National Health Service Secondary Care Research Articles

Study protocol: optical coherence tomography angiography for the detection of neovascular age-related macular degeneration: a comprehensive multicentre diagnostic accuracy study in the UK—the ATHENA study

IntroductionThe diagnosis of neovascular age-related macular degeneration (nAMD), the leading cause of visual impairment in the developed world, relies on the interpretation of various imaging tests of the retina. These...

Off-pump injectable versus on-pump conventional tissue valves for pulmonary valve replacement: the injectable valve implantation randomised trial (INVITE)

ObjectivesTo assess the effectiveness of injectable tissue pulmonary valve compared with standard pulmonary valve in patients requiring pulmonary valve replacement surgery.DesignA multicentre, single-blind, parallel two-group randomised controlled trial. Participants were...

National statutory reporting: not even ticking the boxes? The quality of ‘Learning from Deaths’ reporting in quality accounts within the NHS in England 2017–2020

IntroductionRegulation through statutory reporting is used in healthcare internationally to improve accountability, quality of care and patient safety. Since 2017, within the National Health Service (NHS) in England, NHS Secondary...

Is anybody ‘Learning’ from deaths? Sequential content and reflexive thematic analysis of national statutory reporting within the NHS in England 2017–2020

IntroductionThe imperative to learn when a patient dies due to problems in care is absolute. In 2017, the Learning from Deaths (LfDs) framework, a countrywide patient safety programme, was launched...

Study protocol for a randomised placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression (the PAX-BD study)

BackgroundTreatment Resistant Bipolar Depression (TRBD) is a major contributor to the burden of disease associated with Bipolar Disorder (BD). Treatment options for people experiencing bipolar depression are limited to three interventions listed by National Institute for Health and Care: lamotrigine, quetiapine and olanzapine, of which the latter two are often not well tolerated. The majority of depressed people with BD are therefore prescribed antidepressants despite limited efficacy. This demonstrates an unmet need for additional interventions. Pramipexole has been shown to improve mood symptoms in animal models of depression, in people with Parkinson’s Disease and two proof of principle trials of pramipexole for people with BD who are currently depressed.MethodsThe PAX-BD study, funded by the United Kingdom (UK) National Institute for Health Research, aims to extend previous findings by assessing the efficacy, safety and health economic impact of pramipexole in addition to mood stabilisers for patients with TRBD. A randomised, double-blind, placebo controlled design is conducted in a naturalistic UK National Health Service setting. An internal pilot study to examine feasibility and acceptability of the study design is included. Participants with TRBD are screened from National Health Service secondary care services in up to 40 mental health trusts in the UK, with the aim of recruiting approximately 414 participants into a pre-randomisation phase to achieve a target of 290 randomised participants. Primary safety and efficacy measures are at 12 weeks following randomisation, with follow up of participants to 52 weeks. The primary outcome is depressive symptoms as measured by Quick Inventory for Depressive Symptomatology – Self Report. Secondary outcomes include changes in anxiety, manic symptoms, tolerability, acceptability, quality of life and cost-effectiveness. Outcome measures are collected remotely using self-report tools implemented online, and observer-rated assessments conducted via telephone. ANCOVA will be used to examine the difference in rating scale scores between treatment arms, and dependent on compliance in completion of weekly self-report measures. A mixed effects linear regression model may also be used to account for repeated measures.Trial registrationISRCTN72151939. Registered on 28 August 2019, http://www.isrctn.com/ISRCTN72151939Protocol Version: 04-FEB-2021, Version 9.0.

Evolving Treatment Patterns and Outcomes of Neovascular Age-Related Macular Degeneration Over a Decade

Management of neovascular age-related macular degeneration (nAMD) has evolved over the last decade with several treatment regimens and medications. This study describes the treatment patterns and visual outcomes over 10 years in a large cohort of patients. Retrospective analysis of electronic health records from 27 National Health Service secondary care healthcare providers in the UK. Treatment-naïve patients receiving at least 3 intravitreal anti-vascular endothelial growth factor (VEGF) injections for nAMD in their first 6 months of follow-up were included. Patients with missing data for age or gender and those aged less than 55 years were excluded. Eyes with at least 3 years of follow-up were grouped by years of treatment initiation, and 3-year outcomes were compared between the groups. Data were generated during routine clinical care between September 2008 and December2018. Visual acuity (VA), number of injections, and number of visits. A total of 15 810 eyes of 13 705 patients receiving 195 104 injections were included. Visual acuity improved from baseline during the first year, but decreased thereafter, resulting in loss of visual gains. This trend remained consistent throughout the past decade. Although an increasing proportion of eyes remained in the driving standard, this was driven by better presenting VA over the decade. The number of injections decreased substantially between the first and subsequent years, from a mean of 6.25 in year 1 to 3 in year 2 and 2.5 in year 3, without improvement over the decade. In a multivariable regression analysis, final VA improved by 0.24 letters for each year since 2008, and younger age and baseline VA were significantly associated with VA at 3 years. Our findings show that despite improvement in functional VA over the years, primarily driven by improving baseline VA, patients continue to lose vision after the first year of treatment, with only marginal change over the past decade. The data suggest these results may be related to suboptimal treatment patterns, which have not improved over the years. Rethinking treatment strategies may be warranted, possibly on a national level or through the introduction of longer-acting therapies.

Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis.

ObjectivesIntra-articular steroid injection is commonly used to treat base of thumb osteoarthritis (BTOA), despite a lack of large-scale data on safety and effectiveness. We estimate the incidence of serious complications and further procedures following BTOA injection, including the risk of post-operative serious surgical site infection for subsequent operative intervention.MethodsHospital Episode Statistics data linked to mortality records from 1 April 1998 to 31 March 2017 were used to identify all BTOA injections undertaken in adults in the National Health Service secondary care in England. Patients were followed up longitudinally until death or 31 March 2017. A multivariable regression with a Fine and Gray model adjusting for the competing risk of mortality in addition to age, sex and socioeconomic deprivation was used to identify factors associated with progression to further procedure. Secondary outcomes included serious complications after injection and subsequent surgical site infection.ResultsA total of 19 120 primary injections were performed during the 19-year period in 18 356 patients. Of these 76.5% were female; mean age 62 years (s.d. 10.6); 50.48% underwent further procedure; 22.40% underwent surgery. Median time to further intervention was 412 days (IQR 110–1945). Female sex was associated with increased risk of proceeding to surgery. Serious complication rate following injection was 0.04% (0.01–0.08) within 90 days. Of those proceeding to surgery 0.16% (0.06–0.34) presented with a wound infection within 30 days and 90 days, compared with an overall post-operative wound infection rate of 0.03% (0.02–0.05).ConclusionsVery low rates of serious complications were identified following BTOA injections performed in secondary care; only one in five patients proceeded to subsequent surgery.Clinical trial registrationclinicaltrials.gov, https://www.clinicaltrials.gov, NCT03573765

Evaluating follow-up and complexity in cancer clinical trials (EFACCT): an eDelphi study of research professionals’ perspectives

ObjectivesTo evaluate patient follow-up and complexity in cancer clinical trial delivery, using consensus methods to: (1) identify research professionals’ priorities, (2) understand localised challenges, (3) define study complexity and workloads...

Predictors of disengagement from cognitive behavioural therapy for psychosis in a National Health Service setting: A retrospective evaluation

To evaluate whether demographic and clinical variables are related to disengagement rates in cognitive behavioural therapy (CBT) for psychosis in a clinical setting. The medical records and symptom severity data (from Health of the Nation Outcome Scales) were analysed retrospectively for 103 referrals for CBT for psychosis in a National Health Service secondary care and Early Intervention in Psychosis team. Overall, 42.7% (n=44) disengaged from CBT. There was no impact of gender or ethnicity, and no impact of clinical variables such as risk history and comorbid diagnosis. However, risk of disengagement was significantly higher for those who were younger, F=6.89, partial η2 =.064, p=<.05; those with greater total HoNOS scores, F=4.22, partial η2 =.04, p<.05; more severe symptoms on the HoNOS items of overactive, aggressive, disruptive, or agitated behaviour, χ2 =6.13, p<.01; problem drinking or drug taking, χ2 =7.65, p<.05; depressed mood, χ2 =7.0, p<.01; and problems with occupation and activities: χ2 =3.68, p<.05. There was a non-significant trend for shorter waiting times to be associated with greater levels of disengagement. These results indicate that it may not be psychosis per se that disrupts engagement in CBT, but linked behavioural and emotional factors. A more assertive approach to these factors - overactive, aggressive, disruptive, or agitated behaviour, problem drinking or drug taking, depressed mood, and problems with occupation and activities, particularly in younger people - may be valuable prior to or early on in therapy as a means of increasing engagement in CBT for psychosis. Risk of disengagement from CBT for psychosis increases with overactive, aggressive, disruptive, or agitated behaviour (54.9% vs. 30.8%), problem drinking and drug taking (61.1% vs. 32.8%), depressed mood (56% vs. 30.2%), and problems with occupation and activities (53.3% vs. 34.5%), with a trend for younger age. An assertive and motivational approach to engagement and a focus on addressing low mood and problematic behaviours, prior to or early in therapy, may be warranted, particularly for younger people. This evaluation is limited by small sample size and being retrospective. These results speak to the question of whether psychosis itself renders people inappropriate for CBT for psychosis, or whether problems arise due to behavioural and emotional factors that might be addressed to increase access to CBT for psychosis.

Intention, beliefs and mood assessed using electronic diaries predicts attendance at cardiac rehabilitation: An observational study

BackgroundCardiac rehabilitationis effective in promoting physical/psychological recovery following acute coronary syndrome. Yet, rates of attendance at outpatient cardiac rehabilitation by eligible patients are low. ObjectivesThis study examined the determinants of attendance at outpatient cardiac rehabilitation in acute coronary syndrome patients following discharge until cardiac rehabilitation commencement. DesignA weekly electronic diary measured cardiac-related cognitions and mood and examined their relation to attendance at outpatient cardiac rehabilitation. SettingsThree United Kingdom National Health Service secondary care settings in two Health Board areas in Scotland. ParticipantsAcute coronary syndrome patients were recruited from March 2012 to June 2013 prior to hospital discharge. Of 488 eligible patients referred for cardiac rehabilitation, 214 consented. MethodsConsecutive patients completed a pre-hospital discharge questionnaire targeting age, diagnosis, social class and smoking history. Acute coronary syndrome patients then completed a weekly electronic diary from the first week of discharge until the start of cardiac rehabilitation. Multilevel structural equation models estimated the effects of initial, i.e. baseline and rate of change in cardiac-related cognition and mood on attendance. Intention to attend cardiac rehabilitation was reflected, log transformed, reported thereafter as “do not intend”. The role of “do not intend” was explored as a mediator of the relationship between cardiac-related cognition and mood on attendance. Results166 participants provided, on average, 5 weeks of diary entries before cardiac rehabilitation commenced. High intention (i.e. low “do not intend”) to attend CR and its rate of increase over time predicted attendance. Low negative emotional representation, high perceived necessity, high confidence in maintaining function, low negative affect, and high positive affect following discharge predicted attendance at cardiac rehabilitation. The rate of change in cardiac-related mood and these cognitions was not predictive. Baseline and rate of change in “do not intend” entirely mediated relationships between a) perceived necessity, b) negative affect and attendance at cardiac rehabilitation. ConclusionsNegative affect in the first weeks following discharge represents the key challenge to a patient maintaining their intention to attend cardiac rehabilitation. Intervention to improve attendance should focus on improving intention to attend following discharge and during recovery by improving patient understanding of cardiac rehabilitation and reducing negative affect.

Implementing electronic records in NHS secondary care organizations in England: policy and progress since 1998.

A number of different policies have aimed to introduce electronic records into National Health Service (NHS) secondary care organizations in England over recent years. There has been little formal attempt to explore the overall impact of these policies (as opposed to evaluations of individual initiatives) and how they have developed and progressed over time. National NHS IT policy documents and evaluations of national NHS IT policy between 1998 and 2015. There has been limited progress in implementing integrated electronic records in secondary organizations since 1998. The management and execution of NHS IT policy has been poor, with over ambitious aims contributing to the limited success. Detailed guidance on how to implement electronic records in secondary care organizations is required. The ambitions of current policy should be revisited. Research exploring the costs and benefits of different approaches to introducing electronic records is needed.

The impact of the introduction of fidaxomicin on the management of Clostridium difficile infection in seven NHS secondary care hospitals in England: a series of local service evaluations.

Clostridium difficile infection (CDI) is associated with high mortality. Reducing incidence is a priority for patients, clinicians, the National Health Service (NHS) and Public Health England alike. In June 2012, fidaxomicin (FDX) was launched for the treatment of adults with CDI. The objective of this evaluation was to collect robust real-world data to understand the effectiveness of FDX in routine practice. In seven hospitals introducing FDX between July 2012 and July 2013, data were collected retrospectively from medical records on CDI episodes occurring 12 months before/after the introduction of FDX. All hospitalised patients aged ≥18 years with primary CDI (diarrhoea with presence of toxin A/B without a previous CDI in the previous 3 months) were included. Recurrence was defined as in-patient diarrhoea re-emergence requiring treatment any time within 3 months after the first episode. Each hospital had a different protocol for the use of FDX. In hospitals A and B, where FDX was used first line for all primary and recurrent episodes, the recurrence rate reduced from 10.6 % to 3.1 % and from 16.3 % to 3.1 %, with a significant difference in 28-day mortality from 18.2 % to 3.1 % (p < 0.05) and 17.3 % to 6.3 % (p < 0.05) for hospitals A and B, respectively. In hospitals using FDX in selected patients only, the changes in recurrence rates and mortality were less marked. The pattern of adoption of FDX appears to affect its impact on CDI outcome, with maximum reduction in recurrence and all-cause mortality where it is used as first-line treatment.

Collaborative working within UK NHS secondary care and across sectors for COPD and the impact of peer review: qualitative findings from the UK National COPD Resources and Outcomes Project

WE INVESTIGATED THE EFFECTS ON COLLABORATIVE WORK WITHIN THE UK NATIONAL HEALTH SERVICE (NHS) OF AN INTERVENTION FOR SERVICE QUALITY IMPROVEMENT: informal, structured, reciprocated, multidisciplinary peer review with feedback and action plans. The setting was care for chronic obstructive pulmonary disease (COPD). We analysed semi-structured interviews with 43 hospital respiratory consultants, nurses and general managers at 24 intervention and 11 control sites, as part of a UK randomised controlled study, the National COPD Resources and Outcomes Project (NCROP), using Scott's conceptual framework for action (inter-organisational, intra-organisational, inter-professional and inter-individual). Three areas of care targeted by NCROP involved collaboration across primary and secondary care. Hospital respiratory department collaborations with commissioners and hospital managers varied. Analysis suggested that this is related to team responses to barriers. Clinicians in unsuccessful collaborations told 'atrocity stories' of organisational, structural and professional barriers to service improvement. The others removed barriers by working with government and commissioner agendas to ensure continued involvement in patients' care. Multidisciplinary peer review facilitated collaboration between participants, enabling them to meet, reconcile differences and exchange ideas across boundaries. The data come from the first randomised controlled trial of organisational peer review, adding to research into UK health service collaborative work, which has had a more restricted focus on inter-professional relations. NCROP peer review may only modestly improve collaboration but these data suggest it might be more effective than top-down exhortations to change when collaboration both across and within organisations is required.

Migration and the Human Right to Health

In December 2007 it was revealed that the British government is considering the exclusion of certain groups of migrants—those considered to be present “illegally”—from primary health care provided by the National Health Service (NHS). At present, practitioners have discretion to accept any individual for NHS treatment regardless of their status. A joint Home Office and Department of Health review is examining this access for foreign nationals, and the likely outcome is the restriction of access to irregular migrants, which would, according to the Institute of Public Policy Research, affect around 390,000 people. In 2004 such groups were excluded from NHS secondary care, most controversially from treatment for HIV, and so the present proposal would bar them from all but emergency health treatment.

Local initiatives in clinical effectiveness

With the arrival of clinical governance, psychiatrists working for the National Health Service (NHS) can no longer work in isolation, and commitment to both clinical effectiveness and continuing professional development (CPD) is expected and likely to become mandatory. Clinical governance gives clinical effectiveness a high priority within NHS organisations, both at primary and secondary care levels, together with clearer lines of accountability.