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Background NULevel was a randomized control trial to evaluate a technology-assisted weight loss maintenance (WLM) program in the UK. The program included: (a) a face-to-face goal-setting session; (b) an internet platform, a pedometer, and wirelessly connected scales to monitor and report diet, physical activity, and weight, and; (c) regular automated feedback delivered by mobile phone, tailored to participants' progress. Components were designed to target psychological processes linked to weight-related behavior. Though intervention participants showed increased physical activity, there was no difference in WLM between the intervention and control groups after 12 months (Sniehotta FF, Evans EH, Sainsbury K, et al. Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity: A randomized controlled trial in the UK (NULevel Trial). PLoS Med. 2019; 16(5):e1002793. doi:10.1371/journal.pmed.1002793). It is unclear whether the program failed to alter targeted psychological processes, or whether changes in these processes failed to influence WLM. Purpose We evaluate whether the program influenced 16 prespecified psychological processes (e.g. self-efficacy and automaticity toward diet and physical activity), and whether these processes (at 6 months) were associated with successful WLM (at 12 months). Methods 288 adults who had previously lost weight were randomized to the intervention or control groups. The control group received wireless scales and standard advice via newsletters. Assessments occurred in person at 0, 6, and 12 months. Results The intervention significantly altered 10 of the 16 psychological processes, compared with the control group. However, few processes were associated with WLM, leading to no significant indirect effects of the intervention via the processes on WLM. Conclusions Changes in targeted processes were insufficient to support WLM. Future efforts may more closely examine the sequence of effects between processes, behavior, and WLM. [ABSTRACT FROM AUTHOR]

Shared decision making in advanced chronic kidney disease (CKD) requires unbiased information on survival and person-centred outcomes known to matter to patients: quality of life, symptom burden and support from family and healthcare professionals. To date, when deciding between dialysis and conservative care, patients have had to rely on evidence from small observational studies. Clinicians recognize that like is not being compared with like in these studies, and interpret the results differently. Furthermore, support differs considerably between renal units. What patients choose therefore depends on which renal unit they attend. To address this, a programme of work has been underway in the UK. After reports on survival and symptoms from a small number of renal units, a national, mixed-methods study—the Conservative Kidney Management Assessment of Practice Patterns Study—mapped out conservative care practices and attitudes in the UK. This led to the Prepare for Kidney Care study, a randomized controlled trial comparing preparation for dialysis versus preparation for conservative care. Although powered to detect a positivist 0.345 difference in quality-adjusted life years between the two treatments, this trial also takes a realist approach with a range of person-centred secondary outcomes and embedded qualitative research. To understand generalizability, it is nested in an observational cohort study, which is nested in a CKD registry. Challenges to recruitment and retention have been rapidly identified and addressed using an established embedded mixed methods approach—the QuinteT recruitment intervention. This review considers the background to and progress with recruitment to the trial. [ABSTRACT FROM AUTHOR]

An international double-blind randomized placebo controlled study evaluated the safety and efficacy of four doses of a new sustained release naloxone capsule to treat Opioid Induced Constipation (OIC). Methods Forty patients taking opioids for noncancer related pain, and experiencing OIC, were randomized into 4 cohorts of 10 patients. A multiple ascending dose design was used to evaluate the safety and efficacy of 2.5 mg, 5 mg, 10 mg, and 20 mg naloxone sustained release (NSR) capsules vs placebo. Drug was given once-daily for 3 weeks followed by twice daily (bid) dosing between weeks 4 and 6. Results The incidence of treatment emergent adverse events was highest in the placebo group. The incidence of adverse events among the four active treatment groups were similar. There were no serious adverse events. The number of severe events was low overall but highest in the placebo group. Significant improvements were seen in Spontaneous Bowel Movements with 5 mg, 10 mg, and 20 mg NSR capsules. Mean change in SBMs from baseline of 2.21 ( P = 0.052), 2.37 ( P = 0.032); 4.11 ( P = 0.0005); 5.19 (<0.0001) was noted with NSR 2.5 mg, 5 mg, 10 mg, and 20 mg, respectively, when taken once daily, compared with 1.38 ( P = 0.2) for patients on placebo therapy. No changes in subjective or objective measures of opioid withdrawal as measured by the Subjective Opioid Withdrawal Scale or Clinical Opioid Withdrawal Scale were observed. There was no increase in patient reported pain as measured daily using a visual analogue scale. Conclusions This Phase II study has shown that using a new sustained release formulation to deliver oral naloxone to the colon allows successful treatment of OIC without comprising the desired opioid effects. [ABSTRACT FROM AUTHOR]

Existing randomized controlled trials within the health field suggest that the concept of randomization is not always well understood and that feelings of disappointment may occur when participants are not placed in their preferred arm. This may affect a study's rigour and ethical integrity if not addressed. We aimed to test whether these issues apply to a healthy volunteer sample within a health promotion trial of singing for older people. Written comments from control group participants at two points during the trial were analysed, together with individual semi-structured interviews with a small sample (n = 11) of this group. We found that motivation to participate in the trial was largely due to the appeal of singing and disappointment resulted from allocation to the control group. Understanding of randomization was generally good and feelings of disappointment lessened over time and with a post-research opportunity to sing. Findings suggest that measures should be put in place to minimize the potential negative impacts of randomized controlled trials in health promotion research. [ABSTRACT FROM AUTHOR]

Objectives. Cardiovascular disease (CVD) is responsible for 50% of the excess mortality for patients with RA. This study aimed to evaluate a novel 8-week cognitive behavioural patient education intervention designed to effect behavioural change with regard to modifiable CVD risk factors in people with RA.Methods. This was a non-blinded randomized controlled trial with a delayed intervention arm. Participants were randomly assigned to receive the cognitive behavioural education intervention or a control information leaflet at a ratio of 1:1. The primary outcome measure was patient’s knowledge of CVD in RA; secondary measures were psychological measures relating to effecting behaviour change, actual behaviour changes and clinical risk factors. Data were collected at baseline, 2 and 6 months.Results. A total of 110 participants consented (52 in the intervention group and 58 in the control group) to participate in the study. At 6 months, those in the intervention group had significantly higher knowledge scores (P < 0.001); improved behavioural intentions to increase exercise (P < 0.001), eat a low-fat diet (P = 0.01) and lose weight (P = 0.06); and lower mean diastolic blood pressure by 3.7 mmHg, whereas the control group’s mean diastolic blood pressure increased by 0.8 mmHg. There was no difference between the groups on actual behaviours.Conclusions. Patient education has a significant role to play in CVD risk factor modification for patients with RA, and the detailed development of this programme probably contributed to its successful results. It is disappointing that behaviours, as we measured them, did not change. The challenge, as always, is how to translate behavioural intentions into action. Larger studies, powered specifically to look at behavioural changes, are required.Trial registration. National Institute for Health Research, UKCRN 4566. [ABSTRACT FROM PUBLISHER]

Objective. MTX is widely used to treat synovitis in PsA without supporting trial evidence. The aim of our study was to test the value of MTX in the first large randomized placebo-controlled trial (RCT) in PsA.Methods. A 6-month double-blind RCT compared MTX (15 mg/week) with placebo in active PsA. The primary outcome was PsA response criteria (PsARC). Other outcomes included ACR20, DAS-28 and their individual components. Missing data were imputed using multiple imputation methods. Treatments were compared using logistic regression analysis (adjusted for age, sex, disease duration and, where appropriate, individual baseline scores).Results. Four hundred and sixty-two patients were screened and 221 recruited. One hundred and nine patients received MTX and 112 received placebo. Forty-four patients were lost to follow-up (21 MTX, 23 placebo). Twenty-six patients discontinued treatment (14 MTX, 12 placebo). Comparing MTX with placebo in all randomized patients at 6 months showed no significant effect on PsARC [odds ratio (OR) 1.77, 95% CI 0.97, 3.23], ACR20 (OR 2.00, 95% CI 0.65, 6.22) or DAS-28 (OR 1.70, 95% CI 0.90, 3.17). There were also no significant treatment effects on tender and swollen joint counts, ESR, CRP, HAQ and pain. The only benefits of MTX were reductions in patient and assessor global scores and skin scores at 6 months (P = 0.03, P < 0.001 and P = 0.02, respectively). There were no unexpected adverse events.Conclusions. This trial of active PsA found no evidence for MTX improving synovitis and consequently raises questions about its classification as a disease-modifying drug in PsA.Trial registration. Current Controlled Trials, www.controlled-trials.com, ISRCTN:54376151. [ABSTRACT FROM AUTHOR]

Background In a recent open pilot trial, R-salbutamol sulphate, a well-known molecule with anti-inflammatory effects, was tested successfully on patients with therapy-resistant discoid lupus erythematosus (DLE). Objectives To compare the efficacy and safety of R-salbutamol cream 0·5% vs. placebo on DLE lesions in a multicentre, double-blinded, randomized, placebo-controlled phase II trial. Methods Thirty-seven patients with at least one newly developed DLE lesion were randomized – 19 to the R-salbutamol cream 0·5% and 18 to placebo – and treated twice daily for 8 weeks. Efficacy was evaluated through scores of erythema, scaling/hypertrophy and induration as well as pain and itching; general improvement scored by the investigator and global improvement scored by patients’ assessment were also evaluated. Results The mean area under the curve of improvement for scaling/hypertrophy, pain, itching and global patient assessment was significantly better for the actively treated patients as compared with placebo (scaling/hypertrophy, P = 0·0262; pain, P = 0·0238; itching, P = 0·0135; global patient assessment, P = 0·045). Moreover, the percentage of patients without induration was significantly higher in the active group compared with the placebo group ( P = 0·013), and a statistically significantly greater decrease in the size of the lesional area was also seen in the overall analysis of the R-salbutamol-treated patients ( P = 0·0197). No serious adverse events were reported. Conclusions Application of R-salbutamol cream 0·5% was safe and well tolerated. Statistically significant effects were seen on scaling/hypertrophy, induration, pain and itching as well as patient global assessment, suggesting that R-salbutamol could be a promising new topical therapy alternative for DLE. [ABSTRACT FROM AUTHOR]

Background. Recruitment to health research is known to be problematic. However, evidence concerning ways of improving recruitment is sparse. [ABSTRACT FROM PUBLISHER]

Background Ultraviolet (UV) A sunbeds are widely used by patients with psoriasis in an attempt to treat their skin disease. However, there is little evidence that UVA therapy improves psoriasis, and the long-term risks of sunbed exposure are not known. Objectives To perform a randomized, placebo-controlled study of UVA sunbed therapy for psoriasis. Methods A sunbed and canopy unit was modified to allow UVA exposure on one side of the body (front and back), and ‘placebo’ visible light exposure on the other side of the body. We treated 38 patients with psoriasis, giving 12 exposures over a period of 4 weeks. Assessment was made using a modified Psoriasis Area and Severity Index (PASI) score, individual plaque assessment and patient questionnaire. Results In 17 patients (47%) the PASI score showed a greater reduction on the UVA side compared with placebo, in 11 patients (31%) no difference was recorded between the two sides, and in eight (22%) the improvement was greater on the placebo-treated side. Overall, the median pretreatment half-body modified PASI score was 4·4 units, reducing to 3·9 units on the UVA-treated side and 4·2 units on the placebo-treated side (P = 0·044 for difference in response). Breakdown of the plaque score into the individual components of erythema, scale and thickness revealed significant improvement only with the score for erythema. Although the degree of improvement was small, 64% of patients felt that the response was sufficiently good that they would use a sunbed again to treat their psoriasis. Conclusions Our results show that a short course of sunbed treatment does improve psoriasis in some patients, but that the degree of improvement is small. [ABSTRACT FROM AUTHOR]

Background Previous research has identified the need for a randomised controlled trial (RCT) evaluating the most appropriate corticosteroid induction regimen to be used for children and young people (CYP) with juvenile idiopathic arthritis (JIA). A recent qualitative study found that parents and CYP understood trial concepts and were able to identify potential flaws in a proposed RCT. This confirms the need to involve parents and CYP in co-designing RCTs to best meet the needs of future trial participants. We aimed to co-design components of an RCT of corticosteroid regimens with CYP and parents living with JIA. Methods A focus group was conducted with CYP with JIA and parents as part of a wider consensus and discussion group meeting within the Steroid Induction Regimen for Juvenile Idiopathic Arthritis (SIRJIA) study in December 2018. The discussion focused on two components of the RCT design: i) Discussing the most appropriate treatment protocols; and ii) Addressing practicalities associated with an RCT. Results Two RCT protocol options, chosen through an online survey by a clear majority out of a possible eight protocols, were discussed and critiqued: i) Protocol A (intravenous vs intraarticular corticosteroid delivery); and ii) Protocol B (intravenous vs intraarticular vs intramuscular vs oral corticosteroid delivery). Several issues pertaining to both protocols were raised, related to the influence of age and past experience, routes of administration and concerns over randomisation. Participants emphasised the importance of clinicians/researchers discussing all of the potential risks with them. Participants also wanted enough information to make an informed choice. Participants emphasised the usefulness of combining trial visits with regular follow-up appointments to minimise the burden of taking part in an RCT and had a preference for their usual hospital being the site they visited. Some participants remarked that videos could be a useful way of conveying information beyond traditional participant information sheets. Some also felt that awareness of research opportunities is not equally accessible to them either, depending on where they lived in the country. Participants would want to be kept regularly updated about the progress of the RCT and felt that incentives were a good way of keeping people engaged, although some were apprehensive about hearing negative treatment results. With regards to dissemination, participants felt that study results should be readily available to them in an accessible format, should they wish to view them. Conclusion CYP and parents have a considerable amount of knowledge and experience which can shape the design of RCTs. With adequate support, complex concepts such as treatment protocols can be discussed and critiqued. Involving CYP and parents at the design stage of an RCT has been shown to eliminate some potential challenges in the future. Conflicts of Interest The authors declare no conflicts of interest. [ABSTRACT FROM AUTHOR]

Tetanus is a serious infectious disease that is associated with high morbidity and mortality. It is uncommon in developed countries like the United Kingdom due to widespread immunization. However, cases are still being reported in children who are not immunized. We report a case of an 8-year-old Asian boy who had missed his childhood vaccinations but had been living in the United Kingdom for 3 years. He presented with trismus and muscle spasms needing ventilation in Paediatric Intensive Care for 3 weeks. The case highlights the importance of vaccinating newly arrived children [ABSTRACT FROM PUBLISHER]