Caesarean section on maternal request: a qualitative study of conflicts related to shared decision-making and person-centred care in Sweden.

BACKGROUND: Today, person-centred care is seen as a cornerstone of health policy and practice, but accommodating individual patient preferences can be challenging, for example involving caesarean section on maternal request (CSMR). The aim of this study was to explore Swedish health professionals' perspectives on CSMR and analyse them with regard to potential conflicts that may arise from person-centred care, specifically in relation to shared decision-making. METHODS: A qualitative study using both inductive and deductive content analysis was conducted based on semi-structured interviews. It was based on a purposeful sampling of 12 health professionals: seven obstetricians, three midwives and two neonatologists working at different hospitals in southern and central Sweden. The interviews were recorded either in a telephone call or in a video conference call, and audio files were deleted after transcription. RESULTS: In the interviews, twelve types of expressions (sub-categories) of five types of conflicts (categories) between shared decision-making and CSMR emerged. Most health professionals agreed in principle that women have the right to decide over their own body, but did not believe this included the right to choose surgery without medical indications (patient autonomy). The health professionals also expressed that they had to consider not only the woman's current preferences and health but also her future health, which could be negatively impacted by a CSMR (treatment quality and patient safety). Furthermore, the health professionals did not consider costs in the individual decision, but thought CSMR might lead to crowding-out effects (avoiding treatments that harm others). Although the health professionals emphasised that every CSMR request was addressed individually, they referred to different strategies for avoiding arbitrariness (equality and non-discrimination). Lastly, they described that CSMR entailed a multifaceted decision being individual yet collective, and the use of birth contracts in order to increase a woman's sense of security (an uncomplicated decision-making process). CONCLUSIONS: The complex landscape for handling CSMR in Sweden, arising from a restrictive approach centred on collective and standardised solutions alongside a simultaneous shift towards person-centred care and individual decision-making, was evident in the health professionals' reasoning. Although most health professionals emphasised that the mode of delivery is ultimately a professional decision, they still strived towards shared decision-making through information and support. Given the different views on CSMR, it is of utmost importance for healthcare professionals and women to reach a consensus on how to address this issue and to discuss what patient autonomy and shared decision-making mean in this specific context.

Person-centered care is today a widespread approach, but accommodating individual patient preferences can be challenging, for example involving caesarean section on maternal request (CSMR). This study examines Swedish health professionals' views on CSMR. Interviews with 12 health professionals reveal conflicts between CSMR and key aspects of person-centered care, in particular shared decision-making. While professionals acknowledge women's autonomy, they question CSMR without medical need. Concerns include for example treatment quality and patient safety, and avoiding treatments that harm others. The Swedish context, balancing collective solutions with individualized care, complicates decision-making. Unlike countries with more private healthcare, where CSMR support might be higher, Swedish health professionals emphasize shared decision-making despite viewing the mode of delivery as primarily a professional decision. This study sheds light on the challenges in integrating CSMR into person-centered care frameworks.

Patient activation in adults with visual impairment: a study of related factors.

This study aims to analyze variables related to patient activation in 78 individuals with visual impairment. The Patient Activation Measure (PAM) scores of participants showed no differences between males and females. It was found that the individuals living in urban areas, and participants with higher income and education levels had higher PAM scores. Still, the difference between the groups was statistically insignificant (p > 0.05). The PAM scores of the visually impaired individuals reflect taking action level of activation (66.51 ± 18.14-PAM level 3). There was a moderately significant relationship between PAM scores and visually impaired individuals' self-management, self-efficacy, healthy life awareness, social relations, and environment (p < 0.001). We found that the variables included in the regression model (marital status, self-management, self-efficacy, healthy life awareness, social relations, and environment) explained 72.2% of the PAM score. Individuals with visual impairment can be given training on self-management, self-efficacy, healthy life awareness, and quality of life associated with social relations and environment to develop positive health behaviors.

Correlates of Control Preferences, Participation in Decision-making and Activation in Patients with Substance Use Disorder.

BACKGROUND: Treatment of Substance Use Disorder (SUD) is complex and therefore including patients in the therapeutic process is needed. Patient-Centered Care (PCC) and Shared Decision-Making (SDM) have been associated with greater satisfaction, self-control, and less substance use. However, correlates of SDM have not been investigated in this population. METHOD: A cross-sectional analysis was carried out in 214 SUD patients to identify sociodemographic, clinical and psychological correlates of preferences and perceptions about participation in SDM and degree of activation. The Control Preference Scale (CPS), the Shared Decision-Making Questionnaire (SDM-9-Q) and the Patient Activation Measure (PAM) were used to assess the PCC elements. Multinomial logistic regression was used to analyze the correlates of the CPS variables (preferred role, perceived role, and role matching). For SDM-9-Q and PAM, multilevel linear regression was used. RESULTS: Preferring an active role, compared to a shared one, was significantly associated with higher educational level, lower neuroticism, absence of affective and alcohol use disorders, and higher quality of life. Perceiving greater participation was significantly associated with not being a new patient, having fewer legal problems, higher severity of alcohol consumption, not presenting polydrug use and main substance use different than opioids or sedatives. Activation was associated with higher scores in the personality trait activity, a preference for an active role and greater perception of being involved in the decision process. CONCLUSIONS: Patients with milder clinical profiles prefer an active role compared to a shared one. Patients who prefer or perceive a shared or passive role did not show relevant differences. Greater activation was related to preference for an active role and the perception of having been involved in decisions.

Patient and family engagement in patient safety in the Eastern Mediterranean Region: a scoping review.

BACKGROUND: Patients can play a key role in delivering safe care by becoming actively involved in their health care. This study aimed at reviewing the literature for evidence of patients' and families' engagement in patient safety in the Eastern Mediterranean Region (EMR). METHODS: We conducted a scoping review of the literature published in English using PubMed, Medline, CINAHL, Scopus, ISI Web of Science, and PsycINFO until June 2023. RESULTS: A total of 9019 studies were screened, with 22 meeting the inclusion criteria. Our review found few published studies of patient and family engagement in patient safety research in the EMR. Thirteen studies explored the attitudes, perceptions, and/or experiences / preferences of patients, families, and healthcare providers (HCPs) regarding patient engagement in patient safety. Nine publications reported patient involvement in patient safety activities at varying levels. Three categories of factors were identified that may affect patient involvement: patient-related (e.g., lack of awareness on their role in preventing harms, unwillingness to challenge HCPs' authority, and cultural barriers); HCP-related (e.g., negative attitudes towards patient engagement, poor patient-provider communication, and high workload); and healthcare setting-related (e.g., lack of relevant policies and guidelines, lack of training for patients, and HCPs, and lack of patient-centered approach). CONCLUSION: This review highlighted limitations in the current literature on patient and family engagement in patient safety in the EMR, including both the depth of evidence and clarity of concepts. Further research is needed to explore how to actively involve patients and their families, as well as to determine whether such involvement translates into improved safety in practice.

The relationship between medication beliefs, patient activation, and self-rated health in patients taking oral anticancer agents.

PURPOSE: Patients on oral anticancer agent (OAA) therapies have the autonomy to manage their cancer treatments in home settings. However, patients may not have adequate knowledge, confidence, or ability to effectively manage OAA-related consequences, which can significantly impact their treatment and health outcomes. This study aims to identify the associations between medication beliefs, patient activation, and self-rated health (SRH) among oncology patients taking OAAs and explore the potential mediation effects of patient activation on the relationship between medication beliefs and SRH. METHODS: A secondary data analysis was conducted on cross-sectional data from 114 patients who were diagnosed with breast, colorectal, lung, or prostate cancer. Patients completed a self-reported survey including items of SRH, Beliefs about Medicines Questionnaire (BMQ), and Patient Activation Measure (PAM-13). Descriptive statistics, bivariate correlation, hierarchical multiple linear regression, and mediation analysis were conducted. RESULTS: The results indicate that patients taking OAAs have ambivalent attitudes toward medication. Both medication necessity (r = - 0.27) and concerns (r = - 0.21) were negatively associated with SRH, while patient activation was positively associated with SRH (r = 0.38). Patient activation had a negative association with medication concerns (r = - 0.36) and fully mediated the relationship between medication concerns and SRH in patients taking OAAs (indirect effect = - 0.154, 95% confidence interval, - 0.276 to - 0.060). CONCLUSION: The findings highlight the significance of activating patients to better understand and manage their OAAs. It is crucial for oncology professionals to provide multifaceted interventions to promote patient activation with an effort to mitigate the negative impact of medication beliefs on patient-perceived health outcomes.

Factors Influencing Willingness to Participate in Clinical Studies in Pediatric Anesthesia (FILIPPA): A vignette-based, structured interview study.

BACKGROUND: Informed consent is a relevant backdrop for conducting clinical trials, particularly those involving children. While several factors are known to influence the willingness to consent to pediatric anesthesia studies, the influence of study design on consenting behavior is unknown. AIMS: To quantify the impact of study complexity on willingness to consent to pediatric anesthesia studies. METHODS: We conducted a vignette-based interview study by presenting three hypothetical studies to 106 parents or legal guardians whose children were scheduled to undergo anesthesia. These studies differed in level of complexity and included an example of a prospective observational study, a randomized controlled trial, and a phase-II-pharmacological study. Primary outcome was the willingness to consent, using a 5-point Likert scale ranging from "absolutely consent" to "absolutely decline". Secondary outcomes were the effects of child-related (such as sex, age, previous anesthesia, research exposure) and proxy-related factors. RESULTS: Response probabilities for "absolute consent" were 90.9% [95% CI 85.3-96.5] for the observational study, 48.6% [95% CI 38.3-58.9] for the randomized controlled trial, and 32.7% [95% CI 23.9-41.6] for the phase-II-pharmacological study. Response probabilities for "absolutely decline" were 1.6% [95% CI 0.3-2.8], 14.4% [95% CI 8.3-20.5], and 24.7% [95% CI 16.6-32.7], respectively. Significant effects were found for previous research exposure (OR = 0.486 [95% CI 0.256-0.923], p = .027), older age (OR = 0.963 [95% CI 0.927-0.999], p = .045) and the gender of the parent or legal guardian, as mothers were less willing to consent (OR = 0.234 [95% CI 0.107-0.512], p < .001). CONCLUSIONS: Willingness to consent decreased with increasing level of study complexity. When conducting more complex studies, greater efforts need to be made to increase the enrollment of pediatric patients.

A cross-sectional survey of clinical trials knowledge, participation, and perspectives in an underserved community of Washington, DC.

The inclusion of participants from underrepresented and underserved groups is lagging in dermatology clinical trials. Through dissemination of a pilot survey at a community skin health fair, knowledge, participation, and perspectives of clinical trials were evaluated in an urban, medically underserved community in Washington, DC. Clinical trial-related questions were derived from the Health Information National Trends Survey 5 Cycle 4. This cross-sectional survey analyzed responses from 39/55 attendees (71% response rate). Most respondents were female (23/37 [62.2%]), between the ages of 25 and 54 (19/38, [50.0%]), and self-identified as non-white (35/39 [89.7%]) with a majority self-identifying as Black (16/31 [41%]). Most respondents self-reported knowing "little" to "nothing" about clinical trials (26/35 [74.3%]), and even more were unaware of the federal resource clinicaltrials.gov (30/37 [81.1%]). Few respondents discussed clinical trials as a treatment option with their healthcare provider (8/35 [22.9%]), yet having a discussion was significantly correlated with clinical trial participation (p = 0.0302). Self-reported level of knowledge was not significantly associated with participation in a clinical trial (p = 0.3035). Healthcare providers were the preferred first source of clinical trial information, followed by an internet search. Respondents rarely cited mistrust or skepticism as a barrier to participation (2/34 [5.9%]). Subjective positive healthcare experiences were significantly correlated to positive expectations with clinical trial participation (p = 0.0242). The findings of this study suggest the essential role healthcare providers, including dermatologists, play in clinical trial education and recruitment of underrepresented populations, and that patient mistrust may be present but is a rarely cited barrier to clinical trial participation.

Using brief reflections to capture and evaluate end-user engagement: a case example using the COMPASS study.

BACKGROUND: Use of participatory research methods is increasing in research trials. Once partnerships are established with end-users, there is less guidance about processes research teams can use to successfully incorporate end-user feedback. The current study describes the use of a brief reflections process to systematically examine and evaluate the impact of end-user feedback on study conduct. METHODS: The Comparative Effectiveness of Trauma-Focused and Non-Trauma- Focused Treatment Strategies for PTSD among those with Co-Occurring SUD (COMPASS) study was a randomized controlled trial to determine the effectiveness of trauma-focused psychotherapy versus non-trauma-focused psychotherapy for Veterans with co-occurring posttraumatic stress disorder and substance use disorder who were entering substance use treatment within the Department of Veterans Affairs. We developed and paired a process of "brief reflections" with our end-user engagement methods as part of a supplemental evaluation of the COMPASS study engagement plan. Brief reflections were 30-minute semi-structured discussions with the COMPASS Team following meetings with three study engagement panels about feedback received regarding study issues. To evaluate the impact of panel feedback, 16 reflections were audio-recorded, transcribed, rapidly analyzed, and integrated with other study data sources. RESULTS: Brief reflections revealed that the engagement panels made recommended changes in eight areas: enhancing recruitment; study assessment completion; creating uniformity across Study Coordinators; building Study Coordinator connection to Veteran participants; mismatch between study procedures and clinical practice; therapist skill with patients with active substance use; therapist burnout; and dissemination of study findings. Some recommendations positively impact study conduct while others had mixed impact. Reflections were iterative and led to emergent processes that included revisiting previously discussed topics, cross-pollination of ideas across panels, and sparking solutions amongst the Team when the panels did not make any recommendations or recommendations were not feasible. CONCLUSIONS: When paired with end-user engagement methods, brief reflections can facilitate systematic examination of end-user input, particularly when the engagement strategy is robust. Reflections offer a forum of accountability for researchers to give careful thought to end-user recommendations and make timely improvements to the study conduct. Reflections can also facilitate evaluation of these recommendations and reveal end-user-driven strategies that can effectively improve study conduct. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04581434) on October 9, 2020; https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1 .

Supporting patient self-management: A cross-sectional and prospective cohort study investigating Patient Activation Measure (PAM) and Clinician Support for PAM scores as part of a multi-centre haemodialysis breakthrough series collaborative.

BACKGROUND: Patient self-management, measured by the Patient Activation Measure (PAM), is associated with reduced healthcare utilisation and better health-related quality of life. Self-management in haemodialysis (HD) is challenging and may require support from clinicians with positive attitudes towards self-management, measured by the Clinician Support for PAM (CSPAM). OBJECTIVES: To assess whether kidney staff CSPAM scores are: 1) associated with their centre's patient PAM scores and 2) modifiable through staff coaching. METHODS: Baseline PAM and CSPAM and six-month CSPAM were collected from HD patients and kidney staff respectively in seven UK kidney centres as part of a six-month breakthrough series collaborative (BTSC), which trained kidney staff in supporting patient independence with HD tasks. Firstly, multivariable linear regression analyses adjusted for patient characteristics were used to test the baseline association between centre-level staff CSPAM scores and patient PAM scores. Secondly, paired univariate and unpaired multivariable linear regression analyses were conducted to compare staff CSPAM scores at baseline and six months. RESULTS: 236 PAM questionnaires (mean score = 55.5) and 89 CSPAM questionnaires (median score = 72.6) were analysed at baseline. There was no significant association between centre-level mean CSPAM scores and PAM scores in univariate analyses (P = 0.321). After adjusting for patient-level characteristics, increasing centre-level mean CSPAM score by 1 point resulted in a non-significant 0.3-point increase in PAM score (0.328 (95% CI: -0.157 to 0.812; P = 0.184). Paired (n = 37) and unpaired (n = 174) staff analyses showed a non-significant change in CSPAM scores following the BTSC intervention (mean change in CSPAM score in unpaired analysis = 1.339 (95% CI: -1.945 to 4.623; P = 0.422). CONCLUSIONS: Lack of a significant: 1) association between CSPAM and PAM scores and 2) change in CSPAM scores suggest that modifying staff beliefs alone is less likely to influence patient self-management, requiring co-production between patients and staff.

Why did this happen to me? Causal attributions of illness and cultural health capital.

This study examines how conversations between patients and clinicians about the causes of their health conditions relate to patient engagement in care. Leveraging cultural health capital (CHC) theory, we find that patient-physician discussions of health attributions are one mechanism to build patient understanding and activate engagement. We present a qualitative interpretive analysis of data collected in three phases with adult home health care patients: phone interviews (n = 28), field observations (n = 61), and semi-structured field interviews (n = 38). We find that engaging in discussions of causal health attributions with clinicians enables patients to overcome uncertainty, envision preventive actions, and engage in setting future goals. Such discussions must be supported by acknowledgement of the co-responsibility of individual factors and structural factors such as social determinants of health. These discussions are not easy to navigate but they can potentially help patients transition from a mindset of treating the disease (pathogenic approach) to an awareness of their available capabilities to improve health (salutogenic approach). This study contributes to research on attribution theory and cultural health capital theory by demonstrating how discussing causes for poor health can enable patients resolve doubts and accrue instrumental and symbolic resources that facilitate healing.

The Patient Activation Measure-13 (PAM-13) in an oncology patient population: psychometric properties and dimensionality evaluation.

BACKGROUND: Accurate assessment and enhancement of health-related skills among oncology patients are pivotal for optimizing cancer care. The Patient Activation Measure (PAM-13), a questionnaire designed to reflect an individual's knowledge, skills, and confidence in self-healthcare management, has been validated across diverse countries and settings. Concerns have been raised regarding the cross-situational applicability, as patients with specific diseases and cultural backgrounds interpret questionnaire items differently. This study aimed to examine the structural validity and psychometric properties of the PAM-13 in an oncological patient cohort. METHODS: Baseline data from a longitudinal non-randomized controlled study involving cancer out-patients (n = 1,125) from Comprehensive Cancer Centres in Southern Germany were analysed. The German version of the PAM-13 was employed. With classical test and item response theory methods data quality, reliability, convergent and structural validity, as well as psychometric properties were assessed. Exploratory (EFA) and confirmatory factor analyses (CFA) were employed to investigate the postulated unidimensionality of the underlying construct. With a partial credit model (PCM) we examined item fit, targeting, local independence and differential item functioning. RESULTS: Participants were predominantly female (73.0%) with a breast cancer diagnosis (41.3%). While items were generally well-accepted, ceiling effects were observed and a high mean PAM-13 score (69.7, SD = 14.2) was noted, potentially compromising responsiveness to interventions. Reliability was adequate (Cronbach's α = 0.81), person and item separation reliability were good to excellent (0.81 and 0.99, respectively). Explorations of the unidimensionality of the construct (EFA, CFA, PCM) yielded inconclusive results, hinting towards a two-factor solution. Item difficulty rankings deviated from the original. No differential item functioning was identified, and local independence was confirmed. CONCLUSIONS: While the PAM-13 serves as a valuable instrument for comprehending and promoting health-related skills in cancer patients, the identification of ceiling effects, disordered item-difficulty rankings, and inconclusive findings regarding unidimensionality contribute to the expanding body of evidence, emphasizing the dependency of PAM-13's validity and reliability on distinctive characteristics within the population under investigation. Future research should prioritize refining or adding PAM-13 items to better capture the specific health-related challenges within diverse populations, paving the way for more effective patient engagement strategies in oncology. TRIAL REGISTRATION NUMBER: DRKS00021779.

Asking those who know their needs best: A framework for active engagement and involvement of childhood cancer survivors and parents in the process of psychosocial research-A workshop report.

BACKGROUND: Patient and public involvement and engagement (PPIE) in healthcare research is crucial for effectively addressing patients' needs and setting appropriate research priorities. However, there is a lack of awareness and adequate methods for practicing PPIE, especially for vulnerable groups like childhood cancer survivors. AIMS: This project aimed to develop and evaluate engagement methods to actively involve pediatric oncological patients, survivors, and their caregivers in developing relevant research questions and practical study designs. METHODS AND RESULTS: An interdisciplinary working group recruited n = 16 childhood cancer survivors and their caregivers to work through the entire process of developing a research question and a practicable study design. A systematic literature review was conducted to gather adequate PPIE methods which were then applied and evaluated in a series of three workshop modules, each lasting 1.5 days. The applied methods were continuously evaluated, while a monitoring group oversaw the project and continuously developed and adapted additional methods. The participants rated the different methods with varying scores. Over the workshop series, the participants successfully developed a research question, devised an intervention, and designed a study to evaluate their project. They also reported increased expertise in PPIE and research knowledge compared to the baseline. The project resulted in a practical toolbox for future research, encompassing the final workshop structure, evaluated methods and materials, guiding principles, and general recommendations. CONCLUSION: These findings demonstrate that with a diverse set of effective methods and flexible support, actively involving patients, survivors, and caregivers can uncover patients' unmet disease-related needs and generate practical solutions apt for scientific evaluation. The resulting toolbox, filled with evaluated and adaptable methods (workbook, Supplement 1 and 2), equips future scientists with the necessary resources to successfully perform PPIE in the development of health care research projects that effectively integrate patients' perspectives and address actual cancer-related needs. This integration of PPIE practices has the potential to enhance the quality and relevance of health research and care, as well as to increase patient empowerment leading to sustainable improvements in patients' quality of life.

Interactive digital tools to support empowerment of people with cancer: a systematic literature review.

PURPOSE: To identify and synthesise interactive digital tools used to support the empowerment of people with cancer and the outcomes of these tools. METHODS: A systematic literature review was conducted using PubMed, CINAHL, Web of Science, Cochrane, Eric, Scopus, and PsycINFO databases in May 2023. Inclusion criteria were patient empowerment as an outcome supported by interactive digital tools expressed in study goal, methods or results, peer-reviewed studies published since 2010 in cancer care. Narrative synthesis was applied, and the quality of the studies was assessed following Joanna Briggs Institute checklists. RESULTS: Out of 1571 records screened, 39 studies published in 2011-2022 with RCT (17), single-arm trial (15), quasi-experimental (1), and qualitative designs (6) were included. A total of 30 interactive digital tools were identified to support empowerment (4) and related aspects, such as self-management (2), coping (4), patient activation (9), and self-efficacy (19). Significant positive effects were found on empowerment (1), self-management (1), coping (1), patient activation (2), and self-efficacy (10). Patient experiences were positive. Interactivity occurred with the tool itself (22), peers (7), or nurses (7), physicians (2), psychologists, (2) or social workers (1). CONCLUSION: Interactive digital tools have been developed extensively in recent years, varying in terms of content and methodology, favouring feasibility and pilot designs. In all of the tools, people with cancer are either active or recipients of information. The research evidence indicates positive outcomes for patient empowerment through interactive digital tools. Thus, even though promising, there still is need for further testing of the tools.

Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review.

BACKGROUND: Poor representation of pregnant and lactating women and people in clinical trials has marginalised their health concerns and denied the maternal-fetal/infant dyad benefits of innovation in therapeutic research and development. This mixed-methods systematic review synthesised factors affecting the participation of pregnant and lactating women in clinical trials, across all levels of the research ecosystem. METHODS AND FINDINGS: We searched 8 databases from inception to 14 February 2024 to identify qualitative, quantitative, and mixed-methods studies that described factors affecting participation of pregnant and lactating women in vaccine and therapeutic clinical trials in any setting. We used thematic synthesis to analyse the qualitative literature and assessed confidence in each qualitative review finding using the GRADE-CERQual approach. We compared quantitative data against the thematic synthesis findings to assess areas of convergence or divergence. We mapped review findings to the Theoretical Domains Framework (TDF) and Capability, Opportunity, and Motivation Model of Behaviour (COM-B) to inform future development of behaviour change strategies. We included 60 papers from 27 countries. We grouped 24 review findings under 5 overarching themes: (a) interplay between perceived risks and benefits of participation in women's decision-making; (b) engagement between women and the medical and research ecosystems; (c) gender norms and decision-making autonomy; (d) factors affecting clinical trial recruitment; and (e) upstream factors in the research ecosystem. Women's willingness to participate in trials was affected by: perceived risk of the health condition weighed against an intervention's risks and benefits, therapeutic optimism, intervention acceptability, expectations of receiving higher quality care in a trial, altruistic motivations, intimate relationship dynamics, and power and trust in medicine and research. Health workers supported women's participation in trials when they perceived clinical equipoise, had hope for novel therapeutic applications, and were convinced an intervention was safe. For research staff, developing reciprocal relationships with health workers, having access to resources for trial implementation, ensuring the trial was visible to potential participants and health workers, implementing a woman-centred approach when communicating with potential participants, and emotional orientations towards the trial were factors perceived to affect recruitment. For study investigators and ethics committees, the complexities and subjectivities in risk assessments and trial design, and limited funding of such trials contributed to their reluctance in leading and approving such trials. All included studies focused on factors affecting participation of cisgender pregnant women in clinical trials; future research should consider other pregnancy-capable populations, including transgender and nonbinary people. CONCLUSIONS: This systematic review highlights diverse factors across multiple levels and stakeholders affecting the participation of pregnant and lactating women in clinical trials. By linking identified factors to frameworks of behaviour change, we have developed theoretically informed strategies that can help optimise pregnant and lactating women's engagement, participation, and trust in such trials.

Oncology patients' willingness to report their medication safety concerns from home: a qualitative study.

PURPOSE: Oncology patients often struggle to manage their medications and related adverse events during transitions of care. They are expected to take an active role in self-monitoring and timely reporting of their medication safety events or concerns to clinicians. The purpose of this study was to explore the factors influencing oncology patients' willingness to report adverse events or concerns related to their medication after their transitions back home. METHODS: A qualitative interview study was conducted with adult patients with breast, prostate, lung, or colorectal cancer who experienced care transitions within the previous year. A semi-structured interview guide was developed to understand patients' perceptions of reporting mediation-related safety events or concerns from home. All interviews were conducted via phone calls, recorded, and transcribed for thematic data analysis. RESULTS: A total of 41 individuals participated in the interviews. Three main themes and six subthemes emerged, including patients' perceived relationship with clinicians (the quality of communication and trust in clinicians), perceived severity of adverse medication events (perceived severe vs. non-severe events), and patient activation in self-management (self-efficacy in self-management and engagement in monitoring health outcomes). CONCLUSION: The patient-clinician relationship significantly affects patients' reporting behaviors, which can potentially interact with other factors, including the severity of adverse events. It is important to engage oncology patients in medication safety self-reporting from home by enhancing health communication, understanding patients' perceptions of severe events, and promoting patient activation. By addressing these efforts, healthcare providers should adopt a more patient-centered approach to enhance the overall quality and safety of oncological care.

"Let them be": Family members' perspectives on the participation of advanced cancer patients in nursing research: A qualitative descriptive study.

BACKGROUND: Recruiting advanced cancer patients is crucial for nursing research in cancer care. However, nurse researchers often face various socio-cultural challenges, particularly in mainland China, where cultural taboos around death pose significant obstacles. An unexplored constraint in this context is the pivotal role Chinese family members play in patients' healthcare decision-making. This research gap underscores the need for a deeper understanding of Chinese family members' perspectives on the engagement of advanced cancer patients in nursing research. OBJECTIVE: To explore the perceptions and concerns of family members regarding the recruitment and participation of advanced cancer patients in nursing research. DESIGN: A qualitative descriptive study was conducted. SETTINGS: Three cancer hospitals in mainland China. PARTICIPANTS: A purposive sample of 18 family members, consisting of children or spouses of advanced cancer patients, was recruited as participants. METHODS: Semi-structured interviews were conducted to collect data between September 2022 and January 2023. The thematic analysis method was used to analyze the data. RESULTS: Three themes were identified: The absence of prior participation, Family members' reluctance to facilitate patient involvement, and Strategies to encourage patients' future participation. Family members were hesitant to allow their relatives with advanced cancer to engage in nursing research, primarily due to concerns about distressing patients, the use of potential sensitive language, stigma, and the risks involved in participation. To address these concerns, they emphasized the importance of gaining family approval prior to patient enrolment. They highlighted the need of family involvement on behalf of sick relatives in research, advocating for the inclusion of a wide range of patients rather than targeting specific subgroups. They also reiterated the significance of choosing the right time for participation and avoiding using sensitive terms such as 'cancer', 'dying', and 'death' when engaging with patients. Moreover, they proposed the recruitment of patients by trusted professionals, shortening the duration of research activities and simplifying research procedures. CONCLUSIONS: This study provides fresh insights into the perspectives of family members concerning the recruitment and engagement of advanced cancer patients in nursing research. It emphasizes the importance of addressing their concerns and recommendations, aiding nurse researchers in developing culturally sensitive recruitment strategies and fostering the inclusive participation of advanced cancer patients in nursing research within the context of family-centered care and cultural taboos surrounding death.

The role of Patient and public involvement (PPI) in pre-clinical spinal cord research: An interview study.

BACKGROUND: Patient and public involvement in research (PPI) has many benefits including increasing relevance and impact. While using PPI in clinical research is now an established practice, the involvement of patients and the public in pre-clinical research, which takes place in a laboratory setting, has been less frequently described and presents specific challenges. This study aimed to explore the perspectives of seriously injured rugby players' who live with a spinal cord injury on PPI in pre-clinical research. METHODS: Semi-structured interviews were conducted via telephone with 11 seriously injured rugby players living with spinal cord injury on the island of Ireland. A purposive sampling approach was used to identify participants. Selected individuals were invited to take part via gatekeeper in a charitable organisation that supports seriously injured rugby players. Interviews were transcribed verbatim and analysed thematically. FINDINGS: Six themes were identified during analysis: 'appreciating potential benefits of PPI despite limited knowledge', 'the informed perspectives of people living with spinal cord injury can improve pre-clinical research relevance', 'making pre-clinical research more accessible reduces the potential for misunderstandings to occur', 'barriers to involvement include disinterest, accessibility issues, and fear of losing hope if results are negative', 'personal contact and dialogue helps people feel valued in pre-clinical research, and 'PPI can facilitate effective dissemination of pre-clinical research as desired by people living with spinal cord injury.' CONCLUSION: People affected by spinal cord injury in this study desire further involvement in pre-clinical spinal cord injury research through dialogue and contact with researchers. Sharing experiences of spinal cord injury can form the basis of PPI for pre-clinical spinal cord injury research.

Dose‒Response Effects of Patient Engagement on Anxiety and Depression in a Cognitive-Behavioral Intervention: Secondary Analysis of a Pilot Randomized Controlled Trial and a Clinical Controlled Trial.

Understanding the dose‒response relationship between patient engagement in cognitive behavioral therapy (CBT) and health outcomes is critical for developing and implementing effective CBT programs. In studies of CBT interventions, patient engagement is measured only at a single time point, and outcomes are typically assessed before and after the intervention. Examination of the dose‒response relationship between patient engagement in CBT and outcomes is limited. It is unclear whether a dose‒response relationship exists between patient engagement in on-site CBT intervention and anxiety and depression in people living with HIV (PLWH). If present, does this dose‒response relationship occur early or later in the intervention? This study aimed to address this gap by examining the dose‒response relationships between patient engagement and anxiety and depression in CBT interventions among PLWH. Utilizing data from a pilot randomized trial (10 participants) and a clinical controlled trial (70 participants), our secondary analysis spans baseline, 3-month, and 6-month assessments. Both trials implemented the nurse-led CBT intervention. Cluster analysis identified two groups based on on-site attendance and WeChat activity. Patients with good adherence (6-10 times) of on-site attendance exhibited significantly lower anxiety and depression scores at 3 months (ß = 1.220, P = 0.047; ß = 1.270, P = 0.019), with no significant differences observed at 6 months. WeChat activity did not significantly influence anxiety or depression scores. The findings highlight a significant short-term dose‒response relationship, endorsing nurse-led CBT interventions for mental health in PLWH. Organizational strategies should focus on incentivizing and facilitating patient engagement, particularly through enhancing WeChat features.