Good while it lasted? Estimating the long-term and withdrawal effects of results-based financing in Malawi on maternal care utilisation using routine data

Objectives
This study aimed to evaluate the effect of introduction and subsequent withdrawal of the Results-based Financing for Maternal and Newborn Health Initiative (RBF4MNH) in Malawi on utilisation of facility-based childbirths, antenatal care (ANC) and postnatal care (PNC).

Design
A controlled interrupted time series design was used with secondary data from the Malawian Health Management Information System.

Setting
Healthcare facilities at all levels identified as providing maternity services in four intervention districts and 20 non-intervention districts in Malawi.

Participants
Routinely collected, secondary data of total monthly service utilisation of facility-based childbirths, ANC and PNC services.

Interventions
The intervention is the RBF4MNH initiative, introduced by the Malawian government in 2013 to improve maternal and infant health outcomes and withdrawn in 2018 after ceasing of donor funding.

Outcome measures
Differences in total volume and trends of utilisation of facility-based childbirths, ANC and PNC services, compared between intervention versus non-intervention districts, for the study period of 90 consecutive months.

Results
No significant effect was observed, on utilisation trends for any of the three services during the first 2.5 years of intervention. In the following 2.5 years after full implementation, we observed a small positive increase for facility-based childbirths (+0.62 childbirths/month/facility) and decrease for PNC (–0.55 consultations/month/facility) trends of utilisation respectively. After withdrawal, facility-based childbirths and ANC consultations dropped both in immediate volume after removal (–10.84 childbirths/facility and –20.66 consultations/facility, respectively), and in trends of utilisation over time (–0.27 childbirths/month/facility and -1.38 consultations/month/facility, respectively). PNC utilisation levels seemed unaffected in intervention districts against a decline in the rest of the country.

Conclusions
Concurrent with wider literature, our results suggest that effects of complex health financing interventions, such as RBF4MNH, can take a long time to be seen. They might not be sustained beyond the implementation period if measures are not adopted to reform existing health financing structures.

Leggi
Marzo 2024

Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP): rationale, design and study protocol for a multicentre randomised controlled trial

Introduction
The prevalence of atrial fibrillation (AF) is increasing globally, and stroke prevention is the key to reduce the morbidity and mortality related to AF. Currently, direct oral anticoagulants (DOACs) are the primary options for stroke prevention, while it increases risk of bleeding. Left atrial appendage (LAA) is suspected as a vital source of cerebral emboli and may lead to ischaemic stroke, and thoracoscopic LAA clipping procedure provides an alternative option for stroke prevention in high-risk patients. However, high-quality evidence comparing LAA clipping to DOACs in terms of stroke prevention is lacking. This trial is designed to assess whether the efficacy of thoracoscopic LAA clipping is superior to DOACs for stroke prevention in AF patients at high risk of thrombosis (CHA2DS2-VASc≥2 in men and ≥3 in women)[CHA2DS2-VASc stands for “congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female)”].

Methods and analysis
This is a prospective, multicentre, open-labelled, randomised controlled study. This trial will randomly assign 290 patients with non-paroxysmal AF to thoracoscopic LAA clipping group or DOAC therapy group in a 1:1 randomisation. The primary endpoint is defined as a composite endpoint event consisting of stroke, systemic embolism, all-cause mortality, major bleeding events and clinically relevant non-major bleeding events at 24 months after randomisation. The secondary endpoints consist of the components of the primary composite endpoint, surgery-related adverse events and minor bleeding events.

Ethics and dissemination
The central ethics committee at Fuwai Hospital approved the trial entitled “Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP trial)”. The results of this study will be disseminated through publications in peer-reviewed journals and conference presentations.

Trial registration number
NCT06021808.

Leggi
Marzo 2024

Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial

Introduction
Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise guidelines for its initiation. We aim to evaluate two strategies of VA-ECMO initiation in the perioperative period in patients with obstructive or restrictive lung disease requiring bilateral LTx. In the control ‘on-demand’ arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental ‘systematic’ arm, VA-ECMO will be pre-emptively initiated. We hypothesise a ‘systematic’ strategy will increase the number of ventilatory-free days at day 28.

Methods and analysis
We designed a multicentre randomised controlled trial in parallel groups. Adult patients with obstructive or restrictive lung disease requiring bilateral LTx, without a formal indication for pre-emptive VA-ECMO before LTx, will be included. Patients with preoperative pulmonary hypertension with haemodynamic collapse, ECMO as a bridge to transplantation, severe hypoxaemia or hypercarbia will be secondarily excluded. In the systematic group, VA-ECMO will be systematically implanted before the first pulmonary artery cross-clamp. In the on-demand group, VA-ECMO will be implanted intraoperatively if haemodynamic or respiratory indices meet preplanned criteria. Non-inclusion, secondary exclusion and VA-ECMO initiation criteria were validated by a Delphi process among investigators. Postoperative weaning of ECMO and mechanical ventilation will be managed according to best practice guidelines. The number of ventilator-free days at 28 days (primary endpoint) will be compared between the two groups in the intention-to-treat population. Secondary endpoints encompass organ failure occurrence, day 28, day 90 and year 1 vital status, and adverse events.

Ethics and dissemination
The sponsor is the Assistance Publique–Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.

Trial registration number
NCT05664204.

Leggi
Marzo 2024

Effectiveness of mHealth interventions to promote physical activity and reduce sedentary behaviours on work-related productivity and performance: a systematic review protocol

Introduction
Technologies such as health and fitness applications (apps) and wearable activity trackers have recently gained popularity and may play a key role in promoting physical activity and reducing sedentary behaviours. Although several systematic reviews have investigated their efficacy in physical activity and sedentary behaviours, few studies have focused on their impact on work-related outcomes among workers. Here, to explore the effects of mHealth interventions designed to encourage physical activity and decrease sedentary behaviours on work-related outcomes, including absenteeism, presenteeism, productivity, work performance and workability among workers, we will conduct a systematic review based on recent articles and an extensive literature search.

Methods and analysis
The literature search will be performed using PubMed, Web of Science, the Cochrane Library and the Japan Medical Abstracts Society from inception to 23 September 2023. We will select studies that (1) investigated the impact of mHealth interventions to promote physical activity and reduce sedentary behaviours on work-related outcomes such as absenteeism, presenteeism, productivity, work performance and workability; (2) were designed as a randomised controlled trial (RCT) or non-randomised study of interventions (NRSI); (3) were conducted among workers and (4) were published as full-text original articles in Japanese or English. We will assess the review quality with the AMSTAR 2 tool. The risk of bias will be assessed with the RoB tool 2.0 and ROBINS-I.

Ethics and dissemination
Ethical approval is unnecessary as the study will rely solely on previously published articles. The research results will be submitted for publication in a peer-reviewed scientific journal.

Trial registration number
The study protocol has been registered with the UMIN Clinical Trials Registry (ID=UMIN000052290).

Leggi
Marzo 2024

43 The UCLP-primrose project: transformative care – are we looking at it right?

BackgroundPeople with severe mental illness (SMI) have a higher risk of cardiovascular disease (CVD) and premature mortality than people without SMI. UCLP-Primrose is an evidence-based integrated pathway which guides healthcare staff to support patients with SMI, in order of patients’ CVD risk, to engage with their physical health checks, and when needed, address modifiable CVD risks through intensive behavioural change and support patients’ health and wellbeing in a holistic way including offering peer coaching sessions.AimTo explore and understand factors influencing the implementation of UCLP-Primrose in the current healthcare context.MethodWe are testing a new implementation research protocol which allows within-system learning and an increased chance of our research impacting practice in integrated care teams across three boroughs in London and in Bradford. This includes collecting data about the process (such as from meeting notes covering implementation plans and actions), ethnographic observations, and short and long form interviews with a range of people implementing, delivering, and receiving UCLP-Primrose. Data is being analysed using reflexive thematic analysis, the Consolidated Framework for Implementation Research, and Normalisation Process Theory, with ongoing findings shared with sites through lightning reports.ResultsTriangulated findings to date include insights into how implementation is taking place, and in-depth experiential finding from the reflexive thematic analysis. We will focus our presentation on the early three themes which relate to and have important implications for implementation within the current uncertainty and pressures of healthcare: 1) questioning implementation progress through turbulent contexts, 2) the role of accountability within relational implementation, and 3) transformative care – are we looking at it right?ConclusionOur findings advance understanding and knowledge around implementing interventions aiming to tackle the inequalities around multiple long-term conditions and provide insights into the challenges/gaps for the still developing integrated care system.

Leggi
Marzo 2024

13 'Dont let it hold you back: the experience of transition to adulthood in young people with primary ciliary dyskinesia

BackgroundPrimary ciliary dyskinesia (PCD) is a rare genetic ciliopathy characterised by recurrent respiratory infections, sinonasal disease, reduced hearing, infertility and situs inversus. It is a chronic condition with no curative therapy. The aim of this research was to understand the experiences of young people with PCD as they transition into adulthood and to adult healthcare services.MethodsAn interpretative phenomenological analytical method was applied. Semi-structured virtual interviews were conducted with three participants aged 18–24 years who were enrolled via PCD Support UK.ResultsFour interconnected group experiential themes were identified:The first theme was ‘Reconceptualising a stigmatised identity’. Participants demonstrated concealment of their condition and experienced both external and internalised stigmatisation. However, PCD was often reconceptualised as positive and contributory to their identities.The second theme was ‘Sharing the journey to independence’. Support was sought for and found in family, friends and others with shared experiences.The third theme was ‘Entering adulthood with newfound autonomy’. The transition to adulthood was marked by recognition of their own responsibility and the ability to make informed choices about their lives. They sought success in their chosen pathways and mitigated risks arising from their condition in realising these goals.The fourth theme was ‘Anticipating an uncertain future’. Participants shared a concerted yearning to succeed against a future that was entangled with uncertainty in view of their health.ConclusionTransition for young people with PCD is a complex and dynamic period marked by identity-formation, creating systems of support, and becoming an autonomous adult. They remained committed to their hopes and desires and refused to be ‘held back’. The improved understanding of these experiences can be applied to future practice that eases the process of transition, provides appropriate support, and identifies areas for further qualitative research.

Leggi
Marzo 2024

Implementation of an intervention to reduce urine dipstick testing in aged care homes: a qualitative study of enablers and barriers, and strategies to enhance delivery

Objective
The ‘To Dip or Not to Dip’ (TDONTD) intervention aims to reduce antibiotic prescribing for urinary tract infection (UTI) by reducing low-value dipstick testing. The aims of this study were to use a qualitative approach to (1) evaluate potential influences on the delivery of the TDONTD intervention in Australian residential aged care homes (RACHs) by identifying perceived barriers and enablers to delivery and acceptance; and (2) propose intervention strategies to address barriers and enhance enablers.

Design
A qualitative before–after process evaluation of a multisite implementation study using interviews with nurse and pharmacist implementers.

Setting
This study was conducted in 12 Australian RACHs.

Participants
Participants included 17 on-site nurse champions and 4 pharmacists (existing contracted providers).

Intervention
Resources from England’s TDONTD intervention were adapted for an Australian context. Key resources delivered were case-based education, staff training video, clinical pathway and an audit tool.

Results
Key barriers to TDONTD were beliefs about nursing capabilities in diagnosing infection, beliefs about consequences (fear of missing infection) and social influences (pressure from family, doctors and hospitals). Key enablers were perceived increased nurse and carer knowledge (around UTI and asymptomatic bacteriuria), resources from a credible source, empowerment of nurse champions to apply knowledge and skills in delivering operational change initiatives, pharmacist-delivered education and organisational policy or process change. Of TDONTD’s key components, the clinical pathway substituted dipstick testing in diagnosing UTI, delivery of case-based education was enhanced by their attendance and support of the intervention and the antibiotic audit tool generated feedback that champions shared with staff.

Conclusions
Our study confirms the core components of TDONTD and strategies to enhance delivery and overcome barriers. To further reduce barriers to TDONTD, broader advocacy work is required to raise awareness of dipstick testing as a low-value test in older persons and by linking it to healthcare professionals and consumer education.

Leggi
Marzo 2024

First mobilisation after abdominal and cardiothoracic surgery: when is it actually performed? A national, multicentre, cross-sectional study

Objectives
Knowledge of clinical practice regarding mobilisation after surgery is lacking. This study therefore aimed to reveal current mobilisation routines after abdominal and cardiothoracic surgery and to identify factors associated with mobilisation within 6 hours postoperatively.

Design
A prospective observational national multicentre study.

Setting
18 different hospitals in Sweden.

Participants
1492 adult patients undergoing abdominal and cardiothoracic surgery with duration of anaesthesia >2 hours.

Primary and secondary outcomes
Primary outcome was time to first postoperative mobilisation. Secondary outcomes were the type and duration of the first mobilisation. Data were analysed using multivariate logistic regression and general structural equation modelling, and data are presented as ORs with 95% CIs.

Results
Among the included patients, 52% were mobilised to at least sitting on the edge of the bed within 6 hours, 70% within 12 hours and 96% within 24 hours. Besides sitting on the edge of the bed, 76% stood up by the bed and 22% were walking away from the bedside the first time they were mobilised. Patients undergoing major upper abdominal surgery required the longest time before mobilisation with an average time of 11 hours post surgery. Factors associated with increased likelihood of mobilisation within 6 hours of surgery were daytime arrival at the postoperative recovery unit (OR: 5.13, 95% CI: 2.16 to 12.18), anaesthesia

Leggi
Febbraio 2024