Publication bias in animal research: a systematic review protocol.

BACKGROUND: Systematic reviews and meta-analyses of pre-clinical studies, in vivo animal experiments in particular, can influence clinical care. Publication bias is one of the major threats of validity in systematic reviews and meta-analyses. Previous empirical studies suggested that systematic reviews and meta-analyses have become more prevalent until 2010 and found evidence for compromised methodological rigor with a trend towards improvement. We aim to comprehensively summarize and update the evidence base on systematic reviews and meta-analyses of animal studies, their methodological quality and assessment of publication bias in particular. METHODS/DESIGN: The objectives of this systematic review are as follows: âeuro¢To investigate the epidemiology of published systematic reviews of animal studies until present. âeuro¢To examine methodological features of systematic reviews and meta-analyses of animal studies with special attention to the assessment of publication bias. âeuro¢To investigate the influence of systematic reviews of animal studies on clinical research by examining citations of the systematic reviews by clinical studies. Eligible studies for this systematic review constitute systematic reviews and meta-analyses that summarize in vivo animal experiments with the purpose of reviewing animal evidence to inform human health. We will exclude genome-wide association studies and animal experiments with the main purpose to learn more about fundamental biology, physical functioning or behavior. In addition to the inclusion of systematic reviews and meta-analyses identified by other empirical studies, we will systematically search Ovid Medline, Embase, ToxNet, and ScienceDirect from 2009 to January 2013 for further eligible studies without language restrictions. Two reviewers working independently will assess titles, abstracts, and full texts for eligibility and extract relevant data from included studies. Data reporting will involve a descriptive summary of meta-analyses and systematic reviews. DISCUSSION: Results are expected to be publicly available later in 2013 and may form the basis for recommendations to improve the quality of systematic reviews and meta-analyses of animal studies and their use with respect to clinical care.

Systematic review protocol to define classical IgE-associated diseases from birth to adolescence: the MeDALL study

BACKGROUND: Classical disease phenotypes are mainly based on descriptions of symptoms and the hypothesis that a given pattern of symptoms provides a diagnosis. With refined technologies there is growing evidence that disease expression in patients is much more diverse and subtypes need to be defined to allow a better targeted treatment. One of the aims of the Mechanisms of the Development of Allergy Project (MeDALL,FP7) is to re-define the classical phenotypes of IgE-associated allergic diseases from birth to adolescence, by consensus among experts using a systematic review of the literature and identify possible gaps in research for new disease markers. This paper describes the methods to be used for the systematic review of the classical IgE-associated phenotypes applicable in general to other systematic reviews also addressing phenotype definitions based on evidence. METHODS/DESIGN: Eligible papers were identified by PubMed search (complete database through April 2011). This search yielded 12,043 citations. The review includes intervention studies (randomized and clinical controlled trials) and observational studies (cohort studies including birth cohorts, case-control studies) as well as case series. Systematic and non-systematic reviews, guidelines, position papers and editorials are not excluded but dealt with separately. Two independent reviewers in parallel conducted consecutive title and abstract filtering scans. For publications where title and abstract fulfilled the inclusion criteria the full text was assessed. In the final step, two independent reviewers abstracted data using a pre-designed data extraction form with disagreements resolved by discussion among investigators. DISCUSSION: The systematic review protocol described here allows to generate broad,multi-phenotype reviews and consensus phenotype definitions. The in-depth analysis of the existing literature on the classification of IgE-associated allergic diseases through such a systematic review will 1) provide relevant information on the current epidemiologic definitions of allergic diseases, 2) address heterogeneity and interrelationships and 3) identify gaps in knowledge.

Identifying effective behavioural components of Intervention and Comparison group support provided in SMOKing cEssation interventions (IC-SMOKE) : a systematic review protocol

Funding The research described in this paper is funded by Cancer Research UK, registered under application number C50862/A18446. The systematic review protocol reported in this paper was previously peer-reviewed by Cancer Research UK as part of the funding process. The funders had no role in protocol design, decision to publish, or preparation of the manuscript.

Effectiveness of the interventions in preventing the progression of pre-frailty and frailty in older adults:a systematic review protocol

REVIEW QUESTION / OBJECTIVE : The objective of this review is to identify the effectiveness of the interventions in preventing progression of pre-frailty and frailty in older adults. More specifically, the review questions are: - What is the effectiveness of interventions in preventing or reducing frailty in older adults? - How does effectiveness vary with degree of frailty? - Are there factors that influence the effectiveness of interventions? - What is the economic feasibility of interventions for pre-frailty and frailty? INCLUSION CRITERIA : Types of participants This review will consider studies that include older adults (female and male) aged 65 years and over, explicitly identified as pre-frail or frail by the researchers or associated medical professionals according to a pre-specified scale or index, and who have received health care and support services in any type of setting (primary care, nursing homes, hospitals). This review will exclude studies that: - Include participants who have been selected because they have one specific illness - Consider people with a terminal diagnosis only. - Types of intervention(s)/phenomena of interest: The clinical/medical component of the review will consider studies that evaluate any type of interventions to prevent the progression of pre-frailty and frailty in older adults. These interventions will include, but will not be limited to, physical activity, multifactorial intervention, psychosocial intervention, health and social care provision, and cognitive, nutrition or medication/medical maintenance and adherence focused interventions. The economic component of the review will consider studies that have performed any type of health economic analysis of ...

Systematic Review Protocol to Evaluate the Effectiveness and Cost Effectiveness of Personalised Surveillance after Colorectal Adenomatous Polypectomy

Lifetime risk of developing colorectal cancer (CRC) is 5% and five-year survival at early-stage is 92%. CRC risk following index colonoscopy should establish post-screening surveillance benefit, which may be greater in high-risk patients. This review evaluated published cost-effectiveness estimates of post-polypectomy surveillance to assess the potential for personalised recommendations by risk sub-group. Current data suggested colonoscopy identifies those at low-risk of CRC, who may not benefit from intensive surveillance, which risks unnecessary harms and inefficient use of colonoscopy resources. Meta-analyses of incidence of advanced-neoplasia post-polypectomy for low-risk was comparable to those without adenoma; both rates were under the lifetime risk of 5%. Therefore, greater personalisation through de-intensified strategies for low-risk individuals could be beneficial and could employ non-invasive testing such as faecal immunochemical tests (FIT) combined with primary prevention or chemoprevention, thereby reserving colonoscopy for targeted use in personalised risk-stratified surveillance.
This systematic review aims to:
1. Assess if there is evidence supporting a program of personalised surveillance in patients with colorectal adenoma according to risk sub-group.
2. Compare the effectiveness of surveillance colonoscopy with alternative prevention strategies.
3. Assess trade-off between costs, benefits and adverse effects which must be considered in a decision to adopt or reject personalised surveillance.

The use of motivational interviews by nurses to promote health behaviors in adolescents: A scoping review protocol

Abstract The developmental changes during adolescence may affect subsequent risk for diseases and health-related behaviors. Traditionally, professionals assume that knowledge is sufficient for behavioral changes; however adolescents continue to engage in unhealthy behaviors despite clearly knowing what they should do and how to change. "What is lacking is the motivation to apply that knowledge". Motivational Interview (MI) may be taken as an essential tool in the provision of nursing care to adolescents, being itself a workspace with possible therapeutic effects. Objectives The objective of this scoping is to examine and map the use of MI by nurses in their clinical practice with adolescents to promote health behaviors. The review will focus on knowing what is the current extent of the use of nurse-led MI; which adolescent populations were included; in which contexts nurses use MI; which MI techniques/strategies have been used and what outcomes on health behaviors promotion have been reported. Methodology This scoping review will be informed by JBI methodology. The population of this study is adolescents aged 10 to 19 years participating in nurse-led MI. The concept of MI include MI done by personal or telephone call, with any number of sessions, brief interventions and other motivational interventions grounded but not limited to the principles described by Miller & Rollnick (2008). All geographical and all clinical practice contexts where nurses' undertake MI with adolescents such as hospitals, primary health care, health care centers, community or schools will be contemplated. English, Spanish and Portuguese published studies will be considered for inclusion. Results An initial limited search of MEDLINE and CINAHL was undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe the concepts, synonyms (with truncations), MeSH Terms and Cinhal headings of this study. It was identified 5 synonyms for "Adolescents", 7 for "MI" and 2 for "nurse". A first search using the all 14 identified keywords and index terms was made at Medline (Title/Abstract) and brought up 125 articles. Other 16 databases referenced at the protocol will be searched to identify additional studies. Articles identified from the final search will be assessed for relevance to the review, based on information provided in the title and abstract. The full article will be retrieved for all studies that meet the inclusion criteria of the review. It is expected that findings from this Scoping Review provide needed information to nurses related to the use of MI to promote health behaviors in adolescents. Conclusions There is little knowledge of what works for whom (which adolescent subpopulation) under what circumstances (in which setting, for what problem) in relation to nurse-led MI. There is a need for scoping or mapping the nurse-led MI with adolescents to identify evidence gaps and to inform opportunities for future development in nursing practice. Moreover, information regarding implemented and evaluated interventions, techniques used, contexts of application and adolescents groups is dispersed in the literature which impedes the formulation of questions about the outcomes and effectiveness of those interventions. The practical implication of this mapping will be clarifying all these aspects.

The use of motivational interviews by nurses to promote health behaviors in adolescents: a scoping review protocol

Adolescents - defined as young people between 10 and 19 years of age1 - are, in general, a relatively healthy segment of the population.2 However, the developmental changes that take place during adolescence may affect their subsequent risk for diseases and for a variety of health-related behaviors. In fact, early onset of preventable health problems (e.g. obesity, malnutrition, STDs) and the engagement in health risk behaviors (e.g., sedentary life style, excessive alcohol consumption, unprotected sex) during adolescence, are likely to put them at greater risk for physical and mental health problems at a later stage in life. Moreover, health related problems and health risk behaviors may disrupt adolescents' physical and cognitive development and therefore may affect their ability to think and act in relation to decisions about their health in the future.1 In summary, health-related behaviors in adolescence, apart from their influence on the continuum of "health-disease", they also have the potential to influence future behaviors. In fact, several studies have shown that past behaviors are good predictors of future behaviors .3,4 Thus, promoting healthy practices during adolescence and taking measures to better protect young people from health risks are essential for the prevention of health problems in adulthood.5 According to the World Health Organization, the main problems affecting young people include mental health problems (such as behavioral disorders, eating disorders, suicide, anxiety or depression), the use of substances (illegal substances, alcohol and tobacco), interpersonal violence, nutrition (a proper nutrition consists of healthy eating habits and physical exercise), unintentional injuries (which are a leading cause of death and disability among young people, with road traffic injuries accounting for about 700 deaths per day), sexual and reproductive health (for example, risky sexual behaviors, early pregnancy and childbirth) and HIV (resulting from sexual transmission and drug injection).5,6 On the other hand, the number of children and youth with chronic health conditions has increased dramatically in the past four decades7 as larger numbers of chronically ill children survive beyond the age of 10.8 Despite the lack of data on adolescents' health making it difficult to determine the prevalence of chronic illnesses in this age group9, it is known that one in ten adolescents suffers from a chronic condition worldwide.10 In fact, national population based studies from Western countries show that 20-30% of teenagers have a chronic illness, defined as one that lasts longer than six months.8 The most prevalent chronic illness among adolescents is asthma and the one with the highest incidence is diabetes mellitus, particularly type II.9 Traditionally, healthcare professionals have been mainly investing in health education activities, through the transmission of knowledge with a view to creating habits, customs and behaviors, and promoting healthy lifestyles. However, empowering people does not only consist of giving them the right information11 , i.e. good information is not enough to cause people to make changes.12 The motivation or desire to change unhealthy behaviors and habits depends on many factors, namely intrinsic motivation, control over personal decisions, self-confidence and perception of effectiveness, personal ambivalence, and individualized assistance.12 Many professionals assume that supplying knowledge is sufficient for behavioral changes; however, even very good advice often fails to generate behavioral change. After all, people continue to engage in unhealthy behaviors despite clearly knowing what they should do and how to change. "What is lacking is the motivation to apply that knowledge".13, p.1233 In fact, behavioral change is a complex phenomenon with multiple determinants that also includes motivational variables. It is associated with ambivalent processes expressed in the dilemma between keeping the current status and moving on to new ways of acting. For example, telling adolescents that if they keep on engaging in a certain behavior, they are increasing the risk of developing a long-term condition such as cardiovascular disease, stroke or diabetes is rarely enough to trigger the desired behavioral change; people are more likely to change when they believe that the change is really effective and that they are able to implement it.12 Therefore, it is essential to provide specific training for "healthcare professionals to master motivational techniques, avoid confrontation with the users, and facilitate behavioral changes".14 In this context, motivating patients to make behavioral changes is also an important nursing task where change in lifestyle is a major element of patients' treatment and preventive interventions.15 One of the nurse's goals is to help improve a patient's health or help them to manage existing health conditions. Once nurses are in a position where they have to focus on accomplishing tasks and telling patients what needs to be accomplished16, the role of the nurse is expanding even more into the use of motivational strategies.17 MI is bringing nurses back to therapeutic communication and moving them closer to successful health promotion and disease management, by promoting behavior change and empowering their patients. As the nursing profession evolves, MI is seen as a challenge and the basis of nurse's interactions with individuals, families and communities.16, 17 In the same way, MI may be taken as an essential tool in the provision of nursing care to adolescents, being itself a workspace with possible therapeutic effects regarding problems, clarification of doubts, and development of skills.18 In fact, MI may be particularly applicable in work with adolescents because of their specific developmental stage. Adolescents attempt to establish their own autonomy and identity while struggling with social interactions and moral issues, which leads to ambivalence.19 Consistent with the developmental challenges during adolescence, "MI explicitly honors autonomy, people's right and irrevocable ability to decide about their own behavior"20 while allowing the person to explore possibilities for change of risky or maladaptive behaviours.19 MI can be defined as a directive, client-centred counselling style for eliciting behavior change by helping clients to explore and resolve ambivalence. It is most centrally defined not by technique but by its spirit as a facilitative style of interpersonal relationship.21 It is a set of strategies and techniques widely used in clinical practice based on the transtheoretical model of change. The Stages of Change model describes five stages of readiness—precontemplation, contemplation, preparation, action, and maintenance—and provides a framework for understanding behavior change.22 The MI has been widely tested and applied in different areas, such as modification of addictive behaviors, interventions with offenders in the context of justice, eating disorders, promotion of therapeutic adherence among chronic patients, promotion of learning in school settings or intervention with adolescents at risk.18,23 In general, clinical practice has been adopting the perspective of motivation as something relatively immutable, i.e., the adolescent is either motivated for change/treatment and, in these conditions, the professional's role is to help him/her, or the adolescent is not motivated and then change/treatment is not feasible. Alternatively the theoretical model underlying the MI technique postulates that the individual's adherence to change/treatment depends on his/her motivation, which can change throughout the therapeutic intervention. As several studies found positive results for effects of MI24-26 and its use by health professionals is encouraged23,27 nurses may play an important role in patients' process of change. As nurses have a crucial role in clinical contexts, they can facilitate the process of ending risk behaviors and/or adopting positive health behaviors through some motivational techniques, namely with adolescents. A considerable number of systematic reviews about MI already exist pointing to some benefits of its use in the treatment of a broad range of behavioral problems and diseases.13,28,29 Some of the current reviews focus on examining the effectiveness of MI for adolescents with diverse health risks/problems 30-32. However, to date there are no reviews that present and assess the evidence for the use of nurse-led MI in adolescents. Therefore, we have little knowledge of what works for whom (which adolescent subpopulation) under what circumstances (in which setting, for what problem) in relation to motivational interviewing by nurses. There is a clear need for scoping or mapping the use of MI by nurses with adolescents to identify evidence gaps and to inform opportunities for future development in nursing practice. On the other hand, information regarding nurse-led implemented and evaluated interventions, techniques and/or strategies used, contexts of application and adolescents subpopulation groups is dispersed in the literature33-36 which impedes the formulation of precise questions about the effectiveness of those interventions conducted by nurses and therefore the realization of a systematic review. In other words, it is known that different kind of motivational interventions have been implemented in different contexts by nurses, however does not exist a map about all the motivational techniques and/or strategies used. Furthermore the literature does not clarify which is the role of nurses at cross professional motivational intervention implemented programs and finally the outcomes and evaluation of interventions are unclear. Thus, the practical implication of this mapping will be clarifying all these aspects. Without this clarification is not possible to proceed to the realization of a systematic review about the effectiveness of the use of motivational interviews by nurses to promote health behaviors in adolescents, in a particular context and/or health risk behavior; or regarding the effectiveness of certain technique and/or strategy of MI. Consequently, there are important questions about the nature of the evidence in this area that need to be answered before formulating a precise question of effectiveness. This scoping review aims to respond to these questions. An initial search of the JBI Database of Systematic Reviews & Implementation Reports, Cochrane Database of Systematic Reviews, , Database of promoting health effectiveness reviews (DoPHER), The Campbell Library, Medline and CINAHL, has revealed that currently there is no Scoping Review (published or in progress) on the subject. In this context, this scoping review will examine and map the published and unpublished research around the use of MI by nurses implemented and evaluated to promote health behaviors in adolescents; to establish its current extent, range and nature and identify its feasibility, outcomes and gaps in the evidence defining research priorities in this field. This scoping review will be informed by the JBI methodology37 that suggests a five stage methodological framework for conducting scoping reviews which includes: identifying the research question, searching for relevant studies, selecting studies, charting data, collating, summarizing and reporting the results.

The use of motivational interviews by nurses to promote health behaviors in adolescents: A scoping review protocol

Abstract The developmental changes during adolescence may affect subsequent risk for diseases and health-related behaviors. Motivational Interview (MI) may be taken as an essential tool in the provision of nursing care to adolescents, being itself a workspace with possible therapeutic effects. At this context, it is important to examine and map the use of MI by nurses in their clinical practice with adolescents to promote health behaviors. Objetives A scoping review has been currently undertaking to find out what is the current extent of the use of nurse-led MI; which adolescent populations were included; in which contexts nurses use MI; which MI techniques/strategies have been used and what outcomes on health behaviors promotion have been reported. The first task was to develop a search strategy to identify relevant studies for this review. It is described here the experience in constructing a search strategy for this review. Methodology This scoping review will be informed by JBI methodology. An initial search of MEDLINE and CINAHL was undertaken. An analysis of the text words contained in the title and abstract, and of the index terms used to describe the searched articles were retrieved and these were then used to construct a search strategy for use in Medline and Cinahl. Results Analysis of the text words and the index terms generated 19 keywords: It was identified 5 synonyms for "Adolescents", 12 for "MI" and 2 for "nurse". A new research formula was designed using the text words identified. Adolescen*[Title/Abstract]) OR Younger*[Title/Abstract]) OR Youth*[Title/Abstract]) OR Teen*[Title/Abstract]) OR Adolescent[MeSH Terms])) AND (((((((((((("Motivational interview"[Title/Abstract]) OR "Motivational intervention"[Title/Abstract]) OR "Motivational interviews"[Title/Abstract]) OR "Motivational interventions"[Title/Abstract]) OR "motivational interviewing"[Title/Abstract]) OR "motivational counseling"[Title/Abstract]) OR "motivational support"[Title/Abstract]) OR "Motivational enhancement"[Title/Abstract]) OR "Brief intervention"[Title/Abstract]) OR "Brief interventions"[Title/Abstract]) OR Motivational Interviewing[MeSH Terms]) OR Directive Counseling[MeSH Terms])) AND ((nurs*[Text Word]) OR Nurses[MeSH Terms]). Limiters - Language: English, Portuguese, Spanish. In MEDLINE this research formula generated 125 results. Other 16 databases referenced at the protocol will be searched to identify additional studies. Articles identified from the final search will be assessed for relevance to the review, based on information provided in the title and abstract. The full article will be retrieved for all studies that meet the inclusion criteria of the review. Conclusions It was presented here the initial results of this search. Next steps of this study will be to develop and refine the search strategy for use in other databases. It is expected that findings from this Scoping Review provide needed information to nurses related to the use of MI to promote health behaviors in adolescents and inform opportunities for future development in nursing practice.

Integration of oral health into primary care : a scoping review protocol

Integrated care has been introduced as a means of improving health outcomes and access to care, and reducing the cost of healthcare. Despite its importance, the integration of oral health into primary care is still an emerging healthcare pathway. This scoping review protocol has been developed and funded by the Canadian Institutes of Health Research to provide an evidence-based synthesis on a primary oral healthcare approach and its effectiveness in improving oral health outcomes.

Integration of oral health into primary care : a scoping review protocol

Integrated care has been introduced as a means of improving health outcomes and access to care, and reducing the cost of healthcare. Despite its importance, the integration of oral health into primary care is still an emerging healthcare pathway. This scoping review protocol has been developed and funded by the Canadian Institutes of Health Research to provide an evidence-based synthesis on a primary oral healthcare approach and its effectiveness in improving oral health outcomes.

A systematic literature review on agile project

In the 21st century, agile project management (APM) has emerged as a major evolutionary step in the area of software project management. APM is defined as a conceptual framework, consisting of various methods such as Scrum, quick respond to change, better customer collaboration, minimum coverage of documentation and extreme programming (XP) that facilitates to produce working software in multiple iterations with team work. Because agile project management has become more popular in the software industry in recent years, it constitutes an interesting and comprehensive research topic. This thesis presents a systematic literature review (SLR) of published research articles concerning agile project management. Based on a predefined search strategy, 273 such articles were identified, of which 44 were included in the review. The selected 44 articles were published between years 2005 and 2012. The thesis defines a review process by developing a review protocol and presenting the results of the review. The results are expected to provide researchers, software man

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

BACKGROUND: There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. METHODS: Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. RESULTS: Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used. CONCLUSIONS: Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments. PROSPERO REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525 . Registered on 12 March 2015 revised on 15 March 2016.