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Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions

Por: Wilkinson · J. · Heal · C. · Antoniou · G. A. · Flemyng · E. · Alfirevic · Z. · Avenell · A. · Barbour · G. · Brown · N. J. L. · Carlisle · J. · Clarke · M. · Dicker · P. · Dumville · J. C. · Grey · A. · Grohmann · S. · Gurrin · L. · Hayden · J. A. · Heathers · J. · Hunter · K. E. · Lasser
Introduction

Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions.

Methods and analysis

The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare.

Ethics and dissemination

The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

Interactions that support older inpatients with cognitive impairments to engage with falls prevention in hospitals: An ethnographic study

Abstract

Aims

To explore the nature of interactions that enable older inpatients with cognitive impairments to engage with hospital staff on falls prevention.

Design

Ethnographic study.

Methods

Ethnographic observations on orthopaedic and older person wards in English hospitals (251.25 h) and semi-structured qualitative interviews with 50 staff, 28 patients and three carers. Findings were analysed using a framework approach.

Results

Interactions were often informal and personalised. Staff qualities that supported engagement in falls prevention included the ability to empathise and negotiate, taking patient perspectives into account. Although registered nurses had limited time for this, families/carers and other staff, including engagement workers, did so and passed information to nurses.

Conclusions

Some older inpatients with cognitive impairments engaged with staff on falls prevention. Engagement enabled them to express their needs and collaborate, to an extent, on falls prevention activities. To support this, we recommend wider adoption in hospitals of engagement workers and developing the relational skills that underpin engagement in training programmes for patient-facing staff.

Implications for Profession and Patient Care

Interactions that support cognitively impaired inpatients to engage in falls prevention can involve not only nurses, but also families/carers and non-nursing staff, with potential to reduce pressures on busy nurses and improve patient safety.

Reporting Method

The paper adheres to EQUATOR guidelines, Standards for Reporting Qualitative Research.

Patient or Public Contribution

Patient/public contributors were involved in study design, evaluation and data analysis. They co-authored this manuscript.

Retrospective cross-sectional analysis of concurrent VTE diagnosis in hospitalised socially excluded individuals in Ireland

Por: Carpenter · C. · O Farrell · A. · Ni Ainle · F. · Ni Cheallaigh · C. · Kevane · B.
Objective

Social exclusion (such as that experienced by people who are homeless, incarcerated or use drugs) increases morbidity across a range of diseases but is poorly captured in routine data sets. The aim of this study was to use a novel composite variable in a national-level hospital usage dataset to identify social exclusion and to determine whether social exclusion is associated with concurrent venous thromboembolism (VTE) in hospitalised patients in Ireland. Identifying and characterising this association in people who are socially excluded will inform VTE prevention and treatment strategies.

Design

Retrospective cross-sectional study.

Setting

Irish Hospital Inpatient Enquiry (HIPE) system, which collects diagnostic information by International Classification of Diseases Tenth Revision code on all hospital admission episodes in the Ireland.

Participants

All hospital admission episodes involving a VTE diagnosis (in a primary ‘Dx 1’ or secondary ‘Dx 2–30’ coding position) during a 12-month period in the Ireland were identified from consolidated, national-level datasets derived from the Irish HIPE system. Social exclusion was defined as the presence of one or more indicators of homelessness, drug use, incarceration, health hazards due to socioeconomic status or episodes of healthcare terminated prematurely.

Results

Of 5701 admission episodes involving a VTE diagnosis (in a primary or secondary position) during the study period, 271 (4.8%) related to an individual affected by social exclusion. Among hospitalised individuals identified as being socially excluded based on the novel composite variable, the likelihood of having a concurrent VTE diagnosis was over twofold greater than that observed in the general population (OR 2.14, 95% CI 1.79 to 2.26; p

Conclusion

These data suggest that VTE (primary and secondary) is over-represented in hospitalised socially excluded persons in Ireland and that the development of strategies to address this potentially life-threatening accompanying condition in this vulnerable patient group must be prioritised.

Trends in inequalities in avoidable hospitalisations across the COVID-19 pandemic: a cohort study of 23.5 million people in England

Objective

To determine whether periods of disruption were associated with increased ‘avoidable’ hospital admissions and wider social inequalities in England.

Design

Observational repeated cross-sectional study.

Setting

England (January 2019 to March 2022).

Participants

With the approval of NHS England we used individual-level electronic health records from OpenSAFELY, which covered ~40% of general practices in England (mean monthly population size 23.5 million people).

Primary and secondary outcome measures

We estimated crude and directly age-standardised rates for potentially preventable unplanned hospital admissions: ambulatory care sensitive conditions and urgent emergency sensitive conditions. We considered how trends in these outcomes varied by three measures of social and spatial inequality: neighbourhood socioeconomic deprivation, ethnicity and geographical region.

Results

There were large declines in avoidable hospitalisations during the first national lockdown (March to May 2020). Trends increased post-lockdown but never reached 2019 levels. The exception to these trends was for vaccine-preventable ambulatory care sensitive admissions which remained low throughout 2020–2021. While trends were consistent by each measure of inequality, absolute levels of inequalities narrowed across levels of neighbourhood socioeconomic deprivation, Asian ethnicity (compared with white ethnicity) and geographical region (especially in northern regions).

Conclusions

We found no evidence that periods of healthcare disruption from the COVID-19 pandemic resulted in more avoidable hospitalisations. Falling avoidable hospital admissions has coincided with declining inequalities most strongly by level of deprivation, but also for Asian ethnic groups and northern regions of England.

Exploring mobility data for enhancing HIV care engagement in Black/African American and Hispanic/Latinx individuals: a longitudinal observational study protocol

Por: Hassani · M. · De Haro · C. · Flores · L. · Emish · M. · Kim · S. · Kelani · Z. · Ugarte · D. A. · Hightow-Weidman · L. · Castel · A. · Li · X. · Theall · K. P. · Young · S.
Introduction

Increasing engagement in HIV care among people living with HIV, especially those from Black/African American and Hispanic/Latinx communities, is an urgent need. Mobility data that measure individuals’ movements over time in combination with sociostructural data (eg, crime, census) can potentially identify barriers and facilitators to HIV care engagement and can enhance public health surveillance and inform interventions.

Methods and analysis

The proposed work is a longitudinal observational cohort study aiming to enrol 400 Black/African American and Hispanic/Latinx individuals living with HIV in areas of the USA with high prevalence rates of HIV. Each participant will be asked to share at least 14 consecutive days of mobility data per month through the study app for 1 year and complete surveys at five time points (baseline, 3, 6, 9 and 12 months). The study app will collect Global Positioning System (GPS) data. These GPS data will be merged with other data sets containing information related to HIV care facilities, other healthcare, business and service locations, and sociostructural data. Machine learning and deep learning models will be used for data analysis to identify contextual predictors of HIV care engagement. The study includes interviews with stakeholders to evaluate the implementation and ethical concerns of using mobility data to increase engagement in HIV care. We seek to study the relationship between mobility patterns and HIV care engagement.

Ethics and dissemination

Ethical approval has been obtained from the Institutional Review Board of the University of California, Irvine (#20205923). Collected data will be deidentified and securely stored. Dissemination of findings will be done through presentations, posters and research papers while collaborating with other research teams.

Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study

Objectives

This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain.

Design

Prospective, multicentre pre-post study.

Setting

Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up.

Participants

156 patients were included.

Primary and secondary outcome measures

Primary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention’s total cost was estimated by multiplying health resource usage with unit costs.

Results

In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (–0.46%; 95% CI –0.69% to –0.23%), 6 months (–0.49%; 95% CI –0.73% to –0.25%) and 12 months (–0.43%; 95% CI –0.68% to –0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (–0.37; 95% CI –0.62 to –0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss.

Conclusions

The use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.

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