Implementation of a fluid balance control strategy in critically ill patients: POINCARE-2 trial process evaluation.

BACKGROUND: POINCARE-2 trial aimed to assess the effectiveness of a strategy designed to tackle fluid overload through daily weighing and subsequent administration of treatments in critically ill patients. Even in highly standardized care settings, such as intensive care units, effectiveness of such a complex intervention depends on its actual efficacy but also on the extent of its implementation. Using a process evaluation, we aimed to provide understanding of the implementation, context, and mechanisms of change of POINCARE-2 strategy during the trial, to gain insight on its effectiveness and inform the decision regarding the dissemination of the intervention. METHODS: We conducted a mixed-method process evaluation following the Medical Research Council guideline. Both quantitative data derived from the trial, and qualitative data from semi-structured interviews with professionals were used to explain implementation, mechanisms of change of the POINCARE-2 strategy, as well as contextual factors potentially influencing implementation of the strategy. RESULTS: Score of actual exposure to the strategy ranged from 29.1 to 68.2% during the control period, and from 61.9 to 92.3% during the intervention period, suggesting both potential contamination and suboptimal fidelity to the strategy. Lack of appropriate weighing devices, lack of human resources dedicated to research, pre-trial rooted prescription habits, and anticipated knowledge of the strategy have been identified as the main barriers to optimal implementation of the strategy in the trial context. CONCLUSIONS: Both contamination and suboptimal fidelity to POINCARE-2 strategy raised concerns about a potential bias towards the null of intention-to-treat (ITT) analyses. However, optimal fidelity seemed reachable. Consequently, a clinical strategy should not be rejected solely on the basis of the negativity of ITT analyses' results. Our findings showed that, even in highly standardized care conditions, the implementation of clinical strategies may be hindered by numerous contextual factors, which demonstrates the critical importance of assessing the viability of an intervention, prior to any evaluation of its effectiveness. TRIAL REGISTRATION: Number NCT02765009.

Development and evaluation of an algorithm for peripheral venous catheter placement (ALCOV): protocol for a quasi-experimental study.

INTRODUCTION: Multiple punctures during peripheral venous catheter (PVC) placement increase the risk of complications. Scoring for adult difficult intravenous access (A-DIVA Scale) exists but has never been assessed in the framework of a care algorithm (scoring associated with a new decision-making tree for puncture conditions, the A-DIVA Tree). We seek to implement an catheter placement algorithm to decrease the mean number of punctures per patient. The algorithm will be adjusted based on obstacles and levers revealed by the analysis of clinical data. The benefits of the algorithm will be assessed using a step-by-step implementation of the approach. METHODS AND ANALYSIS: 794 PVC placements will be recorded in two inclusion centres (50%/50%). In phase I, 297 PVC placements will be collected, and 16 individual semistructured interviews will be conducted to evaluate the centres' practices. In phase II, 200 PVC placements will be recorded to assess the impact of the A-DIVA Scale alone. The interphase will allow preliminary results based development of the A-DIVA Tree. In phase III, 297 PVC placements will be recorded to assess the impact of the algorithm on the mean number of punctures per patient. ETHICS AND DISSEMINATION: The study and related consent forms were approved by an institutional review board (Comité de Protection des Personnes Sud-Méditerranée I) on 25 April 2023 under reference number 2023-A00223-42. The results will be disseminated in the form of original articles, presentations and guidelines. TRIAL REGISTRATION NUMBER: NCT05935228.

What contextual features affect the outcome and sustainability of therapeutic patient education interventions?

BACKGROUND: Therapeutic patient education interventions are influenced by contextual factors. Therefore, describing the context is crucial to understanding how it can affect therapeutic patient education interventions and contribute to outcomes. We aimed to identify the contextual features that may affect the outcome and sustainability of therapeutic patient education interventions from a healthcare professional perspective. METHODS: Semi-structured individual interviews were conducted with healthcare professionals involved in 14 therapeutic patient education interventions covering different chronic conditions (e.g., kidney and cardiovascular diseases, chronic pain, diabetes, obesity). Interviews were recorded and fully transcribed. We followed a general inductive approach to identify themes from healthcare professionals' discourse to properly capture their perception. RESULTS: Saturation was achieved with 28 interviews with 20 nurses, 6 dieticians, one physiotherapist and one psychologist. The average therapeutic patient education experience was 7 years. Identified contextual features clustered in 5 main themes: 1) conditions for the development of the intervention (genesis of the program: Who and what prompted it?; supports; content development; legislative framework); 2) integration of the program (in the healthcare pathway or the environment, relationship with the institution or local environment); 3) teamwork cohesion, interaction and integration with the environment (exchanges, cohesion of the team); 4) sustainability of the program; and 5) patient and healthcare professional contextual factors. CONCLUSION: New insights into contextual features that may be involved in therapeutic patient education interventions are represented in a framework based on the Medical Research Council evaluation framework. These features need to be addressed in studies of therapeutic patient education interventions and could help healthcare professionals build more effective interventions within the context. However, describing a list of elements of the context is not enough; analyses should also focus on how the contextual elements might affect an intervention and how they interact.

Important issues in proposing autonomy training in home parenteral nutrition for short bowel syndrome patients: a qualitative insight from the patients' perspectives.

OBJECTIVES: The standard treatment for short bowel syndrome is home parenteral nutrition. Patients' strict adherence to protocols is essential to decrease the risk of complications such as infection or catheter thrombosis. Patient training can even result in complete autonomy in daily care. However, some patients cannot or do not want too much responsibility. However, doctors often encourage them to acquire these skills. Based on qualitative investigations with patients, we wanted to document issues of importance concerning perceptions of autonomy in daily care. METHODS: Semistructured interviews were conducted with 13 adult patients treated by home parenteral nutrition using a maximum variation sampling strategy. We proceeded to a thematic analysis following an inductive approach. RESULTS: After achieving clinical management of symptoms, a good quality of life is within the realm of possibility for short bowel syndrome patients with home parenteral nutrition. In this context, achieving autonomy in home parenteral nutrition could be a lever to sustain patients' quality of life by providing better life control. However, counterintuitively, not all patients aim at reducing constraints by reaching autonomy in home parenteral nutrition. First, they appreciate the social contact with the nurses, which is particularly true among patients who live alone. Second, they can feel safer with the nurse's visits. Regaining freedom was the main motivation for patients in the training program and the main benefit for those who were already autonomous. CONCLUSIONS: Medical teams should consider patients' health locus of control (internal or external) for disease management to support them concerning the choice of autonomy in daily care for parenteral nutrition.

Use of qualitative methods to optimize collaborative practices by highlighting differences in perceptions between professionals: an example of patient education.

Interprofessional working must be approached within health promotion interventions using systematic methods to identify areas of suboptimal collaboration. We designed a qualitative study with a purposive sample of seven French therapeutic patient education programs. Semi-structured individual interviews were conducted with 14 healthcare providers and seven clinician leaders (coordinators) involved in patient education. We used the same interview guide and thematic grid regardless of the professional's profile to compare their perceptions on elements affecting outcome, participation and sustainability of programs. Healthcare providers and coordinators addressed non-convergent issues at both ends of a continuum from a micro-level nested in the program delivery to a macro-level corresponding to the structured implementation and sustainability of the program. Meso-level issues featured convergent perspectives. Our methodology could be used at the level of health services in a health system to provide a complete recovery of stakeholders' perspectives (without "blind spots" from one stakeholder or another). In our study, we focused on patient education in the French health system and pointed out possible considerations to optimize the functioning of programs. Such considerations include specific training plan development, encouraging reflection on the content and use of initial assessment, leading sessions in pairs to save on work time, and communication on the ins and outs of organizational imperatives that require healthcare providers' contributions.

A Systematic Review of Qualitative Studies on Factors Associated With Smoking Cessation Among Adolescents and Young Adults.

OBJECTIVE: To summarize findings from qualitative studies on factors associated with smoking cessation among adolescents and young adults. DATA SOURCES: We searched Pubmed, Psychinfo, CINAHL, Embase, Web of Science, and SCOPUS databases, as well as reference lists, for peer-reviewed articles published in English or French between January 1, 2000, and November 18, 2020. We used keywords such as adolescents, determinants, cessation, smoking, and qualitative methods. STUDY SELECTION: Of 1724 records identified, we included 39 articles that used qualitative or mixed methods, targeted adolescents and young adults aged 10-24, and aimed to identify factors associated with smoking cessation or smoking reduction. DATA EXTRACTION: Two authors independently extracted the data using a standardized form. We assessed study quality using the National Institute for Health and Care Excellence checklist for qualitative studies. DATA SYNTHESIS: We used an aggregative meta-synthesis approach and identified 39 conceptually distinct factors associated with smoking cessation. We grouped them into two categories: (1) environmental factors [tobacco control policies, pro-smoking norms, smoking cessation services and interventions, influence of friends and family], and (2) individual attributes (psychological characteristics, attitudes, pre-quitting smoking behavior, nicotine dependence symptoms, and other substances use). We developed a synthetic framework that captured the factors identified, the links that connect them, and their associations with smoking cessation. CONCLUSIONS: This qualitative synthesis offers new insights on factors related to smoking cessation services, interventions, and attitudes about cessation (embarrassment when using cessation services) not reported in quantitative reviews, supplementing limited evidence for developing cessation programs for young persons who smoke. IMPLICATIONS: Using an aggregative meta-synthesis approach, this study identified 39 conceptually distinct factors grouped into two categories: Environmental factors and individual attributes. These findings highlight the importance of considering both environmental and individual factors when developing smoking cessation programs for young persons who smoke. The study also sheds light on self-conscious emotions towards cessation, such as embarrassment when using cessation services, which are often overlooked in quantitative reviews. Overall, this study has important implications for developing effective smoking cessation interventions and policies that address the complex factors influencing smoking behavior among young persons.

Patient Satisfaction and Perspectives on Self-Management Education Programs: A Qualitative Study.

Purpose: According to the Centre for Disease Control and Prevention, "Self-management education (SME) refers to programs that help people who have ongoing health conditions learn how to live life to the fullest". Most studies to date have focused on SME outcomes, such as the acquisition of predefined knowledge or skills or quality of life. However, no study has yet investigated patients' satisfaction with SMEs. The aim of the present study was therefore to explore participants' subjective appreciation of SME programs using qualitative methods and formulate propositions based on patients' preferences to improve ultimately clinical outcomes. Patients and Methods: Twenty-five participants from five French SME programs to conduct focus groups were recruited. An inductive approach using grounded theory as an overall methodology orientation for the thematic analysis process has been followed. The study was reported in compliance with the consolidated criteria for reporting qualitative research criteria (COREQ). Results: Patients expressed great satisfaction concerning the effective delivery of SME sessions. They appreciated the considerations for their concerns and needs, the adaptation of sessions' content to their interests and questions, and learning to take care of themselves. Moreover, patients had a positive opinion on the quality of their relationship with health care providers. However, the major point of improvement of SMEs was the opportunity to repeat the program if needed, as this opportunity was not offered. This consideration was particularly salient when patients did not consider themselves autonomous for disease management at the end of the program, ie, when they had low levels of perceived self-efficacy. Conclusion: While patients expressed great satisfaction regarding SME programs, our results suggest that some changes might be needed to make the endpoint of SME interventions coincide with the patient's perception of self-efficacy in disease self-management and ultimately improve clinical outcomes.

Healthcare providers perception of therapeutic patient education efficacy according to patient and healthcare provider characteristics.

OBJECTIVES: Therapeutic patient education improves numerous health and psychological outcomes in patients with chronic diseases. However, little is known about what makes a therapeutic patient education intervention more effective than another one. This study aims to identify in healthcare professionals the perceived determinants of therapeutic patient education efficacy at the individual level. METHODS: Semi-structured individual interviews have been conducted with healthcare professionals (HCP, n=28, including 20 nurses) involved in therapeutic patient education programs (n=14) covering various chronic conditions (kidney and cardiovascular diseases, chronic pain, diabetes, etc.). A thematic content analysis following an inductive approach was used (Nvivo.11 software). RESULTS: Five themes were retrieved for patient characteristics: understanding and education, personality, readiness and motivation, social environment, and misinformation and beliefs. Four themes were retrieved for healthcare professionals' characteristics: medical knowledge, appropriate attitude and relational skills, pedagogical skills, and training. DISCUSSION: Patient personality is rarely discussed in the literature. Patients who are introverted, lack curiosity, or are not compliant might benefit from specific therapeutic patient education practices or formats. All these potential determinants regarding patients and healthcare professionals should be routinely assessed in future studies about therapeutic patient education efficacy to understand precisely what makes an intervention successful.

Creation and validation of the pictorial ecological momentary well-being instrument (EMOWI) for adolescents.

PURPOSE: Adolescence is characterized by the ongoing maturation of emotion-regulation skills and increased emotional reactivity. There is a need for a measurement tool suitable to the Ecological Momentary Assessment methodology, to better capture within-day variations in well-being, and provide fine-grained data that can help understand how environments, behaviors, and health intersect. This paper presents the development and evaluation of the Ecological MOmentary Well-Being Instrument for adolescents, designed for use in EMA. METHODS: A mixed-methods study was conducted, using both qualitative and quantitative approaches, to develop and assess the EMOWI. A literature review, pictorial production by graphic designers, and qualitative interviews with French and Canadian professionals and adolescents helped design and evaluate the scale face validity. Quantitative evaluation of dimensionality, reliability, and validity was conducted in two samples of French 8th graders. RESULTS: The resulting 8-item EMOWI showed excellent face validity. Confirmatory factor analysis supported a single factor hypothesis (RMSEA = 0.072). Internal consistency (Cronbach's alpha = 0.85) and intraday test-retest reliability (ICC = 0.83) were high. Correlations with existing scales were consistent with preset hypotheses. Ceiling effects were evidenced for all items, yet not on the global score. Quantitative estimations were similar for the verbal and pictorial versions, but qualitative findings argued in favor of the pictorial version. CONCLUSION: The 8-item pictorial EMOWI is a short and innovative instrument to measure momentary well-being in adolescents aged 12 to 17 years. Its strong psychometric properties and its acceptability among adolescents make it an excellent candidate instrument for the Ecological Momentary Assessment of well-being in this population.

French nurses' and allied health professionals' perception of research in their fields: A descriptive qualitative study.

AIM: To gather information from nurses and allied health professionals in the French context of the emergence of research in the field so as to inform the development of a new tool: The research in nursing and allied health sciences' Ideas Generator (GénI) capable of sustaining the identification of research ideas from professionals in the field. BACKGROUND: In many countries, research in nursing and allied health sciences remains underdeveloped. INTRODUCTION: Before developing the Ideas Generator tool, it was essential to explore professionals' basis of reference in providing care, then investigate (1) their representation of research in this field of science and (2) their perception of needs for and obstacles to starting a research process. METHODS: The qualitative research design used focus groups. The study population included 24 participants naive to research in four hospitals in eastern France (13 nurses and 11 allied health professionals). Thematic analysis was used to analyze the data. The study was reported in compliance with the consolidated criteria for reporting qualitative research criteria. FINDINGS: Professionals used tacit knowledge and their experiences to address care, but the culture of scientific evidence was clearly missing (lack of knowledge of the origin of care guidelines, few bibliographic skills). Participation in a research process could hardly be envisaged without a supervised collaboration with a physician. Research was perceived not to be part of professionals' culture. They self-censured for lack of methodological competencies. DISCUSSION: Findings underlined some leverage, obstacles, and need to consider to generate a stimulation in the field, especially in countries where such research is still in its infancy. IMPLICATION FOR NURSING, HEALTH, AND EDUCATION POLICY: Strengthening the field of nursing and allied health research is essential to extend the skills of nurses and allied health workers and to improve the quality of patient care by taking into account results from the literature. The Ideas Generator tool will be implemented to sustain learning the skills of research through education and training.

Web-based and machine learning approaches for identification of patient-reported outcomes in inflammatory bowel disease.

BACKGROUND: Messages from an Internet forum are raw material that emerges in a natural setting (i.e., non-induced by a research situation). AIMS: The FLARE-IBD project aimed at using an innovative approach consisting of collecting messages posted by patients in an Internet forum and conducting a machine-learning study (data analysis/language processing) for developing a patient-reported outcome measuring flare in inflammatory bowel disease meeting international requirements. METHODS: We used web-based and machine learning approaches, in the following steps. 1) Web-scraping to collect all available posts in an Internet forum (23 656 messages) and extracting metadata from the forum. 2) Twenty patients were randomly assigned 50 extracted messages; participants indicated whether the message corresponded or not to the flare phenomenon (labeling). If yes, participants were asked to identify excerpts from the text they considered significant flare markers (annotation). 3) The set of annotated messages underwent a vocabulary analysis. RESULTS: The phenomenon of flare was circumscribed with the identification of 20 surrogate flare markers classified into five dimensions with their frequency within extracted labeled data: impact on life, symptoms, extra-intestinal manifestations, drugs and environmental factors. Web-based and machine-learning approaches met international recommendations to inform the content and structure for the development of patient-reported outcomes.

Tailored patient therapeutic educational interventions: A patient-centred communication model.

BACKGROUND: Tailoring therapeutic education consists of adapting the intervention to patients' needs with the expectation that this individualization will improve the results of the intervention. Communication is the basis for any individualization process. To our knowledge, there is no guide or structured advice to help healthcare providers (HCPs) tailor patient education interventions. OBJECTIVES: We used a data-driven qualitative analysis to (1) investigate the reasons why HCPs tailor their educational interventions and (2) identify how this tailoring is effectively conducted. The perspective aimed to better understand how to individualize therapeutic patient education and to disentangle the different elements to set up studies to investigate the mechanisms and effects of individualization. DESIGN: Individual semistructured interviews with 28 HCPs involved in patient education were conducted. The present study complied with the COREQ criteria. RESULTS: Why individualization is necessary: participants outlined that the person must be thought of as unique and that therapeutic education should be adapted to the patient's personality and cognitive abilities. The first step in the individualization process was formalized by an initial patient assessment. Several informal practices were identified: if needed, giving an individual time or involving a specific professional; eliciting individual objectives; reinforcing the relationship by avoiding asymmetrical posture; focusing on patients' concerns; leading sessions in pairs; and making the patient the actor of decisions. CONCLUSION: From our thematic data analysis, a model for tailoring patient education interventions based on the Haes and Bensing medical communication framework is proposed. The present work paves the way for evaluation, then generation of recommendations and finally implementation of training for individualization in educational interventions. SHORT INFORMATIVE: Tailoring in therapeutic education consists of an adaptation to patients' needs. Communication is the basis for any individualization process. There is no model of patient-centred communication in educational interventions. From semistructured interviews with HCPs, we propose a patient-centred communication model for tailoring patient education intervention.

Flare-IBD: development and validation of a questionnaire based on patients' messages on an internet forum for early detection of flare in inflammatory bowel disease: study protocol.

INTRODUCTION: Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease (IBD), are chronic disabling conditions characterised by flares followed by periods of remission. However, patients with IBD are seen every 3-6 months in the outpatient clinic, and the occurrence of a flare between two outpatient visits is not captured. To our knowledge, there is no validated patient-reported outcome (PRO) tool to measure the phenomenon of flare in IBD. This study aimed to use an innovative methodology to collect messages posted by patients in an internet forum for developing and validating a PRO measuring flare in IBD. METHODS AND ANALYSIS: The design involves (1) computer engineering sciences for scraping extraction of messages posted in an internet forum and for identification of messages related to flare; (2) qualitative methods for thematic content analyse of the messages posted, for candidate items generation, for items selection (Delphi process) and for items adjustment ('think-aloud' interviews) and (3) quantitative methods for psychometric validation of the PRO. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Comité de Protection des Personnes (CPP) CPP Nord-Ouest I (19.07.15.44139) in November 2019. The project aims to provide a tool to evaluate IBD flare in current medical practice that is constructed with patients' perspectives. Items generation from a source corresponding to exchanges in an internet forum is an innovative method in this field and provides a wider coverage of qualitative data. If such a forum can result in interesting material, then this could be a new methodological perspective for generating items for questionnaires. Findings will be reported and disseminated widely through international peer-reviewed journal publications, oral and poster presentations at scientific conferences. TRIAL REGISTRATION NUMBER: NCT04180345.

Qualitative Methods Used to Generate Questionnaire Items: A Systematic Review.

A systematic review of articles using qualitative methods to generate questionnaire items identified in MEDLINE and PsycINFO from 2000 to 2014 was carried out. Articles were analyzed for (a) year of publication and journal domain, (b) qualitative data collection methods, (c) method of data content analysis, (d) professional experts' input in item generation, and (e) debriefing of the newly developed items. In total, 371 articles were included and results showed (a) an acceleration of published articles, (b) individual interviews and focus groups were common ways of generating items and no emergent approach was identified, (c) the content analysis was usually not described (43% of articles), (d) experts were involved in eliciting concepts in less than a third of articles, (e) 61% of articles involved a step of further submission of newly developed items to the population of interest. This review showed an insufficient reporting of qualitative methods used to generate new questionnaires despite previous recommendations.

Development of a Web-Based Formative Self-Assessment Tool for Physicians to Practice Breaking Bad News (BRADNET).

BACKGROUND: Although most physicians in medical settings have to deliver bad news, the skills of delivering bad news to patients have been given insufficient attention. Delivering bad news is a complex communication task that includes verbal and nonverbal skills, the ability to recognize and respond to patients' emotions and the importance of considering the patient's environment such as culture and social status. How bad news is delivered can have consequences that may affect patients, sometimes over the long term. OBJECTIVE: This project aimed to develop a Web-based formative self-assessment tool for physicians to practice delivering bad news to minimize the deleterious effects of poor way of breaking bad news about a disease, whatever the disease. METHODS: BReaking bAD NEws Tool (BRADNET) items were developed by reviewing existing protocols and recommendations for delivering bad news. We also examined instruments for assessing patient-physician communications and conducted semistructured interviews with patients and physicians. From this step, we selected specific themes and then pooled these themes before consensus was achieved on a good practices communication framework list. Items were then created from this list. To ensure that physicians found BRADNET acceptable, understandable, and relevant to their patients' condition, the tool was refined by a working group of clinicians familiar with delivering bad news. The think-aloud approach was used to explore the impact of the items and messages and why and how these messages could change physicians' relations with patients or how to deliver bad news. Finally, formative self-assessment sessions were constructed according to a double perspective of progression: a chronological progression of the disclosure of the bad news and the growing difficulty of items (difficulty concerning the expected level of self-reflection). RESULTS: The good practices communication framework list comprised 70 specific issues related to breaking bad news pooled into 8 main domains: opening, preparing for the delivery of bad news, communication techniques, consultation content, attention, physician emotional management, shared decision making, and the relationship between the physician and the medical team. After constructing the items from this list, the items were extensively refined to make them more useful to the target audience, and one item was added. BRADNET contains 71 items, each including a question, response options, and a corresponding message, which were divided into 8 domains and assessed with 12 self-assessment sessions. The BRADNET Web-based platform was developed according to the cognitive load theory and the cognitive theory of multimedia learning. CONCLUSIONS: The objective of this Web-based assessment tool was to create a "space" for reflection. It contained items leading to self-reflection and messages that introduced recommended communication behaviors. Our approach was innovative as it provided an inexpensive distance-learning self-assessment tool that was manageable and less time-consuming for physicians with often overwhelming schedules.