scholarly journals Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022233 ◽  
Author(s):  
Amanda Jane Blatch-Jones ◽  
Wei Pek ◽  
Emma Kirkpatrick ◽  
Martin Ashton-Key
Keyword(s):  
Feasibility Study ◽  
Randomised Controlled Trials ◽  
Feasibility Studies ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Group 2 ◽  
Randomised Controlled ◽  
Pilot Feasibility Study ◽  
Group 1

ObjectivesTo assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.Study designCross-sectional study.SettingBoth groups included NIHR HTA programme funded studies in the period 1 January 2010–31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.Main outcome measuresThe proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of ‘HTA funded’ trials which used internal and external pilot and feasibility studies to inform the design of the trial.ResultsGroup 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed weretesting recruitment(100% in both groups),feasibility(83%, 100%) andsuggestions for further study/investigation(83%, 100%). Group 2 identified 161 ‘HTA funded’ applications: 59 cited an external pilot/feasibility study wheretesting recruitment(50%, 73%) andfeasibility(42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study wheretesting recruitment(93%, 100%) andfeasibility(44%, 92%) were the most common study elements reported.Conclusions‘HTA funded’ research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.

scholarly journals Is mercury in Tibetan Medicine toxic? Clinical, neurocognitive and biochemical results of an initial cross-sectional study

2016 ◽  
Vol 242 (3) ◽  
pp. 316-332 ◽  
Author(s):  
Sarah Sallon ◽  
Yahav Dory ◽  
Yazeed Barghouthy ◽  
Tsewang Tamdin ◽  
Rigzin Sangmo ◽  
...  
Keyword(s):  
Cross Sectional Study ◽  
Tibetan Medicine ◽  
Atomic Fluorescence Spectrometry ◽  
Mercury Toxicity ◽  
Sectional Study ◽  
Cross Sectional ◽  
Treatment Groups ◽  
Confounding Variables ◽  
Group 2 ◽  
Group 1

Mercury an important therapeutic substance in Tibetan Medicine undergoes complex “detoxification” prior to inclusion in multi-ingredient formulas. In an initial cross-sectional study, patients taking Tibetan Medicine for various conditions were evaluated for mercury toxicity. Two groups were identified: Group 1, patients taking “ Tsothel” the most important detoxified mercury preparation and Group 2, patients taking other mercury preparations or mercury free Tibetan Medicine. Atomic fluorescence spectrometry of Tibetan Medicine showed mercury consumption 130 µg/kg/day (Group 1) and 30 µg/kg/day (Group 2) ( P ≤ 0.001), levels above EPA (RfDs) suggested threshold (0.3 µg/kg /day) for oral chronic exposure. Mean duration of Tibetan Medicine treatment was 9 ± 17 months (range 3–116) (Group 1) and 5 ± 1.96 months (range 1–114) (Group 2) (NS) with cumulative days of mercury containing Tibetan Medicine, 764 days ± 1214 (range 135–7330) vs. 103 days ± 111 (range 0–426), respectively ( P ≤ 0.001). Comparison of treatment groups with healthy referents (Group 3) not taking Tibetan Medicine showed no significant differences in prevalence of 23 non-specific symptoms of mercury toxicity, abnormal neurological, cardiovascular and dental findings and no correlation with mercury exposure variables; consumption, cumulative treatment days, blood/ urine Hg. Liver and renal function tests in treatment groups were not significantly increased compared to referents, with mean urine Beta2 Microglobulin within the normal range and not significantly associated with Hg exposure variables after correcting for confounding variables. Neurocognitive testing showed no significant intergroup differences for Wechsler Memory Scale, Grooved Pegboard, Visual Retention, but Group1 scores were better for Mini-Mental, Brief Word Learning, Verbal Fluency after correcting for confounding variables. These results suggest mercury containing Tibetan Medicine does not have appreciable adverse effects and may exert a possible beneficial effect on neurocognitive function. Since evidence of mercury as a toxic heavy metal, however, is well known, further analysis of literature on mercury use in other Asian traditional systems is highly suggested prior to further studies.

scholarly journals Soluble Inter-Cellular Adhesion Molecule-1 in Urban Asian North Indians: Relationships with Anthropometric and Metabolic Covariates

2002 ◽  
Vol 18 (3) ◽  
pp. 111-120 ◽  
Author(s):  
Astha Sethi ◽  
Anoop Misra ◽  
Ravindra Mohan Pandey ◽  
Kalpana Luthra ◽  
J. Rama Devi ◽  
...  
Keyword(s):  
Risk Factor ◽  
Adhesion Molecule ◽  
Cross Sectional Study ◽  
Urban Slums ◽  
Slum Area ◽  
Sectional Study ◽  
Cross Sectional ◽  
Cellular Adhesion Molecule ◽  
Group 2 ◽  
Group 1

Background:High prevalence of diabetes, obesity, and dyslipidemias in people belonging to poor socio-economic strata in urban slums of northern India has been recorded recently. To assess whether this population has high levels of soluble intercellular adhesion molecule-1 (sICAM-1), a cytokine involved in the pathogenesis of atherosclerosis, we investigated subjects belonging to poor socio-economic strata in urban slums and compared them to healthy control subjects from non-slum urban areas of New Delhi.Design:Cross-sectional study.Methods:Subjects from a previously carried out cross-sectional study, Delhi Urban Slum Project (DUSP) were divided into two groups: Group-1 (n= 56) included subjects dwelling in slum area, having at least one risk factor (hypertension, hyperglycemia, hypertriglyceridemia and hypercholesterolemia), while group-2 (n= 60) consisted of subjects without any risk factor dwelling in the slum area. A third group (n= 29) of non-obese subjects without any risk factor living in non-slum urban area was included for comparison. Measurements included; body mass index (BMI), waist-hip ratio (W-HR), four skinfolds, percentage body fat, fasting plasma glucose (FPG), serum lipids, and serum levels of sICAM-1.Results:Though statistically not significant, mean level of sICAM-1 was higher in group-1 (718.5 ± 232.8 ng/ml) as compared to the other groups. Of note, 35% of subjects in group-1 (p< 0.05 as compared to other two groups), and 25.3% of all subjects had levels of sICAM-1 in uppermost quartile (>850 ng/ml). Partial correlation coefficients (R) of sICAM-1 levels with various parameters adjusted for age were statistically significant for BMI (R= 0.27,p< 0.05) in group-1; W-HR (R= 0.26,p< 0.05) and BMI (R= 0.19,p< 0.05) for group-2; and FPG (R= 0.17,p< 0.05) for all the subjects considered together. For females, the levels of sICAM-1 were significantly higher in the following: BMI ≥ 25 kg/m2(p= 0.04) and FPG >7 mmol/l (p< 0.05). Multiple linear regression analysis suggests that an increment in BMI by one kg/m2would correspond to an increase in the levels of sICAM-1 by 8.5 units controlling for the influence of age and W-HR in the pooled data of all subjects.Conclusions:High percentage of subjects had levels of sICAM-1 in the upper quartile in the study, particularly those dwelling in the slum area and having coronary risk factor (s). The levels of sICAM-1 strongly correlated to the anthropometric and metabolic parameters, particularly in females. These observations are of potential importance for the pathogenesis of atherosclerosis in this population, though further studies are needed to predict those prone to the complications of atherosclerosis, based on sICAM-1 levels, as has been observed in other ethnic groups.

scholarly journals Assessment of Anti-SARS-CoV-2 Antibodies Post-Coronavac Vaccination in the Amazon Region of Brazil

Vaccines ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1169
Author(s):  
Carlos David Araújo Bichara ◽  
Maria Alice Freitas Queiroz ◽  
Ednelza da Silva Graça Amoras ◽  
Gergiane Lopes Vaz ◽  
Izaura Maria Vieira Cayres Vallinoto ◽  
...  
Keyword(s):  
Neutralizing Antibodies ◽  
Cross Sectional Study ◽  
Age Group ◽  
Receptor Binding Domain ◽  
Sectional Study ◽  
Cross Sectional ◽  
Humoral Immune ◽  
High Prevalence ◽  
Group 2 ◽  
Group 1

The present study evaluated the frequency of seropositivity for anti-SARS-CoV-2 (S1 and S2) total antibodies and anti-SARS-CoV-2 (receptor binding domain-RBD-S1) neutralizing antibodies in individuals vaccinated with the immunizing agent Coronavac. This was a cross-sectional study involving 358 individuals divided into two groups. Group 1 consisted of 205 volunteers who were tested for anti-SARS-CoV-2 total antibodies; group 2 consisted of 153 individuals tested for the presence of anti-SARS-CoV-2 neutralizing antibodies. Seropositivity was greater than 70% in both groups, although 17.6% and 20.9% of individuals showed no neutralizing or total antibody reactivity, respectively. The frequency of anti-SARS-CoV-2 total antibodies displayed a significantly different distribution between the sexes but not according to age. The frequency of anti-SARS-CoV-2 neutralizing antibodies was 93.3% (95% CI 68.1–99.8) in the age group from 21 to 40 years but significantly decreased with advancing age, and was 76.2% (95% CI 52.8–91.8) for 41 to 60 years, 72.5% (95% CI 62.8–80.9) for 61 to 80 years, and 46.7% (95% CI 21.3–73.4) for >80 years. Our results reveal a high prevalence of anti-SARS-CoV-2 total antibodies and anti-SARS-CoV-2 neutralizing antibodies in individuals who received both doses of the Coronavac vaccine, suggesting a lower effectiveness of the humoral immune response among those older than 60 years of age, which might be associated with senescence of the immune system.

scholarly journals Adverse pathophysiological influence of early testosterone therapy on the testes of boys with higher grade sex chromosome aneuploidies (HGAs): a retrospective, cross-sectional study

2020 ◽  
Author(s):  
M. Spaziani ◽  
C. Tarantino ◽  
C. Pozza ◽  
A. Anzuini ◽  
F. Panimolle ◽  
...  
Keyword(s):  
Sex Chromosome ◽  
Cross Sectional Study ◽  
Testicular Volume ◽  
Sectional Study ◽  
Testosterone Therapy ◽  
Cross Sectional ◽  
Hormone Profile ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Abstract Purpose Higher grade aneuploidies (HGAs) of the male sex chromosomes are a rare genetic group of pathologies caused by nondisjunction meiotic events. The aim of this study was to evaluate the impact of early androgenic therapy on the testicular secretory hormone profile, and the pathophysiological implications. Patients and methods In this cross-sectional study, 18 HGA subjects aged 6–8 years were recruited. They were divided into two groups, based on whether or not they had previously undergone testosterone therapy (group 1: 11 untreated subjects; group 2: 7 treated subjects). Serum FSH, LH, testosterone (T), inhibin B (INHB) and anti-Müllerian hormone (AMH) were determined, and auxological parameters were assessed. Five group 1 patients and four group 2 patients were treated with hCG (human chorionic gonadotropin) for inguinal cryptorchidism; their hormone profile and auxological parameters were assessed both pre- and post-hCG treatment. Results Group 1 subjects showed significantly higher testicular volume and higher levels of AMH and INHB (p < 0.0001). Subjects who had undergone hCG therapy showed a significantly higher testicular volume, penis length (respectively, p = 0.008 and p = 0.0005 for group 1 and p = 0.04 and p = 0.001 for group 2) and T (p = 0.005 for group 1 and p = 0.004 for group 2). Conclusions HGA patients undergoing early testosterone therapy show an earlier and persistent suppression of testicular secretory function. At this age, the testes are still responsive to stimulation with hCG. The selection of patients to be treated must be accompanied by a thorough clinical and hormonal evaluation.

scholarly journals Evaluation of prescription pattern and quality of life in postmenopausal osteoporosis: a cross sectional study

2019 ◽  
Vol 8 (8) ◽  
pp. 1861
Author(s):  
Siddharth Pravin Agrawal ◽  
Suhani V. Patel ◽  
Supriya Malhotra ◽  
Pankaj R. Patel
Keyword(s):  
Quality Of Life ◽  
Drug Utilization ◽  
Cross Sectional Study ◽  
Minor Trauma ◽  
Sectional Study ◽  
Utilization Pattern ◽  
Cross Sectional ◽  
Group 2 ◽  
Group 1

Background: Osteoporosis (OP) is a silently progressing metabolic bone disease that results in loss of mineralized bone and subsequent fractures with minor trauma. Fracture related pain and physical inability to perform activities of daily living can lead to psychological consequences that impair Quality of Life (QoF). However, much less is known about Indian scenario. Hence, our study becomes imperative. Aim of this study to the drug utilization pattern and to analyze Quality of life of postmenopausal women suffering from osteoporosis.Methods: An analytical cross-sectional study was done on 91 post-menopausal osteoporotic women. Drug utilization pattern was evaluated. Pre-validated QUALEFFO-31 questionnaire was administered to each patient to record patient’s perceived QoL. Scores were calculated according to the algorithm. Higher scores indicated poor QoL. The collected data was analyzed with SPSS software (version 23)and p value ≤0.05 was considered as statistically significant.Results: The mean age group of presenting patients was 56.2±6.6 years. All the patients received Calcium and vitamin D supplements and non-steroidal anti-inflammatory drugs for pain relief. But only 33% of the patients received any one of the bisphosphonates (BP). For analysis, patients were grouped into Group-1(n=60) who did not and Group-2 (n=31) who did receive a BP. QOL analysis showed that pain domain was affected the most. Also, patients in Group 2 reported worse score in all the domains in comparison to Group 1 (P<0.05). It is likely that BP might need more time to show considerable effect or because it was added only to those patients who already had more complaints and could afford the high cost.Conclusion: BP in spite of being the drug of choice for OP is used less commonly in India. OP causes pain and physical debilitation with detrimental effect on mental health. Longer duration prospective studies are needed to study the association of QoL and use of BP in OP patients.

scholarly journals Analysis of conference abstracts of prosthodontic randomised-controlled trials presented at IADR general sessions (2002–2015): a cross-sectional study of the relationship between demographic characteristics, reporting quality and final publication

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034635
Author(s):  
Junsheng Chen ◽  
Yubin Cao ◽  
Meijie Wang ◽  
Xueqi Gan ◽  
Chunjie Li ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Reporting Quality ◽  
Cross Sectional Study ◽  
Publication Rate ◽  
Demographic Characteristics ◽  
Sectional Study ◽  
Cross Sectional ◽  
Randomised Controlled ◽  
The Relationship

ObjectivesTo analyse the relationship between demographic characteristics, reporting quality and final publication rate of conference abstracts of prosthodontic randomised-controlled trials (RCTs) presented at International Association for Dental Research (IADR) general sessions (2002–2015).DesignA cross-sectional study on conference abstracts.MethodsConference abstracts of prosthodontic RCTs presented at IADR general sessions (2002–2015) were obtained. Literature search was performed in multiple databases to confirm the final publication status of conference abstracts. Two investigators independently extracted the data including conference date, origin, presentation type, exact p value, number of centres, institution type, overall conclusion, subspecialty, publication time and journal. The reporting quality of abstracts was assessed by two investigators according to the Consolidated Standards of Reporting Trials statement. The relationship between demographic characteristics, reporting quality and final publication was analysed by χ2test.Setting, participants and interventionsNot applicable.Primary and secondary outcome measuresFinal publication rate, demographic characteristics and reporting quality of conference abstracts of prosthodontic RCTs presented at IADR general sessions (2002–2015).ResultsOf the 340 prosthodontic RCT abstracts, 43.24% were published. The mean time to final publication was 22.86 months. Europe contributed the most number of abstracts but Asia and Australia had the highest publication rate. Oral presentation, multicentre trial and complete denture and overdenture subspecialty were associated with a higher publication rate. Reporting quality of eligibility criteria of participants, random assignment and primary outcome results for each group correlated with a higher final publication rate.ConclusionsOver half of conference abstracts of prosthodontic RCTs presented at IADR general sessions (2002–2015) were unpublished. Oral presentation and multiple centres were associated with higher publication rates. Abstracts’ reporting quality addressing participant recruitment, assignment and primary results correlated with trials’ validity and applicability. Conference attendees may refer to this research to identify valid and applicable prosthodontic trials but should treat and apply results cautiously.

scholarly journals Risk of bias versus quality assessment of randomised controlled trials: cross sectional study

BMJ ◽  
2009 ◽  
Vol 339 (oct19 1) ◽  
pp. b4012-b4012 ◽  
Author(s):  
L. Hartling ◽  
M. Ospina ◽  
Y. Liang ◽  
D. M Dryden ◽  
N. Hooton ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Randomised Controlled Trials ◽  
Cross Sectional Study ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Sectional Study ◽  
Cross Sectional ◽  
Randomised Controlled ◽  
Bias Versus

scholarly journals Triggering Factors for Breakthrough Seizures among Epileptic Patients. Cross Sectional Study in Epileptic Patients Attending Epilepsy Clinic Mansoura University Hospital, Egypt

2019 ◽  
pp. 1-10
Author(s):  
Mohammed Gomaa ◽  
Ahmed Esmael ◽  
Mohammed Saad
Keyword(s):  
Cross Sectional Study ◽  
Idiopathic Epilepsy ◽  
Sectional Study ◽  
Precipitating Factors ◽  
Cross Sectional ◽  
Epileptiform Discharges ◽  
Significant Difference ◽  
Epileptic Patients ◽  
Group 2 ◽  
Group 1

Background: The prevalence of breakthrough seizures in persons with epilepsy is very high in developing countries. Consequently, patients and physicians should be aware of the possible factors that may cause breakthrough seizures. Objective: The aim of our study is to determine the possible factors that may be a precipitating cause for breakthrough seizures in patients with epilepsy. Methods: This cross-sectional study included 100 persons with epilepsy with idiopathic epilepsy receiving antiepileptic drugs (AEDs). They were divided into two groups. Group 1 included 50 persons with epilepsy with a history of recent breakthrough seizures. Group 2 included 50 persons with epilepsy who had not experienced any recent breakthrough seizures. Patients were subjected to a thorough questionnaire addressing precipitating factors. All participants were subjected to an electroencephalogram (EEG) and the Morisky Medication Adherence Scale (MMAS). Results: There was no significant differences between group 1 and group 2 regarding age, sex, age of onset of epilepsy, occupation and marital status (P value range 0.5 – 0.2). The patients in group 1 were found to have longer durations of epilepsy, lower adherence to AEDs (P = 0.001), more missed doses of AEDs (P = 0.0001), more side effects of AEDs (P = 0.0005), more sleep deprivation, lower level of AEDs (P = 0.0006), more frequently on AED polytherapy (P = 0.0002), and more flickering lights (P = 0.04) than the participants in group 2. In terms of the EEG, group 1 showed a higher percentage of abnormal EEGs and more frequent focal epileptiform discharges (P = 0.003). Also, pathological findings in MRI brain were associated with higher breakthrough seizures (P = 0.005). No significant difference was found in both group1 and group 2 regarding emotional stress (P = 0.55), substitution of brand AEDs by generic one (P = 0.83), concurrent illness (P = 1), or the use of non AEDs (P = 0.79). Conclusion: The precipitating factors of breakthrough seizures are multifactorial and it is very important to educate patients about these precipitating factors to achieve better control of epilepsy.

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