Effect of methotrexate on melanoma risk in older adults: Secondary analysis of a randomised controlled trial.
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ABSTRACT:
SUBMITTER: Yan MK
PROVIDER: S-EPMC9265764 | biostudies-literature | 2022 Feb
REPOSITORIES: biostudies-literature
Publications
Effect of methotrexate on melanoma risk in older adults: Secondary analysis of a randomised controlled trial.
Yan Mabel K MK Wolfe Rory R Orchard Suzanne G SG Ernst Michael E ME Mar Victoria J VJ
The Australasian journal of dermatology 20210928 1
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Project description:Background: Meeting recruitment targets for randomised controlled trials is challenging. This trial evaluated the effectiveness of including a pen within the trial invitation pack on the recruitment of older adults into a randomised controlled trial. Methods: This trial was embedded within the Occupational Therapist Intervention Study, a falls-prevention randomised controlled trial. Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices, were randomised to either not receive a pen (n = 1295) or receive a pen (n = 648) with their invitation pack, using a 2:1 ratio. The primary outcome was the likelihood of being randomised, and therefore fully recruited, to the host trial. To be randomised to the host trial, participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar. Secondary outcomes were: the likelihood of returning (and time to return) a screening form; being eligible for the host trial; and remaining in the trial for at least 3 months. Results: The likelihood of being randomised to the host trial did not differ between the pen group (4.5%) and no pen group (4.3%; odds ratio 1.04; 95% confidence interval: 0.65 to 1.67; p = 0.86). There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant. Conclusion: Pens may not be an effective incentive for the recruitment of older adults into randomised controlled trials, though future trials are required. Registration: ISRCTN22202133; SWAT 37.
| S-EPMC6446499 | biostudies-other
Project description:BackgroundThere has been an increasing interest in reablement in Norway recently and many municipalities have implemented this form of rehabilitation despite a lack of robust evidence of its effectiveness. The aim of this study was to investigate the effectiveness of reablement in home-dwelling older adults compared with usual care in relation to daily activities, physical functioning, and health-related quality of life.MethodsThis is a parallel-group randomised controlled trial conducted in a rural municipality in Norway. Sixty-one home-dwelling older adults with functional decline were randomised to an intervention group (n = 31) or a control group (n = 30). The intervention group received ten weeks of multicomponent home-based rehabilitation. The Canadian Occupational Performance Measure (COPM) was used to measure self-perceived activity performance and satisfaction with performance. In addition, physical capacity and health-related quality of life were measured. The participants were assessed at baseline and at 3- and 9-month follow-ups.ResultsThere were significant improvements in mean scores favouring reablement in COPM performance at 3 months with a score of 1.5 points (p = 0.02), at 9 months 1.4 points (p = 0.03) and overall treatment 1.5 points (p = 0.01), and for COPM satisfaction at 9 months 1.4 points (p = 0.03) and overall treatment 1.2 points (p = 0.04). No significant group differences were found concerning COPM satisfaction at 3 months, physical capacity or health-related quality of life.ConclusionA 10-week reablement program resulted in better activity performance and satisfaction with performance on a long-term basis, but not the other outcomes measured.Trial registrationThe trial was registered in ClinicalTrials.gov November 20, 2012, identifier NCT02043262 .
| S-EPMC4634595 | biostudies-literature
Project description:BackgroundCardiovascular risk factors represent an important health issue in older adults. Previous findings suggest that meditation training could have a positive impact on these risk factors. The objective of this study was to investigate the effects of an 18-month meditation-based intervention on cardiovascular health.MethodsAge-Well was a randomized, controlled superiority trial with blinded end point assessment, including community-dwelling cognitively unimpaired adults 65 years and older enrolled between November 24, 2016, and March 5, 2018, in France. One hundred and thirty-four participants were included in this secondary analysis. Participants were randomly affected to an intervention group that received an 18-month meditation-based program or to comparison groups (active control group i.e. non-native language training or passive control group i.e. no intervention). The main outcome was change in the Framingham Risk Score (FRS); other outcomes were changes in cardiovascular and metabolic risk factors.ResultsThere was no difference in FRS change after 18 months between trial arms (p = .38). When assessing individual cardiovascular or metabolic risk factors, meditation training was associated with a greater reduction in diastolic blood pressure than the comparison group in participants with intermediate to high cardiovascular risk (FRS > 10%) at baseline (p = .03).ConclusionAn 18-month meditation training was not effective to increase overall cardiovascular health in older adults, but improved diastolic blood pressure in a subgroup analysis including at-risk participants. These results suggest a potential benefit of a long-term meditation intervention in older adults at-risk of cardiovascular diseases, and highlights the need for future research in more targeted populations.Trial registrationClinicalTrials.gov Identifier: NCT02977819.
| S-EPMC11568626 | biostudies-literature
Project description:ObjectiveTo evaluate the impact of a provider initiated primary care outreach intervention compared with usual care among older adults at risk of functional decline.DesignRandomised controlled trial.SettingPatients enrolled with 35 family physicians in five primary care networks in Hamilton, Ontario, Canada.ParticipantsPatients were eligible if they were 75 years of age or older and were not receiving home care services. Of 3166 potentially eligible patients, 2662 (84%) completed the validated postal questionnaire used to determine risk of functional decline. Of 1724 patients who met the risk criteria, 769 (45%) agreed to participate and 719 were randomised.InterventionThe 12 month intervention, provided by experienced home care nurses in 2004-6, consisted of a comprehensive initial assessment using the resident assessment instrument for home care; collaborative care planning with patients, their families, and family physicians; health promotion; and referral to community health and social support services.Main outcome measuresQuality adjusted life years (QALYs), use and costs of health and social services, functional status, self rated health, and mortality.ResultsThe mean difference in QALYs between intervention and control patients during the study period was not statistically significant (0.017, 95% confidence interval -0.022 to 0.056; P=0.388). The mean difference in overall cost of prescription drugs and services between the intervention and control groups was not statistically significant, (-$C165 ( pound107; euro118; $162), 95% confidence interval -$C16 545 to $C16 214; P=0.984). Changes over 12 months in functional status and self rated health were not significantly different between the intervention and control groups. Ten patients died in each group.ConclusionsThe results of this study do not support adoption of this preventive primary care intervention for this target population of high risk older adults. Trial registration Clinical trials NCT00134836.
| S-EPMC3191725 | biostudies-literature
Project description:To investigate the effects of inhaler device technique education on improving inhaler technique in older people with asthma.In a randomised controlled trial, device technique education was provided to a sample of 123 adults aged >55 years who had a doctor diagnosis of asthma. The active education group received one-on-one technique coaching, including observation, verbal instruction and physical demonstration at baseline. The passive group received a device-specific instruction pamphlet only. Inhaler technique, including the critical steps for each device type, was assessed and scored according to Australian National Asthma Council (NAC) guidelines. Device technique was scored objectively at baseline and again at 3 and 12 months post education.The majority of participants demonstrated poor technique at baseline. Only 11 (21%) of the active intervention group and 7 (16%) of the passive group demonstrated 100% correct technique. By 3 months 26 (48%) of the active group achieved adequate technique. Improvement in technique was observed in the active group at 3 months (P<0.001) and remained significant at 12 months (P<0.001). No statistically significant improvement was observed in the passive group.The provision of active device technique education improves device technique in older adults. Passive education alone fails to achieve any improvement in device technique.
| S-EPMC4373405 | biostudies-other
Project description:ObjectivesAs the world population is ageing, it is vital to understand how older adults can maintain and deepen their psychological well-being as they are confronted with the unique challenges of ageing in a complex world. Theoretical work has highlighted the promising role of intentional mental training such as meditation practice for enhancing human flourishing. However, meditation-based randomised controlled trials in older adults are lacking. We aimed to investigate the effects of meditation training on psychological well-being in older adults.MethodsThis study presents a secondary analysis of the Age-Well trial (ClinicalTrials.gov: NCT02977819), which randomised 137 healthy older adults (age range: 65 to 84 years) to an 18-month meditation training, an active comparator (English language training), or a passive control. Well-being was measured at baseline, mid-intervention, and 18-month post-randomisation using the Psychological Well-being Scale (PWBS), the World Health Organisation's Quality of Life (QoL) Assessment psychological subscale, and composite scores reflecting the meditation-based well-being dimensions of awareness, connection, insight, and a global score comprising the average of these meditation-based dimensions.ResultsThe 18-month meditation training was superior to English training on changes in the global score (0.54 [95% CI: 0.26, 0.82], p = 0.0002) and the subscales of awareness, connection, insight, and superior to no-intervention only on changes in the global score (0.54 [95% CI: 0.26, 0.82], p = 0.0002) and awareness. Between-group differences in psychological QoL in favour of meditation did not remain significant after adjusting for multiple comparisons. There were no between-group differences in PWBS total score. Within the meditation group, psychological QoL, awareness, insight, and the global score increased significantly from baseline to 18-month post-randomisation.ConclusionThe longest randomised meditation training conducted to date enhanced a global composite score reflecting the meditation-based well-being dimensions of awareness, connection, and insight in older adults. Future research is needed to delineate the cognitive, affective, and behavioural factors that predict responsiveness to meditation and thus help refine the development of tailored meditation training.
| S-EPMC10691714 | biostudies-literature
Project description:Objectivesto test whether an occupation-based lifestyle intervention can sustain and improve the mental well-being of adults aged 65 years or over compared to usual care, using an individually randomised controlled trial.Participants288 independently living adults aged 65 years or over, with normal cognition, were recruited from two UK sites between December 2011 and November 2015.Interventionslifestyle Matters is a National Institute for Health and Care Excellence recommended multi-component preventive intervention designed to improve the mental well-being of community living older people at risk of decline. It involves weekly group sessions over 4 months and one to one sessions.Main outcome measuresthe primary outcome was mental well-being at 6 months (mental health (MH) dimension of the SF-36). Secondary outcomes included physical health dimensions of the SF-36, extent of depression (PHQ-9), quality of life (EQ-5D) and loneliness (de Jong Gierveld Loneliness Scale), assessed at 6 and 24 months.Resultsdata on 262 (intervention = 136; usual care = 126) participants were analysed using intention to treat analysis. Mean SF-36 MH scores at 6 months differed by 2.3 points (95 CI: -1.3 to 5.9; P = 0.209) after adjustments.Conclusionsanalysis shows little evidence of clinical or cost-effectiveness in the recruited population with analysis of the primary outcome revealing that the study participants were mentally well at baseline. The results pose questions regarding how preventive interventions to promote well-being in older adults can be effectively targeted in the absence of proactive mechanisms to identify those who at risk of decline.Trial registrationISRCTN67209155.
| S-EPMC5860501 | biostudies-literature
Project description:BackgroundThe Melanoma Genomics Managing Your Risk Study is a randomised controlled trial that aims to evaluate the efficacy of providing information on personal genomic risk of melanoma in reducing ultraviolet radiation (UV) exposure, stratified by traditional risk group (low or high phenotypic risk) in the general population. The primary outcome is objectively measured total daily Standard Erythemal Doses at 12 months. Secondary outcomes include UV exposure at specific time periods, self-reported sun protection and skin-examination behaviours, psychosocial outcomes, and ethical considerations surrounding offering genomic testing at a population level. A within-trial and modelled economic evaluation will be undertaken from an Australian health system perspective to assess the cost-effectiveness of the intervention.ObjectiveTo publish the pre-determined statistical analysis plan (SAP) before database lock and the start of analysis.MethodsThis SAP describes the data synthesis, analysis principles and statistical procedures for analysing the outcomes from this trial. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid potential analysis bias that may arise from knowledge of the outcome data.ResultsThis SAP is consistent with best practice and should enable transparent reporting.ConclusionThis SAP has been developed for the Melanoma Genomics Managing Your Risk Study and will be followed to ensure high-quality standards of internal validity and to minimise analysis bias.Trial registrationProspectively registered with the Australian New Zealand Clinical Trials Registry, ID: ACTR N12617000691347 . Registered on 15 May 2017.
| S-EPMC7329549 | biostudies-literature
Project description:IntroductionPromising evidence is emerging for the procognitive, anti-inflammatory and neuroprotective properties of dietary flavonoids, particularly anthocyanins that provide red, purple and blue plant pigments.Methods and analysisThe 'Food for Thought' study is a multicentre, 6-month randomised, parallel 3-arm clinical trial. Its primary aim is to investigate whether anthocyanin consumption, either through diet or supplementation, can prevent memory loss progression and improve inflammatory and cardiovascular health in older adults at risk for dementia. Eligible participants will include those aged 60-85 years with a diagnosis of amnestic mild cognitive impairment or with a self-referral of memory concerns and scoring ≤13 on the Memory Index Score within the Telephone Montreal Cognitive Assessment screening test. Participants will be randomised to one of three arms: High anthocyanin ('purple foods') diet (aiming for a target of 250 mg anthocyanins/day); freeze-dried product derived from blackcurrants (250 mg anthocyanins/day); or control (coloured maltose powder). The primary outcome is auditory anterograde memory functioning assessed by the Buschke and Grober Free and Cued Selective Reminding Test-Immediate Recall. Secondary outcomes are additional cognitive functions including processing speed, working memory, aspects of executive functioning (attentional shifting and word generativity) and premorbid estimate as well as subjective memory problems and self-reported depression symptoms. Additional secondary outcomes are blood pressure, inflammatory biomarkers, brain-derived neurotrophic factor, fatty acid profile, apolipoprotein E and polyphenol metabolites, gut microbiota composition and function and vascular and microvascular endothelial function tests. Repeated measures analysis of variance and/or mixed linear modelling will evaluate changes over time, with the inclusion of covariates.Ethics and disseminationEthics approval has been obtained from the Greater Western Human Research Ethics Committee (2021/ETH12083). A Consumer Advisory Group was established to guide and review the protocol and dissemination strategy. The results of this trial are intended to be published in a peer-reviewed journal.Trial sponsorNational Health and Medical Research Centre Dementia Collaborative Research Centre.Start date of clinical trial: 02 September 2022.Expected end date: 11 October 2024.Trial registration numberACTRN12622000065796.
| S-EPMC11409387 | biostudies-literature
Project description:BackgroundExercise interventions improve clinical outcomes of pain and function in adults with knee pain due to osteoarthritis and higher levels of physical activity are associated with lower severity of pain and higher levels of physical functioning in older adults with knee osteoarthritis in cross-sectional studies. However, to date no studies have investigated if change in physical activity level during exercise interventions can explain clinical outcomes of pain and function. This study aimed to investigate if change in physical activity during exercise interventions is associated with future pain and physical function in older adults with knee pain.MethodsSecondary longitudinal data analyses of a three armed exercise intervention randomised controlled trial. Participants were adults with knee pain attributed to osteoarthritis, over the age of 45 years old (n = 514) from Primary Care Services in the Midlands and Northwest regions of England. Crude and adjusted associations between absolute change in physical activity from baseline to 3 months (measured by the self-report Physical Activity Scale for the Elderly (PASE)) and i) pain ii) physical function (Western Ontario and McMaster Universities Osteoarthritis Index) and iii) treatment response (OMERACT-OARSI responder criteria) at 3 and 6 months follow-up were investigated using linear and logistic regression.ResultsChange in physical activity level was not associated with future pain, function or treatment response outcomes in crude or adjusted models at 3 or 6 months (P > 0.05). A 10 point increase in PASE was not associated with pain β = - 0.01 (- 0.05, 0.02), physical function β = - 0.09 (- 0.19, 0.02) or likelihood (odds ratio) of treatment response 1.02 (0.99, 1.04) at 3 months adjusting for sociodemographics, clinical covariates and the trial intervention arm. Findings were similar for 6 month outcome models.ConclusionsChange in physical activity did not explain future clinical outcomes of pain and function in this study. Other factors may be responsible for clinical improvements following exercise interventions. However, the PASE may not be sufficiently responsive to measure change in physical activity level. We also recommend further investigation into the responsiveness of commonly used physical activity measures.Trial registration( ISRCTN93634563 ). Registered 29th September 2011.
| S-EPMC5816451 | biostudies-literature