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Background The case has been made for more and better theory-informed process evaluations within trials in an effort to facilitate insightful understandings of how interventions work. In this paper, we provide an explanation of implementation processes from one of the first national implementation research randomized controlled trials with embedded process evaluation conducted within acute care, and a proposed extension to the Promoting Action on Research Implementation in Health Services (PARIHS) framework. Methods The PARIHS framework was prospectively applied to guide decisions about intervention design, data collection, and analysis processes in a trial focussed on reducing peri-operative fasting times. In order to capture a holistic picture of implementation processes, the same data were collected across 19 participating hospitals irrespective of allocation to intervention. This paper reports on findings from data collected from a purposive sample of 151 staff and patients pre- and post-intervention. Data were analysed using content analysis within, and then across data sets. Results A robust and uncontested evidence base was a necessary, but not sufficient condition for practice change, in that individual staff and patient responses such as caution influenced decision making. The implementation context was challenging, in which individuals and teams were bounded by professional issues, communication challenges, power and a lack of clarity for the authority and responsibility for practice change. Progress was made in sites where processes were aligned with existing initiatives. Additionally, facilitators reported engaging in many intervention implementation activities, some of which result in practice changes, but not significant improvements to outcomes. Conclusions This study provided an opportunity for reflection on the comprehensiveness of the PARIHS framework. Consistent with the underlying tenant of PARIHS, a multi-faceted and dynamic story of implementation was evident. However, the prominent role that individuals played as part of the interaction between evidence and context is not currently explicit within the framework. We propose that successful implementation of evidence into practice is a planned facilitated process involving an interplay between individuals, evidence, and context to promote evidence-informed practice. This proposal will enhance the potential of the PARIHS framework for explanation, and ensure theoretical development both informs and responds to the evidence base for implementation. Trial registration ISRCTN18046709 - Peri-operative Implementation Study Evaluation (PoISE).

Background While falls are the leading cause of accidental injury among older people, the current fall prevention strategies have not resulted in a remarkable reduction in fall rates. An alternative novel approach, teaching older adults how to fall safely to prevent injury, has been recently implemented in the FAlling Safely Training (FAST) trial. The current study aimed to explore the views and perceptions of older people about their participation in the safe-falling training program. Methods Focus groups were conducted with eight community-dwelling older adults (age range: 66 to 76 years, five females) at risk of falling who completed the FAST program. Two focus groups involving four participants each were conducted. Recordings were transcribed verbatim and analyzed using thematic analysis. Results Three themes were identified following the analysis: (1) Before the training ; with subthemes: Previous fall prevention strategies and Motivation to participate . Motivations to take part in the training included worries about falling, an awareness of an increased risk of falling, and a desire to decrease the chances of sustaining an injury. (2) Training itself ; with subthemes: General impressions of the training and Learning the techniques. Older people highlighted that the training was well-designed and executed. (3) Going forward ; with subthemes: Training increased confidence , Incorporating in a community setting , and Proposing improvements to the study. It was reported that the training enhanced participants’ confidence about falling without injury. Incorporating the training into a community context was discussed, and suggestions for program enhancements were made. The individual nature of the training was valued, but participants also provided suggestions for how they would see the program taking place successfully in small groups. Conclusions The results indicated that the safe-falling training was acceptable to older adults. The perceived ability to fall without injury was reported to have increased. Individuals who experienced a fall after the training ended reported being able to use the techniques learned in their daily life. The findings have implications for the training to be refined and implemented in the community. Trial registration The article is linked to a randomized controlled trial registered at http://ClinicalTrials.gov (NCT05260034).

Mobile health (mHealth) apps have the potential to be effective tools for encouraging patients with chronic diseases to self-manage their health. The success of mHealth apps is related to technology acceptance and its subsequent use by intended consumers. Therefore, it is essential to gain insights from consumers' perspectives about their use of mHealth apps in daily life. The purpose of this work was to understand consumers' perspectives on use of a self-management app following completion of a clinical trial that tested the efficacy of the app for improving health outcomes. We conducted five focus groups with paricipants of a clinical trial (NCT03182738) who were randomized to use the video information provider (VIP) for HIV-associated nonAIDS (HANA) conditions app (VIP-HANA) or an attention control app. Thematic analysis was conducted, and the themes were organized according to the two key constructs of the technology acceptance model framework: perceived usefulness and perceived ease of use. Thirty-nine people living with HIV (20 from the intervention group and 19 from the control group) participated in the focus group sessions. Of the eight themes identified from focus group data, the five themes related to perceived usefulness were: (1) self-monitoring HIV-related symptoms of HANA conditions, (2) enhanced relationship with clinical providers, (3) improvement in physical and emotional health, (4) long-term impact of self-care strategies on improvement in symptoms of HANA conditions, and (5) inspired lifestyle changes to manage symptoms. The three themes related to perceived ease of use were: (1) easy to navigate, (2) avatar personalization, and (3) privacy/confidentiality maintained even when changing the location of app use. Perceived ease of use was similar in both study groups but perceived usefulness differed between study groups. Participants in both study groups found the VIP-HANA app to be useful in monitoring their symptoms and enhancing communication with their clinical care providers. However, only intervention group participants perceived the app to be useful in improving overall health and long-term symptom management. Findings from this study highlight factors that are essential to ensure the usefulness of self-management apps and facilitate sustained use of mHealth apps for people living with chronic illnesses.

To explore the experiences of undergraduate nursing students regarding hot and cold debriefing styles following Basic Life Support (BLS) training. Debriefing plays a vital role in nursing education, especially in simulation-based experiences. Debriefing is defined as a two-directional, “formal, collaborative, reflective process within the simulation learning activity”. According to the literature, \"hot\" debriefings take place within minutes to hours after the simulation, while \"cold\" debriefings can happen within days to weeks. There is insufficient evidence to determine the most effective debriefing methods for undergraduate nursing students. A qualitative descriptive study was conducted to understand students' perceptions of hot and cold debriefing styles. Data were collected through two focus group interviews with 12 undergraduate nursing students. Participants were randomly assigned to hot debriefing (n = 22) or cold debriefing (n = 22), with six students from each group participating in the focus groups. Five main categories emerged from students' perceptions related to simulation and debriefing experiences: Simulation Experience, Debriefing Experience, Reflection, Debriefing Impact on Learning and Feedback for Educators. It is suggested that incorporating simulation followed by debriefing into the nursing curriculum, particularly for teaching BLS, can be highly beneficial. The study highlights the importance of debriefing in simulation-based education and provides recommendations for enhancing debriefing strategies to enhance nursing skills and knowledge. •Simulation followed by debriefing should be incorporated into nursing curricula.•This study highlights the importance of debriefing in nursing education.•The primary advantage of cold debriefing was the readiness to debrief effectively.•The main benefit of hot debriefing was enhanced recall of the simulation experience.

Background In oncology, Health Care Professionals often experience conducting Advance Care Planning (ACP) conversations as difficult and are hesitant to start them. A structured approach could help to overcome this. In the ACTION trial, a Phase III multi-center cluster-randomized clinical trial in six European countries (Belgium, Denmark, Italy, the Netherlands, Slovenia, United Kingdom), patients with advanced lung or colorectal cancer are invited to have one or two structured ACP conversations with a trained facilitator. It is unclear how trained facilitators experience conducting structured ACP conversations. This study aims to understand how facilitators experience delivering the ACTION Respecting Choices (RC) ACP conversation. Methods A qualitative study involving focus groups with RC facilitators. Focus group interviews were recorded, transcribed, anonymized, translated into English, and thematically analysed, supported by NVivo 11. The international research team was involved in data analysis from initial coding and discussion towards final themes. Results Seven focus groups were conducted, involving 28 of in total 39 trained facilitators, with different professional backgrounds from all participating countries. Alongside some cultural differences, six themes were identified. These reflect that most facilitators welcomed the opportunity to participate in the ACTION trial, seeing it as a means of learning new skills in an important area. The RC script was seen as supportive to ask questions, including those perceived as difficult to ask, but was also experienced as a barrier to a spontaneous conversation. Facilitators noticed that most patients were positive about their ACTION RC ACP conversation, which had prompted them to become aware of their wishes and to share these with others. The facilitators observed that it took patients substantial effort to have these conversations. In response, facilitators took responsibility for enabling patients to experience a conversation from which they could benefit. Facilitators emphasized the need for training, support and advanced communication skills to be able to work with the script. Conclusions Facilitators experienced benefits and challenges in conducting scripted ACP conversations. They mentioned the importance of being skilled and experienced in carrying out ACP conversations in order to be able to explore the patients’ preferences while staying attuned to patients’ needs. Trial registration International Standard Randomised Controlled Trial Number registry 63110516 ( ISRCTN63110516 ) per 10/3/2014.

Background Fever improves pathogen control at a significant metabolic cost. No randomized clinical trials (RCT) have compared fever treatment thresholds in critically ill children. We performed a pilot RCT to determine whether a definitive trial of a permissive approach to fever in comparison to current restrictive practice is feasible in critically ill children with suspected infection. Methods An open, parallel-group pilot RCT with embedded mixed methods perspectives study in four UK paediatric intensive care units (PICUs) and associated retrieval services. Participants were emergency PICU admissions aged > 28 days to < 16 years receiving respiratory support and supplemental oxygen. Subjects were randomly assigned to permissive (antipyretic interventions only at ≥ 39.5 °C) or restrictive groups (antipyretic interventions at ≥ 37.5 °C) whilst on respiratory support. Parents were invited to complete a questionnaire or take part in an interview. Focus groups were conducted with staff at each unit. Outcomes were measures of feasibility: recruitment rate, protocol adherence and acceptability, between group separation of temperature and safety. Results One hundred thirty-eight children met eligibility criteria of whom 100 (72%) were randomized (11.1 patients per month per site) without prior consent (RWPC). Consent to continue in the trial was obtained in 87 cases (87%). The mean maximum temperature (95% confidence interval) over the first 48 h was 38.4 °C (38.2–38.6) in the restrictive group and 38.8 °C (38.6–39.1) in the permissive group, a mean difference of 0.5 °C (0.2–0.8). Protocol deviations were observed in 6.8% (99/1438) of 6-h time periods and largely related to patient comfort in the recovery phase. Length of stay, duration of organ support and mortality were similar between groups. No pre-specified serious adverse events occurred. Staff ( n  = 48) and parents ( n  = 60) were supportive of the trial, including RWPC. Suggestions were made to only include invasively ventilated children for the duration of intubation. Conclusion Uncertainty around the optimal fever threshold for antipyretic intervention is relevant to many emergency PICU admissions. A more permissive approach was associated with a modest increase in mean maximum temperature. A definitive trial should focus on the most seriously ill cases in whom antipyretics are rarely used for their analgesic effects alone. Trial registration ISRCTN16022198 . Registered on 14 August 2017.

Technological advances allow for recording and sharing health-related data in a patient-centric way using smartphones and wearables. Secure sharing of such patient-generated data with physicians would enable close management of individual health trajectories, monitoring of risk factors, and asynchronous feedback. However, most remote patient monitoring (RPM) systems currently available are not fully integrated into hospital IT systems or lack a patient-centric design. The objective of this study was to conceptualize and implement a user-friendly, reusable, interoperable, and secure RPM system incorporating asynchronous feedback mechanisms using a broadly available consumer wearable (Apple Watch). In addition, this study sought to evaluate factors influencing patient acceptance of such systems. The RPM system requirements were established through focus group sessions. Subsequently, a system concept was designed and implemented using an iterative approach ensuring technical feasibility from the beginning. To assess clinical feasibility, the system was used as part of the activeDCM prospective randomized interventional study focusing on dilated cardiomyopathy. Each patient used the system for at least 12 months. The System Usability Scale was used to measure usability from a subjective patient perspective. In addition, an evaluation was conducted on the objective wearable interaction frequency as well as the completeness of transmitted data classified into sensor-based health data (SHD) and patient-reported outcome measures (PROMs). Descriptive statistics using box plots and bootstrapped multiple linear regression with 95% CIs were used for evaluation analyzing the influence of age, sex, device experience, and intervention group membership. The RPM system comprised 4 interoperable components: patient devices, a data server, a data viewer, and a notification service. The system was evaluated with 95 consecutive patients with dilated cardiomyopathy (28/95, 29% female; mean age 50, SD 12 y) who completed the activeDCM study protocol. The system's app achieved a mean System Usability Scale score of 78 (SD 17), which was most influenced by device experience. In total, 87% (83/95) of the patients could integrate the use of the app well or very well into their daily routine, and 71% (67/95) saw a benefit of the RPM system for management of their health condition. On average, patients interacted with the wearable on 61% (SD 26%) of days enrolled in the study. SHD were available on average for 78% (SD 23%) of days, and PROM data were available on 64% (SD 27%) of weeks enrolled in the study. Wearable interaction frequency, SHD, and PROM completeness were most influenced by intervention group membership. Our results mark a first step toward integrating RPM systems based on a consumer wearable device for primary patient input into standardized clinical workflows. They can serve as a blueprint for creating a user-friendly, reusable, interoperable, and secure RPM system that can be integrated into patients' daily routines.

ObjectiveTo determine the acceptability of bubble continuous positive airway pressure (bCPAP) and low-flow oxygen among mothers of children who had received either therapy.SettingA district hospital in Salima, Malawi.ParticipantsWe conducted eight focus group discussions (FGDs) with a total of 54 participants. Eligible participants were mothers of children 1 to 59 months of age with severe pneumonia and a comorbidity (HIV-infection, HIV-exposure, malnutrition or hypoxaemia) who, with informed consent, had been enrolled in a randomised clinical trial, CPAP IMPACT (Improving Mortality for Pneumonia in African Children Trial), comparing low-flow oxygen and bCPAP treatments (ClinicalTrials.gov, NCT02484183).Primary and secondary outcome measuresFGDs assessed mothers’ attitudes and feelings towards oxygen and bCPAP before and after therapy along with general community perceptions of respiratory therapies. Data was analysed using inductive thematic analysis to assess themes and subthemes of the transcripts.ResultsCommunity perceptions of oxygen and bCPAP were widely negative. Mothers recounted that they are told that ‘oxygen kills babies’. They are often fearful of allowing their child to receive oxygen therapy and will delay treatment or seek alternative therapies. Mothers report limiting oxygen and bCPAP by intermittently removing the nasal cannulas or mask. After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.ConclusionThere are significant community misconceptions around oxygen and bCPAP causing mothers to be fearful of either treatment. In order for low-flow oxygen treatment and bCPAP implementation to be effective, widespread community education is necessary.

Background At present, we know relatively little about priorities and problems with topics that older adults experience when completing different examinations in longitudinal population-based studies. To examine these topics, research must be adapted to investigate the meanings, motivations, and interpretations of the individual participants themselves. Therefore, the present study aimed to explore older adults’ motives, understandings and experiences regarding participating in the Gothenburg H70 Birth Cohort Studies (the H-70 study). Methods Focus group discussions were used. A total of thirty-eight persons, 19 women and 19 men participated in nine focus groups. A strategic sampling technique was used to ensure that the focus group participants represented the larger population. Results The results supported the overall theme: “It was well worth the effort,” which summarized how the participants felt about the population health study. The following specific themes were also identified: an intense event, for the benefit of oneself and others, confidence in health research and the researcher, key decisions about test outcomes and the survey raising questions and providing few answers. Conclusions Knowledge of priorities and problems with topics experienced by older adults completing different examinations when participating in longitudinal population-based studies is crucial for research to improve the health and wellbeing of older people. To date, older people’s involvement in population-based cohort studies has largely been as research subjects. This study is a first step toward the participants taking a more active part by allowing them to share their experiences which can be used to improve the research procedures. This requires the participation of older adults in collaboration with the researchers, to ensure the quality of longitudinal studies of older adults. Therefore, our intention when it comes to future research will be to involve older adults—the target group—in the research procedure.

A 10-week group music therapy project was designed to determine whether music therapy influenced quality of life and social anxiety for people with a severe and enduring mental illness living in the community. Ten one-hour weekly sessions including song singing, song writing and improvisation, culminated in each group recording original song/s in a professional studio. The principal outcome measure was the WHOQOLBREF Quality of Life (QoL) Scale; other instruments used were the Social Interaction Anxiety Scale (SIAS) and the Brief Symptom Inventory (BSI). Qualitative data were gathered through focus group interviews and an analysis of lyric themes. Statistically significant improvement was found on five items of the QoL Scale. There were no changes on the BSI indicating that QoL improvement was not mediated by symptomatic change. Themes from the focus groups were: music therapy gave joy and pleasure, working as a team was beneficial, participants were pleasantly surprised at their creativity, and they took pride in their song. An analysis of song lyrics resulted in 6 themes: a concern for the world, peace and the environment; living with mental illness is difficult; coping with mental illness requires strength; religion and spirituality are sources of support; living in the present is healing; and working as a team is enjoyable.