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1.
Nat Prod Res ; : 1-7, 2024 Apr 25.
Article in English | MEDLINE | ID: mdl-38662428

ABSTRACT

Lampranthus glaucus and Lampranthus glaucoides are only reported to have significant cytotoxic activity against certain cancer cell lines with phytochemical investigation of their petroleum ether and the ethyl acetate extracts. Further investigation was suggested concerning their hepatoprotective activity and relating it to the metabolic profile of their defatted methanol extracts using LC-ESI/MS analysis. Hepatoprotective activity was evaluated through assessment of three liver parameters as well as liver histopathological examination in thioacetamide-induced hepatotoxicity model. Sixty-eight and 26 phytochemicals were tentatively identified in L. glaucoides and L. glaucus, respectively, with phenolic compounds as the major class. Both plants showed significant inhibition of serum GPT and GOT levels, inhibition of tissue IL-1ß and TNF-α levels and inhibition of tissue NF-κß and caspase-3 gene expression proving hepatoprotective action. Liver treated with L. glaucoides showed lesion scoring range between negative to mild, whereas L. glaucus showed a range between mild to moderate.

2.
J Med Internet Res ; 25: e48529, 2023 10 06.
Article in English | MEDLINE | ID: mdl-37801343

ABSTRACT

We examined the gender distribution of authors of retracted articles in 134 medical journals across 10 disciplines, compared it with the gender distribution of authors of all published articles, and found that women were underrepresented among authors of retracted articles, and, in particular, of articles retracted for misconduct.


Subject(s)
Biomedical Research , Periodicals as Topic , Scientific Misconduct , Female , Humans , Plagiarism , Retrospective Studies , Publications
3.
Front Surg ; 10: 1134355, 2023.
Article in English | MEDLINE | ID: mdl-37035573

ABSTRACT

Background: Total hip arthroplasty (THA) is a successful procedure for treating end-stage hip osteoarthritis (OA). Regarding the surgical approach for THA, the anterolateral (AL) approach, which requires anterior hemimyotomy of the gluteus medius muscle, has shown a long-term favorable outcome. However, to date, complete information related to hip abductor muscle outcomes after the AL approach is unavailable. This study therefore aimed to evaluate the postoperative outcome of patients who undergo THA using the AL approach in terms of hip abductor muscle recovery, pain, function, and muscle healing status. Methods: Twenty patients diagnosed with unilateral end-stage hip OA underwent cementless THA with the AL approach. All patient procedures were performed by a single surgeon. Preoperative and postoperative data were collected at 2-week, 6-week, 3-month, and 6-month follow-up periods. Hip abductor muscle power was measured via handheld dynamometer. The healing of the musculotendinous repair was evaluated with magnetic resonance imaging at 9 months. Results: After THA, hip abductor muscle power in the operated hip significantly increased as early as 3 months post-procedure when compared with the preoperative value (p < 0.05). The other parameters-including pain score, Harris hip score, and WOMAC score-significantly improved as early as 2 weeks post-operation (p < 0.05). In all patients, MRI scans showed good healing of the muscle repair site without a gap in the gluteus medius muscle. However, three patients (15%) had some fibrosis and tendon swelling at the repair site. Conclusion: This study demonstrated that patients with end-stage hip OA could experience significantly improved hip abductor motor function as early as 3 months after undergoing THA with the AL approach. Moreover, despite patients experiencing anterior hemimyotomy of the gluteus medius muscle, no significant complications emerged at the muscle repair site in the AL approach.

5.
Front Psychol ; 13: 1020854, 2022.
Article in English | MEDLINE | ID: mdl-36389525

ABSTRACT

Linguistic expressions of interest instantiated by interesting, intriguing, and fascinating that signal the authorial stance are not uncommon in applied linguistics research articles. Nevertheless, they have received little scholarly attention. This paper, taking a cognitive semantic approach, reports on a study that sought to examine how linguistically expressed interest in applied linguistics research articles is leveraged by researchers' geo-academic location (the Core vs. the Periphery). Drawing on a semantic frame generated for interest markers in academic writing, this study focused on the incidence of the various elements of the Interest frame in the discipline of applied linguistics based on a mixed-methods approach. The corpus-based quantitative analyses found that academic writers' geo-academic location was a robust predictor of authors' overall use of interest markers and some frame elements associated with the Interest frame. Triangulation with the interview data obtained from disciplinary specialists revealed that the observed differences could be attributable to the hierarchical academia featuring periphery-based scholars' unequal access to the knowledge production market and under-representation.

6.
Front Psychol ; 13: 906641, 2022.
Article in English | MEDLINE | ID: mdl-35693488

ABSTRACT

The purpose of this corpus-based study was to investigate whether different sections in chemistry research articles, i.e., abstract, introduction, and results and discussion, rely on different sets of lexical bundles. Lexical bundles, associated with the above sections, were extracted from a corpus of 4 million words, comprising 1,185 chemistry research articles, using WordSmith Tools 5.0, and were categorized according to their functions. Altogether, 197 key bundles were identified in the three sections of chemistry research articles, 15 in the abstract, 99 in the introduction, and 83 in the results and discussion section. Two functions also emerged for lexical bundles in chemistry research articles, including purpose-oriented bundles, which refer to the aim/aims of the study; and literature-oriented bundles, which are used to refer to the literature. Altogether, the results showed that various sections in chemistry RAs are associated with specific sets of lexical bundles and, as such, deal with different rhetorical functions.

7.
GMS J Med Educ ; 39(1): Doc9, 2022.
Article in English | MEDLINE | ID: mdl-35368833

ABSTRACT

Objective: This study aims at developing a list of academic and technical words commonly used in medical research articles. It is conducted in line with the specificity of academic literacy and vocabulary practices in every individual discipline. Methods: The corpus of this study consisted of 18,462,820 words extracted from 1,784 research articles accessed from three prestigious and widely known journals, i.e., The Lancet, The British Medical Journal (BMJ), and The New England Journal of Medicine (NEJM), published between 2015 and 2019. To analyze the data, the RANGE program as a robust tool for developing viable academic word lists was used. Results: Our quantitative and qualitative data analysis yielded a final academic wordlist which consisted of 1,003 words, covered 1,972,420 words in the corpus, and accounted for 10.68% of the medical research articles. Discussion: The high coverage of the extracted academic and technical words provides a reliable source for medical students, medical educators, material designers, and those who are deeply involved in medical English education.


Subject(s)
Education, Medical , Vocabulary , Humans , Organizations
8.
Heliyon ; 7(11): e08463, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34901507

ABSTRACT

Stance is a feature of academic writing that refers to how writers interact and engage with their readers by means of linguistic devices. This study focuses on the grammatical devices-and semantic distinctions thereof-that are employed by academic writers of English to express stance in research article abstracts in the areas of applied linguistics (AL) and literature (L). To this end, a corpus of 120 research article abstracts (60 in the area of AL and another 60 in that of L) was built and analysed using SPSS and following Biber et al.'s (1999) framework of grammatical devices of stance. The abstracts were extracted from high-quality journals in the respective areas: Applied Linguistics and English: Journal of the English Association. Both are ISI journals and published by Oxford Academic Publishing. A mixed-method approach, applying quantitative and qualitative measures, was adopted to answer the two questions: How is stance grammatically expressed in AL research article abstracts and L research article abstracts, and How is the expression of stance in AL research article abstracts similar to/different from that in L ones? The findings are construed in light of theories of academic discourse and English for Academic Purposes (EAP). The results reveal that there are important similarities and differences in the extent to which and the means through which stance is expressed in AL research article abstracts and L research article abstracts. In particular, the findings show that both AL and L abstracts were similar in the most frequently used stance marker which is the stance complement clause. However, they were different in the frequency of use of other devices. The study provides insights into the ways academic writers express stance in various fields which better our ability to write research article abstracts.

9.
Heliyon ; 7(4): e06909, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33997420

ABSTRACT

Meaning-making choice place a significant position in written communication, as indirect contact needs a particular strategy to achieve the objective. This case study explores how female and male writers utilized their meaning-making choice through experiential meaning in their introduction part of journal article writing published in JEELL. Research articles written by five female writers and five male writers with English teachers' professional backgrounds are involved in this study. The results indicate that both female and male writers tend to use a particular process, such as material processes, to represent their real-world experiences of doing and happening. However, it is also found that there is a difference in the technique used in expressing material processes by female and male writers. The study also implies that male writers apply more verbal processes than female writers in citing or synthesizing sources. Furthermore, the investigations reveal that male writers produced more various type of mental processes than female writers.

10.
Adv Med Educ Pract ; 12: 383-392, 2021.
Article in English | MEDLINE | ID: mdl-33907488

ABSTRACT

BACKGROUND: The International Committee of Medical Journal Editors has published clear guidelines on the authorship of scientific papers. It is the research team's responsibility to review and ensure those guidelines are met. Authorship ethics and practices have been examined among healthcare professionals or among particular health science students such as medical students. However, there is limited evidence to assess the knowledge of authorship roles and practices among health science students. METHODS: We conducted a cross-sectional study to assess the knowledge of authorship guidelines practices among health science students at King Saud bin Abdulaziz University for Health Sciences in Riyadh, Saudi Arabia. A survey was developed and distributed. It covered several domains, including demographic characteristics, participant's knowledge and attitude of authorship practices, knowledge and experience with ghost and guest authorships, and knowledge of institutional authorship policies. Moreover, a score was computed to reflect the respondents' knowledge about authorship practices. RESULTS: Among the 321 participants who agreed to take the survey, two-thirds agreed with and supported that multi-authored articles' credit allocation should be based on the most significant contribution and contributions to the manuscript writing. Almost 47% agreed that team relationships would influence authorship allocation. The majority of the participants were not aware of their institutional research and publication policies. Also, around 50% of participants were not aware of guest or ghost authorships. Finally, the knowledge score about authorship credits, allocation, contribution, order, and guidelines was higher among students who were assigned as corresponding authors and those who were aware of their institutional authorship guidelines and policies. CONCLUSION: In conclusion, our findings suggest that health science students may have limited knowledge about authorship guidelines and unethical behaviors involved in a scientific publication. Universities and research centers should make more efforts to raise the awareness of health science students regarding authorship guidelines while ensuring that they comply with those guidelines.

11.
J Med Ethics ; 45(5): 331-338, 2019 05.
Article in English | MEDLINE | ID: mdl-30824494

ABSTRACT

Sometimes participants in research collaboration die before the paper is accepted for publication. The question we raise in this paper is how authorship should be handled in such situations. First, the outcome of a literature survey is presented. Taking this as our starting point, we then go on to discuss authorship of the dead in relation to the requirements of the Vancouver rules. We argue that in principle the deceased can meet the requirements laid down in these authorship guidelines. However, to include a deceased researcher as author requires a strong justification. The more the person has been involved in the research and writing process before he or she passes away, the stronger the justification for inclusion.


Subject(s)
Authorship , Clinical Trials as Topic/ethics , Publishing/ethics , Research Personnel/ethics , Editorial Policies , Humans , Periodicals as Topic
12.
Trends Ecol Evol ; 33(11): 812-813, 2018 11.
Article in English | MEDLINE | ID: mdl-30213660

Subject(s)
Linguistics , Writing , Alchemy , Science
14.
Front Public Health ; 4: 130, 2016.
Article in English | MEDLINE | ID: mdl-27446896

ABSTRACT

INTRODUCTION: Contact tracing is a critical strategy required for timely prevention and control of Ebola virus disease (EVD) outbreaks. Available evidence suggests that poor contact tracing was a driver of the EVD outbreak in West Africa, including Sierra Leone. In this article, we answered the question as to whether EVD contact tracing, as practiced in Western Area (WA) districts of Sierra Leone from 2014 to 2015, was effective. The goal is to describe contact tracing and identify obstacles to its effective implementation. METHODS: Mixed methods comprising secondary data analysis of the EVD case and contact tracing data sets collected from WA during the period from 2014 to 2015, key informant interviews of contact tracers and their supervisors, and a review of available reports on contact tracing were implemented to obtain data for this study. RESULTS: During the study period, 3,838 confirmed cases and 32,706 contacts were listed in the viral hemorrhagic fever and contact databases for the district (mean 8.5 contacts per case). Only 22.1% (852) of the confirmed cases in the study area were listed as contacts at the onset of their illness, which indicates incomplete identification and tracing of contacts. Challenges associated with effective contact tracing included lack of community trust, concealing of exposure information, political interference with recruitment of tracers, inadequate training of contact tracers, and incomplete EVD case and contact database. While the tracers noted the usefulness of community quarantine in facilitating their work, they also reported delayed or irregular supply of basic needs, such as food and water, which created resistance from the communities. CONCLUSION: Multiple gaps in contact tracing attributed to a variety of factors associated with implementers, and communities were identified as obstacles that impeded timely control of the EVD outbreak in the WA of Sierra Leone. In future outbreaks, early community engagement and participation in contact tracing, establishment of appropriate mechanisms for selection, adequate training and supervision of qualified contact tracers, establishment of a well-managed and complete contact tracing database, and provision of basic needs to quarantined contacts are recommended as measures to enhance effective contact tracing.

15.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-480809

ABSTRACT

Objective To evaluate the teaching effectiveness of applying article structure analysis to improve medical graduate students' ability to read research articles.Methods 48 medical graduate students from basic medicine school of the Fourth Military Medical University were randomly and equally divided into the experimental group and control group.In the reading ability training of scientific research papers,the experimental group used the teaching of the structure analysis,while the control group used the collective self study.Before and after the training,the two groups of students were implemented a unified reading ability test and self reading ability evaluation survey,and after the training,the teaching satisfaction survey was conducted among the experimental group only.SPSS 16 was used to analyze the correlation data and Wilcoxon for signed-rank t est.Results After training the reading ability test results showed that reading ability score (P=0.013),consumed reading time score (P=0.003) and reading efficiency (P=0.004) of the experimental group were significantly higher than those of control group.The two groups of students' self-evaluation of the reading ability showed that after training,the scores of the students in the experimental group were higher than those in the control group,and the differences were statistically significant (P values were less than 0.05).The experimental group students' teaching satisfaction survey to article structure analysis showed students' score in 6 survey contents were greater than 3,namely degree of evaluation was more than general,among which,the score of four survey contents was more than 4,that is to achieve satisfied or very satisfied.Conclttsion Applying article structure analysis can significantly improve medical graduate students' ability to read research articles.

16.
Ecol Evol ; 4(4): 441-9, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24634728

ABSTRACT

Marine anthozoans maintain a mutualistic symbiosis with dinoflagellates that are prolific producers of the algal secondary metabolite dimethylsulfoniopropionate (DMSP), the precursor of the climate-cooling trace gas dimethyl sulfide (DMS). Surprisingly, little is known about the physiological role of DMSP in anthozoans and the environmental factors that regulate its production. Here, we assessed the potential functional role of DMSP as an antioxidant and determined how future increases in seawater pCO2 may affect DMSP concentrations in the anemone Anemonia viridis along a natural pCO2 gradient at the island of Vulcano, Italy. There was no significant difference in zooxanthellae genotype and characteristics (density of zooxanthellae, and chlorophyll a) as well as protein concentrations between anemones from three stations along the gradient, V1 (3232 µatm CO2), V2 (682 µatm) and control (463 µatm), which indicated that A. viridis can acclimate to various seawater pCO2. In contrast, DMSP concentrations in anemones from stations V1 (33.23 ± 8.30 fmol cell(-1)) and V2 (34.78 ± 8.69 fmol cell(-1)) were about 35% lower than concentrations in tentacles from the control station (51.85 ± 12.96 fmol cell(-1)). Furthermore, low tissue concentrations of DMSP coincided with low activities of the antioxidant enzyme superoxide dismutase (SOD). Superoxide dismutase activity for both host (7.84 ± 1.37 U·mg(-1) protein) and zooxanthellae (2.84 ± 0.41 U·mg(-1) protein) at V1 was 40% lower than at the control station (host: 13.19 ± 1.42; zooxanthellae: 4.72 ± 0.57 U·mg(-1) protein). Our results provide insight into coastal DMSP production under predicted environmental change and support the function of DMSP as an antioxidant in symbiotic anthozoans.

17.
GMS Health Technol Assess ; 8: Doc04, 2012.
Article in English | MEDLINE | ID: mdl-22984371

ABSTRACT

UNLABELLED: HEALTH POLITICAL AND SCIENTIFIC BACKGROUND: Bone graft substitutes are increasingly being used as supplements to standard care or as alternative to bone grafts in the treatment of traumatic fractures. RESEARCH QUESTIONS: The efficacy and cost-effectiveness of bone graft substitutes for the treatment of traumatic fractures as well as the ethical, social and legal implications of their use are the main research questions addressed. METHODS: A systematic literature search was conducted in electronic medical databases (MEDLINE, EMBASE etc.) in December 2009. Randomised controlled trials (RCT), where applicable also containing relevant health economic evaluations and publications addressing the ethical, social and legal aspects of using bone graft substitutes for fracture treatment were included in the analysis. After assessment of study quality the information synthesis of the medical data was performed using metaanalysis, the synthesis of the health economic data was performed descriptively. RESULTS: 14 RCT were included in the medical analysis, and two in the heath economic evaluation. No relevant publications on the ethical, social and legal implications of the bone graft substitute use were found. In the RCT on fracture treatment with bone morphogenetic protein-2 (BMP-2) versus standard care without bone grafting (RCT with an elevated high risk of bias) there was a significant difference in favour of BMP-2 for several outcome measures. The RCT of calcium phosphate (CaP) cement and bone marrow-based composite materials versus autogenous bone grafts (RCT with a high risk of bias) revealed significant differences in favour of bone graft substitutes for some outcome measures. Regarding the other bone graft substitutes, almost all comparisons demonstrated no significant difference. The use of BMP-2 in addition to standard care without bone grafting led in the study to increased treatment costs considering all patients with traumatic open fractures. However, cost savings through the additional use of BMP-2 were calculated in a patient subgroup with high-grade open fractures (Gustilo-Anderson grade IIIB). Cost-effectiveness for BMP-2 versus standard care with autologous bone grafts as well as for other bone graft substitutes in fracture treatment has not been determined yet. DISCUSSION: Although there were some significant differences in favour of BMP-2, due to the overall poor quality of the studies the evidence can only be interpreted as suggestive for efficacy. In the case of CaP cements and bone marrow-based bone substitute materials, the evidence is only weakly suggestive for efficacy. From an overall economic perspective, the transferability of the results of the health economic evaluations to the current situation in Germany is limited. CONCLUSIONS: The current evidence is insufficient to evaluate entirely the use of different bone graft substitutes for fracture treatment. From a medical point of view, BMP-2 is a viable alternative for treatment of open fractures of the tibia, especially in cases where bone grafting is not possible. Autologous bone grafting is preferable comparing to the use of OP-1. Possible advantages of CaP cements and composites containing bone marrow over autogenous bone grafting should be taken into account in clinical decision making. The use of the hydroxyapatite material and allograft bone chips compared to autologous bone grafts cannot be recommended. From a health economic perspective, the use of BMP-2 in addition to standard care without bone grafting is recommended as cost-saving in patients with high-grade open fractures (Gustilo-Anderson grade IIIB). Based on the current evidence no further recommendations can be made regarding the use of bone graft substitutes for the treatment of fractures. To avoid legal implications, use of bone graft substitutes outside their approved indications should be avoided.

18.
GMS Health Technol Assess ; 7: Doc06, 2011.
Article in English | MEDLINE | ID: mdl-22031811

ABSTRACT

BACKGROUND: The increasing proportion of elderly people with respective care requirements and within the total population stands against aging personnel and staff reduction in the field of health care where employees are exposed to high load factors. Health promotion interventions may be a possibility to improve work situations and behavior. METHODS: A systematic literature search is conducted in 32 databases limited to English and German publications since 1990. Moreover, internet-searches are performed and the reference lists of identified articles are scanned. The selection of literature was done by two reviewers independently according to inclusion and exclusion criteria. Data extraction and tables of evidence are verified by a second expert just like the assessment of risk of bias by means of the Cochrane Collaboration's tool. RESULTS: We identified eleven intervention studies and two systematic reviews. There were three randomized controlled trials (RCT) and one controlled trial without randomization (CCT) on the improvement of physical health, four RCT and two CCT on the improvement of psychological health and one RCT on both. Study duration ranged from four weeks to two years and the number of participants included from 20 to 345, with a median of 56. Interventions and populations were predominantly heterogeneous. In three studies intervention for the improvement of physical health resulted in less complaints and increased strength and flexibility with statistically significant differences between groups. Regarding psychological health interventions lead to significantly decreased intake of analgesics, better stress management, coping with workload, communication skills and advanced training. DISCUSSION: Taking into consideration the small to very small sample sizes, other methodological flaws like a high potential of bias and poor quality of reporting the validity of the results has to be considered as limited. Due to the heterogeneity of health interventions, study populations with differing job specializations and different lengths of study durations and follow-up periods, the comparison of results would not make sense. CONCLUSIONS: Further research is necessary with larger sample sizes, with a sufficient study duration and follow-up, with a lower risk of bias, by considering of relevant quality criteria and with better reporting in publications.

19.
GMS Health Technol Assess ; 7: Doc04, 2011.
Article in English | MEDLINE | ID: mdl-21808659

ABSTRACT

BACKGROUND: Despite many activities to prevent risky alcohol consumption among adolescents and young adults there is an increase of alcohol intoxications in the group of ten to twenty year old juveniles. OBJECTIVES: This report gives an overview about the recent literature as well as the German federal prevention system regarding activities concerning behavioral and policy prevention of risky alcohol consumption among children, adolescents and young adults. Furthermore, effective components of prevention activities are identified and the efficiency and efficacy of ongoing prevention programs is evaluated. METHODS: A systematic literature review is done in 34 databases using Bool'sche combinations of the key words alcohol, prevention, treatment, children, adolescents and young adults. RESULTS: 401 studies were found and 59 studies were selected for the health technology assessment (HTA). Most of the studies are done in USA, nine in Germany. A family strengthening program, personalized computer based intervention at schools, colleges and universities, brief motivational interventions and policy elements like increase of prices and taxes proved effective. DISCUSSION: Among the 59 studies there are three meta-analyses, 15 reviews, 17 randomized controlled trials (RCT) and 18 cohort studies. Despite the overall high quality of the study design, many of them have methodological weaknesses (missing randomization, missing or too short follow-ups, not clearly defined measurement parameters). The transferability of US-results to the German context is problematic. Only a few prevention activities reach a sustainable reduction of frequency and/or amount of alcohol consumption. CONCLUSION: The HTA-report shows the need to develop specific and target group focused prevention activities for the German situation. Essential for that is the definition of target goals (reduction of consumption, change of behaviour) as well as the definition and empirical validation of risky alcohol consumption. The efficacy of prevention activities should be proven before they are launched. At present activities for the reduction or prevention of risky alcohol consumption are not sufficiently evaluated in Germany concerning their sustainable efficacy.

20.
GMS Health Technol Assess ; 7: Doc01, 2011 Feb 02.
Article in English | MEDLINE | ID: mdl-21468289

ABSTRACT

BACKGROUND: "Patient-Reported Outcome" (PRO) is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA) first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. METHODS: For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI). The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination) and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment). For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT) was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report's chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. RESULTS: Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to operationalisation of PRO). For the empirical analyses 225 RCT (rheumatoid arthritis: 77; breast cancer: 148) and 40 HTA-reports and method papers were found. The analysis of the methodological literature confirms the role of PRO as an umbrella term for a variety of different concepts. The newest classification system facilitates the description of PRO measures by construct, target population and the method of measurement. Steps of operationalisation involve defining a conceptual framework, instrument development, exploration of measurement properties or, possibly, the modification of existing instruments. Seven out of 59 RCT analysing the effects of antibody therapy for rheumatoid arthritis define PRO as the primary endpoint, 38 trials utilize composite measures (ACR, DAS) and ten trials report clinical or radiological parameters as the primary endpoint. Six out of 123 chemotherapy trials for breast cancer define PRO as the primary endpoint, while 98 trials report clinical endpoints (survival, tumour response, progression) in their primary analyses. Discrepancies in the number of trials result from inaccurate specifications of endpoints in the publications. This distribution is reflected in the HTA-reports: while almost all reports on rheumatoid arthritis refer to PRO, this is only the case in about half of the reports on breast cancer. CONCLUSIONS: As definition and classification of PRO are concerned, coherent concepts are found in the literature. Their operationalisation and implementation must be guided by scientific principles. The type and frequency of PRO used in clinical trials largely depend on the disease analysed. The HTA-community seems to pursue the utilization of PRO proactively - in case of missing data the need for further research is stated.

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