scholarly journals Randomised controlled trial and economic evaluation of a targeted cancer awareness intervention for adults living in deprived areas of the UK

2021 ◽  
Author(s):  
Yvonne Moriarty ◽  
Mandy Lau ◽  
Bernadette Sewell ◽  
Rob Trubey ◽  
Harriet Quinn-Scoggins ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cancer Awareness ◽  
Post Intervention ◽  
Clinical Trial Registration ◽  
Symptom Recognition ◽  
Randomised Controlled ◽  
Post Randomisation ◽  
Deprived Areas

Abstract Background 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. Methods 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. Intervention: personalised behavioural advice facilitated by a trained lay advisor. Control: usual care. Follow-up at two weeks and six months post-randomisation. Primary outcome: total cancer symptom recognition score two weeks post-randomisation. Results 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. Conclusions 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. Clinical trial registration ISRCTN16872545.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals A randomised controlled trial to investigate the effectiveness of sustained photoprotective behaviour in xeroderma pigmentosum after intervention

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S287-S287
Author(s):  
Tamara Searle ◽  
Jessica Walburn ◽  
Sam Norton
Keyword(s):  
Randomised Controlled Trial ◽  
Self Efficacy ◽  
Xeroderma Pigmentosum ◽  
Controlled Trial ◽  
Premalignant Lesions ◽  
Mental Wellbeing ◽  
Group Effect ◽  
Post Intervention ◽  
Randomised Controlled

AimsThis study aimed to investigate whether an intervention designed to improve photoprotective behaviours is effective at changing behaviour and whether any change could be maintained.BackgroundXeroderma Pigmentosum (XP) is a rare condition in which patients are at risk of malignancies when exposed to ultra-violet radiation (UVR). Sufferers must take extra precautions to protect themselves from UVR. They must apply sunscreen to exposed skin, wear thick clothing, gloves, and a UVR-protective visor. Treatments include preventative photoprotective measures; the use of sunscreen and protective clothing. Additionally, frequent eye and skin examinations are required and swift removal of any premalignant lesions.MethodIn this randomised controlled trial, 16 participants with XP were given questionnaires at 4 time points; baseline, post-intervention, 5 months and 9 months post-intervention. The intervention involved 7 one-on-one counselling sessions, as well as telephone consultations. Counselling sessions encouraged photoprotection adherence, self-efficacy and discussions of any barriers to improving photoprotective behaviour. This study focused on psychosocial variables, attitudes and photoprotection. Questionnaires included the photoprotection self-efficacy questionnaire, Self-Reported Behavioural Automaticity Index, Short Warwick-Edinburgh Mental Wellbeing Scale, Quality of Life and Brief Photoprotection Adherence Questionnaire.ResultThe intervention was shown to have no significant effect on participants’ questionnaires scores. Univariate ANCOVA revealed a group effect between follow-up 1 (FU1) and follow-up 2 (FU2); η2 = 0.422 for self-efficacy in wearing photoprotective clothing. A group effect was identified from BL to FU1 and FU1 to FU2; η2 = 0.343 and η2 = 0.378 respectively in how often participants reapplied sunscreen to their face when outside for longer periods. Univariate ANCOVA revealed no group or time effect for the other outcome variables; for example, sunscreen self-efficacy.ConclusionThe intervention had no significant effect on photoprotective behaviour questionnaire scores. Future research could focus on recruiting more participants globally to generate more statistically powered results. Research should focus on producing a maintainable intervention so that any positive change would produce better long-term health outcomes. This study lays the foundations for future XP research, which will be vital to improve understanding and enhance photo protective behaviour.

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

scholarly journals Acupuncture for Irritable Bowel Syndrome: 2-Year Follow-Up of a Randomised Controlled Trial

2017 ◽  
Vol 35 (1) ◽  
pp. 17-23 ◽  
Author(s):  
Hugh MacPherson ◽  
Helen Tilbrook ◽  
Deborah Agbedjro ◽  
Hannah Buckley ◽  
Catherine Hewitt ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Point Estimate ◽  
Irritable Bowel ◽  
Randomised Controlled ◽  
Post Randomisation

Background A recent randomised controlled trial (RCT) of acupuncture as a treatment for irritable bowel syndrome (IBS) demonstrated sustained benefits over a period of 12 months post-randomisation. Aim To extend the trial follow-up to evaluate the effects of acupuncture at 24 months post-randomisation. Methods Patients in primary care with ongoing IBS were recruited to a two-arm pragmatic RCT of acupuncture for IBS. Participants were randomised to the offer of up to 10 weekly sessions of acupuncture plus usual care (n=116 patients) or to continue with usual care alone (n=117). The primary outcome was the self-reported IBS symptom severity score (IBS SSS) measured at 24 months post-randomisation. Analysis was by intention-to-treat using an unstructured multivariate linear model incorporating all repeated measures. Results The overall response rate was 61%. The adjusted difference in mean IBS SSS at 24 months was −18.28 (95% CI −40.95 to 4.40) in favour of the acupuncture arm. Differences at earlier time points estimated from the multivariate model were: −27.27 (−47.69 to −6.86) at 3 months; −23.69 (−45.17 to −2.21) at 6 months; −24.09 (−45.59 to −2.59) at 9 months; and −23.06 (−44.52 to −1.59) at 12 months. Conclusions There were no statistically significant differences between the acupuncture and usual care groups in IBS SSS at 24 months post-randomisation, and the point estimate for the mean difference was approximately 80% of the size of the statistically significant results seen at 6, 9 and 12 months. Trial registration number ISRCTN08827905.

scholarly journals Evaluation of an Ultrasound-Guided Palpation Intervention for Palpation Skill Training: A Single-Blind, Parallel Group, Randomised Controlled Trial

2021 ◽  
Author(s):  
Takashi Kitagawa ◽  
Yuma Aoki ◽  
Hotaka Sugimoto ◽  
Natsumi Ozaki
Keyword(s):  
Medical Students ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Single Blind

Abstract Although there are increasing reports on the usefulness of sonopalpation with ultrasound imaging, many previous studies have reported interventions without a control group. This single-blind, parallel group randomised controlled trial aimed to determine whether educational instruction with sonopalpation for medical students has a superior effect on skill improvement than traditional instruction without ultrasonography. Twenty-nine medical students participated in the study and were randomised using block randomisation into an ultrasound imaging group (n = 15) and a control group (n = 14). Then, they underwent three training sessions focusing on the shoulder joint. Participants underwent a scoring assessment of their palpation skills at pre-intervention, post-intervention, and follow-up 3 months after training. The raters were blinded to the subjects’ group. The Friedman and Mann–Whitney U tests were used for data analysis. The intervention group showed a significant increase in scores at post-intervention and at the 3-month follow-up when compared with the pre-intervention group (p < 0.05); the effect sizes were large (0.849 and 0.849, respectively). A comparison of the scores at different time points after the intervention at the 3-month follow-up revealed that there was no significant difference between the groups. Education using ultrasound images may improve the sonopalpation skills of medical students.

scholarly journals A randomised controlled trial to reduce highest priority critically important antimicrobial prescription in companion animals

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
David A. Singleton ◽  
Angela Rayner ◽  
Bethaney Brant ◽  
Steven Smyth ◽  
Peter-John M. Noble ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Companion Animals ◽  
Intervention Group ◽  
Control Group ◽  
Prescription Data ◽  
Post Intervention ◽  
Electronic Prescription ◽  
Randomised Controlled

AbstractRobust evidence supporting strategies for companion animal antimicrobial stewardship is limited, despite frequent prescription of highest priority critically important antimicrobials (HPCIA). Here we describe a randomised controlled trial where electronic prescription data were utilised (August 2018–January 2019) to identify above average HPCIA-prescribing practices (n = 60), which were randomly assigned into a control group (CG) and two intervention groups. In March 2019, the light intervention group (LIG) and heavy intervention group (HIG) were notified of their above average status, and were provided with educational material (LIG, HIG), in-depth benchmarking (HIG), and follow-up meetings (HIG). Following notification, follow-up monitoring lasted for eight months (April–November 2019; post-intervention period) for all intervention groups, though HIG practices were able to access further support (i.e., follow-up meetings) for the first six of these months if requested. Post-intervention, in the HIG a 23.5% and 39.0% reduction in canine (0.5% of total consultations, 95% confidence interval, 0.4-0.6, P = 0.04) and feline (4.4%, 3.4-5.3, P < 0.001) HPCIA-prescribing consultations was observed, compared to the CG (dogs: 0.6%, 0.5-0.8; cats: 7.4%, 6.0-8.7). The LIG was associated with a 16.7% reduction in feline HPCIA prescription (6.1% of total consultations, 5.3-7.0, P = 0.03). Therefore, in this trial we have demonstrated effective strategies for reducing veterinary HPCIA prescription.

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