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REST: a preoperative tailored sleep intervention for patients undergoing total knee replacement - feasibility study for a randomised controlled trial

Por: Bertram · W. · Penfold · C. · Glynn · J. · Johnson · E. · Burston · A. · Rayment · D. · Howells · N. · White · S. · Wylde · V. · Gooberman-Hill · R. · Blom · A. · Whale · K.
Objectives

To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement.

Design

Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study.

Setting

Two National Health Service (NHS) secondary care hospitals in England and Wales.

Participants

Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0–28 on the Sleep Condition Indicator questionnaire.

Intervention

The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals.

Outcome measures

The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients.

Results

Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable.

Conclusions

This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible.

Trial registration number

ISRCTN14233189.

The impact of the COVID‐19 pandemic on longitudinal trends of surgical mortality and inpatient quality of care in Ontario, Canada

Abstract

Aims

Previous studies have shown the COVID-19 pandemic was associated with reductions in volume across a spectrum of non-SARS-CoV-2 hospitalizations. In the present study, we examine the impact of the pandemic on patient safety and quality of care.

Design

This is a retrospective population-based study of discharge abstracts.

Methods

We applied a set of nationally validated indicators for measuring the quality of inpatient care to hospitalizations in Ontario, Canada between January 2010 and December 2022. We measured 90-day mortality after selected types of higher risk admissions (such as cancer surgery and cardiovascular emergency) and the rate of patient harm events (such as delirium, pressure injuries and hospital-acquired infections) occurring during the hospital stay.

Results

A total 13,876,377 hospitalization episodes were captured. Compared with the pre-pandemic period, and independent of SARS-CoV-2 infection, the pandemic period was associated with higher rates of mortality after bladder cancer resection (adjusted risk ratio [aRR] 1.20 (1.07–1.34)) and open repair for abdominal aortic aneurysm (aRR 1.45 (1.06–1.99)). The pandemic was also associated with higher rates of delirium (adjusted odds ratio [aOR] 1.04 (1.02–1.06)), venous thromboembolism (aOR 1.10 (1.06–1.13)), pressure injuries (aOR 1.28 (1.24–1.33)), aspiration pneumonitis (aOR 1.15 (1.12–1.18)), urinary tract infections (aOR 1.02 (1.01–1.04)), Clostridiodes difficile infection (aOR 1.05 (1.02–1.09)), pneumothorax (aOR 1.08 (1.03–1.13)), and use of restraints (aOR 1.12 (1.10–1.14)), but was associated with lower rates of viral gastroenteritis (aOR 0.22 (0.18–0.28)). During the pandemic, SARS-CoV-2-positive admissions were associated with a higher likelihood of various harm events.

Conclusion

The COVID-19 pandemic was associated with higher rates of patient harm for a wide range of non-SARS-CoV-2 inpatient populations.

Impact

Understanding which quality measures are improving or deteriorating can help health systems prioritize quality improvement initiatives.

Patient or Public Contribution

No patient or public contribution.

Non-pharmacological interventions to support coronary artery bypass graft (CABG) patient recovery following discharge: protocol for a scoping review

Por: Billard · J. N. · Wells · R. · Farrell · A. · Curran · J. A. · Sheppard · G.
Background

In Canada, approximately 15 000 people undergo coronary artery bypass grafting (CABG) each year. However, 9.5% of these patients are urgently readmitted to hospital within 30 days of surgery. Postoperative interventions following discharge play an important role in reducing readmissions and improving CABG patient outcomes. Therefore, it is important to determine effective interventions available to enhance CABG patient recovery following postoperative discharge.

Objectives

Our scoping review aims to identify non-pharmacological interventions available to support recovery of patients who are discharged after CABG in the community setting.

Methods

The methodological framework described by Arksey and O’Malley will be applied to this review. Our search strategy will include electronic databases (Medline, Embase, Cochrane Library and CINAHL), and studies will be screened and reviewed by two independent reviewers. Studies looking at non-pharmacological interventions targeting patients who are discharged after CABG will be included. Preliminary searches were conducted March 2022 and following abstract screening, full-text screening was completed May 2023. Data extraction is planned to begin September 2023 with an expected finish date of October 2023. The study is expected to be completed by January 2024.

Ethics and dissemination

This scoping review will retrieve and analyse previously published studies in which informed consent was obtained by primary investigators. Therefore, no ethical review or approval will be required. This scoping review aims to enumerate available non-pharmacological interventions to support recovery of patients who are discharged after CABG and identify gaps in postoperative recovery after discharge to support the development of innovative and targeted interventions. On completion of this review, we will ensure broad dissemination of our findings through peer-reviewed, open-access journals, conference presentations and hold meetings to engage stakeholders, including clinicians, policy makers and others.

South Asian individuals experiences on the NHS low-calorie diet programme: a qualitative study in community settings in England

Por: Dhir · P. · Maynard · M. · Drew · K. J. · Homer · C. V. · Bakhai · C. · Ells · L. J.
Background

Existing literature examines barriers to the provision of ethnically diverse dietary advice, however, is not specific to total diet replacement (TDR). There is a lack of literature from the UK, limiting the potential applicability of existing findings and themes to the UK context. This study addresses this gap in research by interviewing participants of South Asian ethnicity who have undertaken the National Health Service (NHS) low-calorie diet programme (LCD) for people with type 2 diabetes living with overweight or obesity. This study explores factors that may affect the uptake and acceptability of its TDR, food reintroduction and weight maintenance stages. This aims to provide rich data that can inform effective tailoring of future programmes with South Asian participants.

Objective

To explore the perspectives of individuals of South Asian ethnicity on an NHS programme using TDR approaches for the management of type 2 diabetes (T2D).

Design

Qualitative study.

Setting

Individuals in the community undertaking the NHS LCD programme.

Participants

Twelve one-to-one interviews were conducted with individuals from a South Asian ethnicity participating in the NHS LCD.

Main outcome measures

Qualitative semistructured interviews conducted through different stages of the programme. Reflexive thematic analysis was used to analyse the transcripts.

Results

Key themes highlighted positive and negative experiences of the programme: (1) more work is needed in the programme for person centeredness; (2) it is not the same taste; (3) needing motivation to make changes and feel better; (4) a mixed relationship with the coach; (5) social experiences; (6) culture-related experiences.

Conclusion

This study provides important experience-based evidence of the need for culturally tailored T2D programmes. Action to address these findings and improve the tailoring of the NHS LCD may improve experience, retention and outcomes on the programme for people of South Asian ethnicity and thereby reduce inequalities.

Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol

Por: Hanssen · H. M. · Fjellstad · M. S. · Skjevling · L. · Johnsen · P. H. · Kulseng · B. · Goll · R. · Alma · K. H. · Valle · P.-C.
Introduction

Obesity is one of the main threats to public health in western countries and increases the risk of several diseases, overall morbidity and mortality. Sustained weight loss will reduce risk factors and improve several obesity comorbidities. Options are conservative treatment such as lifestyle changes, bariatric surgery or medications. Conservative treatment has a low success rate, and bariatric surgery is typically not reversible, with the risk of complications and recurrences. Treatment of obesity with medications has in recent years shown great promise, but the side effects are many, and the long-term effect is unknown. There is also a need for an option for patients where surgery has contraindications and conservative follow-up does not succeed.

The research on obesity and gut microbiota has yielded promising results regarding weight reduction and metabolic health, but more research is needed to better understand the relationship between gut microbiota and severe obesity. This study could show proof of concept that gut microbiota from a lean donor could, in addition to lifestyle intervention, contribute to weight reduction in people suffering from severe obesity.

Method and analysis

This study aims to investigate if a fecal microbiota transplantation (FMT) from a lean donor leads to weight reduction in participants suffering from severe obesity. The study is a single-centre, double-blinded, placebo-controlled, parallel-group study with 60 participants. Participants will be randomised 1:1 for FMT from a lean donor or placebo. FMT or placebo will be delivered once by enema.

We will include participants from the outpatient clinic for severe obesity, at the Medical Department, University Hospital of North Norway, Harstad, by invitation only. The study has a follow-up period of 12 months, with study visits of 3, 6 and 12 months post FMT. The primary endpoint is a weight reduction of ≥10%, 12 months after intervention.

The results of the study will be published in open access journals. At the end of the study, the participants will receive information on which treatment group they belong to.

Ethics and dissemination

The Regional Ethical Committee in North Norway (REK) approved the study protocol (2017/1655/REK Nord). We plan to present the results from the study at (inter)national conferences and publish in open-access general peer-reviewed journals. The enema method for FMT administration used in this study was developed by our study team.

Trial registration number

NCT03273855.

Scheduled and urgent inguinal hernia repair in Ontario, Canada between 2010 and 2022: Population-based cross sectional analysis of trends and outcomes

by Steven Habbous, David Gomez, David Urbach, Erik Hellsten

Introduction

We examine trends in inguinal hernia repairs with respect to the COVID-19 pandemic and secular trends in Ontario, Canada.

Methods

This was a retrospective cohort study. Hernia repairs performed January 1, 2010-December 31, 2022 were captured from health administrative inpatient and outpatient databases. Patients managed in three clinical settings were examined: public hospital in-patient, semi-private hospital in-patient (Shouldice Hospital), and public hospital out-patient. We examined the effect of the COVID-19 pandemic on surgical volumes, clinical setting, patient characteristics by setting, time from diagnosis until surgery, hospital length-of-stay, and patient outcomes (90-day readmissions, 1-year reoperations). We used multivariable logistic regression to examine whether patient outcomes were comparable between the COVID-19 period and the pre-pandemic period, adjusted sociodemographic and clinical factors. Shouldice Hospital is the only semi-private hospital in Ontario specializing in hernia repair (patients pay for the mandated admission, but not for the procedure).

Results

During the pandemic (March 2020-December 2022), there were 8,162 fewer (15%) scheduled inguinal hernia repairs than expected, but the age-sex standardized rate of urgent repairs remained unchanged. Shouldice Hospital performed more surgeries in the COVID-19 era than pre-pandemic and had a shorter average LOS by 24 hours, despite treating more patients with older age, higher ASA score [adjusted odds ratio (aOR) 2.13 (1.93–2.35) III vs I-II] and greater comorbidity [aOR 1.36 (1.08–1.70) for 2 vs none] than pre-pandemic. Patients treated in the COVID-19 era experienced a longer time until surgery, being the longest in 2022 (median 133 days). Ninety-day readmissions and 1-year reoperations were lower in the COVID-19 era and lower for patients receiving surgery at Shouldice Hospital.

Conclusion

During the COVID-19 pandemic, there were 8,162 fewer scheduled hernia repairs than expected, longer wait-times until surgery, shorter length-of-stay, and more patients with comorbidities, but outcomes were not worse compared with the pre-pandemic period.

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