BMJ Open

Sandberg, Magnus; Axmon, Anna; Ahlström, Gerd; Kristensson, Jimmie

doi: 10.1136/bmjopen-2023-072679pmid: 37407048

ObjectivesTo compare somatic healthcare usage among older people with intellectual disabilities (ID) to that of their age-peers in the general population, taking into account health and demographic factors, and to identify predictors for somatic healthcare usage among older people with ID.ParticipantsEqually sized cohorts, one with people with ID and one referent cohort, one-to-one-matched by sex and year of birth, were created. Each cohort comprised 7936 people aged 55+ years at the end of 2012.DesignRetrospective register-based study.SettingAll specialist inpatient and outpatient healthcare clinics in Sweden.Outcome measuresData regarding planned/unplanned and inpatient/outpatient specialist healthcare were collected from the Swedish National Patient Register for 2002–2012. Diagnoses, previous healthcare usage, sex, age and cohort affiliation was used to investigate potential impact on healthcare usage.ResultsCompared with the referent cohort, the ID cohort were more likely to have unplanned inpatient and outpatient care but less likely to have planned outpatient care. Within the ID cohort, sex, age and previous use of healthcare predicted healthcare usage.ConclusionsOlder people with ID seem to have lower risks of planned outpatient care compared with the general population that could not be explained by diagnoses. Potential explanations are that people with ID suffer from communication difficulties and experience the healthcare environment as unfriendly. Moreover, healthcare staff lack knowledge about the particular needs of people with ID. Altogether, this may lead to people with ID being exposed to discrimination. Although these problems are known, few interventions have been evaluated, especially related to planned outpatient care.

Ajitsaria, Pragya; Lott, Natalie; Baker, Angela; Lacey, Jeanette; Magnusson, Monique; Douglas, Jeanene Lizbeth; Healey, Paul; Tan-Gore, Eileen; Szwec, Stuart V; Barker, Daniel; Deeming, Simon; Tavener, Meredith; Smith, Steve; Gani, Jon; Attia, John

doi: 10.1136/bmjopen-2022-070159pmid:

Warren, Cirle A; Shin, Jae Hyun; Bansal, Ekta N; Costa, Deiziane V D S; Wang, Xin Qun; Wu, Martin; Swann, Jonathan R; Behm, Brian W; Targonski, Paul V; Archbald-Pannone, Laurie

doi: 10.1136/bmjopen-2023-075721pmid: 37474181

IntroductionClostridioides difficile is the leading cause of healthcare-associated infections in the USA, with an estimated 1 billion dollars in excess cost to the healthcare system annually. C. difficile infection (CDI) has high recurrence rate, up to 25% after first episode and up to 60% for succeeding episodes. Preliminary in vitro and in vivo studies indicate that alanyl-glutamine (AQ) may be beneficial in treating CDI by its effect on restoring intestinal integrity in the epithelial barrier, ameliorating inflammation and decreasing relapse.Methods and analysisThis study is a randomised, placebo-controlled, double-blind, phase II clinical trial. The trial is designed to determine optimal dose and safety of oral AQ at 4, 24 and 44 g doses administered daily for 10 days concurrent with standard treatment of non-severe or severe uncomplicated CDI in persons age 18 and older. The primary outcome of interest is CDI recurrence during 60 days post-treatment follow-up, with the secondary outcome of mortality during 60 days post-treatment follow-up. Exploratory analysis will be done to determine the impact of AQ supplementation on intestinal and systemic inflammation, as well as intestinal microbial and metabolic profiles.Ethics and disseminationThe study has received University of Virginia Institutional Review Board approval (HSR200046, Protocol v9, April 2023). Findings will be disseminated via conference presentations, lectures and peer-reviewed publications.Trial registration numberNCT04305769.

Zhu, Haizhen; Yang, Guangrong; Ma, Ying; Huo, Qianwen; Wan, Deli; Yang, Qiao

doi: 10.1136/bmjopen-2023-072945pmid: 37419634

ObjectivesAn updated epidemiological analysis of gastrointestinal stromal tumour (GIST), the change of cancer-specific survival (CSS) and patterns of initial treatment are of interest.DesignA retrospective study using data from the Surveillance, Epidemiology and End Results (SEER) database.Setting and participantsA total of 5625 patients with GIST diagnosed between 2010 and 2019 were identified.Primary outcome measuresAge-standardised incidence rate (ASIR) and annual prevalence rate were calculated. SEER combined stage, period CSS rate and initial treatment were summarised. All the data were calculated by SEER*Stat software.ResultsFrom 2010 to 2019, the ASIR of GIST increased from 0.79 to 1.02 per 100 000 person-years, with an increase of 2.4% annually. The increase was across age and sex subgroups. The prevalence trend was similar with the ASIR trend in each subgroup. The stage distributions were similar between different age groups, but varied among different primary tumour sites. More importantly, a stage shift from regional stage to localized stage at diagnosis was found, which may result in the improvement of CSS over years. Overall, the 5-year CSS rate of GIST was approximately 81.3%. Even for metastatic GIST, the rate exceeded 50%. Surgery was the most common treatment regimen for GIST, followed by surgery and systemic treatment. Whereas approximately 7.0% patients were undertreated, which was more pronounced among patients with distant and unknown stages.ConclusionsThe findings of this study suggest an improving early detection of GIST and an improving ability of accurate staging. Though most patients are effectively treated and perform good survivals, approximate 7.0% patients may be undertreated.

Fu, Yu; Jackson, Cath; Nelson, Andrea; Iles-Smith, Heather; McGowan, Linda

doi: 10.1136/bmjopen-2023-071831pmid: 37400236

ObjectivesMany women attempt to manage urinary incontinence (UI) independently with variable success while health professionals may be unaware of their needs. This study aimed to (1) understand older women’s experiences of UI, their self-management strategies and support needs; (2) explore health professionals’ experiences of supporting women and providing relevant services and (3) combine their experiences contribute to development of a theory-based and evidence-based self-management package for UI.DesignQualitative semi-structured interviews were conducted with 11 older women with UI and 11 specialist health professionals. Data were analysed independently using the framework approach, then synthesised in a triangulation matrix to identify implications for content and delivery of the self-management package.SettingCommunity centres, community continence clinic and urogynaecology centre of a local teaching hospital in northern England.ParticipantsWomen aged 55 years and over who self-reported symptoms of UI and health professionals delivering UI services.ResultsThree overarching themes emerged. Older women see UI as a ‘fact of life’ but many struggle with it: women typically considered UI as part of ageing yet expressed annoyance, distress, embarrassment and had made significant lifestyle changes. Access to information and limited high-quality professional support: health professionals provided specialist UI care and information. Yet less than half of women accessed specialist services, those who had, highly valued these services. ‘Trial and error’ with different self-management strategies: women had tried or were using different strategies (continence pads, pelvic floor exercises, bladder management and training, fluid management and medication), with mixed success. Health professionals provided evidence-based, personalised support and motivation.ConclusionsFindings informed the content of the self-management package that focused on providing facts, acknowledging challenges of living with/self-managing UI, sharing others’ experiences, using motivational strategies and self-management tools. Delivery preferences were independent use by women or working through the package with a health professional.

Omale, Ugwu I; Ewah, Richard L; Amuzie, Chidinma I; Ikegwuonu, Cordis O; Nkwo, Glory E; Iwegbulam, Chimaobi C; Ekwuazi, Louisa C

doi: 10.1136/bmjopen-2022-068953pmid: 37438066

IntroductionVaccine-preventable infectious diseases (VPDs) are major causes of morbidity/mortality among children under 5 years of age worldwide and in Nigeria/Ebonyi state. Routine childhood immunisation is an invaluable prevention strategy for many VPDs. Due to suboptimal coverage and untimely receipt/delay in receipt of vaccinations, outbreaks of VPDs such as measles, yellow fever, diphtheria and others continue to reoccur around the world and in Nigeria/Ebonyi state. This study aims to evaluate the effectiveness of hybrid parents and health workers adaptive intervention in increasing the optimal/timely (cumulative age-appropriate) routine childhood immunisation coverage in the communities in Ebonyi state, Nigeria.Methods and analysesA two-arm, parallel, open label, covariate-constrained cluster-randomised controlled trial with 1:1 allocation of 16 geographical clusters (the nearest catchment areas for at least one public primary healthcare (PHC) facility with at least 500 households or a population size of 3000) will be used to evaluate the effects of hybrid/combined parents and PHC workers adaptive engagement compared with control. The primary outcomes are the optimal/timely (cumulative age-appropriate) receipt of the recommended vaccines in the routine childhood immunisation schedule by children aged 5–9 completed months and 10–11 completed months and the age-appropriate vaccines receipt score for the recommended vaccines. The outcomes will be measured through a population-based household survey of at least 15 children aged 5–9 and 10–11 months per cluster at baseline and at the end of the study using a structured interviewer-administered questionnaire in KoBoCollect installed in android devices. All analyses will be done using a cluster-level method on as-randomised basis.Ethics and disseminationEthical approval for the trial was obtained from the Ebonyi State Health Research and Ethics Committee (EBSHREC/01/06/2022–31/05/2023) and verbal consent will be obtained from participants. Study findings will be reported at local/national and international levels as appropriate.Trial registration numberISRCTN59811905.

Krakau, Lina; Leuzinger-Bohleber, Marianne; Brähler, Elmar; Schmidt, Peter; Rost, Felicitas; Huber, Dorothea; Klug, Guenther; Löffler-Stastka, Henriette; Rössler-Schülein, Hemma; Leichsenring, Falk; Salzer, Simone; Brockmann, Josef; Jakobsen, Thorsten; Ernst, Mareike; Beutel, Manfred E

Dalla Via, Jack; Stewart, Nina; Kennedy, Mary A; Cehic, Daniel A; Purnell, Peter; Toohey, Joanne; Morton, Jamie; Ramchand, Sabashini K; Lewis, Joshua R; Zissiadis, Yvonne

doi: 10.1136/bmjopen-2023-072376pmid: 37463809

IntroductionA coronary artery calcium (CAC) CT scan can identify calcified plaque and predict risk of future cardiac events. Cancer survivors undergoing thoracic radiotherapy routinely undergo a planning CT scan, which presents a unique opportunity to use already obtained medical imaging to identify those at the highest risk of cardiac events. While radiation therapy is an important modality for many cancer treatments, radiation dose to the heart in thoracic radiotherapy leads to cardiotoxicity and may accelerate pre-existing atherosclerosis. The primary aims of this study are to investigate the feasibility of using CAC scores calculated on thoracic radiotherapy planning CT scans to identify a subset of cancer survivors at an increased risk of future cardiac events, and to establish and evaluate a referral pathway for assessment and management in a cardio-oncology clinic. An optional substudy aims to investigate using abdominal aortic calcification (AAC) as a practical, low-radiation alternative to CAC to evaluate and monitor vascular health.Methods and analysisThis is an observational, prospective study in a minimum of 100 cancer survivors commencing radiotherapy. Participants will have CAC scored from thoracic radiotherapy planning CT scans. Those identified as high risk (CAC score>0) will be referred to a cardio-oncology clinic. Feasibility, determined by adherence to the recommended pathway, and impact on quality of life and anxiety measured via questionnaire, will be assessed. Participants in Western Australia will be invited to participate in a 12-month observational pilot substudy, investigating lifestyle behaviours and the use of a dual-energy X-ray absorptiometry machine to measure musculoskeletal health and AAC.Ethics and disseminationEthics approval has been obtained from St Vincent’s Hospital, Sydney (Project number 2021/ETH11847), GenesisCare and Edith Cowan University (2022-03326-DALLAVIA). Study results will be reported in peer-reviewed academic journals, at scientific conferences, and at clinical forums, irrespective of the results observed.Trial registration numberACTRN12621001343897.

Kibret, Kelemu Tilahun; Backholer, Kathryn; Peeters, Anna; Tesfay, Fisaha; Nichols, Melanie

doi: 10.1136/bmjopen-2022-071319pmid: 37451731

BackgroundLong-term and comparative assessments of trends in non-communicable disease (NCD) burden attributable to metabolic risk are sparse. This study aimed to assess burdens and trends of NCD attributable to metabolic risk factors in Australia, 1990–2019.DesignPopulation-based observational study.Settings and data sourceData were extracted from the Global Burden of Disease Study 2019 for Australia and trends in NCD burden attributable metabolic risks were estimated using the joinpoint regression model.Main outcome measuresNCD deaths and disability-adjusted life-years (DALYs) attributed to metabolic risk factors, 1990–2019.ResultsResults indicate a 1.1% yearly increase in exposure to combined metabolic risk factors from 1990 to 2019. Between 1990 and 2019, the estimated absolute number of deaths from NCDs attributed to combined metabolic risks increased by 17.0%. However, metabolic risk-related NCD burdens in Australia decreased between 1990 and 2019. In 2019, 34.0% of NCD deaths and 20.0% of NCD DALYs were attributed to metabolic risk factors, compared with 42.9% and 24.4%, respectively, in 1990. In 2019, cardiovascular diseases (CVDs), neoplasms and chronic kidney diseases were the most common NCD deaths attributed to metabolic risks. High body mass index accounted for the highest proportion of diabetes deaths (47.0%) and DALYs (58.1%) as well as chronic kidney disease deaths (35.4%) and DALYs (39.7%). Similarly, high systolic blood pressure contributed to a high proportion of chronic kidney disease deaths (60.9%) and DALYs (53.2%), and CVDs deaths (44.0%) and DALYs (46.0%).ConclusionWhile the contribution of metabolic risk factors to the burden of NCDs has declined from 1990 to 2019, their role in NCD death and disability remains a challenge as the prevalence of these risk factors has increased. Prevention strategies should focus on metabolic risks particularly high body mass index and high systolic blood pressure to substantially reduce NCD burdens.

Sanftenberg, Linda; Dreischulte, Tobias; Härdtlein, Annette; Kosub, Helena; Gagyor, Ildiko; Kurotschka, Peter Konstantin; Kühlein, Thomas; Burggraf, Larissa; Eck, Stefanie; Roos, Marco; Gensichen, Jochen

doi: 10.1136/bmjopen-2022-065947pmid: 37438058

IntroductionGeneral practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their engagement in primary care research remains limited. In order to enhance primary care research, the German government has funded six regional practice based research networks (PBRNs). Within the Bavarian PBRN (BayFoNet), two cluster-randomised pilot trials will be conducted. This paper presents the protocol of the process evaluation accompanying both trials, which aims to explore relevance, feasibility, acceptability and credibility of clinical research in primary care from the perspectives of BayFoNet researchers, general practitioners, and patients.Methods and analysisThe BayFoNet will be established by recruiting general practices (GPs) as prospective research collaborators in two cluster randomised pilot trials. Research teams will provide training in good clinical practice, and support practices in patient recruitment, data collection and documentation. Our process evaluation explores barriers and facilitators in the set up of the BayFoNet PBRN and both cluster randomised pilot trials, under the application of the consolidated framework for implementation research and the theoretical domains framework. In a mixed-methods concept, we will use qualitative and quantitative approaches to evaluate both pilot cluster-randomised trials as well as the BayFoNet itself: focus groups with researchers, semi-structured interviews with general practitioners and questionnaires for patients participating in the pilot cluster-randomised trials at three different time points.Ethics and disseminationResearch ethical approval for this study was granted by the Ethics Committee of the Medical Department, Ludwig-Maximilians-University Munich (AZ 21-1135). Results will be published in international peer-reviewed journals and summaries will be provided to the funders of the study as well as other PBRNs, GP teams and patients.Trial registration numbersDRKS00028805, NCT05667207.