Background Recruitment and retention of participants in randomised controlled trials (RCTs) is a key determinant of success but is challenging. Trialists and UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) are increasingly exploring the use of digital tools to identify, recruit and retain participants. The aim of this UK National Institute for Health Research (NIHR) study was to identify what digital tools are currently used by CTUs and understand the performance characteristics required to be judged useful. Methods A scoping of searches (and a survey with NIHR funding staff), a survey with all 52 UKCRC CTUs and 16 qualitative interviews were conducted with five stakeholder groups including trialists within CTUs, funders and research participants. A purposive sampling approach was used to conduct the qualitative interviews during March–June 2018. Qualitative data were analysed using a content analysis and inductive approach. Results Responses from 24 (46%) CTUs identified that database-screening tools were the most widely used digital tool for recruitment, with the majority being considered effective. The reason (and to whom) these tools were considered effective was in identifying potential participants (for both Site staff and CTU staff) and reaching recruitment target (for CTU staff/CI). Fewer retention tools were used, with short message service (SMS) or email reminders to participants being the most reported. The qualitative interviews revealed five themes across all groups: ‘ security and transparency ’; ‘ inclusivity and engagement ’; ‘ human interaction ’; ‘ obstacles and risks ’; and ‘ potential benefits ’. There was a high level of stakeholder acceptance of the use of digital tools to support trials, despite the lack of evidence to support them over more traditional techniques. Certain differences and similarities between stakeholder groups demonstrated the complexity and challenges of using digital tools for recruiting and retaining research participants. Conclusions Our studies identified a range of digital tools in use in recruitment and retention of RCTs, despite the lack of high-quality evidence to support their use. Understanding the type of digital tools in use to support recruitment and retention will help to inform funders and the wider research community about their value and relevance for future RCTs. Consideration of further focused digital tool reviews and primary research will help to reduce gaps in the evidence base.

There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity. Automated web-based interventions might provide a solution, but evidence suggests that they may be ineffective without additional human support. The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care, comparing different levels of nurse support, to determine the optimal combination of web-based and personal support to be tested in a full trial.

Objective To determine the effect of clinical scores that predict streptococcal infection or rapid streptococcal antigen detection tests compared with delayed antibiotic prescribing. Design Open adaptive pragmatic parallel group randomised controlled trial. Setting Primary care in United Kingdom. Patients Patients aged ≥3 with acute sore throat. Intervention An internet programme randomised patients to targeted antibiotic use according to: delayed antibiotics (the comparator group for analyses), clinical score, or antigen test used according to clinical score. During the trial a preliminary streptococcal score (score 1, n=1129) was replaced by a more consistent score (score 2, n=631; features: fever during previous 24 hours; purulence; attends rapidly (within three days after onset of symptoms); inflamed tonsils; no cough/coryza (acronym FeverPAIN). Outcomes Symptom severity reported by patients on a 7 point Likert scale (mean severity of sore throat/difficulty swallowing for days two to four after the consultation (primary outcome)), duration of symptoms, use of antibiotics. Results For score 1 there were no significant differences between groups. For score 2, symptom severity was documented in 80% (168/207 (81%) in delayed antibiotics group; 168/211 (80%) in clinical score group; 166/213 (78%) in antigen test group). Reported severity of symptoms was lower in the clinical score group (−0.33, 95% confidence interval −0.64 to −0.02; P=0.04), equivalent to one in three rating sore throat a slight versus moderate problem, with a similar reduction for the antigen test group (−0.30, −0.61 to −0.00; P=0.05). Symptoms rated moderately bad or worse resolved significantly faster in the clinical score group (hazard ratio 1.30, 95% confidence interval 1.03 to 1.63) but not the antigen test group (1.11, 0.88 to 1.40). In the delayed antibiotics group, 75/164 (46%) used antibiotics. Use of antibiotics in the clinical score group (60/161) was 29% lower (adjusted risk ratio 0.71, 95% confidence interval 0.50 to 0.95; P=0.02) and in the antigen test group (58/164) was 27% lower (0.73, 0.52 to 0.98; P=0.03). There were no significant differences in complications or reconsultations. Conclusion Targeted use of antibiotics for acute sore throat with a clinical score improves reported symptoms and reduces antibiotic use. Antigen tests used according to a clinical score provide similar benefits but with no clear advantages over a clinical score alone. Trial registration ISRCTN32027234

Objective. To provide a responsiveness analysis of the self-report and therapist-rated upper extremity functional outcome measures used in a rehabilitation trial.Methods. A variety of commonly used therapist-assessed and self-report structural impairment and functional outcome measures were compared for the ability to detect and measure change in wrist and hand status in an early rheumatoid arthritis population over 12 months. Responsiveness was measured using the standardized response mean (SRM) and effect size (ES).Results. The most responsive measures were the Michigan Hand Outcomes Questionnaire (SRM 0.49 [95% confidence interval (95% CI) 0.27, 0.72], ES = 0.37 [95% CI 0.21, 0.54]), dominant metacarpophalangeal joint ulnar deviation (SRM 0.46 [95% CI 0.27, 0.65], ES = 0.58 [95% CI 0.34, 0.82]), and mean power handgrip test (SRM 0.45 [95% CI 0.26, 0.64], ES = 0.32 [95% CI 0.18, 0.45]) The least responsive measure was the Health Assessment Questionnaire (SRM -0.12 [95% CI -0.31, 0.08], ES = -0.08 [95% CI -0.21, 0.05]).Conclusion. Over 12 months, there was substantial variation in wrist and hand outcome measures to detect change over time in an early RA population. Careful consideration is required to choose the most appropriate measure that can detect change.

The aims of the study were to determine the nature and prevalence of mental disorders, the mental health treatment needs, the extent to which these needs are identified by prison health services and the care provided to women in prison who had children under the age of 18 months. We compared our findings with those of our study of women in prison mother and baby units. A survey of 112 mothers in seven prisons was conducted; a standardised semi-structured interview was administered, participants inmate medical records examined and information obtained from participants general practice records. One-third of the participants were from ethnic minorities and a majority were serving sentences for dishonesty-related offences. Ninety percent of the women had one or more of the five specific forms of mental disorder and 42% were depressed. The majority of inmate medical records contained very little information about participants' mental health and treatment needs.

Background: Birth in periods with universal newborn screening (UNS) for PCHI and early confirmation of PCHI have been associated with superior subsequent language ability in children with permanent childhood hearing impairment (PCHI). However their effects on reading and communication skills have not been addressed in a population-based study. Methods: In a follow-up study of a large birth cohort in southern England, we measured reading by direct assessment and communication skills by parent report in 120 children with bilateral moderate, severe or profound PCHI aged 5.4 to 11.7 years, of whom 61 had been born in periods with UNS, and in a comparison group of 63 children with normal hearing. Results: Compared to birth during periods without UNS, birth during periods with UNS was associated with better reading scores (inter-group difference 0.39 SDs, 95% CI 0.02 to 0.76, p= 0.042) and communication skills scores (difference 0.51 SDs, 95% CI: 0.06 to 0.95, p= 0.026). Compared with later confirmation, confirmation of PCHI by age nine months was also associated with better reading (difference 0.51 SDs, 95% CI: 0.15 to 0.87, p= 0.006) and communication skills,(difference 0.56 SDs, 95% CI 0.12 to 1.00, p= 0.013). In the children with PCHI, reading, communication and language ability were highly correlated (r= 0.62 to 0.84, p< 0.001).Conclusion: Birth during periods with UNS and early confirmation of PCHI predict better reading and communication abilities at primary school age. These benefits represent functional gains of sufficient magnitude to be important in children with PCHI. on 24 December 2008 adc. bmj. com …

OBJECTIVE. The goal was to examine the relationships between management after confirmation, family participation, and speech and language outcomes in the same group of children with permanent childhood hearing impairment. METHODS. Speech, oral language, and nonverbal abilities, expressed as z scores and adjusted in a regression model, and Family Participation Rating Scale scores were assessed at a mean age of 7.9 years for 120 children with bilateral permanent childhood hearing impairment from a 1992–1997 United Kingdom birth cohort. Ages at institution of management and hearing aid fitting were obtained retrospectively from case notes. RESULTS. Compared with children managed later (>9 months), those managed early (≤9 months) had higher adjusted mean z scores for both receptive and expressive language, relative to nonverbal ability, but not for speech. Compared with children aided later, a smaller group of more-impaired children aided early did not have significantly higher scores for these outcomes. Family Participation Rating Scale scores showed significant positive correlations with language and speech intelligibility scores only for those with confirmation after 9 months and were highest for those with late confirmed, severe/profound, permanent childhood hearing impairment. CONCLUSIONS. Early management of permanent childhood hearing impairment results in improved language. Family participation is also an important factor in cases that are confirmed late, especially for children with severe or profound permanent childhood hearing impairment.

Background: Sustained and subtle hyperventilation can result in a wide variety of symptoms, leading to a chronic condition that has been termed hyperventilation syndrome (HVS). Treatment options include physiotherapy, in the form of breathing retraining (BR), but additional approaches aim to reduce the anxiety that is recognized as being a frequent component of this condition. Objectives: The aim of this study was to evaluate whether acupuncture is an appropriate treatment for HVS to reduce anxiety, and whether a crossover trial is an appropriate study design to evaluate acupuncture in this condition. Design: A single-blind crossover trial was carried out comparing the effects of 4 weeks (30 minutes twice weekly) acupuncture and BR on patients with HVS. Subjects: Ten (10) patients diagnosed with HVS were recruited to the trial and randomized into two groups. Both groups received acupuncture and BR with a washout period of 1 week. Outcome measures: The primary outcome measure used was the Hospital Anxiety and Depression (HAD) Scale. Other outcome measures used were the Nijmegen questionnaire and Medical Research Council Dyspnea scale. Results: The results showed statistically significant treatment differences between acupuncture and breathing retraining, in favor of acupuncture. Reductions were found in the HAD A (anxiety) (p = 0.02) and Nijmegen (symptoms) (p = 0.03) scores. There was no statistical evidence of any carryover effects. However, when graphically examining individual anxiety scores, in those who received acupuncture first, there was a reduction in anxiety levels which persisted through the washout period, suggesting that there may have been some carryover effect from this treatment. Conclusions: This study suggests that acupuncture may be beneficial in the management of HVS in terms of reducing anxiety levels and symptom severity. However, there may be some carryover effect, after acupuncture treatment, which went undetected because the small sample size. This preliminary study provides the basis for a larger, sufficiently powered and methodologically sound trial.

In the present study, we investigated the expression of Mcl-1 and Bcl-2 by immunohistochemistry in 85 patients of grades 1-3 and transformed follicular lymphoma (FL). In lymphoma tissue, centroblasts uniformly expressed high levels of Mcl-1 (Mcl-1(hi)) whereas centrocytes demonstrated low Mcl-1 expression (Mcl-1(lo)). Bcl-2 expression in centroblasts/centrocytes was reciprocal to Mcl-1 staining in most cases. A high number of Mcl-1(hi) centroblasts in tissue sections (> or =200/high-power field) correlated with poor overall survival (P < 0.001), independent of the International Prognostic Index and FL grade. This suggests that the number of centroblasts with strong Mcl-1 staining is associated with clinical outcome in FL patients.

The aims of this study were to determine the social and demographic context, prevalence of mental disorder, and psychiatric treatment needs of women in prison mother and baby units in England. We conducted a survey of 55 mothers in the four prison mother and baby units in England, using semi-structured interviews, data from inmate medical records, and general practice records. More than half of the women were married or co-habiting and the vast majority had been living in their own homes prior to arrest. Many were from ethnic minorities and serving sentences for drug offences. In all, 60% had one or more of the five specific forms of mental disorder and a third were depressed. According to their inmate medical records, few were identified as having mental problems and only three were receiving any kind of treatment. Women in prison mother and baby units have particular characteristics that distinguish them from the rest of the female prison population. Admission criteria appear to select out women with psychiatric morbidity, child care problems, and other difficulties that may make them unsuitable for a mother and baby unit. The inmate medical records are a poor and unreliable source of mental health information and GP records provided no further information than the women themselves. Without treatment depression will impact on the mothers' ability to function effectively and it may have an adverse effect on the children's development.

Choosing between preference-based instruments of health-related quality of life (HR-QOL) in particular situations is an important area for research. Even where instruments can be assumed to be measuring the same thing, they may not be interchangeable. The study presented investigates the extent to which EQ-5D and SF-6D instruments are interchangeable in an older, chronically ill patient group undergoing haemodialysis. Head-to-head comparisons were made using 'practicality', 'descriptive validity', 'empirical validity', mean utilities and associated distributions. Overall it was difficult to choose between instruments on the basis of descriptive or empirical validity, since both performed similarly. Important differences were, however, found relating to practicality: a significantly higher response rate in favour of EQ-5D; and lower levels of missing data to derive health states. Non-response was significantly associated with age and co-morbidity of respondents. We suggest that in patients undergoing haemodialysis, and potentially other older chronically ill patient groups, EQ-5D is the primary preference-based generic HR-QOL instrument.

BACKGROUND:The prevalence rate of renal replacement therapy in the United Kingdom has increased significantly, particularly by long-term hemodialysis (HD) therapy in renal satellite units (RSUs). These are largely nurse-run units linked to main renal units (MRUs). We compared outcomes, processes of care, and costs in RSUs with those in MRUs.METHODS:A cross-sectional comparison was performed of HD patients from a representative sample of 12 RSUs in England and Wales and HD patients in the linked MRUs deemed suitable by the senior nurse for RSU care. Data for patient characteristics, clinical process and outcome measures, health-related quality of life (HRQoL), and patient satisfaction were collected. A partial analysis of National Health Service and social care costs was undertaken. Geographic access was assessed by road time and distance traveled to dialysis sessions.RESULTS:Seven hundred thirty-six of 895 eligible patients (82%) participated. RSU patients were older (mean age, 63 versus 57 years), but had comorbidity similar to that of MRU patients. There were no significant differences in most processes of care or clinical outcomes; achievement of standards for adequacy of dialysis (urea reduction ratio) was significantly greater in RSU patients and hospitalization in the last year was less frequent. Patient HRQoL was similar, but patient satisfaction was greater in RSU patients. RSU patients potentially saved 19 minutes traveling for each dialysis session. Costs for routine dialysis and health/social care were similar.CONCLUSION:RSUs appear to be as effective as main HD units for a wide spectrum of patients, improve geographic access, and are more acceptable to patients. There is evidence that they are as cost-effective as main units.

● Background: This study aims to determine the incidence rate and prognosis of detected chronic kidney disease (CKD) in a defined population. Methods: This is a retrospective cohort study of all new cases of CKD from Southampton and South-West Hampshire Health Authority (population base, 405,000) determined by a persistently increased serum creatinine (SCr) level (>1.7 mg/dL [>150 mol/L] for 6 months) identified from chemical pathology records. Follow-up was for a mean of 5.5 years for survival, cause of death, and acceptance to renal replacement therapy (RRT). Results: The annual incidence rate of detected CKD was 1,701 per million population (pmp; 95% confidence interval [CI], 1,613 to 1,793) and 1,071 pmp (95% CI, 1,001 to 1,147) in those younger than 80 years. There was a steep age gradient; median age was 77 years. The man-woman rate ratio was 1.6 (95% CI, 1.4 to 1.8), with a male excess in all age groups older than 40 years. Incidence increased in areas with greater socioeconomic deprivation. Median survival was 35 months. Age, SCr level, and deprivation index were all significantly associated with survival. Standardized mortality ratios were 36-fold in those aged 16 to 49 years, 12-fold in those aged 50 to 64 years, and more than 2-fold in those older than 65 years. Cardiovascular disease (CVD) was the most common cause of death (46%). Only 4% of patients were accepted to RRT. Conclusion: The incidence of diagnosed CKD is common, especially in the elderly, and is greater in more deprived areas. Prognosis is poor, with CVD prominent. More research is needed to assess the effectiveness and costs of increasing referral to nephrologists of patients with CKD. Am J Kidney Dis 42:677-684. © 2003 by the National Kidney Foundation, Inc.