Rapid qualitative analysis of recruitment obstacles in the FORVAD (Posterior Cervical Foraminotomy surgery versus Anterior Cervical Discectomy surgery in the treatment of cervical brachialgia) randomised, controlled trial.

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. TRIAL REGISTRATION: ISRCTN, ISRCTN reference: 10,133,661. Registered 23rd November 2018.

Reboot coaching programme: a mixed-methods evaluation assessing resilience, confidence, burnout and depression in medical students.

BACKGROUND: Poor mental health in medical students is a global concern. Effective interventions are required, which are tailored towards the training-related stressors medical students experience. The Reboot coaching programme is an online, tailored intervention based on cognitive-behavioural principles. AIMS: To evaluate whether the Reboot coaching programme tailored for medical students was feasible and associated with improvements in mental health outcome indicators. METHODS: Medical students participated in two group online workshops and a one-to-one coaching call with a Reboot-trained licensed psychological therapist. Participants provided data at: baseline (T1), post-workshops (T2), post-coaching call (T3) and 4-month follow-up (T4). Outcome measures included resilience, confidence, burnout and depression. Feedback was provided regarding the workshops at T2. RESULTS: 115 participants (93/80.9% women; mage = 23.9; SD = 2.8) were recruited, 83 (72.2%) completed all intervention elements and 82 (71.3%) provided T4 data, surpassing recruitment and retention targets. There were significant improvements following baseline in resilience (ps < .001), confidence (ps < .001), burnout (ps < .001) and depression (ps ≤ .001). Most participants agreed the workshops imparted useful skills (n = 92; 99%) and would recommend Reboot to others (n = 89; 95.6%). CONCLUSIONS: Existing interventions have produced mixed results regarding their effectiveness in improving medical students' mental health. Reboot is a feasible intervention in this group which is associated with improvements in resilience, confidence, burnout and depression. Further controlled studies of Reboot are now needed.

Social anxiety, behavioural activation and depression risk in older men: protection through Men's Shed membership.

Reducing rates of depressive symptoms in older adults is a public health priority. Men's Sheds are a community organisation that may protect against depressive symptoms in older men. It is currently unclear how social anxiety and behavioural activation may relate to depressive symptoms for Men's Shed members. We employed a cross-sectional design to explore whether the relationships between social anxiety, behavioural activation and depressive symptoms were contingent upon Shed social network quality in a sample of 164 Men's Shed members. Conditional effects analysis found social anxiety (B = -0.08, p < 0.01) and behavioural activation's (B = 0.02, p < 0.001) relationships with depression to be contingent on Shed social network quality. Additionally, we found evidence for a conditional effect of social anxiety on the relationship between behavioural activation and depression (B = -0.03, p < 0.01) such that this relationship was stronger for those with higher levels of social anxiety. Our findings suggest that a strong social network within a Men's Shed weakens the association between social anxiety and depression, that the relationship between behavioural activation and depression is stronger in those with poorer Shed social networks, and that the relationship between behavioural activation and depression may be stronger for those with higher levels of social anxiety. We suggest that our findings contribute to increasing quantitative support for the mental health benefits of Men's Shed membership, highlight the potential importance of Shed social network quality and explore how social anxiety may affect the mental health outcomes for members.

Posterior cervical foraminotomy versus anterior cervical discectomy for Cervical Brachialgia: the FORVAD RCT.

Background: Posterior cervical foraminotomy and anterior cervical discectomy are routinely used operations to treat cervical brachialgia, although definitive evidence supporting superiority of either is lacking. Objective: The primary objective was to investigate whether or not posterior cervical foraminotomy is superior to anterior cervical discectomy in improving clinical outcome. Design: This was a Phase III, unblinded, prospective, United Kingdom multicentre, parallel-group, individually randomised controlled superiority trial comparing posterior cervical foraminotomy with anterior cervical discectomy. A rapid qualitative study was conducted during the close-down phase, involving remote semistructured interviews with trial participants and health-care professionals. Setting: National Health Service trusts. Participants: Patients with symptomatic unilateral cervical brachialgia for at least 6 weeks. Interventions: Participants were randomised to receive posterior cervical foraminotomy or anterior cervical discectomy. Allocation was not blinded to participants, medical staff or trial staff. Health-care use from providing the initial surgical intervention to hospital discharge was measured and valued using national cost data. Main outcome measures: The primary outcome measure was clinical outcome, as measured by patient-reported Neck Disability Index score 52 weeks post operation. Secondary outcome measures included complications, reoperations and restricted American Spinal Injury Association score over 6 weeks post operation, and patient-reported Eating Assessment Tool-10 items, Glasgow-Edinburgh Throat Scale, Voice Handicap Index-10 items, PainDETECT and Numerical Rating Scales for neck and upper-limb pain over 52 weeks post operation. Results: The target recruitment was 252 participants. Owing to slow accrual, the trial closed after randomising 23 participants from 11 hospitals. The qualitative substudy found that there was support and enthusiasm for the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial and randomised clinical trials in this area. However, clinical equipoise appears to have been an issue for sites and individual surgeons. Randomisation on the day of surgery and processes for screening and approaching participants were also crucial factors in some centres. The median Neck Disability Index scores at baseline (pre surgery) and at 52 weeks was 44.0 (interquartile range 36.0-62.0 weeks) and 25.3 weeks (interquartile range 20.0-42.0 weeks), respectively, in the posterior cervical foraminotomy group (n = 14), and 35.6 weeks (interquartile range 34.0-44.0 weeks) and 45.0 weeks (interquartile range 20.0-57.0 weeks), respectively, in the anterior cervical discectomy group (n = 9). Scores appeared to reduce (i.e. improve) in the posterior cervical foraminotomy group, but not in the anterior cervical discectomy group. The median Eating Assessment Tool-10 items score for swallowing was higher (worse) after anterior cervical discectomy (13.5) than after posterior cervical foraminotomy (0) on day 1, but not at other time points, whereas the median Glasgow-Edinburgh Throat Scale score for globus was higher (worse) after anterior cervical discectomy (15, 7, 6, 6, 2, 2.5) than after posterior cervical foraminotomy (3, 0, 0, 0.5, 0, 0) at all postoperative time points. Five postoperative complications occurred within 6 weeks of surgery, all after anterior cervical discectomy. Neck pain was more severe on day 1 following posterior cervical foraminotomy (Numerical Rating Scale - Neck Pain score 8.5) than at the same time point after anterior cervical discectomy (Numerical Rating Scale - Neck Pain score 7.0). The median health-care costs of providing initial surgical intervention were £2610 for posterior cervical foraminotomy and £4411 for anterior cervical discectomy. Conclusions: The data suggest that posterior cervical foraminotomy is associated with better outcomes, fewer complications and lower costs, but the trial recruited slowly and closed early. Consequently, the trial is underpowered and definitive conclusions cannot be drawn. Recruitment was impaired by lack of individual equipoise and by concern about randomising on the day of surgery. A large prospective multicentre trial comparing anterior cervical discectomy and posterior cervical foraminotomy in the treatment of cervical brachialgia is still required. Trial registration: This trial is registered as ISRCTN10133661. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 21. See the NIHR Journals Library website for further project information.

Cervical brachialgia is pain that starts in the neck and passes down into the arm. Although most people with cervical brachialgia recover quickly, in some patients pain persists, and in 15% of patients pain is so severe that they are unable to work. In the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial, we investigated two neck surgeries used to treat this problem: posterior cervical foraminotomy (surgery from the back of the neck) and anterior cervical discectomy (surgery from the front of the neck). This trial aimed to find out if one of them is better than the other at relieving pain and more cost-effective for the National Health Service. We assessed patients' quality of life 1 year after their surgery and how their pain changed over the course of the year. We also measured the number of complications patients had in the first 6 weeks after their operation. Recruitment was slow and so the trial was stopped early, after only 23 patients from 11 hospitals had been randomly allocated to the two surgery groups. We had planned to recruit 252 participants to the trial; the number of participants we were able to recruit in practice was too small to enable us to determine which surgery is better at relieving pain. To find out why the trial had struggled to recruit, we asked hospital staff and participants about their experiences. We found that hospital staff sometimes struggled to organise everything needed to randomise patients on the day of surgery. Some staff also found it difficult to randomise patients as they had an opinion on which surgery they thought the patient should receive. The data collected in the trial will still be useful to help design future research. Finding out which surgery is better at relieving pain remains important, and the data we have collected will support answering this question in future.

Pathways from Men's Shed engagement to wellbeing, health-related quality of life, and lower loneliness.

Extensive qualitative evidence, but limited quantitative evidence, indicates that mutual aid organizations such as Men's Sheds have positive impacts on wellbeing, health-related quality of life, and loneliness. A recently developed theoretical model proposes that Men's Sheds may have these impacts via mediating factors such as broadening social networks, increasing behavioural activation and physical activity, reducing alcohol use, and providing meaning in life. The aim of this study was to quantitatively test a model whereby psychological safety (feeling safe, accepted, and valued) is associated with Men's Shed engagement (frequency of attendance, duration of membership, diversity of activities), which is associated with the hypothesized mediators, which, in turn, are associated with wellbeing, health-related quality of life, and loneliness. Men's Shed members (N = 333, Mage = 70.90 years, SD = 10.34, 98% male) completed a survey assessing the factors in the model. The hypothesized path model provided an excellent fit to the data. Findings indicated that higher psychological safety was associated with higher engagement, which, in turn, was associated with larger social networks and more meaning in life, which were associated with higher wellbeing and lower loneliness. Higher behavioural activation and less alcohol use were also associated with higher wellbeing. Higher Men's Shed engagement was not associated with higher behavioural activation and physical activity, or less alcohol use, but behavioural activation and alcohol use were directly associated with health-related quality of life. Implications for optimizing health outcomes within Men's Sheds are discussed.

Spatial and temporal variations of microplastic concentrations in Portland's freshwater ecosystems.

While microplastics are a pollutant of growing concern in various environmental compartments, less is known regarding the sources and delivery pathways of microplastics in urban rivers. We investigated the relationship between microplastic concentrations and various spatiotemporal factors (e.g., land use, arterial road length, water velocity, precipitation) in two watersheds along an urban-rural gradient in the Portland metropolitan area. Samples were collected in August, September, and February and were analyzed for total microplastic count and type. Nonparametric statistics were used to evaluate potential relationships with the explanatory variables, derived at both the subwatershed and near stream scales. In August, microplastic concentrations were significantly higher than in February. August concentrations also negatively correlated with flow rate, suggesting that lower flow rates may have facilitated the accumulation of microplastics. Smaller size microplastic particles (< 100 µm) were found more in August than September and February, while larger size particles were more dominant in February than the other months. Microplastic concentrations were positively related to 24-h antecedent precipitation in February. Negative correlations existed between wet season microplastic concentrations and agricultural lands at the near stream level. The results indicate that near stream variables may more strongly influence the presence and abundance of microplastics in Portland's waterways than subwatershed-scale variables. Fragments were the most commonly observed microplastic morphology, with a dominance of gray particles and the polymer polyethylene. The findings of this study can inform management decisions regarding microplastic waste and identify hotspots of microplastic pollution that may benefit from remediation.

Microplastics in freshwater: A global review of factors affecting spatial and temporal variations.

Microplastics are a pollutant of growing concern, capable of harming aquatic organisms and entering the food web. While freshwater microplastic research has expanded in recent years, much remains unknown regarding the sources and delivery pathways of microplastics in these environments. This review aims to address the scientific literature regarding the spatial and temporal factors affecting global freshwater microplastic distributions and abundances. A total of 75 papers, published through June 2021 and containing an earliest publication date of October 2014, was identified by a Web of Science database search. Microplastic spatial distributions are heavily influenced by anthropogenic factors, with higher concentrations reported in regions characterized by urban land cover, high population density, and wastewater treatment plant effluent. Spatial distributions may also be affected by physical watershed characteristics such as slope and elevation (positive and negative correlations with microplastic concentrations, respectively), although few studies address these factors. Temporal variables of influence include precipitation and stormwater runoff (positive correlations) and water flow/discharge (negative correlations). Despite these overarching trends, variations in study results may be due to differing scales or contributing area delineations. Thus, more rigorous and standardized spatial analytical methods are needed. Future research could simultaneously evaluate both spatial and temporal factors and incorporate finer temporal resolutions into sampling campaigns.

Care assistant experiences of dementia care in long-term nursing and residential care environments.

Care assistants have a unique insight into the lives of service users and those factors which may impede or enhance the delivery of high quality dementia oriented care. To address the paucity of research in this area, the present study examined care assistant experiences of dementia care in British long-term residential and nursing environments. Semi-structured interviews were conducted with eight care assistants and transcripts were analysed using interpretive phenomenological analysis. Super-ordinate themes emerging from the data were psychological wellbeing of the care assistant, barriers to effective dementia care, the dementia reality and organisational issues within the care environment. The study revealed important deficiencies in understanding and varying levels of dementia training. Whilst person centred strategies were being implemented, task orientated care remained dominant. Furthermore, care assistants reported taking the perspectives of those with dementia into account, and actively using these to develop relationship centred care.