Imperial College London

DrLeilaJanani

Faculty of MedicineSchool of Public Health

Deputy Head of Trial Methodology
 
 
 
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Contact

 

+44 (0)20 7594 1737l.janani

 
 
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Location

 

Stadium HouseWhite City Campus

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Summary

 

Publications

Publication Type
Year
to

73 results found

Gupta A, Whiteley WN, Godec T, Rostamian S, Ariti C, Mackay J, Whitehouse A, Janani L, Poulter NR, Sever PS, ASCOT-10 Investigatorset al., 2024, Legacy benefits of blood pressure treatment on cardiovascular events are primarily mediated by improved blood pressure variability: the ASCOT trial, European Heart Journal, ISSN: 0195-668X

BACKGROUND AND AIMS: Visit-to-visit systolic blood pressure variability (BPV) is an important predictor of cardiovascular (CV) outcomes. The long-term effect of a period of blood pressure (BP) control, but with differential BPV, is uncertain. Morbidity and mortality follow-up of UK participants in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure-Lowering Arm has been extended for up to 21 years to determine the CV impact of mean systolic blood pressure (SBP) control and BPV during the trial, and amongst those allocated to amlodipine- and atenolol-based treatment. METHODS: Eight thousand five hundred and eighty hypertensive participants (4305 assigned to amlodipine ± perindopril-based and 4275 to atenolol ± diuretic-based treatment during the in-trial period (median 5.5 years) were followed for up to 21 years (median 17.4 years), using linked hospital and mortality records. A subgroup of participants (n = 2156) was followed up 6 years after the trial closure with a self-administered questionnaire and a clinic visit. In-trial mean SBP and standard deviation of visit-to-visit SBP as a measure of BPV, were measured using >100 000 BP measurements. Cox proportional hazard models were used to estimate the risk [hazard ratios (HRs)], associated with (i) mean with SBP and BPV during the in-trial period, for the CV endpoints occurring after the end of the trial and (ii) randomly assigned treatment to events following randomization, for the first occurrence of pre-specified CV outcomes. RESULTS: Using BP data from the in-trial period, in the post-trial period, although mean SBP was a predictor of CV outcomes {HR per 10 mmHg, 1.14 [95% confidence interval (CI) 1.10-1.17], P < .001}, systolic BPV independent of mean SBP was a strong predictor of CV events [HR per 5 mmHg 1.22 (95% CI 1.18-1.26), P < .001] and predicted events even in participants with well-controlled BP. During 21-year follow-up, those on amlodipine-based compared with atenolol-

Journal article

Liu X, Munro APS, Wright A, Feng S, Janani L, Aley PK, Babbage G, Baker J, Baxter D, Bawa T, Bula M, Cathie K, Chatterjee K, Dodd K, Enever Y, Fox L, Qureshi E, Goodman AL, Green CA, Haughney J, Hicks A, Jones CE, Kanji N, van der Klaauw AA, Libri V, Llewelyn MJ, Mansfield R, Maallah M, McGregor AC, Minassian AM, Moore P, Mughal M, Mujadidi YF, Belhadef HT, Holliday K, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Saralaya D, Sharma S, Sheridan R, Stokes M, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Lambe T, Nguyen-Van-Tam JS, Cornelius V, Snape MD, Faust SN, COV-BOOST study groupet al., 2023, Persistence of immune responses after heterologous and homologous third COVID-19 vaccine dose schedules in the UK: eight-month analyses of the COV-BOOST trial, Journal of Infection, Vol: 87, Pages: 18-26, ISSN: 0163-4453

BACKGROUND: COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of seven COVID-19 vaccines used as a third booster dose in June 2021. Monovalent messenger RNA (mRNA) COVID-19 vaccines were subsequently widely used for the third and fourth-dose vaccination campaigns in high-income countries. Real-world vaccine effectiveness against symptomatic infections following third doses declined during the Omicron wave. This report compares the immunogenicity and kinetics of responses to third doses of vaccines from day (D) 28 to D242 following third doses in seven study arms. METHODS: The trial initially included ten experimental vaccine arms (seven full-dose, three half-dose) delivered at three groups of six sites. Participants in each site group were randomised to three or four experimental vaccines, or MenACWY control. The trial was stratified such that half of participants had previously received two primary doses of ChAdOx1 nCov-19 (Oxford-AstraZeneca; hereafter referred to as ChAd) and half had received two doses of BNT162b2 (Pfizer-BioNtech, hereafter referred to as BNT). The D242 follow-up was done in seven arms (five full-dose, two half-dose). The BNT vaccine was used as the reference as it was the most commonly deployed third-dose vaccine in clinical practice in high-income countries. The primary analysis was conducted using all randomised and baseline seronegative participants who were SARS-CoV-2 naïve during the study and who had not received a further COVID-19 vaccine for any reason since third dose randomisation. RESULTS: Among the 817 participants included in this report, the median age was 72 years (IQR: 55-78) with 50.7% being female. The decay rates of anti-spike IgG between vaccines are different among both populations who received initial doses of ChAd/ChAd and BNT/BNT. In the population that previously received ChAd/ChAd, mRNA vaccines had the highest titre at D242 following their vaccine dose although Ad26.COV2.S (Janssen; hereafter ref

Journal article

Blake C, Tajik R, Janani L, Mora-Peris Bet al., 2023, Identification of barriers to recruitment in studies exploring treatments for sexually transmitted infections, Publisher: BMJ PUBLISHING GROUP, Pages: A93-A94, ISSN: 1368-4973

Conference paper

Liu X, Munro APS, Feng S, Janani L, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dejnirattisai W, Dodd K, Enever Y, Qureshi E, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, Klaauw AAVD, Kwok J, Libri V, Llewelyn MJ, McGregor AC, Minassian AM, Moore P, Mughal M, Mujadidi Y, Holliday K, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Serafimova T, Saralaya D, Screaton GR, Sharma S, Sheridan R, Sturdy A, Supasa P, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Lambe T, Nguyen-Van-Tam JS, Cornelius V, Snape M, Faust SNet al., 2023, Persistence of immunogenicity after seven COVID-19 vaccines given as third dose boosters following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK: Three month analyses of the COV-BOOST trial (vol 84, pg 795, 2022), JOURNAL OF INFECTION, Vol: 86, Pages: 540-541, ISSN: 0163-4453

Journal article

Asadi-Aliabadi M, Karimi SM, Mirbaha-Hashemi F, Tehrani-Banihashemi A, Janani L, Babaee E, Nojomi M, Moradi-Lakeh Met al., 2023, Motivating non-physician health workers to reduce the behavioral risk factors of non-communicable diseases in the community: a field trial study, Archives of Public Health, Vol: 81

<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>Non-communicable diseases behavioral risk factors can be improved if effective interventions are designed considering the health system’s capabilities and local resources. This study evaluated the effectiveness of interventions that aimed at increasing non-physician community health workers’ motivation in reducing non-communicable diseases behavioral risk factors in the community.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>A randomized field trial study was conducted in 32 community health centers in 4 Iranian districts after a baseline population survey on the status of NCDs of 30–70-year-old individuals (<jats:italic>n</jats:italic> = 1225). The interventions were performed to improve insufficient physical activity, insufficient fruit consumption, insufficient vegetable consumption, high salt intake, and tobacco use. Four intervention packages were implemented in 24 community health centers; the other 8 centers were used as control groups. The non-physician community health workers performed the interventions. The packages additively included goal-setting, evidence-based education, operational planning, and incentive payments. A second survey was conducted 1 year after the start of the interventions to identify the effects on an independent random sample of 30–70-year-old individuals (<jats:italic>n</jats:italic> = 1221). Difference-in-difference method was used to quantify the interventions’ effects.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>The average age of participants in both surveys was about 49 

Journal article

Sohouli MH, Buckland G, Clark CCT, Santos HO, Athayde FL, Sanati V, Janani L, Sajadian AS, Zarrati Met al., 2023, The relationship between diet quality indices and odds of breast cancer in women: a case–control study, BMC Women's Health, Vol: 23

<jats:title>Abstract</jats:title><jats:p>Dietary quality is an important factor in the etiology of breast cancer (BrCa), but further studies are required to better elucidate this relationship. Accordingly, we sought to analyze if diet quality, assessed using the Diet Quality Index-International (DQI-I), Mean Adequacy Ratio (MAR), and Dietary Energy Density (DED), was related to BrCa. In this Hospital-based case–control study, 253 patients with BrCa and 267 non BrCa controls were enrolled. Individual food consumption data from a food frequency questionnaire was used to calculate the Diet Quality Indices (DQI). Employing a case–control design, odds ratios (ORs) and 95% confidence intervals (CIs) were obtained, and a dose–response analysis investigated. After adjusting for potential confounders, those in the highest quartile of the MAR index had significantly lower odds of BrCa than those in the lowest (OR = 0.42, 95% CI 0.23–0.78; P for trend = 0.007). Although there was no association between individual quartiles of the DQI-I and BrCa, there was evidence of a significant trend across all the quartile categories (P for trend = 0.030).There was no significant association was found between DED index and the odds of BrCa in the crude and fully adjusted models. We found that higher MAR indices were associated with decreased odds of BrCa, Therefore, the dietary patterns reflected by these scores may serve as a possible guide to preventing BrCa in Iranian women.</jats:p>

Journal article

Munro APS, Feng S, Janani L, Cornelius V, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dodd K, Enever Y, Qureshi E, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, van der Klaauw AA, Kanji N, Libri V, Llewelyn MJ, McGregor AC, Maallah M, Minassian AM, Moore P, Mughal M, Mujadidi YF, Holliday K, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Bawa T, Saralaya D, Sharma S, Sheridan R, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Lambe T, Nguyen-Van-Tam JS, Snape MD, Liu X, Faust SN, COV-BOOST study groupet al., 2022, Safety, immunogenicity, and reactogenicity of BNT162b2 and mRNA-1273 COVID-19 vaccines given as fourth-dose boosters following two doses of ChAdOx1 nCoV-19 or BNT162b2 and a third dose of BNT162b2 (COV-BOOST): a multicentre, blinded, phase 2, randomised trial, Lancet Infectious Diseases, Vol: 22, Pages: 1131-1141, ISSN: 1473-3099

BACKGROUND: Some high-income countries have deployed fourth doses of COVID-19 vaccines, but the clinical need, effectiveness, timing, and dose of a fourth dose remain uncertain. We aimed to investigate the safety, reactogenicity, and immunogenicity of fourth-dose boosters against COVID-19. METHODS: The COV-BOOST trial is a multicentre, blinded, phase 2, randomised controlled trial of seven COVID-19 vaccines given as third-dose boosters at 18 sites in the UK. This sub-study enrolled participants who had received BNT162b2 (Pfizer-BioNTech) as their third dose in COV-BOOST and randomly assigned them (1:1) to receive a fourth dose of either BNT162b2 (30 μg in 0·30 mL; full dose) or mRNA-1273 (Moderna; 50 μg in 0·25 mL; half dose) via intramuscular injection into the upper arm. The computer-generated randomisation list was created by the study statisticians with random block sizes of two or four. Participants and all study staff not delivering the vaccines were masked to treatment allocation. The coprimary outcomes were safety and reactogenicity, and immunogenicity (anti-spike protein IgG titres by ELISA and cellular immune response by ELISpot). We compared immunogenicity at 28 days after the third dose versus 14 days after the fourth dose and at day 0 versus day 14 relative to the fourth dose. Safety and reactogenicity were assessed in the per-protocol population, which comprised all participants who received a fourth-dose booster regardless of their SARS-CoV-2 serostatus. Immunogenicity was primarily analysed in a modified intention-to-treat population comprising seronegative participants who had received a fourth-dose booster and had available endpoint data. This trial is registered with ISRCTN, 73765130, and is ongoing. FINDINGS: Between Jan 11 and Jan 25, 2022, 166 participants were screened, randomly assigned, and received either full-dose BNT162b2 (n=83) or half-dose mRNA-1273 (n=83) as a fourth dose. The median age of these participants was 70

Journal article

Liu X, Munro APS, Feng S, Janani L, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dejnirattisai W, Dodd K, Enever Y, Qureshi E, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, van der Klaauw AA, Kwok J, Libri V, Llewelyn MJ, McGregor AC, Minassian AM, Moore P, Mughal M, Mujadidi YF, Holliday K, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Serafimova T, Saralaya D, Screaton GR, Sharma S, Sheridan R, Sturdy A, Supasa P, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Lambe T, Nguyen-Van-Tam JS, Cornelius V, Snape MD, Faust SN, COV-BOOST study groupet al., 2022, Persistence of immunogenicity after seven COVID-19 vaccines given as third dose boosters following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK: Three month analyses of the COV-BOOST trial, Journal of Infection, Vol: 84, Pages: 795-813, ISSN: 0163-4453

OBJECTIVES: To evaluate the persistence of immunogenicity three months after third dose boosters. METHODS: COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of seven COVID-19 vaccines used as a third booster dose. The analysis was conducted using all randomised participants who were SARS-CoV-2 naïve during the study. RESULTS: Amongst the 2883 participants randomised, there were 2422 SARS-CoV-2 naïve participants until D84 visit included in the analysis with median age of 70 (IQR: 30-94) years. In the participants who had two initial doses of ChAdOx1 nCov-19 (Oxford-AstraZeneca; hereafter referred to as ChAd), schedules using mRNA vaccines as third dose have the highest anti-spike IgG at D84 (e.g. geometric mean concentration of 8674 ELU/ml (95% CI: 7461-10,085) following ChAd/ChAd/BNT162b2 (Pfizer-BioNtech, hearafter referred to as BNT)). However, in people who had two initial doses of BNT there was no significant difference at D84 in people given ChAd versus BNT (geometric mean ratio (GMR) of 0.95 (95%CI: 0.78, 1.15). Also, people given Ad26.COV2.S (Janssen; hereafter referred to as Ad26) as a third dose had significantly higher anti-spike IgG at D84 than BNT (GMR of 1.20, 95%CI: 1.01,1.43). Responses at D84 between people who received BNT (15 μg) or BNT (30 μg) after ChAd/ChAd or BNT/BNT were similar, with anti-spike IgG GMRs of half-BNT (15 μg) versus BNT (30 μg) ranging between 0.74-0.86. The decay rate of cellular responses were similar between all the vaccine schedules and doses. CONCLUSIONS: 84 days after a third dose of COVID-19 vaccine the decay rates of humoral response were different between vaccines. Adenoviral vector vaccine anti-spike IgG concentrations at D84 following BNT/BNT initial doses were similar to or even higher than for a three dose (BNT/BNT/BNT) schedule. Half dose BNT immune responses were similar to full dose responses. While high antibody tires are desirable in situations of high transmission of new

Journal article

Jones T, Janani L, Gordon A, Al-Beidh F, Antcliffe Det al., 2022, A novel role for cytochrome P450 epoxygenase metabolites in septic shock, Critical Care Explorations, Vol: 4, ISSN: 2639-8028

Objectives Oxylipins are oxidative breakdown products of cell membrane fatty acids. Animal models have demonstrated that oxylipins generated by the P450 epoxygenase pathway may be implicated in septic shock pathology. However, these mediators are relatively unexplored in humans with septic shock. We aimed to determine if there were patterns of oxylipins that were associated with 28-day septic shock mortality and organ dysfunction. Design Retrospective analysis of samples collected during the Vasopressin vs. Norepinephrine as Initial Therapy in Septic Shock trial.Setting Intensive Care Units in the United KingdomPatients Adults recruited within six hours of onset of septic shock. Interventions Trial interventions were not considered in this analysis.Measurements and Main Results Oxylipin profiling was performed on 404 serum samples from 152 patients using liquid chromatography-mass spectrometry. Non-survivors were found to have higher levels of 14,15-dihydroxyeicosatrienoic acid at baseline (DHET) than survivors (p=0.02). Patients with 14,15-DHET levels above the lower limit of quantification of the assay were more likely to die than patients with levels below this limit (Hazard Ratio 2.3, 95% CI 1.2-4.5). Patients with measurable 14,15-DHET had higher levels of organ dysfunction and fewer renal failure free days than those in whom it was unmeasurable. Considering samples collected over the first week of intensive care stay, measurable levels of DHET species were associated with higher daily SOFA scores which appeared to be accounted for predominantly by the liver component. Measurable 14,15-DHET showed positive correlation with bilirubin (rs=0.38, p<0.001) and lactate (rs=0.27, p=0.001).Conclusions The P450 epoxygenase-derived DHET species of oxylipins were associated with organ, particularly liver, dysfunction in septic shock and 14,15-DHET was associated with septic shock mortality. These results support further investigation into the role of the P450 epoxygena

Journal article

Ranjbar M, Matloubi M, Sadegh S, Fallahpour M, Janani L, Assarehzadegan M-Aet al., 2021, IL1RL1 single nucleotide polymorphisms are associated with asthma in the Iranian population, Monaldi Archives for Chest Disease, ISSN: 1122-0643

<jats:p>Asthma is a chronic and multifactorial disease which is known to result from environmental and genetic factors. Interleukin 1 receptor-like 1 (IL1RL1) is a receptor, which promotes inflammatory responses after binding to its ligand IL-33. Several studies have shown that IL1RL1 gene polymorphisms are related to susceptibility or protection to asthma. The objective of this study was to evaluate the association between two IL1RL1 single nucleotide polymorphisms (rs10208293 and rs1041973) and the risk of asthma in the Iranian population. We performed genotyping of the IL1RL1 SNPs in 126 adult asthmatics and 300 healthy controls using TaqMan genotyping assay. Moreover, total serum IgE level, eosinophil count, and skin prick test were accomplished. The results indicated that the AA genotype of rs10208293 was positively associated with asthma susceptibility (p=0.028). We did not find any association between rs1041973 and asthma. Overall, our findings indicate that rs10208293 has a positive association with asthma in the Iranian population.</jats:p>

Journal article

Munro APS, Janani L, Cornelius V, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dodd K, Enever Y, Gokani K, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, van der Klaauw AA, Kwok J, Libri V, Llewelyn MJ, McGregor AC, Minassian AM, Moore P, Mughal M, Mujadidi YF, Murira J, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Salkeld J, Saralaya D, Sharma S, Sheridan R, Sturdy A, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Nguyen-Van-Tam JS, Snape MD, Liu X, Faust SN, COV-BOOST study groupet al., 2021, Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial, The Lancet, Vol: 398, ISSN: 0140-6736

BACKGROUND: Few data exist on the comparative safety and immunogenicity of different COVID-19 vaccines given as a third (booster) dose. To generate data to optimise selection of booster vaccines, we investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines as a third dose after two doses of ChAdOx1 nCov-19 (Oxford-AstraZeneca; hereafter referred to as ChAd) or BNT162b2 (Pfizer-BioNtech, hearafter referred to as BNT). METHODS: COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of third dose booster vaccination against COVID-19. Participants were aged older than 30 years, and were at least 70 days post two doses of ChAd or at least 84 days post two doses of BNT primary COVID-19 immunisation course, with no history of laboratory-confirmed SARS-CoV-2 infection. 18 sites were split into three groups (A, B, and C). Within each site group (A, B, or C), participants were randomly assigned to an experimental vaccine or control. Group A received NVX-CoV2373 (Novavax; hereafter referred to as NVX), a half dose of NVX, ChAd, or quadrivalent meningococcal conjugate vaccine (MenACWY) control (1:1:1:1). Group B received BNT, VLA2001 (Valneva; hereafter referred to as VLA), a half dose of VLA, Ad26.COV2.S (Janssen; hereafter referred to as Ad26) or MenACWY (1:1:1:1:1). Group C received mRNA1273 (Moderna; hereafter referred to as m1273), CVnCov (CureVac; hereafter referred to as CVn), a half dose of BNT, or MenACWY (1:1:1:1). Participants and all investigatory staff were blinded to treatment allocation. Coprimary outcomes were safety and reactogenicity and immunogenicity of anti-spike IgG measured by ELISA. The primary analysis for immunogenicity was on a modified intention-to-treat basis; safety and reactogenicity were assessed in the intention-to-treat population. Secondary outcomes included assessment of viral neutralisation and cellular responses. This trial is registered with ISRCTN, number 73765130. FINDINGS: Between June 1 and June

Journal article

Shamsoddin E, Torkashvand-Khah Z, Sofi-Mahmudi A, Janani L, Kabiri P, Shamsi-Gooshki E, Mesgarpour Bet al., 2021, Assessing research misconduct in Iran: a perspective from Iranian medical faculty members, BMC Medical Ethics, Vol: 22

<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>Research misconduct is a global concern in biomedical science. There are no comprehensive data regarding the perception and situation of scientific misconduct among the Iranian medical faculty members. We conducted a nationwide survey to assess the research misconduct among the medical faculty members in Iran.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>We used the Persian version of the research misconduct questionnaire (PRMQ) on the Google Forms platform. We sent the survey link to a systematic random sample of medical faculty members in Iran (<jats:italic>N</jats:italic> = 4986). Descriptive analyses were performed on the individual items of the PRMQ, with frequencies and percentages for categorical and Likert-type response items, and means and standard deviation (S.D.) for continuous variables. Chi-square analysis was conducted to test hypotheses examining differences in the frequency of responses related to factors influencing misconduct. We also defined four tenure categories (TC) based on the working years of the participants as tenured faculty members. All the analyses were performed using R 3.6.0.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>The response rate was 13.8% (692 responses). Nearly 70% of the respondents agreed that their publication output would be of higher quality if there were no publication pressure. Approximately three-quarters (<jats:italic>N</jats:italic> =499, 72.1%) of the respondents had been aware of some instances of research misconduct during the previous year according to their understanding of misconduct. Among the participant

Journal article

Hoseini-Esfidarjani S-S, Negarandeh R, Delavar F, Janani Let al., 2021, Psychometric evaluation of the perceived access to health care questionnaire, BMC Health Services Research, Vol: 21

<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background and objective</jats:title> <jats:p>Access to health care is a universal concern. Therefore, this study was conducted to develop a questionnaire to assess the Perceived Access to Health care based on Penchansky and Thomas’s definition of access and the assessment of its psychometric properties.</jats:p> </jats:sec><jats:sec> <jats:title>Method</jats:title> <jats:p>The initial questionnaire contains 31 items developed based on a deductive approach with an extensive review of the related literature. Content validity, face validity, construct validity, internal consistency, and instrument reliability were further examined. Data analysis was conducted using SPSS software version 24, R software version 4, and lavaan package.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>The initial questionnaire was examined using qualitative content validity, and the necessary modifications were applied to each item. The content validity ratio (CVR) was approved in 30 items with a value greater than 0.78, and one item with a CVR value lower than 0.78 was removed. In the case of the content validity index (CVI), 29 items were approved with a CVI value of greater than 0.79, and one item with a CVI value between 0.70 and 0.79 was revised. In qualitative face validity, all items were approved by a panel of experts and the participants. All 30 items with an impact score index higher than 1.5 were approved for the next steps. The confirmatory factor analysis results showed that the six-factor model of access to health care has an appropriate fit. Cronbach’s alpha coefficient for the questionnaire was calculated 0.86. The value of Cronbach’s alpha for the dimensions

Journal article

Rostamzadeh S, Saremi M, Vosoughi S, Bradtmiller B, Janani L, Farshad AA, Taheri Fet al., 2021, Analysis of hand-forearm anthropometric components in assessing handgrip and pinch strengths of school-aged children and adolescents: a partial least squares (PLS) approach, BMC Pediatrics, Vol: 21

<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>The purpose of this study was to examine the influence of hand-forearm anthropometric dimensions on handgrip and pinch strengths among 7–18 years children and adolescents and to investigate the extent to which these variables can be used to predict hand strength.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>Four types of hand strengths including handgrip, tip to tip, key, and three-jaw chuck pinches were measured in 2637 healthy children and adolescents (1391 boys and 1246 girls) aged 7–18 years using standard adjustable Jamar hydraulic hand dynamometer and pinch gauge. A set of 17 hand-forearm anthropometric dimensions were also measured with an accurate digital caliper and tape measure.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>No significant differences were found between the hand strengths of boys and girls up to the age of 10 years. Gender related differences in handgrip and pinches were observed from the age of 11 years onwards, with boys always being stronger. The dominant hand was stronger than the non-dominant hand (8% for handgrip and by about 10% for all three types of pinches). The strongest correlations were found between the hand length and hand strengths (r &gt; 0.83 for handgrip and three all pinches; p &lt; 0.001, 2-tailed). Based on the partial least squares (PLS) analysis, 8 out of 17 anthropometric indices including hand length, hand circumference, thumb length, index finger length, middle finger length, and forearm length had considerable loadings in the PLS analysis, which together accounted for 46% of the total var

Journal article

Pourmalek F, Rezaei Hemami M, Janani L, Moradi-Lakeh Met al., 2021, Rapid review of COVID-19 epidemic estimation studies for Iran, BMC Public Health, Vol: 21

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>To inform researchers about the methodology and results of epidemic estimation studies performed for COVID-19 epidemic in Iran, we aimed to perform a rapid review.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We searched for and included published articles, preprint manuscripts and reports that estimated numbers of cumulative or daily deaths or cases of COVID-19 in Iran. We found 131 studies and included 29 of them.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The included studies provided outputs for a total of 84 study-model/scenario combinations. Sixteen studies used 3–4 compartmental disease models. At the end of month two of the epidemic (2020-04-19), the lowest (and highest) values of predictions were 1,777 (388,951) for cumulative deaths, 20,588 (2,310,161) for cumulative cases, and at the end of month four (2020-06-20), were 3,590 (1,819,392) for cumulative deaths, and 144,305 (4,266,964) for cumulative cases. Highest estimates of cumulative deaths (and cases) for latest date available in 2020 were 418,834 on 2020-12-19 (and 41,475,792 on 2020-12-31). Model estimates predict an ominous course of epidemic progress in Iran. Increase in percent population using masks from the current situation to 95% might prevent 26,790 additional deaths (95% confidence interval 19,925–35,208) by the end of year 2020.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Meticulousness and degree of details reported for disease modeling and statistical methods used in the included studies varied widely. Greater heterogeneity was observed regarding the results of predicted outcomes. Consideration of minimum and preferred reporting items in epidemic estimation studies might b

Journal article

Tanha K, Mottaghi A, Nojomi M, Moradi M, Rajabzadeh R, Lotfi S, Janani Let al., 2021, Investigation on factors associated with ovarian cancer: an umbrella review of systematic review and meta-analyses, Journal of Ovarian Research, Vol: 14, ISSN: 1757-2215

Following cervical and uterine cancer, ovarian cancer (OC) has the third rank in gynecologic cancers. It often remains non-diagnosed until it spreads throughout the pelvis and abdomen. Identification of the most effective risk factors can help take prevention measures concerning OC. Therefore, the presented review aims to summarize the available studies on OC risk factors. A comprehensive systematic literature search was performed to identify all published systematic reviews and meta-analysis on associated factors with ovarian cancer. Web of Science, Cochrane Library databases, and Google Scholar were searched up to 17th January 2020. This study was performed according to Smith et al. methodology for conducting a systematic review of systematic reviews. Twenty-eight thousand sixty-two papers were initially retrieved from the electronic databases, among which 20,104 studies were screened. Two hundred seventy-seven articles met our inclusion criteria, 226 of which included in the meta-analysis. Most commonly reported genetic factors were MTHFR C677T (OR=1.077; 95 % CI (1.032, 1.124); P-value<0.001), BSML rs1544410 (OR=1.078; 95 %CI (1.024, 1.153); P-value=0.004), and Fokl rs2228570 (OR=1.123; 95 % CI (1.089, 1.157); P-value<0.001), which were significantly associated with increasing risk of ovarian cancer. Among the other factors, coffee intake (OR=1.106; 95 % CI (1.009, 1.211); P-value=0.030), hormone therapy (RR=1.057; 95 % CI (1.030, 1.400); P-value<0.001), hysterectomy (OR=0.863; 95 % CI (0.745, 0.999); P-value=0.049), and breast feeding (OR=0.719, 95 % CI (0.679, 0.762) and P-value<0.001) were mostly reported in studies. Among nutritional factors, coffee, egg, and fat intake significantly increase the risk of ovarian cancer. Estrogen, estrogen-progesterone, and overall hormone therapies also are related to the higher incidence of ovarian cancer. Some diseases, such as diabetes, endometriosis, and polycy

Journal article

Janani L, Bamehr H, Tanha K, Mirzabeigi P, Montazeri H, Tarighi Pet al., 2021, Effects of Sitagliptin as Monotherapy and Add-On to Metformin on Weight Loss among Overweight and Obese Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis, Drug Research, Vol: 71, Pages: 477-488, ISSN: 2194-9379

<jats:title>Abstract</jats:title><jats:p> Background Sitagliptin is known as an antidiabetic agent inhibiting the dipeptidyl peptidase-4. Although sitagliptin may influence weight, controversial results have been reported, and there is no general agreement on this issue. Therefore, this study assessed the effect of sitagliptin as monotherapy and add-on therapy to metformin on weight reduction in overweight or obese cases with type 2 diabetes.</jats:p><jats:p> Methods We reviewed the following databases to identify all relevant papers published until 1st April 2021: Web of Science, MEDLINE, Embase, Scopus, Cochrane Central Register of Controlled Trials Cochrane Library, and Google Scholar. The research included all clinical trials investigating the effect of sitagliptin in obese or overweight adult patients with type 2 diabetes without any language restriction.</jats:p><jats:p> Results In total, eighteen randomized controlled trials with 2009 participants were included in our meta-analysis. Results showed supplementation of sitagliptin has led to weight loss for sitagliptin treated (MD  −0.99; 95% CI; (−1.87, −0.12); p=0.026)) and sitagliptin+metformin treated groups (MD  −1.09; 95% CI; (−1.69, −0.49); p&lt;0.001)). Also, the intervention has influenced body mass index in sitagliptin treated (MD  −0.23; 95% CI; (−0.45, 0.02); p=0.033)) and sitagliptin+metformin treated groups (MD −0.52; 95% CI; (−0.96, 0.08); p=0.020)) comparing to placebo.<

Journal article

Rajabzadeh R, Janani L, Motevalian SA, 2021, Effects of different invitation strategies on participation in a cohort study of Iranian public sector employees: a cluster randomized trial, BMC MEDICAL RESEARCH METHODOLOGY, Vol: 21

Journal article

Hosseini AM, Keshavarz SA, Nasli-Esfahani E, Amiri F, Janani Let al., 2021, The effects of Chlorella supplementation on glycemic control, lipid profile and anthropometric measures on patients with type 2 diabetes mellitus, European Journal of Nutrition, Vol: 60, Pages: 3131-3141, ISSN: 1436-6207

Journal article

Aghajanloo A, Negarandeh R, Janani L, Tanha K, HoseiniEsfidarjani Set al., 2021, Self‐care status in patients with heart failure: Systematic review and meta‐analysis, Nursing Open, Vol: 8, Pages: 2235-2248, ISSN: 2054-1058

<jats:title>Abstract</jats:title><jats:sec><jats:title>Aim</jats:title><jats:p>To systematically review the status of self‐care in patients with heart failure through the Self‐Care of Heart Failure Index scale.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>A systematic review and meta‐analysis.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Following national and international databases were searched to retrieve eligible studies: PubMed, Web of Science, Embase, Google Scholar, Scientific Information Database and Magiran. The studies were screened and selected by two researchers. Data analysed through the random‐effects model, and the <jats:italic>I</jats:italic><jats:sup>2</jats:sup> index was used to assess heterogeneity. Stata software version 12.0 was used for analysis. The PRISMA statement was used to report systematic review and meta‐analysis.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of the 5,953 articles initially identified, 39 studies were included. The average score was estimated at 58.16 (CI: 54.39–61.94) for self‐care maintenance, 53.11 (CI: 49.17–57.05) for self‐care management and 58.66 (CI: 54.32–63.00) for self‐care confidence. Despite the high heterogeneity of the studies, the results indicated that self‐care practice is inadequate in all the three dimensions of self‐care (maintenance, management and confidence).</jats:p></jats:sec>

Journal article

Hashemi-madani N, Emami Z, Janani L, Khamseh MEet al., 2021, Typical chest CT features can determine the severity of COVID-19: A systematic review and meta-analysis of the observational studies, Clinical Imaging, Vol: 74, Pages: 67-75, ISSN: 0899-7071

Journal article

Sokoty L, Rimaz S, Hassanlouei B, Kermani M, Janani Let al., 2021, Short-term effects of air pollutants on hospitalization rate in patients with cardiovascular disease: a case-crossover study, Environmental Science and Pollution Research, Vol: 28, Pages: 26124-26131, ISSN: 0944-1344

Journal article

Dehghani F, Sezavar Seyedi Jandaghi SH, Janani L, Sarebanhassanabadi M, Emamat H, Vafa Met al., 2021, Effects of quercetin supplementation on inflammatory factors and quality of life in post‐myocardial infarction patients: A double blind, placebo‐controlled, randomized clinical trial, Phytotherapy Research, Vol: 35, Pages: 2085-2098, ISSN: 0951-418X

<jats:p>Myocardial infarction (MI) is one of the leading causes of death in the world. Epidemiological studies have shown that dietary flavonoids are inversely related to cardiovascular morbidity and mortality. The study aimed to determine whether quercetin supplementation can improve inflammatory factors, total antioxidant capacity (TAC) and quality of life (QOL) in patients following MI. This randomized double‐blind, placebo‐controlled trial was conducted on 88 post‐MI patients. Participants were randomly assigned into quercetin (<jats:italic>n</jats:italic> = 44) and placebo groups (<jats:italic>n</jats:italic> = 44) receiving 500 mg/day quercetin or placebo tablets for 8 weeks. Quercetin supplementation significantly increased serum TAC compared to placebo (Difference: 0.24 (0.01) mmol/L and 0.00 (0.00) mmol/L respectively; <jats:italic>p</jats:italic> &lt; .001). TNF‐α levels significantly decreased in the quercetin group (<jats:italic>p</jats:italic> = .009); this was not, however, significant compared to the placebo group. As for QOL dimensions, quercetin significantly lowered the scores of insecurity (Difference: −0.66 (12.5) and 0.00 (5.55) respectively; <jats:italic>p</jats:italic> &lt; .001). No significant changes in IL‐6, hs‐CRP, blood pressure and other QOL dimensions were observed between the two groups. Quercetin supplementation (500 mg/day) in post‐MI patients for 8 weeks significantly elevated TAC and improved the insecurity dimension of QOL, but failed to show any significant effect on inflammatory factors, blood pressure and other QOL dimensions.</jats:p>

Journal article

Raji Lahiji M, Najafi S, Janani L, Yazdani B, Razmpoosh E, Zarrati Met al., 2021, The effect of synbiotic on glycemic profile and sex hormones in overweight and obese breast cancer survivors following a weight-loss diet: A randomized, triple-blind, controlled trial, Clinical Nutrition, Vol: 40, Pages: 394-403, ISSN: 0261-5614

Journal article

Honardoost M, Janani L, Aghili R, Emami Z, Khamseh MEet al., 2021, The Association between Presence of Comorbidities and COVID-19 Severity: A Systematic Review and Meta-Analysis, Cerebrovascular Diseases, Vol: 50, Pages: 132-140, ISSN: 1015-9770

<jats:p>&lt;b&gt;&lt;i&gt;Aim:&lt;/i&gt;&lt;/b&gt; Several studies reported the accompaniment of severe COVID-19 with comorbidities. However, there is not a systematic evaluation of all aspects of this association. Therefore, this meta-analysis aimed to assess the association between all underlying comorbidities in COVID-19 infection severity. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Electronic literature search was performed via scientific search engines. After the removal of duplicates and selection of articles of interest, 28 studies were included. A fixed-effects model was used; however, if heterogeneity was high (&lt;i&gt;I&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt; &amp;#x3e; 50%) a random-effects model was applied to combine the data. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; A total of 6,270 individuals were assessed (1,615 severe and 4,655 non-severe patients). The median age was 63 (95% confidence interval [CI]: 49–74) and 47 (95% CI: 19–63) years in the severe and non-severe groups, respectively. Moreover, about 41% of patients had comorbidities. Severity was higher in patients with a history of cerebrovascular disease: OR 4.85 (95% CI: 3.11–7.57). The odds of being in a severe group increase by 4.81 (95% CI: 3.43–6.74) for a history of cardiovascular disease (CVD). This was 4.19 (95% CI: 2.84–6.19) for chronic lung disease and 3.18, 95% CI: 2.09–4.82 for cancer. The odds ratios of diabetes and hypertension were 2.61 (95% CI: 2.02–3.3) and 2.37 (95% CI: 1.80–3.13), respectively. &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; The presence of comorbidities is associated with severity of COVID-19 infection. The strongest association was observed for cerebrovascular disease, followed by CVD, chronic lung disease, cancer, diabetes, and hype

Journal article

Mohammady M, Radmehr M, Janani L, 2021, Slow versus fast subcutaneous heparin injections for prevention of bruising and site pain intensity, COCHRANE DATABASE OF SYSTEMATIC REVIEWS, ISSN: 1469-493X

Journal article

Shamsoddin E, Janani L, Ghamari K, Kabiri P, Shamsi Gooshki E, Mesgarpour Bet al., 2020, Psychometric properties of Persian version of the research misconduct questionnaire (PRMQ), Journal of Medical Ethics and History of Medicine

<jats:p>Assessment of scientific misconduct is considered to be an increasingly important topic in medical sciences. Providing a definition for scientific research misconduct and proposing practical methods for evaluating and measuring it in various fields of medicine discipline are required. This study aimed at assessing the psychometric properties of Scientific Research Misconduct-Revised (SMQ-R) and Publication Pressure Questionnaires (PPQ). After translation and merging of these two questionnaires, the validity of the translated draft was evaluated by 11-member expert panel using Content Validity Index (CVI) and Content Validity Ratio (CVR). Reliability of the final questionnaire, completed by 100 participants randomly chosen from medical academic members, was assessed by calculating Cronbach’s alpha coefficient. The final version was named Persian Research Misconduct Questionnaire (PRMQ) and consisted of 63 question items. The item-level content validity indices of 61 questions were above 0.79, and reliability assessment showed that 6 out of 7 subscales had alpha values higher than 0.6. Hence, PRMQ can be considered an acceptable, valid and reliable tool to measure research misconduct in biomedical sciences researches in Iran.</jats:p>

Journal article

Gharacheh M, Khalajabadi Farahani F, Mirghafourvand M, Janani L, Ranjbar Fet al., 2020, A multicenter randomized controlled trial protocol to evaluate the effectiveness of an educational intervention on fertility knowledge, intention and behavior among Iranian new couples, BMC Public Health, Vol: 20

<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>Recent evidence shows that men and women have inadequate fertility knowledge which may negatively affect their childbearing decisions in future. Given the fact that decision making for fertility needs accurate information, targeted educational interventions especially through media are needed to improve knowledge regarding the best age of fertility, factors affecting fertility potential and fertility options available for sub-fertile couples. Aim of the study is to evaluate whether a fertility educational program can be effective in increasing fertility knowledge, childbearing intention and the planned pregnancy rate among couples referring to premarital counselling centers.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>This study is a parallel randomised clinical trial with pre-test/post-test design. We will recruit 1240 marrying couples referring for compulsory premarital counselling in public health centers through stratified sampling in five metropolitan cities of Iran. The intervention group will receive both the typical premarital counselling training and a fertility knowledge package containing verbal and virtual educational package at five time episodes (one verbal session and four virtual sessions) within 4 weeks. The primary outcomes are fertility knowledge, childbearing intention and the first planned pregnancy rate (positive pregnancy test) and the secondary outcomes include contraception method use, miscarriage and unplanned pregnancy. Participants will respond to a self-administered demographic/reproductive characteristics questionnaire, the Cardiff Fertility Knowledge Scale (CFKS) and the childbearing intention questionnaire.</jats:p> <jats:p>Data will be col

Journal article

Saadati H, Baradaran HR, Danaei G, Ostovar A, Hadaegh F, Janani L, Steyerberg EW, Khalili Det al., 2020, Iranian general populations' and health care providers' preferences for benefits and harms of statin therapy for primary prevention of cardiovascular disease, BMC Medical Informatics and Decision Making, Vol: 20

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>The use of statins for primary prevention of cardiovascular diseases is associated with different benefit and harm outcomes. The aime of this study is how important these outcomes are for people and what people's preferences are.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We conducted a preference-eliciting survey incorporating a best–worst scaling (BWS) instrument in Iran from June to November 2019. The relative importance of 13 statins-related outcomes was assessed on a sample of 1085 participants, including 913 general population (486 women) and 172 healthcare providers from the population covered by urban and rural primary health care centers. The participants made trade-off decisions and selected the most and least worrisome outcomes concurrently from 13 choice sets; each contains four outcomes generated using the balanced incomplete block design.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>According to the mean (SD) BWS scores, which can be (+ 4) in maximum and (− 4) in minimum, in the general population, the most worrisome outcomes were severe stroke (3.37 (0.8)), severe myocardial infarction (2.71(0.7)), and cancer (2.69 (1.33)). While myopathy (− 3. 03 (1.03)), nausea/headache (− 2.69 (0.94)), and treatment discontinuation due to side effects (− 2.24 (1.14)) were the least worrisome outcomes. Preferences were similar between rural and urban areas and among health care providers and the general population with overlapping uncertainty intervals.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The rank of health outcomes may be similar in various socio-cultural contexts. The preferences for benefi

Journal article

Safarpour P, Daneshi-Maskooni M, Vafa M, Nourbakhsh M, Janani L, Maddah M, Amiri F-S, Mohammadi F, Sadeghi Het al., 2020, Vitamin D supplementation improves SIRT1, Irisin, and glucose indices in overweight or obese type 2 diabetic patients: a double-blind randomized placebo-controlled clinical trial, BMC Family Practice, Vol: 21

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Vitamin D (VD) may increase sirtuin 1 (SIRT1) and subsequently PPAR-γ coactivator 1α (PGC-1α) and irisin levels and these improvements may reduce insulin resistance (IR). The aim was to assess the effects of vitamin D supplementation on SIRT1, irisin, and IR in overweight/obese type 2 diabetes (T2D) patients.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Ninety T2D males and females were recruited as a clinical trial study (mean of age and body mass index (BMI) of intervention and placebo groups were 50.05 ± 10.17 and 50.36 ± 10.2 yrs. and 31.37 ± 3.4 and 30.43 ± 3.2 kg/m<jats:sup>2</jats:sup>, respectively). The inclusion criteria were T2D, VD deficient, BMI &gt; 25 kg/m<jats:sup>2</jats:sup>, and serum HbA1c &lt; 8.5%. The exclusion criteria were using vitamin and mineral supplements, having any acute disease, recent modifying dose or type of drugs. The supplementation was 50,000 IU/week VD or placebo for 8 weeks. The demographic characteristics, anthropometrics, dietary intakes and physical activity status, sun exposure status, fasting blood sugar (FBS) and insulin, glycosylated hemoglobin (HbA1c), irisin, SIRT1, 25-hydroxy D3 (25(OH)VD), homeostasis model assessment of insulin resistance (HOMA-IR), and quantitative insulin sensitivity check index (QUICKI) were determined. The significant<jats:italic>P</jats:italic>-value was ≤0.05.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The increase of serum VD, SIRT1, and irisin in the intervention group was significant (<jats:italic>p</jats:italic> &lt;&

Journal article

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