify the reported study outcome measures according to the ICF. This systematic review was conducted in four major steps.

First, we performed an extensive search of several commonly used literature databases to locate studies on exercise and SCI, and selected studies that met eligibility criteria. Second, studies were scored for methodological quality using the Downs and Black checklist. Finally, the concepts within the outcome measures were linked to the categories of the ICF.

The Downs and Black checklist was designed to evaluate the methodological quality of both randomized and nonrandomized comparative studies. Scores range from 0 to 28 with higher scores indicating a better methodological quality of the study. The first item is not included to calculate the PEDro score. Scores range from 0 to 10 with higher scores indicating a better methodological quality of the RCT.

The outcome measures of the exercise intervention studies were classified using the ICF taxonomy. Letters b-body functions, s-body structures, d-activities and participation and e-environmental factors represent the four components, followed by a numeric code starting with the chapter number one digit indicating the first level, followed by the second level two digits and the third and fourth levels one digit each , which represent an increase in the level of precision in describing the outcome measures.

Outcome measures extracted from the selected studies were linked to categories in the ICF using linking rules established by Cieza et al. We aimed to include studies that provided original data on the effects of exercise training in adults with SCI. Studies were eligible for inclusion if the independent variable was an exercise intervention lasting at least 4 weeks in duration with a focus other than task-specific training that is typically conducted in clinical rehabilitation settings that is, outpatient physical therapy.

Studies were excluded if the outcome measures of the prescribed intervention were only task-specific, such as studies utilizing body-weight supported treadmill training BWSTT with outcomes only focused on that task for example, improvements in gait. Additional exclusion criteria were: not employing a prescribed exercise intervention that had a known frequency, duration and mode for example, physical activity promotion interventions , respiratory muscle training interventions or studies that included participants with common comorbidities of SCI for example, traumatic brain injury.

All types and etiologies of SCI were included to provide a comprehensive, unbiased review of the literature. Articles were reviewed independently by two authors SS and LS. First, articles were evaluated for methodological quality using the Downs and Black checklist. Study designs were determined by the primary reviewer SS with agreement from the second reviewer LS. The intraclass correlation coefficient for Downs and Black methodological quality scores between the two reviewers was 0.

When discrepancies in ratings between reviewers were more than one scoring point, discussion between reviewers with consultation from a third party SB was sought to resolve the difference. Second, outcome measures within each article were extracted by the primary reviewer SS. Discrepancies in linking outcomes were discussed between reviewers with consultation from a third party JL when necessary.

A total of abstracts were retrieved, 57 studies met the eligibility criteria Figure 1. Study design, intervention type, methodological quality scores and outcome measures of these 57 studies are presented in Table 2.

The distribution of methodological quality scores based on the Downs and Black checklist are presented in Figure 2. Methodological quality score distribution based on the Downs and Black checklist. Possible range of scores 0— A total of outcomes were extracted from the selected studies. For those outcome measures that belong to multi-item surveys, we attempted to retrieve survey documents to include as many ICF codes as possible.

Tables 3 , 4 , 5 represent the first and second-level ICF categories with frequency of occurrences in the coded outcome measures. Frequency of occurrence refers to the total number of outcome measures including survey items that were linked to a unique ICF code. There were 41 outcome measures that were not coded to the ICF listed as not coded, personal factors, or quality of life. Measures that could not be linked to a specific ICF category included quality of life and some anthropometric measures such as waist to hip ratio.

Figure 3 represents the percentages of the ICF categories referred to by the outcome measures. A total of concepts could be linked to 35 unique second-level ICF categories. Percentage of outcome measures linked to specific ICF categories.

A total of outcomes were extracted. Of the exercise interventions for people with SCI studies evaluated in this report, the overall methodological quality of the studies was fair according to the suggested categorization scheme for the Downs and Black score. Even though exercise is considered to be beneficial for health and is often recommended for people with SCI, this systematic review revealed that there are insufficient numbers of high quality studies of exercise interventions in people with SCI to support the health and function benefits of exercise for this population.

Results of this systematic review give an overview of the current research design and methodological quality issues for studies examining exercise interventions for individuals with SCI.

The majority of studies utilized either a one-group pretest—posttest or a nonrandomized controlled design. These findings are in agreement with other reviews of exercise interventions in people with chronic conditions. Two recent reviews of exercise interventions for individuals with traumatic brain injury and muscle disease, yielded only six and three RCTs, respectively.

Inability to recruit a sufficiently large sample and group heterogeneity in the SCI population may partly explain the frequent use of lower-quality study designs. In regard to the scoring of the review studies using the Downs and Black checklist, some studies did not satisfy the criteria because information was not included within the publication. According to the Downs and Black scoring criterion, if the study did not explicitly state a certain requested methodology for a particular item, that item must be scored as not satisfying the criterion.

The methodological rating criteria that were most frequently not satisfied in the papers we reviewed were related to blinding, randomization, representativeness of the sample group and adjustment for confounding factors in data analysis. As the SCI population is a heterogeneous group, variables such as lesion level, completeness and age should be controlled for statistically, particularly if the study design did not employ randomization or group matching.

The Downs and Black checklist includes a criterion concerning appropriate statistical tests, 15 however it is unclear if there was adequate control for the risk of type I errors among the reviewed studies.

Some studies included a large number of outcome measures, particularly that measuring multidirectional upper-extremity strength; however, the statistical analyses did not always indicate if appropriate statistical adjustments were utilized. Owing to the inherent risk of type I error, researchers should be cautious when considering the inclusion of a high number of outcome measures that address the same research question. Within this second-level category, however, muscular strength and power are considered together.

This was problematic for outcome measures in exercise intervention studies because power and strength are often considered as different concepts, whereas in the ICF, they share the same code. As a result, only the second-level code was used to address upper-extremity strength. For the studies examined, this code typically included the outcomes of glucose tolerance as measured by oral glucose tolerance test and blood lipids.

We also coded cholesterol and triglyceride levels within this category as they are a component of fat metabolism. When considering components of metabolic syndrome, the b category is a useful descriptor because it covers both glucose tolerance and blood lipid levels. Within the s code we included muscle size, muscle fiber size and muscle cross-sectional area. We chose to use this category s for bone mineral density BMD when a specific lower extremity site was stated as an outcome measure.

When considering total BMD, following standard linking rules by Cieza et al. In studies where the exercise intervention was BWSTT, the outcome measure walking time was frequently used. This includes using assistive devices such as a wheelchair or scooter. For example, muscle biochemistry, which involves both body structures and functions, but there are no specific codes for muscle biochemistry within either component. The studies included in the current review were selected from papers published over a year period from to The ICF was introduced in , bringing increased awareness and attention to researchers and scientists that encouraged inclusion of outcome measures that assessed domains other than body structures and functions.

We acknowledge that there were significant contributions to the literature on exercise and SCI before , but including exercise papers before this time would certainly have biased our findings even more as there were few studies with outcome measures that targeted domains other than body structures and functions. The results of this review indicate that studies focusing on exercise interventions for individuals with SCI face both methodological and measurement deficiency.

The methodological quality of the studies for this review was generally low. Previous research has suggested that nonrandomized study designs are more frequently conducted due to inherent difficulties in studying chronic condition populations, such as SCI.

Methodological quality can be improved in future studies that utilize nonrandomized controlled designs by improving statistical control for confounding factors such as lesion level and level of completeness. Given that small sample size and heterogeneous characteristics of the participants are always an issue to conducting exercise intervention research in this population, higher methodological quality studies could be achieved by using multi-site RCTs that would allow for a greater number of participants to be recruited.

High drop-out rates were another main issue that reduced the methodological quality of the reviewed studies. Future exercise intervention studies for this population may benefit from improving the research design and developing sophisticated incentive strategies to improve participant retention.

We believe that future research may benefit from evaluating the influence of environmental factors related to exercise interventions for individuals with SCI. Measurement instruments are available to assess participation for people with SCI; however, to our knowledge, they have not been widely implemented as an outcome measure for exercise interventions for people with SCI.

Currently available evidence indicates that outcome measures of exercise intervention for individuals with SCI are primarily targeted at body functions and body structures. Future research on the efficacy of exercise interventions on individuals with SCI should place increased emphasis on the outcome measures related to activities and participation, and attempt to include the influence of environment.

Participation after spinal cord injury: the evolution of conceptualization and measurement.

A Systematic Review and Meta-Analysis to Assess Patient-Reported Outcomes after Lung Cancer Surgery

The rapid pace of modern life requires working-age women to juggle occupational, family and social demands. This modern lifestyle has been shown to have a detrimental effect on health, often associated with increased smoking and alcohol consumption, depression and cardiovascular disease risk factors. It is important that appropriate and effective behavioural interventions targeting PA are developed and identified to improve the MVPA levels of working-age women. As these women spend a substantial proportion of their waking hours at work, workplaces may be an opportune, efficient and relatively controlled setting to implement programmes and strategies to target PA in an effort to improve MVPA levels and impact cardiometabolic health. Grey literature including theses, dissertations and government reports will also be included. Meta-analyses will be conducted where possible among studies with sufficient homogeneity.

A item checklist developed to guide standardized reporting of non randomized controlled trials. Des Jarlais, D. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: TheTRENDstatement. American Journal of Public Health, 94, Has information on Information on validated instruments such as psychometric and biometric properties but does not state if the TREND statement is validated itself. Developed to assess the quality of nonrandomised studies with its design, content and ease of use directed to the task of incorporating the quality assessments in the interpretation of meta-analytic results.

Received 17th August, ; Received in revised form 15th September, ; Accepted 29th October, ; Published online 24th November, This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. There is a large proportion of people with chronic diseases, such as kidney disease, and this fact has been associated with levels of anxiety to a considerable extent.

Johnson, Demetrios J. Kutsogiannis, Eric L. The main objective of this review was to systematically review, assess, and report on the studies that have assessed health related quality of life HRQOL after VATS and thoracotomy for resection of lung cancer. We performed a systematic review of six databases.

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Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated. Show full item record Give your opinion. Stress, salivary cortisol and periodontitis : a systematic review and meta-analysis of observational studies. Periodontal disease Salivary cortisol Stress Systematic review Meta-analysis. Stress, salivary cortisol and periodontitis: A systematic review and meta-analysis of observational studies.

I am going to try to post a pdf of this - pdf so it is in some relatively immutable form​. Downs and Black say to give points according to increasingly stringent power levels: 1 pt I'm using this tool as my review includes non-randomised studies.


Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. DOI: Downs and N. Downs , N. OBJECTIVE To test the feasibility of creating a valid and reliable checklist with the following features: appropriate for assessing both randomised and non-randomised studies; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting, internal validity bias and confounding and power, but also for external validity. View on BMJ.

A systematic review guideline will often determine the study design to answer the formulated question , and it is not enough in trusting the evidence of systematic review over observational studies. There are several terms like quality assessment, critical appraisal, or internal validity, which are used for the evaluation of studies supported by the guideline. Whereas in the risk of bias, the bias determines the factor that can affect the observations and findings of the study systematically and report it to be different from the actual conclusion. In other words, a study affected by bias can be inaccurate and thus leads to an inappropriate guideline recommendation. Therefore, inadequate study design or the conduct of the study will give false findings which result in wasting time and resources, and missing opportunity for effective intervention. Quality assessment or risk of bias assessment helps in regulating and establishing transparency of evidence synthesis data collection methods, search strategies, etc.

ГЛАВА 72 В погруженной во тьму шифровалке Сьюзан Флетчер осторожно пробиралась к платформе кабинета Стратмора. Только туда ей и оставалось идти в наглухо запертом помещении. Поднявшись по ступенькам, она обнаружила, что дверь в кабинет шефа открыта, поскольку электронный замок без электропитания бесполезен.

Сьюзан испытала от этих слов странное облегчение. - У него есть охрана. - В общем-то. - Он прячется в укрытии. Стратмор пожал плечами.

Ты очень бледна.  - Затем повернулся и вышел из комнаты. Сьюзан взяла себя в руки и быстро подошла к монитору Хейла. Протянула руку и нажала на кнопку.

 - Добрый вечер, мистер Хейл.

Насмерть перепуганный священник упал, чаша взлетела вверх, и красное вино разлилось по белому мрамору пола. Монахи и служки у алтаря бросились врассыпную, а Беккер тем временем перемахнул через ограждение. Глушитель кашлянул, Беккер плашмя упал на пол. Пуля ударилась о мрамор совсем рядом, и в следующее мгновение он уже летел вниз по гранитным ступеням к узкому проходу, выходя из которого священнослужители поднимались на алтарь как бы по милости Божьей. У подножия ступенек Беккер споткнулся и, потеряв равновесие, неуправляемо заскользил по отполированному камню.

Мистер Густафсон остановился. Наверное, он сейчас у. - Понимаю.  - В голосе звонившего по-прежнему чувствовалась нерешительность.  - Ну, тогда… надеюсь, хлопот не .

Неужели ему предстояло погибнуть по той же причине.

Немец побелел. - Mord. Убийство. - Да.

Стратмор закрыл лицо руками. - Хорошо. Это на нижнем этаже. Возле фреоновых помп. Сьюзан повернулась и направилась к двери, но на полпути оглянулась.

Нужно было думать о долге - о стране и о чести. Стратмор полагал, что у него еще есть время. Он мог отключить ТРАНСТЕКСТ, мог, используя кольцо, спасти драгоценную базу данных. Да, подумал он, время еще. Он огляделся - кругом царил хаос.

 Мистер Клушар, очень важно, чтобы вы вспомнили это.  - Внезапно Беккер понял, что говорит чересчур громко. Люди на соседних койках приподнялись и внимательно наблюдали за происходящим. В дальнем конце палаты появилась медсестра и быстро направилась к. - Хоть что-нибудь, - настаивал Беккер.


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Appendix 12 (as supplied by the authors): Modified Downs and Black checklist for the assessment of the methodological quality of both randomized and.