Good Study Quality Research Articles

Immunogenicity and safety of Cervarix HPV-16/18 AS04-adjuvant vaccine against HPV induced cervical cancer in women (15+ years)

Background: The incidence of cervical cancer has decreased by over 50% from the mid-1970s to the mid-2000s. This is due in part to an increase in screening, which can identify cervical changes before they turn cancerous. Decreasing incidence rates in young women may be due to the use of the HPV vaccine. There are currently three types of HPV vaccines on the market: bivalent, quadrivalent and nine-valent HPV vaccines. These are administered in three-doses to both sexes from age 15 upwards to prevent HPV infection. Many medical systems support the vaccination of teenage girls and boys with HPV vaccines during their secondary school years in order to reduce the incidence of HPV-related cervical cancer in women. Despite the discovery of the link between HPV and cervical cancer in 1985, the beginning of vaccine production in 2002, and promotion of screening procedures since the 1960’s, cervical cancer is still the fourth most common cancer in women worldwide today. Objective: This review aims to analyse the immunogenicity and safety of Cervarix®, also known as HPV-16/18 AS04-adjuvant vaccine, in women (15+ years) against cervical cancer. Methods: The literature review analysing the effectiveness and immunogenicity of HPV-16/18 AS04-ADJUVANTED Vaccine against cervical cancer, was conducted by using two main databases: EbescoHost (Medline and Academic Search) and PubMed. Advanced searches were conducted using specific key words, various filters and Boolean operators ‘OR’ and ‘AND’ to find the most suitable literature. This process resulted in over 100 results. From this cohort, clinical trials were selected in accordance with the specific inclusion and exclusion criteria determined for the review. After duplicates from both databases were removed, the studies were assessed in order or title, population and objective relevance, and the top 10 most relevant articles to the title of the literature review, were selected for the literature review. Results: The 10 clinical trials selected all obtained a minimum of 10 out of the 11 CASP requirements indicating good study quality. All 10 studies were successful in proving the immunogenicity and safety of the HPV-16/18 AS04-adjuvant vaccine in protecting women 15+ (15-55 years) from developing HPV-induced cervical cancer [15, 16, 17, 18, 19, 20, 21, 22, 23, 24]. This confers that vaccination against HPV-16/18 virus proves to be effective in preventing HPV-induced CIN and cervical cancer and is a safe to administer vaccine.

Virtual reality exercise programs ameliorate frailty and fall risks in older adults: A meta-analysis.

Virtual reality (VR) technology constitutes a promising rehabilitation strategy, but its effect on frailty in older adults remains inconclusive. This study examined the effects of interactive VR training programs on lower-limb muscle strength, walking speed, balance, and fall risks in older adults with frailty. Various electronic databases comprising PubMed, the Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, Embase, the Chinese Electronic Periodical Service, the Chinese National Knowledge Infrastructure, and gray literature were searched from their inception through December 31, 2022 for relevant studies. Randomized controlled trials that examined the effects of interactive VR training programs on lower-limb muscle strength, balance, walking speed, and fall risks as measured by validated scales or methods. in older adults aged 65 years and older with frailty were included. A random-effects model was employed to examine the overall effect size, and the trim-and-fill method was adopted to examine publication bias. For those studies that defined frailty using fall risks, substantial evidence demonstrated that interactive VR training interventions increased lower-limb muscle strength (Hedges' g = 0.35, p = 0.015), walking speed (Hedges' g = 0.29, p = 0.003), balance (Hedges' g = 0.62, p = 0.011), and fall risks (Hedges' g = -0.61, p < 0.001). Studies that defined frailty in accordance with the Fried frailty phenotype criteria indicated that interactive VR training interventions only increased walking speed (Hedges' g = 0.28, p = 0.023) and balance (Hedges' g = 0.27, p = 0.049). Interactive VR training programs may benefit older adults with frailty with respect to walking speed and balance. More studies with good study quality are required to validate the effects of interactive VR exercise training on these frailty-related parameters in older adults.

IMPLEMENTATION THEMATIC STUDENT STUDY SERVICE FACULTY OF TEACHER TRAINING AND EDUCATION UNIVERSITAS PASUNDAN DURING COVID 19 PANDEMIC

The Covid-19 pandemic is still something that worries everyone. The Covid-19 outbreak has made everyone cannot carry out activities both in the fields of education, society, and Village government. In Indonesia itself, there have been large restrictions on activities namely PSBB and PPKM. This research activity was carried out during PPKM conditions. The students try continue to serve in the fields of education, community, and village government. College student What is done in terms of education is to provide online learning assistance and activities other. While in the social community service is carried out by counseling or work devotion. And the last service in the field of village government is helping the village in run village programs. By providing learning assistance, students can produce good study quality. While in community service, realizing how to live live healthy during the current pandemic. The village government is helped by the service that is done by assisting in carrying out village programs. The thematic student study service work program that has been planned can run well even though there are some activities that have been changed due to several obstacles in the field. Forming students to be more mature in responding to existing problems and being able to understand how to live in society, besides that they can form independent personalities and are responsible for the tasks that must be carried out. Students gain new knowledge that is not found in the material in class that is useful later for use in everyday life. The local government and the community were enthusiastic and very helpful in the implementation of the Thematic Community Service Program. This thematic student study service activity is a student service effort to the community.

Risk factors for asthma exacerbations during pregnancy: a systematic review and meta-analysis.

Conflicting literature exists regarding the risk factors for exacerbations among pregnant women with asthma. This systematic review and meta-analysis aimed to determine risk factors for asthma exacerbations during pregnancy. Electronic databases were searched for the following terms: (asthma or wheeze) and (pregnan* or perinat* or obstet*) and (exacerb* or flare up or morbidit* or attack*).All studies published between 2000 and 24 August 2021 were considered for inclusion if they reported at least one potential risk factor of asthma exacerbations in pregnant women with asthma. Of the 3337 references considered, 35 publications involving 429 583 pregnant women with asthma were included. Meta-analyses were conducted to determine mean difference in risk factor between exacerbation groups, or the relative risks of exacerbation with certain risk factors. Good study quality was found through the Newcastle-Ottawa Scale (median score 8, interquartile range 7-9). Increased maternal age (mean difference 0.62, 95% CI 0.11-1.13), obesity (relative risk 1.25, 95% CI 1.15-1.37), smoking (relative risk 1.35, 95% CI 1.04-1.75), black ethnicity (relative risk 1.62, 95% CI 1.52-1.73), multiparity (relative risk 1.31, 95% CI 1.01-1.68), depression/anxiety (relative risk 1.42, 95% CI 1.27-1.59), moderate-severe asthma (relative risk 3.44, 95% CI 2.03-5.83, versus mild) and severe asthma (relative risk 2.70, 95% CI 1.85-3.95, versus mild-moderate) were associated with an increased risk of asthma exacerbations during pregnancy. Future interventions aimed at reducing exacerbations in pregnancy could address the modifiable factors, such as smoking and depression/anxiety, and introduce more regular monitoring for those with nonmodifiable risk factors such as obesity and more severe asthma.

Polymorphisms Contributing to Calcium Status: A Systematic Review.

This systematic review assessed genotypes and changes in calcium homeostasis. A literature search was performed in EMBASE, Medline and CENTRAL on 7 August 2020 identifying 1012 references. Studies were included with any human population related to the topic of interest, and genetic variations in genes related to calcium metabolism were considered. Two reviewers independently screened references, extracted relevant data and assessed study quality using the Q-Genie tool. Forty-one studies investigating Single Nucleotide Polymorphisms (SNPs) in relation to calcium status were identified. Almost half of the included studies were of good study quality according to the Q-Genie tool. Seventeen studies were cross-sectional, 14 case-control, seven association and three were Mendelian randomization studies. Included studies were conducted in over 18 countries. Participants were mainly adults, while six studies included children and adolescents. Ethnicity was described in 31 studies and half of these included Caucasian participants. Twenty-six independent studies examined the association between calcium and polymorphism in the calcium-sensing receptor (CASR) gene. Five studies assessed the association between polymorphisms of the Vitamin D receptor (VDR) gene and changes in calcium levels or renal excretion. The remaining ten studies investigated calcium homeostasis and other gene polymorphisms such as the CYP24A1 SNP or CLDN14. This study identified several CASR, VDR and other gene SNPs associated with calcium status. However, to provide evidence to guide dietary recommendations, further research is needed to explore the association between common polymorphisms and calcium requirements.

Spexin status in relation to obesity and its related comorbidities: a systematic review.

Spexin, a novel 14-amino acid peptide, has multiple physiological functions. The purpose of this paper was to systematically evaluate the current literature on the role of Spexin neuropeptide in obesity and its related comorbidities, food intake and overall metabolic status in human, animal and in vitro studies. Multiple databases, including PubMed, EMBASE, ProQuest, Scopus and Google Scholar were searched for English-language papers published since inception until December 2018, that investigated Spexin levels in relation to chronic metabolic diseases, overall metabolism control and feeding-related behaviors.The quality of the included observational studies was assessed by a version of the Newcastle Ottawa Scale (NOS) designed for non-randomized studies and SYRCLE's assessment tool for animal models. Out of 224 records screened, search results led to a total of 24 related studies (12 human studies (ten cross-sectional studies, one cohort study, and one longitudinal study) and 12 studies in either animals or in vitro).Nine of the included cross-sectional studies and one Longitudinal study had moderate to good study quality, and one cross-sectional and one cohort study had high-quality (or low risk of bias). It appears that Spexin has a positive impact on overall metabolic status. As a novel appetite-regulating peptide, Spexin can act as an anorexigenic factor. Information about Spexin is very limited, and well-designed randomized controlled clinical trials are warranted for replicating, validating, and extending the current findings. CRD42018117198).

The Effects of Mind-Body Exercise on Cognitive Performance in Elderly: A Systematic Review and Meta-Analysis.

Background: As the situation of cognitive aging is getting worse, preventing or treating cognitive decline through effective strategies is highly important. This systematic review aims to investigate whether mind-body exercise is an effective approach for treating cognition decline. Methods: Searches for the potential studies were performed on the eight electronic databases (MEDLINE, Scopus, Web of Science, SPORTDiscus, CINAHL, PsycArtilces, CNKI, and Wanfang). Randomized controlled trials (RCTs) examining the effect of mind-body exercise on cognitive performance in older adults were included. Data were extracted and effect sizes were pooled with 95% confidence intervals (95% CI) using random-effects models. The Physiotherapy Evidence Database Scale was employed to examine the study quality. Results: Nineteen RCTs including 2539 elders (67.3% female) with fair to good study quality were identified. Mind-body exercise, relative to control intervention, showed significant benefits on cognitive performance, global cognition (Hedges’g = 0.23), executive functions (Hedges’g = 0.25 to 0.65), learning and memory (Hedges’g = 0.37 to 0.49), and language (Hedges’g = 0.35). In addition, no significant adverse events were reported. Conclusion: Mind-body exercise may be a safe and effective intervention for enhancing cognitive function among people aged 60 years or older. Further research evidence is still needed to make a more conclusive statement.

Factors that predict remission of infant atopic dermatitis: a systematic review.

The individual prognosis of infants with atopic dermatitis (AD) is important for parents, healthcare professionals, and society. The aim of this study was to investigate predictors for remission of infant AD until school age. A systematic review was carried out of clinical and epidemiological studies investigating the effect of filaggrin gene (FLG) loss-of-function mutations, sex, exposure to pets, topical anti-inflammatory treatment, disease severity, and atopic sensitization during infancy on complete remission of infant-onset AD until 6-7 years of age. Systematic electronic searches until September 2013, data abstraction, and study quality assessment (Newcastle-Ottawa Scale) were performed. From 3,316 abstracts identified, 2 studies of good study quality were included. Parental allergies and sex did not significantly affect remission. For non-remission of AD, the included articles reported an association with any atopic sensitization at 2 years old (adjusted odds ratio [aOR] 2.76; 95% confidence interval (CI) 1.29-5.91), frequent scratching with early AD (aOR 5.86; 95% CI 3.04-11.29), objective severity score at 2 years old (aOR 1.10; 95% CI 1.07-1.14), and exposure to pets (cat OR 2.33; 95% CI 0.85-6.38). It is largely unknown which factors predict remission of infant AD. This is a highly relevant research gap that hinders patient information on the prognosis of infant-onset AD.

Physical Activity and Asthma: A Systematic Review and Meta-Analysis

IntroductionThis review aims to give an overview of available published evidence concerning the association between physical activity and asthma in children, adolescents and adults.MethodsWe included all original articles in which both physical activity and asthma were assessed in case-control, cross-sectional or longitudinal (cohort) studies. Excluded were studies concerning physical fitness, studies in athletes, therapeutic or rehabilitation intervention studies such as physical training or exercise in asthma patients. Methodological quality of the included articles was assessed according to the Newcastle-Ottawa Scale (NOS).ResultsA literature search was performed until June 2011 and resulted in 6,951 publications derived from PubMed and 1,978 publications from EMBASE. In total, 39 studies met the inclusion criteria: 5 longitudinal studies (total number of subjects n = 85,117) with physical activity at baseline as exposure, and asthma incidence as outcome. Thirty-four cross-sectional studies (n = 661,222) were included. Pooling of the longitudinal studies showed that subjects with higher physical activity levels had lower incidence of asthma (odds ratio 0.88 (95% CI: 0.77–1.01)). When restricting pooling to the 4 prospective studies with moderate to good study quality (defined as NOS≥5) the pooled odds ratio only changed slightly (0.87 (95% CI: 0.77–0.99)). In the cross-sectional studies, due to large clinical variability and heterogeneity, further statistical analysis was not possible.ConclusionsThe available evidence indicates that physical activity is a possible protective factor against asthma development. The heterogeneity suggests that possible relevant effects remain hidden in critical age periods, sex differences, or extremes of levels of physical activity (e.g. sedentary). Future longitudinal studies should address these issues.

UNIVERSITETINIŲ STUDIJŲ PROBLEMATIKA STUDENTŲ POŽIŪRIU: PRIVALUMAI IR TRŪKUMAI

The problems of higher university education are not only urgent but, it can be asserted, that due to many reasons they are getting sharper. The dynamism of labour market and always changing society require flexible, innovative and creative lifelong learning possibilities; higher education institutions do not limit themselves to primary preparation of specialists, the possibilities ought to be found for the development of specialists and professionals, for specialisation change, for the development of personal abilities and for expansion of high level professional competences. Continuing education at universities is becoming more and more urgent in the Strategic priorities of European education. It is necessary to seek for high scientific activity and high study level and for the results acknowledged on an international level. On the other hand, the competition among universities is evidently getting stronger both on national and international levels. Very often blind orientation only to a consumer (a student), only to service provision to him, make the quality of studies and at the same time the quality of acquirable education worse. The solution of any problem requires reliable and adequate information. The researches, regarding university students’ opinions on higher education problems do not lose their urgency. On the contrary, in this way rather objective primary information about processes taking place in this sector is obtained. The empiric research (N=544), carried out in January-February 2012, showed that student opinions on higher university education are controversial, in fact. Having carried out content analysis on the respondents’ expressed positions, considerable advantages and disadvantages of university studies were discerned. Education acquisition and good study quality are pointed out as the most important university education advantages. These positions have relatively the biggest weight among all categories defining the advantages. Self-realisation and career possibilities occupy the middle position in the advantage category scale. Their weight fluctuates in the interval of 10-20 percent. Communication possibilities and study management are not regarded as considerable advantages. It has been stated, that a considerable shortage of university education is study quality. One third of the respondents gave the biggest weight to that category. It can be asserted, that study quality and conditions for practical ability formation in the study process worry the respondents most. Evaluating study quality, the respondents most often express dissatisfaction with the overloading of the study content: a lot of insignificant subjects must be studied, too many unnecessary lectures, inexpedient lectures, poor lectures, worthless; a lot of unnecessary study programmes and so on. A part of respondents accentuate dissatisfaction with the teachers’ work: poor competence of some teachers, unfair student evaluation, the requirements raised are too high. It can be asserted, that university studies are more often understood as experience process, during which theoretical and practical knowledge are integrated and on this basis professional experience is acquired and professionalism is mastered. Key words: survey, empiric research, qualitative analysis, university education.

Diagnostic precision of magnetic resonance imaging for preoperative prediction of the circumferential margin involvement in patients with rectal cancer

Circumferential margin involvement (CMI) is an important prognostic indicator for patients with rectal cancer. This meta-analysis aims at evaluating the diagnostic precision of magnetic resonance imaging (MRI) for the preoperative evaluation of CMI in patients with rectal cancer. Quantitative meta-analysis was performed comparing MRI against histology after total mesorectal excision. Sensitivity, specificity and diagnostic odds ratio (DOR) were calculated for each study. Summary receiver operating characteristic (SROC) curves and subgroup analysis were undertaken. Study quality and heterogeneity were evaluated. Meta-regression meta-analysis was used to evaluate the significance of the difference in relative DORs. Nine studies evaluating 529 patients were included. Pooled results showed an overall sensitivity and specificity for MRI detecting CMI preoperatively of 94% and 85% respectively. The SROC analysis demonstrated an overall weighted area under the curve (AUC) of 0.92 (DOR 57.21, 95% CI 18.21-179.77), without significant heterogeneity between the studies (Q-value 14.66, P = 0.06). Good study quality further increased the sensitivity and specificity of MRI. The use of a 1.5 Tesla coil, a phased array coil and the inclusion of two interpreters also resulted in high preoperative diagnostic precision. Meta-regression meta-analysis showed a significant difference in the DOR for studies published in or since 2003 (P = 0.019). Magnetic resonance imaging can accurately predict CMI preoperatively for rectal cancer in single units and this is reproducible across different centres. This strategy has important implications for selection of patients for adjuvant therapy prior to surgery.

Beware of Big Gifts in Small Studies

In the current issue of JPEN, Tiengou and colleagues present a small randomized study comparing a standard isotonic tube-feeding formula vs a predigested formula for jejunal feeding of acute pancreatitis. Accepting a current mantra that many patients with acute pancreatitis should be fed jejunally, the authors sought to answer the question, what type of formula should be infused into the jejunal tube, a predigested (semi-elemental) formula or an intact formula requiring digestion (polymeric)? Reporting on 30 patients who successfully completed the study, the authors suggest that, while both formulas were well and equally tolerated, the predigested formula ensured a more favorable clinical course, as evidenced by a shorter length of hospital stay and less weight loss. How robust are these conclusions, and should we now feed every pancreatitic patient a jejunal predigested formula? I would like to approach these questions with a 3-pronged focus. How does consideration of study methodology contribute to our understanding of the strength of the conclusions? What are some questions that arise from the study? Finally, is the question asked even appropriate; where are we with respect to certainty that jejunal feeding is appropriate for acute pancreatitis? Why does study quality matter? Is not a randomized controlled trial sufficient to draw conclusions? Quality matters because it has been demonstrated by those who ponder study quality that lower-quality studies tend to demonstrate more positive outcomes; differences between approaches are less likely to be pronounced in high-quality studies. What makes a study “high quality?” A variety of measures have been proposed. A “Jadad score” was developed to assess bias in clinical trials and is often used to assess study quality. This system asks 3 questions: (1) was the study described as randomized; (2) was the study described as double blinded; and (3) are all participants in the trial included in the final analysis? Additional points are awarded in questions 1 and 2 with respect to appropriateness of randomization and blinding. High-quality studies have a maximum score of 5, and low-quality studies score 1 or 2. How would the present study score? Randomization appears to have occurred and to have used appropriate methodology (stratification for illness severity, centralization by an outside source, using sealed envelopes). Score 2 points. The study was said to be single blinded, but this presumably was the patient who did not know which formula he or she received. Although the authors suggest that the “clinician who decided resumption of oral feeding and discharge was not the doctor responsible for the nutrition prescription,” this would imply that the feeding formula was known to clinic staff and that unintended bias could have been introduced into the evaluation. No points given. Finally, of 36 patients entered into the protocol, full data are available on only 30. The authors give data on length of stay, including all 36 as an afterthought, but full information is not available. Give 0 points for full follow-up, resulting in a final score of 2, low quality. Over the years, I have developed my own quality checklist which I teach our gastroenterology fellows and medical residents, the list being a compilation of reading points acquired or lifted from various colleagues and the literature. Starting with a randomized controlled clinical trial, the first question that I ask of the study is what is the question that the study asks? In order to answer a question, a question, or more specifically, a hypothesis needs to be formulated. Even more specifically, the hypothesis needs to be measurable and defined. The hypothesis cannot be a fishing expedition: what might we find if we administer a predigested formula vs a standard diet; the hypothesis must state what single result do we expect: length of stay will be shortened by 3 days, death rate will decrease from 30%–10%, infectious complications (defined) will decrease from 20%–10%, etc. Why do I look for this? Because the study’s primary statistics depend on it. Because with this estimate of an effect size, a power calculation can be performed to determine a sample size: how many subjects are needed in each group to “prove” to a reasonable extent the hypothesis. So effect size, power calculation, sample size determination—all important for good study quality. If these are present, a statistical difference is most likely meaningful. If not, the difference could have occurred by Received for publication September 28, 2005. Accepted for publication October 11, 2005. Correspondence: Timothy O. Lipman, MD, Chief, GI-HepatologyNutrition Section, Department of Veterans Affairs Medical Center, 50 Irving St NW, Washington, DC 20422. Electronic mail may be sent to timothy.lipman@med.va.gov. 0148-6071/06/3001-0066$03.00/0 Vol. 30, No. 1 JOURNAL OF PARENTERAL AND ENTERAL NUTRITION Printed in U.S.A. Copyright © 2006 by the American Society for Parenteral and Enteral Nutrition