Abstract:
BACKGROUND:The term "Patient Reported Outcomes" (PRO) is defined as any result assessed directly by the patient and based on his perception of the illness and its treatment. The scope of the study is to determine and compare the use of PRO measures with other types of effectiveness endpoints in the summary of the products characteristics (SPC) of medicines with active substances approved by first time from 2000 to 2012 in Spain. METHODS:A review and descriptive analysis of the effectiveness endpoints used in the clinical trials described in the SPCs studied, classifying them into the following categories: PRO, clinician-reported outcomes (CROs), and laboratory test/device measurement endpoints (ML). Chi-square and Fisher exact texts were used for comparative purposes, and odds ratio to determine the strongest of association. RESULTS:PROs were included in 65 (19.7%) of the SPCs studied. CRO were the most frequently reported 188 (57%) cases, followed by ML:128 (38,7%). PROs were included as only effectiveness endpoint in 6 medicines. A growing trend toward statistical significance (R2=0.525; p=0.079) has been observed in reporting PROs during the period of time studied. CONCLUSION:The use frequency of PRO in SPCs is clearly minor compared to other efficacy endpoints considered, being the difference significantly higher in case of its use as only efficacy endpoint. The therapeutic areas where PROs were most reported were nervous system medicines, immunologic system modulator medicines, respiratory system, muscle and skeleton system.
journal_name
Rev Esp Salud Publicajournal_title
Revista espanola de salud publicaauthors
Pueyo Velasco JI,Rejas Gutiérrez Jdoi
10.4321/S1135-57272014000500006subject
Has Abstractpub_date
2014-10-01 00:00:00pages
613-27issue
5eissn
1135-5727issn
2173-9110pii
S1135-57272014000500006journal_volume
88pub_type
杂志文章abstract::This study analyses the historical background data on Spanish community nutrition by means of the study of the first attempts toward institutionalization which took place in the Nutrition and Food Hygiene Division of the Spanish National Health School, restricting the search to the 1930-1936 period. In conjunction wit...
journal_title:Revista espanola de salud publica
pub_type: 历史文章,杂志文章
doi:10.1590/s1135-57272007000500003
更新日期:2007-09-01 00:00:00
abstract:BACKGROUND:Directive 98/8/EC harmonizes and regulates in the European market authorization and registration of biocides and establishes a period of 14 years for review of active substances. This study analyzes the most significant changes produced in the registry of biocides used as disinfectants registered since the p...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:10.1590/S1135-57272011000200006
更新日期:2011-03-01 00:00:00
abstract:BACKGROUND:This a prospective study of the incidence, etiology and epidemiological profile of human brucellosis in the regions of Pallars Jussà y Sobirà (Lleida) for the 1995-1998 period. METHODS:Fifty-five patients diagnosed as having brucellosis were studied. Information was recorded regarding the gender, age, town ...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2000-01-01 00:00:00
abstract:OBJECTIVE:Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are widely used but they increase the risk of gastrointestinal haemorrage among other adverse effects. The objective of this study was to compare potentially inappropriate medications (PIM) by NSAIDs using the original Beers Criteria, a global reference for evalu...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2018-05-28 00:00:00
abstract:BACKGROUND:The gradual increase of women in the health professions does not correspond with her presence in positions of power. Given that professional colleges have an essential role in the representation and professional regulation, arises as an aim to describe the presence of women in the managerial structures of th...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:10.4321/S1135-57272015000600010
更新日期:2015-11-01 00:00:00
abstract:OBJECTIVE:One of the fist lines of action of the National Plan against Antibiotic Resistance (PRAN) is to monitor the use of antibiotics as a fundamental basis for the fight against resistance. In order to know the antibiotic prescription habits, we pretended to describe the outpatient prescription of systemic antibiot...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2020-09-25 00:00:00
abstract:BACKGROUND:The high number of computer workers wearing contact lenses raises the question whether the sum of these two risk factors for eye health may cause a worsening of Computer Vision Syndrome. The aim of this review is to synthesize the knowledge about ocular and visual alterations related with computer use in con...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章,评审
doi:10.4321/S1135-57272014000200004
更新日期:2014-03-01 00:00:00
abstract:BACKGROUND:Human immuno-deficiency virus (HIV) infection is one of the leading public health problems in our country. Preventive education has shown itself to be a useful tool for curtailing this disease. The objective of this study is that of assessing the effectiveness of a preventive intervention at the Secondary Sc...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2003-05-01 00:00:00
abstract::Performance measurement, in their different meanings--either balance scorecard or outputs measurement--have become an essential tool in today's organizations (World-Class organizations) to improve service quality and reduce costs. This paper presents a performance measurement system for the hospital supply chain. The ...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2001-07-01 00:00:00
abstract:OBJECTIVE:Immune-mediated inflammatory diseases (IMID) are chronic and highly disabling diseases that share inflammatory sequences and immunological dysregulations. Considered as a disease in itself, the prevalence of IMID is virtually unknown. The aim of this study was to assess the prevalence of 10 selected UDI, incl...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2019-03-25 00:00:00
abstract:BACKGROUND:Research concerning the prevalence of Parkinson's disease in our community was scarce. In addition, this had been carried out using different methodologies. Therefore it was not possible to determine its true impact on public health in our community. Research into the consumption of specific and compulsory d...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:1995-11-01 00:00:00
abstract:BACKGROUND:the prevalence of chronic viral hepatitis in Spain could vary because of the immigrants coming from countries having an elevated with a higher endemicity of hepatitis B and C virus. Hepatitis B and hepatitis C virus infections are an important health problem worldwide taking into account their chronic conseq...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章,评审
doi:10.4321/S1135-57272014000600012
更新日期:2014-11-01 00:00:00
abstract:BACKGROUND:Given that there are different ways of setting out clinical test results, this study is aimed at ascertaining whether the way in which these results are set out has any bearing on the intention to prescribed on the part of Primary Care physicians. METHODS:Randomized, multi-center cross-study. Following a ra...
journal_title:Revista espanola de salud publica
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1590/s1135-57272004000100004
更新日期:2004-01-01 00:00:00
abstract:OBJECTIVE:The partner notification is one of the main activities of epidemiological surveillance in Public Health. The primary objective was to estimate the compliance of the partner notification by health professionals who reported sexually transmitted diseases (HIV, Gonorrhoea, Syphilis and Chlamydia) during 2017 in ...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2019-12-02 00:00:00
abstract:BACKGROUND:Nutritional evaluation during pre-menopause and menopause plays an important role in assessing the changes taking place in a woman's body, a comparison being drawn in this study between the parameters body fat and body fat-muscle ratio (BFMR) estimated by impedancemetry and the body mass index (BMI) for defi...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2002-11-01 00:00:00
abstract:BACKGROUND:The Medical Death Certificate and the Death Statistics Bulletin were unified and implemented in the year 2009 in Spain. National statistics detected an unusual increase for diabetes mellitus (DM) and hypertensive disease (HT) deaths in 2009, in relation to previous years trend.The objective is to study the d...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:10.1590/S1135-57272012000300003
更新日期:2012-05-01 00:00:00
abstract::The following article shows the evolution of the schools contribution to the Health Education of children and young people. Moving on from the traditional concept of health, today, Health Education has a general and global meaning, which encompasses all of the physical, psychological and social aspects of health. Thes...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2001-11-01 00:00:00
abstract:BACKGROUND:It is described an acute gastroenteritis outbreak of probable hydric transmission in Ontinyent (Valencia). It was declared on the 31st of January, 1992 and affected 3541 people according to the declaration done by the sanitary services who attended the patients. The clinical situation was characterized by th...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:1995-03-01 00:00:00
abstract:BACKGROUND:This study assesses the effectiveness of the palliative home care for the purpose of ascertaining whether terminal cancer patients treated by Homecare Support Teams have a better quality of life than those treated by Primary Care Teams. METHODS:A quasi-experimental prospective study conducted in Madrid Heal...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2003-09-01 00:00:00
abstract:OBJECTIVE:The phenomenon of reverse drug trafficking in the legal supply chain is an unlawful practice to serious risks to public health. The aims was to identify proactively pharmacies that carry out these illegal activities. METHODS:An analysis was performed through the crossing billing data to SAS of 52 million pac...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2016-04-04 00:00:00
abstract::Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed recommendations on what s...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:10.1590/s1135-57272008000300002
更新日期:2008-05-01 00:00:00
abstract:OBJECTIVE:In the last decade, public policy makers are applying new tools to promote healthy habits, starting from the behavioral economics sciences and social psychology. These tools are known as nudges, and before being applied, the degree of acceptance that the population presents about them must be analyzed. The ob...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2020-07-24 00:00:00
abstract:BACKGROUND:Calcium supplements and vitamin D are involved in current debates of health, as cardiovascular safety of calcium, and correction of vitamin levels. The aim is to review the possibilities of making better use of supplements marketed in Spain, depending on their availability, information and related epidemiolo...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章,评审
doi:10.4321/S1135-57272012000500002
更新日期:2012-10-01 00:00:00
abstract::This article analyzes all of the food safety-related aspects related to the use of genetically modified organisms into agriculture and food. A discussion is provided as to the uncertainties related to the insertion of foreign genes into organisms, providing examples of unforeseen, undesirable effects and of instabilit...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章,评审
doi:10.1590/s1135-57272005000200013
更新日期:2005-03-01 00:00:00
abstract:BACKGROUND:Lost bone in osteoporotic patients increases the risk of fractures and back pain, and decreases quality of life. The aim of this study was to analyse the effect of teriparatide (TPTD) in osteoporotic patients with vertebral pain. METHODS:A prospective observational study between April 2006 and February 2014...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:10.4321/S1135-57272015000200009
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND:There are different scales in Spanish for cognitive and behavioral assessment of patients with severe dementia. The objective of this study was to select those scales that are more accessible, useful and with better psychometric properties, both for clinical practice and for research. METHODS:Literature rev...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章,评审
doi:
更新日期:2020-09-21 00:00:00
abstract:BACKGROUND:During the summer of 2009, Spain experienced the circulation of the novel influenza (H1N1)2009 virus, beyond the usual period of influenza activity, increasingly evolving up to the presentation in the early autumn of the first wave of the pandemic virus. The objectives of this study are to describe the evolu...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:10.1590/s1135-57272010000500009
更新日期:2010-09-01 00:00:00
abstract::The paper analyzes the situation of the psychiatric reform 25 years of the General Health Law. The author wonders what has been done and what has been left undone, on the degree of implementation of the Community model that adopts the law and its future sustainability. It highlights, among the strengths, the loss of h...
journal_title:Revista espanola de salud publica
pub_type: 历史文章,杂志文章
doi:10.1590/S1135-57272011000500002
更新日期:2011-10-01 00:00:00
abstract:BACKGROUND:Pneumococcal vaccine is an effective preventive measure against pneumococcal infections. Cost-effectiveness of pneumococcal vaccination of 5 or more years aged population of Catalonia has been evaluated in this study. METHODS:Cost-effectiveness has been estimated in terms of net cost per life-year gained (L...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:1995-09-01 00:00:00
abstract:BACKGROUND:Accidents have been largely unstudied in the area of Primary Care. They are one of the most frequent motives for consultation in the Emergency Services and the first assistance that accident victims receive is usually in primary care centres. Establishment of the incidence and clinicoepidemiological characte...
journal_title:Revista espanola de salud publica
pub_type: 杂志文章
doi:
更新日期:2002-01-01 00:00:00