Cancer outcomes are poor in socioeconomically deprived communities, with low symptom awareness contributing to prolonged help-seeking and advanced disease. Targeted cancer awareness interventions ...require evaluation.
This is a randomised controlled trial involving adults aged 40+ years recruited in community and healthcare settings in deprived areas of South Yorkshire and South-East Wales.
personalised behavioural advice facilitated by a trained lay advisor.
usual care. Follow-up at two weeks and six months post-randomisation.
total cancer symptom recognition score two weeks post-randomisation.
Two hundred and thirty-four participants were randomised. The difference in total symptom recognition at two weeks adjusted mean difference (AMD) 0.6, 95% CI: -0.03, 1.17, p = 0.06 was not statistically significant. Intervention participants reported increased symptom recognition (AMD 0.8, 95% CI: 0.18, 1.37, p = 0.01) and earlier intended presentation (AMD -2.0, 95% CI: -3.02, -0.91, p < 0.001) at six months. "Lesser known" symptom recognition was higher in the intervention arm (2 weeks AMD 0.5, 95% CI: 0.03, 0.97 and six months AMD 0.7, 95% CI: 0.16, 1.17). Implementation cost per participant was £91.34, with no significant between-group differences in healthcare resource use post-intervention.
Improved symptom recognition and earlier anticipated presentation occurred at longer-term follow-up. The ABACus Health Check is a viable low-cost intervention to increase cancer awareness in socioeconomically deprived communities.
ISRCTN16872545.
Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and ...optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain.
RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio HR 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047.
Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 95% CI 0·612–0·975; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths.
Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy.
Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society.
INTRODUCTION In Australia, rural adolescents still face barriers to obtaining professional psychological help due to poor availability and accessibility of services in rural areas when delay in ...seeking help for mental health problems can lead to poorer treatment outcomes. The aims of this study were to: investigate the preferences and intentions of rural Australian youth towards seeking help for mental health problems; determine predictors of help-seeking intention among rural adolescents; and verify results from previous qualitative research on the barriers to help-seeking in a rural context.
Participants were 201 adolescents recruited from 8 rural schools in the state of Victoria, Australia. Participants ranged in age from 11 to 18 years. Using the Accessibility and Remoteness Index of Australia (ARIA+), approximately 149 participants were classified as currently living in an inner regional area of Victoria, whereas 52 participants lived in an outer regional area. Participants completed an open-ended survey of help-seeking intention.
Overall, 55.7% of the sample indicated that they would seek help for a mental health problem. The majority of participants, regardless of subgroup, indicated that they would seek help for a mental health problem from a school counsellor as their first choice. Gender differences were observed such that males had a higher preference for seeking help from a psychologist than females. Furthermore, older adolescents were more likely to prefer seeking help from a GP than younger participants. A multivariate analysis of help-seeking intentions revealed that ARIA was the only predictor of help-seeking intention; however, when extreme scores of depression and anxiety were also taken into account, these also predicted help-seeking intention. A content analysis of the barriers to help-seeking nominated by participants revealed that perceived limited availability of professional services in towns, perceived social proximity and fear of rural gossip, and difficulties associated with travelling to obtain help were the most significant concerns for these youth.
These findings verify previous research on help-seeking among rural youth and reinforce that these young people face additional barriers to help-seeking by virtue of living in a rural environment. The availability of services for rural youth needs to be improved, as do young people's knowledge of service availability and access (especially travel options). It must be taken into account that rural adolescents of different ages and sex may differ in their help-seeking preferences. Finally, mental health promotion work with rural youth should consider the influence of rural culture on help-seeking intentions.
Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems. Optimal management of perioperative intravenous fluids ...may reduce mortality rates and improve outcomes from surgery. Previous small trials of cardiac-output guided haemodynamic therapy algorithms in patients undergoing gastrointestinal surgery have suggested this intervention results in reduced complications and a modest reduction in mortality. However, this existing evidence is based mainly on elective (planned) surgery, with little evaluation in the emergency setting. There are fundamental clinical and pathophysiological differences between the planned and emergency surgical setting which may influence the effects of this intervention. A large definitive trial in emergency surgery is needed to confirm or refute the potential benefits observed in elective surgery and to inform widespread clinical practice.
The FLO-ELA trial is a multi-centre, parallel-group, open, randomised controlled trial. 3138 patients aged 50 and over undergoing major emergency gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, or usual care without cardiac output monitoring. The trial intervention will be carried out during surgery and for up to 6 h postoperatively. The trial is funded through an efficient design call by the National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) programme and uses existing routinely collected datasets for the majority of data collection. The primary outcome is the number of days alive and out of hospital within 90 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation. Participant recruitment started in September 2017 with a 1-year internal pilot phase and is ongoing at the time of publication.
This will be the largest contemporary randomised trial examining the effectiveness of perioperative cardiac output-guided haemodynamic therapy in patients undergoing major emergency gastrointestinal surgery. The multi-centre design and broad inclusion criteria support the external validity of the trial. Although the clinical teams delivering the trial interventions will not be blinded, significant trial outcome measures are objective and not subject to detection bias.
ISRCTN 14729158. Registered on 02 May 2017.
Highlights • The implementation and experience of a telestroke service using multimodal CT imaging is proposed. • Using multimodal CT imaging is in line with the paradigm shift seen in modern stroke ...care. • The addition of multimodal CT imaging does not seem to pose a risk for patient safety. • The addition of multimodal CT imaging leads to increased detection of stroke mimics. • The addition of CT angiography may lead to increased detection of intracranial vessel occlusions.
Background:
In Australia, clinical trial drugs are conventionally dispensed through clinical trial pharmacies only, while community pharmacies dispense drugs approved by Australia’s regulatory body. ...A large HIV pre-exposure prophylaxis study aimed to deliver clinical trial drug through community pharmacies to improve convenience and mimic real world prescribing. This paper describes the process of making community trials compliant with good clinical practice and reports outcomes of delivering clinical trial drug through community pharmacies.
Methods:
Eight community and four clinical trial pharmacies across three Australian states were approached to participate. A good clinical practice checklist was generated and pharmacies underwent a number of changes to meet clinical trial pharmacy requirements prior to study opening. Changes were made to community pharmacies to make them compliant with good clinical trial practice including; staff training, structural changes, and implementing monitoring of study drug and prescribing practices. Study drug was ordered through standard clinical trial processes and dispensed from study pharmacies by accredited pharmacists. Throughout the trial, record logs for training, prescriber signature and delegation, temperature, participant, and drug accountability were maintained at each pharmacy. The study team monitored each log and delivered on-site training to correct protocol variations.
Results:
Each pharmacy that was approached agreed to participate. All community pharmacies achieved good clinical practice compliance prior to dispensing study drug. Over the course of the study, 20,152 dispensations of study drug occurred, 83% of these occurred at community pharmacies. Only 2.0% of dispensations had an error, and errors were predominantly minor. On five occasions a pharmacist who was not accredited dispensed study drug.
Conclusions:
Community based pharmacies can undergo training and modifications to achieve good clinical practice compliance and dispense clinical trial study drug. Community based pharmacies recorded few variations from study protocol. Community based pharmacies offer a useful alternative to clinical trial pharmacies to increase convenience for study participants and expanded use of these pharmacies should be considered for large clinical trials, including HIV prevention trials.
Abstract Background Nonlocalizing neurologic deficits detectable by clinical evaluation–“soft signs”–are a robust finding in patients diagnosed with schizophrenia, but their conceptual and ...neuroanatomical correlates remain unclear. The purpose of this study was to evaluate the organization of these deficits and their clinical correlates using the Neurological Evaluation Scale (NES). Methods Ninety-three male veterans with schizophrenia and schizoaffective disorder were evaluated using a detailed clinical assessment that included the NES, the Extrapyramidal Symptom Rating Scale, the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Scale, the Positive and Negative Syndrome Scale, the Wisconsin Card Sorting Test (WCST), the Schedule for the Deficit Syndrome (SDS), and the Digit Symbol Substitution Task (DSST). Results Four factors explained 73% of the variance and had distinct clinical and neuropsychological correlates. Factor 1 reflected deficits involved with memory and sensory integration, and was associated with lower PANSS positive and higher AIMS scores. Factor 2 reflected impairments in motor control, and was associated with lower intelligence, more cognitive deficits, and deficit-syndrome schizophrenia. Factor 3 was related to lower intelligence and more perseverative errors on the WCST. Factor 4 was related to increasing age, more extrapyramidal symptoms, more perseverative errors, and worse scores on the DSST. Conclusions Neurologic deficits in schizophrenia have an intrinsic organization that appears to have clinical significance, highlighting the continued utility of the NES in studies of neurological deficits in schizophrenia patients. The theoretical underpinning of this organization remains unclear.
Objectives
The aim of the study was to assess, among people living with HIV, knowledge of their latest HIV viral load (VL) and CD4 count.
Methods
Agreement between self‐report and clinic record was ...assessed among 2771 HIV‐diagnosed individuals on antiretroviral treatment (ART) in the UK Antiretrovirals, Sexual Transmission Risk and Attitudes Study (2011–2012). A confidential self‐completed questionnaire collected information on demographic, socioeconomic, HIV‐related and health‐related factors. Participants were asked to self‐report their latest VL undetectable (≤ 50 copies/mL), detectable (> 50 copies/mL) or “don't know” and CD4 count (< 200, 200–350, 351–500 or > 500 cells/μL, or “don't know”). Latest clinic‐recorded VL and CD4 count were documented.
Results
Of 2678 participants on ART, 434 (16.2%) did not accurately report whether their VL was undetectable. Of 2334 participants with clinic‐recorded VL ≤ 50 copies/mL, 2061 (88.3%) correctly reported undetectable VL; 49 (2.1%) reported detectable VL; 224 (9.6%) did not know their VL. Of 344 participants with clinic‐recorded VL > 50 copies/mL, 183 (53.2%) correctly reported detectable VL; 76 (22.1%) reported undetectable VL; 85 (24.7%) did not know their VL. Of 2137 participants who reported undetectable VL, clinic‐recorded VL was ≤ 50 copies/mL for 2061 (96.4%) and <1000 copies/mL for 2122 (99.3%). In analyses adjusted for gender/sexual orientation, ethnicity, age and time since starting ART, factors strongly associated with inaccurate self‐report of VL (including “don't know”) included socioeconomic disadvantage prevalence ratio (95% CI) for “not” vs. “always” having enough money for basic needs: 2.4 (1.9, 3.1), poor English fluency 3.5 (2.4, 5.1) vs. UK born, nondisclosure of HIV status 1.7 (1.3, 2.1), ART nonadherence 2.1 (1.7, 2.7) for three or more missed doses vs. none in the past 2 weeks and depressive symptoms (PHQ‐9 score ≥ 10) 1.9 (1.6, 2.2). Overall, 612 (22.9%) of 2667 participants on ART did not accurately self‐report whether or not their CD4 count was ≤ 350 cells/μL.
Conclusions
There is a high level of accuracy of a self‐report of undetectable VL in people on ART in the UK. Overall, accurate knowledge of personal VL level varied according to demographic, socioeconomic, HIV‐related and health‐related factors. Active identification of people who may benefit from increased levels of support and engagement in care is important.
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