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Background Endovascular coiling is usually the first line treatment modality for most ruptured intracranial aneurysms. However, there is still some debate as to whether microsurgical clipping or coiling is the treatment of choice for complex wide-necked ruptured middle cerebral artery (MCA) aneurysms. Our aim was to assess the efficacy, safety and longevity of simple endovascular coiling for ruptured MCA aneurysms Methods This was a single-centre 10 years retrospective study (2008–2019) of all endovascularly treated patients with ruptured MCA aneurysms ( n = 148). Patients were treated with simple coiling ( n = 111), balloon-assisted coiling ( n = 13), dual micro-catheter coiling ( n = 19), balloon-assisted and dual micro-catheter coiling ( n = 4) and woven endobridge (WEB) device ( n = 1). The standard follow-up protocol consisted of Magnetic Resonance angiography at 6, 12 and 24 months. Our primary endpoints were mortality at 2, 12 and 24 months and dependency at discharge. Secondary endpoints included aneurysm occlusion, complications, re-canalisation, rebleeding and retreatment rates. Results All-cause mortality at 2, 12 and 24 months was 4.7% ( n = 7), 8.1% ( n = 12) and 10.8% ( n = 16), respectively. 81.3% of patients remained independent in activities of daily livings (ADLs) at the point of discharge. Over a mean follow-up period of 19.7 months, we demonstrated re-bleeding and re-treatment rates of 2.7% ( n = 4) and 4.1% ( n = 6) respectively. Complete occlusion was achieved in 54% ( n = 79) of aneurysms, with recanalisation observed in 18.2% ( n = 27) of the patients. Conclusions Our results demonstrate that simple endovascular coiling techniques offer a safe and effective solution in the management of ruptured MCA aneurysms without the requirement for re-treatment either surgically or endovascularly using endoluminal stents or other devices.

BackgroundCommon memory aids for people with dementia at home are recommended. However, rigorous evaluation is lacking, particularly what guidance or support is valued.ObjectiveTo investigate effects of memory aids and guidance by dementia support practitioners (DSPs) for people in early-stage dementia through a pragmatic, randomised controlled trial.MethodsOf 469 people with mild-to-moderate dementia and their informal carers, 468 were randomised to a DSP with memory aids or to usual care plus existing dementia guide. Allocation was stratified by Trust/Health Board; time since first attendance at memory service; gender; age; and living with primary carer or not. Primary outcome was Bristol Activities of Daily Living Scale (BADLS) Score at 3 and 6 months (primary end-point). Secondary outcomes for people with dementia: quality of life (CASP-19; DEMQOL); cognition and functioning (Clinical Dementia Rating Scale; S-MMSE); capability (ICECAP-O); social networks (LSNS-R); and instrumental daily living activities (R-IDDD). Secondary outcomes for carers: psychological health (GHQ-12); sense of competence (SSCQ).ResultsDSPs were successfully trained, compliance was good and welcomed by participants. Mean 6 months BADLS Score increased to 14.6 (SD: 10.4) in intervention and 12.6 (SD: 8.1) in comparator, indicative of greater dependence in the activities of daily living. Adjusted between-group difference was 0.38 (95% CI: −0.89 to 1.65, p=0.56). Though this suggests greater dependency in the intervention group the difference was not significant. No differences were found in secondary outcomes.ConclusionsThis intervention did not maintain independence in the activities of daily living with no improvement in other outcomes for people with dementia or carers.Trial registration numberCurrent Controlled TrialsISRCTN12591717.

Objectives Gender service utilisation according to ethnicity is largely under-researched. The present research looked at demographics and service user-engagement according to ethnicity of young people accessing a gender service for children. Method A total of 2063 ( M = 14.19 years, SD = 2.59, assigned male = 556, 1495 assigned female = 1495, no-specification=12) referrals were included in the analysis. Self-defined ethnicity in financial years (FY) 2016–2017, 2018–2019, and referrer-defined ethnicity in FY 2020–2021 were compared between years, to the national UK-population, and child and adolescent mental health service (CAMHS) averages. Numbers of offered, attended and non-attended appointments were compared across the White and the ethnic minority population (EMP). Results Across years 93.35% young people identified as White (higher than the CAMHS and national population averages); 6.65% as EMP. Service utilisation was similar in FY 2016–2017. In FY 2018–2019, the EMP subgroup was offered and attended more appointments compared to the White subgroup, ‘did not attended’ average was similar. Conclusions The majority of young people self-identified with a White ethnic-background. Service engagement was comparable between the EMP and White ethnicity subgroups in 2016–2017, while the EMP group was offered and attended more appointments in 2018–2019. Due to the low EMP group numbers, findings need to be interpreted with caution.

Background: Arthroplasty of the proximal interphalangeal (PIP) joint is a widely performed procedure for patients with osteoarthritis. Its use in the index finger is often discouraged due to concerns over implant longevity and stability secondary to coronal forces this digit is exposed to during pinch. Methods: We analyzed 47 consecutive index finger silastic interposition arthroplasties, performed through a dorsal approach, at a mean follow-up of 5.15 years. Results: Only 2 patients had ulnar deviation greater than 15°. The reoperation rate was 12.8%, with only 1 finger requiring arthrodesis. The mean Visual Analog Scale score was 1.1; and of the whole series, only 1 patient would retrospectively have preferred a fusion. Conclusions: Our series shows that excellent functional results and patient satisfaction can be gained using silastic PIP joint arthroplasty in the index finger. We would advocate offering this procedure, especially in lower demand patients as an alternative to arthrodesis, with the benefit of providing good pain relief while preserving movement.

BackgroundUsing computer software in general practice to predict patient risk of emergency hospital admission has been widely advocated, despite limited evidence about effects. In a trial evaluating the introduction of a Predictive Risk Stratification Model (PRISM), statistically significant increases in emergency hospital admissions and use of other NHS services were reported without evidence of benefits to patients or the NHS.AimTo explore GPs’ and practice managers’ experiences of incorporating PRISM into routine practice.Design and settingSemi-structured interviews were carried out with GPs and practice managers in 18 practices in rural, urban, and suburban areas of south Wales.MethodInterviews (30–90 min) were conducted at 3–6 months after gaining PRISM access, and ∼18 months later. Data were analysed thematically using Normalisation Process Theory.ResultsResponders (n = 22) reported that the decision to use PRISM was based mainly on fulfilling Quality and Outcomes Framework incentives. Most applied it to ConclusionQualitative results suggest mixed views of predictive risk stratification in general practice and raised awareness of highest-risk patients potentially affecting rates of unplanned hospital attendance and admissions. To inform future policy, decision makers need more information about implementation and effects of emergency admission risk stratification tools in primary and community settings.

Background Individuals with low serum vitamin B-12 and high serum folate have higher plasma concentrations of methylmalonic acid (MMA). Whether folic acid (FA) causes an increase in MMA is not known. Objectives We aimed to determine the impact of FA supplementation on plasma MMA concentration in people with low or marginal serum vitamin B-12. Methods We conducted a multicenter double-blind placebo-controlled randomized trial of oral FA (5 mg/d for 12 wk) in middle-aged patients treated with antidepressant medication participating in the FoLATED (Folate Augmentation of Treatment—Evaluation for Depression) trial. Participants defined as having “low” serum vitamin B-12 (vitamin B-12 ≥150 and

BackgroundIndividuals with depression often do not respond to medication or psychotherapy. Radically open dialectical behaviour therapy (RO DBT) is a new treatment targeting overcontrolled personality, common in refractory depression.AimsTo compare RO DBT plus treatment as usual (TAU) for refractory depression with TAU alone (trial registration: ISRCTN 85784627).MethodRO DBT comprised 29 therapy sessions and 27 skills classes over 6 months. Our completed randomised trial evaluated RO DBT for refractory depression over 18 months in three British secondary care centres. Of 250 adult participants, we randomised 162 (65%) to RO DBT. The primary outcome was the Hamilton Rating Scale for Depression (HRSD), assessed masked and analysed by treatment allocated.ResultsAfter 7 months, immediately following therapy, RO DBT had significantly reduced depressive symptoms by 5.40 points on the HRSD relative to TAU (95% CI 0.94–9.85). After 12 months (primary end-point), the difference of 2.15 points on the HRSD in favour of RO DBT was not significant (95% CI –2.28 to 6.59); nor was that of 1.69 points on the HRSD at 18 months (95% CI –2.84 to 6.22). Throughout RO DBT participants reported significantly better psychological flexibility and emotional coping than controls. However, they reported eight possible serious adverse reactions compared with none in the control group.ConclusionsThe RO DBT group reported significantly lower HRSD scores than the control group after 7 months, but not thereafter. The imbalance in serious adverse reactions was probably because of the controls' limited opportunities to report these.

Background Alcohol consumption and related harm increase rapidly from the age of 12 years. We evaluated whether alcohol screening and brief intervention is effective and cost-effective in delaying hazardous or harmful drinking amongst low-risk or abstaining adolescents attending Emergency Departments (EDs). Methods This ten -centre, three-arm, parallel-group, single-blind, pragmatic, individually randomised trial screened ED attenders aged between 14 and 17 years for alcohol consumption. We sampled at random one third of those scoring at most 2 on AUDIT-C who had access to the internet and, if aged under 16, were Gillick competent or had informed consent from parent or guardian. We randomised them between: screening only (control intervention); one session of face-to-face Personalised Feedback and Brief Advice (PFBA); and PFBA plus an electronic brief intervention (eBI) on smartphone or web. We conducted follow-up after six and 12 months. The principal outcomes were alcohol consumed over the 3 months before 12-month follow up, measured by AUDIT-C; and quality-adjusted life-years. Findings Between October 2014 and May 2015, we approached 5,016 eligible patients of whom 3,326 consented to be screened and participate in the trial; 2,571 of these were low-risk drinkers or abstainers, consuming an average 0.14 units per week. We randomised: 304 to screening only; 285 to PFBA; and 294 to PFBA and eBI. We found no significant difference between groups, notably in weekly alcohol consumption: those receiving screening only drank 0.10 units (95% confidence interval 0.05 to 0.18); PFBA 0.12 (0.06 to 0.21); PFBA and eBI 0.10 (0.05 to 0.19). Interpretation While drinking levels remained low in this population, this trial found no evidence that PFBA with or without eBI was more effective than screening alone in reducing or delaying alcohol consumption.

Background We aimed to estimate the clinical effectiveness of Community Occupational Therapy for people with dementia and family carers–UK version (Community Occupational Therapy in Dementia–UK version [COTiD-UK]) relative to treatment as usual (TAU). We hypothesised that COTiD-UK would improve the ability of people with dementia to perform activities of daily living (ADL), and family carers’ sense of competence, compared with TAU. Methods and findings The study design was a multicentre, 2-arm, parallel-group, assessor-masked, individually randomised controlled trial (RCT) with internal pilot. It was conducted in 15 sites across England from September 2014 to January 2018. People with a diagnosis of mild to moderate dementia living in their own home were recruited in pairs with a family carer who provided domestic or personal support for at least 4 hours per week. Pairs were randomised to either receive COTiD-UK, which comprised 10 hours of occupational therapy delivered over 10 weeks in the person with dementia’s home or TAU, which comprised the usual local service provision that may or may not include standard occupational therapy. The primary outcome was the Bristol Activities of Daily Living Scale (BADLS) score at 26 weeks. Secondary outcomes for the person with dementia included the following: the BADLS scores at 52 and 78 weeks, cognition, quality of life, and mood; and for the family carer: sense of competence and mood; plus the number of social contacts and leisure activities for both partners. Participants were analysed by treatment allocated. A total of 468 pairs were recruited: people with dementia ranged from 55 to 97 years with a mean age of 78.6 and family carers ranged from 29 to 94 with a mean of 69.1 years. Of the people with dementia, 74.8% were married and 19.2% lived alone. Of the family carers, 72.6% were spouses, and 22.2% were adult children. On randomisation, 249 pairs were assigned to COTiD-UK (62% people with dementia and 23% carers were male) and 219 to TAU (52% people with dementia and 32% carers were male). At the 26 weeks follow-up, data were available for 364 pairs (77.8%). The BADLS score at 26 weeks did not differ significantly between groups (adjusted mean difference estimate 0.35, 95% CI −0.81 to 1.51; p = 0.55). Secondary outcomes did not differ between the groups. In total, 91% of the activity-based goals set by the pairs taking part in the COTiD-UK intervention were fully or partially achieved by the final COTiD-UK session. Study limitations include the following: Intervention fidelity was moderate but varied across and within sites, and the reliance on primarily proxy data focused on measuring the level of functional or cognitive impairment which may not truly reflect the actual performance and views of the person living with dementia. Conclusions Providing community occupational therapy as delivered in this study did not improve ADL performance, cognition, quality of life, or mood in people with dementia nor sense of competence or mood in family carers. Future research should consider measuring person-centred outcomes that are more meaningful and closely aligned to participants’ priorities, such as goal achievement or the quantity and quality of activity engagement and participation. Trial Registration Current Controlled Trials ISRCTN10748953., Jennifer Wenborn and colleagues investigate the effectiveness of community occupational therapy program in improving activities of daily living, cognition, and mood for people with dementia., Author summary Why was this study done? Maintaining everyday and pleasurable activities can be difficult for a person with dementia, as well as their family carer who often feels increasingly stressed as they need to give more and more support. Occupational therapists assist people to improve their health and well-being through carrying on with the activities they need and want to do. It is therefore important to develop effective strategies to deliver occupational therapy to people with dementia and their family carers who support them. What did the researchers do and find? We tested the effectiveness of the Community Occupational Therapy in Dementia–UK version (COTiD-UK) programme compared to the care that people with mild to moderate dementia and their family carers usually receive, through a clinical trial. We recruited 468 pairs comprising a person with dementia and a family carer across England who were randomly allocated to either take part in the COTiD-UK programme or to continue with their usual care. We found no statistical evidence that COTiD-UK gave more benefit to people with dementia or their carers than the usual care provided in terms of the people with dementia being able to carry out activities or their mood or quality of life nor their family carers’ sense of competence or mood. The pairs who took part in the COTiD-UK intervention set an average of 4.09 goals each, of which 91% were fully or partially achieved by the final COTiD-UK session. What do these findings mean? We did not find evidence to support commissioning the COTiD-UK intervention for people with mild to moderate dementia and their family carers. Future studies need to develop more realistic methods of measuring the effectiveness of programmes such as this, particularly to focus on the outcomes that most matter to the individuals taking part and to truly reflect the actual performance, experience, and views of the person living with dementia.

Literature has documented inflated rates of features associated with autism spectrum (AS) in clinic referred, gender diverse young people. This study examined scores on the Social Responsiveness Scale, Second Edition (SRS-2) over time in a group of clinic referred, gender diverse adolescents accessing gonadotropin-releasing hormone analogues (GnRHa) to supress puberty. Primary caregivers of 95 adolescents presenting to the Gender Identity Development Service (GIDS) completed the SRS-2 prior to receiving endocrine input (mean age: 13.6 ± SEM: 0.11) and after approximately one year of accessing GnRHa (mean age: 14.6 ± SEM: 0.13). No significant differences in SRS-2 scores over time and between birth assigned sex were found. No interactions between time and birth assigned sex were established for SRS-2 subscales or total scores.

Rapid thrombolysis treatment for acute ischemic stroke reduces disability among patients who are carefully selected, but service delivery is challenging.To determine whether an enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) intervention increased hospital thrombolysis rates.This multicenter, cluster randomized clinical trial took place between December 2015 and July 2018 in 3 ambulance services and 15 hospitals. Clusters were paramedics based within ambulance stations prerandomized to PASTA or standard care. Patients attended by study paramedics were enrolled after admission if a hospital specialist confirmed a stroke and paramedic assessment started within 4 hours of onset. Allocation to PASTA or standard care reflected the attending paramedic's randomization status.The PASTA intervention included additional prehospital information collection, a structured hospital handover, practical assistance up to 15 minutes after handover, a predeparture care checklist, and clinician feedback. Standard care reflected national guidelines.Primary outcome was the proportion of patients receiving thrombolysis. Secondary outcomes included time intervals and day 90 health (with poor status defined as a modified Rankin Score2, to represent dependency or death).A total of 11 478 patients were screened following ambulance transportation; 1391 were eligible and approached, but 177 did not consent. Of 1214 patients enrolled (mean [SD] age, 74.7 [13.2] years; 590 women [48.6%]), 500 were assessed by 242 paramedics trained in the PASTA intervention and 714 were assessed by 355 paramedics continuing with standard care. The paramedics trained in the PASTA intervention took a mean of 13.4 (95% CI, 9.4-17.4) minutes longer (P .001) to complete patient care episodes. There was less thrombolysis among the patients in the PASTA group, but this was not significant (PASTA group, 197 of 500 patients [39.4%] vs the standard care group, 319 of 714 patients [44.7%]; adjusted odds ratio, 0.81 [95% CI, 0.61-1.08]; P = .15). Time from a paramedic on scene to thrombolysis was a mean of 8.5 minutes longer in the PASTA group (98.1 [37.6] minutes) vs the standard care group (89.4 [31.1] minutes; P = .01). Poor health outcomes did not differ significantly but occurred less often among patients in the PASTA group (313 of 489 patients [64.0%]) vs the standard care group (461 of 690 patients [66.8%]; adjusted odds ratio, 0.86 [95% CI, 0.60-1.20]; P = .39).An enhanced paramedic assessment did not facilitate thrombolysis delivery. The unexpected combination of thrombolysis and health outcomes suggests possible alternative influences on treatment decisions by the intervention, requiring further evaluation.ISRCTN Registry Identifier: ISRCTN12418919.

ObjectiveTo estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.DesignPragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.Setting11 diabetes clinics in England and Wales.ParticipantsBetween February 2010 and August 2011, we validly randomised 308 children aged 6–18 years; 201 received the intervention.InterventionWe designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment.Outcome measures at 3 and 6 monthsPrimary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use.ResultsOf the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=−4.68; SE=1.74; 95%CI from −8.10 to −1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=−3.20; SE=1.33; 95% CI from −5.73 to −0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents.ConclusionsStandardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes.Trial registration numberNCT17551624.

BackgroundStratifying patient populations by risk of adverse events was believed to support preventive care for those identified, but recent evidence does not support this. Emergency admission risk stratification (EARS) tools have been widely promoted in UK policy and GP contracts.AimTo describe availability and use of EARS tools across the UK, and identify factors perceived to influence implementation.Design and settingCross-sectional survey in UK.MethodOnline survey of 235 organisations responsible for UK primary care: 209 clinical commissioning groups (CCGs) in England; 14 health boards in Scotland; seven health boards in Wales; and five local commissioning groups (LCGs) in Northern Ireland. Analysis results are presented using descriptive statistics for closed questions and by theme for open questions.ResultsResponses were analysed from 171 (72.8%) organisations, of which 148 (86.5%) reported that risk tools were available in their areas. Organisations identified 39 different EARS tools in use. Promotion by NHS commissioners, involvement of clinical leaders, and engagement of practice managers were identified as the most important factors in encouraging use of tools by general practices. High staff workloads and information governance were identified as important barriers. Tools were most frequently used to identify individual patients, but also for service planning. Nearly 40% of areas using EARS tools reported introducing or realigning services as a result, but relatively few reported use for service evaluation.ConclusionEARS tools are widely available across the UK, although there is variation by region. There remains a need to align policy and practice with research evidence.

ObjectiveTo explore patients’ experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury.DesignQualitative interviews within a feasibility trial about an alternative to routine prehospital pain management for patients with suspected hip fracture.SettingPatients treated by paramedics in the catchment area of one emergency department in South Wales.ParticipantsSix patients and one carer of a patient who received fascia iliaca compartment block (FICB).InterventionFICB administered to patients with suspected hip fracture by trained paramedics. We randomly allocated eligible patients to FICB—a local anaesthetic injection directly into the hip region—or usual care—most commonly morphine—using audited scratch cards.OutcomesAcceptability and experience of receiving FICB, assessed through interview data. We audio-recorded, with participants’ consent, and conducted thematic analysis of interview transcripts. The analysis team comprised two researchers, one paramedic and one lay member.ResultsPatients had little or no memory of being offered, consenting to or receiving FICB. They recalled the reassuring manner and high quality of care received. They accepted FICB without question. Partial or confused memory characterised experience of subsequent hospital care until surgery. They said their priorities when calling for emergency help were to receive effective care. After hospital treatment, they wanted to regain their health and mobility and resume the quality of life they experienced before their injury.ConclusionsThis study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture. It adds to existing evidence about patient and carer experience of on-scene care for people with suspected hip fracture. Further research is needed to assess safety, effectiveness and cost effectiveness of this health technology in a new setting.Trial registration numberNCT60065373.

ObjectiveTo estimate the effect of deprivation on the demand for calls to National Health Service Direct Wales (NHSDW) controlling for confounding factors.DesignStudy of routine data on over 400 000 calls to NHSDW using multiple regression to analyse the logarithms of ward-specific call rates across Wales by characteristics of call, patient and ward, notably the Welsh Index of Multiple Deprivation.Setting810 electoral wards with average population of 3300, defined by 1998 administrative boundaries.PopulationAll calls to NHSDW between January 2002 and June 2004.Main outcome measuresWe used ward populations as denominators to calculate the rates of three categories of calls: calls seeking advice, calls seeking information and all calls combined.ResultsConfounding variables explained 31% of variation in advice call rates, but only 14% of variation in information call rates and in all call rates (all significant at 0.1% level). However, deprivation was only a statistically significant predictor of information call rates. The proportion of the ward population categorised as ‘white’ was a highly significant predictor of all three call rates. For advice calls and combined calls, rates decreased highly significantly with the proportion of those who called the service for themselves. Information call rates were higher on weekdays and highest on Mondays, while advice call rates were highest on Sundays.ConclusionsDeprivation had no consistent effect on demand for the service and the relationship needs further exploration. While our data may have underestimated the ‘need’ of deprived patients, they yield no evidence that policy-makers should seek to improve demand from those patients. However, we found differences in the way callers use advice and information calls. Previously unexplored variables that help to predict ward-specific call rates include: ethnicity, day of the week and whether patients made the calls themselves.

ObjectivesTo explore paramedics’ experience of delivering fascia iliaca compartment block(FICB) to patients with suspected hip fracture at the scene of injury.DesignFocus groups within a randomised controlled trial.SettingParamedics based at ambulance stations in the catchment area of one Emergency Department in South Wales, recruited and trained in a feasibility study about an alternative to routine prehospital pain management for patients with suspected hip fracture.Participants11 paramedics.InterventionParamedic-administered FICB to patients with suspected hip fracture. We randomly allocated eligible patients to FICB, a local anaesthetic injection directly into the hip region—or usual care, most commonly morphine - using audited scratch cards.OutcomesParamedics’ experiences of administering FICB gathered through thematic analysis of interview transcripts by two researchers, one paramedic and one lay member.ResultsRespondents believed that FICB was a suitable intervention for paramedics to deliver. It aligned with routine practice and was within people’s capabilities. They said it took up to 10 minutes longer than usual care to prepare and deliver, in part due to nervousness and unfamiliarity with a new procedure. They praised the training provided but said they were anxious about causing harm by injecting into the wrong location. Confidence increased after one paramedic team successfully treated a patient for local anaesthetic toxicity. Reported challenges related to the emergency context: patients often waited many hours for ambulance arrival; moving patients exacerbated their pain; family and neighbours were present as paramedics administered treatment.ConclusionsParamedics are willing and able to administer FICB to patients with suspected hip fracture before ambulance transport to hospital. Feasibility study findings will inform further research.Trial registration numberISRCTN60065373; Pre results.

AimWe evaluated the introduction of a predictive risk stratification model (PRISM) into primary care. Contemporaneously National Health Service (NHS) Wales introduced Quality and Outcomes Framework payments to general practices to focus care on those at highest risk of emergency admission to hospital. The aim of this study was to evaluate the costs and effects of introducing PRISM into primary care.MethodsRandomised stepped wedge trial with 32 general practices in one Welsh health board. The intervention comprised: PRISM software; practice-based training; clinical support through two ‘general practitioner (GP) champions’ and technical support. The primary outcome was emergency hospital admissions.ResultsAcross 230 099 participants, PRISM implementation increased use of health services: emergency hospital admission rates by 1 % when untransformed (while change in log-transformed rate ΔL=0.011, 95% CI 0.010 to 0.013); emergency department (ED) attendance rates by untransformed 3 % (while ΔL=0.030, 95% CI 0.028 to 0.032); outpatient visit rates by untransformed 5 % (while ΔL=0.055, 95% CI 0.051 to 0.058); the proportion of days with recorded GP activity by untransformed 1 % (while ΔL=0.011, 95% CI 0.007 to 0.014) and time in hospital by untransformed 3 % (while ΔL=0.029, 95% CI 0.026 to 0.031). Thus NHS costs per participant increased by £76 (95% CI £46 to £106).ConclusionsIntroduction of PRISM resulted in a statistically significant increase in emergency hospital admissions and use of other NHS services without evidence of benefits to patients or the NHS.

Background There is a growing need for an evidence-based approach to home support for people with dementia and their carers following diagnosis but research on the effectiveness and cost-effectiveness of different approaches is sparse. The Dementia Early Stage Cognitive Aids New Trial (DESCANT) will evaluate the clinical and cost-effectiveness of a range of memory aids, training and support to people with mild to moderate dementia and their carers at home and compares that intervention with treatment as usual. Methods/design This is a multi-site, pragmatic randomised trial preceded by a feasibility study and internal pilot. We aim to allocate at random 360 pairs comprising a person with mild to moderate dementia and an identified carer between the DESCANT intervention and treatment as usual. We assess participants at baseline, 13 and 26 weeks. The primary outcome measure is the Bristol Activities of Daily Living Scale; other participant outcomes include cognition, quality of life, activities of daily living and social networking; carer outcomes include quality of life, sense of competence and mental health. To enhance this quantitative evaluation we are conducting a qualitative component and a process evaluation to assess the implementation process and identify contextual factors associated with variation. Discussion The DESCANT intervention reflects current policy to enhance the capabilities of people with dementia after diagnosis and their carers. If it is clinically and cost-effective, its modest nature and cost will enhance the likelihood of it being incorporated into mainstream practice. Trial registration Current Controlled Trials, ISRCTN12591717. Registered on 29 July 2016. Protocol number: 31288: North West - Haydock Research Ethics Committee, 20/06/2016, ref.: 16/NW/0389.

BackgroundThe value of qualitative methods within trials is widely recognised, but their full potential is not being realised. There are also issues with the visibility, recognition and reporting of qualitative methods in trials. To identify potential improvements in qualitative research within trials, we need to study trials that have included qualitative methods. We aimed to explore the frequency of reporting qualitative methods in registered trials, the types of trials using qualitative methods and where in the world these trials were conducted.MethodsWe included registries if they were searchable using keywords and held summaries of trials rather than listing reports or publications. We searched the included registries from the first available record in 1999 to the end of 2016 for the term ‘qualitative’. We included trials only if we could confirm that they used qualitative methods through documented use of qualitative data collection and analysis in the registry summary. We analysed registered trials reporting the use of qualitative methods by: year registered, the country responsible for overseeing governance of the trial and the type of trial intervention (categorised as surgical, medical device, behavioural, drug or other).ResultsWe included three registries: ClinicalTrials.gov, the International Standard Randomised Controlled Trial Number Registry (ISRCTN) and the World Health Organisation International Clinical Trials Registry Platform (WHO ICTRP). A total of 615,311 trials appear in these three registries from 1999 until the end of 2016. Numbers differed across registries with the WHO ICTRP the largest (366,753 trials), ClinicalTrials.gov the second largest (233,277) and ISRCTN the smallest (15,301). Of these registered trials, we confirmed that 1492 (0.24%) reported using qualitative methods. The ISRCTN contributed the highest percentage of trials reported as using qualitative methods (3.4%); in contrast, ClinicalTrials.gov reported 0.3% and WHO ICTRP reported 0.03%. The number and percentage of trials reported to use qualitative methods increased over time from 0 (0.0%) in 1999 to 285 (0.38%) in 2016. Trials reported as using qualitative methods originated from 52 countries across the world. Most were in Western higher-income countries: 38% in the United Kingdom and 28% in the United States. Most registered trials reported as using qualitative methods evaluated behavioural (39%) or other interventions with many fewer trials evaluating drugs (5%), medical devices (5%) or surgical interventions (4%).ConclusionThe reported use of qualitative methods in registered trials has increased over time and worldwide. They are reportedly more frequent in high-income countries and in trials of behavioural and other interventions. Trialists and other stakeholders need to recognise the benefits of using qualitative methods in surgical, device and drug trials, and trials conducted in poorer countries. Moreover, they should seriously consider using qualitative methods in these trials.

Young people are presenting to specialist gender services in higher numbers than before and many with significant psychosocial difficulties. Negative experiences of stigma, difficult peer relationships and discrimination exacerbate distress and psychological difficulties, negatively impacting wellbeing and resilience. Social support is advocated as a means of supporting young people with diverse gender identifications, such as through peer support groups. This article describes the establishment of a young persons’ group in 2011 within the United Kingdom’s Gender Identity Development Service (GIDS), for those attending the service as a means of enabling their coping with difficult experiences and facilitating their wellbeing and resilience through effective social support. The group was evaluated using qualitative and quantitative measures and has subsequently run each year. Now in its sixth year, the authors reflect on their learning and experiences.

Objective To estimate and compare the optimal cut-off score of Alcohol Use Disorders Identification Test (AUDIT) and AUDIT-C in identifying at-risk alcohol consumption, heavy episodic alcohol use, ICD-10 alcohol abuse and alcohol dependence in adolescents attending ED in England. Design Opportunistic cross-sectional survey. Setting 10 emergency departments across England. Participants Adolescents (n = 5377) aged between their 10th and 18th birthday who attended emergency departments between December 2012 and May 2013. Measures Scores on the AUDIT and AUDIT-C. At-risk alcohol consumption and monthly episodic alcohol consumption in the past 3 months were derived using the time-line follow back method. Alcohol abuse and alcohol dependence was assessed in accordance with ICD-10 criteria using the MINI-KID. Findings AUDIT-C with a score of 3 was more effective for at-risk alcohol use (AUC 0.81; sensitivity 87%, specificity 97%), heavy episodic use (0.84; 76%, 98%) and alcohol abuse (0.98; 91%, 90%). AUDIT with a score of 7 was more effective in identifying alcohol dependence (0.92; 96%, 94%). Conclusions The 3-item AUDIT-C is more effective than AUDIT in screening adolescents for at-risk alcohol use, heavy episodic alcohol use and alcohol abuse. AUDIT is more effective than AUDIT-C for the identification of alcohol dependence.

Objectives: To develop a tool for the accurate reporting and aggregation of findings from each of the multiple methods used in a complex evaluation in an unbiased way. Study Design and Setting: We developed a Method for Aggregating The Reporting of Interventions in Complex Studies (MATRICS) within a gastroenterology study [Evaluating New Innovations in (the delivery and organisation of) Gastrointestinal (GI) endoscopy services by the NHS Modernisation Agency (ENIGMA)]. We subsequently tested it on a different gastroenterology trial [Multi-Institutional Nurse Endoscopy Trial (MINuET)]. We created three layers to define the effects, methods, and findings from ENIGMA. We assigned numbers to each effect in layer 1 and letters to each method in layer 2. We used an alphanumeric code based on layers 1 and 2 to every finding in layer 3 to link the aims, methods, and findings. We illustrated analogous findings by assigning more than one alphanumeric code to a finding. We also showed that more than one effect or method could report the same finding. We presented contradictory findings by listing them in adjacent rows of the MATRICS. Results: MATRICS was useful for the effective synthesis and presentation of findings of the multiple methods from ENIGMA. We subsequently successfully tested it by applying it to the MINuET trial. Conclusion: MATRICS is effective for synthesizing the findings of complex, multiple-method studies.

Background Standard precautions (SPs) aim to reduce the risk of cross-transmission of microorganisms. The objectives of the present study were to assess institutional policies for SPs promotion, available resources for SPs implementation, and education of health care workers (HCWs) and their compliance with SPs. Methods A multisite mixed-methods audit was conducted in 2011. Self-assessment questionnaires were administered at institution, ward, and HCW levels in French health care facilities (HCFs). Results were given as percentage of objectives achieved (POA) or percentage of "never or sometimes," "often," and "always" responses for each question. Results A total of 1599 HCFs participated, including 14,968 wards and 203,840 HCWs. At an institutional level, the POA was 88%, covering SPs promotion (91%), procedures (99%), and SPs evaluation (63%). At the ward level, the POA was 94%, covering procedures (95%) and resources (93%). HCWs reported the best compliance for changing gloves between patients (94.5% "always"), and the worst compliance for the use of gloves for intramuscular injection and the use of eye protection in cases of blood exposure risk (34.5% and 24.4% of "always," respectively). Conclusions A literature review found no other study of SPs that included such a large study group. These results led to SPs promotion actions at local and regional levels. Reinforcement of SPs observance will be prioritized in the next national program from the French Ministry of Health.

Objectives To develop and validate a gastrointestinal (GI) symptom rating questionnaire for patients with luminal GI symptoms including where no diagnosis has been made. Study Design and Setting We developed and validated the Gastrointestinal Symptom Rating Questionnaire (GSRQ) in three stages: (1) item generation to identify the relevant items for scale inclusion; (2) development and piloting on patients with a known GI disorder; and (3) testing in a sample of trial patients. We examined the underlying dimensions of the scale, internal consistency, validity, reproducibility, and responsiveness. Results We identified four interpretable factors on the GSRQ. The GSRQ had good internal consistency (corrected item-subscale correlations between 0.4 and 0.8) and Cronbach's alpha greater than 0.7 for each subscale. Construct validity was demonstrated by modest but significant correlations with the Short Form 36 and the EQ5D index value. We demonstrated good reproducibility with intraclass correlations for test–retest scores between 0.71 and 0.77, and significant responsiveness ratios for all subscales in patients who had improved, and in two of the subscales in patients who had deteriorated. Conclusion The GSRQ could be a useful tool to monitor quality of life in various luminal GI conditions and where a formal diagnosis has not been made.

BACKGROUND: A colposcopy examination is the main management option for women with an abnormal cervical screening test result. Although some women experience adverse psychological effects after colposcopy, those at greatest risk are unknown. We investigated predictors of worries about cervical cancer, sex, future fertility and general health during 12 to 30 months after colposcopy.METHODS: We invited 1,515 women, aged 20 to 59 years with low-grade cervical cytology who attended colposcopy to complete questionnaires at recruitment (∼8 weeks after cytology result) and after 12, 18, 24, and 30 months of follow up. Outcomes were worries about having cervical cancer, having sex, future fertility, and general health at any time during follow-up. Factors significantly associated with each outcome were identified using multiple logistic regression.RESULTS: At one or more time points during follow-up, 40% of women reported worries about having cervical cancer, 26% about having sex, 24% about future fertility, and 60% about general health. For all outcomes except sex, worries reported at recruitment were associated with significantly increased risk of worries during follow-up. Significant anxiety at recruitment was associated with all worries during follow-up. Women diagnosed with CIN2+ had significantly higher risks of worries about cervical cancer and future fertility. Management received was associated significantly with worries about cervical cancer and having sex. Younger women significantly more often reported worries about future fertility, whereas women who had children had reduced risk of future fertility worries but increased risk of cervical cancer worries.CONCLUSION: Clinical, sociodemographic, lifestyle, and psychological factors predicted risk of reporting worries after colposcopy.

Aim To review the evidence for home support approaches directed at tertiary prevention; ameliorating difficulties and enhancing well-being. Background With population ageing dementia represents a significant care challenge with 60% of people with dementia living at home. However, little is known about existing forms of home support and their relative effectiveness. Design A two-stage design: First, an overview of systematic reviews of psychosocial interventions for dementia to identify their components; second, a systematic review of the effectiveness of home support interventions to older people with dementia/their carers. Methods We will search electronic databases using specific search terms with additional searches of other known studies. Data will be extracted by two reviewers according to pre-determined categories. An initial synthesis will elicit components of interventions from stage 1 and operationalize them in terms of specific techniques. These will then be used in synthesis of data in stage 2, to determine the extent to which each home support intervention relies on these components and distill evidence concerning outcomes. Studies from stage 2 are expected to be methodologically diverse; if so, a narrative approach to synthesis will be taken. Study findings will be explored with Patient, Public and Carer Involvement groups. Discussion The review seeks to develop a theory of home support: how and why interventions may work; in what contexts; and for whom. We will identify effective home support approaches, informing policy-makers and establishing how they might be experienced by people with dementia and their carers.

Objectives To develop and undertake initial validation of a patient-reported outcome measure to assess health-related quality of life in patients with breast cancer–related upper limb lymphedema (ULL). Study Design and Setting We developed and validated the Upper Limb Lymphedema Quality of Life (ULLQoL) scale in two stages: devising the items and pretesting with patients and clinicians; longitudinal validation to test its psychometric properties-underlying dimensions, internal consistency, test-retest reliability, construct validity, and responsiveness. Patients with ULL were recruited from two outpatient clinics. Results We derived the ULLQoL scale from a pool of 98 items generated by patients. After further consultation, we produced the draft ULLQoL scale. For validation, 103 patients with ULL completed the draft scale and two generic health measures: SF-36 and ED-5D-3L. Psychometric analysis identified two components, physical and emotional well-being, with good internal consistency and test-retest reliability. Significant correlations with SF-36, EQ-5D-3L, and percentage excess limb volume confirmed construct validity. The ULLQoL scale showed good responsiveness to change reported by lymphedema patients and moderate to large effect sizes. Conclusion The 14-item ULLQoL scale is a robust ULL-specific measure that is feasible and valid to use in both the clinical and research settings.

Study objective\ud We aim to determine clinical and cost-effectiveness of a paramedic protocol for the care of older people who fall.\ud \ud Methods\ud We undertook a cluster randomized trial in 3 UK ambulance services between March 2011 and June 2012. We included patients aged 65 years or older after an emergency call for a fall, attended by paramedics based at trial stations. Intervention paramedics could refer the patient to a community-based falls service instead of transporting the patient to the emergency department. Control paramedics provided care as usual. The primary outcome was subsequent emergency contacts or death.\ud \ud Results\ud One hundred five paramedics based at 14 intervention stations attended 3,073 eligible patients; 110 paramedics based at 11 control stations attended 2,841 eligible patients. We analyzed primary outcomes for 2,391 intervention and 2,264 control patients. One third of patients made further emergency contacts or died within 1 month, and two thirds within 6 months, with no difference between groups. Subsequent 999 call rates within 6 months were lower in the intervention arm (0.0125 versus 0.0172; adjusted difference –0.0045; 95% confidence interval –0.0073 to –0.0017). Intervention paramedics referred 8% of patients (204/2,420) to falls services and left fewer patients at the scene without any ongoing care. Intervention patients reported higher satisfaction with interpersonal aspects of care. There were no other differences between groups. Mean intervention cost was $23 per patient, with no difference in overall resource use between groups at 1 or 6 months.\ud \ud Conclusion\ud A clinical protocol for paramedics reduced emergency ambulance calls for patients attended for a fall safely and at modest cost.

Background:Dementia is a major health problem with a growing number of people affected by the condition, both directly and indirectly through caring for someone with dementia. Many live at home but little is known about the range and intensity of the support they receive. Previous studies have mainly reported on discrete services within a single geographical area. This paper presents a protocol for study of different services across several sites in England. The aim is to explore the presence, effects, and cost-effectiveness of approaches to home support for people in later stage dementia and their carers.Methods:This is a prospective observational study employing mixed methods. At least 300 participants (people with dementia and their carers) from geographical areas with demonstrably different ranges of services available for people with dementia will be selected. Within each area, participants will be recruited from a range of services. Participants will be interviewed on two occasions and data will be collected on their characteristics and circumstances, quality of life, carer health and burden, and informal and formal support for the person with dementia. The structured interviews will also collect qualitative data to explore the perceptions of older people and carers.Conclusions:This national study will explore the components of appropriate and effective home support for people with late stage dementia and their carers. It aims to inform commissioners and service providers across health and social care.

BackgroundEmergency calls are frequently made to ambulance services for older people who have fallen, but ambulance crews often leave patients at the scene without any ongoing care. We evaluated a new clinical protocol which allowed paramedics to assess older people who had fallen and, if appropriate, refer them to community-based falls services.ObjectivesTo compare outcomes, processes and costs of care between intervention and control groups; and to understand factors which facilitate or hinder use.DesignCluster randomised controlled trial.ParticipantsParticipating paramedics at three ambulance services in England and Wales were based at stations randomised to intervention or control arms. Participants were aged 65 years and over, attended by a study paramedic for a fall-related emergency service call, and resident in the trial catchment areas.InterventionsIntervention paramedics received a clinical protocol with referral pathway, training and support to change practice. Control paramedics continued practice as normal.OutcomesThe primary outcome comprised subsequent emergency health-care contacts (emergency admissions, emergency department attendances, emergency service calls) or death at 1 month and 6 months. Secondary outcomes included pathway of care, ambulance service operational indicators, self-reported outcomes and costs of care. Those assessing outcomes remained blinded to group allocation.ResultsAcross sites, 3073 eligible patients attended by 105 paramedics from 14 ambulance stations were randomly allocated to the intervention group, and 2841 eligible patients attended by 110 paramedics from 11 stations were randomly allocated to the control group. After excluding dissenting and unmatched patients, 2391 intervention group patients and 2264 control group patients were included in primary outcome analyses. We did not find an effect on our overall primary outcome at 1 month or 6 months. However, further emergency service calls were reduced at both 1 month and 6 months; a smaller proportion of patients had made further emergency service calls at 1 month (18.5% vs. 21.8%) and the rate per patient-day at risk at 6 months was lower in the intervention group (0.013 vs. 0.017). Rate of conveyance to emergency department at index incident was similar between groups. Eight per cent of trial eligible patients in the intervention arm were referred to falls services by attending paramedics, compared with 1% in the control arm. The proportion of patients left at scene without further care was lower in the intervention group than in the control group (22.6% vs. 30.3%). We found no differences in duration of episode of care or job cycle. No adverse events were reported. Mean cost of the intervention was £17.30 per patient. There were no significant differences in mean resource utilisation, utilities at 1 month or 6 months or quality-adjusted life-years. In total, 58 patients, 25 paramedics and 31 stakeholders participated in focus groups or interviews. Patients were very satisfied with assessments carried out by paramedics. Paramedics reported that the intervention had increased their confidence to leave patients at home, but barriers to referral included patients’ social situations and autonomy.ConclusionsFindings indicate that this new pathway may be introduced by ambulance services at modest cost, without risk of harm and with some reductions in further emergency calls. However, we did not find evidence of improved health outcomes or reductions in overall NHS emergency workload. Further research is necessary to understand issues in implementation, the costs and benefits of e-trials and the performance of the modified Falls Efficacy Scale.Trial registrationCurrent Controlled Trials ISRCTN60481756 and PROSPERO CRD42013006418.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 13. See the NIHR Journals Library website for further project information.

Objectives. People with dementia are susceptible to adverse effects of medicines. However, they are not always closely monitored. We explored (1) feasibility and (2) clinical impact of nurse-led medication monitoring.Design. Feasibility “before-and-after” intervention study.Setting. Three care homes in Wales.Participants. Eleven service users diagnosed with dementia, taking at least one antipsychotic, antidepressant, or antiepileptic medicine.Intervention. West Wales Adverse Drug Reaction (ADR) Profile for Mental Health Medicines.Outcome Measures. (1) Feasibility: recruitment, retention, and implementation. (2) Clinical impact: previously undocumented problems identified and ameliorated, as recorded in participants’ records before and after introduction of the profile, and one month later.Results. Nurses recruited and retained 11 of 29 eligible service users. The profile took 20–25 minutes to implement, caused no harm, and supplemented usual care. Initially, the profile identified previously undocumented problems for all participants (mean 12.7 (SD 4.7)). One month later, some problems had been ameliorated (mean 4.9 (3.6)). Clinical gains included new prescriptions to manage pain (2 participants), psoriasis (1), Parkinsonian symptoms (1), rash (1), dose reduction of benzodiazepines (1), new care plans for oral hygiene, skin problems, and constipation.Conclusions. Participants benefited from structured nurse-led medication monitoring. Clinical trials of our ADR Profile are feasible and necessary.

PurposeGlobally, alcohol use is the leading cause of ill health and life years lost in adolescents, although its clinical impact is often overlooked, particularly in England where most research is based in schools. This study aims to examine the prevalence of alcohol consumption and the association between alcohol consumption and age of onset with health and social consequences among adolescents presenting to emergency departments (EDs). Methods Consecutive attenders (n = 5,576) aged 10–17 years at 10 EDs were included. Information was collected on general health and functioning, quality of life, alcohol use, and alcohol-related health and social consequences. Results Nearly 40% of adolescents reported the consumption of alcohol that was more than a sip in their lifetime. Age of the first alcohol consumption before the age of 15 years was associated with tobacco use (p < .001), lower quality of life (p = .003), and evidence of an alcohol use disorder (p = .002). It was also associated with general social functioning (problems with conduct p = .001 and hyperactivity p = .001) and alcohol-related health and social consequences (accident p = .046, problems with a parent p = .017, school p = .0117, or police p = .012). Conclusions Rates of alcohol consumption in adolescents presenting to the ED were similar to those reported in schools in England and globally. Associations of alcohol consumption and earlier onset of drinking with poorer health and social functioning were observed. The ED can offer an opportunity for the identification of hazardous alcohol use in adolescents. National Institute for Health Research (NIHR) Programme Grants for Applied Research (RP-PG-0609-10162)

Background. Achieving knowledge translation in healthcare is growing in importance but methods to capture impact of research are not well developed. We present an attempt to capture impact of a programme of research in prehospital emergency care, aiming to inform the development of EMS models of care that avoid, when appropriate, conveyance of patients to hospital for immediate care.Methods. We describe the programme and its dissemination, present examples of its influence on policy and practice, internationally, and analyse routine UK statistics to determine whether conveyance practice has changed.Results. The programme comprises eight research studies, to a value of >£4 m. Findings have been disseminated through 18 published papers, cited 274 times in academic journals. We describe examples of how evidence has been put into practice, including new models of care in Canada and Australia. Routine statistics in England show that, alongside rising demand, conveyance rates have fallen from 90% to 58% over a 12-year period, 2,721 million fewer journeys, with publication of key studies 2003–2008.Comment. We have set out the rationale, key features, and impact on practice of a programme of publicly funded research. We describe evidence of knowledge translation, whilst recognising limitations in methods for capturing impact.

The authors respond to the article by H. F. Coelho, P. H. Canter, and E. Ernst (2007), which reviewed the current status of mindfulness-based cognitive therapy (MBCT). First, they clarify the randomization procedures in the 2 main MBCT trials. Second, they report posttreatment and follow-up data to show that trial participants allocated to "treatment as usual" did not become worse. Third, they discuss which experimental designs are better for identification of the active component of treatment. Finally, they report reanalyses of the 2 main MBCT trials with multilevel modeling that corrected for intragroup correlations. These analyses reinforce the original findings: For patients with 3 or more previous episodes, MBCT significantly reduced the risk of a further episode of depression and significantly decreased mean scores on the Beck Depression Inventory (A. T. Beck, C. H. Ward, M. Mendelson, J. Mock, and J. Erbaugh, 1961) after treatment.

BackgroundJoint reminiscence groups, involving people with dementia and family carers together, are popular, but the evidence-base is limited. This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care.MethodsThis multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group. A restricted dynamic method of randomisation was used, with an overall allocation ratio of 1:1, restricted to ensure viable sized intervention groups. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (primary end-point), usually in the person's home. Participants were recruited in eight centres, mainly through NHS Memory Clinics and NHS community mental health teams. Included participants were community resident people with mild to moderate dementia (DSM-IV), who had a relative or other care-giver in regular contact, to act as informant and willing and able to participate in intervention. 71% carers were spouses. 488 people with dementia (mean age 77.5)were randomised: 268 intervention, 220 control; 350 dyads completed the study (206 intervention, 144 control). The intervention evaluated was joint reminiscence groups (with up to 12 dyads) weekly for twelve weeks; monthly maintenance sessions for further seven months. Sessions followed a published treatment manual and were held in a variety of community settings. Two trained facilitators in each centre were supported by volunteers. Primary outcome measures were self-reported quality of life for the person with dementia (QoL-AD), psychological distress for the carer (General Health Questionnaire, GHQ-28). Secondary outcome measures included: autobiographical memory and activities of daily living for the person with dementia; carer stress for the carer; mood, relationship quality and service use and costs for both.ResultsThe intention to treat analysis (ANCOVA) identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes (self-reported QoL-AD mean difference 0.07 (-1.21 to 1.35), F = 0.48, p = 0.53). Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a General Health Questionnaire-28 sub-scale at the ten month end-point (mean difference 1.25 (0.25 to 2.26), F = 8.28, p = 0.04). Compliance analyses suggested improved autobiographical memory, quality of life and relationship quality for people with dementia attending more reminiscence sessions, however carers attending more groups showed increased care-giving stress. Economic analyses from a public sector perspective indicated that joint reminiscence groups are unlikely to be cost-effective. There were no significant adverse effects attributed to the intervention. Potential limitations of the study include less than optimal attendance at the group sessions--only 57% of participants attended at least half of the intervention sessions over the 10 month period, and a higher rate of study withdrawal in the control group.ConclusionsThis trial does not support the clinical effectiveness or cost-effectiveness of joint reminiscence groups. Possible beneficial effects for people with dementia who attend sessions as planned are offset by raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions.Trial registrationISRCTN Registry ISRCTN42430123.

There is evidence that Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy are effective in mild to moderate dementia. There is, however, little evidence available for its implementation in practice and the impact of outreach support on the sustainability of the programme.Two hundred and forty-one staff members were randomised from 63 dementia care settings between outreach support including an online forum, email, and telephone support, compared to usual Cognitive Stimulation Therapy control group. The primary outcome was average number of attendees to the Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy programmes.There was no difference in average number of attendees between the intervention and usual Cognitive Stimulation Therapy control groups for the Cognitive Stimulation Therapy (p = 0.82) or the maintenance Cognitive Stimulation Therapy programme (p = 0.97).Outreach support does not affect the average number of people with dementia attending the Cognitive Stimulation Therapy or maintenance Cognitive Stimulation Therapy programme. Irrespective of outreach support, the programmes remain widely implemented and yield perceived benefits for people with dementia. Copyright © 2017 John WileySons, Ltd.

Background Cognitive stimulation therapy (CST) is a well-established group psychosocial intervention for people with dementia. There is evidence that home-based programmes of cognitive stimulation delivered by family caregivers may benefit both the person and the caregiver. However, no previous studies have evaluated caregiver-delivered CST. This study aimed to evaluate the effectiveness of a home-based, caregiver-led individual cognitive stimulation therapy (iCST) program in (i) improving cognition and quality of life (QoL) for the person with dementia and (ii) mental and physical health (well-being) for the caregiver. Methods and findings A single-blind, pragmatic randomised controlled trial (RCT) was conducted at eight study sites across the United Kingdom. The intervention and blinded assessment of outcomes were conducted in participants’ homes. Three hundred fifty-six people with mild to moderate dementia and their caregivers were recruited from memory services and community mental health teams (CMHTs). Participants were randomly assigned to iCST (75, 30-min sessions) or treatment as usual (TAU) control over 25 wk. iCST sessions consisted of themed activities designed to be mentally stimulating and enjoyable. Caregivers delivering iCST received training and support from an unblind researcher. Primary outcomes were cognition (Alzheimer’s Disease Assessment Scale–cognitive [ADAS-Cog]) and self-reported QoL (Quality of Life Alzheimer’s Disease [QoL-AD]) for the person with dementia and general health status (Short Form-12 health survey [SF-12]) for the caregiver. Secondary outcomes included quality of the caregiving relationship from the perspectives of the person and of the caregiver (Quality of the Carer Patient Relationship Scale) and health-related QoL (European Quality of Life–5 Dimensions [EQ-5D]) for the caregiver. Intention to treat (ITT) analyses were conducted. At the post-test (26 wk), there were no differences between the iCST and TAU groups in the outcomes of cognition (mean difference [MD] = −0.55, 95% CI −2.00–0.90; p = 0.45) and self-reported QoL (MD = −0.02, 95% CI −1.22–0.82; p = 0.97) for people with dementia, or caregivers’ general health status (MD = 0.13, 95% CI −1.65–1.91; p = 0.89). However, people with dementia receiving iCST rated the relationship with their caregiver more positively (MD = 1.77, 95% CI 0.26–3.28; p = 0.02), and iCST improved QoL for caregivers (EQ-5D, MD = 0.06, 95% CI 0.02–0.10; p = 0.01). Forty percent (72/180) of dyads allocated to iCST completed at least two sessions per week, with 22% (39/180) completing no sessions at all. Study limitations include low adherence to the intervention. Conclusions There was no evidence that iCST has an effect on cognition or QoL for people with dementia. However, participating in iCST appeared to enhance the quality of the caregiving relationship and caregivers’ QoL. Trial registration The iCST trial is registered with the ISRCTN registry (identified ISRCTN 65945963, URL: DOI 10.1186/ISRCTN65945963)., In a randomized controlled trial, Martin Orrell and colleagues investigate the impact of individual cognitive stimulation therapy (iCST) on cognition, quality of life, caregiver health, and family relationships for people with dementia., Author summary Why was this study done? Cognitive stimulation therapy (CST) is a structured group activity programme for people with dementia that has been shown to improve quality of life (QOL) and cognition. This therapy is recommended by organisations such as the Alzheimer’s Disease International (ADI) and the UK National Institute for Health and Care Excellence. Although CST is becoming more widely available both in the UK and internationally, some people may not have access to groups because groups are not available near their home, they are not able to get to centres offering groups because of transport, health, or mobility problems, or they would prefer not to do group activities. This study aimed to look at the potential use and benefits of an adapted version of CST called individual CST (iCST) delivered by a family carer or friend at the person with dementia’s home for 30 min ideally two or three times a week. What did the researchers do and find? The research team produced the iCST programme (including a manual, activity workbook, and materials such as maps and dominoes) in collaboration with people with dementia, carers, health care professionals, and experts. In a randomised controlled trial (RCT), 356 pairs of people with dementia and carers were split between two groups; 180 pairs received iCST, and 176 pairs continued with activities, treatments, and services offered as part of usual care but did not receive iCST, to test whether iCST benefits cognition and QOL for people with dementia and mental and physical health for carers. The study found that people with dementia receiving iCST did not benefit in terms of cognition or QOL, and neither was there evidence to suggest iCST improved carers’ mental or physical health. However, people with dementia in the iCST group reported better relationship quality with their family carer at 26 wk, and carers delivering iCST had better QOL at 26 wk. What do these findings mean? We did not find that iCST improves cognition or QOL for people with dementia. Given that iCST appears to have a positive effect on the caregiving relationship and carer well-being, the programme might be a useful part of personally tailored home care packages.

Background Few robust studies have tested whether enhancing housing also improves health. Aim To evaluate the effectiveness of installing ventilation systems, and central heating where necessary, in the homes of children with moderate or severe asthma. Design and setting Pragmatic randomised controlled trial (RCT) in homes within Wrexham County Borough, Wales, UK. Method A pragmatic RCT was carried out, of a tailored package of housing improvements providing adequate ventilation and temperature, following inspection by a housing officer. One hundred and ninety-two children with asthma aged 5 to 14 years, identified from general practice registers, were randomised to receive this package, either immediately or a year after recruitment. At baseline, and after 4 and 12 months, parents reported their child's asthma-specific and generic quality of life, and days off school. Results The package improved parent-reported asthma-specific quality of life significantly at both 4 and 12 months. At 12 months, this showed an adjusted mean difference between groups of 7.1 points (95% confidence interval [CI] = 2.8 to 11.4, P = 0.001): a moderate standardised effect size of 0.42. The generic quality-of-life scale showed reported physical problems were significantly reduced at 4 months, but not quite at 12 months, when the mean difference was 4.5 (95% CI = -0.2 to 9.1, P = 0.061). The improvement in psychosocial quality of life at 12 months was not significant, with a mean difference of 2.2 (95% CI = -1.9 to 6.4, P = 0.292). Parent-reported school attendance improved, but not significantly Conclusion This novel and pragmatic trial, with integrated economic evaluation, found that tailored improvement of the housing of children with moderate to severe asthma significantly increases parent-reported asthma-related quality of life and reduces physical problems. Collaborative housing initiatives have potential to improve health.

The use of Latin squares and related block designs in implementation research Ian Nicholas Steen*, Marion K. Campbell, Martin P. Eccles, Jeremy M. Grimshaw, Craig R. Ramsay, Ian T. Russell Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle Upon Tyne, NE2 4AX, UK Health Services Research Unit, Aberdeen University, 3rd Floor, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK Clinical Epidemiology Program, Ottawa Hospital Research Institute and Department of Medicine, University of Ottawa, Centre for Practice-Changing Research (CPCR), 501 Smyth Road, Room 1286, Ottawa, Ontario K1H 8L6, Canada College of Medicine, Swansea University, Institute of Life Science 2, Singleton Park, Swansea, SA2 8PP, UK

Background: The debate continues regarding the best management for women with low-grade abnormal cervical cytology attending colposcopy. We compared psychosocial outcomes of alternative management policies in these women. Methods: In all, 989 women, aged 20–59 years, with low-grade abnormal cytology, were randomised to immediate large loop excision (LLETZ) or two to four targeted punch biopsies taken immediately with recall for LLETZ if these showed cervical intra-epithelial neoplasia 2/3. At 6 weeks after the last procedure, women completed the hospital anxiety and depression scale (HADS) and the impact of event scale (IES). At 12, 18, 24 and 30 months post recruitment, women completed the HADS and process outcome specific measure (POSM). Prevalence of significant depression (⩾8), significant anxiety (⩾11) and distress (⩾9) and median POSM scores were compared between arms. Multivariate odds ratios (ORs) for immediate LLETZ vs biopsy and recall were computed. Results: Over the entire follow-up, there was no significant difference between arms in cumulative prevalence or risk of significant depression (OR=0.78, 95% CI 0.52–1.17) or significant anxiety (OR=0.83, 95% CI 0.57–1.19). At 6 weeks post procedure, distress did not differ significantly between arms. At later time points, 8–11% had significant depression and 14–16% had significant anxiety but with no differences between arms. The POSM scores did not differ between the arms. Conclusions: There is no difference in long- or short-term psychosocial outcomes of immediate LLETZ and punch biopsies with selective recall.

This article presents four focus groups conducted with health professionals, part of a mixed-method evaluation of modernization of endoscopy services in England catalyzed by the UK National Health Service Modernisation Agency. Transcripts were analyzed adapting van Manen’s “sententious” or “wholistic” approach to thematic analysis. Seven analysts worked to distil lengthy transcripts into summative paragraphs to capture the essentiality of text. Five major themes emerged: lack of senior management understanding and appropriate management systems, inadequate resources, loss of personal autonomy and erosion of professionalism, barriers and facilitators to change, and differences between English and Welsh units—the Welsh perspective . Achieving long-lasting, positive effects of modernization within complex systems demands senior management to actively support innovations, consider staff morale, and provide appropriate levels of funding. However, although professional morale was low, ambition to improve services was strong. The methodological framework offered a comprehensive and applicable approach to data analysis, and our analysis approach was inclusive and collaborative, with far-reaching possibilities for experimental studies and large-scale, mixed-method studies, including trials.

Aims Intensive 5-day educational interventions for people with Type 1 diabetes have shown improved outcomes in a number of European studies. The aim was to assess the effectiveness of a brief (2.5 days) psycho-educational intervention.Methods Our randomized trial in a secondary-care setting had 54 and 60 participants allocated to intervention and control groups, respectively. Primary outcomes were HbA1c and severe hypoglycaemia. Secondary outcomes were blood pressure, weight, height, lipids and psychometric profile.Results HbA1c showed no statistically significant change at 3 months [difference = 0.01, 95% confidence interval (CI) –0.23, 0.26, P = 0.92], 6 months (difference = –0.06, 95% CI –0.32, 0.20, P = 0.67) and 12 months (difference = 0.01, 95% CI –0.30, 0.32, P = 0.94). Incidence of severe hypoglycaemia (per patient per year) in the intervention group (0.41) and control group (0.48) was not statistically different. Treatment satisfaction improved at 3 months (difference = 9.4, 95% CI 5.2, 13.6, P = 0.0005), 6 months (difference = 10.4, 95% CI 6.0, 14.8, P = 0.0005) and 12 months (difference = 7.1, 95% CI 2.1, 12.1, P = 0.006). The ‘Managing psychological aspects’ and ‘Setting and achieving goals’ dimensions of the Diabetes Empowerment Scale also showed significant improvement at 3, 6 and 12 months. Diabetes Knowledge Test, Illness Perception Questionnaire, Hypoglycaemia Fear Scale and Short Form 36 showed no significant change.Conclusions This brief intervention had no significant impact on HbA1c or severe hypoglycaemia, but improved diabetes treatment satisfaction and patient empowerment. Current Controlled Trials ISRCTN75807800.

Objective We investigated the differences in response rates and the presence of response bias in two randomized surveys of prescribing intentions for statins and asthma. Study Design and Setting We conducted the surveys of British general practitioners (GPs) in 2002. The two surveys had similar designs, formats, administration time, administration methods, and target populations. We compared the response rates to the two surveys while controlling for the characteristics of respondents with nonrespondents. We also compared early respondents with late respondents and assessed heterogeneity in the answers of early and late respondents to two key questions. Results The response rates to the two surveys were significantly different (statins: 27%; asthma: 19%; P =0.002). We found no interaction between the survey type and any of the GP and practice characteristics we examined. The GPs' answers to the key questions did not differ regardless of the timing of the responses. Conclusion We demonstrated that the surveys' contents significantly influenced the response rates. We found no evidence that the nonrespondents would have answered the key questions differently. Future studies should investigate the mechanisms by which contents of surveys may influence response rate.

OBJECTIVE Book Prescription Wales (BPW) is a pilot bibiliotherapy scheme launched in July 2005 as a primary care treatment option for people with mild to moderate mental health problems. In an innovative model, patients are prescribed self-help books from a list, to borrow from local libraries. Our objective was to evaluate its implementation, focusing on the issue of equity of service delivery. METHODS Data were gathered from Welsh Assembly Government concerning project set-up and borrowing rates. Mailed questionnaires were completed by 21/22 (95.4%) Local Health Boards and 44/64 (68.8%) Community Mental Health Teams. In addition, 327 out of 497 (66%) primary care practices were surveyed by telephone, 20 prescribers took part in in-depth telephone interviews and three focus groups were conducted with library staff. RESULTS From July 2005-March 2006, books were borrowed 15,236 times. There was a 10-fold variation in borrowing rates across local authorities (1.07 to 10.18 loans/1000 people). The priority which Local Health Board staff reported giving to the scheme varied. Uptake among prescribers was mixed: in 35% of general practices (n = 116) no-one participated. Prescribers reported different ways of using the bibliotherapy scheme. Library staff reported issues of patchy uptake. CONCLUSION Variation in usage of bibliotherapy raises questions about equity; it is unlikely to reflect the distribution of people who could potentially benefit. Factors influencing variation existed all along the implementation chain. It is not always possibly to separate demand-side and supply-side factors when considering equity and service innovation in health care.

Introduction Emergency admission risk prediction models are increasingly used to identify patients, typically with one or more chronic conditions, for proactive management in primary care to avoid admissions, save costs and improve patient experience. Aim To identify and review the published evidence on the costs, effects and implementation of emergency admission risk prediction models in primary care for patients with, or at risk of, chronic conditions. Methods We shall search for studies of healthcare interventions using routine data-generated emergency admission risk models. We shall report: the effects on emergency admissions and health costs; clinician and patient views; and implementation findings. We shall search ASSIA, CINAHL, the Cochrane Library, HMIC, ISI Web of Science, MEDLINE and Scopus from 2005, review references in and citations of included articles, search key journals and contact experts. Study selection, data extraction and quality assessment will be performed by two independent reviewers. Ethics and dissemination No ethical permissions are required for this study using published data. Findings will be disseminated widely, including publication in a peer-reviewed journal and through conferences in primary and emergency care and chronic conditions. We judge our results will help a wide audience including primary care practitioners and commissioners, and policymakers. Trial registration number CRD42015016874; Pre-results.

Background Accidental needle-stick injuries (NSIs) are a hazard for health-care workers and for the general public. Objectives To estimate the presentation rate of NSIs to general medical practices, their relation to practice characteristics, and review practice policies for managing NSIs. Method Descriptive study using logistic regression analysis. Results Annual rates of 2.73 (95% CI 2.08, 3.50) occupational NSIs per 100 clinical practice staff and 2.14 (95% CI 1.39, 3.13) nonoccupational NSIs per 100 000 practice population were recorded. Stepwise logistic regressions showed that chance of a practice reporting at least one occupational NSI in previous five years was best predicted by being a single-handed practice (decreased odds). In contrast, the chance of a practice reporting at least one non-occupational NSI was best predicted by being a rural practice (increased odds). About one in five practices possessed no written policy on managing NSIs. Stepwise logistic regressions showed that the chance of a practice owning a NSI policy was best predicted by being located in an LHB area with a coastline (increased odds). Conclusion NSIs are an important public health issue in Wales. We have tried to address the lack of guidance by developing new guidelines in Wales.

Rural and urban differences in the effects of care-giving are not well documented. This paper reports data on 122 carers for people with stroke or dementia living in rural and urban settings in Wales.Carers completed a postal questionnaire, including the SF-12v2 Health Survey. Definitions of rural and urban were based on the Urban/Rural Indicator from the Office of National Statistics (ONS) All Fields Postcode Directory 2004.Carers' mean Mental Component Summary (MCS) score (adjusted for age and sex) was one standard deviation below the population mean (-12.03). Male carers living in urban areas reported better mental health than male carers in rural areas (p0.05) and female carers in both settings (p0.05). A full model and a parsimonious model were developed, using MCS scores as outcome variables. In the full model sitting service provision in rural and urban locations was linked to better carer mental health, while support from friends and family was linked to better mental health for urban carers only.Our findings indicate the existence of both gender and location differences in carer experiences.

BackgroundLittle is known about the treatment of delusional parasitosis with typical and atypical antipsychotics.AimsTo evaluate the effectiveness of typical and atypical antipsychotics in primary delusional parasitosis (delusional disorder, somatic type).MethodA systematic review was conducted.ResultsNo randomised trials were found and hence we collected the best evidence from 16 other trials and case reports, separating primary from other forms of delusional parasitosis. Studies using typical antipsychotics showed partial or full remission in between 60 and 100% of patients. Analysis of selected patients with primary delusional parasitosis showed that typical and atypical antipsychotics were effective in the majority, but that remission rates did not differ significantly between typical and atypical antipsychotics.ConclusionsIn the absence of controlled trials there is limited evidence that antipsychotics are effective in primary delusional parasitosis. Rigorous studies are needed to evaluate their effectiveness and to compare typical and atypical antipsychotics directly.

Background There has been continuing change in the nature of care homes in the UK with 80 % of residents now living with some form of dementia or memory problem. Caring in this environment can be complex, challenging and stressful for staff; this can affect the quality of care provided to residents, lead to staff strain and burnout, and increase sickness, absence and turnover rates. It is therefore important to find interventions to increase the wellbeing of staff that will not only benefit staff themselves but also residents and care providers. Mindfulness training is known to be effective in treating a variety of physical and mental health conditions. Methods and design The study uses mixed methods centred on a stepped-wedge cluster randomised trial. Thirty care homes in Wales are implementing a brief web-based mindfulness training course, starting in random sequence. Four to ten consenting staff from each facility undertake the course and complete validated questionnaires at baseline and after eight and 20 weeks. We shall also interview a stratified sample of ten trained staff and analyse the transcripts thematically. The primary outcome is stress; secondary outcomes include job satisfaction, attitudes towards residents and sickness absence rates. Discussion With increasing numbers of people living with dementia in care homes and causing stress in their carers, it is important to evaluate support strategies for staff. Mindfulness-based therapies may be of potential benefit and need detailed examination. Trial registration ISRCTN registry. ISRCTN80487202. Registered 24 July 2013.

The objective of the study is to examine caregiver factors as predictors of BPSD-related distress and their potential mechanisms.Informal caregivers of people with dementia (n = 157) recruited from 28 community mental health teams in six NHS Trusts across England completed questionnaires regarding psychosocial factors (relationship quality, competence, guilt, health-related quality of life in the caregiver and person with dementia, reactivity to behavioural and psychological symptoms in dementia [BPSD] and burden) and frequency of BPSD. Analyses of BPSD-related distress include hierarchical multiple regression, mediation, moderation and path analysis.Caregiver psychosocial factors explained 56% of the variance in BPSD-related distress. After controlling for these factors, frequency of BPSD was not a significant predictor of BPSD-related distress. Caregiver reactivity to BPSD, burden, competence and relationship quality directly influenced BPSD-related distress. Guilt influenced distress indirectly via competence, burden and reactivity to BPSD. The final model accounted for 41% of the variance in BPSD-related distress and achieved a good fit to the data (χCaregiver psychosocial factors including sense of competence, guilt, burden and reactivity to BPSD contribute to BPSD-related distress. Tailored interventions for managing behaviour problems in family settings could focus on these factors associated with BPSD-related distress to minimise distress in families. Copyright © 2016 John WileySons, Ltd.