scholarly journals Cross-sectional analysis of UK research studies in 2015: results from a scoping project with the UK Health Research Authority

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e022340 ◽  
Author(s):  
Tim Clark ◽  
Richard H Wicentowski ◽  
Matthew R Sydes
Keyword(s):  
Health Research ◽  
Clinical Studies ◽  
Public Involvement ◽  
Secondary Outcome ◽  
Ethical Review ◽  
Free Text ◽  
Research Activities ◽  
The Uk ◽  
The Impact ◽  
Research Studies

ObjectivesTo determine whether data on research studies held by the UK Health Research Authority (HRA) could be summarised automatically with minimal manual intervention. There are numerous initiatives to reduce research waste by improving the design, conduct, analysis and reporting of clinical studies. However, quantitative data on the characteristics of clinical studies and the impact of the various initiatives are limited.DesignFeasibility study, using 1 year of data.SettingWe worked with the HRA on a pilot study using research applications submitted for UK-wide ethical review. We extracted into a single dataset, information held in anonymised XML files by the Integrated Research Application System (IRAS) and the HRA Assessment Review Portal (HARP). Research applications from 2014 to 2016 were provided. We used standard text extraction methods to assess information held in free-text fields. We use simple, descriptive methods to summarise the research activities that we extracted.ParticipantsNot applicable—records-based studyInterventionsNot applicable.Primary and secondary outcome measuresFeasibility of extraction and processing.ResultsWe successfully imported 1775 non-duplicate research applications from the XML files into a single database. Of these, 963 were randomised controlled trials and 812 were other studies. Most studies received a favourable opinion. There was limited patient and public involvement in the studies. Most, but not all, studies were planned for publication of results. Novel study designs (eg, adaptive and Bayesian designs) were infrequently reported.ConclusionsWe have demonstrated that the data submitted from IRAS to the HRA and its HARP system are accessible and can be queried for information. We strongly encourage the development of fully resourced collaborative projects to further this work. This would aid understanding of how study characteristics change over time and across therapeutic areas, as well as the progress of initiatives to improve the quality and relevance of research studies.

scholarly journals Impact of the COVID-19 pandemic on clinical research activities: Survey of study participants and health care workers participating in a hypertension trial in Vietnam

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0253664
Author(s):  
Hoa L. Nguyen ◽  
Oanh T. Tran ◽  
Duc A. Ha ◽  
Van H. Phan ◽  
Cuc T. Nguyen ◽  
...  
Keyword(s):  
Health Care ◽  
Community Health ◽  
Health Care Workers ◽  
Health Research ◽  
Intervention Group ◽  
Future Health ◽  
Research Activities ◽  
Care Workers ◽  
The Impact ◽  
Research Studies

Background The COVID-19 pandemic has had a profound worldwide impact. Vietnam, a lower middle-income country with limited resources, has successfully slowed this pandemic. The objectives of this report are to explore the impact of the COVID-19 pandemic on the research activities of an ongoing hypertension trial using a storytelling intervention in Vietnam. Methods Data were collected in a mixed-methods study among 86 patients and 10 health care workers participating in a clinical trial designed to improve hypertension control. Several questions related to the impact of COVID-19 on patient’s daily activities and adherence to the study interventions were included in the follow-up visits. A focus group discussion was conducted among health care workers to discuss the impact of COVID-19 on research related activities. Results Fewer patients in the intervention group reported that they faced difficulties in adhering to prescribed study interventions, wanted to receive a call from a dedicated hotline, or have a visit from a community health worker as compared with those in the comparison group. Most study patients are willing to participate in future health research studies. When asked about the potential use of mobile phones in health research studies, fewer patients in the intervention group felt comfortable using a mobile phone for the delivery of intervention and interviews compared with those in the comparison condition. Community health workers shared that they visited patient’s homes more often than previously due to the pandemic and health care workers had to perform more virus containment activities without a corresponding increase in ancillary staff. Conclusions Both patients and health care workers in Vietnam faced difficulties in adhering to recommended trial interventions and procedures. Multiple approaches for intervention delivery and data collection are needed to overcome these difficulties during future health crises and enhance the implementation of future research studies. Trial registration ClinicalTrials.gov. Registration number: https://clinicaltrials.gov/ct2/show/NCT03590691 (registration date July 17, 2018).

scholarly journals Impact of COVID-19 pandemic social restriction measures on people with rheumatic and musculoskeletal diseases in the UK: a mixed-methods study

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048772
Author(s):  
Toby O Smith ◽  
Pippa Belderson ◽  
Jack R Dainty ◽  
Linda Birt ◽  
Karen Durrant ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Qualitative Study ◽  
Online Survey ◽  
Musculoskeletal Diseases ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Healthcare Provision ◽  
Social Restriction ◽  
The Uk ◽  
The Impact

ObjectivesTo determine the impact of COVID-19 pandemic social restriction measures on people with rheumatic and musculoskeletal diseases (RMDs) and to explore how people adapted to these measures over time.DesignMixed-methods investigation comprising a national online longitudinal survey and embedded qualitative study.SettingUK online survey and interviews with community-dwelling individuals in the East of England.ParticipantsPeople in the UK with RMDs were invited to participate in an online survey. A subsection of respondents were invited to participate in the embedded qualitative study.Primary and secondary outcome measuresThe online survey, completed fortnightly over 10 weeks from April 2020 to August 2020, investigated changes in symptoms, social isolation and loneliness, resilience and optimism. Qualitative interviews were undertaken assessing participant’s perspectives on changes in symptoms, exercising, managing instrumental tasks such a shopping, medication and treatment regimens and how they experienced changes in their social networks.Results703 people with RMDs completed the online survey. These people frequently reported a deterioration in symptoms as a result of COVID-19 pandemic social restrictions (52% reported increase vs 6% reported a decrease). This was significantly worse for those aged 18–60 years compared with older participants (p=0.017). The qualitative findings from 26 individuals with RMDs suggest that the greatest change in daily life was experienced by those in employment. Although some retired people reported reduced opportunity for exercise outside their homes, they did not face the many competing demands experienced by employed people and people with children at home.ConclusionsPeople with RMDs reported a deterioration in symptoms when COVID-19 pandemic social restriction measures were enforced. This was worse for working-aged people. Consideration of this at-risk group, specifically for the promotion of physical activity, changing home-working practices and awareness of healthcare provision is important, as social restrictions continue in the UK.

scholarly journals What was the impact of a participatory research project in Australian Indigenous primary healthcare services? Applying a comprehensive framework for assessing translational health research to Lessons for the Best

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040749
Author(s):  
Shanthi Ann Ramanathan ◽  
Sarah Larkins ◽  
Karen Carlisle ◽  
Nalita Turner ◽  
Ross Stewart Bailie ◽  
...  
Keyword(s):  
Learning Community ◽  
Primary Healthcare ◽  
Health Research ◽  
Return On Investment ◽  
Health Centre ◽  
Healthcare Services ◽  
Secondary Outcome ◽  
Cost Consequence ◽  
Comprehensive Framework ◽  
The Impact

ObjectivesTo (1) apply the Framework to Assess the Impact from Translational health research (FAIT) to Lessons from the Best to Better the Rest (LFTB), (2) report on impacts from LFTB and (3) assess the feasibility and outcomes from a retrospective application of FAIT.SettingThree Indigenous primary healthcare (PHC) centres in the Northern Territory, Australia; project coordinating centre distributed between Townsville, Darwin and Cairns and the broader LFTB learning community across Australia.ParticipantsLFTB research team and one representative from each PHC centre.Primary and secondary outcome measuresImpact reported as (1) quantitative metrics within domains of benefit using a modified Payback Framework, (2) a cost-consequence analysis given a return on investment was not appropriate and (3) a narrative incorporating qualitative evidence of impact. Data were gathered through in-depth stakeholder interviews and a review of project documentation, outputs and relevant websites.ResultsLFTB contributed to knowledge advancement in Indigenous PHC service delivery; enhanced existing capacity of health centre staff, researchers and health service users; enhanced supportive networks for quality improvement; and used a strengths-based approach highly valued by health centres. LFTB also leveraged between $A1.4 and $A1.6 million for the subsequent Leveraging Effective Ambulatory Practice (LEAP) Project to apply LFTB learnings to resource development and creation of a learning community to empower striving PHC centres.ConclusionRetrospective application of FAIT to LFTB, although not ideal, was feasible. Prospective application would have allowed Indigenous community perspectives to be included. Greater appreciation of the full benefit of LFTB including a measure of return on investment will be possible when LEAP is complete. Future assessments of impact need to account for the limitations of fully capturing impact when intermediate/final impacts have not yet been realised and captured.

scholarly journals Cardiovascular-related deaths at the beginning of the COVID-19 outbreak: a prospective analysis based on the UK Biobank

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046931
Author(s):  
Junren Wang ◽  
Jianwei Zhu ◽  
Huazhen Yang ◽  
Yao Hu ◽  
Yajing Sun ◽  
...  
Keyword(s):  
Primary Diagnosis ◽  
Secondary Outcome ◽  
Hospital Inpatient ◽  
Reference Period ◽  
Stress Reactions ◽  
Uk Biobank ◽  
The Uk ◽  
The Impact ◽  
Distinct Increase ◽  
Related Mortality

ObjectiveTo assess the impact of the COVID-19 outbreak on cardiovascular disease (CVD) related mortality and hospitalisation.DesignCommunity-based prospective cohort study.SettingThe UK Biobank.Participants421 372 UK Biobank participants who were registered in England and alive as of 1 January 2020.Primary and secondary outcome measuresThe primary outcome of interest was CVD-related death, which was defined as death with CVD as a cause in the death register. We retrieved information on hospitalisations with CVD as the primary diagnosis from the UK Biobank hospital inpatient data. The study period was 1 January 2020 to June 30 2020, and we used the same calendar period of the three preceding years as the reference period. In order to control for seasonal variations and ageing of the study population, standardised mortality/incidence ratios (SMRs/SIRs) with 95% CIs were used to estimate the relative risk of CVD outcomes during the study period, compared with the reference period.ResultsWe observed a distinct increase in CVD-related deaths in March and April 2020, compared with the corresponding months of the three preceding years. The observed number of CVD-related deaths (n=218) was almost double in April, compared with the expected number (n=120) (SMR=1.82, 95% CI 1.58 to 2.07). In addition, we observed a significant decline in CVD-related hospitalisations from March onwards, with the lowest SIR observed in April (0.45, 95% CI 0.41 to 0.49).ConclusionsThere was a distinct increase in the number of CVD-related deaths in the UK Biobank population at the beginning of the COVID-19 outbreak. The shortage of medical resources for hospital care and stress reactions to the pandemic might have partially contributed to the excess CVD-related mortality, underscoring the need of sufficient healthcare resources and improved instructions to the public about seeking healthcare in a timely way.

scholarly journals Modelling the impact of the tier system on SARS-CoV-2 transmission in the UK between the first and second national lockdowns

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e050346
Author(s):  
Daniel J Laydon ◽  
Swapnil Mishra ◽  
Wes R Hinsley ◽  
Pantelis Samartsidis ◽  
Seth Flaxman ◽  
...  
Keyword(s):  
Real Time ◽  
Reproduction Number ◽  
Secondary Outcome ◽  
Bayesian Hierarchical ◽  
Time Reproduction ◽  
Tier System ◽  
The Uk ◽  
National Trends ◽  
Tier 3 ◽  
The Impact

ObjectiveTo measure the effects of the tier system on the COVID-19 pandemic in the UK between the first and second national lockdowns, before the emergence of the B.1.1.7 variant of concern.DesignThis is a modelling study combining estimates of real-time reproduction number Rt (derived from UK case, death and serological survey data) with publicly available data on regional non-pharmaceutical interventions. We fit a Bayesian hierarchical model with latent factors using these quantities to account for broader national trends in addition to subnational effects from tiers.SettingThe UK at lower tier local authority (LTLA) level. 310 LTLAs were included in the analysis.Primary and secondary outcome measuresReduction in real-time reproduction number Rt.ResultsNationally, transmission increased between July and late September, regional differences notwithstanding. Immediately prior to the introduction of the tier system, Rt averaged 1.3 (0.9–1.6) across LTLAs, but declined to an average of 1.1 (0.86–1.42) 2 weeks later. Decline in transmission was not solely attributable to tiers. Tier 1 had negligible effects. Tiers 2 and 3, respectively, reduced transmission by 6% (5%–7%) and 23% (21%–25%). 288 LTLAs (93%) would have begun to suppress their epidemics if every LTLA had gone into tier 3 by the second national lockdown, whereas only 90 (29%) did so in reality.ConclusionsThe relatively small effect sizes found in this analysis demonstrate that interventions at least as stringent as tier 3 are required to suppress transmission, especially considering more transmissible variants, at least until effective vaccination is widespread or much greater population immunity has amassed.

scholarly journals Impact of tobacco tax increases and industry pricing on smoking behaviours and inequalities: a mixed-methods study

2020 ◽  
Vol 8 (6) ◽  
pp. 1-140
Author(s):  
Timea R Partos ◽  
Rosemary Hiscock ◽  
Anna B Gilmore ◽  
J Robert Branston ◽  
Sara Hitchman ◽  
...  
Keyword(s):  
Public Health ◽  
Health Research ◽  
Tobacco Industry ◽  
Control Policy ◽  
Public Health Research ◽  
Pricing Strategies ◽  
The Uk ◽  
Tax Changes ◽  
The Impact ◽  
Evaluation Project

Background Increasing tobacco prices through taxation is very effective for reducing smoking prevalence and inequalities. For optimum effect, understanding how the tobacco industry and smokers respond is essential. Tobacco taxation changes occurred in the UK over the study period, including annual increases, a shift in structure from ad valorem to specific taxation and relatively higher increases on roll-your-own tobacco than on factory-made cigarettes. Objectives Understanding tobacco industry pricing strategies in response to tax changes and the impact of tax on smokers’ behaviour, including tax evasion and avoidance, as well as the effect on smoking inequalities. Synthesising findings to inform how taxation can be improved as a public health intervention. Design Qualitative analysis and evidence synthesis (commercial and Nielsen data) and longitudinal and aggregate cross-sectional analyses (International Tobacco Control Policy Evaluation Project data). Setting The UK, from 2002 to 2016. Data sources and participants Data were from the tobacco industry commercial literature and retail tobacco sales data (Nielsen, New York, NY, USA). Participants were a longitudinal cohort (with replenishment) of smokers and ex-smokers from 10 surveys of the International Tobacco Control Policy Evaluation Project (around 1500 participants per survey). Main outcome measures (1) Tobacco industry pricing strategies, (2) sales volumes and prices by segments over time and (3) smokers’ behaviours, including products purchased, sources, brands, consumption, quit attempts, success and sociodemographic differences. Review methods Tobacco industry commercial literature was searched for mentions of tobacco products and price segments, with 517 articles extracted. Results The tobacco industry increased prices on top of tax increases (overshifting), particularly on premium products, and, recently, the tobacco industry overshifted more on cheap roll-your-own tobacco than on factory-made cigarettes. Increasingly, price rises were from industry revenue generation rather than tax. The tobacco industry raised prices gradually to soften impact; this was less possible with larger tax increases. Budget measures to reduce cheap product availability failed due to new cheap factory-made products, price marking and small packs. In 2014, smokers could buy factory-made (roll-your-own tobacco) cigarettes at real prices similar to 2002. Exclusive roll-your-own tobacco and mixed factory-made cigarettes and roll-your-own tobacco use increased, whereas exclusive factory-made cigarette use decreased, alongside increased cheap product use, rather than quitting. Quitting behaviours were associated with higher taxes. Smokers consumed fewer factory-made cigarettes and reduced roll-your-own tobacco weight over time. Apparent illicit purchasing did not increase. Disadvantaged and dependent smokers struggled with tobacco affordability and were more likely to smoke cheaper products, but disadvantage did not affect quit success. Limitations Different for each data set; triangulation increased confidence. Conclusions The tobacco industry overshifted taxes and increased revenues, even when tax increases were high. Therefore, tobacco taxes can be further increased to reduce price differentials and recoup public health costs. Government strategies on illicit tobacco appear effective. Large, sudden tax increases would reduce the industry’s ability to manipulate prices, decrease affordability and increase quitting behaviours. More disadvantaged, and dependent, smokers need more help with quitting. Future work Assessing the impact of tax changes made since 2014; changing how tax changes are introduced (e.g. sudden intermittent or smaller continuous); and tax changes on tobacco initiation. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 6. See the NIHR Journals Library website for further project information.

scholarly journals Efficient identification of patients eligible for clinical studies using case-based reasoning on Scottish Health Research Register (SHARE).

2019 ◽  
Author(s):  
Wen Shi ◽  
Tom Kelsey ◽  
Frank Sullivan
Keyword(s):  
Health Research ◽  
Clinical Studies ◽  
Search Strategy ◽  
Database Search ◽  
Prediction Score ◽  
Free Text ◽  
Case Based Reasoning ◽  
Study Participation ◽  
Research Register ◽  
Case Based

Abstract Background: Trials often struggle to achieve their target sample size with only half doing so. Some researchers have turned to Electronic Health Records (EHRs), seeking a more efficient way of recruitment. The Scottish Health Research Register (SHARE) obtained patients’ consent for their EHRs to be used as a searching base from which researchers can find potential participants. However, due to the fact that EHR data is not complete, sufficient or accurate, a database search strategy may not generate the best case-finding result. The current study aims to evaluate the performance of a case-based reasoning method in identifying participants for population-based clinical studies recruiting through SHARE, and assess the difference between its resultant cohort and the original one deriving from searching EHRs.Methods: A case-based reasoning framework was applied to 119 participants in nine projects using two-fold cross-validation, with records from a further 86,292 individuals used for testing. A prediction score for study participation was derived from the diagnosis, procedure, pharmaceutical prescription, and laboratory test results attributes of each participant. Evaluation was conducted by calculating Area Under the ROC Curve and information retrieval metrics for the ranking list of the test set by prediction score. We compared the most likely participants as identified by searching a database to those ranked highest by our model. Results: The average ROCAUC for nine projects was 81% indicating strong predictive ability for these data. However, the derived ranking lists showed lower predictive performance, with only 21% of the persons ranked within top 50 positions being the same as identified by searching databases.Conclusions: Case-based reasoning is may be more effective than a database search strategy for participant identification for clinical studies using population EHRs. The lower performance of ranking lists derived from case-based reasoning means that patients identified as highly suitable for study participation may still not be recruited. This suggests that further study is needed into improvements in the collection and curation of population EHRs such as use of free text data to better define the characteristics of people more likely to be recruited.

Involving older people in the design and conduct of clinical trials

2015 ◽  
Author(s):  
Kate Wilde ◽  
Zena Jones
Keyword(s):  
Personal Experience ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Power Struggle ◽  
Research Strategies ◽  
Academic Knowledge ◽  
Key Points ◽  
The Uk ◽  
New Treatments ◽  
The Impact

Key points• There are strong policy drivers in the UK to involve patients not only as participants in research, but also as members of the research team.• Patient and public involvement (PPI) can have significant benefits to the patient as well as to the research project.• Many research funders require PPI explicitly described and evaluated in research proposals.• Researchers need increased awareness of PPI, guidance, and a framework of how best to implement PPI within their research strategies.• There is a risk of ‘tokenistic’ involvement of service users.• There is the potential for a power struggle between the PPI representative with personal experience and the lead researcher with academic knowledge of the condition studied.• There is a need to formally evaluate the impact of PPI on the effectiveness of research to bring new treatments to patients.

scholarly journals The Perceived Impact of Suicide Bereavement on Specific Interpersonal Relationships: A Qualitative Study of Survey Data

2019 ◽  
Vol 16 (10) ◽  
pp. 1801 ◽  
Author(s):  
Valeriya Azorina ◽  
Nicola Morant ◽  
Hedvig Nesse ◽  
Fiona Stevenson ◽  
David Osborn ◽  
...  
Keyword(s):  
Interpersonal Relationships ◽  
Online Survey ◽  
Extended Family ◽  
Social Withdrawal ◽  
Free Text ◽  
Increased Risk ◽  
Suicide Bereavement ◽  
Social Discomfort ◽  
The Uk ◽  
The Impact

People bereaved by suicide have an increased risk of suicide and suicide attempt, yet report receiving less support than people bereaved by other sudden deaths. Reductions in support may contribute to suicide risk, yet their nature is unclear. We explored the impact of suicide bereavement on the interpersonal relationships of young adults in the UK using an online survey to collect qualitative data. We conducted thematic analysis of free-text responses from 499 adults to questions capturing the impact of bereavement on relationships with partners, close friends, close family, extended family, and other contacts. We identified four main themes describing the changes in relationships following the suicide: (1) Social discomfort over the death (stigma and taboo; painfulness for self or others to discuss; socially prescribed grief reactions); (2) social withdrawal (loss of social confidence; withdrawal as a coping mechanism); (3) shared bereavement experience creating closeness and avoidance; (4) attachments influenced by fear of further losses (overprotectiveness towards others; avoiding attachments as protective). These findings contribute to understanding deficits in support and pathways to suicidality after suicide bereavement. Such disrupted attachments add to the burden of grief and could be addressed by public education on how to support those bereaved by suicide.

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