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AnteayerBMJ Open

Implementing a complex mental health intervention in occupational settings: process evaluation of the MENTUPP pilot study

Por: Tsantila · F. · Coppens · E. · De Witte · H. · Arensman · E. · Aust · B. · Pashoja · A. C. · Corcoran · P. · Cully · G. · De Winter · L. · Doukani · A. · Dushaj · A. · Fanaj · N. · Griffin · E. · Hogg · B. · Holland · C. · Leduc · C. · Leduc · M. · Mathieu · S. · Maxwell · M. · Ni Dhalaigh
Background

According to the Medical Research Council (MRC) framework, the theorisation of how multilevel, multicomponent interventions work and the understanding of their interaction with their implementation context are necessary to be able to evaluate them beyond their complexity. More research is needed to provide good examples following this approach in order to produce evidence-based information on implementation practices.

Objectives

This article reports on the results of the process evaluation of a complex mental health intervention in small and medium enterprises (SMEs) tested through a pilot study. The overarching aim is to contribute to the evidence base related to the recruitment, engagement and implementation strategies of applied mental health interventions in the workplace.

Method

The Mental Health Promotion and Intervention in Occupational Settings (MENTUPP) intervention was pilot tested in 25 SMEs in three work sectors and nine countries. The evaluation strategy of the pilot test relied on a mixed-methods approach combining qualitative and quantitative research methods. The process evaluation was inspired by the RE-AIM framework and the taxonomy of implementation outcomes suggested by Proctor and colleagues and focused on seven dimensions: reach, adoption, implementation, acceptability, appropriateness, feasibility and maintenance.

Results

Factors facilitating implementation included the variety of the provided materials, the support provided by the research officers (ROs) and the existence of a structured plan for implementation, among others. Main barriers to implementation were the difficulty of talking about mental health, familiarisation with technology, difficulty in fitting the intervention into the daily routine and restrictions caused by COVID-19.

Conclusions

The results will be used to optimise the MENTUPP intervention and the theoretical framework that we developed to evaluate the causal mechanisms underlying MENTUPP. Conducting this systematic and comprehensive process evaluation contributes to the enhancement of the evidence base related to mental health interventions in the workplace and it can be used as a guide to overcome their contextual complexity.

Trial registration number

ISRCTN14582090.

Dimensions of suffering and the need for palliative care: experiences and expectations of patients living with cancer and diabetes and their caregivers in Mexico - a qualitative study

Por: Doubova · S. V. · Bhadelia · A. · Perez-Moran · D. · Martinez-Vega · I. P. · Garcia-Cervantes · N. · Knaul · F.
Objectives

Over 40 million people in low-income and middle-income countries (LMICs) experience serious health-related suffering (SHS) annually and require palliative care. Patient and caregiver experiences of SHS in LMICs are understudied despite their importance in guiding palliative care provision. Diabetes and cancer are the second-leading and third-leading causes of death in Mexico, causing a significant SHS burden on patients, families and health systems. This study examines SHS and palliative care from the point of view of patients with cancer and diabetes and their caregivers.

Design

A qualitative descriptive study based on in-depth telephone interviews was conducted between August 2021 and February 2022. Data were analysed through inductive thematic analysis.

Participants

Overall, 20 patients with end-stage cancer, 13 patients with diabetes and 35 family caregivers were interviewed individually.

Setting

Participants were recruited from two family medicine clinics and a pain clinic in Mexico City.

Results

Seven themes emerged: (1) suffering as a multifaceted phenomenon, (2) diversity in perceptions of suffering, (3) different coping strategies, (4) need and perceived importance of relief from suffering, (5) barriers to accessing services to relieve suffering, (6) demand for the health sector’s active and humane role in addressing suffering and (7) preferences and need for comprehensive care for relief from suffering. The primary coping strategies included family companionship, protective buffering and faith-based support. Participants lacked knowledge of palliative care. They expressed the importance of relief from suffering, viewing it as the health sector’s responsibility and requesting more humane, personalised care and access to medicines and pain clinics.

Conclusions

The multifaceted nature of SHS highlights the health system’s responsibility to provide high-quality palliative care. Policies to enhance access to palliative care should integrate it into primary care, redesigning services towards patient and caregiver biopsychosocial and spiritual needs and ensuring access to medicines and competent health personnel.

Observational and prospective study: evaluation of beliefs and representations of chronic treatments of polymedicated patients hospitalised in a vascular medicine and surgery department

Por: Kotry · D. · Saillard · J. · Bonsergent · M. · Volteau · C. · Benichou · A. · Prot-Labarthe · S. · Huon · J.-F.
Objectives

Today, the involvement of patients in their care is essential. As the population ages increases, the number of patients with chronic diseases is increasing. In the vascular medicine and surgery departments, patients are polymedicated and mostly suffer from several chronic diseases. Approximately 50% of patients with a chronic disease are not adherent. Among the factors that can influence therapeutic adherence are the beliefs and representations of patients.

To evaluate the beliefs and representations of chronic treatments in patients with multiple medications and hospitalised in a vascular medicine and surgery department, and to evaluate the medication adherence, the knowledge and the importance patients attach to their treatments.

Design

Observational, prospective and a single-centre study.

Setting

The study was conducted in a French tertiary hospital centre of around 3000 beds in 9 institutions.

Participants

Adult polymedicated (ie, minimum of five chronic treatments) patients hospitalised in a vascular medicine and surgery department were included after application of the exclusion criteria.

Methods

Patient interviews were carried out in the department and were based on three interviewer-administered questionnaires (a global questionnaire, the Belief Medical Questionnaire and the GIRERD questionnaire).

Results

Our study showed that patients perceived their treatments as beneficial rather than worrying. A correlation between medication adherence and beliefs was observed. ‘Non-adherent’patients had a more negative overall view of medication than ‘adherent’ patients. The level of compliance and knowledge of our patients was low. Only 11% of the patients were ‘good adherent’, 16% of the patients could perfectly name their treatment and 36% knew all the indications.

Conclusion

Knowledge of treatment representation and beliefs are central to understanding patient behaviour. Considering patients’ representations will allow the identification of levers, and the development of actions and educational tools adapted to improve their adherence, their knowledge and therefore their drug management.

Consensus building on definitions and types of child maltreatment to improve recording and surveillance in Europe: protocol for a multi-sectoral, European, electronic Delphi study

Por: Nurmatov · U. · Cowley · L. E. · Rodrigues · L. B. · Naughton · A. · Debelle · G. · Alfandari · R. · Lamela · D. · Otterman · G. · Jud · A. · Ntinapogias · A. · Laajasalo · T. · Soldino · V. · Stancheva · V. · Caenazzo · L. · Vaughan · R. · Christian · C. W. · Drabarek · K. · Kemp · A. M.
Introduction

Child maltreatment (CM) is a complex global public health issue with potentially devastating effects on individuals’ physical and mental health and well-being throughout the life course. A lack of uniform definitions hinders attempts to identify, measure, respond to, and prevent CM. The aim of this electronic Delphi (e-Delphi) study is to build consensus on definitions and types of CM for use in surveillance and multi-sectoral research in the 34 countries in the Euro-CAN (Multi-Sectoral Responses to Child Abuse and Neglect in Europe) project (COST Action CA19106).

Methods and analysis

The e-Delphi study will consist of a maximum of three rounds conducted using an online data collection platform. A multi-disciplinary expert panel consisting of researchers, child protection professionals (health and social care), police, legal professionals and adult survivors of CM will be purposefully recruited. We will approach approximately 100 experts, with between 50 and 60 of these anticipated to take part. Participants will rate their agreement with a range of statements relating to operational definitions and types of CM, and free-text comments on each of the statements to give further detail about their responses and areas of uncertainty. Consensus has been defined a priori as ≥70% of the panel agreeing or disagreeing with the statement after the final round. The responses to the open-ended questions will be analysed using a ‘codebook’ approach to thematic analysis, and used to refine the statements between rounds where no consensus is reached.

Ethics and dissemination

Ethical approval has been granted from the Cardiff University School of Medicine ethics committee (reference number SMREC22/96). Results will be submitted for publication in a peer-reviewed journal and presented at workshops (including for the participants) and international academic conferences. The Euro-CAN network will also be used to disseminate the results, with results briefings and presentations to key public health and other relevant organisations in the field.

Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial

Por: Adrian · M. · McCauley · E. · Gallop · R. · Stevens · J. · Jobes · D. A. · Crumlish · J. · Stanley · B. · Brown · G. K. · Green · K. L. · Hughes · J. L. · Bridge · J. A.
Introduction

Brief interventions that reduce suicide risk following youth’s experience with acute care due to suicidality are needed.

Methods and analysis

The study will use a three-arm randomised controlled trial designed to test the effectiveness of the Safety Planning Intervention with structured follow-up (SPI+) and the Collaborative Assessment and Management of Suicidality (CAMS) compared with enhanced usual care. The primary outcomes measure will be suicidal events, defined as death by suicide, attempted suicide, preparatory acts toward imminent suicidal behaviour or suicidal ideation resulting in a change in emergency evaluation or inpatient admission. Secondary measures will be the number of suicide attempts and severity of suicidal ideation. The experimental interventions, SPI+ and CAMS, consist of up to eight sessions over approximately 8 weeks that are designed to manage (SPI+) or treat (CAMS) patient-identified ‘drivers’ of suicidal thoughts and behaviours. Mechanisms and moderators of change will be evaluated to understand treatment impacts.

Ethics and dissemination

This study has been approved by the Seattle Children’s Institutional Review Board and is monitored by external agencies including the University of Washington Institute for Translational Health Sciences, and a National Institute of Mental Health (NIMH)-appointed Data Safety and Monitoring Board. Trial results will help establish evidence towards safe and effective treatment strategies for youth transitioning from acute to outpatient care due to a suicidal crisis. The data will be shared with the NIMH Data Archives and disseminated through publications and conferences.

Trial registration number

NCT05078970.

How did New Zealands regional District Health Board groupings work to improve service integration and health outcomes: a realist evaluation

Por: Penno · E. · Atmore · C. · Maclennan · B. · Richard · L. · Wyeth · E. · Richards · R. · Doolan-Noble · F. · Gray · A. R. · Sullivan · T. · Gauld · R. · Stokes · T.
Objectives

In Aotearoa New Zealand (NZ), integration across the healthcare continuum has been a key approach to strengthening the health system and improving health outcomes. A key example has been four regional District Health Board (DHB) groupings, which, from 2011 to 2022, required the country’s 20 DHBs to work together regionally. This research explores how this initiative functioned, examining how, for whom and in what circumstances regional DHB groupings worked to deliver improvements in system integration and health outcomes and equity.

Design

We used a realist-informed evaluation study design. We used documentary analysis to develop programme logic models to describe the context, structure, capabilities, implementation activities and impact of each of the four regional groupings and then conducted interviews with stakeholders. We developed a generalised context-mechanisms-outcomes model, identifying key commonalities explaining how regional work ‘worked’ across NZ while noting important regional differences.

Setting

NZ’s four regional DHB groupings.

Participants

Forty-nine stakeholders from across the four regional groupings. These included regional DHB governance groups and coordinating regional agencies, DHB senior leadership, Māori and Pasifika leadership and lead clinicians for regional work streams.

Results

Regional DHB working was layered on top of an already complex DHB environment. Organisational heterogeneity and tensions between local and regional priorities were key contextual factors. In response, regional DHB groupings leveraged a combination of ‘hard’ policy and planning processes, as well as ‘soft’, relationship-based mechanisms, aiming to improve system integration, population health outcomes and health equity.

Conclusion

The complexity of DHB regional working meant that success hinged on building relationships, leadership and trust, alongside robust planning and process mechanisms. As NZ reorients its health system towards a more centralised model underpinned by collaborations between local providers, our findings point to a need to align policy expectations and foster environments that support connection and collegiality across the health system.

Impact of health system governance on healthcare quality in low-income and middle-income countries: a scoping review

Por: George · J. · Jack · S. · Gauld · R. · Colbourn · T. · Stokes · T.
Introduction

Improving healthcare quality in low-/middle-income countries (LMICs) is a critical step in the pathway to Universal Health Coverage and health-related sustainable development goals. This study aimed to map the available evidence on the impacts of health system governance interventions on the quality of healthcare services in LMICs.

Methods

We conducted a scoping review of the literature. The search strategy used a combination of keywords and phrases relevant to health system governance, quality of healthcare and LMICs. Studies published in English until August 2023, with no start date limitation, were searched on PubMed, Cochrane Library, CINAHL, Web of Science, Scopus, Google Scholar and ProQuest. Additional publications were identified by snowballing. The effects reported by the studies on processes of care and quality impacts were reviewed.

Results

The findings from 201 primary studies were grouped under (1) leadership, (2) system design, (3) accountability and transparency, (4) financing, (5) private sector partnerships, (6) information and monitoring; (7) participation and engagement and (8) regulation.

Conclusions

We identified a stronger evidence base linking improved quality of care with health financing, private sector partnerships and community participation and engagement strategies. The evidence related to leadership, system design, information and monitoring, and accountability and transparency is limited.

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK

Por: Walsh · T. S. · Aitken · L. M. · McKenzie · C. A. · Boyd · J. · Macdonald · A. · Giddings · A. · Hope · D. · Norrie · J. · Weir · C. · Parker · R. A. · Lone · N. I. · Emerson · L. · Kydonaki · K. · Creagh-Brown · B. · Morris · S. · McAuley · D. F. · Dark · P. · Wise · M. P. · Gordon · A. C.
Introduction

Almost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care.

Methods and analysis

Adult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of –2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.

The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40–50 UK ICUs.

Ethics and dissemination

The Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines.

Trial registration number

ClinicalTrials.gov NCT03653832.

Finnish Retirement and Aging Study: a prospective cohort study

Por: Stenholm · S. · Suorsa · K. · Leskinen · T. · Myllyntausta · S. · Pulakka · A. · Pentti · J. · Vahtera · J.
Purpose

The Finnish Retirement and Aging (FIREA) Study was set up to study changes in health behavioural and cardiometabolic risk factors across retirement transition, and to examine the long-term consequences of work and retirement on health and functioning with advancing age.

Participants

Public sector workers whose estimated statutory retirement date was in 2014–2019 were invited to participate by sending them a questionnaire 18 months prior to their estimated retirement date. In the first phase of the FIREA Study, participants were followed up with annual surveys, accelerometer and clinical measurements during retirement transition into post-retirement years. The FIREA survey cohort includes 6783 participants, of which 908 belong also to the activity substudy and 290 to the clinical substudy.

Findings to date

Collected data include survey measures about health, lifestyle factors, psychosocial distress, work-related factors as well as retirement intentions. Accelerometer and GPS devices are used to measure 24-hour movement behaviours. Clinical examination includes blood and hair sample, measurements of anthropometry, cardiovascular function, physical fitness, physical and cognitive function. Our results suggest that in general retirement transition seems to have beneficial influence on health behaviours as well as on physical and mental health, but there are large individual differences, and certain behaviours such as sedentariness tend to increase especially among those retiring from manual occupations.

Future plans

The second phase of the FIREA Study will be conducted during 2023–2025, when participants are 70 years old. The FIREA Study welcomes research collaboration proposals that fall within the general aims of the project.

Specialist healthcare services for concussion/mild traumatic brain injury in England: a consensus statement using modified Delphi methodology

Por: Karvandi · E. · Helmy · A. · Kolias · A. G. · Belli · A. · Ganau · M. · Gomes · C. · Grey · M. · Griffiths · M. · Griffiths · T. · Griffiths · P. · Holliman · D. · Jenkins · P. · Jones · B. · Lawrence · T. · McLoughlin · T. · McMahon · C. · Messahel · S. · Newton · J. · Noad · R. · Raymont
Objective

To establish a consensus on the structure and process of healthcare services for patients with concussion in England to facilitate better healthcare quality and patient outcome.

Design

This consensus study followed the modified Delphi methodology with five phases: participant identification, item development, two rounds of voting and a meeting to finalise the consensus statements. The predefined threshold for agreement was set at ≥70%.

Setting

Specialist outpatient services.

Participants

Members of the UK Head Injury Network were invited to participate. The network consists of clinical specialists in head injury practising in emergency medicine, neurology, neuropsychology, neurosurgery, paediatric medicine, rehabilitation medicine and sports and exercise medicine in England.

Primary outcome measure

A consensus statement on the structure and process of specialist outpatient care for patients with concussion in England.

Results

55 items were voted on in the first round. 29 items were removed following the first voting round and 3 items were removed following the second voting round. Items were modified where appropriate. A final 18 statements reached consensus covering 3 main topics in specialist healthcare services for concussion; care pathway to structured follow-up, prognosis and measures of recovery, and provision of outpatient clinics.

Conclusions

This work presents statements on how the healthcare services for patients with concussion in England could be redesigned to meet their health needs. Future work will seek to implement these into the clinical pathway.

Psychosocial interventions promoting personal recovery in people with schizophrenia: a scoping review protocol

Por: Quistgaard · M. · Myklebust · O. L. P. · Aure · T. · Austin · S. F. · Berring · L. L. · Vernal · D. L. · Storebo · O. J.
Introduction

Personal recovery is an important aspect for many individuals diagnosed with schizophrenia, as people can live rich, fulfilling lives despite ongoing symptoms. Prior reviews have found several factors to be associated with personal recovery, but a comprehensive overview of the psychosocial interventions aimed at improving personal recovery in schizophrenia is needed.

Methods and analysis

Key terms relating to personal recovery and psychosocial interventions to promote personal recovery will be searched for in the following databases: PubMed, EMBASE, PsycINFO, CINAHL, MEDLINE, Google Scholar, Web of Science Core Collection and Cochrane. Additionally, a simple search for grey literature will be conducted in The Networked Digital Library of Theses and Dissertations. Two reviewers will individually screen and extract the data, and the selection of sources will be documented in a Preferred Reporting Items for Systematic reviews and Meta-Analyses flow chart. A content analysis will be conducted on the data, and the findings will be presented in tables, and narratively synthesised. Lastly, research gaps will be identified, and recommendations for future research will be proposed.

Ethics and dissemination

Ethics approval was not required for the development or publishing of this protocol. Findings will be disseminated through conferences, meeting with patient organisations and consumers, and published in a peer-reviewed scientific journal.

Mhealth tools for community-based infectious disease surveillance in Africa: a scoping review protocol

Por: Aku · F. Y. · Amuasi · J. H. · Debrah · L. B. · Opoku · D. · Gmanyami · J. M. · Hoerauf · A. · Debrah · A. Y. · Quentin · W.
Introduction

Countries in the WHO’s African region have found community-based surveillance useful in ensuring the effectiveness of the Integrated Disease Surveillance and Response strategy. This approach encourages community participation in the surveillance system, in addition to early detection of outbreaks and other health threats. Thus, advancements in mobile health have the potential to improve community-based surveillance in Africa. The purpose of this review is to map evidence on available mhealth tools for community-based infectious disease surveillance in Africa.

Methods and analysis

The scoping review will follow a mixed-methods approach in line with the framework of Arksey and O’Malley amended by Levac and colleagues and the Joanna Briggs Institute. To retrieve published literature, PubMed, Scopus, Web of Science, Google Scholar and Google databases will be explored. Websites of organisations involved in surveillance activities across the African region will also be explored. Authors will be interested in published literature between 2000 and 2022 in any language. The primary investigator and a second author will independently review the retrieved titles according to the inclusion criteria, while a third reviewer will resolve conflicts that may arise. The review will map evidence according to the key concepts (mhealth, community-based surveillance and Africa) to inform stakeholders and mhealth designers on best practices to adopt involving mhealth approaches at the community level and mhealth tool designs, respectively. Results following the review will be presented according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review Guidelines.

Ethics and dissemination

Ethical approval is not required for scoping reviews as it does not involve the use of human subjects. This review is the first phase in an overall project on digital health. The findings of the review will be published in a peer-reviewed journal and disseminated at suitable forums and conferences.

'It was a joint plan we worked out together. How the I-WOTCH programme enabled people with chronic non-malignant pain to taper their opioids: a process evaluation

Por: Nichols · V. P. · Abraham · C. · Eldabe · S. · Sandhu · H. K. · Underwood · M. · Seers · K. · On behalf of the I-WOTCH team · Sharisse · Shyam · Lauren · Katie · Dawn · Furlan Andrea · Kirstie · C Paola · Ranjit · Andrea · Dipesh · Jennifer · Anisur · Jane · Tang Nicole · Stephanie
Background

The Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial found that a group-based educational intervention to support people using strong opioids for chronic non-malignant pain helped a significant proportion of people to stop or decrease opioid use with no increase in pain-related disability. We report a linked process evaluation of the group-based intervention evaluated in comparison to a usual-care control group that received a self-help booklet and relaxation CD.

Methods

We interviewed 18 intervention facilitators, and 20 intervention and 20 control participants who had chronic non-malignant pain and were recruited from general (family) practices in the UK. Quantitative data included change mechanism questions on the trial questionnaires which explored motivation, expectations and self-efficacy. Fidelity was assessed by listening to a sample of audio-recorded group sessions and nurse consultations. Quantitative and qualitative data were integrated using ‘follow a thread’ and a mixed-methods matrix.

Findings

Four overarching themes emerged: (1) the right time to taper, (2) the backdrop of a life with chronic pain, (3) needing support and (4) the benefits of being in a group. Delivery fidelity was good, adherence (83%) and competence (79%) across a range of intervention groups. Staff delivering the intervention found three typical responses to the intervention: resistance, open to trying and feeling it was not the right time. The group experience was important to those in the intervention arm. It provided people with a forum in which to learn about the current thinking about opioid usage and its effects. It also gave them examples of how feasible or personally relevant coming off opioids might be.

Conclusion

The process evaluation data showed that the I-WOTCH intervention was well delivered, well received and useful for most interviewees. Being ‘the right time’ to taper and having support throughout tapering, emerged as important factors within the context of living with chronic pain.

Trial registration number

ISRCTN49470934.

Impact of the COVID-19 pandemic on Canadian transplant journeys: a mixed methods study

Por: Fox · D. · Hall · M. · Thibodeau · C. · Coldwell · K. · Lauder · L. · Dewell · S. · Davidson · S.
Background

Navigating the organ donation and transplantation system in Canada can be challenging for individuals on transplant journeys. Although it is likely that the COVID-19 pandemic has further contributed to these challenges, the experiences of individuals during the pandemic in Canada have not been well elicited.

Objective

To illuminate how the COVID-19 pandemic has impacted individuals on transplant journeys in Canada.

Design

Convergent parallel mixed-methods study.

Setting

Canada.

Participants

Adult patients, caregivers, and donors on transplant journeys across Canada.

Data collection

Eight focus groups and an online survey between May and November 2021. Focus group transcripts were analysed using an inductive conventional content analysis approach. Survey data were analysed using descriptive statistics. The study was guided by individuals with lived experience of organ donation and transplantation.

Results

A total of 830 participants completed three COVID-19 related survey questions, with 21 participating in the focus groups. Survey results: over 50% of patients and caregivers reported that the pandemic impacted their access to their healthcare team, their mental health (60% and 65%, respectively) and their comfort going out in public (80% and 75%, respectively). Although many donors reported several factors that impacted their transplant journey, the impact appeared to be greater for patients and caregivers. Qualitative results: three themes emerged from the qualitative data that contextualise participant’s experiences: compounding isolation, disruption amid uncertainty and unforeseen benefits.

Conclusion

The COVID-19 pandemic has exacerbated many of the challenges that individuals on transplant journeys experience. It will be critical for transplant programmes to consider these factors in future care provision.

Understanding medication-related burden from patient perspectives: a qualitative study testing the applicability of the conceptual model among chronically ill outpatients in Finland

Por: Mikkola · H. · Dimitrow · M. · Hämeen-Anttila · K. · Laukkanen · E. · Airaksinen · M.
Objectives

Disease self-management and medication therapy can cause burden to patients that can influence adherence. The conceptual model ‘patients’ lived experience with medicine’ (PLEM) brings new insights into medication-related burden (MRB) from patient perspective. This study aimed to test the applicability of the PLEM model by interviewing chronically ill patients in Finland and to investigate the MRB experienced by the Finnish patients.

Design

Focus group discussion study conducted online via Zoom. Directed qualitative content analysis guided by the PLEM model.

Setting

Outpatient primary care in Finland.

Participants

Chronically ill outpatients (n=14) divided into five focus groups according to their chronic condition: asthma (n=3), heart disease (n=3), diabetes (n=6), intestinal disease (n=2).

Results

Our findings were mainly in line with the PLEM model although some new contributing factors to MRB emerged. In general, the participants were satisfied with their medication, and that it enabled them to live normal lives. The most common causes of MRB were medication routines and the healthcare system. The participants introduced two new aspects contributing to MRB: medication-related environmental anxiety associated with the waste resulting from medicine use, and the effect of medication use on their working life. Our findings are consistent with previous findings that a higher level of MRB may lead to independently modifying the medication regimen or not taking the medicine.

Conclusions

Our findings provide further evidence that the PLEM model is an applicable tool also in the Finnish context for gaining better understanding of MRB in chronically ill patients self-managing their long-term medications. The model provides a promising tool to understand the connection between MRB and the rationale for not always taking medicines as prescribed. Further research is needed to explore the potential of the model in extending patient perspectives in chronic disease management.

Population-based birth cohort study on diabetes in pregnancy and infant hospitalisations in Cree, other First Nations and non-Indigenous communities in Quebec

Por: Huang · R. · Xiao · L. · Zhu · J. · Cheng · J. · Torrie · J. · McHugh · N. G.-L. · Auger · N. · Luo · Z.-C.
Objectives

Diabetes in pregnancy, whether pre-gestational (chronic) or gestational (de novo hyperglycaemia), increases the risk of adverse birth outcomes. It is unclear whether gestational diabetes increases the risk of postnatal morbidity in infants. Cree First Nations in Quebec are at high risk for diabetes in pregnancy. We assessed whether pre-gestational or gestational diabetes may increase infant hospitalisation (an infant morbidity indicator) incidence, and whether this may be related to more frequent infant hospitalisations in Cree and other First Nations in Quebec.

Design

Population-based birth cohort study through administrative health data linkage.

Setting and participants

Singleton infants (≤1 year) born to mothers in Cree (n=5070), other First Nations (9910) and non-Indigenous (48 200) communities in rural Quebec.

Results

Both diabetes in pregnancy and infant hospitalisation rates were much higher comparing Cree (23.7% and 29.0%) and other First Nations (12.4% and 34.1%) to non-Indigenous (5.9% and 15.5%) communities. Compared with non-diabetes, pre-gestational diabetes was associated with an increased risk of any infant hospitalisation to a greater extent in Cree and other First Nations (relative risk (RR) 1.56 (95% CI 1.28 to 1.91)) than non-Indigenous (RR 1.26 (1.15 to 1.39)) communities. Pre-gestational diabetes was associated with increased risks of infant hospitalisation due to diseases of multiple systems in all communities. There were no significant associations between gestational diabetes and risks of infant hospitalisation in all communities. The population attributable risk fraction of infant hospitalisations (overall) for pre-gestational diabetes was 6.2% in Cree, 1.6% in other First Nations and 0.3% in non-Indigenous communities.

Conclusions

The study is the first to demonstrate that pre-gestational diabetes increases the risk of infant hospitalisation overall and due to diseases of multiple systems, but gestational diabetes does not. High prevalence of pre-gestational diabetes may partly account for the excess infant hospitalisations in Cree and other First Nations communities in Quebec.

Patient perspectives and barriers in the treatment of neovascular age-related macular degeneration in Denmark: a qualitative study

Por: Thinggaard · B. S. · Pedersen · M. · Sorensen · T. L. · Grauslund · J. · Stokholm · L.
Objectives

This qualitative study aims to identify patient-reported barriers to treatment for neovascular age-related macular degeneration (nAMD) and investigate their impact on quality of life.

Design

Using a qualitative explorative design.

Setting

Semi-structured individual or dyadic interviews were conducted with patients and their relatives.

Participants

Twenty-one patients completed the interview, with four of them having a relative present.

Interventions

Gadamer’s hermeneutics guided the epistemological approach, and maximum variation sampling was employed to capture diverse patient experiences. An advisory board consisting of patients, relatives and ophthalmologists ensured the relevance of the study. Thematic analysis was conducted using NVivo software.

Primary and secondary outcome measures

To investigate patient-reported barriers to the recommended treatment for nAMD and impact on quality of life.

Results

The study included 21 patients with nAMD, with a median age of 79 years. Five themes emerged: (1) good compliance with intravitreal treatment, (2) the dual role of relatives, (3) treatment commute, (4) hospital barriers, (5) preventive health literacy.

Conclusion

This study highlights the resilience and adherence of patients with nAMD in Denmark to their treatment despite various barriers. While the therapy may have negative effects on their well-being, patients do not opt out of treatment. These findings underscore the importance of personalised treatment plans that provide, for example, convenient access to care and clear future agreements at the hospital. By adopting more patient-centred approaches, healthcare providers can enhance patient satisfaction and improve treatment adherence, ultimately leading to better patient outcomes and quality of life.

Hidden sodium in effervescent-tablet dietary supplements and over-the-counter drugs: a comparative cross-sectional study

Por: Kunz · M. · Götzinger · F. · Jacobs · C. M. · Lauder · L. · Ukena · C. · Meyer · M. R. · Laufs · U. · Schulz · M. · Böhm · M. · Mahfoud · F.
Objective

Dietary sodium intake represents a risk factor for cardiovascular disease and mortality. The study sought to analyse the sodium content of effervescent dietary supplements and drugs in Germany and the USA.

Design

Comparative cross-sectional study.

Setting and methods

The sodium content of 39 dietary supplement effervescent tablets available in Germany was measured in May and June 2022 using optical emission spectrometry with inductively coupled argon plasma. The sodium content of 33 common pharmacy-only effervescent tablets (over-the-counter (OTC) drugs) in Germany was obtained from the summary of product characteristics. We compared the sodium content of the measured German dietary supplement effervescent tablets to that of 51 dietary supplement effervescent tablets available in the USA (data: National Institutes of Health’s Dietary Supplement Label Database).

Results

The measured sodium content in the German dietary supplements was 283.9±122.6 mg sodium/tablet, equivalent to 14±6% of the maximum recommended daily sodium intake (MRDSI). Vitamin products had the highest (378.3±112.8 mg, 19±6% of MRDSI), and calcium products had the lowest mean sodium content (170.4±113.2 mg, 9±6% of MRDSI). Vitamin products contained significantly more sodium than magnesium (378.3 mg vs 232.7 mg; p=0.004), calcium (378.3 mg vs 170.4 mg; p=0.006) and mineral products (378.3 mg vs 191.6 mg; p=0.048). The sodium content measured in products available in Germany was higher when compared with the declared sodium content on the label of the products sold in the USA (283.9 mg vs 190.0 mg; p

Conclusion

Effervescent tablets of nutritional supplements and OTC drugs contain high amounts of sodium, which often is not disclosed.

Palliative care interventions for patients with head and neck cancer: protocol for a scoping review

Por: Ratnasekera · N. · Fazelzad · R. · Bagnarol · R. · Cunha · V. · Zimmermann · C. · Lau · J.
Introduction

A head and neck cancer (HNC) diagnosis significantly impacts a patient’s quality of life (QOL). Palliative care potentially improves their QOL. We will conduct a scoping review to identify existing knowledge about palliative care interventions for patients with HNC.

Methods and analysis

This scoping review was designed in accordance with the JBI Manual for Evidence Synthesis: Scoping Reviews and will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Our eligibility criteria follow the Population, Intervention, Comparison or Control, Outcomes and Study characteristics framework. The population is adult patients with locally advanced, metastatic, unresectable and/or recurrent HNC. We include peer-reviewed journal articles and articles in the press, in English, reporting on palliative care interventions with at least two of the eight National Consensus Project on Clinical Practice Guidelines for Quality Palliative Care domains; studies with and without comparators will be included. The outcomes are patient QOL (primary) and symptom severity, patients’ satisfaction with care, patients’ mood, advance care planning and place of death (secondary). We developed a search strategy across ten databases, to be searched from the inception to 11 September 2023: Medline ALL (Medline and EPub Ahead of Print and In-Process, In-Data-Review & Other Non-Indexed Citations), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase Classic+Embase, Emcare and PsycINFO all from the OvidSP platform; CINAHL from EBSCOhost, Scopus from Elsevier, Web of Science from Clarivate and Global Index Medicus from WHO. We will extract data using a piloted data form and analyse the data through descriptive statistics and thematic analysis.

Ethics and dissemination

Ethics approval is not needed for a scoping review. We will disseminate the findings to healthcare providers and policy-makers by publishing the results in a scientific journal.

Implementation and the effects of a Parkinson Network Therapy (PaNTher) on activities of daily living and health-related quality of life in Parkinsons disease patients: study protocol of an mixed-method observational cohort study in outpatient care

Por: Loidl · V. · Ziegler · K. · Hoppmann · D. · Wagner · C. · Fietzek · U. M. · Ceballos-Baumann · A. O. · Grill · E.
Introduction

Parkinson’s disease (PD) represents the fastest growing neurodegenerative disease with an increasing prevalence worldwide. It is characterised by complex motor and non-motor symptoms that lead to considerable disability. Specialised physiotherapy has been shown to benefit patients with PD. The Parkinson Netzwerk Therapie (PaNTher) was created to improve access to specialised physiotherapy tailored to care priorities of PD patients. This study aims to evaluate the effectiveness, acceptability and needs of the PaNTher network by neurologists and physiotherapists involved in the network in outpatient care.

Methods and analysis

This is a mixed-method, prospective, pragmatic non-randomised cohort study of parallel groups, with data collection taking place in Bavaria, Germany, between 2020 and 2024. Patients with PD insured by the Allgemeine Ortskrankenkasse Bayern (AOK Bayern) living in Bavaria will be recruited for study participation by network partners. Patients in the intervention group must reside in Munich or the surrounding area to ensure provision of specialised physiotherapy in close proximity to their place of residence. Controls receive care as usual. Six and 12 months after baseline, all patients receive a follow-up questionnaire. Mixed-effect regression models will be used to examine changes in impairment of activities of daily living and quality of life of patients with PD enrolled in the programme over time compared with usual care. Qualitative interviews will investigate the implementation processes and acceptability of the PaNTher network among neurologists and physiotherapists. The study is expected to show that the PaNTher network with an integrative care approach will improve the quality and effectiveness of the management and treatment of patients with PD.

Ethics and dissemination

The study has been approved by the ethics committee at the medical faculty of the Ludwig-Maximilians-University Munich (20-318). Results will be published in scientific, peer-reviewed journals and presented at national and international conferences.

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