Cent Of Participants Research Articles

An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia: the Journeying through Dementia RCT.

There are few effective interventions for dementia. To determine the clinical effectiveness and cost-effectiveness of an intervention to promote self-management, independence and self-efficacy in people with early-stage dementia. To undertake a randomised controlled trial of the Journeying through Dementia intervention compared with usual care, conduct an internal pilot testing feasibility, assess intervention delivery fidelity and undertake a qualitative exploration of participants' experiences. A pragmatic two-arm individually randomised trial analysed by intention to treat. A total of 480 people diagnosed with mild dementia, with capacity to make informed decisions, living in the community and not participating in other studies, and 350 supporters whom they identified, from 13 locations in England, took part. Those randomised to the Journeying through Dementia intervention (n = 241) were invited to take part in 12 weekly facilitated groups and four one-to-one sessions delivered in the community by secondary care staff, in addition to their usual care. The control group (n = 239) received usual care. Usual care included drug treatment, needs assessment and referral to appropriate services. Usual care at each site was recorded. The primary outcome was Dementia-Related Quality of Life score at 8 months post randomisation, with higher scores representing higher quality of life. Secondary outcomes included resource use, psychological well-being, self-management, instrumental activities of daily living and health-related quality of life. Participants were randomised in a 1 : 1 ratio. Staff conducting outcome assessments were blinded. Outcome measures were administered in participants' homes at baseline and at 8 and 12 months post randomisation. Interviews were conducted with participants, participating carers and interventionalists. The mean Dementia-Related Quality of Life score at 8 months was 93.3 (standard deviation 13.0) in the intervention arm (n = 191) and 91.9 (standard deviation 14.6) in the control arm (n = 197), with a difference in means of 0.9 (95% confidence interval -1.2 to 3.0; p = 0.380) after adjustment for covariates. This effect size (0.9) was less than the 4 points defined as clinically meaningful. For other outcomes, a difference was found only for Diener's Flourishing Scale (adjusted mean difference 1.2, 95% confidence interval 0.1 to 2.3), in favour of the intervention (i.e. in a positive direction). The Journeying through Dementia intervention cost £608 more than usual care (95% confidence interval £105 to £1179) and had negligible difference in quality-adjusted life-years (-0.003, 95% confidence interval -0.044 to 0.038). Therefore, the Journeying through Dementia intervention had a mean incremental cost per quality-adjusted life-year of -£202,857 (95% confidence interval -£534,733 to £483,739); however, there is considerable uncertainty around this. Assessed fidelity was good. Interviewed participants described receiving some benefit and a minority benefited greatly. However, negative aspects were also raised by a minority. Seventeen per cent of participants in the intervention arm and 15% of participants in the control arm experienced at least one serious adverse event. None of the serious adverse events were classified as related to the intervention. Study limitations include recruitment of an active population, delivery challenges and limitations of existing outcome measures. The Journeying through Dementia programme is not clinically effective, is unlikely to be cost-effective and cannot be recommended in its existing format. Research should focus on the creation of new outcome measures to assess well-being in dementia and on using elements of the intervention, such as enabling enactment in the community. This trial is registered as ISRCTN17993825. 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. 26, No. 24. See the NIHR Journals Library website for further project information.

Pain trajectories and well-being in children and young people with cerebral palsy: A cohort study.

To identify 5-week pain intensity trajectories and their association with physical and psychological well-being in children/young people with cerebral palsy (CP). A cohort study was conducted with 101 Canadian children/young people with CP, of whom 49 were female, with an overall mean age of 12 years 11 months (SD 3 years 1 month), range of 8 to 18 years, and classified in any Gross Motor Function Classification System level. Self-reported pain intensity (Faces Pain Scale - Revised) was collected weekly for 5 weeks and physical and psychological well-being (KIDSCREEN-27) at baseline and 5 weeks. Statistical analyses included latent class growth and general linear models. All Gross Motor Function Classification System levels were represented (I=40.6%; II=15.8%; III=20.8%; IV=13.9%; V=8.9%). Five pain intensity trajectories were identified. Three trajectories had very low (35.4%), low (32.4%), or high (4.9%) mean stable pain. Two trajectories had moderate changing pain (16.8%) and high pain decreasing to moderate levels (10.5%) respectively. Trajectory participants with stable high pain had the lowest physical well-being (adjusted β=-10.01; 95% confidence interval [CI]=-19.37 to -0.66). Those in the three trajectories with the highest mean baseline pain intensity (>3 out of 10) had the lowest psychological well-being (adjusted β=-8.27, 95% CI=-14.84 to -1.70; β=-6.74, 95% CI=-12.43 to -1.05; β=-5.82, 95% CI=-15.34 to 3.71). Almost one-third of participants had moderate-to-high pain intensity trajectories. Membership in the higher pain intensity trajectories was associated with lower physical and psychological well-being. Five distinct 5-week pain intensity trajectories were identified in children/young people with cerebral palsy. Thirty-two per cent of participants had moderate-to-high pain intensity trajectories. Participants in the trajectories with higher pain intensity reported lower physical and psychological well-being.

Absolute cardiovascular risk scores and medication use in rural India: a cross-sectional study

ObjectivesWe compared the performance of laboratory-based cardiovascular risk prediction tools in a low-income and middle-income country setting, and estimated the use of antihypertensive and lipid-lowering medications in those deemed at...

Prevalence and associated factors of frailty among Southern Chinese Han patients on haemodialysis: a multicentre, observational cross-sectional study

ObjectivesFrailty has been extensively studied in the general population. However, there is little information on frailty among patients undergoing haemodialysis (HD) in China. This study analysed the prevalence and associated...

Oral antihistamine-decongestant-analgesic combinations for the common cold.

Oral antihistamine-decongestant-analgesic combinations for the common cold.

Salutogenic and Pathogenic Factors Among Young Adult Refugees in Germany: An Exploratory Study

Abstract In this cross-sectional study, we explored the association of salutogenic variables—resilience and quality of life (QOL)—with posttraumatic stress (PTS) and depressive symptoms of 55 refugees who came to Germany as minors from various disputed Middle East and Africa countries. Results revealed that 53 per cent of participants showed a clinically relevant level of PTS, and 32 per cent scored in the clinical range for depression. Levels of resilience and QOL were moderate. Regression models revealed that resilience was the only significant variable associated with PTS over and above traumatic events and demographic variables. Pre-migration traumatic events and QOL were found to be significant variables associated with depression. Quality of life was found to mediate the relation between resilience and depression. Pre- and peri-traumatic events were not associated with resilience or QOL. Post-migration stressors were negatively associated with resilience and QOL. These findings suggest that the impact of forced migration on the young adults’ adjustment should be investigated not only in terms of psychological symptoms, but also in terms of resilience and QOL. In addition, therapeutic interventions should focus not only on diminishing psychological difficulties, but also in helping these young refugees increase, build, and maintain resilience and QOL.

Normobaric Oxygen Therapy in Acute Stroke: A Systematic Review and Meta-Analysis

Purpose: Normobaric oxygen (NBO) is potentially a readily accessible neuroprotective therapy. We undertook a systematic review to assess NBO in acute stroke. Methods: MEDLINE, EMBASE, and CENTRAL databases were searched to December 2020. Randomized controlled trials of NBO administered <7 days after stroke to normoxic patients with no other indication for oxygen were identified. Data on early neurological recovery; functional outcome; mortality; oxygen saturation, and imaging markers were collected. Findings: Fifteen publications involving 12 cohorts and 9,255 participants were identified. One study with 8,003 participants had low risk of bias, but the designs of smaller trials had limitations. Ninety-seven per cent of participants were in studies of low-flow oxygen (≤4 L/min). 82.8% had ischaemic stroke. Median time to treatment was 19.3 h. Meta-analysis demonstrated no significant effect on: reduction in National Institutes of Health Stroke Scale at 7 days in all stroke or ischaemic stroke only (mean difference −0.16 [−1.11 to 0.80] and −0.73 [−3.54 to 2.08], respectively); modified Rankin scale at 3–6 months of follow-up (combined standardized mean difference [SMD] −0.08 [−0.38 to 0.22]; 3 months SMD −0.01 [−0.03 to 0.029]; 6-month SMD −0.20 [−1.49 to 1.09]), or mortality (odds ratio 1.15 [0.87–1.53]). Discussion: The majority of patients were administered low-flow oxygen in the sub-acute phase. Intervention strategies targeted at modification of early tissue survival (higher oxygen delivery and administration at early time points when significant volumes of viable tissue persist) have not been tested adequately. Conclusion: Studies of NBO have shown no significant effect on early neurological recovery, functional outcome, or mortality in acute stroke. Oxygen has been predominantly low-flow and commenced in the sub-acute phase.

Cohort profile: the Spanish Early-onset Colorectal Cancer (SECOC) cohort: a multicentre cohort study on the molecular basis of colorectal cancer among young individuals in Spain

PurposeThe Spanish Early-onset Colorectal Cancer (SECOC) study is a multicentre prospective cohort established in Spain to investigate the molecular basis of early-onset colorectal cancer (EOCRC), including metabolic alterations.Participants220 patients with...

Smoking prevention in adolescents: a cross-sectional and qualitative evaluation of a newly implemented prevention program in Switzerland

ObjectivesIn 2014, a hospital-based smoking prevention programme ‘Nichtrauchen ist clever!’ (NIC!) for adolescents aged 12–14 was initiated. The aim of the study was to evaluate participants’ smoking behaviour and to...

Evaluation of an early career clinical academic training programme using the CIPP model

ObjectivesThis study describes the successful implementation and outputs of a combined clinical academic training programme for doctors in their first postgraduate year in Ireland, the Academic Internship Track (AIT).DesignThe AIT...

Health Service Experiences of the Foreign Origin SGMs in Finland: An Intersectional Analysis

Abstract Background The size of the sexual and gender minority (SGM) population in Finland is estimated to be between 5 and 15 per cent of the total Finnish population. In the 2019 School Health Promotion Survey, approximately 7-8 per cent of participants who identified as belonging to sexual or gender minorities, also identified as being of foreign origin. Research on the experiences of individuals who belong to sexual and/or gender minorities and also identify as members of the foreign origin population in Finland is, however, limited. Methods Qualitative data on SGMs among foreign origin populations were collected by the Finnish Institute for Health and Welfare as a part of the Manifold More project. The data collection was implemented through a participatory approach. Semi-structured interviews (n = 40) with the members of the target population and focus group interviews (n = 8) with organizations and projects that work to support the target population were collected. The data was gathered and analyzed with an intersectional approach. Through the analysis, the experiences of sexual and gender minorities who also identify as members of the foreign origin population in Finland were explored. Results The preliminary results suggest that professionals of health and well-being services often lack an intersectional understanding and LGBTQI+ specific matters in their work. This often generates discriminative and detrimental situations when the target population is using health and well-being services. Conclusions There is a growing need for examining the health disparities among the diverse group of SGMs and incorporate an intersectional understanding to the services of health and wellbeing professionals. Key messages Health professionals need to pay specific attention to LGBTQI+ specific matters. It is necessary to incorporate intersectionality in health to services of health and wellbeing.

The Role of European Schools and University Departments of Public Health in the 2020 COVID-19 Response, European Region, 2020.

Objective: The main objective was to examine, how European Schools of Public Health (SPHs) responded to the COVID-19 pandemic through 2020, across the main activity domains of the SPHs. Methods: A cross-sectional survey based on an online questionnaire concerning the anti-COVID-19 activities from 1st March to 31st October 2020 of the 117 members of the Association of Schools of Public Health in the European Region (ASPHER). The questionnaire asked about 33 sub-themes within the four main themes of teaching, health communication to the public, research, and consultancy/advice. Results: Fifty-nine SPHs (50%) completed the questionnaire. Seventy-nine per cent of participants were involved in COVID-19 related teaching; health communication to the public, 76%; research, 80%; consultancy/advice, 81%. Eight out of ten participants had been involved in all of the four main themes. Conclusion: The study demonstrated a substantial body of COVID-19 related work by SPHs in Europe, and an outstanding potential to deliver crucial knowledge and skills to support the governance and the public health systems necessary to combat COVID-19.

Egocentric social network characteristics and cardiovascular risk among patients with hypertension or diabetes in western Kenya: a cross-sectional analysis from the BIGPIC trial

ObjectivesManagement of cardiovascular disease (CVD) is an urgent challenge in low-income and middle-income countries, and interventions may require appraisal of patients’ social networks to guide implementation. The purpose of this...

Community pharmacists' perceptions and role in the management of common dermatological problems in Lebanon: a cross-sectional study.

To explore the types and frequency of dermatologic disorders routinely encountered by community pharmacists in Lebanon, identify their educational preparedness and confidence, reasons for referrals to dermatologists and their attitude toward the potential pharmacist role in the treatment of dermatologic disorders. A cross-sectional descriptive study was conducted between June and October 2017. It involved the use of a self-administered questionnaire, distributed to a randomly selected sample of 500 community pharmacists from all Lebanese districts. A total of 456 pharmacists completed the questionnaire. Sixty-four per cent of participants had received a dermatology course at university and 38.7% had undertaken some form of postgraduate education in dermatology. Pharmacists believed that the most commonly encountered disorders were sunburn (22.6%) and acne (15.6%) during spring/summer and skin dryness (18.8%) followed by head lice (13.1%) during autumn/winter. Additionally, more than half of respondents reported that skin-related advice requests were 6-15% of the total advice offered to patients. Sixty-four per cent were confident or extremely confident in advising patients with dermatological complaints. Pharmacists ranked 'unsure of diagnosis' as the most common reason for patient referral to dermatologists. Pharmacists who received postgraduate dermatology training had higher self-reported confidence in tackling skin diseases and their treatments (P < 0.05). Our study revealed that community pharmacists in Lebanon commonly encounter a limited number of dermatologic disorders and the majority believed that they can confidently advise and manage patients. Nonetheless, they admitted a gap in their dermatology education at both undergraduate and postgraduate levels.

Adherence to anti-hypertensive medication in pregnancy.

To assess adherence to anti-hypertensive medication by pregnant women and to identify the factors associated with adherence or lack thereof. Observational study in 100 pregnant women with either chronic hypertension or gestational hypertension who were being treated with at least one anti-hypertensive medication and attending antenatal clinics at one of two maternity hospitals. In-depth interviews were conducted with a subset of 27 women from the same group. Quotes from interview transcripts were used to illustrate the quantitative results. BP control, self-reported adherence, complexity of medication regimen. Participants (mean age 33 [±4.9] years; mean gestation 29 (±7) weeks) had a median blood pressure (BP) of 130/80 mmHg (IQR: 16/15). Sixty-five women had chronic hypertension, of whom 13 were diagnosed during pregnancy, before 20 weeks gestation. Thirty-five women had gestational hypertension. Ninety-two per cent of participants had sub-optimal adherence. There were no significant differences in adherence scores between participants with chronic hypertension and their counterparts. The main contributors to sub-optimal adherence were intentionally putting up with medical problems before taking any action, confusion about the medication, and making changes to the recommended medication regimen to suit lifestyle. Nine out of ten pregnant women using anti-hypertensives self-reported some degree of suboptimal adherence, intentionally and/or unintentionally. Health professionals, including pharmacists, general practitioners and obstetricians, have a role in promoting optimal medication adherence.

Pilot evaluation of a group stabilisation intervention for refugees and asylum seekers with PTSD.

Post-traumatic stress disorder (PTSD) is commonly experienced by asylum seekers and refugees (ASR). Evidence supports the use of cognitive behavioural therapy-based treatments, but not in group format for this population. However, group-based treatments are frequently used as a first-line intervention in the UK. This study investigated the feasibility of delivering a group-based, manualised stabilisation course specifically developed for ASR. The second aim was to evaluate the use of routine outcome measures (ROMs) to capture psychological change in this population. Eighty-two participants from 22 countries attended the 8-session Moving On After Trauma (MOAT) group-based stabilisation treatment. PHQ-9, GAD-7, IES-R and idiosyncratic outcomes were administered pre- and post-intervention. Seventy-one per cent of participants (n = 58) attended five or more of the treatment sessions. While completion rates of the ROMs were poor - measures were completed at pre- and post-intervention for 46% participants (n = 38) - a repeated-measures MANOVA indicated significant improvements in depression (p = .001, ηp2 = .262), anxiety (p = .000, ηp2 = .390), PTSD (p = .001, ηp2 = .393) and idiosyncratic measures (p = .000, ηp2 = .593) following the intervention. Preliminary evidence indicates that ASR who attended a low-intensity, group-based stabilisation group for PTSD experienced lower mental health scores post-group, although the lack of a comparison group means these results should be interpreted with caution. There are significant challenges in administering ROMs to individuals who speak many different languages, in a group setting. Nonetheless, groups have benefits including efficiency of treatment delivery which should also be considered.

The value priorities of consumer innovators

AbstractContributing to the understanding of drivers for innovation, we report the first study of the value base of consumer innovation. Based on a survey with representative samples across ten European countries (N ≈ 10,000), about 5 per cent of participants are engaged in innovation activities in their leisure time, which is in line with earlier, single-country studies. The study confirms that consumer innovation is significantly related to personal value priorities and as expected, consumer innovators give higher priority to openness-to-change values than non-innovators. More surprisingly, consumer innovators are less motivated by hedonistic goals (fun and enjoyment) and more by concern for other people and society (i.e. self-transcendence values) than non-innovators. This adds an important dimension to existing knowledge and understanding of what motivates consumer innovation, helps differentiate consumer innovators from other consumers, and offers important input to the development of policies for facilitating or supporting consumer innovation.

Community-based smoking cessation treatment for adults with high anxiety sensitivity: a randomized clinical trial.

People with anxiety disorders are more likely to smoke and less likely to succeed when they try to quit. Anxiety sensitivity may underlie both phenomena, such that people with high anxiety sensitivity react to interoceptive distress by avoidance. This study aimed to test the efficacy of an exercise program that induced interoceptive distress and thereby created tolerance to this distress in a safe environment. Randomized clinical trial at four YMCA branches in Austin, Texas, USA. Participants [n=150; 130 (86.7%) white; 101 (67.3%) female; meanage =38.6, standard deviation (SD)age =10.4] were adult, daily smokers with high anxiety sensitivity motivated to quit smoking, who reported no regular moderate-intensity exercise. Participants were assigned a YMCA personal trainer who guided them through a 15-week intervention aerobic exercise program. Participants assigned to the personalized intervention trained at 60-85% of their heart rate reserve (HRR), whereas participants assigned to the control intervention trained at 20-40% of their HRR. Participants in both groups received standard behavioral support and nicotine replacement therapy. The primary outcome was biologically verified 7-day point prevalence abstinence (PPA) at 6-month follow-up. Sixty-one per cent of participants were available at the 6-month follow-up. PPA at 6months was higher in the personalized intervention than the control intervention [27.6 versus 14.8%; odds ratio (OR)=2.20, 95% confidence interval (CI)=1.28, 3.80, P=0.005], assuming missing at random. Anxiety sensitivity declined in both groups with no evidence that this differed between groups. An exercise program of high intensity increased abstinence from smoking in people with high anxiety sensitivity, but may not have done so by reducing anxiety sensitivity.

Microdiscectomy compared with transforaminal epidural steroid injection for persistent radicular pain caused by prolapsed intervertebral disc: the NERVES RCT.

Sciatica is a common condition reported to affect > 3% of the UK population at any time and is most often caused by a prolapsed intervertebral disc. Currently, there is no uniformly adopted treatment strategy. Invasive treatments, such as surgery (i.e. microdiscectomy) and transforaminal epidural steroid injection, are often reserved for failed conservative treatment. To compare the clinical effectiveness and cost-effectiveness of microdiscectomy with transforaminal epidural steroid injection for the management of radicular pain secondary to lumbar prolapsed intervertebral disc for non-emergency presentation of sciatica of < 12 months' duration. Patients were randomised to either (1) microdiscectomy or (2) transforaminal epidural steroid injection. A pragmatic, multicentre, randomised prospective trial comparing microdiscectomy with transforaminal epidural steroid injection for sciatica due to prolapsed intervertebral disc with < 1 year symptom duration. NHS services providing secondary spinal surgical care within the UK. A total of 163 participants (aged 16-65 years) were recruited from 11 UK NHS outpatient clinics. The primary outcome was participant-completed Oswestry Disability Questionnaire score at 18 weeks post randomisation. Secondary outcomes were visual analogue scores for leg pain and back pain; modified Roland-Morris score (for sciatica), Core Outcome Measures Index score and participant satisfaction at 12-weekly intervals. Cost-effectiveness and quality of life were assessed using the EuroQol-5 Dimensions, five-level version; Hospital Episode Statistics data; medication usage; and self-reported cost data at 12-weekly intervals. Adverse event data were collected. The economic outcome was incremental cost per quality-adjusted life-year gained from the perspective of the NHS in England. Eighty-three participants were allocated to transforaminal epidural steroid injection and 80 participants were allocated to microdiscectomy, using an online randomisation system. At week 18, Oswestry Disability Questionnaire scores had decreased, relative to baseline, by 26.7 points in the microdiscectomy group and by 24.5 points in the transforaminal epidural steroid injection. The difference between the treatments was not statistically significant (estimated treatment effect -4.25 points, 95% confidence interval -11.09 to 2.59 points). Nor were there significant differences between treatments in any of the secondary outcomes: Oswestry Disability Questionnaire scores, visual analogue scores for leg pain and back pain, modified Roland-Morris score and Core Outcome Measures Index score up to 54 weeks. There were four (3.8%) serious adverse events in the microdiscectomy group, including one nerve palsy (foot drop), and none in the transforaminal epidural steroid injection group. Compared with transforaminal epidural steroid injection, microdiscectomy had an incremental cost-effectiveness ratio of £38,737 per quality-adjusted life-year gained and a probability of 0.17 of being cost-effective at a willingness to pay threshold of £20,000 per quality-adjusted life-year. Primary outcome data was invalid or incomplete for 24% of participants. Sensitivity analyses demonstrated robustness to assumptions made regarding missing data. Eighteen per cent of participants in the transforaminal epidural steroid injection group subsequently received microdiscectomy prior to their primary outcome assessment. To the best of our knowledge, the NErve Root Block VErsus Surgery trial is the first trial to evaluate the comparative clinical effectiveness and cost-effectiveness of microdiscectomy and transforaminal epidural steroid injection. No statistically significant difference was found between the two treatments for the primary outcome. It is unlikely that microdiscectomy is cost-effective compared with transforaminal epidural steroid injection at a threshold of £20,000 per quality-adjusted life-year for sciatica secondary to prolapsed intervertebral disc. These results will lead to further studies in the streamlining and earlier management of discogenic sciatica. Current Controlled Trials ISRCTN04820368 and EudraCT 2014-002751-25. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 24. See the NIHR Journals Library website for further project information.

Relationship between de novo lipogenesis and serum sex hormone binding globulin in humans.

ObjectiveObesity and liver fat are associated with decreased levels of serum sex hormone binding globulin (SHBG). Laboratory studies suggest that hepatic de novo lipogenesis (DNL) is involved in the downregulation of SHBG synthesis. The aim of the present study was to address the role of DNL on serum SHBG in humans.DesignA cross‐sectional study examining the association between DNL, measured by stable isotopes, and serum SHBG, stratified by sex.ParticipantsHealthy men (n = 34) and women (n = 21) were combined from two cross‐sectional studies. Forty‐two per cent of participants had hepatic steatosis, and the majority were overweight (62%) or obese (27%).ResultsDNL was inversely associated with SHBG in women (β: −0.015, 95% CI: −0.030; 0.000), but not in men (β: 0.007, 95% CI: −0.005; 0.019) (p for interaction = .068). Adjustment for study population, age and body mass index did not materially change these results, although statistical significance was lost after adjustment for serum insulin.ConclusionsAn inverse association between DNL and SHBG may explain the decreased SHBG levels that are observed in obesity, at least in women.