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Example of roles and responsibilities of school committees in Madhya Pradesh (MP). | (DOCX)Click here for additional data file. | PMC10016677 | ||
Definition of low caste groups. | (DOCX)Click here for additional data file. | PMC10016677 | ||
Inclusivity in global research. | (DOCX)Click here for additional data file. | PMC10016677 | ||
Share of rural, literate and poor populations in India, MP, UP and Karnataka. | (DOCX)Click here for additional data file. | PMC10016677 | ||
Baseline characteristics by randomized treatment status in MP, UP and Karnataka. | Mean values represent shares except indicated otherwise. Sample size is in parentheses when differs due to missing values. Karnataka did not have contract teachers in public schools during the study period.(DOCX)Click here for additional data file. | PMC10016677 | ||
Baseline school council awareness outcomes by treatment status in MP, UP and Karnataka. | Mean values represent shares except indicated otherwise. School council variables represent member response aggregated at village cluster level by member type (chair, secretary, parent member). Sample size is in parentheses in cell when differs due to missing values.(DOCX)Click here for additional data file. | PMC10016677 | ||
Difference-in-differences linear regression where change in teacher effort outcome from baseline to follow-up is dependent variable, MP and UP. | Sample consists of civil-service teachers by characteristics. Value represents coefficient on treatment variable. 95% confidence interval in parentheses.(DOCX)Click here for additional data file. | PMC10016677 | ||
Difference-in-differences linear regression where change in school council awareness outcome from baseline to follow-up is dependent variable, MP, UP and Karnataka. | Value represents coefficient on treatment variable. 95% confidence interval in parentheses.(DOCX)Click here for additional data file. | PMC10016677 | ||
Difference-in-differences linear regression where change in school council outcome from baseline to follow-up is dependent variable, UP. | Value represents coefficient on treatment variable. 95% confidence interval in parentheses.(DOCX)Click here for additional data file. | PMC10016677 | ||
Difference-in-differences linear regression where change in school council outcome from baseline to follow-up is dependent variable, MP. | Value represents coefficient on treatment variable. 95% confidence interval in parentheses.(DOCX)Click here for additional data file. | PMC10016677 | ||
Difference-in-differences linear regression results where change in outcome from baseline to follow-up is dependent variable, Karnataka. | Value represents coefficient on treatment variable. 95% confidence interval in parentheses. Since the two treatments differ in one dimension only and are otherwise identical, the table reports the average impact of the two treatments pooled compared with the control group and additional impact of the second treatment compared with the first.(DOCX)Click here for additional data file. | PMC10016677 | ||
Focus group discussions, MP and UP. | (DOCX)Click here for additional data file. | PMC10016677 | ||
Approximate cost-benefit calculations of (increased teacher effort due to) the intervention in MP and UP. | Number of civil-service primary school teachers is taken from National University of Education Planning and Administration (NUEPA), 2009 [S10.1]. Attendance is valued at teacher cost for the total number of civil service teachers in the state. In this case teacher cost is taken as the monthly average salary of Indian Rupees 15,000 for a teacher in each state [(DOCX)Click here for additional data file.I am deeply indebted to Savita Dhingra, Julie-Anne Graitge, Renu Gupta and Karthika Radhakrishnan for providing invaluable support and assistance in the study. I gratefully acknowledge creative advice from the Nike Foundation in the design of campaign tools. And thank Samuel Carlson, Nazmul Chaudhury, Amit Dar, Deon Filmer, Stuti Khemani, Reema Nayar, Michelle Riboud and seminar participants for helpful comments. Special thanks are due to Sangeeta Goyal and Venkatesh Sundararaman for invaluable support in the study throughout. Special gratitude goes to Michelle Riboud and Amit Dar for supporting the study through its various stages. | PMC10016677 | ||
References | PMC10016677 | |||
Abstract | Christian Patrick Jauernik and Or Joseph Rahbek contributed equally to this work. | PMC10234657 | ||
Background | DISEASE | Invitations to screening programmes may include influences that are intending to increase the participation rates. This study had two objectives: (i) to assess if different categories of influences had a significant effect on the intention to participate in a screening programme for a fictitious disease and (ii) whether participants were aware of the influences, and if the intention to participate was associated to this awareness. | PMC10234657 | |
Methods | ITP | ITP | A seven-armed randomized controlled trial. Six hundred passers-by were randomly allocated to receive one of seven pamphlets inviting to a fictitious screening programme (neutral, relative risk reductions, misrepresentation of harms, pre-booked appointment, recommendation of participation, fear appeals, all combined). Participants were surveyed to assess (i) intention to participate (ITP) in the screening programme and (ii) awareness of an exerted influence. Chi-squared test was used to calculate the effect of the influences on ITP and the association of ITP with indicating awareness of an exerted influence and correctly locating an influence. | PMC10234657 |
Results | ITP | ITP | Five hundred and eighty-nine participants were included for analysis. ITP was significantly increased ( | PMC10234657 |
Conclusion | The application of influences should be carefully considered for interventions where an informed choice is desired. | PMC10234657 | ||
Introduction | cancer, cancers | CANCER, CANCERS | Screening programmes for different cancers are implemented in many developed countries. They have intended benefits including reduction in mortality and morbidity plus less radical treatments.It is understandable that health authorities would actively use influences to maximize potential benefits of cancer screening programmes, but by defining participation as ‘the right choice’ for all, the health authorities’ interest conflicts with the interest of the individual citizens. Not all citizens will share the same assessment of the benefits/harms as the health authorities. And even if they agree with the health authorities that the benefits outweigh the harms on a population level, they may still not wish to participate because they on an individual level might receive more harm than benefit—current evidence suggests that the more informed citizens are less likely to participate in cancer screening.A scoping review from 2019 identified influences intended to increase participation that appeared in invitations to cancer screening programmes and constructed five categories of these influencesPrevious studies have found a considerable increase in both the intention to participate in screening programmes (relative risk reductions | PMC10234657 |
Methods | MAY | The study followed a seven-arm randomized controlled design that took place in 19 different public locations (libraries, citizen service centres, parks and town squares) in Copenhagen and six proximal municipalities through May–July 2017. | PMC10234657 | |
Participants | Passers-by assessed by the interviewers to be above the age of 18 were selectively approached to attain a wide distribution of age and sex. The number and sex of passers-by who refused to participate or did not respond were recorded. Sociodemographic data (age, sex, level of education and employment status) for every 10th non-participant was collected. If the 10th non-participant refused to answer these questions, the following non-participant was asked until data was obtained.Potential participants were not included if they were illiterate, had insufficient Danish language skills or were too busy to commit the necessary time (at least 5 minutes) for the interview. | PMC10234657 | ||
Material | cancer, colorectal cancer, CRC, non-communicable life-threatening disease | DISEASE, CANCER, COLORECTAL CANCER | The authors created an invitational pamphlet (four A5 sheets with a total of 606 words) in Danish that invited the receiver to attend a medical screening programme for a fictitious, non-communicable life-threatening disease named ‘cytoliosis’. It was anticipated that the threat of cancer would trigger particularly strong emotions in respondents, and thus lead to cancer-specific results. Therefore, cytoliosis was invented to eliminate any preconceptions and fears regarding cancer.The pamphlet for screening for cytoliosis was partially based on the Danish colorectal cancer (CRC) screening pamphlet, and cytoliosis shared the same incidence and mortality as CRC.Five other pamphlets were made based on the ‘neutral’ one (A). Each of these incorporated one of the categories of influences mentioned in the introduction. One pamphlet made use of relative risk reductions (B) to emphasize mortality reduction. A third pamphlet omitted harms and emphasized benefits (C). Pre-booked appointments (D) were introduced in a fourth pamphlet as an example of an opt-out system and the fifth pamphlet contained explicit recommendation for participation (E) from the Danish Health Agency and Danish Patient Society. A sixth pamphlet used fear appeals (F), e.g. underlining the severity of the disease. Finally, a pamphlet combining all five influences (G) was made. See All the types of influence studied were inspired by actual examples from cancer screening programmes.One hundred pilot interviews were conducted to evaluate face validity, content validity and project feasibility and to develop an interview guide for the present study. | PMC10234657 |
Sample size determination | An | PMC10234657 | ||
Randomization and interviews | RECRUITMENT | Each pamphlet was assigned according to a randomized, computer-generated allocation sequence where the neutral pamphlet (A) occurred twice as much as each of the other pamphlets [2; 1; 1; 1; 1; 1; 1]. Recruitment and the structured interviews were based on an interview guide (see | PMC10234657 | |
Primary outcome: intention to participate | The effect of the influences was measured by differences in intention to participate between the neutral pamphlet (A) and the pamphlets containing the influences (B–G). Intention to participate was measured by asking the surveyed person if they wanted to participate in the screening programme | PMC10234657 | ||
Secondary outcomes | To evaluate whether the surveyed persons were aware of the effort to influence their choice each surveyed person was asked which of two statements he/she agreed with the most: ‘The pamphlet provides me information in order to help me make my own choice’ or ‘The pamphlet provides me information in order to direct me towards the choice that the pamphlet favours’. If the surveyed person felt that the pamphlet tried to direct their choice, (s)he was asked if there were anywhere specific in the pamphlet that made them feel so. It was then noted if the selected paragraph contained an influence or not. More general responses were also recorded, i.e. ‘the first page is trying to scare me’ or ‘there is no mention of harms’. It was then decided by the coding interviewer whether the response indicated awareness or non-awareness to the influence.The effect of awareness of the influences on intention to participate was assessed by comparing odds ratios (ORs) of intention to participate between three groups: one group who felt the pamphlet tried to help the receiver make their own choice, one group who felt the pamphlet tried to direct their choice and subsequently correctly located an influence and the last group who felt the pamphlet was trying to direct their choice but failed to correctly locate an influence. | PMC10234657 | ||
Sociodemographic | Information regarding age, sex, level of education, employment status, household status and mother tongue was obtained through a simple, self-reported questionnaire following each interview. | PMC10234657 | ||
Statistical analysis | REGRESSION, SECONDARY, RECRUITMENT | Chi-squared (χFor the primary outcome, ORs from logistic regression analysis were used to assess the difference in intention to participate for each pamphlet relative to the neutral pamphlet (A), both unadjusted and adjusted for all the pre-determined gathered sociodemographic data including the location of recruitment. For analysis, age was grouped into four categories: under 30, 31–45, 46–60 and over 60. For the secondary outcome, logistic regression analysis was used to obtain ORs and adjust for the distribution of the pamphlets in each group.The statistician was blinded to the group allocations during the whole process.A | PMC10234657 | |
Contribution | All listed authors attest that they meet authorship criteria and that no others meeting the criteria have been omitted. The study design was conceived by all authors. O.J.R. and C.P.J. drafted the interview guide and the pamphlets, and T.P. and J.B. provided comments that led to revisions. All interviews were conducted and coded by O.J.R. and C.P.J. V.S. generated the allocation sequence and conducted statistical analyses. O.J.R. and C.P.J. drafted the manuscripts and T.P., J.B. and V.S. contributed to revisions. O.J.R. and C.P.J. are guarantors for this paper. | PMC10234657 | ||
Ethics issues | According to the Danish Scientific Ethical Committees Act §1 stk. 4, this project does not require review from the committee, as it is not classified as a health research study. No personal data were collected. All participants were informed before participation that cytoliosis and the screening programme were fictitious. | PMC10234657 | ||
Results | PMC10234657 | |||
Participant characteristics | The authors approached 1489 passers-by (718 men, 771 women). Of those, 600 committed to participate (40.30%), where two were excluded due to age under 18 (one from group B and one from group D). Nine dropped out of the study while reading the pamphlet but before the interview: eight because they could not provide the necessary time (two from group A, four from group B, one from group E and one from group F) and one because of insufficient Danish skills (one from group B). This left 589 for analysis. See the flowchart in Participants differed from the sampled non-participants: Participants were generally longer educated, younger and more often employed or studying. See Participant and non-participant sociodemographic dataNA, not applicable. | PMC10234657 | ||
Primary outcome: intention to participate across the influences | RECRUITMENT | The lowest proportion of intention to participate (31.8%) was seen in the group receiving the neutral pamphlet (A), while the proportion from the other pamphlets ranged between 39.2% and 80.0%. An OR > 1 was seen across all pamphlets comprising influences both adjusted and unadjusted for all gathered sociodemographic data, including the location of recruitment (The intention to participate for each pamphlet with an influence (B–G) relative to the neutral pamphlet (A) | PMC10234657 | |
Secondary outcome: awareness of the influences | A majority varying from 60.0% to 78.3% did not indicate awareness that their choice was trying to be influenced (pamphlets B–G). There was no clear difference between the answers to the neutral pamphlet (A), and the pamphlets containing a deliberate attempt at influencing the participants choice. The participants who found that the pamphlet tried to direct their choice could correctly locate the influences more often than not in pamphlets C, F and G, while almost none were able to correctly locate the influences in pamphlets B, D and E. See The number of participants indicating awareness of the influences and ability to correctly locate the influences, stratified for each pamphletNA = Not applicable. | PMC10234657 | ||
Secondary outcome: the effect of awareness of the influences on intention to participate | Participants receiving a pamphlet with an influence (B–G), who did not indicate awareness that their choice was trying to be influenced had an increased intention to participate compared to both those who felt the pamphlet was trying to direct their choice and subsequently correctly located an influence, and those who felt the pamphlet was trying to direct their choice but failed to correctly locate an influence (Intention to participate stratified for the indication of awareness of the influences, adjusted | PMC10234657 | ||
Discussion | cancer | CANCER, DISEASE, RECRUITMENT, SECONDARY, DISEASES | All five categories of influences proved to increase intention to participate with an adjusted OR > 1. Less than half of the participants indicated awareness of the influences, and not indicating awareness was associated with an increased intention to participate. For those who indicated a general awareness of influences, there was no statistically significant difference in intention to participate between those who correctly and those who incorrectly located the influences.A strength of this study is the randomized design where blinding of the interviewers was broken only after recruitment and thereby eliminating possible confounding. The interviews were conducted in consistence with a structured guide that addressed potential biases associated with breaking the blinding. Another potential strength is using an unknown, fictitious disease as cytoliosis eliminating fears and preconceptions associated with, e.g., cancer and well-known life-threatening diseases that could overestimate the intention to participate across all pamphlets. Our primary outcome was calculated as intention to participate, which we consider a strength because the intention to participate is regarded as a valid outcome of informed choice regarding cancer screening participation.A potential limitation of the present study is the risk of an interviewer’s effect on participants who might strive to answer what they believe is confirming the hypothesis of the researchers. This was addressed during the interviews through the structured interview guide.The results of the secondary outcomes should be interpreted with caution. Since the secondary outcomes are measured after the participants indicate their intention to participate, it may affect their response as to whether the pamphlet was trying to direct their choice. We hypothesize that the participants who intended to participate might be more reluctant to admit that they have been potentially influenced. This would understate the measured awareness in the groups with the highest intention to participate.Another limitation could be that the external validity of the study is limited due to cytoliosis being a fictitious disease. This might explain why pamphlet (D) (pre-booked appointments) has a relatively low effect size (adjusted OR 1.15) since participants could not relate to opting out of a ‘false’ screening programme. This could explain the discrepancy with a different study that found that the impact of pre-booked appointments compared to mailed reminders almost doubled participation within 6 months (risk ratio 1.9, 95% CI: 1.5–2.3).Before and after adjustment all six pamphlets proved an OR >1. We hypothesize that the statistically insignificant ORs might prove significant in a larger population. Regardless, decision-makers should take into consideration that a slightly positive OR can translate to great numbers of influenced participants in screening populations.Not indicating awareness of being influenced is associated with a stronger intention to participate. Citizens who are less alert to attempts at influencing their choices might therefore enrol in a screening programme because of being influenced rather than being convinced by unbiased information. These results beg consideration and discussion of the use of different types of influences applied to increase the participation rate in cancer screening programmes. The potential harms of participating in cancer screening programmes can be severe and substantial, and the intended effect of increasing the participation rate using influences must be carefully weighed against the unintended effect of potentially bypassing the participants’ informed choice. This indicates a need for alternative ways of appraising cancer screening programmes than by participation rate. One such alternative could be the rate of informed decisions by potential screening participants. However, appraising screening programmes by the rate of informed choice introduces new problems. Citizens might feel distressed trying to comprehend the many consequences, benefits and harms of the offered programmes.For future research, it is relevant to investigate the potential negative effects of using the influences. An example of such a negative effect is weakened trust in healthcare authorities.Informational material is not the only aspect of decision-making, and this study does not examine external reasons for the participants’ choices, e.g. society’s (health) culture, one’s own and society’s general attitudes to health interventions, sense of duty, behaviour and opinions of relatives, barriers to intention and actual behaviour, health professionals’ financial incentives to increase screening uptake, etc. The impact of informational material on actual choice may be limited.In conclusion, the considerable effect of the influences that are further enhanced by non-awareness suggests that the application of such influences should be carefully considered for interventions where participation on an informed basis is intended. Further research about the potential negative effects of influences is warranted, i.e. weakened trust in health authorities. | PMC10234657 |
Supplementary Material | Click here for additional data file. | PMC10234657 | ||
Supplementary data | PMC10234657 | |||
Funding | Cancer | CANCER | C.P.J. and O.J.R. have received financial support in the form of research grants for this work, from the Danish Cancer society (R168-A11066, R190-A11702, R190-A11701, R168-A11065). The funders had no role in the study design, data collection analysis, reporting or writing of the manuscript. C.P.J. and O.J.R. are fully independent from the funders. All authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.
Omission of harms/exaggeration of benefits, fear appeals and a combination of the former in addition to pre-booked appointments, relative risk reductions and explicit recommendations to participate significantly increases citizens’ intention to participate in a fictitious medical screening programme.Only a minority of citizens are able to indicate awareness of the influences, and non-awareness is associated with an increased intention to participate.Public Health Authorities must carefully consider the use of (un)intended influences when inviting to screening programmes.There is a need of more knowledge and debate to determine if and under which circumstances the use of such influences are acceptable. | PMC10234657 |
Data availability | The complete dataset is available upon request to the corresponding author. | PMC10234657 | ||
References | PMC10234657 | |||
Background | depression, anxiety | Evidence suggests that menopause can be associated with a variety of negative psychological changes such as depression and anxiety, and improving the mental health status of women during menopause is one of the important priorities and challenges of the health system. The aim of this study was to determine the effect of saffron ( | PMC10233190 | |
Methods | white rock candy | In this randomized clinical trial which was conducted in 2021, 72 postmenopausal women were enrolled and divided into intervention and control groups. The randomization blocks method was used for random allocation, and the Oxford Happiness Questionnaire was utilized to measure the scores. The intervention included the use of 30 mg of dried stigmas of the saffron plant, which was boiled once (in the morning, in 300 ml of boiling water for 10–15 min) and consumed with white rock candy as one cup of saffron tea daily. To compare the trend of changes and after removing the effect of other variables, generalized estimating equation (GEE) was used. | PMC10233190 | |
Results | There was no significant difference between the intervention and control groups in any of the quantitative and qualitative characteristics ( | PMC10233190 | ||
Conclusion | depression | Saffron herbal tea had a positive effect on reducing depression and increasing the happiness score; thus, it is recommended that it should be used as a complementary treatment in consultation with the treating physician. | PMC10233190 | |
Trial registration | The present study was registered with the code of IRCT20210403050818N1 (Registration date: 09/04/2021) in the Iranian Registry of Clinical Trials. It was also approved by the Ethics Committee of Larestan University of Medical Sciences (Approval ID: IR.LARUMS.REC.1399.017). | PMC10233190 | ||
Keywords | PMC10233190 | |||
Background | depression, happiness, pain | COMPLICATIONS | Women are regarded as the foundation of family health; in addition to managing the health of the family members, they are the main role model of educating and promoting a healthy lifestyle for future generations. Menopause is one of the natural processes in a female’s life, the most prominent feature of which is the end of fertility and menstruation [Another animal study showed that intraperitoneal administration of alcoholic saffron extract with doses of 200 and 800 mg/kg and aqueous extracts of saffron with doses of 160 and 320 mg/kg significantly reduced immobility time compared to normal saline.In the open box test, saffron aqueous extract, unlike the alcoholic extract, with doses of 160 and 320 mg/kg, significantly reduced overall movement compared to normal saline. A decrease in the time of remaining motionless in the swimming test was observed with the effective substances of saffron, i.e. A study designed with the aim of the effect of saffron supplement and resistance training on the markers involved in the level of depression and happiness in untrained young men showed that 6 weeks of saffron supplementation along with resistance training improved the level of happiness, serotonin, dopamine, beta endorphin, anandamide and 2-arachidonoylglycerol [Given the high number of postmenopausal women, the possibility of unpleasant mood changes among this group due to menopausal complications, the need to improve the mental state of this group, the responsibility of nurses in assessing the mental state of this group of people, the need to implement appropriate measures, and lack of a similar study on the effect of saffron herbal tea on the happiness of postmenopausal women, researchers decided to conduct a study to determine the effect of saffron tea on the postmenopausal women’s happiness. Hopefully, the results of this study will be an effective step in recognizing complementary and alternative medicine treatments, especially the use of herbal teas, in the nursing community, and can alleviate the patients' pain. | PMC10233190 |
Methods | PMC10233190 | |||
Study type | The present study was a randomized controlled trial study conducted in 2021 in Iran. | PMC10233190 | ||
Study population | The participants in this study consisted of all postmenopausal women who referred to community health centers affiliated to Larestan University of Medical Sciences in 2021. | PMC10233190 | ||
Sample size | To determine the sample size using a similar study [ | PMC10233190 | ||
Sampling | First, the list of community health centers affiliated to Larestan University of Medical Sciences, to which postmenopausal women referred for health services, was extracted. In the next step, the name of each center was placed in a separate envelope and by simple random sampling, the envelope was selected. | PMC10233190 | ||
Random allocation | For allocation of individuals to the intervention and control groups, the randomized blocks method was used. According to the total sample size ( | PMC10233190 | ||
Blinding | BLIND | In the present research, it was not possible to blind the study participants. | PMC10233190 | |
Inclusion criteria | cognitive diseases, chronic and debilitating diseases, dementia, psychosis |
Willingness to participate in the study.Not suffering from acute psychosis, chronic and debilitating diseases, and cognitive diseases such as dementia.Not being under similar treatment recently.Not being familiar with the Persian language.Not participating in other treatment programs that interfere with the present study.Being able to swallow and having no oral or digestive problems that interfere with drinking.Lack of menstruation for at least 12 months. | PMC10233190 | |
Exclusion criteria | allergy, psychiatric, Infection | CHRONIC ILLNESS, ALLERGY, INFECTION |
Occurrence of any social and family crisis during the study. Hospitalization or acute and chronic illness that interferes with research. History of allergy to herbal medicines. Unwillingness to continue participating in the research. Addiction to drugs and alcohol and painkillers. Consumption of psychiatric drugs. Infection of the participant or her family members with COVID-19. | PMC10233190 |
Questionnaire | Depression | In the present study, two demographic information and happiness questionnaires were used. To complete the questionnaires, two assistant researchers distributed the questionnaires among the participants. Demographic information questionnaire included questions on age, marital status, level of education, and menopausal age.Happiness Questionnaire: The Oxford Happiness Questionnaire was developed in 1990 by revising the Beck Depression Scale. This scale has 29 items that are graded based on a four-point scale ranging from 1 to 4. Therefore, the minimum score of each subject is 29 and the maximum score 116. The higher the subject's score, the higher his/her happiness, and vice versa [If willing to cooperate, postmenopausal women were randomly divided into two intervention groups: the group which received saffron herbal tea and control group. Postmenopausal women in each group were then assessed for their happiness using a questionnaire. | PMC10233190 | |
Intervention | white rock candy [ | The intervention was the use of 30 mg dried stigmas of the saffron plant (Mostafavi company, Iran. This company is one of the largest producers of saffron in Iran and the world), which was boiled once (in the morning) (in 300 ml of boiling water for 10–15 min); one cup of saffron tea was consumed daily with white rock candy [ | PMC10233190 | |
Control group | depression | In the present study, lukewarm water and white rock candy were considered for the control group, and the subjects in this group were asked to consume it one glass daily. A similar study that measured the effect of lavender tea on depression used lukewarm water and white rock candy for the control group [ | PMC10233190 | |
Side effects | According to the results of previous studies, the maximum safe daily dose of saffron is 1.5 g, so it was expected that the dose in the present study did not cause side effects [ | PMC10233190 | ||
Ethical considerations | The present study was registered with the code of IRCT20210403050818N1 (Registration date: 09/04/2021) in the Iranian Registry of Clinical Trials. It was also approved by the Ethics Committee of Larestan University of Medical Sciences (Approval ID: IR.LARUMS.REC.1399.017). After assigning the participants to the two groups of intervention and control, informed consent was obtained from them and in all stages of the study, and the participants were ensured that their information would remain confidential. | PMC10233190 | ||
Statistical methods | After completing the questionnaires by the samples, the data were entered into SPSS software, version 25. Fisher's exact test was used to measure the relationship between qualitative variables and independent sample t-test was used to compare the mean happiness scores in the intervention and control groups. Also, the comparison of the mean happiness score in the stage before and after the intervention in each group was performed using paired sample t-test. To compare the trend of changes and after removing the effect of other variables, generalized estimating equation (GEE) was used. A statistical significance level of 0.05 was considered. | PMC10233190 | ||
Discussion | depression, dry mouth | DRY MOUTH | From the past to the present, saffron and its main derivatives, as well as organoleptic properties, are commonly used in traditional medicine due to their numerous therapeutic properties such as anti-anxiety, anti-depressant, and anti-seizure effects [In the present study, saffron herbal tea was used for postmenopausal women. The results of the study showed that saffron herbal tea significantly increased the mean score of happiness in postmenopausal women, and there was a statistically significant difference between the intervention and control groups. In other words, the results showed that saffron herbal tea could have a positive effect on the participants' happiness, which was similar to the results of previous studies.The findings of Shahmansouri et al.’s [A study on the comparison of the effects of saffron and Imipramine in the treatment of mild to moderate depression showed that a 10 mg dose of saffron capsule had the same effect in the treatment of mild to moderate depression as imipramine. In addition, this study showed that Imipramine had anticholinergic effects such as dry mouth [Human and animal studies have shown that saffron and its compounds have a therapeutic effect on mild to moderate depression, which seems to be due to interaction with serotonin and noradrenaline; however, more clinical and laboratory studies are recommended to find a more precise mechanism of action [One of the limitations of the present study was that it coincided with the increase in the prevalence of COVID-19 in Iran, which might have indirectly affected the results of the study. The authors of this study suggest that researchers in other parts of the world conduct more studies to find out the mechanism of saffron's effect and provide more guarantee for its happy effects. | PMC10233190 |
Acknowledgements | The present study is the result of a research project with the code number of 1399-64 in Larestan University of Medical Sciences. Authors would like to thank and appreciate the Larestan University of Medical Sciences for financial support of the project. | PMC10233190 | ||
Authors’ contributions | Hamed Delam: Study design, Methodology, Supervision and Writing Original draft preparation. Zahra Keshtkaran: Investigation and Conceptualization. Nasrin Shokrpour: Critical revision of the manuscript for important intellectual content. Ahmadreza Eidi: analysis and interpretation of data, Mohammad-Rafi Bazrafshan: Conceptualization. All authors read and approved the text of the manuscript. | PMC10233190 | ||
Funding | This research was supported by the Larestan University of Medical Sciences with the code number of 1399–64. | PMC10233190 | ||
Availability of data and materials | The data used and analyzed in this study are available from the corresponding author on reasonable request. | PMC10233190 | ||
Declarations | PMC10233190 | |||
Ethics approval and consent to participate | The present study approved by the ethics committee of Larestan University of Medical Sciences (Approval ID: IR.LARUMS.REC.1399.017). After assigning the participants to the two groups of intervention and control, informed consent was obtained from them and in all stages of the study, and the participants were ensured that their information would remain confidential. All methods were carried out in accordance with declaration of Helsinki. | PMC10233190 | ||
Consent for publication | Not applicable. | PMC10233190 | ||
Competing interests | The authors declare no competing interests. | PMC10233190 | ||
References | PMC10233190 | |||
Methods | dyspeptic | This was a retrospective cohort study. This study included 1,050 dyspeptic patients diagnosed with | PMC10688878 | |
Results | Of 1,050 patients with | PMC10688878 | ||
Conclusions | Nonadherence, infections | INFECTIONS | AST either before or after treatment failure correlated with a higher proportion of successful eradication. Nonadherence and the MDR infections predicted treatment failure. Tailored therapy and 4-times-daily dosing of | PMC10688878 |
Data Availability | All relevant data are within the paper and its | PMC10688878 | ||
Methods | PMC10688878 | |||
Study design | This was a retrospective cohort study conducted at tertiary care center in Thailand. The study was conducted from February 22, 2022 to February 19, 2023. Patients’ data were retrospectively collected by chart review between March 6, 2014, and October 31, 2021. The inclusion criteria were patients older than 15 years old with The primary aim of this study was to determine predictive factors for successful eradication in patients experiencing | PMC10688878 | ||
Diagnosis of | During upper GI endoscopy, at least four biopsies from antrum and body of stomach were performed and sent for rapid urease test and histological examination. | PMC10688878 | ||
Statistical analysis | All data were analysed by using SPSS version 22 (SPSS Inc., Chicago, IL, USA). Categorical variables were analysed by Chi-square test, or Fisher’s exact test where appropriate. Continuous variables were analysed by using Student’s t-test and reported as mean ± standard deviation (SD). Univariate analysis was performed to identify predictive factors associated with successful eradication after | PMC10688878 | ||
Ethics statements | The study obtained ethical approval by the Human Research Ethics Committee of Thammasat University, Thailand and was conducted according to the good clinical practice guideline, as well as the Declaration of Helsinki. All data had been fully anonymized before they were accessed. Waiver of documentation of informed consent was issued by the Ethics Committee because of no more than minimal risk to study subjects. Authors did not have access to information that could identify individual participants during or after data collection. | PMC10688878 | ||
Results | PMC10688878 | |||
Demographic data of patients with | upper gastrointestinal endoscopy | During the study period, 1,840 patients underwent upper gastrointestinal endoscopy at tertiary care center in Thailand. Of 1,840 patients, there were 1,050 with | PMC10688878 | |
Time trends of eradication rates of each first-line regimen during 2014–2021. | PMC10688878 | |||
Baseline characteristics and univariate analysis of predictors associated with treatment failure. | BMI = body mass index, FH = family history, VPZ = Vonoprazan, MDR = multidrug-resistant | PMC10688878 | ||
Predictive factors associated with treatment success of first-line failure | After first-line eradication failure, 301 patients received a second-line treatment. Levofloxacin triple therapy and bismuth quadruple therapy were the most commonly used empiric second-line regimens as recommended by the Thai guideline [ | PMC10688878 | ||
Eradication rates, univariate and multivariate analyses of strategies associated with treatment success after first-line eradication failure. | AMX = amoxicillin, PPI = proton pump inhibitor | PMC10688878 | ||
Effects of antibiotic susceptibility testing on eradication rates | Patients with | PMC10688878 | ||
Eradication rates of 3 subgroups according to the time of performed AST. | AST = Antibiotic susceptibility testing. | PMC10688878 | ||
Antibiotic resistance in Thailand during 2014–2021 compared with 2004–2012. | AST was performed for 192 strains (TET = Tetracycline, AMX = Amoxicillin, CLR = Clarithromycin, LVX = Levofloxacin, MTZ = Metronidazole, MDR = Multidrug-resistant strains. | PMC10688878 | ||
Antibiotic resistance pattern of | PMC10688878 | |||
The prevalence of | TET = Tetracycline, AMX = Amoxicillin, CLR = Clarithromycin, LVX = Levofloxacin, MTZ = Metronidazole, MDR = Multidrug-resistant strains, N/A = Not availableOur study has several strengths. This is a large population-based study demonstrating predictors for successful eradication in patients experiencing In conclusion, | PMC10688878 | ||
Supporting information | PMC10688878 | |||
Four-times-daily dosing of amoxicillin in successful eradication regimens (N = 42). | (DOCX)Click here for additional data file. | PMC10688878 | ||
Vonoprazan-containing regimens used after first-line failure. | (DOCX)Click here for additional data file. | PMC10688878 | ||
STROBE statement—Checklist of items that should be included in reports of observational studies. | (DOCX)Click here for additional data file. | PMC10688878 | ||
References | PMC10688878 | |||
Supplementary Information | overweight or obesity | The objective of this study was to investigate changes in sedentary and active behaviors when previously inactive adults start exercising in the morning or evening. One-hundred adults with overweight or obesity (BMI ≥ 25 kg/mThe online version contains supplementary material available at 10.1007/s10865-022-00370-x. | PMC10261239 |
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