Written information about retinopathy of prematurity in Aotearoa New Zealand: identification, review and opportunities for improvement.

AIMS: The aims of this research include adapting a patient information tool for whanau (extended family) Maori needs, identifying and reviewing written information provided for the retinopathy of prematurity eye examination (ROPEE) and identifying improvements to ROPEE written information. METHODS: ROPEE patient information (printed leaflets, website, app) was obtained from all tertiary neonatal intensive care units in Aotearoa New Zealand (Aotearoa). Information was reviewed using an adapted "20 good-design principles" guide and given a star rating and Flesch-Kincaid readability score to identify acceptability and usability for patients. RESULTS: Seven ROPEE information materials were reviewed and varied in alignment with the adapted good-design principles tool. Based on the adapted good-design principles, opportunities were identified in many aspects of the written information for improvement, including words and language, tone and meaning, content and design. The Flesch-Kincaid grade level reading scores ranged from 12-22 years reading age. Written information also did not use te reo Maori (Aotearoa Indigenous language) or extensively use Maori imagery. CONCLUSION: Opportunities exist to improve ROPEE whanau information, including making content more readable, understandable and visually appealing. Optimising the clinical information on ROPEE nationally for Aotearoa will support whanau decision making, and aligning written information with Maori (Indigenous peoples of Aotearoa) is a priority.

Série educativa da fauna sinantrópica: taturana

Folhedo informativo sobre a taturana (lonomia oblíqua)

Série educativa da fauna sinantrópica: barata (periplaneta americana)

Folheto educativo referente à barata: biologia, medidas preventivas e importância para a saúde

Série educativa da fauna sinantrópica: abelha & vespa (apis spp e vespidae)

Folhedo informativo sobre o abelhas e vespas

Evaluation of clinical effectiveness of blood stasis leaflet in patients with blood stasis: A prospective, randomized, and crossover trial.

BACKGROUND: Blood stasis (BS) refers to a pattern of symptoms resulting from circulatory dysfunction or stagnation in the human body. Due to its historical origin and diverse interpretations, communication between patients and doctors of traditional Korean medicine (DKMs) presents challenges. Efforts to improve patients understanding in traditional Korean medicine (TKM) have led to the development of disease-specific standard clinical practice guidelines. However, there is a limited focus on creating clinical practice guidelines or informative leaflet specifically addressing BS, which is a frequently encountered pattern of symptoms in TKM. METHODS: This study aimed to bridge the gap between patients and DKMs by developing an informative leaflet focusing on BS for metabolic diseases. We assessed its appropriateness through expert advisory meetings and the Delphi process, and evaluated its clinical effectiveness. We conducted a prospective, randomized, crossover trial to compare the clinical effectiveness of using BS leaflets in TKM treatment. The hypothesis investigated whether the leaflet group would show higher scores in satisfaction of DKMs' explanations, understanding of DKMs' explanations, improving the reliability of TKM, satisfaction with treatment time, improvement in explanations compared to previous TKM experiences, and necessity of managing BS treatment, compared to the no-leaflet group. RESULTS: In a study involving 40 patients (mean age: 62.3 ±â€…7.8 years), symptoms persisted for an average of 16.75 ±â€…9.3 hours daily, with a severity rating of 2.53. The leaflet group exhibited significantly higher satisfaction scores than the no-leaflet group in all aspects (all P < .0001). After confirming the absence of sequence and period effects using a linear-mixed effect model, we were able to ascertain the presence of a treatment effect, as evidenced by statistically significant higher scores across all survey items in the leaflet group compared to the no-leaflet group (all P < .0001). CONCLUSION: Expert consensus on symptoms aligning with the BS pattern resulted in the development of an informative leaflet. Its utilization notably improved patient satisfaction, comprehension, and trust in TKM treatment, unaffected by temporal influences, thus demonstrating its clinical effectiveness. In summary, the BS leaflet significantly enhanced patient understanding and optimized treatment procedures.

Trial participants' self-reported understanding of randomisation phrases in participation information leaflets can be high, but acceptability of some descriptions is low, especially those linked to gambling and luck.

BACKGROUND: Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback. METHODS: We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase. RESULTS: Two hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases. CONCLUSIONS: Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice.

Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol: an analysis of adult participant information leaflets and their corresponding protocols.

BACKGROUND: Retaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are developed at the planning stage, i.e. post-funding during protocol development, but some protocols include strategies for participant retention as retention is considered and planned for early in the trial planning stage. It is yet unknown if these plans are communicated in the corresponding participant information leaflets (PILs). The purpose of our study was to determine if PILs communicate plans to promote participant retention and, if so, are these outlined in the corresponding trial protocol. METHODS: Ninety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate. RESULTS: Plans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use "combined strategies" to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies). CONCLUSION: Retention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL.

Development of an Education Material Targeting Patients Undergoing Lower Extremity Amputation due to Severe Limb Ischemia-A Qualitative Study.

INTRODUCTION: Critical limb-threatening ischemia (CLTI) is associated with a high risk of amputation, yet patients undergoing amputation due to CLTI have little knowledge of the amputation process and the rehabilitation that awaits. The aim of the present study was to develop and validate information material for patients undergoing amputation. METHODS: Nine participants were included in the study. Two focus group interviews were performed with seven patients who had undergone lower extremity amputation due to CLTI within the past 2 y. Additionally, two individual interviews were carried out. A semistructured interview guide was used, and the interviews were transcribed verbatim and analysed using qualitative content analysis with a deductive approach. RESULTS: Three themes were identified as essential for the design of the written information: Perspectives on design and formatting, Providing information to enhance participation in care, and Accessibility to information and support. The prototyped information leaflet was perceived as acceptable, useable, relevant, and comprehensible by the participants. CONCLUSIONS: For patients to actively engage in their care, it is vital that their information needs are met and that they are provided with psychosocial support when needed. Written and oral information should be provided by a trusted healthcare professional.

Adherence of individuals with shoulder pain to home exercise booklets: Barriers, facilitators, and the impact of disability, self-efficacy, and treatment expectations.

BACKGROUND: home exercise booklets offer several benefits to individuals with shoulder pain. However, it is necessary to investigate the factors that determine adherence to home exercises. OBJECTIVES: 1) To investigate the level of adherence of individuals with chronic shoulder pain to a home exercise booklet conducted without the mediation of a healthcare professional, 2) To describe the barriers and facilitators to adherence, and 3) to determine if shoulder disability, self-efficacy, and treatment expectations are predictors of the level of adherence. DESIGN: prospective longitudinal study. METHODS: A total of 47 individuals with chronic shoulder pain were recruited. The Numeric Pain Rating Scale (NPRS) was used to assess pain intensity, the Shoulder Pain and Disability Index (SPADI) to measure shoulder disability, the Pain Self-Efficacy Questionnaire (PSEQ-10) for self-efficacy, and a likert scale to measure treatment expectations. Adherence was measured by Exercise Adherence Assessment Scale (EAAE-Br). RESULTS: A total of 23 individuals (48.93%) adhered to the home exercise program. The most commonly cited barriers were pain and health-related issues, while the most cited facilitators were pain improvement and symptom relief. Barriers associated with adherence were time constraints and other commitments, while the facilitator associated with adherence was enjoying the exercises. Binary logistic regression analysis revealed that shoulder disability, self-efficacy, and treatment expectations were unable to predict adherence to home exercises in individuals with shoulder pain [F (1,47) = 2.384; p = 0.130; R2 = 0.056]. CONCLUSION: The study revealed barriers and facilitators to home exercise in individuals with shoulder pain. Disability, self-efficacy, and treatment expectations were not able to predict adherence.

Patient information leaflets for placebo-controlled surgical trials: a review of current practice and recommendations for developers.

INTRODUCTION: Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has not been explored. Patient information leaflets (PILs) are a core component of the informed consent process. This study aimed to investigate the key content of PILs for recently completed placebo-controlled trials of invasive procedures, including surgery, to highlight areas of good practice, identify gaps in information provision for trials of this type and provide recommendations for practice. METHODS: PILs were sought from trials included in a recent systematic review of placebo-controlled trials of invasive procedures, including surgery. Trial characteristics and data on surgical and placebo interventions under evaluation were extracted. Directed content analysis was applied, informed by published regulatory and good practice guidance on PIL content and existing research on placebo-controlled surgical trials. Results were analysed using descriptive statistics and presented as a narrative summary. RESULTS: Of the 62 eligible RCTs, authors of 59 trials were contactable and 14 PILs were received for analysis. At least 50% of all PILs included content on general trial design. Explanations of how the placebo differs or is similar to the surgical intervention (i.e. fidelity) were reported in 6 (43%) of the included PILs. Over half (57%) of the PILs included information on the potential therapeutic benefits of the surgical intervention. One (7%) included information on potential indirect therapeutic benefits from invasive components of the placebo. Five (36%) presented the known risks of the placebo intervention, whilst 8 (57%) presented information on the known risks of the surgical intervention. A range of terms was used across the PILs to describe the placebo component, including 'control', 'mock' and 'sham'. CONCLUSION: Developers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar) to the surgical intervention and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials.

An evaluation of written materials for supporting hypertensive patient education and counselling when performing a new medicine service in Poland.

BACKGROUND: The New Medicine Service (NMS) was developed in England more than ten years ago, as a three-stage consultation led by community pharmacists to support patients taking new medication for a chronic disease. In Poland, the scheme was officially introduced in January 2023. However, its implementation into common practice has been presented with various obstacles, including the need to develop relationships with general practitioners, resolve the payment structure, and provide training with adequate supporting materials. Hence, written materials have been designed for use as an optional tool for counselling patients receiving an NMS in community pharmacies. METHODS: The present study evaluates the ability of these materials to inform patients about the need to adhere to anti-hypertensive medication. A group of 401 randomly-selected adult visitors to pharmacies and/or healthcare centres were surveyed; one third had hypertension in their history. RESULTS: The structure, grammar and readability of the text achieved the required threshold of 40% according to the Plain Language Index. The designed materials effectively informed the patients about anti-hypertensive medication, reflected in an increased score in a knowledge test, and were rated positively regarding information level, comprehensibility and presentation. CONCLUSION: The proposed material may serve as an additional, "patient-friendly" educational tool for use as part of an NMS.

When describing harms and benefits to potential trial participants, participant information leaflets are inadequate.

BACKGROUND: Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs). METHODS: A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third. RESULTS: Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas. CONCLUSION: Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.

Supporting health and social care professionals in serious illness conversations: Development, validation, and preliminary evaluation of an educational booklet.

Serious illness conversations aim to align the care process with the goals and preferences of adult patients suffering from any advanced disease. They represent a challenge for healthcare professionals and require specific skills. Conversation guides consistent with task-centered instructional strategies may be particularly helpful to improve the quality of communication. This study aims to develop, validate, and preliminarily evaluate an educational booklet to support Italian social and healthcare professionals in serious illness conversations. A three-step approach, including development, validation, and evaluation, was followed. A co-creation process with meaningful stakeholders led to the development of the booklet, validated by 15 experts on clarity, completeness, coherence, and relevance. It underwent testing on readability (Gulpease index, 0 = lowest-100 = maximum) and design (Baker Able Leaflet Design criteria, 0 = worst to 32 = best). Twenty-two professionals with different scope of practice and care settings evaluated acceptability (acceptable if score ≥30), usefulness, feasibility to use (1 = not at all to 10 = extremely), and perceived acquired knowledge (1 = not at all to 5 = extremely). After four rounds of adjustments, the booklet scored 97% for relevance, 60 for readability, and 25/32 for design. In all, 18 (81.8%), 19 (86.4%) and 17 (77.3%) professionals deemed the booklet acceptable, moderate to highly useful, and feasible to use, respectively; 18/22 perceived gain in knowledge and all would recommend it to colleagues. The booklet has good readability, excellent design, high content validity, and a high degree of perceived usefulness and acquired knowledge. The booklet is tailored to users' priorities, mirrors their most frequent daily practice challenges, and offers 1-minute, 2-minute and 5-minute solutions for each scenario. The co-creation process ensured the development of an educational resource that could be useful regardless of the scope of practice and the care setting to support professionals in serious illness conversations.

Recommended Tips for Treating Veterinary Patients.

These recommended tips can be set up as free-of-charge, attractive pamphlets, which can either be given to the veterinary patient's owner when medications are supplied or made available as a display.

Série educativa da fauna sinantrópica: Aedes aegypti

Folhedo informativo sobre o Aedes aegypti

Evaluation of parental anxiety following three methods of pre-anesthesia counseling: Video, brochure and verbal communication.

BACKGROUND: The purpose of this study is to provide comprehensive and efficient pre-anesthesia counseling (PAC) utilizing audiovisual aids and to examine their effect on parental anxiety. METHODS: For this prospective, controlled study, 174 parents were recruited and randomized into three groups of 58 (Group A: video, Group B: brochure, and Group C: verbal). During pre-anesthesia counseling, the parent was provided with a detailed explanation of preoperative preparation, fasting instructions, transport to the operating room, induction, the emergence of anesthesia, and nursing in the post-anesthesia care unit based on their assigned group. We evaluated parental anxiety using Spielberger's State-Trait Anxiety Inventory before and after the pre-anesthesia counseling. RESULTS: The results of our study show a statistically significant difference in the final mean STAI scores among the three groups (Group A: 34.69 ± 5.31, Group B: 36.34 ± 8.59, and Group C: 43.59 ± 3.39; p < .001). When compared to the brochure and verbal groups, the parents in the video group have the greatest difference in mean baseline and final Spielberger's State-Trait Anxiety Inventory scores (12.207 ± 5.291, p .001). CONCLUSION: The results of our study suggest that pre-anesthesia counseling by video or a brochure before the day of surgery is associated with a higher reduction in parental anxiety when compared to verbal communication.

Originalarbeiten / Original Articles. Entwicklung und Evaluation einer Aufklärungsbroschüre zu Ängsten und Angststörungen für Jugendliche.

Development and Evaluation of an Information Brochure on Anxiety and Anxiety Disorders for Adolescents Low mental health literacy and fear of being stigmatized are two main barriers that detain adolescents fromseeking professional help. An information brochure about anxiety disorders for adolescents was developed. To make a first statement about the quality of the brochure, 19 experts, consisting of (child and adolescents) psychotherapists, psychiatrists, and psychologists, rated a first version of the brochure regarding content validity and age-appropriatness. To evaluate the efficacy in knowledge and the acceptance of the brochure, a revised version was evaluated by N = 174 adolscents (106 female-, 66 male- and two non-binary) between 14 and 17 years of age (M = 16.56 years.; SD = 0.57).The experts' approval of all content items totals a mean average of 95.2 % (range: 84.2-100 %). In the adolescent sample, the intervention increased knowledge about anxiety disorders (d = 1.04) and improved attitudes about coping strategies (d = 0.99). Results of the experts' rating showed that content validity of the brochure can be assumed.The revised brochure seems to be a useful and effective tool to inform adolescents about anxiety disorders.

Booklet and Motivational Interviewing to Promote Self-efficacy in Parents/Caregivers of Children with Asthma: A Clinical Trial.

Background: Asthma is the most common chronic disease in childhood which accounts for numerous annual hospitalizations due to a lack of management and proper management of the disease. Thus, this study aimed to evaluate the effect of using an educational booklet with or without combination with motivational interviewing (MI) on the self-efficacy of parents/caregivers in the control and management of childhood asthma. Methods: A clinical trial was carried out with 86 parents/caregivers of children with asthma aged between 2 and 12 years who were followed up in primary health care units from March 2019 to December 2020. Participants were randomly assigned to two groups: one of the groups read the booklet and the other read the booklet combined with the MI. The Brazilian version of the Self-Efficacy and Their Child's Level of Asthma Control scale was applied before and 30 days after the intervention for assessment of self-efficacy. Data were analyzed using SPSS version 20.0 and R 3.6.3 software. P values<0.05 were considered significant. Results: There were 46 participants in the booklet group and 40 in the booklet and MI group. Both groups were effective in increasing total self-efficacy scores after the intervention (P<0.001). No statistically significant difference was found between the scores of the two groups (P=0.257). Conclusion: The educational booklet with or without combination with MI can increase the self-efficacy of parents/caregivers of children with asthma. The findings could be considered by healthcare providers for the empowerment of caregivers of children with asthma in the control and management of their children's asthma.Trial Registration Number: U1111-1254-7256.

Patient information videos via QR codes: An innovative and sustainable approach in ophthalmology.

BACKGROUND: We explore an innovative approach by transforming patient information leaflet (PILs) into Quick Response (QR) code linked patient information videos (PIVs) in ophthalmology. Our objectives are to assess the subjective utility of a PIV on glaucoma and analyse the use of QR codes as a delivery method. METHODS: A prospective study was conducted in Ninewells Hospital, NHS Tayside. A glaucoma PIV was created and linked to a QR code provided to 130 glaucoma patients. Pre- and post-video questionnaires evaluated the patients' perception of using a QR code and subjective improvement in their understanding of glaucoma. RESULTS: Out of 102 responses collected, 55% of patients had no prior experience with QR codes. However, 81% of patients were able to watch the PIV. The average view duration of the video was 3:26, with 82.5% view retention. Statistically significant improvement in glaucoma knowledge was observed across all six areas questioned (p < 0.001) using a 5-point Likert scale. Overall, 70% of patients preferred PIVs over PILs, and 77% acknowledged that PIVs could be a sustainable alternative. CONCLUSION: QR codes for delivering PIVs were well-received, with patients finding them easy to use. Our PIV on glaucoma effectively enhanced patients' understanding of the condition.