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2.  Impact of missing participant data for dichotomous outcomes on pooled effect estimates in systematic reviews: a protocol for a methodological study 
Systematic Reviews  2014;3(1):137.
Background
There is no consensus on how authors conducting meta-analysis should deal with trial participants with missing outcome data. The objectives of this study are to assess in Cochrane and non-Cochrane systematic reviews: (1) which categories of trial participants the systematic review authors consider as having missing participant data (MPD), (2) how trialists reported on participants with missing outcome data in trials, (3) whether systematic reviewer authors actually dealt with MPD in their meta-analyses of dichotomous outcomes consistently with their reported methods, and (4) the impact of different methods of dealing with MPD on pooled effect estimates in meta-analyses of dichotomous outcomes.
Methods/Design
We will conduct a methodological study of Cochrane and non-Cochrane systematic reviews. Eligible systematic reviews will include a group-level meta-analysis of a patient-important dichotomous efficacy outcome, with a statistically significant effect estimate. Teams of two reviewers will determine eligibility and subsequently extract information from each eligible systematic review in duplicate and independently, using standardized, pre-piloted forms. The teams will then use a similar process to extract information from the trials included in the meta-analyses of interest. We will assess first which categories of trial participants the systematic reviewers consider as having MPD. Second, we will assess how trialists reported on participants with missing outcome data in trials. Third, we will compare what systematic reviewers report having done, and what they actually did, in dealing with MPD in their meta-analysis. Fourth, we will conduct imputation studies to assess the effects of different methods of dealing with MPD on the pooled effect estimates of meta-analyses. We will specifically calculate for each method (1) the percentage of systematic reviews that lose statistical significance and (2) the mean change of effect estimates across systematic reviews.
Discussion
The impact of different methods of dealing with MPD on pooled effect estimates will help judge the associated risk of bias in systematic reviews. Our findings will inform recommendations regarding what assumptions for MPD should be used to test the robustness of meta-analytical results.
Electronic supplementary material
The online version of this article (doi:10.1186/2046-4053-3-137) contains supplementary material, which is available to authorized users.
doi:10.1186/2046-4053-3-137
PMCID: PMC4285551  PMID: 25423894
Missing participant data; Imputation; Risk of bias; Trials; Systematic reviews; Meta-analysis
3.  The validity of recommendations from clinical guidelines: a survival analysis 
Background:
Clinical guidelines should be updated to maintain their validity. Our aim was to estimate the length of time before recommendations become outdated.
Methods:
We used a retrospective cohort design and included recommendations from clinical guidelines developed in the Spanish National Health System clinical guideline program since 2008. We performed a descriptive analysis of references, recommendations and resources used, and a survival analysis of recommendations using the Kaplan–Meier method.
Results:
We included 113 recommendations from 4 clinical guidelines with a median of 4 years since the most recent search (range 3.9–4.4 yr). We retrieved 39 136 references (range 3343–14 787) using an exhaustive literature search, 668 of which were related to the recommendations in our sample. We identified 69 (10.3%) key references, corresponding to 25 (22.1%) recommendations that required updating. Ninety-two percent (95% confidence interval 86.9–97.0) of the recommendations were valid 1 year after their development. This probability decreased at 2 (85.7%), 3 (81.3%) and 4 years (77.8%).
Interpretation:
Recommendations quickly become outdated, with 1 out of 5 recommendations being out of date after 3 years. Waiting more than 3 years to review a guideline is potentially too long.
doi:10.1503/cmaj.140547
PMCID: PMC4216254  PMID: 25200758
4.  Diagnostic tools for alzheimer’s disease dementia and other dementias: an overview of diagnostic test accuracy (DTA) systematic reviews 
BMC Neurology  2014;14(1):183.
Background
Dementia includes a group of neurodegenerative disorders characterized by progressive loss of cognitive function and a decrease in the ability to perform activities of daily living. Systematic reviews of diagnostic test accuracy (DTA) focus on how well the index test detects patients with the disease in terms of figures such as sensitivity and specificity. Although DTA reviews about dementia are essential, at present there is no information about their quantity and quality.
Methods
We searched for DTA reviews in MEDLINE (1966–2013), EMBASE (1980–2013), The Cochrane Library (from its inception until December 2013) and the Database of Abstracts of Reviews of Effects (DARE). Two reviewers independently assessed the methodological quality of the reviews using the AMSTAR measurement tool, and the quality of the reporting using the PRISMA checklist. We describe the main characteristics of these reviews, including basic characteristics, type of dementia, and diagnostic test evaluated, and we summarize the AMSTAR and PRISMA scores.
Results
We selected 24 DTA systematic reviews. Only 10 reviews (41.6%), assessed the bias of included studies and few (33%) used this information to report the review results or to develop their conclusions Only one review (4%) reported all methodological items suggested by the PRISMA tool. Assessing methodology quality by means of the AMSTAR tool, we found that six DTA reviews (25%) pooled primary data with the aid of methods that are used for intervention reviews, such as Mantel-Haenszel and separate random-effects models (25%), while five reviews (20.8%) assessed publication bias by means of funnel plots and/or Egger’s Test.
Conclusions
Our assessment of these DTA reviews reveals that their quality, both in terms of methodology and reporting, is far from optimal. Assessing the quality of diagnostic evidence is fundamental to determining the validity of the operating characteristics of the index test and its usefulness in specific settings. The development of high quality DTA systematic reviews about dementia continues to be a challenge.
Electronic supplementary material
The online version of this article (doi:10.1186/s12883-014-0183-2) contains supplementary material, which is available to authorized users.
doi:10.1186/s12883-014-0183-2
PMCID: PMC4189736  PMID: 25248284
Diagnosis; Dementia; Alzheimer’s disease dementia; Systematic review; PRISMA checklist; AMSTAR tool
6.  Updated recommendations: an assessment of NICE clinical guidelines 
Background
Updating is important to ensure clinical guideline (CG) recommendations remain valid. However, little research has been undertaken in this field. We assessed CGs produced by the National Institute for Health and Care Excellence (NICE) to identify and describe updated recommendations and to investigate potential factors associated with updating. Also, we evaluated the reporting and presentation of recommendation changes.
Methods
We performed a descriptive analysis of original and updated CGs and recommendations, and an assessment of presentation formats and methods for recording information. We conducted a case-control study, defining cases as original recommendations that were updated (‘new-replaced’ recommendations), and controls as original recommendations that were considered to remain valid (‘not changed’ recommendations). We performed a comparison of main characteristics between cases and controls, and we planned a multiple regression analysis to identify potential predictive factors for updating.
Results
We included nine updated CGs (1,306 recommendations) and their corresponding original versions (1,106 recommendations). Updated CGs included 812 (62%) recommendations ‘not reviewed’, 368 (28.1%) ‘new’ recommendations, 104 (7.9%) ‘amended’ recommendations, and 25 (1.9%) recommendations reviewed but unchanged. The presentation formats used to indicate the changes in recommendations varied widely across CGs. Changes in ‘amended’, ‘deleted’, and ‘new-replaced’ recommendations (n = 296) were reported infrequently, mostly in appendices. These changes were recorded in 167 (56.4%) recommendations; and were explained in 81 (27.4%) recommendations. We retrieved a total of 7.1% (n = 78) case recommendations (‘new-replaced’) and 2.4% (n = 27) control recommendations (‘not changed’) in original CGs. The updates were mainly from ‘Fertility CG’, about ‘gynaecology, pregnancy and birth’ topic, and ‘treatment’ or ‘prevention’ purposes. We did not perform the multiple regression analysis as originally planned due to the small sample of recommendations retrieved.
Conclusion
Our study is the first to describe and assess updated CGs and recommendations from a national guideline program. Our results highlight the pressing need to standardise the reporting and presentation of updated recommendations and the research gap about the optimal way to present updates to guideline users. Furthermore, there is a need to investigate updating predictive factors.
doi:10.1186/1748-5908-9-72
PMCID: PMC4067507  PMID: 24919856
Clinical practice guidelines; Information dissemination; Evidence-based medicine; Knowledge translation; Methods; Updating
7.  Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise 
Background:
Although several tools to evaluate the credibility of health care guidelines exist, guidance on practical steps for developing guidelines is lacking. We systematically compiled a comprehensive checklist of items linked to relevant resources and tools that guideline developers could consider, without the expectation that every guideline would address each item.
Methods:
We searched data sources, including manuals of international guideline developers, literature on guidelines for guidelines (with a focus on methodology reports from international and national agencies, and professional societies) and recent articles providing systematic guidance. We reviewed these sources in duplicate, extracted items for the checklist using a sensitive approach and developed overarching topics relevant to guidelines. In an iterative process, we reviewed items for duplication and omissions and involved experts in guideline development for revisions and suggestions for items to be added.
Results:
We developed a checklist with 18 topics and 146 items and a webpage to facilitate its use by guideline developers. The topics and included items cover all stages of the guideline enterprise, from the planning and formulation of guidelines, to their implementation and evaluation. The final checklist includes links to training materials as well as resources with suggested methodology for applying the items.
Interpretation:
The checklist will serve as a resource for guideline developers. Consideration of items on the checklist will support the development, implementation and evaluation of guidelines. We will use crowdsourcing to revise the checklist and keep it up to date.
doi:10.1503/cmaj.131237
PMCID: PMC3928232  PMID: 24344144
8.  Attitudes and Perceptions about Clinical Guidelines: A Qualitative Study with Spanish Physicians 
PLoS ONE  2014;9(2):e86065.
Background
Clinical guidelines (CGs) are popular for healthcare decision making but their acceptability and use by healthcare providers is influenced by numerous factors. Some of these factors are professional-related, such as knowledge and perceptions of and attitudes toward CGs in general. The aim of our study was to evaluate attitudes and perceptions of Spanish physicians towards CGs.
Methods
We coordinated six discussion groups with a total of 46 physicians. The participants were drawn from 12 medical specialties from both specialized and primary care. We recorded the sessions and transcribed the content verbatim. We analyzed the data using an approach based on the grounded theory.
Results
We identified two main constructs that defined the physicians' perceptions towards guidelines: knowledge and usefulness. “Knowledge” defined the theoretical meanings of guidelines, while “Usefulness” referred to the pragmatic approach to guidelines. These constructs were interrelated through a series of categories such as confidence, usability, accessibility, dissemination and formats.
Conclusions
In our study, the constructs that impacted most on physician's attitudes to clinical guidelines were knowledge and usefulness. The tension between the theoretical and the pragmatic constructs determined the attitudes and how physicians use guidelines. Groups developing guidelines should ask relevant clinical questions and develop implementable and context specific recommendations. Developers should be explicit and consistent in the development and presentation of recommendations.
doi:10.1371/journal.pone.0086065
PMCID: PMC3914780  PMID: 24505253
9.  Guidance for updating clinical practice guidelines: a systematic review of methodological handbooks 
Background
Updating clinical practice guidelines (CPGs) is a crucial process for maintaining the validity of recommendations. Methodological handbooks should provide guidance on both developing and updating CPGs. However, little is known about the updating guidance provided by these handbooks.
Methods
We conducted a systematic review to identify and describe the updating guidance provided by CPG methodological handbooks and included handbooks that provide updating guidance for CPGs. We searched in the Guidelines International Network library, US National Guidelines Clearinghouse and MEDLINE (PubMed) from 1966 to September 2013. Two authors independently selected the handbooks and extracted the data. We used descriptive statistics to analyze the extracted data and conducted a narrative synthesis.
Results
We included 35 handbooks. Most handbooks (97.1%) focus mainly on developing CPGs, including variable degrees of information about updating. Guidance on identifying new evidence and the methodology of assessing the need for an update is described in 11 (31.4%) and eight handbooks (22.8%), respectively. The period of time between two updates is described in 25 handbooks (71.4%), two to three years being the most frequent (40.0%). The majority of handbooks do not provide guidance for the literature search, evidence selection, assessment, synthesis, and external review of the updating process.
Conclusions
Guidance for updating CPGs is poorly described in methodological handbooks. This guidance should be more rigorous and explicit. This could lead to a more optimal updating process, and, ultimately to valid trustworthy guidelines.
doi:10.1186/1748-5908-9-3
PMCID: PMC3904688  PMID: 24383701
Clinical practice guidelines; Evidence-based medicine; Handbooks; Methodology; Systematic review
10.  A methodological survey of the analysis, reporting and interpretation of Absolute Risk ReductiOn in systematic revieWs (ARROW): a study protocol 
Systematic Reviews  2013;2:113.
Background
Clinicians, providers and guideline panels use absolute effects to weigh the advantages and downsides of treatment alternatives. Relative measures have the potential to mislead readers. However, little is known about the reporting of absolute measures in systematic reviews. The objectives of our study are to determine the proportion of systematic reviews that report absolute measures of effect for the most important outcomes, and ascertain how they are analyzed, reported and interpreted.
Methods/design
We will conduct a methodological survey of systematic reviews published in 2010. We will conduct a 1:1 stratified random sampling of Cochrane vs. non-Cochrane systematic reviews. We will calculate the proportion of systematic reviews reporting at least one absolute estimate of effect for the most patient-important outcome for the comparison of interest. We will conduct multivariable logistic regression analyses with the reporting of an absolute estimate of effect as the dependent variable and pre-specified study characteristics as the independent variables. For systematic reviews reporting an absolute estimate of effect, we will document the methods used for the analysis, reporting and interpretation of the absolute estimate.
Discussion
Our methodological survey will inform current practices regarding reporting of absolute estimates in systematic reviews. Our findings may influence recommendations on reporting, conduct and interpretation of absolute estimates. Our results are likely to be of interest to systematic review authors, funding agencies, clinicians, guideline developers and journal editors.
doi:10.1186/2046-4053-2-113
PMCID: PMC3867670  PMID: 24330779
Systematic reviews; Meta-analysis; Statistical data; Evidence-based medicine; Numbers needed to treat; Data reporting; Absolute effect measures
11.  Strategies to assess the validity of recommendations: a study protocol 
Background
Clinical practice guidelines (CPGs) become quickly outdated and require a periodic reassessment of evidence research to maintain their validity. However, there is little research about this topic. Our project will provide evidence for some of the most pressing questions in this field: 1) what is the average time for recommendations to become out of date?; 2) what is the comparative performance of two restricted search strategies to evaluate the need to update recommendations?; and 3) what is the feasibility of a more regular monitoring and updating strategy compared to usual practice?. In this protocol we will focus on questions one and two.
Methods
The CPG Development Programme of the Spanish Ministry of Health developed 14 CPGs between 2008 and 2009. We will stratify guidelines by topic and by publication year, and include one CPG by strata.
We will develop a strategy to assess the validity of CPG recommendations, which includes a baseline survey of clinical experts, an update of the original exhaustive literature searches, the identification of key references (reference that trigger a potential recommendation update), and the assessment of the potential changes in each recommendation.
We will run two alternative search strategies to efficiently identify important new evidence: 1) PLUS search based in McMaster Premium LiteratUre Service (PLUS) database; and 2) a Restrictive Search (ReSe) based on the least number of MeSH terms and free text words needed to locate all the references of each original recommendation.
We will perform a survival analysis of recommendations using the Kaplan-Meier method and we will use the log-rank test to analyse differences between survival curves according to the topic, the purpose, the strength of recommendations and the turnover. We will retrieve key references from the exhaustive search and evaluate their presence in the PLUS and ReSe search results.
Discussion
Our project, using a highly structured and transparent methodology, will provide guidance of when recommendations are likely to be at risk of being out of date. We will also assess two novel restrictive search strategies which could reduce the workload without compromising rigour when CPGs developers check for the need of updating.
doi:10.1186/1748-5908-8-94
PMCID: PMC3765147  PMID: 23967896
Clinical practice guidelines; Diffusion of innovation; Dissemination and implementation; Evidence-based medicine; Information storage and retrieval; Knowledge translation; Methodology; Updating
12.  Rationale, design and organization of the delayed antibiotic prescription (DAP) trial: a randomized controlled trial of the efficacy and safety of delayed antibiotic prescribing strategies in the non-complicated acute respiratory tract infections in general practice 
BMC Family Practice  2013;14:63.
Background
Respiratory tract infections are an important burden in primary care and it’s known that they are usually self-limited and that antibiotics only alter its course slightly. This together with the alarming increase of bacterial resistance due to increased use of antimicrobials calls for a need to consider strategies to reduce their use. One of these strategies is the delayed prescription of antibiotics.
Methods
Multicentric, parallel, randomised controlled trial comparing four antibiotic prescribing strategies in acute non-complicated respiratory tract infections. We will include acute pharyngitis, rhinosinusitis, acute bronchitis and acute exacerbation of chronic bronchitis or chronic obstructive pulmonary disease (mild to moderate). The therapeutic strategies compared are: immediate antibiotic treatment, no antibiotic treatment, and two delayed antibiotic prescribing (DAP) strategies with structured advice to use a course of antibiotics in case of worsening of symptoms or not improving (prescription given to patient or prescription left at the reception of the primary care centre 3 days after the first medical visit).
Discussion
Delayed antibiotic prescription has been widely used in Anglo-Saxon countries, however, in Southern Europe there has been little research about this topic. The DAP trial wil evaluate two different delayed strategies in Spain for the main respiratory infections in primary care.
Trial registration
This trial is registered with ClinicalTrials.gov, number http://NCT01363531.
doi:10.1186/1471-2296-14-63
PMCID: PMC3682866  PMID: 23682979
Delayed antibiotic prescription; Respiratory infections; Family medicine; Pharyngitis; Acute tonsillitis; Rhinosinusitis; Acute bronchitis; Chronic obstructive pulmonary disease
13.  Addressing Dichotomous Data for Participants Excluded from Trial Analysis: A Guide for Systematic Reviewers 
PLoS ONE  2013;8(2):e57132.
Introduction
Systematic reviewer authors intending to include all randomized participants in their meta-analyses need to make assumptions about the outcomes of participants with missing data.
Objective
The objective of this paper is to provide systematic reviewer authors with a relatively simple guidance for addressing dichotomous data for participants excluded from analyses of randomized trials.
Methods
This guide is based on a review of the Cochrane handbook and published methodological research. The guide deals with participants excluded from the analysis who were considered ‘non-adherent to the protocol’ but for whom data are available, and participants with missing data.
Results
Systematic reviewer authors should include data from ‘non-adherent’ participants excluded from the primary study authors' analysis but for whom data are available. For missing, unavailable participant data, authors may conduct a complete case analysis (excluding those with missing data) as the primary analysis. Alternatively, they may conduct a primary analysis that makes plausible assumptions about the outcomes of participants with missing data. When the primary analysis suggests important benefit, sensitivity meta-analyses using relatively extreme assumptions that may vary in plausibility can inform the extent to which risk of bias impacts the confidence in the results of the primary analysis. The more plausible assumptions draw on the outcome event rates within the trial or in all trials included in the meta-analysis. The proposed guide does not take into account the uncertainty associated with assumed events.
Conclusions
This guide proposes methods for handling participants excluded from analyses of randomized trials. These methods can help in establishing the extent to which risk of bias impacts meta-analysis results.
doi:10.1371/journal.pone.0057132
PMCID: PMC3581575  PMID: 23451162
14.  Developing and evaluating communication strategies to support informed decisions and practice based on evidence (DECIDE): protocol and preliminary results 
Background
Healthcare decision makers face challenges when using guidelines, including understanding the quality of the evidence or the values and preferences upon which recommendations are made, which are often not clear.
Methods
GRADE is a systematic approach towards assessing the quality of evidence and the strength of recommendations in healthcare. GRADE also gives advice on how to go from evidence to decisions. It has been developed to address the weaknesses of other grading systems and is now widely used internationally. The Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence (DECIDE) consortium (http://www.decide-collaboration.eu/), which includes members of the GRADE Working Group and other partners, will explore methods to ensure effective communication of evidence-based recommendations targeted at key stakeholders: healthcare professionals, policymakers, and managers, as well as patients and the general public. Surveys and interviews with guideline producers and other stakeholders will explore how presentation of the evidence could be improved to better meet their information needs. We will collect further stakeholder input from advisory groups, via consultations and user testing; this will be done across a wide range of healthcare systems in Europe, North America, and other countries. Targeted communication strategies will be developed, evaluated in randomized trials, refined, and assessed during the development of real guidelines.
Discussion
Results of the DECIDE project will improve the communication of evidence-based healthcare recommendations. Building on the work of the GRADE Working Group, DECIDE will develop and evaluate methods that address communication needs of guideline users. The project will produce strategies for communicating recommendations that have been rigorously evaluated in diverse settings, and it will support the transfer of research into practice in healthcare systems globally.
doi:10.1186/1748-5908-8-6
PMCID: PMC3553065  PMID: 23302501
Guidelines; Recommendations; Communication; Presentation formats
15.  Strategies for monitoring and updating clinical practice guidelines: a systematic review 
Background
Scientific knowledge is in constant change. The flow of new information requires a frequent re-evaluation of the available research results. Clinical practice guidelines (CPGs) are not exempted from this phenomenon and need to be kept updated to maintain the validity of their recommendations. The objective of our review is to systematically identify, describe and assess strategies for monitoring and updating CPGs.
Study design and setting
We conducted a systematic review of studies evaluating one or more methods of updating (with or without monitoring) CPGs or recommendations. We searched MEDLINE (PubMed) and The Cochrane Methodology Register (The Cochrane Library) from 1966 to June 2012. Additionally, we hand-searched reference lists of the included studies and the Guidelines International Network book of abstracts. If necessary, we contacted study authors to obtain additional information.
Results
We included a total of eight studies. Four evaluated if CPGs were out of date, three updated CPGs, and one continuously monitored and updated CPGs. The most detailed reported phase of the process was the identification of new evidence. As opposed to studies updating guidelines, studies evaluating if CPGs were out of date applied restricted searches. Only one study compared a restricted versus an exhaustive search suggesting that a restricted search is sufficient to assess recommendations’ Validity. One study analyzed the survival time of CPGs and suggested that these should be reassessed every three years.
Conclusions
There is limited evidence about the optimal strategies for monitoring and updating clinical practice guidelines. A restricted search is likely to be sufficient to monitor new evidence and assess the need to update, however, more information is needed about the timing and type of search. Only the exhaustive search strategy has been assessed for the update of CPGs. The development and evaluation of more efficient strategies is needed to improve the timeliness and reduce the burden of maintaining the validity of CPGs.
doi:10.1186/1748-5908-7-109
PMCID: PMC3520818  PMID: 23164220
Clinical practice guidelines; Diffusion of innovation; Evidence-based medicine; Information storage and retrieval; Methodology; Updating; Implementation science; Dissemination and implementation; Knowledge translation
16.  Evaluating patient values and preferences for thromboprophylaxis decision making during pregnancy: a study protocol 
Background
Pregnant women with prior venous thromboembolism (VTE) are at risk of recurrence. Low molecular weight heparin (LWMH) reduces the risk of pregnancy-related VTE. LMWH prophylaxis is, however, inconvenient, uncomfortable, costly, medicalizes pregnancy, and may be associated with increased risks of obstetrical bleeding. Further, there is uncertainty in the estimates of both the baseline risk of pregnancy-related recurrent VTE and the effects of antepartum LMWH prophylaxis. The values and treatment preferences of pregnant women, crucial when making recommendations for prophylaxis, are currently unknown. The objective of this study is to address this gap in knowledge.
Methods
We will perform a multi-center cross-sectional interview study in Canada, USA, Norway and Finland. The study population will consist of 100 women with a history of lower extremity deep vein thrombosis (DVT) or pulmonary embolism (PE), and who are either pregnant, planning pregnancy, or may in the future consider pregnancy (women between 18 and 45 years). We will exclude individuals who are on full dose anticoagulation or thromboprophylaxis, who have undergone surgical sterilization, or whose partners have undergone vasectomy. We will determine each participant's willingness to receive LMWH prophylaxis during pregnancy through direct choice exercises based on real life and hypothetical scenarios, preference-elicitation using a visual analog scale (“feeling thermometer”), and a probability trade-off exercise. The primary outcome will be the minimum reduction (threshold) in VTE risk at which women change from declining to accepting LMWH prophylaxis. We will explore possible determinants of this choice, including educational attainment, the characteristics of the women’s prior VTE, and prior experience with LMWH. We will determine the utilities that women place on the burden of LMWH prophylaxis, pregnancy-related DVT, pregnancy-related PE and pregnancy-related hemorrhage. We will generate a “personalized decision analysis” using participants’ utilities and their personalized risk of recurrent VTE as inputs to a decision analytic model. We will compare the personalized decision analysis to the participant’s stated choice.
Discussion
The preferences of pregnant women at risk of VTE with respect to the use of antithrombotic therapy remain unexplored. This research will provide explicit, quantitative expressions of women's valuations of health states related to recurrent VTE and its prevention with LMWH. This information will be crucial for both guideline developers and for clinicians.
doi:10.1186/1471-2393-12-40
PMCID: PMC3495041  PMID: 22646475
17.  Medical student attitudes towards family medicine in Spain: a statewide analysis 
BMC Family Practice  2012;13:47.
Background
Family and community medicine (FM) became a recognized specialty in Spain in 1978; however, most medical schools in Spain still lack mandatory core courses in FM. In order to explore the perceptions, expectations and level of information amongst medical students in Spain in relation to FM and PC, and the training in these areas in the curriculum of the Medical Schools, a survey was developed to be administered in medical schools every two years. This article presents data from the first questionnaire administration.
Methods
The study population was all first-, third-, and fifth-year students (2009–2010) in 22 participating medical schools in Spain (of 27 total). The 83-item survey had three sections: personal data, FM training, professional practice expectations, and preferences). Chi-squared test or analyses of variance were used, as appropriate.
Results
We had a 41.8% response rate (n = 5299/12924); 89.8% considered the social role of FM to be essential, while only 20% believed the specialty was well respected within the medical profession. The appeal of FM increased with years of study, independent of student characteristics or medical school attended. Among third and fifth-year students, 54.6% said their specialty preferences had changed during medical school; 73.6% felt that FM specialists should teach FM courses, and 83.3% thought that FM rotations in primary care centres were useful.
Conclusions
Students valued the social role of FM more highly than its scientific standing. The vast majority believe that FM training should be mandatory. Only 25% of first-year students have clear preferences for a specialization. Interest in FM increases moderately over their years of study. Working conditions in FM have decisive influence in choosing a specialty.
doi:10.1186/1471-2296-13-47
PMCID: PMC3436784  PMID: 22642617
18.  Attitudes and perceptions of medical students about family medicine in Spain: protocol for a cross-sectional survey 
BMJ Open  2011;1(2):e000231.
Background
Despite the fact that family medicine (FM) has become established as a specialty in the past 25 years, this has not been reflected in the inclusion of the specialty in the majority of medical schools in Spain. Almost 40% of the students will work in primary care but, in spite of this, most universities do not have an assessed placement as such. There are only specific practice periods in health centres or some student-selected components with little weight in the overall curricula.
Objectives
To evaluate the attitudes and perceptions of medical students about FM in the health system and their perception about the need for specific training in FM at the undergraduate level. To explore change over time of these attitudes and perceptions and to examine potential predictive factors for change. Finally, we will review what teaching activity in FM is offered across the Spanish schools of medicine.
Methods
Descriptive cross-sectional survey. Each one of the different analyses will consist of two surveys: one for all the students in the first, third and fifth year of medical school in all the Spanish schools of medicine asking about their knowledge, perceptions and attitudes in relation to primary care and FM. There will be an additional survey for the coordinating faculty of the study in each university about the educational activities related to FM that are carried out in their centres. The repetition of the study every 2 years will allow for an analysis of the evolution of the cohort of students until they receive their degree and the potential predictive factors.
Discussion
This study will provide useful information for strategic planning decisions, content and educational methodology in medical schools in Spain and elsewhere. It will also help to evaluate the influence of the ongoing changes in FM, locally and at the European level, on the attitudes and perceptions of the students towards FM in Spain.
Article summary
Article focus
There is a need to explore further the reasons for which students choose a specific specialty for training and future practice. This protocol outlines the design of a cross-sectional survey to evaluate attitudes and perceptions of medical students about family medicine.
The project will assess the potential impact of medical school teaching on the final profiles of students, both in perceptions and expectations and in the choice of specialty.
Key messages
This is a protocol of a multicentre survey that will take place in Spanish medical schools. The study includes a survey for students and one for the coordinators of family medicine in each centre.
The repetition of the student survey every 2 years will allow for an analysis of the evolution of student cohorts until the end of their studies.
The results of this study will provide valuable information for curriculum development related to family medicine in the different schools of medicine and will help to prioritise those activities that are likely to be most effective for promoting this specialty.
Strengths and limitations of this study
The research team for this study includes coordinating faculty from 22 of the 27 universities throughout Spain. The study will be repeated every 2 years and will explore change over time of the issues addressed.
The principal limitations of this study are related to its design, of observational nature. The results observed will serve as hypotheses generating and cannot be regarded as definitive. Finally, the fact that the survey will be anonymous will impede the evaluation, at an individual level, of change over time.
doi:10.1136/bmjopen-2011-000231
PMCID: PMC3278481  PMID: 22189348
19.  The updating of clinical practice guidelines: insights from an international survey 
Background
Clinical practice guidelines (CPGs) have become increasingly popular, and the methodology to develop guidelines has evolved enormously. However, little attention has been given to the updating process, in contrast to the appraisal of the available literature. We conducted an international survey to identify current practices in CPG updating and explored the need to standardize and improve the methods.
Methods
We developed a questionnaire (28 items) based on a review of the existing literature about guideline updating and expert comments. We carried out the survey between March and July 2009, and it was sent by email to 106 institutions: 69 members of the Guidelines International Network who declared that they developed CPGs; 30 institutions included in the U.S. National Guideline Clearinghouse database that published more than 20 CPGs; and 7 institutions selected by an expert committee.
Results
Forty-four institutions answered the questionnaire (42% response rate). In the final analysis, 39 completed questionnaires were included. Thirty-six institutions (92%) reported that they update their guidelines. Thirty-one institutions (86%) have a formal procedure for updating their guidelines, and 19 (53%) have a formal procedure for deciding when a guideline becomes out of date. Institutions describe the process as moderately rigorous (36%) or acknowledge that it could certainly be more rigorous (36%). Twenty-two institutions (61%) alert guideline users on their website when a guideline is older than three to five years or when there is a risk of being outdated. Twenty-five institutions (64%) support the concept of "living guidelines," which are continuously monitored and updated. Eighteen institutions (46%) have plans to design a protocol to improve their guideline-updating process, and 21 (54%) are willing to share resources with other organizations.
Conclusions
Our study is the first to describe the process of updating CPGs among prominent guideline institutions across the world, providing a comprehensive picture of guideline updating. There is an urgent need to develop rigorous international standards for this process and to minimize duplication of effort internationally.
doi:10.1186/1748-5908-6-107
PMCID: PMC3191352  PMID: 21914177
20.  EBM in primary care: a qualitative multicenter study in Spain 
BMC Family Practice  2011;12:84.
Background
Evidence based medicine (EBM) has made a substantial impact on primary care in Spain over the last few years. However, little research has been done into family physicians (FPs)' attitudes related to EBM. The present study investigates FPs' perceptions of EBM in the primary care context.
Methods
This study used qualitative methodology. Information was obtained from 8 focus groups composed of 67 FPs from 47 health centers in 4 autonomous regions in Spain. Intentional sampling considered participants' previous education in EBM, and their experience as tutors in family medicine or working groups' members of the Spanish Society of Family Practice. Sociological discourse analysis was used with the support of the MAXqda software. Results were validated by means of triangulation among researchers and contrast with participants.
Results
Findings were grouped into three main areas: 1) The tug-of-war between the "science" of EBM and "experience" in the search for good clinical practice in primary care; 2) The development of EBM sensemaking as a reaction to contextual factors and interests; 3) The paradox of doubt and trust in the new EBM experts.
The meaning of EBM was dynamically constructed within the primary care context. FPs did not consider good clinical practice was limited to the vision of science that EBM represents. Its use appeared to be conditioned by several factors that transcended the common concept of barriers. Along with concerns about its objectivity, participants showed a tendency to see EBM as the use of simplified guidelines developed by EBM experts.
Conclusions
The identification of science with EBM and its recognition as a useful but insufficient tool for the good clinical practice requires rethinking new meanings of evidence within the primary care reality. Beyond the barriers related to accessing and putting into practice the EBM, its reactive use can determine FPs' questions and EBM development in a direction not always centred on patients' needs. The questioning of experts' authority as a pillar of EBM could be challenged by the emergence of new kinds of EBM texts and experts to believe in.
doi:10.1186/1471-2296-12-84
PMCID: PMC3166903  PMID: 21827662
21.  GRADE: an emerging consensus on rating quality of evidence and strength of recommendations 
BMJ : British Medical Journal  2008;336(7650):924-926.
Guidelines are inconsistent in how they rate the quality of evidence and the strength of recommendations. This article explores the advantages of the GRADE system, which is increasingly being adopted by organisations worldwide
doi:10.1136/bmj.39489.470347.AD
PMCID: PMC2335261  PMID: 18436948
22.  Drugs for pre-osteoporosis: prevention or disease mongering? 
BMJ : British Medical Journal  2008;336(7636):126-129.
After looking at data used to support treatment of women with slightly lowered bone mineral density, Pablo Alonso-Coello and colleagues argue thatproponents have overstated the benefits and underplayed the harms
doi:10.1136/bmj.39435.656250.AD
PMCID: PMC2206291  PMID: 18202066
23.  Perceptions and attitudes of clinicians in Spain toward clinical practice guidelines and grading systems: a protocol for a qualitative study and a national survey 
Background
Clinical practice guidelines (CPGs) have become a very popular tool for decision making in healthcare. While there is some evidence that CPGs improve outcomes, there are numerous factors that influence their acceptability and use by healthcare providers. While evidence of clinicians' knowledge, perceptions and attitudes toward CPGs is extensive, results are still disperse and not conclusive. Our study will evaluate these issues in a large and representative sample of clinicians in Spain.
Methods/Design
A mixed-method design combining qualitative and quantitative research techniques will evaluate general practitioners (GPs) and hospital-based specialists in Spain with the objective of exploring attitudes and perceptions about CPGs and evidence grading systems. The project will consist of two phases: during the first phase, group discussions will be carried out to gain insight into perceptions and attitudes of the participants, and during the second phase, this information will be completed by means of a survey, reaching a greater number of clinicians. We will explore these issues in GPs and hospital-based practitioners, with or without previous experience in guideline development.
Discussion
Our study will identify and gain insight into the perceived problems and barriers of Spanish practitioners in relation to guideline knowledge and use. The study will also explore beliefs and attitudes of clinicians towards CPGs and evidence grading systems used to rate the quality of the evidence and the strength of recommendations. Our results will provide guidance to healthcare researchers and healthcare decision makers to improve the use of guidelines in Spain and elsewhere.
doi:10.1186/1472-6963-10-328
PMCID: PMC3016354  PMID: 21129195
24.  IVF/ICSI with or without preimplantation genetic screening for aneuploidy in couples without genetic disorders: a systematic review and meta-analysis 
Purpose
To assess the efficacy of preimplantation genetic screening to increase ongoing pregnancy rates in couples without known genetic disorders.
Methods
Systematic review and meta-analysis of randomized controlled trials. Two reviewers independently determined study eligibility and extracted data.
Results
Ten randomized trials (1,512 women) were included. The quality of evidence was moderate. Meta-analyses using a random-effects model suggest that PGS has a lower rate of ongoing pregnancies (risk ratio=0.73, 95% confidence interval 0.62–0.87) and a lower rate of live births (risk ratio=0.76, 95% confidence interval 0.64–0.91) than standard in vitro fertilization/intracytoplasmic sperm injection.
Conclusions
In women with poor prognosis or in general in vitro fertilization program, in vitro fertilization/intracytoplasmic sperm injection with preimplantation genetic screening for aneuploidy does not increase but instead was associated with lower rates of ongoing pregnancies and live births. The use of preimplantation genetic screening in daily practice does not appear to be justified.
doi:10.1007/s10815-009-9328-4
PMCID: PMC2719075  PMID: 19629673
Meta-analysis; Preimplantation genetic screening; Aneuploidy; IVF/ICSI; Advanced maternal age; Recurrent pregnancy loss; Repeated IVF failure
25.  Hormone Replacement Therapy advertising: sense and nonsense on the web pages of the best-selling pharmaceuticals in Spain 
BMC Public Health  2010;10:134.
Background
The balance of the benefits and risks of long term use of hormone replacement therapy (HRT) have been a matter of debate for decades. In Europe, HRT requires medical prescription and its advertising is only permitted when aimed at health professionals (direct to consumer advertising is allowed in some non European countries). The objective of this study is to analyse the appropriateness and quality of Internet advertising about HRT in Spain.
Methods
A search was carried out on the Internet (January 2009) using the eight best-selling HRT drugs in Spain. The brand name of each drug was entered into Google's search engine. The web sites appearing on the first page of results and the corresponding companies were analysed using the European Code of Good Practice as the reference point.
Results
Five corporate web pages: none of them included bibliographic references or measures to ensure that the advertising was only accessible by health professionals. Regarding non-corporate web pages (n = 27): 41% did not include the company name or address, 44% made no distinction between patient and health professional information, 7% contained bibliographic references, 26% provided unspecific information for the use of HRT for osteoporosis and 19% included menstrual cycle regulation or boosting feminity as an indication. Two online pharmacies sold HRT drugs which could be bought online in Spain, did not include the name or contact details of the registered company, nor did they stipulate the need for a medical prescription or differentiate between patient and health professional information.
Conclusions
Even though pharmaceutical companies have committed themselves to compliance with codes of good practice, deficiencies were observed regarding the identification, information and promotion of HRT medications on their web pages. Unaffected by legislation, non-corporate web pages are an ideal place for indirect HRT advertising, but they often contain misleading information. HRT can be bought online from Spain, without a medical consultation or prescription constituting a serious issue for public health. In our information society, it is the right and obligation of public health bodies to ensure that such information is not misleading.
doi:10.1186/1471-2458-10-134
PMCID: PMC2850342  PMID: 20233393

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