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Point-of-choice kilocalorie labelling practices in large, out-of-home food businesses: a preobservational versus post observational study of labelling practices following implementation of The Calorie Labelling (Out of Home Sector) (England) Regulations 2

Por: Polden · M. · Jones · A. · Essman · M. · Adams · J. · Bishop · T. · Burgoine · T. · Donohue · A. · Sharp · S. · White · M. · Smith · R. · Robinson · E.
Background and objectives

On 6 April 2022, the UK government implemented mandatory kilocalorie (kcal) labelling regulations for food and drink products sold in the out-of-home food sector (OHFS) in England. Previous assessments of kcal labelling practices in the UK OHFS found a low prevalence of voluntary implementation and poor compliance with labelling recommendations. This study aimed to examine changes in labelling practices preimplementation versus post implementation of mandatory labelling regulations in 2022.

Methods

In August–December 2021 (preimplementation) and August–November 2022 (post implementation), large OHFS businesses (250 or more employees) subject to labelling regulations were visited. At two time points, a researcher visited the same 117 food outlets (belonging to 90 unique businesses) across four local authorities in England. Outlets were rated for compliance with government regulations for whether kcal labelling was provided at any or all point of choice, provided for all eligible food and drink items, provided per portion for sharing items, if labelling was clear and legible and if kcal reference information was displayed.

Results

There was a significant increase (21% preimplementation vs 80% post implementation, OR=40.98 (95% CI 8.08 to 207.74), p

Conclusion

The number of large businesses in the OHFS providing kcal labelling increased following the implementation of mandatory labelling regulations. However, around one-fifth of eligible outlets sampled were not providing kcal labelling 4–8 months after the regulations came into force, and the majority of businesses only partially complied with government guidance. More effective enforcement may be required to further improve kcal labelling practices in the OHFS in England.

Preregistration

Study protocol and analysis strategy preregistered on Open Science Framework (https://osf.io/pfnm6/).

Protocol for the process evaluation of an intervention to improve antenatal smoking cessation support (MOHMQuit) in maternity services in New South Wales, Australia

Por: Longman · J. · Paul · C. · Cashmore · A. · Twyman · L. · Barnes · L. A. J. · Adams · C. · Bonevski · B. · Milat · A. · Passey · M. E.
Introduction

Smoking cessation in pregnancy remains a public health priority. Our team used the Behaviour Change Wheel to develop the Midwives and Obstetricians Helping Mothers to Quit smoking (MOHMQuit) intervention with health system, leader (including managers and educators) and clinician components. MOHMQuit addresses a critical evidence to practice gap in the provision of smoking cessation support in antenatal care. It involves nine maternity services in New South Wales in a cluster randomised stepped-wedge controlled trial of effectiveness. This paper describes the design and rationale for the process evaluation of MOHMQuit. The process evaluation aims to assess to what extent and how MOHMQuit is being implemented (acceptability; adoption/uptake; appropriateness; feasibility; fidelity; penetration and sustainability), and the context in which it is implemented, in order to support further refinement of MOHMQuit throughout the trial, and aid understanding and interpretation of the results of the trial.

Methods and analysis

The process evaluation is an integral part of the stepped-wedge trial. Its design is underpinned by implementation science frameworks and adopts a mixed methods approach. Quantitative evidence from participating leaders and clinicians in our study will be used to produce individual and site-level descriptive statistics. Qualitative evidence of leaders’ perceptions about the implementation will be collected using semistructured interviews and will be analysed descriptively within-site and thematically across the dataset. The process evaluation will also use publicly available data and observations from the research team implementing MOHMQuit, for example, training logs. These data will be synthesised to provide site-level as well as individual-level implementation outcomes.

Ethics and dissemination

The study received ethical approval from the Population Health Services Research Ethics Committee for NSW, Australia (Reference 2021/ETH00887). Results will be communicated via the study’s steering committee and will also be published in peer-reviewed journals and presented at conferences.

Trial registration number

Australian New Zealand Trials Registry ACTRN12622000167763. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12622000167763.

Sustained Mood Improvement with Laughing Gas Exposure (SMILE): Study protocol for a randomized placebo-controlled pilot trial of nitrous oxide for treatment-resistant depression

by Karim S. Ladha, Jiwon Lee, Gabriella F. Mattina, Janneth Pazmino-Canizares, Duminda N. Wijeysundera, Fatemeh Gholamali Nezhad, Kaylyssa Philip, Vanessa K. Tassone, Fathima Adamsahib, Venkat Bhat, on behalf of the SMILE Study Investigators

Background

Nitrous oxide has shown potentially as an efficacious intervention for treatment-resistant depression, yet there remains insufficient evidence pertaining to repeated administration of nitrous oxide over time and active placebo-controlled studies with optimal blinding. Thus, we aim to examine the feasibility and preliminary efficacy of a six-week follow up study examining the effects of a 4 week course of weekly administered nitrous oxide as compared to the active placebo, midazolam.

Methods

In this randomized, active placebo-controlled, pilot trial, 40 participants with treatment-resistant depression will receive either inhaled nitrous oxide (1 hour at 50% concentration) plus intravenous saline (100mL) or inhaled oxygen (1 hour at 50% concentration) plus intravenous midazolam (0.02 mg/kg in 100mL, up to 2mg) once per week, for 4 consecutive weeks. Participants will be followed up for 6 weeks starting from the first treatment visit. Primary feasibility outcomes include recruitment rate, withdrawal rate, adherence, missing data, and adverse events. The primary exploratory clinical outcome is change in Montgomery-Åsberg Depression Rating Scale (MADRS) score at day 42 of the study. Other exploratory clinical outcomes include remission (defined as MADRS score Discussion

This pilot study will provide valuable information regarding the feasibility and preliminary efficacy of repeated nitrous oxide administration over time for treatment-resistant depression. If feasible, this study will inform the design of a future definitive trial of nitrous oxide as an efficacious and fast-acting treatment for treatment-resistant depression.

Trial registration

ClinicalTrials.gov NCT04957368. Registered on July 12, 2021.

Factors influencing implementation and sustainability of interventions to improve oral health and related health behaviours in adults experiencing severe and multiple disadvantage: a mixed-methods systematic review

Por: John · D. A. · Adams · E. A. · McGowan · L. J. · Joyes · E. C. · Richmond · C. · Beyer · F. R. · Landes · D. · Watt · R. G. · Sniehotta · F. F. · Paisi · M. · Bambra · C. · Craig · D. · Kaner · E. · Ramsay · S. E.
Objectives

Among people experiencing severe and multiple disadvantage (SMD), poor oral health is common and linked to smoking, substance use and high sugar intake. Studies have explored interventions addressing oral health and related behaviours; however, factors related to the implementation of these interventions remain unclear. This mixed-methods systematic review aimed to synthesise evidence on the implementation and sustainability of interventions to improve oral health and related health behaviours among adults experiencing SMD.

Methods

Bibliographic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, EBSCO, Scopus) and grey literature were searched from inception to February 2023. Studies meeting the inclusion criteria were screened and extracted independently by two researchers. Quality appraisal was undertaken, and results were synthesised using narrative and thematic analyses.

Results

Seventeen papers were included (published between 1995 and 2022). Studies were mostly of moderate quality and included views from SMD groups and service providers. From the qualitative synthesis, most findings were related to aspects such as trust, resources and motivation levels of SMD groups and service providers. None of the studies reported on diet and none included repeated offending (one of the aspects of SMD). From the quantitative synthesis, no difference was observed in programme attendance between the interventions and usual care, although there was some indication of sustained improvements in participation in the intervention group.

Conclusion

This review provides some evidence that trust, adequate resources and motivation levels are potentially important in implementing interventions to improve oral health and substance use among SMD groups. Further research is needed from high quality studies and focusing on diet in this population.

PROSPERO registration number

CRD42020202416.

Qualitative exploration of the perceptions of exercise in patients with cancer initiated during chemotherapy: a meta-synthesis

Por: Andersen · C. · Adamsen · L. · Damhus · C. S. · Piil · K. · Missel · M. · Jarden · M. · Larsen · A. · Larsen · H. B. · Moller · T.
Objective

To synthesise qualitative literature on (1) the perceptions of patients with cancer of participating in an exercise intervention while undergoing chemotherapy and (2) to inform and guide professionals in oncology and haematology practice.

Design

A qualitative meta-synthesis based on Noblit and Hare’s seven-step meta-ethnography.

Data sources

Six electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, EMBASE, PubMed, SCI-Expanded—SSCI and Scopus (final search June 2022) were used to identify qualitative literature containing individual or focus group interviews. The transparency of reporting for each study was assessed using the Consolidated criteria for Reporting Qualitative research checklist.

Results

The search identified 5002 articles, 107 of which were selected for full-text review. Seventeen articles from five countries with patients undergoing chemotherapy during exercise interventions were included. Eleven articles were included in the meta-synthesis, which comprised 193 patients with various cancer diagnoses, disease stages, sexes and ages. Four main themes were identified: chemotherapy overpowers the body; exercise in battle with side effects; a break from gloomy thoughts; and a question of survivorship.

Conclusions and implications

The meta-synthesis emphasised that patients with cancer undergoing chemotherapy and simultaneously participating in exercise interventions may experience momentary relief from overwhelming side effects, even though full bodily recovery may be perceived as a distant prospect. The synthesis offers a sparse empirical basis for gaining insight into what patients experience existentially following exercise interventions. It is up to patients to independently apply the transfer value of exercise to their own existential circumstances.

Field study examining the mucosal microbiome in equine glandular gastric disease

by Linda J. Paul, Aaron C. Ericsson, Frank M. Andrews, Zachary McAdams, Michael L. Keowen, Michael P. St Blanc, Heidi E. Banse

Equine glandular gastric disease (EGGD) is a common disease among athletic horses that can negatively impact health and performance. The pathophysiology of this EGGD remains poorly understood. Previous studies using controlled populations of horses identified differences in the gastric glandular mucosal microbiome associated with disease. The objective of this study was to compare the gastric microbiome in horses with EGGD and those without across multiple barns and differing management practices. We hypothesized that alterations in the microbiome of the gastric glandular mucosa are associated with EGGD. A secondary objective was to perform a risk factor analysis for EGGD using the diet and management data collected. Microbial populations of biopsies from normal pyloric mucosa of horses without EGGD (control biopsies), normal pyloric mucosa of horses with EGGD (normal biopsies) and areas of glandular mucosal disruption in horses with EGGD (lesion biopsies) were compared. Lesion biopsies had a different microbial community structure than control biopsies. Control biopsies had a higher read count for the phylum Actinomycetota compared to lesion biopsies. Control biopsies also had an enrichment of the genera Staphylococcus and Lawsonella and the species Streptococcus salivarius. Lesion biopsies had an enrichment of the genera Lactobacillus and Actinobacillus and the species Lactobacillus equigenerosi. These results demonstrate differences in the gastric glandular microbiome between sites of disrupted mucosa in horses with EGGD compared to pyloric mucosa of horses without EGGD. Risk factor analysis indicated that exercise duration per week was a risk factor for EGGD.

Clinical impacts of an integrated electronic health record-based smoking cessation intervention during hospitalisation

Por: Banerjee · S. · Alabaster · A. · Adams · A. S. · Fogelberg · R. · Patel · N. · Young-Wolff · K.
Objective

To assess the effects of an electronic health record (EHR) intervention that prompts the clinician to prescribe nicotine replacement therapy (NRT) at hospital admission and discharge in a large integrated health system.

Design

Retrospective cohort study using interrupted time series (ITS) analysis leveraging EHR data generated before and after implementation of the 2015 EHR-based intervention.

Setting

Kaiser Permanente Northern California, a large integrated health system with 4.2 million members.

Participants

Current smokers aged ≥18 hospitalised for any reason.

Exposure

EHR-based clinical decision supports that prompted the clinician to order NRT on hospital admission (implemented February 2015) and discharge (implemented September 2015).

Main outcomes and measures

Primary outcomes included the monthly percentage of admitted smokers with NRT orders during admission and at discharge. A secondary outcome assessed patient quit rates within 30 days of hospital discharge as reported during discharge follow-up outpatient visits.

Results

The percentage of admissions with NRT orders increased from 29.9% in the year preceding the intervention to 78.1% in the year following (41.8% change, 95% CI 38.6% to 44.9%) after implementation of the admission hard-stop intervention compared with the baseline trend (ITS estimate). The percentage of discharges with NRT orders increased acutely at the time of both interventions (admission intervention ITS estimate 15.5%, 95% CI 11% to 20%; discharge intervention ITS estimate 13.4%, 95% CI 9.1% to 17.7%). Following the implementation of the discharge intervention, there was a small increase in patient-reported quit rates (ITS estimate 5.0%, 95% CI 2.2% to 7.8%).

Conclusions

An EHR-based clinical decision-making support embedded into admission and discharge documentation was associated with an increase in NRT prescriptions and improvement in quit rates. Similar systemic EHR interventions can help improve smoking cessation efforts after hospitalisation.

Changes in soft drinks purchased by British households associated with the UK soft drinks industry levy: a controlled interrupted time series analysis

Por: Rogers · N. T. · Pell · D. · Mytton · O. T. · Penney · T. L. · Briggs · A. · Cummins · S. · Jones · C. · Rayner · M. · Rutter · H. · Scarborough · P. · Sharp · S. · Smith · R. · White · M. · Adams · J.
Objective

To determine changes in household purchases of drinks 1 year after implementation of the UK soft drinks industry levy (SDIL).

Design

Controlled interrupted time series.

Participants

Households reporting their purchasing to a market research company (average weekly n=22 091), March 2014 to March 2019.

Intervention

A two-tiered tax levied on soft drinks manufacturers, announced in March 2016 and implemented in April 2018. Drinks with ≥8 g sugar/100 mL (high tier) are taxed at £0.24/L, drinks with ≥5 to

Main outcome measures

Absolute and relative differences in the volume of, and amount of sugar in, soft drinks categories, all soft drinks combined, alcohol and confectionery purchased per household per week 1 year after implementation.

Results

In March 2019, compared with the counterfactual, purchased volume of high tier drinks decreased by 140.8 mL (95% CI 104.3 to 177.3 mL) per household per week, equivalent to 37.8% (28.0% to 47.6%), and sugar purchased in these drinks decreased by 16.2 g (13.5 to 18.8 g), or 42.6% (35.6% to 49.6%). Purchases of low tier drinks decreased by 170.5 mL (154.5 to 186.5 mL) or 85.8% (77.8% to 93.9%), with an 11.5 g (9.1 to 13.9 g) reduction in sugar in these drinks, equivalent to 87.8% (69.2% to 106.4%). When all soft drinks were combined irrespective of levy tier or eligibility, the volume of drinks purchased increased by 188.8 mL (30.7 to 346.9 mL) per household per week, or 2.6% (0.4% to 4.7%), but sugar decreased by 8.0 g (2.4 to 13.6 g), or 2.7% (0.8% to 4.5%). Purchases of confectionery and alcoholic drinks did not increase.

Conclusions

Compared with trends before the SDIL was announced, 1 year after implementation, volume of all soft drinks purchased combined increased by 189 mL, or 2.6% per household per week. The amount of sugar in those drinks was 8 g, or 2.7%, lower per household per week. Further studies should determine whether and how apparently small effect sizes translate into health outcomes.

Trial registration number

ISRCTN18042742.

Molecular characterization of <i>G6PD</i> mutations identifies new mutations and a high frequency of intronic variants in Thai females

by Kamonwan Chamchoy, Sirapapha Sudsumrit, Jutamas Wongwigkan, Songsak Petmitr, Duantida Songdej, Emily R. Adams, Thomas Edwards, Ubolsree Leartsakulpanich, Usa Boonyuen

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an X-linked enzymopathy caused by mutations in the G6PD gene. A medical concern associated with G6PD deficiency is acute hemolytic anemia induced by certain foods, drugs, and infections. Although phenotypic tests can correctly identify hemizygous males, as well as homozygous and compound heterozygous females, heterozygous females with a wide range of G6PD activity may be misclassified as normal. This study aimed to develop multiplex high-resolution melting (HRM) analyses to enable the accurate detection of G6PD mutations, especially among females with heterozygous deficiency. Multiplex HRM assays were developed to detect six G6PD variants, i.e., G6PD Gaohe (c.95A>G), G6PD Chinese-4 (c.392G>T), G6PD Mahidol (c.487G>A), G6PD Viangchan (c.871G>A), G6PD Chinese-5 (c.1024C>T), and G6PD Union (c.1360C>T) in two reactions. The assays were validated and then applied to genotype G6PD mutations in 248 Thai females. The sensitivity of the HRM assays developed was 100% [95% confidence interval (CI): 94.40%–100%] with a specificity of 100% (95% CI: 88.78%–100%) for detecting these six mutations. The prevalence of G6PD deficiency was estimated as 3.63% (9/248) for G6PD deficiency and 31.05% (77/248) for intermediate deficiency by phenotypic assay. The developed HRM assays identified three participants with normal enzyme activity as heterozygous for G6PD Viangchan. Interestingly, a deletion in intron 5 nucleotide position 637/638 (c.486-34delT) was also detected by the developed HRM assays. G6PD genotyping revealed a total of 12 G6PD genotypes, with a high prevalence of intronic variants. Our results suggested that HRM analysis-based genotyping is a simple and reliable approach for detecting G6PD mutations, and could be used to prevent the misdiagnosis of heterozygous females by phenotypic assay. This study also sheds light on the possibility of overlooking intronic variants, which could affect G6PD expression and contribute to enzyme deficiency.

Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)

Por: Adams · N. · Stirrup · O. · Blackstone · J. · Krutikov · M. · Cassell · J. A. · Cadar · D. · Henderson · C. · Knapp · M. · Gosce · L. · Leiser · R. · Regan · M. · Cullen-Stephenson · I. · Fenner · R. · Verma · A. · Gordon · A. · Hopkins · S. · Copas · A. · Freemantle · N. · Flowers · P. · Sh
Introduction

Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes.

Methods and analysis

The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.

The trial will be delivered by a multidisciplinary research team through a series of five work packages.

The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers.

Ethics and dissemination

The study has been approved by the London—Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants.

Trial registration number

ISRCTN13296529.

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