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Background: External randomised pilot trials aim to assess whether a future definitive randomised controlled trial (RCT) is feasible. Pre-specified progression criteria help guide the interpretation of pilot trial findings to decide whether, and how, a definitive trial should be conducted. We aimed to examine how researchers report and plan to assess progression criteria in external pilot trial funding applications submitted to the NIHR Research for Patient Benefit Programme., Methods: We conducted a cross-sectional study of progression criteria inclusion in Stage 1 (outline) and corresponding Stage 2 (full) funding applications for external randomised external pilot trials submitted to NIHR RfPB between July 2017 and July 2019., Results: Of the 100 Stage 1 outline applications assessed, 95 were eligible for inclusion (of these, 52 were invited to Stage 2 full application; 43 were rejected) and 49/52 were eligible for inclusion at Stage 2 full application (of these, 35 were awarded funding; 14 were rejected). Over half of applications assessed at Stage 1 (48/95, 51%), and 73% of those assessed at Stage 2 (36/49) included progression criteria in their research plans. Progression criteria were most often reported in a stop-go format, often with additional specified factors that should be considered when determining feasibility (Stage 1 33/48, 69%; Stage 2 21/36, 58%). Recruitment and retention were the most frequent indicators of feasibility to inform progression criteria. One-third of applications provided some justification or rationale for their targets (Stage 1 16/48, 33%; Stage 2 12/36, 33%). Funding committee feedback mentioned progression criteria in over 20% of applications (Stage 1 22/95, 23%; Stage 2 11/49, 22%) to either request the addition of progression criteria or provide justification for the criteria stipulated., Conclusions: Our findings indicate that researchers do not always include progression criteria in external randomised pilot trial applications submitted to research funders. This can result in a lack of transparency in the assessment of randomised pilot trial feasibility., Trial Registration: Open Science Framework osf.io/89ap7, registered 29th June 2021., (© 2022. The Author(s).)

Background: Feasibility studies are often conducted before committing to a randomised controlled trial (RCT), yet there is little published evidence to inform how useful feasibility studies are, especially in terms of adding or reducing waste in research. This study attempted to examine how many feasibility studies demonstrated that the full trial was feasible and whether some feasibility studies were inherently likely to be feasible or not feasible, based on the topic area and/or research setting., Methods: Keyword searches were conducted on the International Standard Randomised Controlled Trials Number (ISRCTN) registry to identify all completed feasibility studies which had been conducted in the UK., Results: A total of 625 records from the 1933 identified were reviewed before it became evident that it would be futile to continue. Of 329 feasibility studies identified, 160 had a known outcome (49%), 133 (83%) trials were deemed to be feasible and only 27 (17%) were reported to be non-feasible. There were therefore too few studies to allow the intended comparison of differences in non-feasible studies by topic and/or setting., Conclusions: There were too few studies reported as non-feasible to draw any useful conclusions on whether topic and/or setting had an effect. However, the high feasibility rate (83%) may suggest that non-feasible studies are subject to publication bias or that many feasible studies are redundant and may be adding waste to the research pathway., (© 2021. The Author(s).)

In the context of avoiding research waste, the conduct of a feasibility study before a clinical trial should reduce the risk that further resources will be committed to a trial that is likely to 'fail'. However, there is little evidence indicating whether feasibility studies add to or reduce waste in research. Feasibility studies funded by the National Institute for Health Research's (NIHR) Research for Patient Benefit (RfPB) programme were examined to determine how many had published their findings, how many had applied for further funding for a full trial and the timeframe in which both of these occurred. A total of 120 feasibility studies which had closed by May 2016 were identified and each Principal Investigator (PI) was sent a questionnaire of which 89 responses were received and deemed suitable for analysis. Based on self reported answers from the PIs a total of 57 feasibility studies were judged as feasible, 20 were judged not feasible and for 12 it was judged as uncertain whether a full trial was feasible. The RfPB programme had spent approximately £19.5m on the 89 feasibility studies of which 16 further studies had been subsequently funded to a total of £16.8m. The 20 feasibility studies which were judged as not feasible potentially saved up to approximately £20m of further research funding which would likely to have not completed successfully. The average RfPB feasibility study took 31 months (range 18 to 48) to complete and cost £219,048 (range £72,031 to £326,830) and the average full trial funded from an RfPB feasibility study took 42 months (range 26 to 55) to complete and cost £1,163,996 (range £321,403 to £2,099,813). The average timeframe of feasibility study and full trial was 72 months (range 56 to 91), however in addition to this time an average of 10 months (range -7 to 29) was taken between the end of the feasibility study and the application for the full trial, and a further average of 18 months (range 13 to 28) between the application for the full trial and the start of the full trial. Approximately 58% of the 89 feasibility studies had published their findings with the majority of the remaining studies still planning to publish. Due to the long time frames involved a number of studies were still in the process of publishing the feasibility findings and/or applying for a full trial. Feasibility studies are potentially useful at avoiding waste and de-risking funding investments of more expensive full trials, however there is a clear time delay and therefore some potential waste in the existing research pathway.

Purpose: Little is known about the detection and treatment of psychological disorders arising during military service. We investigated whether personnel who developed disorders while serving in the UK armed forces came to the attention of medical services for these problems, received corresponding diagnoses, and were treated., Methods: For this retrospective record-based study 132 veterans in receipt of a war pension for psychological or physical problems received a lifetime diagnostic interview. Those with onsets of PTSD, depression, or alcohol abuse while in service were compared with those who never developed any condition or only developed it after discharge. Their medical records were inspected for contemporaneous contacts, diagnoses, and treatment., Results: PTSD and depression, but not alcohol abuse, were independently associated with mental health contacts while in service. The median time from PTSD onset to first contact was 1 month. Under half of personnel meeting criteria for these disorders received a corresponding diagnosis, and alcohol abuse was more likely to be recognised in the context of comorbid PTSD. PTSD was as well recognised in earlier as in later years covered by the study. Most personnel with disorders received treatment, and those treated were more likely to be medically downgraded or discharged., Conclusions: War pensioners are more likely than not to have had their psychological problems acknowledged and treated while in service. The fact that these problems are still largely present 10 years later raises questions over the continuity of care associated with the transition to civilian life.

Differences in symptoms, trauma exposure, dissociative and emotional reactions to trauma, and subsequent life stress in war veterans reporting immediate-onset or delayed-onset posttraumatic stress disorder (PTSD) or no PTSD were investigated. The role of life stress in delayed-onset PTSD was also studied. Retrospective interviews were conducted with 142 United Kingdom veterans receiving a war pension for PTSD or physical disability. Immediate-onset and delayed-onset PTSD were similar in the number and type of symptoms reported at onset, but the delayed-onset group differed in showing a gradual accumulation of symptoms that began earlier and continued throughout their military career. They were more likely to report major depressive disorder and alcohol abuse prior to PTSD onset. Both groups described similar amounts of trauma exposure, but those in the delayed-onset group reported significantly less peritraumatic dissociation, anger, and shame. Veterans with delayed onsets were more likely than veterans with no PTSD to report the presence of a severe life stressor in the year before onset. In conclusion, the results suggest that delayed onsets involve a more general stress sensitivity and a progressive failure to adapt to continued stress exposure., (PsycINFO Database Record 2009 APA, all rights reserved.)

This study investigated the hypothesis that the negative effect of life difficulties on examination performance in university students (Andrews & Wilding, 2004) can be explained by impairment of working memory efficiency. UK-based students were given an extensive interview covering recent life stressors, and carried out a task testing working memory span, in which they had to judge the truth of arithmetic expressions while retaining words. Students reporting one or more life difficulties in the preceding 12 months recalled significantly fewer words than those reporting no such difficulties, but showed no difference in processing time on the task. However, while the number of words recalled was unrelated to examination performance at the end of the year, students who took longer on the task did significantly less well in the examination. This relation was more marked in Science than in Arts students. A number of possible explanations for this pattern of results are considered, which need to be explored in further research. In particular it is suggested that the number of words retained in the working memory span task reflects current state, and is reduced by intrusive thoughts provoked by current life difficulties, while time on the task reflects more permanent efficiency of the processing system and, therefore, efficiency in study and examinations.

Background: Recent reports note a reliance on self-report measures and a lack of information about diagnosable mental disorder in university students. Professional concern about perceived increases in student mental health problems raises questions about whether questionnaire assessments can provide valid approximations of such disorders in this group. The aim of this study was to validate the Hospital Anxiety and Depression Scale (HADS) against DSM-IV diagnoses in university students., Methods: Eighty-nine students were administered with the HADS followed by the Structured Interview for DSM-IV., Results: At recommended cut-offs HADS anxiety and depression scales both showed good sensitivity in detecting DSM-IV anxiety and depression disorders, and the depression scale showed good specificity and overall efficiency. The HADS anxiety scale showed poor specificity and moderate overall efficiency. In the absence of an anxiety diagnosis, high HADS anxiety scores were not significantly associated with other measured indicators of serious mental health problems., Limitations: Further research is needed to investigate whether the current findings hold for student populations with higher social diversity., Conclusions: The HADS depression scale is likely to be a reasonably accurate indicator of depressive conditions in university students at the recommended cut-off but the HADS anxiety scale overestimates the extent of clinical anxiety. Students' self-reported higher symptom levels in comparison to general population norms cannot be assumed to indicate higher levels of more serious mental health conditions. However this is not to deny the genuine distress and severe problems that some students experience.