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IMPAACT: IMproving the PArticipAtion of older people in policy decision-making on common health CondiTions - a study protocol

Por: Ambagtsheer · R. C. · Hurley · C. J. · Lawless · M. · Braunack-Mayer · A. · Visvanathan · R. · Beilby · J. · Stewart · S. · Cornell · V. · Leach · M. J. · Taylor · D. · Thompson · M. · Dent · E. · Whiteway · L. · Archibald · M. · O'Rourke · H. M. · Williams · K. · Chudecka · A.
Introduction

Rapid population ageing is a demographic trend being experienced and documented worldwide. While increased health screening and assessment may help mitigate the burden of illness in older people, issues such as misdiagnosis may affect access to interventions. This study aims to elicit the values and preferences of evidence-informed older people living in the community on early screening for common health conditions (cardiovascular disease, diabetes, dementia and frailty). The study will proceed in three Phases: (1) generating recommendations of older people through a series of Citizens’ Juries; (2) obtaining feedback from a diverse range of stakeholder groups on the jury findings; and (3) co-designing a set of Knowledge Translation resources to facilitate implementation into research, policy and practice. Conditions were chosen to reflect common health conditions characterised by increasing prevalence with age, but which have been underexamined through a Citizens’ Jury methodology.

Methods and analysis

This study will be conducted in three Phases—(1) Citizens’ Juries, (2) Policy Roundtables and (3) Production of Knowledge Translation resources. First, older people aged 50+ (n=80), including those from traditionally hard-to-reach and diverse groups, will be purposively recruited to four Citizen Juries. Second, representatives from a range of key stakeholder groups, including consumers and carers, health and aged care policymakers, general practitioners, practice nurses, geriatricians, allied health practitioners, pharmaceutical companies, private health insurers and community and aged care providers (n=40) will be purposively recruited for two Policy Roundtables. Finally, two researchers and six purposively recruited consumers will co-design Knowledge Translation resources. Thematic analysis will be performed on documentation and transcripts.

Ethics and dissemination

Ethical approval has been obtained through the Torrens University Human Research Ethics Committee. Participants will give written informed consent. Findings will be disseminated through development of a policy brief and lay summary, peer-reviewed publications, conference presentations and seminars.

Dietary quality and cardiometabolic indicators in the USA: A comparison of the Planetary Health Diet Index, Healthy Eating Index-2015, and Dietary Approaches to Stop Hypertension

by Sarah M. Frank, Lindsay M. Jaacks, Christy L. Avery, Linda S. Adair, Katie Meyer, Donald Rose, Lindsey Smith Taillie

Background

The Planetary Health Diet Index (PHDI) measures adherence to the sustainable dietary guidance proposed by the EAT-Lancet Commission on Food, Planet, Health. To justify incorporating sustainable dietary guidance such as the PHDI in the US, the index needs to be compared to health-focused dietary recommendations already in use. The objectives of this study were to compare the how the Planetary Health Diet Index (PHDI), the Healthy Eating Index-2015 (HEI-2015) and Dietary Approaches to Stop Hypertension (DASH) relate to cardiometabolic risk factors.

Methods and findings

Participants from the National Health and Nutrition Examination Survey (2015–2018) were assigned a score for each dietary index. We examined disparities in dietary quality for each index. We used linear and logistic regression to assess the association of standardized dietary index values with waist circumference, blood pressure, HDL-C, fasting plasma glucose (FPG) and triglycerides (TG). We also dichotomized the cardiometabolic indicators using the cutoffs for the Metabolic Syndrome and used logistic regression to assess the relationship of the standardized dietary index values with binary cardiometabolic risk factors. We observed diet quality disparities for populations that were Black, Hispanic, low-income, and low-education. Higher diet quality was associated with improved continuous and binary cardiometabolic risk factors, although higher PHDI was not associated with high FPG and was the only index associated with lower TG. These patterns remained consistent in sensitivity analyses.

Conclusions

Sustainability-focused dietary recommendations such as the PHDI have similar cross-sectional associations with cardiometabolic risk as HEI-2015 or DASH. Health-focused dietary guidelines such as the forthcoming 2025–2030 Dietary Guidelines for Americans can consider the environmental impact of diet and still promote cardiometabolic health.

MISSION ABC: transforming respiratory care through one-stop multidisciplinary clinics - an observational study

Por: Heiden · E. · Longstaff · J. · Chauhan · M. J. A. · DeVos · R. · Lanning · E. · Neville · D. · Jones · T. L. · Begum · S. · Amos · M. · Mottershaw · M. · Micklam · J. · Holdsworth · B. · Rupani · H. · Brown · T. · Chauhan · A. J. · Mission ABC Collaborators · Baghammar · Bannell · Domin
Objectives

The Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness and Chronic Obstructive Pulmonary Disease (COPD) (MABC) service aimed to enhance disease management for chronic respiratory conditions through specialist multidisciplinary clinics, predominantly in the community. This study assesses the outcomes of these clinics.

Design

This study used a prospective, longitudinal, participatory action research approach.

Setting

The study was conducted in primary care practices across Hampshire, UK.

Participants

Adults aged 16 years and above with poorly controlled asthma or COPD, as well as those with undifferentiated breathlessness not under specialist care, were included.

Interventions

Participants received care through the multidisciplinary, specialist-led MABC clinics.

Primary and secondary outcome measures

Primary outcomes included disease activity, quality of life and healthcare utilisation. Secondary outcomes encompassed clinic attendance, diagnostic changes, patient activation, participant and healthcare professional experiences and cost-effectiveness.

Results

A total of 441 participants from 11 general practitioner practices were recruited. Ninety-six per cent of participants would recommend MABC clinics. MABC assessments led to diagnosis changes for 64 (17%) participants with asthma and COPD and treatment adjustments for 252 participants (57%). Exacerbations decreased significantly from 236 to 30 after attending the clinics (p

Conclusions

Specialist-supported multidisciplinary teams in MABC clinics improved diagnosis accuracy and adherence to guidelines. High patient satisfaction, disease control improvements and reduced exacerbations resulted in decreased unscheduled healthcare use and cost savings.

Trial registration number

NCT03096509.

Cannabis for medical use versus opioids for chronic non-cancer pain: a systematic review and network meta-analysis of randomised clinical trials

Por: Jeddi · H. M. · Busse · J. W. · Sadeghirad · B. · Levine · M. · Zoratti · M. J. · Wang · L. · Noori · A. · Couban · R. J. · Tarride · J.-E.
Objective

The objective of this study is to evaluate the comparative benefits and harms of opioids and cannabis for medical use for chronic non-cancer pain.

Design

Systematic review and network meta-analysis.

Data sources

EMBASE, MEDLINE, CINAHL, AMED, PsycINFO, PubMed, Web of Science, Cannabis-Med, Epistemonikos and the Cochrane Library (CENTRAL) from inception to March 2021.

Study selection

Randomised trials comparing any type of cannabis for medical use or opioids, against each other or placebo, with patient follow-up ≥4 weeks.

Data extraction and synthesis

Paired reviewers independently extracted data. We used Bayesian random-effects network meta-analyses to summarise the evidence and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach to evaluate the certainty of evidence and communicate our findings.

Results

Ninety trials involving 22 028 patients were eligible for review, among which the length of follow-up ranged from 28 to 180 days. Moderate certainty evidence showed that opioids provide small improvements in pain, physical functioning and sleep quality versus placebo; low to moderate certainty evidence supported similar effects for cannabis versus placebo. Neither was more effective than placebo for role, social or emotional functioning (all high to moderate certainty evidence). Moderate certainty evidence showed there is probably little to no difference between cannabis for medical use and opioids for physical functioning (weighted mean difference (WMD) 0.47 on the 100-point 36-item Short Form Survey physical component summary score, 95% credible interval (CrI) –1.97 to 2.99), and cannabis resulted in fewer discontinuations due to adverse events versus opioids (OR 0.55, 95% CrI 0.36 to 0.83). Low certainty evidence suggested little to no difference between cannabis and opioids for pain relief (WMD 0.23 cm on a 10 cm Visual Analogue Scale (VAS), 95% CrI –0.06 to 0.53) or sleep quality (WMD 0.49 mm on a 100 mm VAS, 95% CrI –4.72 to 5.59).

Conclusions

Cannabis for medical use may be similarly effective and result in fewer discontinuations than opioids for chronic non-cancer pain.

PROSPERO registration number

CRD42020185184.

How can community pharmacists be supported to manage skin conditions? A multistage stakeholder research prioritisation exercise

Por: Harvey · J. · Shariff · Z. · Anderson · C. · Boyd · M. J. · Ridd · M. J. · Santer · M. · Thomas · K. S. · Maidment · I. · Leighton · P.
Objective

To establish research priorities which will support the development and delivery of community pharmacy initiatives for the management of skin conditions.

Design

An iterative, multistage stakeholder consultation consisting of online survey, participant workshops and prioritisation meeting.

Setting

All data collection took place online with participants completing a survey (delivered via the JISC Online Survey platform, between July 2021 and January 2022) and participating in online workshops and meetings (hosted on Microsoft Teams between April and July 2022).

Participants

174 community pharmacists and pharmacy staff completed the online survey.

53 participants participated in the exploratory workshops (19 community pharmacists, 4 non-pharmacist members of pharmacy staff and 30 members of the public). 4 healthcare professionals who were unable to attend a workshop participated in a one-to-one interview.

29 participants from the workshops took part in the prioritisation meeting (5 pharmacists/pharmacy staff, 1 other healthcare professional and 23 members of the public).

Results

Five broad areas of potential research need were identified in the online survey: (1) identifying and diagnosing skin conditions; (2) skin conditions in skin of colour; (3) when to refer skin conditions; (4) disease-specific concerns and (5) product-specific concerns.

These were explored and refined in the workshops to establish 10 potential areas for research, which will support pharmacists in managing skin conditions. These were ranked in the prioritisation meeting. Among those prioritised were topics which consider how pharmacists work with other healthcare professionals to identify and manage skin conditions.

Conclusions

Survey responses and stakeholder workshops all recognised the potential for community pharmacists to play an active role in the management of common skin conditions. Future research may support this in the generation of resources for pharmacists, in encouraging public take-up of pharmacy services, and in evaluating the most effective provision for dealing with skin conditions.

Key factors for effective implementation of healthcare workers support interventions after patient safety incidents in health organisations: a scoping review

Por: Guerra-Paiva · S. · Lobao · M. J. · Simoes · D. G. · Fernandes · J. · Donato · H. · Carrillo · I. · Mira · J. J. · Sousa · P.
Objectives

This study aims to map and frame the main factors present in support interventions successfully implemented in health organisations in order to provide timely and adequate response to healthcare workers (HCWs) after patient safety incidents (PSIs).

Design

Scoping review guided by the six-stage approach proposed by Arksey and O’Malley and by PRISMA-ScR.

Data sources

CINAHL, Cochrane Library, Embase, Epistemonikos, PsycINFO, PubMed, SciELO Citation Index, Scopus, Web of Science Core Collection, reference lists of the eligible articles, websites and a consultation group.

Eligibility criteria for selecting studies

Empirical studies (original articles) were prioritised. We used the Mixed Methods Appraisal Tool Version 2018 to conduct a quality assessment of the eligible studies.

Data extraction and synthesis

A total of 9766 records were retrieved (last update in November 2022). We assessed 156 articles for eligibility in the full-text screening. Of these, 29 earticles met the eligibility criteria. The articles were independently screened by two authors. In the case of disagreement, a third author was involved. The collected data were organised according to the Organisational factors, People, Environment, Recommendations from other Audies, Attributes of the support interventions. We used EndNote to import articles from the databases and Rayyan to support the screening of titles and abstracts.

Results

The existence of an organisational culture based on principles of trust and non-judgement, multidisciplinary action, leadership engagement and strong dissemination of the support programmes’ were crucial factors for their effective implementation. Training should be provided for peer supporters and leaders to facilitate the response to HCWs’ needs. Regular communication among the implementation team, allocation of protected time, funding and continuous monitoring are useful elements to the sustainability of the programmes.

Conclusion

HCWs’ well-being depends on an adequate implementation of a complex group of interrelated factors to support them after PSIs.

Contribution of hospitals and clinical services to global warming: protocol for a scoping review

Por: Merino-Urrutia · W. · Carcamo-Fuentes · C. · Pena · M. · Martinez-Zapata · M. J.
Introduction

Climate change is one of the greatest threats to public health today, placing considerable pressure on the healthcare sector. During patient care processes, hospital facilities contribute to greenhouse gas emissions through the use of greater resources and higher energy consumption. Consequently, there is growing interest among researchers, universities, organisations and governments to study the impact of the healthcare sector on the environment and to develop strategies to mitigate its effects. The aim of this scoping review is to determine the extent and nature of current literature on global warming from hospitals and clinical services, and ways in which they contribute to its effect. Planning and execution of future research are possible once those areas with existing gaps are identified.

Methods and analysis

A broad literature search will be carried out to illustrate the ways in which hospitals and clinical services, processes and activities contribute to climate change. Our protocol was drafted using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. The final protocol was registered prospectively with the Open Science Framework. All identified studies indexed in Medline, Scopus and Embase will be examined.

Ethics and dissemination

This project is literature-based research; therefore, it does not require ethical approval. The results will be presented to researchers as well as policymakers in this particular area, via conferences, webinars, podcasts and online events. A peer-reviewed publication will be submitted to specific journals of interest.

Prison is a barrier to high-quality, comprehensive midwifery care

Por: Paynter · M. J.

Commentary on: Abbott L, Scott T, Thomas H. Experiences of midwifery care in English prisons. Birth. 2023 Mar;50(1):244-251. doi: 10.1111/birt.12692. Epub 2022 Nov 12.

Implications for practice and research

  • Incarceration presents barriers to best midwifery practices, restricting patient choice in care provider and place of birth. Midwives play an important role advocating for incarcerated patients.

  • Prison staff misunderstand midwifery and conceptualise access to care as a reward for good behaviour. Future research should assess outcomes of alternatives to incarceration.

  • Context

    Women continue to be one of the fastest growing populations experiencing incarceration, with significant consequences for their newborns and children. Despite international and national requirements for equivalent care to what is available in community, existing research in the field of prison perinatal health has found delays and gaps in care and poor neonatal outcomes associated with pregnancy in prison.1 This study by...

    Ischaemic stroke in patients with diabetes requiring urgent procedures during the COVID-19 pandemic in South Korea: a retrospective, nationwide, population-based cohort study using data from the National Emergency Department Information System

    Por: Park · M. J. · Hwang · J. · Ahn · J. · Park · S. J. · Song · E. · Jang · A. · Choi · K. M. · Baik · S. H. · Yoo · H. J.
    Objectives

    The COVID-19 pandemic resulted in suboptimal care for ischaemic stroke. Patients with diabetes mellitus (DM), a high-risk group for stroke, had compromised routine care during the pandemic, which increases the chance of stroke. We examined influence of the COVID-19 pandemic on the management of ischaemic stroke in patients with DM in South Korea.

    Design

    Retrospective, nationwide, population-based cohort study.

    Setting

    Data from the National Emergency Department Information System.

    Participants

    We analysed 11 734 patients diagnosed with acute ischaemic stroke who underwent intravenous thrombolysis or endovascular thrombectomy between 2019 (the reference year) and 2020 (the pandemic year). Among them, 1014 subjects with DM were analysed separately.

    Outcome measures

    The frequency of emergency department (ED) visits, time from symptom onset to ED, from ED visit to admission and in-hospital mortality were compared between two periods in the overall population and in patients with DM.

    Results

    During the pandemic, the incidence of ischaemic stroke requiring urgent procedures increased by 7.57% in total and by 9.03% in patients with DM. Time delay from symptom onset to ED (reference vs pandemic, total: 1.50 vs 1.55 hours; p

    Conclusions

    During the COVID-19 pandemic, the incidence of ischaemic stroke requiring urgent procedures increased, and older patients with DM showed a higher ICU admission rate. However, the pandemic was not associated with an increased in-hospital stroke mortality.

    What are the features of high-performing quality improvement collaboratives? A qualitative case study of a state-wide collaboratives programme

    Por: McGowan · J. G. · Martin · G. P. · Krapohl · G. L. · Campbell · D. A. · Englesbe · M. J. · Dimick · J. B. · Dixon-Woods · M.
    Objectives

    Despite their widespread use, the evidence base for the effectiveness of quality improvement collaboratives remains mixed. Lack of clarity about ‘what good looks like’ in collaboratives remains a persistent problem. We aimed to identify the distinctive features of a state-wide collaboratives programme that has demonstrated sustained improvements in quality of care in a range of clinical specialties over a long period.

    Design

    Qualitative case study involving interviews with purposively sampled participants, observations and analysis of documents.

    Setting

    The Michigan Collaborative Quality Initiatives programme.

    Participants

    38 participants, including clinicians and managers from 10 collaboratives, and staff from the University of Michigan and Blue Cross Blue Shield of Michigan.

    Results

    We identified five features that characterised success in the collaboratives programme: learning from positive deviance; high-quality coordination; high-quality measurement and comparative performance feedback; careful use of motivational levers; and mobilising professional leadership and building community. Rigorous measurement, securing professional leadership and engagement, cultivating a collaborative culture, creating accountability for quality, and relieving participating sites of unnecessary burdens associated with programme participation were all important to high performance.

    Conclusions

    Our findings offer valuable learning for optimising collaboration-based approaches to improvement in healthcare, with implications for the design, structure and resourcing of quality improvement collaboratives. These findings are likely to be useful to clinicians, managers, policy-makers and health system leaders engaged in multiorganisational approaches to improving quality and safety.

    Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial

    Por: Pyne · S. · Sach · T. H. · Lawrence · M. · Renz · S. · Eminton · Z. · Stuart · B. · Thomas · K. S. · Francis · N. · Soulsby · I. · Thomas · K. · Permyakova · N. V. · Ridd · M. J. · Little · P. · Muller · I. · Nuttall · J. · Griffiths · G. · Layton · A. M. · Santer · M.
    Objective

    This study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks.

    Design

    Economic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial.

    Setting

    Primary and secondary healthcare, community and social media advertising.

    Participants

    Women ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment.

    Interventions

    Participants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment.

    Main outcome measures

    Cost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator’s global assessment, IGA

    Results

    Spironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence’s threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis).

    Conclusions

    The results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis.

    Trial registration number

    ISRCTN registry (ISRCTN12892056).

    Influence of physical fitness components on personality factors and risk perception of children and adolescents: a cross-sectional study

    Objectives

    To examine the associations of cardiorespiratory fitness (VO2 max) and muscular strength with indicators related to the risk scale, such as perceived competence, sensation seeking, competitiveness, risk taking and risk perception in sports.

    Design

    Cross-sectional study.

    Setting

    High schools from the Region of Murcia (Spain).

    Participants

    Three-hundred-and-seventeen adolescents participated (mean age: 13.69±1.2 years old).

    Primary and secondary outcome measures

    Body mass, body height, Course-Navette test, upper limb strength and psychoeducational factors that determine the propensity towards sports accidents in school children, the Sports Accident Propensity Scale were evaluated. It was performance t-test for independent samples, stepwise multiple linear regression models and a multiple mediation analysis.

    Results

    The analysis showed significant differences with respect to sex in height, VO2 max, handgrip strength and in all factors of the questionnaire (p=0.02-2 max, strength in the handgrip test and age showed a higher score in factors 1 and 3. Higher scores in factor 2 were associated with better VO2 max and strength in handgrip test. Youngers and better values of strength in the handgrip showed higher score in factors 4 and 5. The mediation analysis with two mediating variables (handgrip strength and VO2 max) showed a significant indirect effect. When handgrip strength and VO2 max were included in the equations, the association between sex and each factor ceased to be significant.

    Conclusion

    This study highlights the potential benefits of muscular strength (handgrip) and VO2 max in the perceived risk scale, and the variable of age on this.

    Trial registration number

    Clinical trial: NCT05544370 (pre-results).

    Advanced practice nursing in Europe—Results from a pan‐European survey of 35 countries

    Abstract

    Aim

    To report the results of a mapping exercise by the European Federation of Nurses on current advanced practice nursing frameworks and developments across Europe.

    Design

    Online, cross-sectional, questionnaire study.

    Methods

    An online questionnaire was distributed among 35 national nurses' associations across Europe in March 2021. The questionnaire solicited input on 60 items concerning key features of advanced practice nursing, intending to map existing developments and better understand the current state of advanced practice nursing in Europe. Data analysis used descriptive statistics, including counts and percentages, tabulation; open-text responses were handled with thematic synthesis techniques.

    Results

    The definition, sense-making and operationalization of advanced practice nursing vary across Europe. Important variations were noted in the definition and requirements of advanced practice nursing, resulting in different views on the competencies and scope of practice associated with this role. Importantly, the level of education and training required to qualify and practice as an advanced practice nurse varies across European countries. Furthermore, only 11 countries reported the existence of a national legislation establishing minimum educational requirements.

    Conclusion

    Significant variation exists in how countries define advanced practice nursing and how it is regulated at academic and practice levels. More research is needed to clarify whether this variation results from designing models of advanced practice nursing that work in different contexts; and what impact a standardized regulatory framework could have to grow the volume of advanced practice nurses across Europe.

    Impact

    The current paper exposes the lack of clarity on the development and implementation of advanced practice nursing across Europe. We found significant variation in the definition, recognition, regulation and education of advanced practice nurses. Our data are essential to policymakers, professional associations and employers to ensure a coordinated and systematic effort in the consistency and ongoing development of advanced practice nurses across Europe.

    Patient or Public Contribution

    No patient or public contribution applied; the participants were national nurses' associations.

    Exploring the outcomes of research engagement using the observation method in an online setting

    Por: Marshall · D. A. · Suryaprakash · N. · Lavallee · D. C. · Barker · K. L. · Mackean · G. · Zelinsky · S. · McCarron · T. L. · Santana · M. J. · Moayyedi · P. · Bryan · S.
    Objective

    The objective of this study was to explore the outcomes of research engagement (patient engagement, PE) in the context of qualitative research.

    Design

    We observed engagement in two groups comprised of patients, clinicians and researchers tasked with conducting a qualitative preference exploration project in inflammatory bowel disease. One group was led by a patient research partner (PLG, partner led group) and the other by an academic researcher (RLG, researcher led group). A semistructured guide and a set of critical outcomes of research engagement were used as a framework to ground our analysis.

    Setting

    The study was conducted online.

    Participants

    Patient research partners (n=5), researchers (n=5) and clinicians (n=4) participated in this study.

    Main outcome measures

    Transcripts of meetings, descriptive and reflective observation data of engagement during meetings and email correspondence between group members were analysed to identify the outcomes of PE.

    Results

    Both projects were patient-centred, collaborative, meaningful, rigorous, adaptable, ethical, legitimate, understandable, feasible, timely and sustainable. Patient research partners (PRPs) in both groups wore dual hats as patients and researchers and influenced project decisions wearing both hats. They took on advisory and operational roles. Collaboration seemed easier in the PLG than in the RLG. The RLG PRPs spent more time than their counterparts in the PLG sharing their experience with biologics and helping their group identify a meaningful project question. A formal literature review informed the design, project materials and analysis in the RLG, while the formal review informed the project materials and analysis in the PLG. A PRP in the RLG and the PLG lead leveraged personal connections to facilitate recruitment. The outcomes of both projects were meaningful to all members of the groups.

    Conclusions

    Our findings show that engagement of PRPs in research has a positive influence on the project design and delivery in the context of qualitative research in both the patient-led and researcher-led group.

    Evaluating the impact of COVID-19 pandemic-related home confinement on the refractive error of school-aged children in Germany: a cross-sectional study based on data from 414 eye care professional centres

    Por: Sanz Diez · P. · Ohlendorf · A. · Barraza-Bernal · M. J. · Kratzer · T. · Wahl · S.
    Objective

    This study aimed at evaluating refractive changes in German school-aged children before and after the COVID-19 pandemic.

    Design

    Cross-sectional study.

    Setting

    414 eye care professional centres from Germany.

    Participants

    Refractive data from 59 926 German children aged 6–15 years were examined over a 7-year period (2015–2021).

    Primary and secondary outcome measures

    Spherical equivalent refraction was assessed as a function of year, age and gender. The refractive values concerning 2020 and 2021 were compared with those assigned to prior years (2015–2019).

    Results

    The refractive data associated with 2020 and 2021 showed a myopic refractive shift of approximately –0.20D compared with the 2015–2019 range. The refractive change was statistically considerable in the 6 to 11-year range (p

    Conclusion

    Disruption of normal lifestyle due to pandemic-related home confinement appears to lead to a myopic refractive shift in children aged 6–11 years in Germany. The greater effect observed at younger ages seems to emphasise the importance of refractive development in this age group.

    Pembrolizumab monotherapy for non-small cell lung cancer (NSCLC): can patient stratification be improved in the UK Tayside population? A retrospective cohort study

    Por: Mander · E. S. · Merrick · C. B. · Nicholson · H. A. · Lord · H. K. · Ferguson · M. J. · Smith · G.
    Objective

    Pembrolizumab is a programmed cell death protein-1 (PD-1) inhibitor used to treat advanced patients with non-small cell lung cancer (NSCLC) with a programmed cell death ligand-1 (PD-L1) tumour proportion score (TPS) ≥50. Further sub-division of TPS-based stratification has not been evaluated in the UK, although smoking-induced tumour mutational burden and the immunogenic effects of prior radiotherapy are suggested to improve response.

    Aims

    To investigate if PD-L1 TPS ≥80%, smoking status or radiotherapy before or within 2 months of treatment influenced progression-free survival (PFS) in patients with NSCLC treated with pembrolizumab monotherapy.

    Methods

    PD-L1 TPS, smoking status and radiotherapy exposure were compared in patients with NSCLC in National Health Service (NHS) Tayside (n=100) treated with pembrolizumab monotherapy between 1 November 2017 and 18 February 2022. Survival estimates were compared using log-rank analysis, and Cox proportional hazards analysis was used to investigate the influence of potential confounding factors, including tumour stage and performance status.

    Results

    PFS was not significantly different (log-rank HR=0.330, p=0.566) comparing patients with PD-L1 TPS 50–79% and PD-L1 TPS ≥80%. Smokers had significantly improved PFS (log-rank HR=4.867, p=0.027), while patients receiving radiotherapy had significantly decreased PFS (log-rank HR=6.649, p=0.012). A Cox regression model confirmed that both radiotherapy (p=0.022) and performance status (p=0.009) were independent negative predictors of PFS.

    Conclusions

    More rigorous PD-L1 TPS stratification did not influence survival outcomes. Smoking history improved PFS, although it was not an independent response predictor, while radiotherapy and performance status independently influenced clinical response. We suggest that further stratification of PD-L1 TPS is not warranted, while performance status and radiotherapy treatment may be additional clinically useful biomarkers of response to pembrolizumab in patients with NSCLC.

    Can online and app-based interventions be used by people with diabetes to reduce diabetes distress? A protocol for a scoping review

    Por: Andersen · C. M. · Mathiesen · A. S. · Pouwer · F. · Mouritsen · J. D. · Mathiasen · K. · Rothmann · M. J.
    Introduction

    Diabetes distress has been defined as "the negative emotional or affective experience resulting from the challenge of living with the demands of diabetes". Diabetes distress affects 20%–25% of individuals living with diabetes and can have negative effects on both diabetes regulation and quality of life. For people living with diabetes distress, innovative tools/interventions such as online or app-based interventions may potentially alleviate diabetes distress in a cost-effective way. The specific research questions of this scoping review are: (1) what are the effects of online or app-based interventions on diabetes distress for adults with type 1 or type 2 diabetes, and (2) what are the characteristics of these interventions (eg, type of intervention, duration, frequency, mode of delivery, underlying theories and working mechanisms)?

    Methods and analysis

    A scoping review will be conducted, using the methodological framework of Arksey and O’Malley along with Levac et al. Eligible studies are: studies of adults ≥18 years old with type 1 or 2 diabetes using an online or app-based intervention and assessing diabetes distress as the primary or secondary outcome. Five databases (Medline, EMBASE, CINAHL, PsycINFO and Scopus) will be searched and is limited to articles written in English, Danish, Norwegian, Swedish or Dutch. Two reviewers will independently screen potentially eligible studies in Covidence, select studies, and together chart data, collate, summarise, and report the results. We will adhere to the Preferred reporting Items for Systematic Reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR).

    Ethics and dissemination

    The scoping review has been exempt from full ethical review by the Regional Committees on Health Research Ethics for Southern Denmark (case number: S-20232000-88). The results of the review will be published in a peer-reviewed journal and presented at relevant conferences and workshops with relevant stakeholders.

    REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol

    Por: Deane · A. M. · Alhazzani · W. · Guyatt · G. · Finfer · S. · Marshall · J. C. · Myburgh · J. · Zytaruk · N. · Hardie · M. · Saunders · L. · Knowles · S. · Lauzier · F. · Chapman · M. J. · English · S. · Muscedere · J. · Arabi · Y. · Ostermann · M. · Venkatesh · B. · Young · P. · Thabane · L
    Introduction

    The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE.

    Methods and analysis

    REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial.

    Ethics and dissemination

    All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to – Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide.

    Trial registration number

    NCT03374800.

    Workplace-based learning about health promotion in individual patient care: a scoping review

    Por: Verhees · M. J. M. · Engbers · R. · Landstra · A. M. · Bremer · A. E. · van de Pol · M. · Laan · R. F. J. M. · Assendelft · W. J. J.
    Objective

    To outline current knowledge regarding workplace-based learning about health promotion in individual patient care.

    Design

    Scoping review.

    Data sources

    PubMed, ERIC, CINAHL and Web of Science from January 2000 to August 2023.

    Eligibility criteria

    We included articles about learning (activities) for healthcare professionals (in training), about health promotion in individual patient care and in the context of workplace-based learning.

    Data extraction and synthesis

    The studies were evaluated using a charting template and were analysed thematically using a template based on Designable Elements of Learning Environments model.

    Results

    From 7159 studies, we included 31 that described evaluations of workplace-based learning about health promotion, around a variety of health promotion topics, for different health professions. In the articles, health promotion was operationalised as knowledge, skills or attitudes related to specific lifestyle factors or more broadly, with concepts such as health literacy, advocacy and social determinants of health. We assembled an overview of spatial and instrumental, social, epistemic and temporal elements of learning environments in which health promotion is learnt.

    Conclusions

    The studies included in our analysis varied greatly in their approach to health promotion topics and the evaluation of learning outcomes. Our findings suggest the importance of providing opportunities for health profession learners to engage in authentic practice situations and address potential challenges they may experience translating related theory into practice. Additionally, our results highlight the need for conscious and articulated integration of health promotion in curricula and assessment structures. We recommend the exploration of opportunities for health profession students, professionals and patients to learn about health promotion together. Additionally, we see potential in using participatory research methods to study future health promotion learning.

    Study registration

    Open Science Framework, https://doi.org/10.17605/OSF.IO/6QPTV.

    Development and evaluation of a theory-based health promotion programme aimed at improving retirees psychological well-being and quality of life: a protocol for a mixed-method study

    Por: Shoushtari Moghaddam · E. · Kaveh · M. H. · Karimi · M. · Tarrahi · M. J. · Soltani · E.
    Introduction

    The changes that retirees experience during their retirement years will challenge their ability to cope, potentially endangering their health and quality of life. This study aims to design and evaluate a theory-based health promotion programme to improve retirees’ psychological well-being and quality of life.

    Methods and analysis

    This mixed-method, non-blinded study uses an embedded design. The purposive sampling method will be employed for the qualitative aspect of the study. Qualitative data will be collected at baseline, focusing on retirement adjustment, through semistructured, in-depth individual interviews and focus group discussions. The data will be analysed using Graneheim and Lundman’s qualitative content analysis method. A pre–post test controlled group design will be conducted for the quantitative part of the study. A sample size of 80 is estimated for both the intervention and control groups. Systematic sampling and the block randomisation method will be employed for sampling. The training programme in the intervention group will consist of eight 60 min sessions and environmental support, implemented after assessing the research environment and obtaining approval from the relevant officials. A brief training programme unrelated to the intervention group’s focus (home safety) will be implemented for the control group. Quantitative measures will be collected in both groups at baseline, 3 months and 6 months after the intervention. These measures will include self-administered questionnaires covering demographic variables, retirement adjustment, retirement resources, quality of life, coping methods, spiritual well-being and psychological well-being. Analytical statistics will be performed using the generalised linear model, with p values≤0.05 considered significant.

    Ethics and dissemination

    This protocol has received approval from the ethics committee of Shiraz University of Medical Sciences. The research findings will be disseminated through peer-reviewed manuscripts, presentation in abstracts at National and International Scientific Conferences, and data sharing among researchers.

    Trial registration number

    IRCT20180516039690N2.

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