Search

Objective: This paper presents the findings of a study evaluating the effectiveness, accessibility, sustainability and patient satisfaction of the Assessment PLUS model. This model aimed to reduce patients' symptomology, improve their functioning and alleviate the demand on Psychological Therapies Team (PTT) staff, particularly in response to the challenges posed by the COVID‐19 pandemic. Methods: The intervention was offered to 55 patients with mild‐to‐moderate mental health conditions across three localities in Lanarkshire, UK, of whom only 25 completed the sessions. Clinical outcome measure scores, patients' feedback, wait times, discharge, returning patients and re‐referral rates were analysed using a mixed methods approach. Results: The results of the statistical analysis highlight a statistically significant improvement (p < 0.001) in patients' presentations and results of the thematic analysis reveal that almost all patients found the intervention helpful and returned overall positive feedback. On completing the intervention, less than a third of patients returned to the waiting list, while more than half were discharged completely. At the 6‐month follow‐up, those returning to the PTT waitlists (n = 12) had between 6 and 8 sessions on average, while over the 80% of those discharged from A+ did not require further psychological input. The average wait time across the full sample was 6 weeks. Conclusions: In summary, the results of the mixed methods analysis demonstrate a significant improvement in patients' presentations after completing the A+ intervention. The majority of patients found the intervention helpful and provided positive feedback. Moreover, a significant proportion of patients were discharged completely, and those who returned to the PTT waitlists required fewer sessions on average. The average wait time for the full sample was just over 6 weeks. [ABSTRACT FROM AUTHOR]

Summary: Over a decade ago, bibliometric analysis predicted the disappearance of UK publishing in anaesthesia by 2020. We repeated this analysis to assess if this had turned out to be the case, searching PubMed for papers associated with UK consultant anaesthetists for 2017–2019 across 15 journals. Although the rate of decline has flattened using the same search filter, including a wider range of publication types shows that outputs still remain at half 1990s levels (381 papers for all 3 years combined), authored by 769 anaesthetists, 274 of whom are associated with an academic centre. There are now 11 identifiable academic units, and a further 15 places where anaesthetists have affiliations with academic centres as individuals. The majority of papers (71%) are in secondary analysis (observational, database and association studies, surveys and meta‐analyses), rather than in primary research (clinical trials or laboratory studies). These data reflect the current academic capacity in terms of publications, academic units and staffing. We discuss how this information can be used to inform a new strategy for UK academic anaesthesia. [ABSTRACT FROM AUTHOR]

Background: Advancing physical therapy interventions for children and young people is a high research priority. This includes research to describe and specify the control condition, typically 'current care', for effectiveness trials. This paper aims to identify physical therapy outcomes commonly targeted, and intervention techniques and approaches commonly used, by physiotherapists working with children (aged 2–19 years) with mobility limitations in the United Kingdom. Methods: A cross‐sectional survey. Participants were recruited through the interactive Chartered Society of Physiotherapy members‐only online discussion forum, the Association of Paediatric Chartered Physiotherapists, direct emails and snowball sampling within the authors' professional networks and Twitter. Data were collected using a structured online questionnaire and analysed using descriptive statistics. Results: We received 146 responses, 95/146 (65.1%) of which were fully complete. Therapists reported targeting 367 unique outcome constructs, of which 193 (52.6%) mapped onto activities and participation (e.g. moving around using equipment, maintaining body position and walking), 158 (43.1%) on body functions (e.g. muscle strength, joint mobility and gait functions), 11 (3.0%) on body structure (e.g. muscle length) and 3 (0.8%) on environmental factors (e.g. access home environment, access school environment and family confidence). The most commonly used interventions related to postural management (115/133 of respondents, 86.4%) and exercise therapy (116/137, 84.67%) and included techniques such as 'use equipment' (118/137, 86.1%), 'instruct how to do something' (117/137, 85.4%), 'practice' (105/137, 76.6%) and 'stretch' (99/137, 72.3%). Conclusions: In designing trials, current care can be described as a combination of biomechanical and physiological techniques and approaches targeted at body functions and through that to activity and participation. Although some environmental behaviour change techniques and strategies were reported, the explicit use of these in current care appears limited. [ABSTRACT FROM AUTHOR]

International efforts to minimize coercive practices include the US Six Core Strategies© (6CS). This innovative approach has limited evidence of its effectiveness, with few robustly designed studies, and has not been formally implemented or evaluated in the UK. An adapted version of the 6CS, which we called 'REsTRAIN Yourself' (RY), was devised to suit the UK context and evaluated using mixed methods. RY aimed to reduce the use of physical restraint in mental health inpatient ward settings through training and practice development with whole teams, directly in the ward settings where change was to be implemented and barriers to change overcome. In this paper, we present qualitative findings that report on staff perspectives of the impact and value of RY following its implementation. Thirty‐six staff participated in semi‐structured interviews with data subject to thematic analysis. Eight themes are reported that highlight perceived improvements in every domain of the 6CS after RY had been introduced. Staff reported more positively on their relationships with service users and felt their attitudes towards the use of coercive practices such as restraint were changed; the service as a whole shifted in terms of restraint awareness and reduction; and new policies, procedures, and language were introduced despite certain barriers. These findings need to be appreciated in a context wherein substantial reductions in the use of physical restraint were proven possible, largely due to building upon empathic and relational alternatives. However, yet more could be achieved with greater resourcing of inpatient care. [ABSTRACT FROM AUTHOR]

Aim: Neurodevelopment is a key outcome for many childhood trials and observational studies. Clinically important decisions may rest on finding relatively small differences in neurodevelopment between groups receiving complex and costly interventions. Our purpose was to determine whether studies which measure neurodevelopment report the numbers, training, and auditing of assessors and, for multiple assessor studies, whether the results were adjusted and if so by which method?Method: Electronic searches were conducted using Medline, Embase, Cinahl, PsycINFO, and the Cochrane Library. A study was eligible if it reported neurodevelopmental outcome in children resident in the UK, less than or equal to 18 years and was published between 2000 and 2015. Trials and observational studies were included.Results: Three hundred and seven full papers were reviewed: 52% of papers did not report the number of assessors used; 21% used a single assessor; and 27% used multiple assessors. Thirty-five per cent mentioned that assessors were trained in the use of the neurodevelopmental tool; 13% of assessors were audited; and only 1% of studies adjusted statistically for the number of assessors.Interpretation: At the very least, the quality of reporting the use of assessors in these research publications is poor, while at worst, the variability of assessors may mask the true relationship between an intervention/observation and neurodevelopmental outcome. [ABSTRACT FROM AUTHOR]

Abstract: Aim: The Association of Coloproctology of Great Britain and Ireland (ACPGBI) Delphi process identified prevention and treatment of parastomal hernia (PSH) as the second highest priority non‐cancer related colorectal pathology. This position statement aims to summarize the current evidence base. Methods: Four broad themes were identified (prevention, diagnosis/classification, management and operative repair). Guidelines are based on evidence from an extensive literature review using organized searches on the PubMed, MEDLINE, Embase and Cochrane databases. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was adhered to for classifying the quality of evidence and reporting the strength of recommendations. Results: The suture repair of PSH other than for patients in extremis is not recommended. Synthetic non‐absorbable mesh can be used safely in the short term in the construction of colostomies post rectal surgery, but longer‐term follow‐up is needed. Other broad recommendations are made around access to stoma care nurses, prevention classification and management. Conclusion: There is a lack of high quality evidence for many domains in the prevention and treatment of PSH but the results of several studies are awaited. What does this paper add to the literature?: Parastomal hernias are a common and debilitating condition following stoma formation. This position statement from ACPGBI details the current evidence base and ongoing research for the prevention, diagnosis and management of parastomal hernias. [ABSTRACT FROM AUTHOR]

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk-proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand. [ABSTRACT FROM AUTHOR]

The first paper in this section is a review by several highly respected authors of diagnostic criteria for evaluating patients with symptomatic stress urinary incontinence, and is followed by a review of the role of urgency and its measurement in the overactive bladder symptom syndrome, with emphasis on current concepts and future prospects. These are two important papers, which point the reader in the direction of a greater understanding of these conditions.The concept ofα-blockade before a trial without catheter after acute urinary retention is revisited by authors from the UK, who used tamsulosin in a randomized controlled trial. They found that it is appropriate to recommend tamsulosin for such use in this condition. [ABSTRACT FROM AUTHOR]

The United Kingdom Prospective Diabetes Study, and Diabetes Control and Complications Trial have shown that aggressive glucose control, especially early in the natural history of the disease, might result in a significant reduction of microvascular as well as macrovascular complications. However, more recent trials have increased the level of complexity of the relationship between 'tight glucose control/chronic complications', with several factors influencing the risk-to-benefit ratio to be considered, such as age, presence of established complications and diabetes duration. According to this strategy, a more intensive goal is desirable for young patients with no cardiovascular disease, whereas less stringent control is suitable for all people who are relatively late in the natural history of diabetic complications. Numerous calls for an individualized therapy have been proposed during the past years, but still debated is the level of glucose lowering necessary to reduce complications balanced by the risk and costs of the means used. The present paper briefly reviews the rationale and the clinical trials that support specific glycemic goals towards a 'tailored' approach for the management of hyperglycemia in diabetes. [ABSTRACT FROM AUTHOR]

In the past, the Declaration of Helsinki insisted on a fundamental distinction between medical research (of no therapeutic benefit) and clinical research (carried out to gain insight into a patient's condition and inform treatment). However, recent versions of the Helsinki Declaration no longer rehearse this distinction, instead recognising how experimental and clinical practices often and increasingly overlap. This paper argues that this same distinction might also be re-thought within health geography and that much can be gained through exploring how spaces of health can be simultaneously research laboratory and therapeutic place. This is done in two key ways. Firstly, through an analysis of the Common Cold Unit, a medical research facility based near Salisbury in the UK that recruited volunteers by emphasising its qualities as a rather unusual holiday destination. Secondly, by a review of current work in human geography, medical sociology and anthropology that highlights the blending of research and clinical space. I conclude by considering some of the implications and challenges posed by the mixing of experimental and therapeutic space, with an emphasis on ethics, inequality and care. [ABSTRACT FROM AUTHOR]

Exploratory approaches for first-in-human clinical studies have evolved over the last few years and have stimulated the issuance of national regulatory guidances in some European countries as well as the United States. With the increasing implementation of these approaches and the recent preparation of a multiregional regulatory guidance (ICH M3 rev2), an exchange of experiences on the opportunities and challenges of exploratory clinical trials was desirable; thus, a workshop focusing on the use of this clinical approach was planned and conducted in Lisbon, Portugal, March 18–19, 2009 sponsored by the Portuguese Health Authority (INFARMED) and DIA. The structure of the workshop focused in three main areas. Regulatory representatives from Portugal, Belgium, Germany, the United Kingdom and the United States formally reviewed their experiences. This was followed by a discussion on issues from an ethics review perspective as well as an insight to the opportunities in the area of biologics. The industry perspective was presented by representatives from Merck, Pfizer, J&J, Novartis, Speedel, AstraZeneca, GSK, and Roche. Finally, through break out sessions, issues were identified to be addressed moving forward. It is the purpose of this paper to report on the outcome of this workshop. Clin Trans Sci 2010; Volume #: 1–4 [ABSTRACT FROM AUTHOR]

We undertook this survey to identify the trend in the published output of original research in anaesthesia emanating from the United Kingdom (UK) in a 10-year period from 1997 to 2006, inclusive. We examined seven major anaesthetic journals for each of the 10 years, and four other specialist journals for the years 1997, 2000, 2003 and 2006. We included papers on experimental research, randomised controlled clinical trials, large observational studies and case series, formal equipment and apparatus assessments, but we excluded editorials, comments, reviews including systematic reviews, special articles, small case series and case reports, questionnaire surveys of clinical practice and correspondence. We found a highly significant reduction in published research output from the UK in the period under study (% change per year; −5.7 (95% CI −7.4 to −4.0), a trend which was significantly different (p < 0.001) from the trend of changes in research publications worldwide (−1.0% change per year; 95% CI −1.7 to 0.0). We discuss the implications of these findings for UK anaesthesia research strategy. [ABSTRACT FROM AUTHOR]

Aims and Objectives. The aim of this paper was to illustrate the socially inclusive nature of the Bug Busting ‘whole-school approach’ to head louse eradication. Background. In the UK, Belgium and Denmark, persistent head lice in families of all socio-economic status (SES) is a problem. Since 1995 in the UK and 1998 elsewhere, an educational programme intended to teach families how to detect and treat head lice by using the Bug Busting wet combing method has been organized in some areas. Local schools lead this community strategy for prevention, known as a ‘whole-school approach’ (UK). Design and methods. We describe five studies applying the Bug Busting approach, four set in districts where some disadvantaged families live (UK and Belgium) and a fifth set in Denmark. Feasibility and consumer satisfaction are examined. One UK study analyses data on area prescribing for head lice and the impact in a deprived locality of raising the profile of Bug Busting. Results. We find parental education in Bug Busting enables families of all SES to participate in a ‘whole-school approach’ to head lice. Best results are obtained when each family has a Bug Buster Kit. This provides all the combs necessary with full instructions on their use with ordinary shampoo and conditioner to detect lice, eradicate an infestation mechanically, or to check the success of any treatment. In the UK, the promotion of the Bug Busting approach is reducing primary care expenditure on treatment for head lice and professional time spent with worried parents. As a result, healthcare providers can give time to the few families who require one-to-one guidance. Relevance to Clinical Practice. Incorporation of the Bug Busting approach to head lice into clinical practice in school communities contributes to sustainable control whilst overcoming health inequalities in participating families. [ABSTRACT FROM AUTHOR]

Evidence-based health care is now a reality within the national health service (NHS) and the randomised controlled trial (RCT) is the linchpin of this movement. In modem health care, there has also been a shift towards understanding client perspectives. With regard to clients' participation in research, much consideration has been given to ethical issues and barriers to participation. However, less attention has been paid to the participants' views of clinical trials and understanding how they construe the research. This paper reports a study of the attitudes of parents whose children took part in an RCT. Data were collected from the parents of 20 children, using qualitative in-depth interviews. Parents talked about the meaning of their participation, their motivation for taking part and their understanding of the nature of the trial. The implications of the findings for future research will be considered. [ABSTRACT FROM AUTHOR]

RATIONALE: The area of phase I trials is fraught with ethical dilemmas and controversy. Most existing research focuses on issues of human rights and the informed consent procedure. Little attention has been given to patients' perceptions of participating in such trials. DESIGN: This paper describes a study using qualitative interviews and open-stem questionnaires to begin to explore patients' own perceptions of any benefits from participating in phase I trials. RESULTS: Findings suggest that for some patients, phase I trials fulfil a need to try everything in their fight against cancer. The study also suggests that being on treatment allows some patients to construct their lives meaningfully by providing a supportive structure and enabling hope. Implications for nursing practice and further research are discussed. [ABSTRACT FROM AUTHOR]

Individuals at increased cardio-metabolic (CM) risk have a greater chance of developing diabetes mellitus and suffering premature cardiovascular events. The metabolic syndrome (MetS) is a constellation of risk factors which confer increased CM risk. MetS was originally proposed by Reaven (1998) and the currently accepted definition was agreed by AHA/NHLBI,WH,IASIASO (Alberti et al., 2009). More recently, increased liver fat has been proposed as a marker of CM risk. The aims of this study were to evaluate the inter-relationships between percentage liver fat and established CM risk factors and identify those with MetS. This paper presents a secondary analysis of baseline data from a sample ( n = 37) (56 ± 5.32 years), of overweight men who were at increased CM risk but otherwise healthy,, and recruited into a randomised dietary intervention crossover study to investigate how dietary carbohydrate influences the metabolism of plasma lipoproteins in overweight volunteers with moderately high (>10% <20%) and low (<2%) levels of liver fat. Anthropometric and biochemistry measurements were obtained, and from a sub-sample, the percentage of liver fat by magnetic resonance imaging. The participants were also assigned a metabolic score based on the number of indicators of the MetS according to the AHA/NHLBI, WH, IASIASO definition (Alberti, 2009). Non-parametric statistical analyses was used, as not all variables were normally distributed, there were a number of outliers and a small sample size. Pearson Correlation Co-efficients were used to investigate relationships between continuous and categorical variables. The variables were not adjusted for age or BMI because of a small sample size. Statistical significance was set at P ≤ 0.05 and all analyses were carried out using SPSS 16.0. Fifty nine per cent of the participants had MetS ( n = 21). There was evidence of significant, positive associations between the metabolic score for MetS and total cholesterol:HDL-C ratio ( P = 0.030), and between percentage liver fat and plasma glucose and insulin ( P = 0.010 and P = 0.003 respectively). The percentage of liver fat was also notably higher than that reported in other studies (Yamada et al., 2010; Kotronen et al., 2007) and there was positive correlation between the liver enzyme alanine transaminase (ALT) and plasma insulin ( P = 0.012). The strong associations between established risk factors and liver fat suggest that the latter may be clinically useful as a marker for CM risk in MetS. Alberti, K., Eckel, R., Grundy, S. et al. (2009) Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation, 1640-1645. Kotronen, A., Westerbacka, A., Bergholm, R., Pietilainen, K.H. & Yki-Jarvinen, H. (2007) Liver fat in the metabolic syndrome. J. Clin. Endocrinol. Metab. , 3490-3497. Reaven, G. (1998) Insulin resistance and human disease: a short history. J. Basic Clin. Physiol. Pharmacol., 387-406. Yamada, T., Fukatsu, M., Suzuki, S. et al. (2010) Fatty liver predicts impaired fasting glucose and type 2 diabetes mellitus in Japanese undergoing a health checkup. J. Gastroenterol. Hepatol., 352-356. [ABSTRACT FROM AUTHOR]