Using linked administrative data for monitoring and evaluating the Family Nurse Partnership in England: A scoping report

This report, commissioned by the FNP National Unit and undertaken by researchers at UCL and the London School of Hygiene and Tropical Medicine, presents a scoping review of how population-based linkage between data from the Family Nurse Partnership (FNP) in England and administrative datasets from other services could be used to generate evidence for commissioning, service evaluation and research. It addresses the methodological considerations, permission pathways and technical challenges of using data from the FNP linked with routinely collected, administrative data from other public services for population-based analyses, at a national and local authority level. Our ambition, when commissioning this work, was to explore whether linking data from FNP with administrative datasets might help provide a richer view about how the FNP intervention is affecting different cohorts of clients and their child after they have graduated. The report suggests that the potential for data linkage to support ongoing evaluation of a wide range of interventions including FNP at a national level is promising and an important area to explore. It makes a significant contribution to understanding the possibilities and constraints for doing this, which include barriers to data linkage at a local level (which we know is crucial for local commissioners) and the significant investment required to realise the potential of this project. We believe this report offers valuable insights other organisations interested in the delivery of evidence based policy may want to pursue

Indicators of adversity recorded in hospitalisation records of children aged less than 5 years or their mothers: a record linkage study of children born in England in 2011

Background Early identification of child adversity (comprising abuse, neglect, social or material adversity) is essential to target early interventions to safeguard children, and support vulnerable families. We determined the prevalence of indicators of adversity recorded in diagnostic codes in child and/or maternal hospital admissions in England. Data Source All birth admissions recorded in the NHS in England in 2011, and subsequent admissions up to 5 years old, linked to maternal records from 1 year before to up to 5 years after delivery. Methods Prevalence of adversity indicators in child and/or maternal admission records that reflect adversity-related injury (ARI), or social or material adversity (SMA). Results Among 646,956 live born children, 2.6% (95% CI: 2.6 to 2.7) had at least one adversity indicator by <5 years (0.8% ARI, 2.6% SMA). Cumulative prevalence was 1.1% in children aged <6 months, 1.2% in children aged <1 year, 2.1% by <=2 years, and 2.6% up to 5 years old. Combined prevalence in maternal and/or child records will be presented. Conclusion To inform health policy, clinical and prognostic significance of adversity indicators requires evaluation through linkage to health and welfare outcomes

Exploring research participation among cancer patients: Analysis of a national survey and an in-depth interview study

Background Inequalities in cancer research participation are thought to exist with certain groups under-represented in research populations; however, much of the evidence is based on small-scale studies. The aim of this study was to explore data from in-depth interviews with cancer patients and a large national survey to investigate variation in who is asked to participate in research and who takes part. Methods Factors associated with research discussion and participation were explored in National Cancer Patient Experience Survey data using multivariate logistic regression and during in-depth interviews with 25 breast cancer patients. Results Survey data were available for 66,953 cancer patients; 30.4 % reported having discussions about, and 18.9 % took part in, research. Barriers to participation at staff, patient and trust level were evident; for example, staff were less likely to discuss research with older patients, Asian and black patients were less likely to take part and patients treated at specialist or teaching trusts had higher levels of discussion and participation. Interviews showed that patients’ willingness to participate changed over time and was not synonymous with participation as some were ineligible. Conclusion Some patient groups were less likely to have discussions about or participate in research. Analysis of this variation vis-à-vis the composition of the patient population may be useful to ensure that there is equity regarding the potential benefits of research participation and that research findings are applicable to target populations in the translational model

The effects of cancer research participation on patient experience: a mixed-methods analysis.

Patient-reported benefits of research participation have been described by study participants; however, many studies have small sample sizes or are limited to patient groups with poor prognoses. The purpose of this study was to explore the effects of research participation on patient experience using survey responses from a large, national sample of cancer patients (N = 66 462) and interviews with breast cancer patients attending a London trust. Multivariate logistic regression was used to investigate associations between taking part in research and positive patient experience. Based on our analysis, patients who participated in research were more likely to rate their overall care and treatment as 'very good/excellent' (ORadj :1.64, 95%CI: 1.53-1.76, P < 0.001) and to describe positive patient experiences, such as better access to non-standard care, better interactions with staff and being treated as an individual. However, findings from our interviews indicated that there was no common understanding of what constitutes cancer research and no clear delineation between research participation and standard care, from the patient perspective. Further work to explore how participation positively influences patient experience would be useful to develop strategies to improve care and treatment for all patients regardless of whether or not they choose, or have the opportunity, to take part in research

Study protocol: a mixed-methods study to evaluate which health visiting models in England are most promising for mitigating the harms of adverse childhood experiences

Introduction: Exposure to adverse childhood experiences (ACEs) is associated with poorer health outcomes throughout life. In England, health visiting is a long-standing, nationally implemented service that aims to prevent and mitigate the impact of adversity in early childhood, including for children exposed to ACEs. A range of health visiting service delivery practices exist across England (from the minimum five recommended contacts to tailored intensive interventions), but there is a lack of evidence on who receives what services, how this varies across local authorities (LAs) and the associated outcomes. Methods and analysis: This study will integrate findings from analysis of individual-level, deidentified administrative data related to hospital admissions (Hospital Episode Statistics (HES)) and health visiting contacts (Community Services Data Set (CSDS)), aggregate LA-level data, in-depth case studies in up to six LAs (including interviews with mothers), a national survey of health visiting services, and workshops with stakeholders and experts by experience. We will use an empirical-to-conceptual approach to develop a typology of health visiting service delivery in England, starting with a data-driven classification generated from latent class analysis of CSDS-HES data, which will be refined based on all other available qualitative and quantitative data. We will then evaluate which models of health visiting are most promising for mitigating the impact of ACEs on child and maternal outcomes using CSDS-HES data for a cohort of children born on 1 April 2015 to 31 March 2019. Ethics and dissemination: The University College London Institute of Education Research Ethics Committee approved this study. Results will be submitted for publication in a peer-reviewed journal and summaries will be provided to key stakeholders including the funders, policy-makers, local commissioners and families

Stratified, precision or personalised medicine? Cancer services in the 'real world' of a London hospital

We conducted ethnographic research in collaboration with a large research-intensive London breast cancer service in 2013-14 so as to understand the practices and potential effects of stratified medicine. Stratified medicine is often seen as a synonym for both personalised and precision medicine but these three terms, we found, also related to distinct facets of treatment and care. Personalised medicine is the term adopted for the developing 2016 NHS England Strategy, in which breast cancer care is considered a prime example of improved biological precision and better patient outcomes. We asked how this biologically stratified medicine affected wider relations of care and treatment. We interviewed formally 33 patients and 23 of their carers, including healthcare workers; attended meetings associated with service improvements, medical decision-making, public engagement, and scientific developments as well as following patients through waiting rooms, clinical consultations and other settings. We found that the translation of new protocols based on biological research introduced further complications into an already-complex patient pathway. Combinations of new and historic forms of stratification had an impact on almost all patients, carers and staff, resulting in care that often felt less rather than more personal

Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial

Background Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. Methods RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Interpretation Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society