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Patients and methods | PMC9926577 | |||
Data source and study cohort | OPSCC, Cancer | CANCER | From the Taiwan Cancer Registry Database (TCRD), we enrolled patients who had received a diagnosis of p16-negative OPSCC between January 1, 2008, and December 31, 2018. The follow-up duration was from the index date to December 31, 2019. Biomarkers commonly used in clinical practice include p16 expression (determined through immunohistochemistry) and HPV 16 viral load (detected through real-time polymerase chain reaction) [ | PMC9926577 |
Selection of cases and controls | OPSCC, AJCC, Cancer | CANCER, METASTASIS, CANCER | Inclusion criteria were having a diagnosis of p16-negative OPSCC, being aged > 20 years, and having American Joint Committee on Cancer (AJCC) clinical stage I–IVA cancer without metastasis. The AJCC 8 | PMC9926577 |
Study covariates | comorbidity | Comorbidities were scored using the Charlson comorbidity index (CCI). | PMC9926577 | |
Statistical analysis | REGRESSION | The cumulative mortality rate was estimated using the Kaplan–Meier method. Differences between the pre-CCRT PET–CT and non-pre-CCRT PET–CT groups were determined using the log-rank test. After adjustment for confounders, the Cox proportional regression model was used to model the time from the index date to all-cause mortality among the cases and controls. HRs were calculated in multivariate analysis with adjustment for sex, age, AJCC clinical stage, differentiation, CCI score, diagnosis year, and hospital volume. All analyses were performed using SAS (version 9.4; SAS, Cary, NC, USA). Two-tailed | PMC9926577 | |
Results | PMC9926577 | |||
Survival curves of case and control groups | oropharyngeal squamous cell carcinoma | OROPHARYNGEAL SQUAMOUS CELL CARCINOMA | Figure Kaplan–Meier curves of overall survival for patients with all stages of p16-negative oropharyngeal squamous cell carcinoma receiving concurrent chemoradiotherapyKaplan–Meier curves of overall survival for patients with early stages of p16-negative oropharyngeal squamous cell carcinoma receiving concurrent chemoradiotherapyKaplan–Meier curves of overall survival for patients with advanced stages of p16-negative oropharyngeal squamous cell carcinoma receiving concurrent chemoradiotherapy | PMC9926577 |
Discussion | OPSCC, head and neck cancers, toxicity, stroke, AJCC | STROKE, RECURRENCE, CARDIOVASCULAR DISEASE, HEAD AND NECK CANCER | According to the NCCN guidelines [Most previous studies have investigated both p16-positive and p16-negative OPSCC [Many studies have reported that PET–CT can be used for determining the response to treatments, including CCRT, or for the detection of recurrence in head and neck cancers [Compared with the control group, more patients in the case group had advanced AJCC stages, advanced cN stages, and poor differentiation, which were identified as poor prognostic factors for OS. Despite the presence of more poor prognostic factors for survival in the PET–CT group, the crude mortality rates of the pre-CCRT PET–CT and non-pre-CCRT PET–CT groups were 61.0% and 64.5%, respectively (Table In the multivariable analysis, we observed that age > 70 years [As shown in Table The strength of our study is that it is the first largest homogenous modality study on PET–CT including a long-term follow-up cohort to examine the survival outcomes of pre-CCRT This study has some limitations. First, because all the patients with p16-negative OPSCC were enrolled from an Asian population, the corresponding ethnic susceptibility compared with that of a non-Asian population remains unclear; hence, our results should be cautiously extrapolated to non-Asian populations. However, no evidence indicates differences in the survival outcomes of patients with p16-negative OPSCC receiving CCRT between Asian and non-Asian populations. Second, the toxicity scores have not been available in the TCRD. Third, the diagnoses of all comorbidities were based on ICD-10-CM codes. However, the combination of the TCRD and National Health Insurance Research Database in Taiwan appears to be a valid resource for population research on cardiovascular disease, stroke, or chronic comobidities [ | PMC9926577 |
Conclusions | Routine use of pre-CCRT | PMC9926577 | ||
Acknowledgements | Lo-Hsu Medical Foundation, LotungPoh-Ai Hospital, supports Szu-Yuan Wu’s work (Funding Numbers: 110908, 10909, 11001, 11002, 11003, 11006. The data sets supporting the study conclusions are included in the manuscript. | PMC9926577 | ||
Author contributions | Conception and Design: Tsung-Ming Chen, MD; Wan-Ming Chen, MS, PhD; Mingchih Chen, PhD; Ben-Chang Shia, PhD; Szu-Yuan Wu, MD, MPH, PhD. Financial Support: Lo-Hsu Medical Foundation, LotungPoh-Ai Hospital, supports Szu-Yuan Wu’s work (Funding Number: 10908, 10,909, 11,001, 11,002, 11,003, 11,006, and 11,013). Collection and Assembly of Data: Tsung-Ming Chen, MD; Wang-Ming Chen, MS; Ben-Chang Shia, PhD; Szu-Yuan Wu, MD, MPH, PhD. Data Analysis and Interpretation: Tsung-Ming Chen, MD; Wang-Ming Chen, MS; Ben-Chang Shia, PhD; Szu-Yuan Wu, MD, MPH, PhD. Administrative Support: Szu-Yuan Wu*. Manuscript Writing: Tsung-Ming Chen, MD. All authors read and approved the final manuscript. | PMC9926577 | ||
Funding | Lo-Hsu Medical Foundation, LotungPoh-Ai Hospital, supports Szu-Yuan Wu’s work (Funding Number: 10908, 10909, 11001, 11002, 11003, 11006. | PMC9926577 | ||
Availability of data and materials | Cancer | CANCER | We used data from the National Health Insurance Research Database and Taiwan Cancer Registry database. The authors confirm that, for approved reasons, some access restrictions apply to the data underlying the findings. The data used in this study cannot be made available in the manuscript, the supplemental files, or in a public repository due to the Personal Information Protection Act executed by Taiwan’s government, starting in 2012. Requests for data can be sent as a formal proposal to obtain approval from the ethics review committee of the appropriate governmental department in Taiwan. Specifically, links regarding contact info for which data requests may be sent to are as follows: | PMC9926577 |
Declarations | PMC9926577 | |||
Ethics approval and consent to participate | Cancer | CANCER | The study protocols were reviewed and approved by the Institutional Review Board of Tzu-Chi Medical Foundation (IRB109-015-B). We used data from the National Health Insurance Research Database and Taiwan Cancer Registry database. The authors confirm that, for approved reasons, some access restrictions apply to the data underlying the findings. The data used in this study cannot be made available in the manuscript, the supplemental files, or in a public repository due to the Personal Information Protection Act executed by Taiwan’s government, starting in 2012. Requests for data can be sent as a formal proposal to obtain approval from the ethics review committee of the appropriate governmental department in Taiwan. Specifically, links regarding contact info for which data requests may be sent to are as follows: | PMC9926577 |
Consent for publication | Authors provide a full Transfer of Copyright to Journal of Otolaryngology-Head & Neck Surgery. | PMC9926577 | ||
Competing interests | Competing | No Competing interests. | PMC9926577 | |
References | PMC9926577 | |||
Background | dengue | DENGUE, DISEASES, CHIKUNGUNYA | Arbovirus diseases such as dengue, Zika, and chikungunya are a public health threat in tropical and subtropical areas. In the absence of a vaccine or specific treatment, vector management (in this case the control of the primary vector | PMC10227988 |
Methods | DENGUE, DISEASE | Baseline surveys were conducted in 5,997 households, randomly selected from 24 clusters (neighbourhoods with on average 2000 houses and 250 households inspected) in the metropolitan area of Cucuta, Colombia. The study established population characteristics including water management and mobility as well as larval-pupal indices which were estimated and compared in all clusters. Additionally, the study estimated disease incidence from two sources: self-reported dengue cases in the household survey and cases notified by the national surveillance system. | PMC10227988 | |
Results | INFESTATION, DISEASE | In all 24 study clusters similar social and demographic characteristics were found but the entomological indicators and estimated disease incidence rates varied. The entomological indicators showed a high vector infestation: House Index = 25.1%, Container Index = 12.3% and Breteau Index = 29.6. Pupae per person Index (PPI) as an indicator of the transmission risk showed a large range from 0.22 to 2.04 indicating a high transmission risk in most clusters. The concrete ground tanks for laundry –mostly outdoors and uncovered- were the containers with the highest production of | PMC10227988 | |
Conclusions | The production of | PMC10227988 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-023-15893-4. | PMC10227988 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10227988 | ||
Introduction | dengue, Arboviral diseases, arboviral disease, Zika | ARBOVIRAL DISEASE, DENGUE, INFESTATION, CHIKUNGUNYA | Arboviral diseases such as dengue, Zika and chikungunya (DZC) are a public health threat in tropical and sub-tropical countries due to the increase of the global burden promoted by the rapid spread of their mosquito vectors, In Colombia, The transmission risk of arboviral disease outbreaks in endemic regions has traditionally been assessed by larval indices (This study describes socio demographic characteristics, identifies breeding habitats and establishes container productivity profiles and level of infestation | PMC10227988 |
Methods | PMC10227988 | |||
Place of study | DEL | The study was conducted within 2.5 months in 2019–20 in Metropolitan Cucuta in the North-East of Colombia, including the city of Cucuta (629,414), and two adjacent municipalities Villa del Rosario (93,735) and Los Patios (81,411 inhabitants) located in the Norte de Santander state [ | PMC10227988 | |
Study design and sample size | This is the baseline study (using a cluster design) for a large cluster randomized trial on the impact of treating water containers with a protective paint. The sample size was calculated for detection of a 50% reduction in the House Index with > 99% power at 5% significance level. Given a baseline HI of 30%, an intra-cluster correlation coefficient (ICC) of 0.01 and a cluster size of 2,000 households it was found that a minimum of 12 clusters per study arm was needed [ | PMC10227988 | ||
Sampling procedure for household survey and entomological inspections | On the basis of available maps, the city was stratified into high, middle and low endemic/infested areas for Selection of clusters in CucutaMap shows the 16 clusters selected in Cucuta which were visited by interviewers and vector control staffVector control staff and trained interviewers participated in the survey. They were divided into “couples” of one vector inspector and one interviewer. Each couple was assigned one cluster where they had to visit the sample houses. The interviewer did the interview with the head of household and simultaneously the inspector (local vector control staff) did the inspection of water containers both of them filling a form. | PMC10227988 | ||
Data collection | The baseline surveys included a household questionnaire and entomological survey (see Additional files | PMC10227988 | ||
Household questionnaire | Demographic and health data was collected through face-to-face interviews using a standard questionnaire that included both structured and semi- structured questions. Household questionnaire was adapted from published research in Colombia [ | PMC10227988 | ||
Entomological survey | The standard entomological survey form was adapted following the guidelines of Standard Operational Procedures (SOPs) by WHO [ | PMC10227988 | ||
Dengue surveillance and case definition | dengue fever, dengue, DF | DENGUE FEVER, DENGUE | Data of the national surveillance system were obtained from SIVIGILA (the national health surveillance system), aggregated by year and setting (study areas) over the study period. Notified dengue cases including those classified as dengue fever (DF) and severe dengue, relying on a clinical case definition or lab confirmed or hospitalized patients. This study used annual population data (from the National Institute of Statistics-DANE; [ | PMC10227988 |
Data management and analysis | DENGUE FEVER | Descriptive analyse and double data entry was practiced (to minimize data entry errors) into a database using Microsoft Office Excel software by an assistant and supervised by the research team. The analysis was done using SPSS software version 28.0.1.1 (15).Socio-demographic data were entered in a database. We assessed the frequency of variables potentially associated with the outcomes of recent dengue virus infection (sex, age, educational level, peoples` mobility) and self-reported dengue fever in household members. Persons’ Chi-square test (χ2) was applied to determine the differences between population characteristics and DZC self-reported cases, and peoples` mobility across all settings. All statistical analyses were performed at a 0.05 significance level.Entomological indices were analysed per cluster and overall to show the presence, distribution and abundance of House index (HI): Percentage of houses infested with larvae and/or pupae.Container index (CI): Percentage of water-holding containers infested with larvae or pupae.Breteau index (BI): Number of positive containers per 100 houses inspected.Pupae per person (PPI): Number of pupae per person in each household.To estimate the pupal count for large container (more than 20 L) the methodology by Romero-Vivas [ | PMC10227988 | |
Ethical considerations | ALBERT | The household questionnaire was only applied to adults who provided information related to the purpose of this study. No child or adolescent below the age of 18 was interviewed in this study. All people participating in the study were informed in local language through the study information sheet in a written and oral way. They were asked to sign the informed consent form. All participants were informed that their participation was voluntary and that their responses remained anonymous, therefore the study used numbers which replaced the names of individuals and codes which replaced the address of house. Before examining the domestic and peri-domestic water-holding containers, the field team requested permission to enter the house, did the inspection and collected entomological and sociodemographic data.The study received approval from local health authorities in Cucuta and Norte de Santander and the study protocol was approved by the ethical committee of the Albert–Ludwigs-Universität (application number 141/19) in Freiburg, Germany and the National Institute of Health in Bogota, Colombia. | PMC10227988 | |
Results | In the baseline survey, a total of 5,997 households with 23,408 people in 24 clusters were visited by the field team. Some data were missing, or some questions were not answered by household participants, these values were excluded from the analysis. | PMC10227988 | ||
Peoples’ mobility | The insect vector | PMC10227988 | ||
Epidemiological information | dengue, arboviral disease | CHIKUNGUNYA, DENGUE, MIXED INFECTION, DEL, DENGUE, CHIKUNGUNYA, ARBOVIRUS DISEASE | Across all clusters, 2.0% (468/23,093) of household members reported to have had any arboviral disease (DZC) during the last 12 months (Dengue incidence was 0.84%). This ranged from 3.0% (116/3,814) in Los Patios, 2.3% (90/3,948) in Villa del Rosario, to 1.7% (262/15,331) in Cucuta. A small group of respondents (68 persons) assumed to have had mixed infections with two arbovirus diseases. The 12-months self-reported incidence was the following: dengue 841.6 per 100,000 inhabitants, Zika 585.3 per 100,000 inhabitants and chikungunya 572.45 per 100,000 inhabitants. Persons with dengue (83.2%) usually went for diagnosis and treatment to the hospital while persons with Zika or Chikungunya used much less the hospital services (45.3% and 57.5% respectively). Figure Self-reported dengue per cluster in the previous 12 monthsThe bar graph shows 12-months incidence rates per 100,000 inhabitants. Cúcuta: cluster 1–16; Los Patios: cluster 17–20; Villa del Rosario: cluster 21–24Table | PMC10227988 |
Dengue incidence notified by the National surveillance system, 2015–2021 | dengue | DENGUE | During the 7-year period, 2015–2021, 8,190 dengue cases were notified by SIVIGILA in the study areas. The number of annual case notifications varied from a low of 333 cases in 2020 (173.1 per 100,000 population) to a high of 1,949 cases in 2019 (1,013.4 per 100,000 population), with a mean of 1,170 cases per year (incidence 608.4 per 100,000 population). Across all clusters, the number of dengue cases varied with a range of 4 to 193 dengue cases between 2015–2021. Cluster 14 had the lowest dengue incidence rate (51.1 per 100,000 population) in 2020 and Cluster 5 had the highest incidence rate (2,933.8 per population (see Table Annual dengue incidence per 100,000 people notified by SIVIGILATable shows the annual dengue incidence from 2015 to 2021 in all study clusters | PMC10227988 |
Most infested container types | A total of 14,386 water holding containers were found in the entomological inspection. These included containers used for water storage as well as some discarded mainly small containers not used for water storage but in which water had accumulated. Overall, the most common containers were concrete ground tanks (48.5%; 6,975/14,386) of which concrete tanks for washing purposes (79.3%; 5,528/6,975) were the most common ones (Fig. A concrete ground tank for washing purposeConcrete ground tanks for washing (Types of water containers inspected and pupae productivityPupal productivity: | PMC10227988 | ||
Pupal productivity in different water container types | DEL | The total number of pupae collected across all cluster was 20,400. Of these 13,800 pupae were collected from the clusters in Cucuta (271 households) with a median of 50.9 total pupae per household; 2,328 pupae were collected from the 4 clusters of the municipality of Los Patios (80 households) with a median of 29.1 and 4,272 from the 4 clusters in the municipality of Villa del Rosario (190 households) with a median of 22.5 pupae per household.The water container type with the highest proportion of pupae was the concrete ground tank, producing 94.5% of all pupae as a proxy for the production of adult mosquitoes (Table | PMC10227988 | |
Ground tanks and water use | SEPARATION | Characteristics of the concrete ground tanks (Regarding the sources of drinking water, only 2.2% (133/5,997) of the houses take drinking water from these ground tanks while the majority uses it for laundry (97.8%) and drink water from the tap provided by the municipal water company. We observed in our survey that people had quite a strict separation of the water sources for drinking and cleaning or washing (water mostly from ground tanks or plastic tanks). Drinking water also is used for cooking, showering and flush toilets. | PMC10227988 | |
Willingness to receive a new vector control intervention | DISEASES, ARBOVIRUS DISEASE | The community in all clusters was interested in receiving the proposed novel vector control method (insecticidal coating for water containers). Overall, 88.3% of respondents held this view and there was no significant difference between clusters (5,296/5,997). The experience of the vector control staff (24 inspectors) was assessed through a short questionnaire; they considered that this study was very useful and interesting for improving public health in the city particularly regarding vector borne diseases, but they wanted to receive more training on arbovirus diseases and all of them would like to participate in the next phase of the study. | PMC10227988 | |
Discussion | arboviral diseases | This study is designed as the baseline study for a large Cluster Randomized Trial (CRT) but provides also by itself important information on the: epidemiological, entomological, and socio-demographic characteristics and assesses the transmission risk of arboviral diseases in an endemic area of Colombia. | PMC10227988 | |
Vector infestation level | The field team reported similar socio demographic characteristics in all clusters, but entomological characteristics were varied. High vector densities were found throughout all clusters. All clusters had a HI above 5% (range 6.0%-37.5%; Table | PMC10227988 | ||
Main Ae. aegypti breeding sites | Concrete ground tanks were the most common type of water containers in all clusters. The population in Cucuta has historically collected water for multiple uses as a common practice of their daily routine due to the occasional shortage of tap water which has been a continuous problem in the region and other parts of the country [The highest pupae production (i.e. % of all pupae in a special container type) was found in these ground or laundry tanks (86.3%). Pupal counts provide a more precise estimate of vector abundance than larval surveys [ | PMC10227988 | ||
Vector control | In Colombia, vector control, such as the application of the organophosphate temephos in ground water containers, is generally only practiced in epidemic situations. For routine control, communities are recommended to keep containers covered and clean [This study showed that almost half of the population (48.7%) had not received any health education or inspection by vector control staff in their houses. The vector control program should reach more houses particularly where they have not applied any vector control method. Studies have demonstrated a significant benefit of involving adding communities and other stakeholders in the existing government DZC control programme [ | PMC10227988 | ||
Considerations for the forthcoming intervention study | toxicity, Chagas disease, leishmaniasis | SECONDARY, CHAGAS DISEASE, LEISHMANIASIS | This study provides cluster specific information on socio-economic indicators and cluster size, on the estimated mosquito abundance, the main breeding places and their pupal productivity, the type and size of water containers, water use for drinking and cleaning which should be considered for the planning of the intervention (covering the productive water containers with a protective and transparent coating) and implementation of the CRT in randomly assigned clusters (using incidence rates and entomological indicators) into intervention and control clusters. The intervention in these ground tanks should be safe for human consumption as a small proportion of households (2.2%) uses the water is also for cooking and drinking. Moreover, people’s willingness to accept the insecticidal coating in their laundry tanks was high in all clusters (88.3%) based on the information, that a sub-study with water samples (to be presented in a different paper) showed no toxicity of the paint and will be delivered for free. Previous studies in Nepal and Bangladesh found that the application of insecticidal coating on house walls was safe and well accepted by communities and health workers. High acceptance (94%) of the households’ participants was reported in the control of leishmaniasis and Chagas disease [A specific challenge for assessing the effectiveness of vector control interventions is people’s mobility during the day as 40.3% of the people in our sample used to leave the cluster area during the day at least for some hours so that they can get infected in other places and bring the viruses home. Male, adult people (20 years and older) and people in secondary education had higher proportion of time spent outside their clusters. This finding is similar to a study in Mexico which found differences in human mobility according to gender and age [The novel insecticidal coating contains two active ingredients pyriproxyfen and alphacypermethrin which have both been widely evaluated for vector control. The concept of coating of surfaces with micro-encapsulated insecticidal/larvicidal products for vector control has gained special attention in comparison with other vector control methods such as insecticide-impregnated bednets, and indoor residual spraying [ | PMC10227988 |
Limitations | infection | INFECTION | Although some studies have shown an association between arbovirus infection and occupation [ | PMC10227988 |
Acknowledgements | DIAZ, DEL | The authors would like to thank the participating families in this study. We gratefully acknowledge the team of the Centre for Medicine and Society, Master Programme Global Urban Health at Freiburg University, particularly Dr. Sonia Diaz for her encouragement and support on this work. We thank the vector control team in Cucuta, Villa del Rosario and Los Patios from the Health Secretary ( | PMC10227988 | |
Authors’ contributions | MP | All authors contributed to the concept and design of the study. MAC, RCS and AK did the interviewer training, and drafted the paper. All authors read and approved the study and the procedures. MAC and RCS prepared the submission to the ethical committee and prepared the logistics. MAC, RCS and JY prepared the field study, contacted the local leaders and organized the logistics. MP contributed to the statistical analysis. MAC, RCS, AK and MP formatted, revised and corrected the article until its final version. All authors read and commented on the draft paper and approved the final version. | PMC10227988 | |
Funding | Open Access funding enabled and organized by Projekt DEAL. MAC and RCS received a scholarship for their doctoral studies from the Ministry of Science, Technology and Innovation (Minciencias) and the State of Norte de Santander in Colombia (Grant number: 753, program: The article processing charge was funded by the German Research Foundation (DFG) and the University of Freiburg in the funding programme Open Access Publishing. | PMC10227988 | ||
Availability of data and materials | All data generated or analysed during this study are included in this published article (Additional file | PMC10227988 | ||
Declarations | PMC10227988 | |||
Ethics approval and consent to participate | The participation in this study was voluntary, anonymous and did not represent a risk for the participants or their families. This study did not include human participants that are minors. Socio-demographic information was provided by a household participant (the head of house or parent) who had to be at least 18 years old and sign an informed consent. All participants were informed they could withdraw from the study at any time. The study was explained in Spanish by a vector control technician to participants. Participants did not receive any kind of compensation for taking part in the study. For data protection the information collected is anonymized: the questionnaire will not record names or addresses. Household address had an individual code for identification. The originals were kept in a safe place (locker) and were not being shown to anybody else. The originals will be kept for 12 months after publication and then destroyed. Study results or publications will present aggregated data only. Researchers confirm that all methods were carried out in accordance with relevant guidelines and regulations. The ethics committee of the Albert-Ludwigs-Universität Freiburg, Germany approved the project and the intervention was authorized by the local health authorities in Colombia. | PMC10227988 | ||
Consent for publication | Not applicable. | PMC10227988 | ||
Competing interests | The authors declare no competing interests. | PMC10227988 | ||
References | PMC10227988 | |||
Background | This study aimed to determine the effect of telephone counseling based on Orem’s Self-Care Model on adherence to treatment and resilience of patients with coronary angioplasty. | PMC10552216 | ||
Methods | cardiovascular and respiratory diseases | This randomized clinical trial was performed on 80 patients in the Cardiac Intensive Care Unit of Shiraz University of Medical Sciences. Patients were randomly divided into two groups of 40 (intervention and control). Questionnaires on adherence to treatment of chronic patients and resilience for patients with cardiovascular and respiratory diseases were filled out before and 8 weeks after the intervention. In the intervention group, the telephone call schedule consisted of three calls per week for 8 weeks. | PMC10552216 | |
Results | Before the intervention, no significant difference was found between the groups about adherence to treatment and resilience. However, after the intervention, a significant difference was found between the groups as to adherence to treatment and resilience (P < 0.001). | PMC10552216 | ||
Conclusion | Nursing consultation using telephone calls based on Orem’s model increases the adherence to treatment and resilience of patients undergoing coronary angioplasty. Telephone counseling can help the patients adhere to their treatment plans and develop resilience skills. | PMC10552216 | ||
Keywords | PMC10552216 | |||
Introduction | death, traumatic, disability, ’ | DISORDER, CARDIOVASCULAR DISEASE, DISEASE, EVENTS, CORONARY ARTERY DISEASE, COMPLICATIONS | Cardiovascular diseases are predicted to be the main cause of death and disability in the world by 2030 [One of the behaviors related to the disease and self-care is patients’ adherence to a treatment regimen that can predict successful treatment and reduce the severity of the disease and its complications [Resilience is a good adaptive indicator that is used when faced with catastrophic disasters such as traumatic events [Resilience refers to the ability to bounce back from times and regain strength by adapting and maintaining an attitude even when facing difficult situations in life [The high prevalence and consequences of coronary artery disease, as a chronic, progressive, and disabling disorder that reduces physical ability, impair the individual and social relationships, and economic problems of the patients, all necessitating the need for nursing interventions [One of the most complete clinical guidelines for planning and implementing self-care principles is the Orem’s self-care model. Orem’s theory is about how individuals look after themselves; accordingly, taking care of yourself means doing things by yourself to keep your body and mind healthy and happy [Remote nursing counseling using a mobile phone not only is cost-effective and provides the uniqueness of each patient’s care, but also facilitates and improves access to effective health care [Upon reviewing the literature, it was found that education played a crucial role in enhancing individuals’ resilience and equipping them with necessary skills to effectively confront the challenges of life in a positive manner [This study aimed to determine the effect of nursing counseling through telephone calls based on Orem’s self-care model on adherence to treatment and resilience in cardiac patients treated with coronary angioplasty. | PMC10552216 |
Methods | PMC10552216 | |||
Design | The present study was a randomized clinical trial. This was registered in the Iranian Registry of Clinical Trail (Number IRCT20210303050562N1, approved 18/06/2021). ( | PMC10552216 | ||
Setting | The study was performed at eight Cardiac Intensive Care Unit (CCU) wards in the hospitals affiliated with Shiraz University of Medical Sciences in 2021. | PMC10552216 | ||
Eligibility criteria for participants | mental illness | The inclusion criteria of the study were being hospitalized post-PCI patients; ranging in age from 18 to 65 years; being able to communicate and no hearing or speech problems; having access to mobile or landline phone and ability to use it; being able to read and write; and being able to perform daily activities. On the other hand, known severe mental illness; incomplete completion of questionnaires; failure to cooperate completely; and participation in a similar intervention in the last 3 months were the exclusion criteria of the study.As Fig. It should be noted that zero drop rate and 100% follow-up in this study may be associated to using the following strategies: (1) Regular follow-up calls caused the participants to ensure their continued participation and addressed any concerns or issues they might have had, (2) Flexible titration schedule for the study medications was implemented to accommodate the participants’ needs and minimize dropout. Moreover, we understand the importance of minimizing dropout in maintaining the integrity and validity of the study. Dropout can introduce bias and affect the generalizability of the results. Regarding the selection process, we would like to clarify that the subjects were chosen based on specific criteria relevant to the study, rather than solely on the likelihood of cooperation. | PMC10552216 | |
Sample size | The research sample size was determined using medcalc software and the study conducted by Akhu-Zaheya et al. (2017) [ | PMC10552216 | ||
Randomization | BLIND | To conduct the randomization, we firstly selected eight CCU wards as eight separate strata. Then, using a statistical software and eight separate strata, we prepared a list of random allocation for 80 subjects. A statistician who was not a member of the research team generated the list and made sequentially numbered containers. Then, based on the random sequence that was prepared, the researcher assistant opened the containers sequentially, and the eighty patients under PCI were randomly divided into the intervention and control groups. Allocation concealment that prevents selection bias was implemented through a randomization for allocation to the two groups; we kept the random allocation sequence in a locked numbered containers, so the statistician and outcomes assessors were blind. | PMC10552216 | |
Blinding | BLIND | In this study, the individual who collected the data and the statistician were blind to the groups. Also, the outcomes were assessed by a blinded examiner before and 8-weeks after the intervention. Moreover, the researcher who selected the participants and allocated them to the groups was blind to them.
Flowchart of the study participants | PMC10552216 | |
The intervention | heart disease | DISEASE, HEART DISEASE | In the interventional group, in addition to educational pamphlets and routine hospital care, telephone counseling was performed for 8 weeks. It was conducted by a MSc nurse that had 3 years of experience working as a nurse in CCU wards. Each patient gave us his/her contact number as well as that of a family member; the researcher gave them her contact number. They were provided with a schedule of telephone calls, which included 3 calls per week for 8-weeks. The average call time was 30 min. The range of contact time was from 8 A.M. to 9 P.M. In the case of any problems or questions, they were in contact with the researcher at the same time interval. The patient was referred to a physician to follow up on his/her questions and problems, if necessary.In the first telephone call, the Orem Needs Assessment was utilized to evaluate the client’s needs during the initial telephone call in the intervention group. This program incorporates distinctive aspects, including the identification of universal and health deviation self-care requisites, as well as promotion of the individuals’ independence and active engagement in self-care for maintaining the structural and functional integrity of a person [The care plan was designed and developed based on the goals in the form of a supporting education system that included: (1) Meeting the patient’s needs in self-care, (2) Making the patient responsible for self-care, and (3) Increasing the patient’s independence in care and his/her adaptation to the changes that have been made, etc. Therefore, the nurse here has an advisory role based on Orem’s supporting education system. For example, for a heart disease patient who has high blood cholesterol, the nurse helps the patient by educating him/her about a healthy diet such as reducing the consumption of saturated fats, losing weight, etc. by increasing awareness about their diet. Moreover, a patient with heart disease who had undergone angioplasty and his self-confidence had decreased due to the limitations, the nurse helped him to trust his abilities against the disease by focusing on the patient’s capabilities, strengthening positive behaviors, and improving the behavioral and mental performance of the patient to help him adapt to the disease and feel good despite the limitations [The content of telephone conversations generally included the researcher’s self-introduction, inquiring about the patient’s general health condition, giving healthcare advice, informing the patient about nutrition and medication, assessing the patient’s level of adherence to dietary and medication regimen, evaluating the behavioral objectives agreed upon by the patients and the researcher, reinforcing health behaviors, terminating the call with the words of encouragement, and arranging the next contact. During the telephone conversation, the researcher emphasized compliance with the plans and proposed possible solutions to the patient’s problems. | PMC10552216 |
The control group | DISEASE | The control group received routine care without any interventions. The patients received the routine care as follows: educational pamphlets and standard hospital care including education about diet, activity, medications, and educational pamphlets about disease and medicine, and the way to see a doctor at the time of discharge were presented, but no pre-planned program was performed. | PMC10552216 | |
Outcomes | diabetes | HYPERLIPIDEMIA, HYPERTENSION, HEART DISEASE, DIABETES | Data collection tools included demographic and clinical characteristics forms, adherence to treatment of chronic patients (Modanloo 2013) [The demographic and clinical characteristics form which was collected at a baseline included information on the patient’s age, gender, marital status, educational level, job, body mass index (BMI), hypertension, diabetes, and hyperlipidemia, family history of heart disease, and history of smoking. | PMC10552216 |
Adherence to treatment | Modanloo’s Chronic Patients Adherence Questionnaire was used to assess adherence to the treatment of heart patients in various dimensions (acceptance of medication, diet, weight control, physical activity, follow-up time for treatment, and lifestyle changes). This scale has 40 items in the form of 7 subscales in the areas of concern in treatment (9 questions), willingness to participate in treatment (7 questions), ability to adapt (7 questions), integration of treatment with life (5 questions), adherence to treatment (4 questions), commitment to treatment (5 questions), and management of treatment (3 questions). This questionnaire is scored based on 5-point Likert scale (strongly agree = 1, disagree = 2, neutral = 3, agree = 4, strongly agree = 5). The higher the total score or the score of each subscale, the higher the adherence of the respondent. In Modanloo’s study, the correlation coefficient test-retest was reported 0.87. The internal consistency was Cronbach’s alpha = 0.92 [ | PMC10552216 | ||
Resilience | cardiovascular and respiratory diseases | Resilience for patients with cardiovascular and respiratory diseases was designed by Ebadi et al. in 2016. This scale has 29 items with 5 subscales in the dimensions of positive adjustment (10 questions), self-management dimension (7 questions), rational empowerment dimension (7 questions), treatment adherence dimension (3 questions), and spirituality dimension (2 questions). This questionnaire is also scored based on a 5-point Likert scale (strongly disagree = 1, disagree = 2, neutral = 3, agree = 4, strongly agree = 5). The scores range from 29 to 145, so the higher the score, the more positive the patient’s resilience. Cronbach alpha coefficient for the whole questionnaire was 0.96. Also, the intra-class correlation coefficient was 0.95, based on the result of the re-test. The psychometrics of the questionnaire was assessed using face and content validity, internal consistency, and stability. The findings showed that the resilience questionnaire for patients with cardiovascular and respiratory diseases (Ebadi 2016) was valid and had a high level of reliability [ | PMC10552216 | |
Ethical considerations | We obtained the code of ethics (1400.167. IR.SUMS.REC) from the Research Ethics Committee of Shiraz University of Medical Sciences; we also obtained permission from the University of Medical Sciences and related hospitals. The written informed consent was signed by the participants in the study. They were assured of the anonymity and confidentiality of information in all stages of the research and had the right to withdraw from the study at any time. | PMC10552216 | ||
Statistical analyses | diabetes | HEART DISEASE, HYPERLIPIDEMIA, REGRESSION, HYPERTENSION, DIABETES | To describe the findings, we used the mean, frequency percentage, variance, and standard deviation. To determine the confounders and other factors that might be associated to adherence to treatment and resilience, we used multiple linear regression analysis. It showed that age, gender, marital status, educational level, job, BMI, having hypertension, diabetes, and hyperlipidemia, family history of heart disease, and history of smoking were not associated to adherence to treatment and resilience. The Kolmogorov-Smirnov test was used to check the normality of data distribution. The studied samples did not have a normal distribution. Statistical analysis (Chi-square test), as well as non-parametric tests (Wilcoxon, Mann-Whitney test), were used for intergroup and intragroup comparisons. The significance level in statistical tests was considered 0.05, and SPSS statistical software version 23 was used to analyze the data. | PMC10552216 |
Results | PMC10552216 | |||
Sample characteristics | The final sample of 80 respondents was randomly assigned into two groups of 40, intervention and control subjects. The youngest participant in this study was 41 years old and the oldest was 65 years old, and the mean age of the participants was 56.60 ± 5.546 years. According to the Mann-Whitney test, there was no significant difference between the two groups in terms of age (P = 0.68). The majority of the subjects in both groups were male (61.3%) and married (83.8%). Most participants in the intervention and control groups (52.5%) had a diploma and were retired (32.5%). The results of the chi-square test showed that there was no significant difference between the two groups in terms of demographic characteristics including gender, marital status, education level, and job (P > 0.05). Details of the respondents are presented in Table The BMI of the participants was reported 25.65 ± 2.896. The means of their BMI were 25.85 ± 2.88, and 25.43 ± 2.92 in the intervention and control groups, respectively. The results showed no significant difference between the two groups in terms of BMI (Z=-4.63, P = 0.67) (Table According to the results shown in Table As shown in Table This study indicated that there was no statistically significant difference between the resilience mean scores of the two groups before the intervention (P = 0.92). On the other hand, the resilience mean score of patients in the intervention and control groups was statistically significant after the intervention (P < 0.001). The mean score of resilience inpatients of the intervention group before and after the intervention was significantly different (P < 0.001). There was a statistically significant difference in the resilience mean scores of patients in the control group before and after the intervention (P = 0.02); however, this difference was reduced in the control group.
Determination and comparison of demographic characteristics in the intervention and control groupsχP = 0.68χP = 0.49χP = 0.76χP = 0.79χP = 0.17†Chi-square (χ
Determination and comparison of demographic in the intervention and control groupsZ=-4.63*P = 0.67* Mann-Whitney U Test (Z)
Determination and comparison of clinical characteristics in the intervention and control groupsχP = 0.49χP = 0.6χP = 0.82χP = 0.65χP = 0.44χP = 0.76χP = 0.31χP = 0.82†Chi-square (χ
Comparison of the mean score of adherence to treatment and resilience of the intervention group compared to the control group before and after the intervention
Z †=-1.86P = 0.06Z†= -7.70P < 0.001*Z= -5.51P < 0. 001*Z =-1P = 0.31Z†= 0.09P = 0.92Z†= -6.78P < 0.001*Z= -5.21P < 0.001*Z= -4.55P = 0.02* Indicates significance level of p < 0.05† Mann-Whitney U Test (Z) | PMC10552216 | ||
Discussion | heart failure, cardiovascular diseases | HEART FAILURE, CARDIOVASCULAR DISEASES | The results of the study showed that there was a difference between the two groups in terms of adherence to treatment and resilience after the intervention. The results of the present study also showed that the mean scores of adherence to treatment and resilience were significantly different in the intervention group before and after the intervention, but they were not significantly different in the control group. According to the findings, adherence to treatment by patients after the intervention was more than that in pre-intervention treatment. Consistent with the present study, Oscalices et al. reported the effect of telephone follow-up and discharge instructions on the adherence to treatment of patients with heart failure [The results of this study showed a significant difference between the two groups in terms of resilience after the telephone counseling based on Orem’s model. According to the results, in the intervention group, the mean resilience after the intervention was significantly higher than that before the intervention. However, in the control group, the mean score of resilience decreased after the intervention compared to before it. Consistent with the present study, Studies have shown that cardiovascular diseases have lower scores in resilience dimensions than healthy people. Also, resilience decreases during time [In this study, the authors devised a care plan for individuals with heart conditions based on their self-care requirements. The plan included educating and guiding patients about their condition and the way to manage their medications as well as assisting them in developing and maintaining independence in self-care. The healthcare team worked closely with patients to identify any gaps or shortcomings in their self-care skills offering activities and interventions to address those areas effectively. Early encouragement of self-care was emphasized to facilitate the patients’ attainment of independence.Furthermore, nurses played a role in educating the patients about the techniques and strategies for self-care. They collaborated with patients to create care plans that catered specifically to their needs and goals. Emotional support was also provided throughout the process. Various efforts were made to meet these care needs while promoting autonomy, such as establishing a supportive environment that encouraged active patient participation in their own care activities. Regular progress assessments were conducted, allowing for adjustments to the care plans in order to instill confidence in patients.Using a specific questionnaire for measuring adherence to treatment in heart patients was one of the strengths of this study. However, it is suggested in another study that the indirect adherence to treatment should be assessed. For example, adherence to medications such as clopidogrel would be assessed by the number of drug administration, skipping administration, and incorrect times and doses. Adherence to diet would indirectly be assessed by some laboratory tests such as the level of cholesterol, triglycerides, LDL, and HDL. Moreover, adherence to the follow-up time for treatment would be assessed by the number of physicians missed. | PMC10552216 |
Conclusion | DISEASE, COMPLICATIONS | The results of the present study showed that nursing counseling by telephone based on the Orem’s model increased the adherence to treatment and resilience of patients who had undergone coronary angioplasty. Therefore, mobile counseling, as an inexpensive method, can change the focus of the treatment and care from the clinic to the patient’s daily life. The widespread use of mobile phones has provided a promising opportunity to improve the care and self-management of heart patients. Nurses can also deal with the complications and effects of the disease by learning resilience methods and changing the patients’ attitudes about the stress caused by coronary angioplasty, thereby improving resilience in patients. | PMC10552216 | |
Acknowledgements | RCC | RCC | This article is the result of a Master’s thesis (NO: 22289) in the School of Nursing and Midwifery of Shiraz University of Medical Sciences. We would like to express our sincere thanks and appreciation to the Vice Chancellor for Research and Graduate Studies of the University, the esteemed officials and staff of the hospitals, and the dear patients who helped us in carrying out this research. The authors would also like to thank Shiraz University of Medical Sciences, Shiraz, Iran, and the Center for Development of Clinical Research of Nemazee Hospital and Dr. Nasrin Shokrpour for editorial assistance in RCC. | PMC10552216 |
Author contributions | Khatereh Rostami, Mahsa Maryami, and Masoume Rambod contributed to this study. All of the authors participated in conceptualization, designed, drafted, read, and revised the manuscript, and approved the study and manuscript. Khatereh Rostami, Mahsa Maryami, and Masoume Rambod participated in data collection management. Khatereh Rostami, Mahsa Maryami, and Masoume Rambod collaborated in data analysis and interpretation. All of the authors approved the draft of the manuscript. | PMC10552216 | ||
Funding | This work was supported by Shiraz University of Medical Sciences, Shiraz, Iran. (NO: 22289) | PMC10552216 | ||
Data Availability | The data that support the findings of this study are available from [Khatereh Rostami], but restrictions apply to the availability of these data, which were used under license for the current study, so they are not publicly available. Data are, however, available from the authors upon reasonable request and with permission of [Khatereh Rostami]. | PMC10552216 | ||
Declarations | PMC10552216 | |||
Ethics approval and consent to participate | We obtained the code of ethics (1400.167. IR.SUMS.REC) from the Research Ethics Committee of Shiraz University of Medical Sciences and we confirm that all methods were performed in accordance with the relevant guidelines and regulations. The study received the code of IRCT20210303050562N1 (Registration date: 18/06/2021); we also obtained permission from the University of Medical Sciences and related hospitals and written informed consents were signed by the participants in the study. They were insured of the anonymity and confidentiality of information in all stages of the research and had the right to cancel and withdraw from the study at any time. | PMC10552216 | ||
Consent for publication | Not applicable. | PMC10552216 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10552216 | ||
References | PMC10552216 | |||
Background | shock | SHOCK | High dose vasopressors portend poor outcome in vasodilatory shock. We aimed to evaluate the impact of baseline vasopressor dose on outcomes in patients treated with angiotensin II (AT II). | PMC10163684 |
Methods | hypotensive, Shock, shock | HYPOTENSIVE, SHOCK, SHOCK | Exploratory post-hoc analysis of the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial data. The ATHOS-3 trial randomized 321 patients with vasodilatory shock, who remained hypotensive (mean arterial pressure of 55–70 mmHg) despite receiving standard of care vasopressor support at a norepinephrine-equivalent dose (NED) > 0.2 µg/kg/min, to receive AT II or placebo, both in addition to standard of care vasopressors. Patients were grouped into low (≤ 0.25 µg/kg/min; n = 104) or high (> 0.25 µg/kg/min; n = 217) NED at the time of study drug initiation. The primary outcome was the difference in 28-day survival between the AT II and placebo subgroups in those with a baseline NED ≤ 0.25 µg/kg/min at the time of study drug initiation. | PMC10163684 |
Results | Of 321 patients, the median baseline NED in the low-NED subgroup was similar in the AT II (n = 56) and placebo (n = 48) groups (median of each arm 0.21 µg/kg/min, | PMC10163684 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13054-023-04446-1. | PMC10163684 | ||
Keywords | PMC10163684 | |||
Introduction | death, shock | VASODILATORY SHOCK, SHOCK | Vasodilatory shock is the most common form of shock and can result in high rates of organ failure and death [Angiotensin II (AT II) is an endogenous peptide hormone and a component of the renin–angiotensin–aldosterone system (RAAS). This compound has a unique mechanism of action, distinct from those of catecholamines and vasopressin [Despite these observations, in the real-world setting, AT II has been initiated at much higher baseline vasopressor doses (i.e., > 0.5 µg/kg/min) than doses used in the ATHOS-3 trial (> 0.2 µg/kg/min), often as ‘salvage therapy’ leading to suboptimal outcomes [ | PMC10163684 |
Methods | PMC10163684 | |||
Study design | The design of ATHOS-3 has been previously reported [ | PMC10163684 | ||
Patients | shock | SHOCK | Patients enrolled in ATHOS-3 were ≥ 18 years of age with vasodilatory shock, MAP of 55–70 mmHg, despite adequate volume resuscitation and receipt of vasopressors at a dose > 0.2 µg/kg/min NED for 6–48 h prior to enrollment; background vasopressor use was not standardized and included catecholamines and vasopressin based on regional availability. | PMC10163684 |
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