Harti Hauora Tamariki: randomised controlled trial protocol for an opportunistic, holistic and family centred approach to improving outcomes for hospitalised children and their families in Aotearoa, New Zealand.

Background: Health and wellbeing inequities between the Indigenous Maori and non-Maori populations in Aotearoa, New Zealand continue to be unresolved. Within this context, and of particular concern, hospitalisations for diseases of poverty are increasing for tamariki Maori (Maori children). To provide hospitalised tamariki Maori, and their whanau (families) comprehensive support, a wellbeing needs assessment; the Harti Hauora Tamariki Tool (The Harti tool) was developed. The purpose of this study is to determine how effective the Harti tool is at identifying wellbeing needs, ensuring the documentation of needs, enabling access to services and improving wellbeing outcomes for tamariki and their whanau. Methods: The study uses a Kaupapa Maori methodology with qualitative and quantitative methods. Qualitative methods include in-depth interviews with whanau. This paper presents an overview of a randomised, two parallel, controlled, single blinded, superiority trial for quantitative evaluation of the Harti programme, and hospital satisfaction with care survey. Participants will be Maori and non-Maori tamariki/children aged 0-4 years admitted acutely to the paediatric medical wards at Waikato Hospital, Hamilton, Aotearoa New Zealand. They will be randomised electronically into the intervention or usual care group. The intervention group will receive usual care in addition to the Harti programme, which includes a 24-section health needs assessment delivered by trained Maori navigators to whanau during the time they are in hospital. The primary endpoint is the relative risk of an acute hospital readmission in the 30 days following discharge for the intervention group patients compared with control group patients. Secondary outcomes include access and utilisation of preventative health services including: oral health care, general practice enrolment, immunisation, healthy home initiatives, smoking cessation and the Well Child Tamariki Ora universal health checks available free of charge for children in Aotearoa New Zealand. Discussion: Randomised controlled trials are a gold standard for measuring efficacy of complex multifaceted interventions and the results will provide high quality evidence for implementing the intervention nationwide. We expect that this study will provide valuable evidence for health services and policy makers who are considering how to improve the configuration of paediatric hospital services. Trial registration: The study is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), registration number: ACTRN12618001079235.

Superiority and cost-effectiveness of Individual Placement and Support versus standard employment support for people with alcohol and drug dependence: a pragmatic, parallel-group, open-label, multicentre, randomised, controlled, phase 3 trial.

Background: Individual Placement and Support (IPS) is a specialist intervention to help people attain employment in the open competitive labour market. IPS has been developed in severe mental illness and other disabilities, but it is of unknown effectiveness for people with alcohol and drug dependence. The Individual Placement and Support-Alcohol and Drug (IPS-AD) is the first superiority trial to evaluate effectiveness and cost-effectiveness. Methods: IPS-AD was a pragmatic, parallel-group, multi-centre, randomised, controlled, phase 3 trial of standard employment support (treatment-as-usual [TAU]) versus IPS. IPS was offered as a single episode for up to 13 months. The study was done at seven community treatment centres for alcohol and drug dependence in England. Study participants were adults (18-65 years), who had been enrolled for at least 14 days in treatment for alcohol use disorder (AUD), opioid use disorder (OUD), or another drug use disorder (DUD; mostly cannabis and stimulants); were unemployed or economically inactive for at least six months; and wished to attain employment in the open competitive labour market. After random allocation to study interventions, the primary outcome was employment during 18-months of follow-up, analysed by mixed-effects logistic regression, using multiple imputation for the management of missing outcome data. There were two cost-effectiveness outcomes: a health outcome expressed as a quality adjusted life year (QALY) using £30,000 and £70,000 willingness-to-pay [WTP] thresholds; and additional days of employment, with a WTP threshold of £200 per day worked. The study was registered with ISRCTN (ISRCTN24159790) and is completed. Findings: Between 8 May 2018 and 30 September 2019, 2781 potentially eligible patients were identified. 812 were excluded before screening, and 1720 participants were randomly allocated to TAU or IPS. In error, nine participants were randomised to study interventions on two occasions-so data for their first randomisation was analysed (modified intention-to-treat). A further 24 participants withdrew consent for all data to be used (full-analysis set therefore 1687 participants [70.1% male; mean age 40.8 years]; TAU, n = 844; IPS, n = 843 [AUD, n = 610; OUD, n = 837; DUD, n = 240]). Standard employment support was received by 559 [66.2%] of 844 participants in the TAU group. IPS was received by 804 [95.37%] of 843 participants in the IPS group. IPS was associated with an increase in attainment of employment compared with TAU (adjusted odds ratio [OR] 1.29; 95% CI 1.02-1.64; p-value 0.036). IPS was effective for the AUD and DUD groups (OR 1.48; 95% CI 1.14-1.92; p-value 0.004; OR 1.45, 95% CI 1.03-2.04, p-value 0.031, respectively), but not the OUD group. IPS returned an incremental QALY outcome gain of 0.01 (range 0.003-0.02) per participant with no evidence of cost-effectiveness at either WTP threshold-but QALY gains were cost-effective for the AUD and DUD groups at the £70,000 WTP threshold (probability 0.52 and 0.97, respectively). IPS was cost-effective for additional days of employment (probability 0.61), with effectiveness relating to the AUD group only (probability >0.99). Serious Adverse Events were reported by 39 participants (13 [1.5%] of 844 participants in the TAU group and 23 [2.7%] of 43 participants in the IPS group). There was a total of 25 deaths (1.5%; 9 in the TAU group and 16 in the IPS group)-none judged related to study interventions. Interpretation: In this first superiority randomised controlled trial of IPS in alcohol and drug dependence, IPS helped more people attain employment in the open competitive labour market than standard employment support. IPS was cost-effective for a QALY health outcome (£70,000 WTP threshold) for the AUD and DUD groups, and for additional days of employment for the AUD group (£200 per day worked WTP threshold). Funding: UK government Work and Health Unit.

Sentinel lymph node mapping with indocyanine green using SPY-PHI in open radical hysterectomy or trachelectomy.

OBJECTIVE: To evaluate the detection rate of at least one sentinel lymph node (SLN) in patients with early cervical cancer who underwent open radical hysterectomy or trachelectomy using indocyanine green (ICG) with the SPY Portable Handler Imager (SPY-PHI) system. METHODS: We retrospectively reviewed patients with cervical cancer FIGO 2018 stage IA1 with lymphovascular invasion up to stage IIIC1p who underwent SLN mapping and open radical hysterectomy or trachelectomy from March 2018 through August 2022 at The University of Texas MD Anderson Cancer Center. ICG was the only tracer used with the SPY-PHI system. Patient demographics, surgical approach, and tumor factors were analyzed. Overall detection, bilateral detection, and empty lymph node packet rates were determined. RESULTS: A total of 106 patients were included. Ninety-four (88.7%) patients underwent open radical hysterectomy and 12 (11.3%) open radical trachelectomy. Median age was 40 years (range, 23-71). Median body mass index was 28.8 kg/m2 (range, 17.6-48.4). The most common FIGO 2018 stages were IB1 (35%) and IB2 (30%). The most common histologic subtypes were squamous cell carcinoma (45%) and adenocarcinoma (45%). Most patients had grade 2 disease (61%) and no lymphovascular invasion (58%). Median tumor size was 1.8 cm (range, 0.3-4). Median number of detected SLN was 4 (range, 0-12). An SLN was identified during surgery in 104 patients (98%), with bilateral mapping in 94 (89%) and unilateral mapping in 10 (9%). The empty lymph node packet rate was 4 (3.8%). The external iliac (73%) was the most common site of SLN detection. Fourteen patients had positive lymph nodes (13.5%); 3 (21.4%) had macrometastases, 9 (64.3%) had micrometastases, and 2 (14.3%) had isolated tumor cells. CONCLUSION: SLN mapping using ICG with the SPY-PHI system in open radical hysterectomy or trachelectomy is reliable and results in high overall and bilateral detection rates in patients with early cervical cancer.

From private incentives to public health need: rethinking research and development for pandemic preparedness.

Pandemic preparedness and response have relied primarily on market dynamics to drive development and availability of new health products. Building on calls for transformation, we propose a new value proposition that instead prioritises equity from the research and development (R&D) stage and that strengthens capacity to control outbreaks when and where they occur. Key elements include regional R&D hubs free to adapt well established technology platforms, and independent clinical trials networks working with researchers, regulators, and health authorities to better study questions of comparative benefit and real-world efficacy. Realising these changes requires a shift in emphasis: from pandemic response to outbreak control, from one-size-fits-all economies of scale to R&D and manufacture for local need, from de novo product development to last-mile innovation through adaptation of existing technologies, and from proprietary, competitive R&D to open science and financing for the common good that supports collective management and sharing of technology and know-how.

The WHO's 75th anniversary: WHO at a pivotal moment in history.

The World Health Organisation (WHO) was inaugurated in 1948 to bring the world together to ensure the highest attainable standard of health for all. Establishing health governance under the United Nations (UN), WHO was seen as the preeminent leader in public health, promoting a healthier world following the destruction of World War II and ensuring global solidarity to prevent disease and promote health. Its constitutional function would be 'to act as the directing and coordinating authority on international health work'. Yet today, as the world commemorates WHO's 75th anniversary, it faces a historic global health crisis, with governments presenting challenges to its institutional legitimacy and authority amid the ongoing COVID-19 pandemic. WHO governance in the coming years will define the future of the Organisation and, crucially, the health and well-being of billions of people across the globe. At this pivotal moment, WHO must learn critical lessons from its past and make fundamental reforms to become the Organisation it was meant to be. We propose reforms in WHO financing, governance, norms, human rights and equity that will lay a foundation for the next generation of global governance for health.

To assess the effects of cross-education on strength and motor function in post stroke rehabilitation: a systematic literature review and meta-analysis.

BACKGROUND: Cross-education refers to the increase in motor output of the untrained limb following unilateral training of the opposite limb. Cross education has been shown to be beneficial in clinical settings. OBJECTIVES: This systematic literature and meta-analysis aims to assess the effects of cross-education on strength and motor function in post stroke rehabilitation. DATA SOURCES: MEDLINE, CINAHL, Cochrane Library, PubMed, PEDro, Web of Science, ClinicalTrails.gov and Cochrane Central registers were searched up to 1st October 2022. STUDY SELECTION: Controlled trials using unilateral training of the less affected limb in individuals diagnosed with stroke and English language. DATA SYNTHESIS: Methodological quality was assessed using Cochrane Risk-of-Bias tools. Quality of evidence was evaluated using Grading of Recommendations Assessment, Development and Evaluation. Meta-analyses were performed using RevMan 5.4.1. RESULTS: Five studies capturing 131 participants were included in the review and three studies capturing 95 participants were included in the meta-analysis. Cross education was shown to have a statistically and clinically significant effect on upper limb strength (p < 0.003; SMD 0.58; 95% CI 0.20-0.97; n = 117) and upper limb function (p = 0.04; SMD 0.40; 95% CI 0.02-0.77; n = 119). LIMITATIONS: Small number of studies, with all studies identified as having some risk of bias. Quality of evidence graded 'low' due to limitations and imprecision. CONCLUSION: Cross education may be beneficial in improving strength and motor function in the more affected upper limb post stroke. Further studies are needed as the research into the benefits of cross education in stroke rehabilitation is still limited. Systematic Review Registration Number: PROSPERO (CRD42020219058).