Information Sheet Research Articles

Diseño y validación de 2 instrumentos para analizar y evaluar la calidad formal en el proceso de consentimiento informado de ensayos clínicos con medicamentos

ObjectiveThe activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation. MethodDesign (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated. ResultsVery good concordance was obtained in both checklists (k ≥ 0.81, p < 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items. ConclusionThe instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.

Type 2 Diabetic Patients’ Knowledge Regarding Preventive Measures of Diabetic Foot

Objective: Assess type 2 diabetic patients’ knowledge regarding preventive measures of diabetic foot. Find out the relationship between of type 2 diabetic patients’ knowledge regarding preventive measures of diabetic foot with certain sociodemographic characteristics Methodology: A descriptive study was carried out from (2nd January 2022 to 26th March 2022). A non –probability (purposive) sample of (60) adult patients who are diagnosed with type2 diabetes mellitus these patients have met the study criteria which was selected from Imam AL-Hussein Medical-City. The study instrument consist of two section: (Demographic Information Sheet, and Foot Care Outcome Expectations Scale) The questionnaire was designer measure the level of diabetic patient' knowledge about preventive measures of diabetic foot, which consisted of (14) items and other structured knowledge questionnaire containing (6) questions were developed by researcher based on the existing resources to assess knowledge of patient regarding preventive measures of diabetic foot. Results: The study indicates that the patient have fair level of knowledge (MS=1.34), and no significant association between diabetic Patients’ Knowledge Regarding Preventive Measures of Diabetic Foot and their demographic characteristics. Conclusion: The results show that the level of knowledge about preventive measures for the diabetic foot of the patients was Fair. There are no significant differences were found regarding demographic variables. Recommendations: The Ministry of Health should use the media to organize public health campaigns to strengthen knowledge towards contributing factors and preventive measures for diabetic foot. Further research is recommended to repeat the research on a large probability sample to achieve further generalization.

QUALITY OF LIFE IN PATIENTS WITH CORONARY ARTERY DISEASE: A PROSPECTIVE STUDY

The objective of the current study is to compare patients' Quality of life with myocardial infarction (MI) and angina pectoris. In a cross-sectional study, 351 people who had been diagnosed with coronary artery disease in 2021 were selected. The QoL, SF-36, and information sheet were employed in this research. Univariate and bivariate binary Logistic Regression was used to analyse the data. Preliminary results show that concerning age, the average was in the AP group and the MI group (40.5 ± 0.2), (52.6 ± 0.3), respectively. Women constituted the highest percentage (57%) in the two groups. Most of the study participants have low education (57%) and are married (92%). In the invariable logistic regression analysis, ORs were higher among patients belonging to the age group ≥ 65 in the AP (OR, 4.11; 95% CI, (2.59–4.14); P= 0.001) and the MI group (OR, 7.18; 95% CI, (5.74–8.97); P&lt; 0.001). Patients' Quality of life suffers significantly after a cardiac attack, particularly in the early stages of recovery. While significant life improvements have been made over time, physicians working with cardiac patients face difficulty due to residual discomfort after a year's follow-up.

Vitamin D and Calcium Supplementation in Nursing Homes-A Quality Improvement Study.

Even though dietary supplements with vitamin D and calcium are recommended to nursing home residents, we recently reported a low adherence to this recommendation. The objective of this 20-week quality improvement study was to use the Model for Improvement and Plan-Do-Study-Act (PDSA) cycles to improve adherence in Danish nursing homes. We included two nursing homes with 109 residents at baseline. An information sheet including the rationale for the recommendation was developed for the nurses to urge residents to take the supplements and seek approval by the general practitioner afterwards (PDSA cycle 1). Moreover, it was included in admission meetings with new residents to address supplementation (PDSA cycle 2). A nurse reviewed patient records for number of residents prescribed adequate doses of vitamin D (≥20 µg) and calcium (≥800 mg) before, during and after the intervention. At baseline, 32% (n = 35) of the residents had adequate doses of vitamin D and calcium. After implementation of the information sheet and adjustment to admission meetings, this increased to 65% (n = 71) at endpoint (p < 0.001). In conclusion, in this quality improvement study, we improved the number of prescriptions of adequate doses of vitamin D and calcium over 20 weeks using the Model for Improvement and PDSA experiments.

Study of Quality of life of family caregivers of hospitalized COVID-19 patients

Background: High morbidity and mortality due to this virus led to an international health crisis. Whereas frontline health workers, face problems due to increased work load, intense working schedule and increased chance of getting exposed to positive cases, the primary caregivers who are mostly family members and are indispensable in providing support to their member with illness in acute care settings, are also affected in various domains of their functioning. This affects their overall quality of life. Materials and Methods: This cross-sectional observational study was done at Sawai Man Singh and attached hospital, Jaipur. It included 45 caregivers of hospitalized COVID-19 patients. All subjects were evaluated by a general information sheet. WHOQOL-BREF was applied and statistical analysis done by SPSS 23. Results &amp; Conclusion: Factors which were significantly associated with QOL and its domains were duration of illness, duration of hospitalization, severity of COVID-19 illness,occupation and marital status. Duration of illness and hospitalization can be reduced with early identification of illness and effective management which may improve QoL of caregivers. Also, there is need to rotate caregivers among family members and incorporating recreational activities for informal caregivers of Covid-19 patients to improve their QoL Keywords:QoL, COVID-19, caregiver

Prospective Randomized Controlled Trial Comparing Laparoscopic Palomo Surgery versus Scrotal Antegrade Sclerotherapy in Adolescent Varicocele.

Varicocele is a common condition in adolescence and the most common correctable cause of infertility. This study aimed to analyze and compare the outcomes of scrotal antegrade sclerotherapy (SAS) and laparoscopic Palomo surgery (LPS) in a tertiary referral centre. Patients with left grade 3 varicocele indicated for surgery were prospectively enrolled and randomly allocated to the SAS and LPS groups, with their respective contralateral normal testes taken as controls. The primary outcome measures were clinical varicocele recurrence, testicular catch-up growth, and post-operative hydrocele. All patients were evaluated clinically and using Doppler ultrasound by radiologists. From 2015 to 2020, 113 patients completed the study and were statistically analyzed (SAS, n = 57; LPS, n = 56). All patients had significantly smaller testes pre-operatively that the testicular volume differences with control testes were -23% in SAS and -19% in LPS. At 12-month follow-up, there were no statistical significant difference in clinical recurrences between the 2 groups (SAS = 5.3% vs LPS = 5.4%, P>.05, non-inferiority test). Testicular catch-up growths were observed in both groups, the mean testicular volume difference between the treatment and control testes reduced from -23% to -8.1% in SAS (P<.001) and -19% to -9.3% in LPS (P<.001) at 12-month follow-up. There was no post-operative hydrocele in SAS compared to 7 in LPS (0% vs 13%, P = .006). Both SAS and LPS are safe and effective procedures for treatment of adolescent varicocele with significant positive effect on testicular catch-up growth. SAS is not inferior to LPS in terms of clinical recurrence rate and with significantly less post-operative hydrocele.

How TikTok Is Being Used to Help Individuals Cope With Breast Cancer: Cross-sectional Content Analysis.

Acknowledging the popularity of TikTok, how quickly medical information can spread, and how users seek support on social media, there is a clear lack of research on breast cancer conversations on TikTok. There is a paucity of information on how these videos can advocate for those impacted by breast cancer as a means to provide support and information as well as raise awareness. The purpose of this cross-sectional content analysis was to describe the content of videos from the hashtag #breastcancer on TikTok. Content related to breast cancer support and coping, cancer education, and heightening the awareness of breast cancer early detection, prevention, and treatment was evaluated. This study included 100 of the most viewed TikTok videos related to breast cancer through June 30, 2022. Videos were excluded if they were not in the English language or relevant to the topic being studied. Content was deductively coded into categories related to video characteristics and content topics using a screener based on expert breast cancer information sheets. Univariable analyses were conducted to evaluate differences in video characteristics and content when stratified as advocating or not advocating for breast cancer (yes or no) support, education, and awareness. The cumulative number of views of the videos included in this study was 369,504,590. The majority (n=81, 81%) of videos were created by patients and loved ones of individuals with breast cancer, and the most commonly discussed topic was breast cancer support (n=88, 88%), followed by coping with the myriad issues surrounding breast cancer (n=79, 79%). Overall, <50% of the videos addressed important issues such as body image (n=48, 48%), surgery (n=46, 46%), medication and therapy (n=41, 41%), or the stigma associated with a breast cancer diagnosis (n=44, 44%); however, in videos that were advocacy oriented, body image (40/62, 64% vs 8/38, 21%; P<.001), stigma associated with breast cancer (33/62, 53% vs 11/38, 29%; P=.02), and breast cancer surgery (36/62, 58% vs 10/38, 26%; P=.002) were discussed significantly more often than in videos that did not specifically advocate for breast cancer. The use of videos to display health journeys can facilitate engagement by patients, family members, and loved ones interested in information about challenging conditions. Collectively, these findings highlight the level of peer-to-peer involvement on TikTok and may provide insights for designing breast cancer educational campaigns.

Is fear of falling key to identifying gait and balance abnormalities in community-dwelling older adults? Protocol of a mixed-methods approach

IntroductionThe ageing population poses an increasing burden to public health systems, particularly as a result of falls. Falls have been associated with poor gait and balance, as measured by commonly...

Study protocol: ‘a large cohort study of postnatal events in a not-for-profit referral centre in Vellore, South India’

IntroductionIn a large developing country, with diverse population characteristics and differential access to healthcare, it is important to identify factors that influence postnatal health. This knowledge will help frame recommendations...

Development and Validation of a Psychological Assessment Scale for Adolescents with Leukemia

The study aimed to develop and validate a scale that records biopsychosocial problems in adolescents with leukemia. First, 30 adolescents with leukemia were individually interviewed to produce an item pool of twenty-eight divergent problems. Repeated items were excluded, and the final 25-item list of distinct problems was pilot tested among 25 adolescents with leukemia as a 4-point self-report measure of the Psychological Symptom Scale. A sample of 250 adolescents received the final 25-item list, the Cancer Pain Rating Scale (Ikram &amp; Rafiq, 2021), and a demographic information sheet containing age, stage of leukemia, and history of the pre-and post-chemotherapy sessions were recorded. Further to validate the items Principle Component Analysis was administered through which 19 items with four factors were identified: biological, emotional, social, and psychological. Results revealed high concurrent and internal validity of the measure. The results have been debated regarding the implications of mental health symptoms for adolescent counseling services and suggest further research.

Social Media Addiction, Self-Compassion, and Psychological Well-Being: A Structural Equation Model.

Research indicates that social media addiction is associated with several psychological consequences, for example, depression. Distressed individuals tend to devote more time to social media, which leads to impairment of daily life. Interestingly, individuals feeling more compassionate toward them tend to devote less time to social media and feel less psychologically distressed. This research aimed to examine the association between social media addiction and self-compassion and whether it can be further explained through the association of psychological distress. A sample of 255 Greek adults received a personal invitation sent to various social media platforms. Invitations included a link, which redirected participants to the information sheet and the study questionnaires, namely the Bergen Social Media Addiction Scale, the Self-Compassion Scale, and the Depression, Anxiety, Stress Scale. Participation was voluntary and no benefit/reward was granted. As predicted, social media addiction was found to negatively correlate with self-compassion and positively with distress. We used structural equation modeling to examine associations between variables, with psychological distress acting as a mediator. Examination of estimated parameters in the model revealed statistically significant correlations, except for the positive dimensions of the Self-Compassion Scale, which were found to be insignificantly associated. Individuals with higher levels of self-compassion tend to report less social media additive behaviors and distress. The extensive use of social media is related to negative feelings and emotions. Self-compassion is a potential protective factor, while distress is a potential risk factor for social media addiction. Intervention programs dealing with social media addiction should consider the role of self-compassion.

Civil Liability for the Key Investment Information Sheet in Denmark

Articles 23(9) and 24(4) of the ECSPR sets out the liability of “at least” the project owner or its administrative, management or supervisory bodies for the information given in the key investment information sheet (KIIS). Further, articles 23(10) and 24(5) of the ECSPR oblige EU Member States to ensure that their laws, regulations and administrative provisions on civil liability apply to those responsible for the key investment information sheet in situations where the sheet contains misleading or inaccurate information and where the information sheet omits key information needed to aid potential investors. No Danish legislation has been enacted regulating civil liability for the key investment information sheet. This article discusses the civil liability regime between the project owner and the CSP who are involved in preparing the key investment information sheet.&#x0D; The article finds that the project owner is the main responsible for the accuracy of the key investment information sheet and as such will be the party to mainly be held responsible for any civil claims resulting from errors and omissions in the information sheet. Until legislation is enacted otherwise, the crowdfunding service providers’ civil liability for the key investment information sheet would most likely be limited to such errors, misleading information and omissions in the information sheet that result from inadequate procedures adopted by the crowdfunding service providers or their failure to comply with such procedures.

Developing an all-wales definition of simulation-based education

Health Education and Improvement Wales’s (HEIW) simulation team is in the process of developing a Simulation-Based Education (SBE) strategy for Wales which will include a definition of SBE. The simulation team originally agreed a working definition of SBE for Wales when the team was formed. However, numerous definitions of simulation or SBE exist in the literature. A shared understanding of SBE is required to optimise its use as an educational strategy [1]. We aimed to reach consensus upon an All-Wales definition of SBE. Ethical approval for the study was granted by Cardiff University. A participant information sheet was provided and informed consent obtained from all participants. A modified Delphi technique was used [2], comprising three rounds of online surveys. Definitions and characteristics of simulation described in the existing literature formed the basis of the first survey round [3]. Any statements not reaching consensus and any new statements offered by participants during round one were included in the second survey round. In the final round, participants were asked to rank all statements which reached consensus in rounds one and two in order of priority from 1- the most important to 10- the least important. Responses were inversely scored and collated. Three members of the research team reviewed and validated the consensus statements at the end of each round. A total of 27 participants from a range of professional backgrounds (nurses, doctors, allied health professionals, and simulation technicians) agreed to be part of the expert panel, of whom 26 (96%) completed the round one survey, 26/26 (100%) returned the round two survey, and 22/26 (81%) responded to the round three survey. Participants reached consensus with high levels of agreement (where the median was less than or equal to 2 with a small IQR; less than or equal to 1.5) upon 39 statements organised under five sections. The highest ranked statement from each section were included in the final definition and the agreed upon definition is shown in Final definition agreed following the modified Delphi technique for the term ‘Simulation-based education’ This appears to be the first study to have used a Delphi technique to agree an interprofessional definition of SBE at a national level. Future planned work would be to share the developed definition more widely with key stakeholders from across the four nations of the UK. There is scope for this to lead to further work on reaching UK-wide consensus or internationally. 1. Posner GD, Clark ML, Grant VJ. Simulation in the clinical setting: towards a standard lexicon. Advances in Simulation. 2017;2(1):1–5. 2. Keeney S, Hasson F, McKenna H. Consulting the oracle: ten lessons from using the Delphi technique in nursing research. Journal of advanced nursing. 2006;53(2):205–212. 3. Hsu CC, Sandford BA. Minimizing non-response in the Delphi process: How to respond to non-response. Practical Assessment, Research, and Evaluation. 2007;12(17):1–6.

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Predictive Role of Mindfulness and Emotion Regulation for Psychological Distress in Pakistani Medical Students

This research was intended to investigate the relationship between mindfulness, emotion regulation, and psychological distress in Pakistani medical students. It was also aimed to assess the predictive role of mindfulness and emotion regulation for psychological distress (depression, anxiety, stress). Correlational research design and purposive sampling techniques were used. The data was collected from both public and private medical colleges. The total sample comprised 216 participants (men; n=96; women; n= 120). Mindful Attention Awareness Scale, Emotion Regulation Questionnaire, Depression, Anxiety, and Stress Scale (DASS-21) along with a demographic information sheet were used to assess the study variables. Results were analyzed through SPSS 21. Findings revealed a significant negative relationship of mindfulness and emotion regulation with psychological distress (depression, anxiety, and stress) in medical students. Furthermore, mindfulness and emotion regulation significantly predicted psychological distress (anxiety). The results of the present study will help clinical psychologists to devise improved training programs and therapeutic interventions for medical students for minimizing their distress so that medical students become able to perform better in their academic activities.

Dietary supplements and beverages: Knowledge, attitudes, and practices among semi-professional soccer players in KwaZulu-Natal, South Africa.

The ingestion of dietary supplements and beverages is prevalent in soccer, at the amateur and professional level. The absence of professional advice at non-professional level makes amateur soccer players susceptible to ingesting unsafe supplements. To determine the knowledge, attitudes and practices of ABC Motsepe League (semi-professional) players in KwaZulu-Natal regarding the use of dietary supplements and beverages. Three hundred and forty-three soccer players participated in a cross-sectional study. Knowledge, attitudes and practices were determined using a questionnaire. Researchers visited twelve teams. On the day of the visit to each team, information sheets and questionnaires were given to participants. Questionnaires were collected immediately following completion. Descriptive statistics were used, including means and standard deviations, where applicable. Inferential statistics, Chi-square and binomial tests were used to analyse the results. Statistical significance was set at p < 0.05. Sports beverages were the most recommended and commonly used, followed by energy beverages. Dietary supplements were the least-known used. Participants used beverages and dietary supplements to assist in providing more energy (67%), improve health (65%) and improve performance (55%) (p<0.001). Seventy-three percent of participants lacked knowledge about the anti-doping policy (p<0.001), with 87% having never attended a workshop on the safe use of supplements and beverages, or anti-doping awareness campaigns (p<0.001). Thirty-eight percent had not heard of the South African Institute for Drug-Free Sport (SAIDS), and 84% were not familiar with the yearly updated World Anti-Doping Agency's (WADA) prohibited list (p<0.001). Of the 59% who did not take dietary supplements or beverages, 75% had insufficient information regarding them (p<0.001), 66% indicated that dietary supplements and beverages were costly (p=0.001), and 55% indicated they did not need dietary supplements and beverages (p=0.32). There is a need for an educational programme on the safe use of dietary supplements, and sports and energy beverages among KwaZulu-Natal semi-professional soccer players.

Psychological Well-Being of School Teachers: Predictive Role of Mindfulness and Emotional Intelligence

Psychological well-being (PWB) is an indicator of the optimal functioning of individuals and can act as psychological capital. Studying PWB among school teachers can help identify factors that can prevent burnout, cope with stress, and effectively manage their classroom. This study analyses the relationship between PWB, mindfulness, and emotional intelligence of school teachers and examines the predictive capability of mindfulness and emotional intelligence for PWBs. This study uses a correlational research design. Participants (N=125) consist of female teachers recruited from English medium private schools in Bangalore, India, through a convenience sampling method. Data were collected using a survey consisting of a demographic information sheet, Scales of Psychological Well-Being (Ryff, 1989), Five Facets of Mindfulness Questionnaire (Baer et al., 2006), and Assessing Emotions Scale (Schutte et al., 2009). Results reveal that PWB has a strong association with mindfulness and a moderate association with emotional intelligence. The association between mindfulness and emotional intelligence is moderate. Data shows that mindfulness and emotional intelligence contributed to higher variance in PWB than only mindfulness. Thus, mindfulness and emotional intelligence may impact the PWB of school teachers and should be considered for school mental health programmes.

Screening for traumatic stress in children and adolescents with congenital heart disease

BackgroundPrevious research has indicated that up to one-third of children undergoing cardiac surgery develop posttraumatic stress disorder (PTSD) following cardiac surgery. Despite the potential long term implications for mental health from this finding, there is no uniform screening procedure for traumatic stress that exists within pediatric cardiac care. ObjectivesA quality improvement initiative was developed to improve standards of care to better identify, manage, and prevent traumatic stress in pediatric cardiology patients. MethodsQuality improvement science methodology was utilized to develop, implement, study, and adopt changes in clinical practice within a pediatric cardiac outpatient clinic. Specifically, children who had undergone cardiac surgery, interventional cardiac catheterization, or heart transplant were offered screening for symptoms of traumatic stress using the Children's Revised Impact of Events Scale. Chi-Square tests and logistic regression were used to analyze differences associated with sociodemographic variables, type of surgical repair, and version of the traumatic stress symptom screener that was utilized. ResultsSuccessful implementation to improve quality of care occurred during a 24-month period as screening of eligible patients for traumatic stress increased from 0 % to 95 %. At risk scores for traumatic stress were found in 14 % of patients who were then subsequently referred to social work for further assessment and triage to mental and behavioral health services. Access to education about traumatic stress increased for patients, parents, and the medical team via the use of informational teaching sheets and increased dialogues among staff. ConclusionA multidisciplinary quality improvement intervention was effective in screening children at risk for traumatic stress who had experienced cardiac surgery, interventional cardiac catheterization, or heart transplant. Administering a screening tool for traumatic stress appears to be an effective means of identifying patients at risk for traumatic stress.

Optimizing Older Adults' Medication Use Nurses can partner with caregivers to promote safe medication administration.

This article is the third in a series, Supporting Family Caregivers in the 4Ms of an Age-Friendly Health System, published in collaboration with the AARP Public Policy Institute as part of the ongoing Supporting Family Caregivers: No Longer Home Alone series. The 4Ms of an Age-Friendly Health System (What Matters, Medication, Mentation, and Mobility) is an evidence-based framework for assessing and acting on critical issues in the care of older adults across settings and transitions of care. Engaging the health care team, including older adults and their family caregivers, with the 4Ms framework can help to ensure that every older adult gets the best care possible, is not harmed by health care, and is satisfied with the care they receive. The articles in this series present considerations for implementing the 4Ms framework in the inpatient hospital setting and incorporating family caregivers in doing so. Resources for both nurses and family caregivers, including a series of accompanying videos developed by AARP and the Rush Center for Excellence in Aging and funded by The John A. Hartford Foundation, are also provided. Nurses should read the articles first, so they understand how best to help family caregivers. Then they can refer caregivers to the informational tear sheet—Information for Family Caregivers—and instructional videos, encouraging them to ask questions. For additional information, see Resources for Nurses. Cite this article as: Zonsius, M.C., et al. Optimizing Older Adults' Medication Use. Am J Nurs 2022; 122(3): 38-43.

Recognizing and Acting on Mentation Concerns Caregivers are key partners in addressing depression, dementia, and delirium in older adults.

This article is the fourth in a series, Supporting Family Caregivers in the 4Ms of an Age-Friendly Health System, published in collaboration with the AARP Public Policy Institute as part of the ongoing Supporting Family Caregivers: No Longer Home Alone series. The 4Ms of an Age-Friendly Health System (What Matters, Medication, Mentation, and Mobility) is an evidence-based framework for assessing and acting on critical issues in the care of older adults across settings and transitions of care. Engaging the health care team, including older adults and their family caregivers, with the 4Ms framework can help to ensure that every older adult gets the best care possible, is not harmed by health care, and is satisfied with the care they receive. The articles in this series present considerations for implementing the 4Ms framework in the inpatient hospital setting and incorporating family caregivers in doing so. Resources for both nurses and family caregivers, including a series of accompanying videos developed by AARP and the Rush Center for Excellence in Aging and funded by The John A. Hartford Foundation, are also provided. Nurses should read the articles first, so they understand how best to help family caregivers. Then they can refer caregivers to the informational tear sheet—Information for Family Caregivers—and instructional videos, encouraging them to ask questions. For additional information, see Resources for Nurses. Cite this article as: Mack, L., et al. Recognizing and Acting on Mentation Concerns. Am J Nurs 2022; 122(5): 50-55