Displaying publications 81 - 100 of 451 in total

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  1. See CK, Turnbull D, Ritson F, Martin S, Tully P, Wittert G
    JBI Database System Rev Implement Rep, 2019 09;17(9):1894-1900.
    PMID: 30925504 DOI: 10.11124/JBISRIR-2017-004035
    OBJECTIVE: The objective of this review is to examine the association between serum testosterone concentration and the presence and severity of depression in men.

    INTRODUCTION: Cross-sectional and longitudinal cohort studies examining the relationship between serum testosterone concentration and depression in men have produced mixed results. There has not, however, been any prior attempt to systematically interrogate the data. Clarification of the relationship has clinical importance because depression may be under-diagnosed in men.

    INCLUSION CRITERIA: This review will consider studies involving community-dwelling men who are not receiving testosterone replacement therapy. The exposure of interest reviewed will include endogenous testosterone concentration measured through validated assays. Studies measuring total and testosterone fraction concentration will be included. This review will include studies with depression or incident depression outcomes as defined by either clinical diagnosis of depression or validated self-administered questionnaire assessing depression symptomatology.

    METHODS: This review will follow the JBI approach for systematic reviews of etiology and risk. The following sources will be searched: PubMed, PsycINFO, Embase, the Cochrane Central Register of Controlled Trials, Australian New Zealand Clinical Trials Registry and the ISRCTN Registry. Analytical observational studies including prospective and retrospective cohort studies, case control studies and analytical cross-sectional studies published in English or other languages with English translation will be considered. Retrieval of full-text studies, assessment of methodological quality and data extraction will be performed independently by two reviewers. Data will be pooled in statistical meta-analysis, where possible.

    SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42018108273.

    Matched MeSH terms: Research Design
  2. Sedigheh Moghadam, Hairul Anuar Hashim
    MyJurnal
    Introduction: Regular aerobic exercise and low-fat milk consumption can improve certain cognitive functions and reducing emotional distress. However, the impacts of combining these modalities are less explored. Thus, the present study examined the effects of combining aerobic exercise and low-fat milk intake among sedentary female students. Methods: Using a nonrandomized pretest – posttest with a control group research design, 85 sedentary females aged 16 years old were assigned into either milk (n = 21), exercise (n = 22), combined low fat milk and exercise (n = 23), or control (n = 19) groups. One serving of low-fat milk was provided to the students during each school day, and a 1-hour supervised step aerobics exercise was conducted twice per week for 3 months. Emotional distress and sus- tained attention were measured at baseline, 6th and 12th weeks after the intervention. A mixed factorial ANOVA was used to analyse the data. Results: The results revealed significantly less emotional distress in the combined (p < 0.01) and exercise groups (p < 0.05) compared with the control group after 12 weeks. Additionally, significant reductions were observed in the total time taken and errors of omission for both digits 6 and 9 of the Digit Vigilance Test in the combined group (p < 0.05, p < 0.001) compared with the control group. Conclusions: The results showed that low fat milk alone did not provide any additional benefits related to distress regulation, but the combination of exercise and low-fat milk contributed to improving sustained attention.
    Matched MeSH terms: Research Design
  3. Schliemann D, Matovu N, Ramanathan K, Muñoz-Aguirre P, O'Neill C, Kee F, et al.
    BMJ Open, 2020 06 11;10(6):e037520.
    PMID: 32532782 DOI: 10.1136/bmjopen-2020-037520
    INTRODUCTION: Colorectal cancer (CRC) imposes a significant global burden of disease. CRC survival rates are much lower in low-income and middle-income countries (LMICs). Screening tends to lead to an improvement in cancer detection and the uptake of available treatments and, in turn, to better chances of cancer survival. Most evidence on CRC screening interventions comes from high-income countries. The objective of this scoping review is to map the available literature on the implementation of CRC screening interventions in LMICs.

    METHODS AND ANALYSIS: We will conduct a scoping review according to the framework proposed by Arksey and O'Malley (2005). We will search MEDLINE, EMBASE, Web of Science and Google Scholar using a combination of terms such as "colorectal cancer", "screening" and "low-middle-income countries". Studies of CRC screening interventions/programmes conducted in the general adult population in LMICs as well as policy reviews (of interventions in LMICs) and commentaries on challenges and opportunities of delivering CRC screening in LMICs, published in the English language before February 2020 will be included in this review. The title and abstract screen will be conducted by one reviewer and two reviewers will screen full-texts and extract data from included papers, independently, into a data charting template that will include criteria from an adapted template for intervention description and replication checklist and implementation considerations. The presentation of the scoping review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews guidance.

    ETHICS AND DISSEMINATION: There are no ethical concerns. The results will be used to inform colorectal screening interventions in LMICs. We will publish the findings in a peer-reviewed journal and present them at relevant conferences.

    Matched MeSH terms: Research Design
  4. Schaafsma A, Deurenberg P, Calame W, van den Heuvel EG, van Beusekom C, Hautvast J, et al.
    Br J Nutr, 2013 Sep;110 Suppl 3:S2-10.
    PMID: 24016763 DOI: 10.1017/S0007114513002067
    Nutrition is a well-known factor in the growth, health and development of children. It is also acknowledged that worldwide many people have dietary imbalances resulting in over- or undernutrition. In 2009, the multinational food company FrieslandCampina initiated the South East Asian Nutrition Survey (SEANUTS), a combination of surveys carried out in Indonesia, Malaysia, Thailand and Vietnam, to get a better insight into these imbalances. The present study describes the general study design and methodology, as well as some problems and pitfalls encountered. In each of these countries, participants in the age range of 0·5-12 years were recruited according to a multistage cluster randomised or stratified random sampling methodology. Field teams took care of recruitment and data collection. For the health status of children, growth and body composition, physical activity, bone density, and development and cognition were measured. For nutrition, food intake and food habits were assessed by questionnaires, whereas in subpopulations blood and urine samples were collected to measure the biochemical status parameters of Fe, vitamins A and D, and DHA. In Thailand, the researchers additionally studied the lipid profile in blood, whereas in Indonesia iodine excretion in urine was analysed. Biochemical data were analysed in certified laboratories. Study protocols and methodology were aligned where practically possible. In December 2011, data collection was finalised. In total, 16,744 children participated in the present study. Information that will be very relevant for formulating nutritional health policies, as well as for designing innovative food and nutrition research and development programmes, has become available.
    Matched MeSH terms: Research Design*
  5. Saokaew S, Rayanakorn A, Wu DB, Chaiyakunapruk N
    Pharmacoeconomics, 2016 12;34(12):1211-1225.
    PMID: 27510721
    BACKGROUND: Although pneumococcal conjugate vaccines (PCVs) have been available for prevention of invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae (S. pneumoniae) for over a decade, their adoption into national immunization programmes in low- and middle-income countries (LMICs) is still limited. Economic evaluations (EEs) play a crucial role in support of evidence-informed decisions.

    OBJECTIVE: This systematic review aims to provide a critical summary of EEs of PCVs and identify key drivers of EE findings in LMICs.

    METHODS: We searched Scopus, ISI Web of Science, PubMed, Embase and Cochrane Central from their inception to 30 September 2015 and limited the search to LMICs. The search was undertaken using the search strings 'pneumococc* AND conjugat* AND (vaccin* OR immun*)' AND 'economic OR cost-effectiveness OR cost-benefit OR cost-utility OR cost-effectiveness OR cost-benefit OR cost-utility' in the abstract, title or keyword fields. To be included, each study had to be a full EE of a PCV and conducted for an LMIC. Studies were extracted and reviewed by two authors. The review involved standard extraction of the study overview or the characteristics of the study, key drivers or parameters of the EE, assumptions behind the analyses and major areas of uncertainty.

    RESULTS: Out of 134 records identified, 22 articles were included. Seven studies used a Markov model for analysis, while 15 studies used a decision-tree analytic model. Eighteen studies performed a cost-utility analysis (CUA), with disability-adjusted life-years, quality-adjusted life-years or life-years gained as a measure of health outcome, while four studies focused only on cost-effectiveness analysis (CEA). Both CEA and CUA findings were provided by eight studies. Herd effects and serotype replacement were considered in 10 and 13 studies, respectively. The current evidence shows that both the 10-valent and 13-valent PCVs are probably cost effective in comparison with the 7-valent PCV or no vaccination. The most influential parameters were vaccine efficacy and coverage (in 16 of 22 studies), vaccine price (in 13 of 22 studies), disease incidence (in 11 of 22 studies), mortality from IPD and pneumonia (in 8 of 22 studies) and herd effects (in 4 of 22 studies). The findings were found to be supportive of the products owned by the manufacturers.

    CONCLUSION: Our review demonstrated that an infant PCV programme was a cost-effective intervention in most LMICs (in 20 of 22 studies included). The results were sensitive to vaccine efficacy, price, burden of disease and sponsorship. Decision makers should consider EE findings and affordability before adoption of PCVs.

    Matched MeSH terms: Research Design
  6. Santos J, Palumbo F, Molsen-David E, Willke RJ, Binder L, Drummond M, et al.
    Value Health, 2017 12;20(10):1227-1242.
    PMID: 29241881 DOI: 10.1016/j.jval.2017.10.018
    As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results. There are nine chapters: 1 - Introduction; 2 - Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 - Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 - Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 - Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 - Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 - Patient Centricity and Patient Engagement new addition, with explanation and guidance; 8 - Publication and Dissemination; and 9 - Conclusion and Limitations.
    Matched MeSH terms: Research Design
  7. Sanjeevannavar MB, Banapurmath NR, Soudagar MEM, Atgur V, Hossain N, Mujtaba MA, et al.
    Chemosphere, 2022 Feb;288(Pt 2):132450.
    PMID: 34624353 DOI: 10.1016/j.chemosphere.2021.132450
    Biodiesel commercialization is questionable due to poor brake thermal efficiency. Biodiesel utilization should be improved with the addition of fuel additives. Hydrogen peroxide is a potential fuel additive due to extra hydrogen and oxygen content, which improves the combustion process. In this experimental study, biodiesel has been produced from Jatropha oil employing catalyzed transesterification homogeneously to examine its influence on the performance and emissions at engine loads with 1500 rpm utilizing a four-stroke single-cylinder diesel engine. D60B40 (having 60% diesel and 40% biodiesel) and D60B30A10 (60% diesel, 30% biodiesel and 10% hydrogen peroxide (H2O2)), are the fuel mixtures in the current study. The addition of H2O2 reduces emissions and enhances the combustion process. This effect occurred due to the micro-explosion of the injected fuel particles (which increases in-cylinder pressure and heat release rate (HRR)). An increase of 20% in BTE and 25% reduction in BSFC for D60B30A10 was observed compared to D60B40. Significant reduction in emissions of HC up to 17.54%, smoke by 24.6% CO2 by 3.53%, and an increase in NOx was noticed when the engine is operated with D60B30A10. The HRR increased up to 18.6%, ID reduced by 10.82%, and in-cylinder pressure increased by 8.5%. Test runs can be minimized as per Taguchi's design of experiments. It is possible to provide the estimates for the full factorial design of experiments. Exhaust gas temperature standards are evaluated and examined for all fuel blends.
    Matched MeSH terms: Research Design
  8. Samsudin H, Auras R, Mishra D, Dolan K, Burgess G, Rubino M, et al.
    Food Res Int, 2018 01;103:515-528.
    PMID: 29389642 DOI: 10.1016/j.foodres.2017.09.021
    Migration studies of chemicals from contact materials have been widely conducted due to their importance in determining the safety and shelf life of a food product in their packages. The US Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA) require this safety assessment for food contact materials. So, migration experiments are theoretically designed and experimentally conducted to obtain data that can be used to assess the kinetics of chemical release. In this work, a parameter estimation approach was used to review and to determine the mass transfer partition and diffusion coefficients governing the migration process of eight antioxidants from poly(lactic acid), PLA, based films into water/ethanol solutions at temperatures between 20 and 50°C. Scaled sensitivity coefficients were calculated to assess simultaneously estimation of a number of mass transfer parameters. An optimal experimental design approach was performed to show the importance of properly designing a migration experiment. Additional parameters also provide better insights on migration of the antioxidants. For example, the partition coefficients could be better estimated using data from the early part of the experiment instead at the end. Experiments could be conducted for shorter periods of time saving time and resources. Diffusion coefficients of the eight antioxidants from PLA films were between 0.2 and 19×10-14m2/s at ~40°C. The use of parameter estimation approach provided additional and useful insights about the migration of antioxidants from PLA films.
    Matched MeSH terms: Research Design
  9. Samer Al-Battawi, Yu Bin Ho, Mohd Talib Latif, Vivien How, Karuppiah Thilakavathy
    MyJurnal
    Polycyclic aromatic hydrocarbons (PAHs) are ubiquitous pollutants with toxic effects and adverse health impacts on general population. Several methods of extraction had been applied to extract PAHs from human blood samples such as solid phase extraction (SPE). The SPE represents one of the most common techniques for extraction and clean-up procedures as it needs low quantity of solvents with less manual efforts. Similarly, various analytical instruments like gas chromatography coupled to mass spectrometry (GC-MS) was used to measure the PAHs levels. Gas chromatog- raphy is a simple, fast, and very efficient method for solvents and small organic molecules. This review provides an overview of the measured concentrations of PAHs in human blood samples through the application of SPE and GC- MS during the last ten years. While these studies used various solvents, their application of SPE method and GC-MS revealed rewarding results about the determination of PAHs levels in the human samples.
    Matched MeSH terms: Research Design
  10. Said HM, Bakar WZ, Farea M, Husein A
    J Conserv Dent, 2012 Jul;15(3):257-60.
    PMID: 22876014 DOI: 10.4103/0972-0707.97952
    The aim of this in vitro study was to evaluate the sealing ability of an endodontic sealer following different techniques of its placement.
    Matched MeSH terms: Research Design
  11. Safitri E, Humaira H, Murniana M, Nazaruddin N, Iqhrammullah M, Md Sani ND, et al.
    Polymers (Basel), 2021 Apr 14;13(8).
    PMID: 33919956 DOI: 10.3390/polym13081276
    A simple optical pH sensor based on immobilization, Dioscorea alata L. anthocyanin methanol extract, onto a pectin-chitosan polyelectrolyte complex (pectin-chitosan PEC), has been successfully fabricated. The optical pH sensor was manufactured as a membrane made of pectin-chitosan PEC and the extracted anthocyanin. This sensor has the highest sensitivity of anthocyanin content at 0.025 mg/L in phosphate buffer and 0.0375 mg/L in citrate buffer. It also has good reproducibility with a relative standard deviation (%RSD) of 7.7%, and gives a stable response at time values greater than 5 min from exposure in a buffer solution, and the sensor can be utilized within five days from its synthesis. This optical pH sensor has been employed to determine saliva pH of people of different ages and showed no significant difference when compared to a potentiometric method.
    Matched MeSH terms: Research Design
  12. Sadia F, Mahmud I, Dhar E, Jahan N, Hossain SS, Zaidi Satter AKM
    Data Brief, 2019 Apr;23:103741.
    PMID: 31372407 DOI: 10.1016/j.dib.2019.103741
    The article identifies the relationship among different agile software development approaches such as response extensiveness, response efficiency, team autonomy, team diversity, and software functionality that software teams face difficult challenges in associating and achieving the right balance between the two agility dimensions. This research strategy, in terms of quantity, is descriptive and correlational. Statistical analysis of the data was carried out, using SmartPLS 3.0. Statistical population, consist of employees of software industries in Bangladesh, who were engaged in 2017 and their total number is about 100 people. The data show that the response extensiveness, response efficiency, team autonomy, team diversity, and software functionality have impact on software development agility and software development performance.
    Matched MeSH terms: Research Design
  13. Sadaghiani MS, Arami-Niya A, Zhang D, Tsuji T, Tanaka Y, Seiki Y, et al.
    J Hazard Mater, 2021 04 05;407:124781.
    PMID: 33412363 DOI: 10.1016/j.jhazmat.2020.124781
    Given the safety issues associated with flammability characteristics of alternative environmentally-friendly refrigerants, it is vital to establish measurement systems to accurately analyse the flammability of these mildly flammable refrigerants. In this study, we used a customised Hartmann bomb analogue to measure the minimum ignition energy (MIE) and laminar burning velocity (BV) for refrigerant/air mixtures of pure ammonia (R717), R32, R1234yf and mixtures of R32 and R1234yf with non-flammable refrigerants of R134a, R125 and carbon dioxide (R744). The MIEs of R717, R32, and R1234yf were measured at an ambient temperature of 24 °C to be (18.0 ± 1.4), (8.0 ± 1.5) and (510 ± 130) mJ at equivalence ratios of 0.9, 1.27 and 1.33, respectively. Adding the non-flammable refrigerants R134a, R125 and R744 along with R32 at volumetric concentrations of 5% each to R1234yf reduced the latter compound's flammability and increased its MIE by one order of magnitude. The laminar burning velocities of pure R717 and R32 were measured at an equivalence ratio of 1.1 using the flat flame method and found to be 8.4 and 7.4 cm/s, respectively. Adding 5% R1234yf to R32 decreased the laminar burning velocity by 11%, while a further 5% addition of R1234yf resulted in a decrease of over 30% in the laminar burning velocity.
    Matched MeSH terms: Research Design
  14. Saat M, Sirisinghe RG, Singh R, Tochihara Y
    Eur J Appl Physiol, 2005 Oct;95(4):313-20.
    PMID: 16151840
    Sixteen male students exercised for 14 days (1 h/day) in the heat for heat acclimation (HA). During deacclimation (DA) one group exercised in the cold (EXG, n=8) for 60 min/day (morning) and was exposed to the cold for another hour (afternoon) for 14 days. The other group was exposed to the cold (EPG, n=8) for 1 h each in the morning and afternoon (Ta: 18.0 degrees C, RH: 58%) over the same period. All returned to exercise in the heat for reacclimation (RA) for 10 days. Subjects were tested on days 1, 16, 21, 32, 36 and 44 on a bicycle ergometer for 60 min at 60% of VO(2max) in the heat (Ta: 31.1 degrees C, RH: 70%). Rectal temperature (T (re)) and heart rate (HR) at 40 min of exercise were used to determine the decay/gain of HA, which was calculated using the formula described by Pandolf et al. (Ergonomics, 20:399-408, 1977). After HA (day 16) T (re) and HR decreased significantly. During DA, EXG showed decay in T (re) of 24 and 35% and HR of 29 and 35% on days 21 and 32, respectively. For EPG the corresponding decay was of 2 and 9% for T (re) and 17 and 17% for HR. After 10 days of RA, EXG showed gains of 11% in T (re) and 12% in HR, while EPG showed gains of 47% in T (re) and 38% in HR. In conclusion, EXG had greater decay during DA and lower gains in RA compared to EPG. However, the differences between groups were significant only for T (re) after 4 days of DA.
    Matched MeSH terms: Research Design
  15. Rosuzeita F, Che Rabiaah M, Rohani I, Mohd Shukri O
    Malays J Med Sci, 2018 Feb;25(1):53-66.
    PMID: 29599635 MyJurnal DOI: 10.21315/mjms2018.25.1.7
    Background: In Malaysia, the rates of mothers practising breastfeeding exclusively among babies at six months of age still do not achieve the Global Nutritional Targets 2025 which is 50%.

    Objective: To determine the effectiveness of breastfeeding intervention in improving breastfeeding outcomes.

    Method: A quasi-experimental design was used involving a purposive sample of 96 primigravidas (intervention group (IG) = 48, control group (CG) = 48) recruited at Hospital USM. Data were collected using the Breastfeeding Assessment Questionnaire. Mothers in IG received the current usual care and two hours of an additional education programme on breastfeeding, breastfeeding booklet, notes from the module, and postnatal breastfeeding support in the first week of postpartum. Mothers in CG received the current usual care only. The mothers were assessed on the first and sixth week and then the fourth and sixth month of postpartum.

    Results: The results indicated that there was a statistically significant difference between the groups on the fourth month postpartum (X2= 5.671,P= 0.017) in practicing full breastfeeding. The breastfeeding duration rates of the IG were longer than those of the CG. However, the results showed only two follow-up weeks that were significant (week 6,X2= 5.414,P= 0.020, month 4,X2= 7.515,P= 0.006). There was a statistically significant difference between IG and CG as determined by one-way ANCOVA on the breastfeeding duration after controlling age and occupation, F (3, 82) = 6.7,P= 0.011. The test revealed that the breastfeeding duration among IG was significantly higher (20.80 ± 6.31) compared to CG (16.98 ± 8.97).

    Conclusions: Breastfeeding intervention can effectively increase breastfeeding duration and exclusivity outcomes among primiparous mothers.

    Matched MeSH terms: Research Design
  16. Rosnah, S., Wan Aishah, W.N.
    MyJurnal
    Introduction: Pre-pregnancy care is an important strategy in prevention of adverse maternal and fetal health as well as continuity of good child care. In multi-ethnicity country such as Malaysia there are many cultural, religion and beliefs related to certain life stages.
    Methodology: A cross sectional study was conducted among the Indian ethnic group to assess the prevalence and factors associated with pre-pregnancy care. A study was conducted in Taman Manickavasangam Hulu Langat Selangor among the age group of 18-45 year old women.
    Result: There were 90 respondents participated in self administered questionnaires. There were 65 respondents (72.2%) married, 24 (26.7%) single and one widow (1.1%). Using a scoring method of analysis (high and low) showed that 55 (61.1%) have high score in knowledge on pre-pregnancy care. The prevalence of pre-pregnancy care practice showed that 63 (70%) scored as high practice. Using correlation analysis showed that there was a significant association between the practice score and increasing age (P=0.03). However, only history of previous pregnancy showed a significant association with the pre-pregnancy care practice and no association found between the practice and knowledge score.
    Conclusion: Prepregnancy care helps in screening risk factors of women before conception. This will help in prevention of adverse effect on maternal and foetal. Giving awareness on the importance of having prepregnancy care screening may help women to continue practicing good antenatal care.
    Matched MeSH terms: Research Design
  17. Ritter P, Duray GZ, Zhang S, Narasimhan C, Soejima K, Omar R, et al.
    Europace, 2015 May;17(5):807-13.
    PMID: 25855677 DOI: 10.1093/europace/euv026
    Recent advances in miniaturization technologies and battery chemistries have made it possible to develop a pacemaker small enough to implant within the heart while still aiming to provide similar battery longevity to conventional pacemakers. The Micra Transcatheter Pacing System is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. The pacemaker is implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and insertion of a pacing lead, thereby potentially avoiding some of the complications associated with traditional pacing systems.
    Matched MeSH terms: Research Design*
  18. Rigutto-Farebrother J, Ahles S, Cade J, Murphy KJ, Plat J, Schwingshackl L, et al.
    Eur J Nutr, 2023 Aug;62(5):2319-2332.
    PMID: 37099211 DOI: 10.1007/s00394-023-03137-5
    PURPOSE: Reporting guidelines facilitate quality and completeness in research reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement is widely applied to dietary and nutrition trials but has no extension specific to nutrition. Evidence suggests poor reporting in nutrition research. The Federation of European Nutrition Societies led an initiative to make recommendations for a nutrition extension to the CONSORT statement towards a more robust reporting of the evidence base.

    METHODS: An international working group was formed of nutrition researchers from 14 institutions in 12 different countries and on five continents. Using meetings over a period of one year, we interrogated the CONSORT statement specifically for its application to report nutrition trials.

    RESULTS: We provide a total of 28 new nutrition-specific recommendations or emphasised recommendations for the reporting of the introduction (three), methods (twelve), results (five) and discussion (eight). We also added two additional recommendations that were not allocated under the standard CONSORT headings.

    CONCLUSION: We identify a need to provide guidance in addition to CONSORT to improve the quality and consistency of the reporting and propose key considerations for further development of formal guidelines for the reporting of nutrition trials. Readers are encouraged to engage in this process, provide comments and conduct specific studies to inform further work on the development of reporting guidelines for nutrition trials.

    Matched MeSH terms: Research Design*
  19. Rigg JR, Jamrozik K, Myles PS, Silbert B, Peyton P, Parsons RW, et al.
    Control Clin Trials, 2000 Jun;21(3):244-56.
    PMID: 10822122
    The Multicenter Australian Study of Epidural Anesthesia and Analgesia in Major Surgery (The MASTER Trial) was designed to evaluate the possible benefit of epidural block in improving outcome in high-risk patients. The trial began in 1995 and is scheduled to reach the planned sample size of 900 during 2001. This paper describes the trial design and presents data comparing 455 patients randomized in 21 institutions in Australia, Hong Kong, and Malaysia, with 237 patients from the same hospitals who were eligible but not randomized. Nine categories of high-risk patients were defined as entry criteria for the trial. Protocols for ethical review, informed consent, randomization, clinical anesthesia and analgesia, and perioperative management were determined following extensive consultation with anesthesiologists throughout Australia. Clinical and research information was collected in participating hospitals by research staff who may not have been blind to allocation. Decisions about the presence or absence of endpoints were made primarily by a computer algorithm, supplemented by blinded clinical experts. Without unblinding the trial, comparison of eligibility criteria and incidence of endpoints between randomized and nonrandomized patients showed only small differences. We conclude that there is no strong evidence of important demographic or clinical differences between randomized and nonrandomized patients eligible for the MASTER Trial. Thus, the trial results are likely to be broadly generalizable.
    Matched MeSH terms: Research Design*
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