BACKGROUND: The number of surgical trials is increasing but such trials can be complex to deliver and pose specific challenges. A multi-centre, Phase III, RCT comparing Posterior Cervical Foraminotomy versus Anterior Cervical Discectomy and Fusion in the Treatment of Cervical Brachialgia (FORVAD Trial) was unable to recruit to target. A rapid qualitative study was conducted during trial closedown to understand the experiences of healthcare professionals who participated in the FORVAD Trial, with the aim of informing future research in this area.
METHODS: Semi-structured interviews were conducted with 18 healthcare professionals who had participated in the FORVAD Trial. Interviews explored participants\' experiences of the FORVAD trial. A rapid qualitative analysis was conducted, informed by Normalisation Process Theory.
RESULTS: Four main themes were generated in the data analysis: (1) individual vs. community equipoise; (2) trial set-up and delivery; (3) identifying and approaching patients; and (4) timing of randomisation. The objectives of the FORVAD trial made sense to participants and they supported the idea that there was clinical or collective equipoise regarding the two FORVAD interventions; however, many surgeons had treatment preferences and lacked individual equipoise. The site which had most recruitment success had adopted a more structured process for identification and recruitment of patients, whereas other sites that adopted more \"ad hoc\" screening strategies struggled to identify patients. Randomisation on the day of surgery caused both medico-legal and practical concerns at some sites.
CONCLUSIONS: Organisation and implementation of a surgical trial in neurosurgery is complex and presents many challenges. Sites often reported low recruitment and discussed the logistical issues of conducting a complex surgical RCT. Future trials in neurosurgery may need to offer more flexibility and time during set-up to maximise opportunities for larger recruitment numbers. Rapid qualitative analysis informed by Normalisation Process Theory was able to quickly identify key issues with trial implementation so rapid qualitative analysis may be a useful approach for teams conducting qualitative research in trials.
BACKGROUND: ISRCTN, ISRCTN reference: 10,133,661. Registered 23rd November 2018.

Clinical trials in depression lack objective measures. Speech latencies are an objective measure of psychomotor slowing with face validity and empirical support. \'Turn latency\' is the response time between speakers. Retrospective analysis was carried-out on the utility of turn latencies as an enrichment tool in a clinical trial of bipolar I depression. Speech data was obtained from 274 participants during 1,352 Montgomery-Åsberg Depression Rating Scale (MADRS) recordings in a randomized, placebo controlled, 6-week clinical trial of SEP-4199 (200 mg or 400 mg). Post-randomization turn latencies were compared between patients with moderate to severe depression and patients whose depression had remitted. A cutoff was determined and applied to turn latencies pre-randomization to classify individuals into two groups: Speech Latencies Slow (SL-Slow) and Speech Latencies Normal (SL-Normal). At week 6, SL-Slow (N = 172) showed significant separation in MADRS scores between placebo and treatment arms. SL-Normal (N = 102) showed larger MADRS improvements and no significant separation between placebo and treatment arms. Excluding SL-Normal increased primary outcome effect size by 52 % and 100 % for the treatment arms. Turn latencies are an objective measure available from standard clinical assessments and may assess the severity of symptoms more accurately and screen out placebo responders.

OBJECTIVE: To explore university nursing students and academic staff\'s perceptions of what increased gender diversity might bring to the nursing profession.
METHODS: An exploratory study with students and academic staff from two university nursing schools.
METHODS: Students and staff in two university nursing schools were invited to participate in an anonymous online survey (October-November 2022). The survey focused on gender diversity within nursing and patient care, asking respondents about existing barriers to gender diversity and inviting ideas on increasing gender diversity within nursing. The survey findings helped inform questions, which were used to further explore views and thoughts of gender diversity within nursing through semi-structured one-to-one interviews (January-February 2023).
RESULTS: Nearly, two-thirds (64%, n = 69) of survey respondents strongly agreed/agreed that the lack of gender diversity in nursing negatively impacted delivering care to a gender-diverse society. Most (84%, n = 90) strongly agreed/agreed that increased gender diversity within the nursing workforce would positively contribute to nursing. Three-quarters (75%, n = 74) strongly agreed/agreed that working with a more gender-diverse nursing workforce would enrich their experience as a nurse. Three themes emerged from the interview data: shared stereotypes; improved care through knowledge, better relations and the presence of a gender-diverse workforce; a culture of welcome: suggested changes for the future.
CONCLUSIONS: Most of those who participated in the study believe there are benefits to be gained from greater gender diversity within nursing. This study provides insight into the lack of gender diversity in the nursing environment, highlights how this might impact patient care and suggests actions to make nursing a more inclusive profession.
UNASSIGNED: Practical solutions were suggested, including the greater visibility of trans and non-binary persons in advertisement and recruitment campaigns to ensure nursing is viewed as a career choice for \"all\". Including a space for considered pronouns on university application forms, hospital documentation and name badges. Gender-neutral titles and uniforms should be considered for all nursing staff, and more gender-neutral toilets should be made available for staff and patients in university and hospital settings.
CONCLUSIONS: This study addressed the lack of gender diversity in nursing and explored what an increase in gender diversity might bring to the nursing profession. The main findings were: (i) Less than a tenth (9%, n = 12) of respondents described their team of colleagues as being \"extremely gender diverse\". (ii) Most (84%, n = 90) strongly agreed/agreed that increased gender diversity within the nursing workforce would be a positive attribute to nursing. (iii) Three-quarters 75% (n = 74) strongly agreed/agreed that working with a more gender-diverse nursing workforce would enrich their experience as a nurse. (iv) Many stereotypes still exist in nursing and tackling them is important to make the profession more inclusive. (v) A nurse\'s gender can impact the care they provide. (vi) A more gender-diverse workforce would better reflect the population it serves. (vii) This research will have an impact on the nursing profession globally.
UNASSIGNED: The consolidated criteria for reporting qualitative studies (COREQ) was used as a guide throughout data collection and analysis.
UNASSIGNED: Every step of the study, including the survey and interview schedule, was co-constructed using an iterative approach with service users, students and staff who had personal experience of gender diversity and were a core part of the study team.

We sought to derive an objective measure of psychomotor slowing from speech analytics during a psychiatric interview to avoid potential burden of dedicated neurophysiological testing. Speech latency, which reflects response time between speakers, shows promise from the literature. Speech data was obtained from 274 subjects with a diagnosis of bipolar I depression enrolled in a randomized, doubleblind, 6-week phase 2 clinical trial. Audio recordings of structured Montgomery-Åsberg Depression Rating Scale (MADRS) interviews at 6 time points were examined (k = 1,352). We evaluated speech latencies, and other aspects of speech, for temporal stability, convergent validity, sensitivity/responsivity to clinical change, and generalization across seven socio-linguistically diverse countries. Speech latency was minimally associated with demographic features, and explained nearly a third of the variance in depression (categorically defined). Speech latency significantly decreased as depression symptoms improved over time, explaining nearly 20 % of variance in depression remission. Classification for differentiating people with versus without concurrent depression was high (AUCs > 0.85) both cross-sectionally and longitudinally. Results replicated across countries. Other speech features offered modest incremental contribution. Neurophysiological speech parameters with face validity can be derived from psychiatric interviews without the added patient burden of additional testing.

BACKGROUND: Home medication management has been insufficiently studied, including the factors that impact the development and effectiveness of adherence strategies under both routine and anomalous circumstances. Older adults are a particularly important population to study due to the greater likelihood of taking medication in combination with the desire to \"age in place.\"
OBJECTIVE: This interview study aims to understand how older adults develop medication management strategies, identify when and why such strategies succeed or fail, learn more about how older adults think about their medication, and explore interventions that increase medication adherence.
METHODS: This study used a qualitative, semistructured interview design to elicit older adults\' experiences with home medication management. Overall, 22 participants aged ≥50 years taking 1 to 3 prescription medications were recruited and interviewed. Interview responses were recorded, and thematic, qualitative analysis was performed by reviewing recordings and identifying recurring patterns and themes. Responses were systematically coded, which not only facilitated the identification of these themes but also allowed us to quantify the prevalence of behaviors and perceptions, providing a robust understanding of medication management and medication adherence.
RESULTS: Participants reported developing home medication management strategies on their own, with none of the participants receiving guidance from health care providers and 59% (13/22) of the participants using trial and error. The strategies developed by study participants were all unique and generally encompassed prescription medication and vitamins or supplements, with no demarcation between what was prescribed or recommended by a physician and what they selected independently. Participants thought about their medications by their chemical name (10/22, 45%), by the appearance of the pill (8/22, 36%), by the medication\'s purpose (2/22, 9%), or by the medication\'s generic name (2/22, 9%). Pill cases (17/22, 77%) were more popular than prescription bottles (5/22, 23%) for storage of daily medication. Most participants (19/22, 86%) stored their pill cases or prescription bottles in visible locations in the home, and those using pill cases varied in their refill routines. Participants used ≥2 routines or objects as triggers to take their medication. Nonadherence was associated with a disruption to their routine. Finally, only 14% (3/22) of the participants used a time-based reminder or alarm, and none of the participants used a medication adherence device or app.
CONCLUSIONS: Participants in our study varied considerably in their home medication management strategies and developed unique routines to remember to take their medication as well as to refill their pill cases. To reduce trial and error in establishing a strategy, there are opportunities for physicians and pharmacists to provide adherence guidance to older adults. To minimize the impact of disruptions on adherence, there are opportunities to develop more durable strategies and to design aids to medication adherence that leverage established daily routines.

BACKGROUND: Cervical cancer remains a significant public health concern in Europe. Effective introduction and scaling up of human papillomavirus (HPV) detection-based cervical cancer screening (CCS) requires a systematic assessment of health systems capacity. However, there is no validated capacity assessment methodology for CCS programmes, especially in European contexts. Addressing this gap, our study introduces an innovative and adaptable protocol for evaluating the capacity of CCS programmes across varying European health system settings.
METHODS: Our research team developed a three-step capacity assessment framework, incorporating a health policy review checklist, a facility visit survey, and key informants\' interview guide followed by a strengths, weaknesses, opportunities and threats (SWOT) analysis. Piloting this comprehensive approach, we explored the CCS capacity in three countries: Estonia, Portugal and Romania. These countries were selected due to their contrasting healthcare structures and resources, providing a diverse overview of the European context.
RESULTS: Conducted over a period of 9 months, the capacity assessment covered multiple resources, 27 screening centres, 16 colposcopy and treatment centres and 15 key informant interviews. Our analysis highlighted both shared and country-specific challenges. A key common issue was ensuring high compliance to follow-up and management of screen-positive women. We identified considerable heterogeneity in resources and organization across the three countries, underscoring the need for tailored, rather than one-size-fits-all, solutions.
CONCLUSIONS: Our study\'s novelty lies in the successful development of this capacity assessment methodology implementable within a relatively short time frame, proving its feasibility for use in various contexts and countries. The resulting set of materials, adaptable to different cancer types, is a ready-to-use toolkit to improve cancer screening processes and outcomes. This research marks a significant stride towards comprehensive capacity assessment for CCS programmes in Europe. Future directions include deploying these tools in other countries and cancer types, thereby contributing to the global fight against cancer.

BACKGROUND: and Purpose: With mindfulness being increasingly recognized for its potential to address psychological challenges related to advanced or terminal illnesses, palliative care professionals are incorporating mindfulness-based interventions into their practice. However, there is limited understanding of the practical applications of mindfulness in clinical settings, particularly for end-of-life patients. This study explored palliative care professionals\' experiences in delivering mindfulness-based therapy to end-of-life patients, thereby aiming to inform the development of effective interventions.
METHODS: Semi-structured interviews were conducted with 15 palliative care professionals. Participants were asked to describe their memorable experiences in applying mindfulness in a clinical setting. Data were analyzed following Moustakas\'s transcendental phenomenology approach.
RESULTS: The interviews produced three themes: clinicians\' mindfulness experiences form the cornerstone of their clinical application of mindfulness; creating an optimal healing environment is essential for mindfulness practice; and patient-centric mindfulness guidance should be implemented.
CONCLUSIONS: This study underscores the critical role of mindfulness in end-of-life care, highlighting its integration into daily life by palliative care professionals. By drawing upon their own mindfulness experiences, palliative care professionals facilitated a therapeutic environment tailored to the unique needs of end-of-life patients. This patient-centered approach not only enhanced the quality of care but also fostered a healing connection rooted in compassion and empathy. The findings advocate for further education and development of mindfulness-based interventions, including group therapies, to support the holistic well-being of patients in collectivist cultures. Future research should further explore the practical applications and benefits of mindfulness in end-of-life care settings.

BACKGROUND: Abdominal pain is one of the most common complaints when patients are admitted to emergency departments (ED). Unfortunately, many of these patients are readmitted to the ED shortly after initial discharge. The perspectives of these patients have not yet been explored.
OBJECTIVE: The study aimed to explore how patients readmitted with acute abdominal pain in the ED experienced their initial admission, the time after discharge, and the cause of readmission.
METHODS: The study had a qualitative explorative design with a phenomenological-hermeneutic approach. Semi-structured individual telephone interviews were conducted with 14 patients readmitted with acute abdominal pain.
RESULTS: The analysis showed four themes: 1) being vulnerable during hospitalisation, 2) the meaning of information during hospitalisation, 3) discharged without being diagnosed, and 4) readmitted in the pursuit of relief. The patients wanted more knowledge and better communication despite their vulnerable condition. Patients were discharged whilst still in pain, and uncertainty of the situation at home contributed to mistrust of the health professionals.
CONCLUSIONS: Patients\' experience of the first ED admission due to acute abdominal pain was loneliness, minimal contact with healthcare professionals, and lack of information and involvement in pain management. Discharge was associated with feelings of insignificance and contributed to a fear of death. Pain was the main reason for readmission. Patients described how multiple readmissions contributed to being taken seriously by healthcare professionals.

OBJECTIVE: The definition and assessment of remission in anorexia nervosa (AN) needs greater consensus. Particularly in adolescents, the use of patient-reported composite indices (such as the Eating Disorder Examination [EDE] Global Score) as the sole measure of psychological remission has the potential to obscure patients\' true clinical status, given developmental factors and the propensity towards symptom minimization in AN.
METHODS: End of treatment (EOT) data from a randomized controlled trial comparing two formats of manualized family-based treatment for adolescents with AN (N = 106) were analyzed. Participants completed the EDE, and their parents completed a parent-as-informant version of the EDE (Parent Eating Disorder Examination; PEDE). Rates of remission were compared across indices (i.e., EDE Global Score vs. diagnostic item analysis) and informant (i.e., adolescent vs. parent), both independently and in combination with the achievement of a percent median body mass index (% mBMI) greater than or equal to 95%.
RESULTS: For both adolescent and parent reports, there were higher rates of remission when defined by Global Score than when defined by EDE or PEDE diagnostic items. There were no significant differences in remission rates based on informant.
CONCLUSIONS: In the assessment of remission in AN, the EDE Global Score may not detect some adolescents who continue to exhibit clinically significant psychological symptoms. This study supports a detailed, multidimensional approach to assessing remission in adolescent AN to optimize sensitivity to patients\' diagnostic profile. Future research should explore whether parent-child concordance on measures of ED psychopathology varies over the course of treatment.

BACKGROUND: Perinatal depression affects a significant number of women during pregnancy and after birth, and early identification is imperative for timely interventions and improved prognosis. Mobile apps offer the potential to overcome barriers to health care provision and facilitate clinical research. However, little is known about users\' perceptions and acceptability of these apps, particularly digital phenotyping and ecological momentary assessment apps, a relatively novel category of apps and approach to data collection. Understanding user\'s concerns and the challenges they experience using the app will facilitate adoption and continued engagement.
OBJECTIVE: This qualitative study explores the experiences and attitudes of users of the Mom2B mobile health (mHealth) research app (Uppsala University) during the perinatal period. In particular, we aimed to determine the acceptability of the app and any concerns about providing data through a mobile app.
METHODS: Semistructured focus group interviews were conducted digitally in Swedish with 13 groups and a total of 41 participants. Participants had been active users of the Mom2B app for at least 6 weeks and included pregnant and postpartum women, both with and without depression symptomatology apparent in their last screening test. Interviews were recorded, transcribed verbatim, translated to English, and evaluated using inductive thematic analysis.
RESULTS: Four themes were elicited: acceptability of sharing data, motivators and incentives, barriers to task completion, and user experience. Participants also gave suggestions for the improvement of features and user experience.
CONCLUSIONS: The study findings suggest that app-based digital phenotyping is a feasible and acceptable method of conducting research and health care delivery among perinatal women. The Mom2B app was perceived as an efficient and practical tool that facilitates engagement in research as well as allows users to monitor their well-being and receive general and personalized information related to the perinatal period. However, this study also highlights the importance of trustworthiness, accessibility, and prompt technical issue resolution in the development of future research apps in cooperation with end users. The study contributes to the growing body of literature on the usability and acceptability of mobile apps for research and ecological momentary assessment and underscores the need for continued research in this area.