BMJ Open

Journal: BMJ Open

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BMJ

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2044-6055

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Publications1 - 10 of 35

Calligraphy-based rehabilitation exercise for improving the upper limb function of stroke patients: protocol for an evaluator-blinded randomised controlled trial
Wu, Xiaodi; Zhang, Qiang; Qiao, Jun; et al. (2022)
BMJ Open
Introduction A common complication of stroke is upper limb dysfunction. Chinese calligraphy handwriting (CCH) is an aesthetical exercise developed from the traditional way of writing in China and holds potential to become a rehabilitation method to improve upper limb functions in patients with stroke. This study aims to design a randomised controlled trial to assess the effect of a customised CCH-based exercise for poststroke rehabilitation of upper limb dysfunction. Methods and analysis A single-blinded randomised controlled trial will be conducted on 60 stroke patients. The patients will be randomly allocated into three groups: (1) conventional occupational therapy (COT) group, (2) COT+CCH group, (3) COT+Graded Repetitive Arm Supplementary Program (GRASP) group. For the COT group, patients will receive COT treatment of 1 hour/day. For the COT+CCH group, patients will receive 30 mins COT treatment and 30 mins CCH training. For the COT+GRASP group, patients will receive 30 mins COT treatment and 30 mins GRASP training. All the interventions will be performed 5 days per week for a total of 3 weeks. The upper limb functions will be assessed before and after the interventions using a series of rating scales. Ethics and dissemination This study has been approved by the Research Ethics Committees of the Second Rehabilitation Hospital of Shanghai (study ID: 2020-32-01) and the Shanghai University of Sport (study ID: 102772021RT043). Results will be directly disseminated to the patients at the end of the study and to the public via publications in peer-reviewed journals and presentations in conferences. Trial registration number ChiCTR 2100043036; Chinese Clinical Trials Registry.
Reference values and validation of the 1-minute sit-to-stand test in healthy 5-16-year-old youth: A cross-sectional study
Haile, Sarah R.; Fühner, Thea; Granacher, Urs; et al. (2021)
BMJ Open
Objectives It is essential to have simple, reliable and valid tests to measure children’s functional capacity in schools or medical practice. The 1-minute sit-to-stand (STS) test is a quick fitness test requiring little equipment or space that is increasingly used in both healthy populations and those with chronic disease. We aimed to provide age-specific and sex-specific reference values of STS test in healthy children and adolescents and to evaluate its short-term reliability and construct validity. Design setting and participants Cross-sectional convenience sample from six public schools and one science fair in central Europe. Overall, 587 healthy participants aged 5–16 years were recruited and divided into age groups of 3 years each. Outcomes 1-minute STS. To evaluate short-term reliability, some children performed the STS test twice. To evaluate construct validity, some children also performed a standing long jump (SLJ) and a maximal incremental exercise test. Results Data from 547 youth aged 5–16 years were finally included in the analyses. The median number of repetitions in 1 min in males (females) ranged from 55 [95% CI: 38 to 72] (53 [95% CI: 35 to 76]) in 14–16-year olds to 59 [95% CI: 41 to 77] (60 [95% CI: 38 to 77]) in 8–10-year olds. Children who repeated STS showed a learning effect of on average 4.8 repetitions more than the first test (95% limits of agreement: −6.7 to 16.4). Moderate correlations were observed between the STS and the SLJ (r=0.48) tests and the maximal exercise test (r=0.43). Conclusions The reported STS reference values can be used to interpret STS test performance in children and adolescents. The STS appears to have good test–retest reliability, but a learning effect of about 10%. The association of STS with other measures of physical fitness should be further explored in a larger study and technical standards for its conduct are needed.
Exploring exhaled breath biomarkers for lactose intolerance diagnosis: The Lactobreath pilot study protocol
Giannoukos, Stamatios; Burton-Pimentel, Kathryn Jane; Guillod, Roxane; et al. (2025)
BMJ Open
Introduction Food intolerances are prevalent in Europe and can cause considerable physical discomfort, dietary restrictions and psychosocial challenges. Among the prominent causes of food intolerance are defects in the digestion and/or transport of short-chain fermentable carbohydrates, fermentable oligo-, di-, monosaccharides and polyols (FODMAPs). A common diagnostic tool for food intolerance is the hydrogen breath test, which monitors the production of H 2 gas from the fermentation of ingested FODMAPs by colonic microbiota. However, this method is limited due to its relatively poor correlation with gastrointestinal (GI) symptoms experienced by patients. Diagnosis is complicated as food intolerance is often associated with functional GI disorders, while FODMAPs may exert their effects individually or in combination. Further research on the pathophysiology and the impact of intervention strategies for these conditions is required to improve the diagnosis of food intolerance. Methods and analyses The Lactobreath pilot study is a randomised, two-arm, double-blinded controlled study. 120 healthy, free-living adults will undergo 6-hour postprandial tests with lactose or glucose (control) to investigate the molecular composition of human exhaled breath (exhalome) as a potential source of biomarkers associated with clinical and metabolic traits of lactose malabsorption (Lactobreath profiles). This serves as a proof-of-concept for the future application of this technology in diagnosing food intolerance. We will use a sensitive, non-invasive, real-time measurement technique based on secondary electrospray ionisation coupled with high-resolution mass spectrometry to analyse the chemical profile of the postprandial exhalome after lactose ingestion. Symptoms of lactose intolerance will be assessed using a standardised questionnaire and mechanistically linked to specific key metabolites of the discriminating breath profile. In parallel, a solid-state sensor will measure postprandial hydrogen gas in breath samples, while GI gases (CH 4, H 2, O 2) and intestinal transit time will be monitored using a novel ingestible gas sensor (Atmo Gas capsule). Metabolites in urine, including lactose-derived metabolites, will be investigated using gas chromatography coupled with mass spectrometry. Postprandial bowel sounds will be recorded by wearable sensors (DigeHealth AG). Baseline assessments will be completed before the dietary challenge to capture usual dietary intake (repeated 24-hour recall), faecal microbiota (shallow shotgun sequencing) and to evaluate genetic polymorphisms using saliva samples (PCR analysis of selected penetrant single-nucleotide polymorphisms). Ethics and dissemination The Lactobreath study has been approved by the Ethics Committee of the Canton of Zurich, Switzerland (#2023-01639). The project results will be published in open-access journals, presented at national and international conferences and communicated to the public and other relevant stakeholders via the communication channels of all investigators and partners. All results derived from the study will be accessible, in line with the Swiss National Science Foundation open access policy. Trial registration number NCT06177938.
Advancing health equity and the role of digital health technologies: a scoping review
Bitomsky, Laura; Pfitzer, Estelle; Nissen, Marcia; et al. (2025)
BMJ Open
Background Health disparities persist, posing significant health, social and economic challenges. Digital health technologies (DHTs) present a promising opportunity to address these inequities and advance health equity. Despite this potential, a comprehensive and structured overview of existing frameworks and guidelines on advancing health equity and a clear understanding of the potential of DHTs in their implementation to systematically close the healthcare gap is yet to be done.Objective To this end, our objectives are twofold: first, to identify frameworks and guidelines that promote health equity and second, to pinpoint the role of DHTs as an avenue for their implementation. We conducted a scoping review informed by Arksey and O'Malley's five-stage framework, methodological guidelines by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.Sources of evidence A comprehensive search was conducted across seven databases on 6 December 2023: PubMed, EMBASE, Cochrane, PsycINFO, Scopus, Web of Science and WISO.Eligibility criteria We included primary and secondary studies published in English between 2010 and 2023 focusing on advancing health equity for priority populations.Charting methods For the analysis, we applied multistaged coding approaches to answer our twofold objective.Results The search identified 6419 studies, of which 38 met our final inclusion criteria and were included in this review. We extracted 559 recommendations on advancing health equity and synthesised these into 82 distinct recommendations across five levels of initiative and 19 areas of initiative. Thereby, 24% of the included studies explicitly mentioned the use of (digital) technology with 10 impact opportunities on advancing health equity.Conclusion Our synthesis offers key insights into the advancement of health equity across different levels of initiative and the role of DHTs in their implementation. This offers practitioners and researchers alike a comprehensive overview to make health equity advancement more tangible and actionable.Registration details https://osf.io/94pht
Impact of digital assistive technologies on the quality of life for people with dementia: a scoping review
Schneider, Charlotte; Nißen, Marcia; Kowatsch, Tobias; et al. (2024)
BMJ Open
Background Digital assistive technologies (DATs) have emerged as promising tools to support the daily life of people with dementia (PWD). Current research tends to concentrate either on specific categories of DATs or provide a generic view. Therefore, it is of essence to provide a review of different kinds of DATs and how they contribute to improving quality of life (QOL) for PWD. Design Scoping review using the framework proposed by Arksey and O’Malley and recommendations from Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Data sources Cochrane, Embase, PubMed, Scopus and Web of Science (January 2013 to May 2023). Eligibility criteria for selecting studies Completed scientific literature with a primary focus on DATs for PWD, perspectives of caregivers, family members or healthcare workers in relation to a PWD, people living in diverse settings and all severities of dementia. Data extraction and synthesis Screening and data extraction were conducted, followed by quantitative and qualitative analyses using thematic analysis principles and Digital Therapeutics Alliance categories for DAT grouping. Results The literature search identified 6083 records, with 1056 duplicates. After screening, 4560 full texts were excluded, yielding 122 studies of different designs. The DATs were categorised into digital therapeutics (n=109), patient monitoring (n=30), digital diagnostics (n=2), care support (n=2) and health system clinical software (n=1). These categories were identified to impact various aspects of QOL: preserving autonomy, engagement, and social interaction, health monitoring and promotion, improving activities of daily living, improving cognition, maintaining dignity, managing behavioural and psychological symptoms of dementia and safety/surveillance. Conclusions Various DATs offer extensive support, elevating the QOL of PWD. Digital therapeutics are predominantly used for ageing-in-place and independent living through assistance with daily tasks. Future research should focus on less-represented digital health technology categories, such as care support, health & wellness or software solutions. Observing ongoing DAT developments and their long-term effects on QOL remains essential.
Comparative effectiveness of biologics in patients with rheumatoid arthritis stratified by body mass index: a cohort study in a Swiss registry
Vallejo-Yagüe, Enriqueta; Burkard, Theresa; Finckh, Axel; et al. (2024)
BMJ Open
Objectives Obesity is associated with lower treatment response in patients with rheumatoid arthritis (RA). In patients with obesity, abatacept was suggested as a preferable option to tumour necrosis factor-alpha inhibitors. We aimed to assess the comparative effectiveness of etanercept, infliximab and abatacept, compared with adalimumab, in patients with RA with obesity. Secondarily, we also investigated this in patients with overweight and normal weight for completeness. Design Observational cohort study. Setting Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) registry (1997–2019). Participants Adult patients with RA from the SCQM registry who received etanercept, infliximab, abatacept or adalimumab as their first biological or targeted synthetic disease-modifying antirheumatic drug were classified based on their body mass index (BMI) at the start of that treatment in three cohorts: obese, overweight, normal weight. They were followed for a maximum of 1 year. Exposure The study exposure of interest was the patients’ first biological, particularly: etanercept, infliximab and abatacept, compared with adalimumab. Primary and secondary outcome measures The primary study outcome was remission within 12 months, defined as 28-joint Disease Activity Score (DAS28) <2.6. Missingness was addressed using confounder-adjusted response rate with attrition correction. Logistic regression was used to compare the effectiveness of etanercept, infliximab and abatacept versus adalimumab. Each BMI cohort was addressed and analysed separately. Results The study included 443 obese, 829 overweight and 1243 normal weight patients with RA. There were no statistically significant differences in the odds of DAS28-remission at ≤12 months for etanercept, infliximab and abatacept, compared with adalimumab, in any of the BMI cohorts. Conclusions No differences in DAS28-remission were found between the study drugs and adalimumab as first biologic in patients with RA, independently of the BMI cohort. We did not find evidence that treatment with abatacept increased the likelihood of remission compared with adalimumab among obese patients with RA.
How do healthcare providers construe patient complexity? A qualitative study of multimorbidity in HIV outpatient clinical practice
Ben-Menahem, Shiko; Sialm, Anastassja; Hachfeld, Anna; et al. (2021)
BMJ Open
Introduction Patient complexity is an increasingly used concept in clinical practice, policy debates and medical research. Yet the literature lacks a clear definition of its meaning and drivers from the health provider’s perspective. This shortcoming is problematic for clinical practice and medical education in the light of a rising number of multimorbid patients and the need for future healthcare providers that are adequately trained in treating complex patients. Objectives To develop an empirically grounded framework of healthcare providers’ perceptions of patient complexity and to characterise the relationship between case complexity, care complexity and provider experience as complexity-contributing factors. Design Qualitative study based on semistructured in-depth interviews with healthcare practitioners. Setting A Swiss hospital-based HIV outpatient clinic. Participants A total of 31 healthcare providers participated. Participants volunteered to take part and comprised 17 nurses, 8 junior physicians (interns) and 6 senior physicians (residents, fellows and attendings). Results Perceived patient complexity arises from the combination of case complexity drivers, the provider’s perceived controllability, and a set of complexity moderators at the levels of the patient, the care provider and the broader care context. We develop a conceptual framework that outlines key relationships among these complexity-contributing factors and present 10 key questions to help guide medical professionals in making complexity more explicit and more manageable in daily practice. Conclusions The framework presented in this study helps to advance a shared understanding of patient complexity. Our findings inform curriculum design and the teaching of essential skills to medical students in areas characterised by high patient complexity such as general internal medicine and geriatrics. From a policy perspective, our findings have important implications for the design of more effective healthcare interventions for complex patients.
Identification of influenza urban transmission patterns by geographical, epidemiological and whole genome sequencing data: protocol for an observational study
Egli, Adrian; Saalfrank, Claudia; Goldman, Nina; et al. (2019)
BMJ Open
Introduction Urban transmission patterns of influenza viruses are complex and poorly understood, and multiple factors may play a critical role in modifying transmission. Whole genome sequencing (WGS) allows the description of patient-to-patient transmissions at highest resolution. The aim of this study is to explore urban transmission patterns of influenza viruses in high detail by combining geographical, epidemiological and immunological data with WGS data. Methods and analysis The study is performed at the University Hospital Basel, University Children’s Hospital Basel and a network of paediatricians and family doctors in the Canton of Basel-City, Switzerland. The retrospective study part includes an analysis of PCR-confirmed influenza cases from 2013 to 2018. The prospective study parts include (1) a household survey regarding influenza-like illness (ILI) and vaccination against influenza during the 2015/2016 season; (2) an analysis of influenza viruses collected during the 2016/2017 season using WGS—viral genomic sequences are compared with determine genetic relatedness and transmissions; and (3) measurement of influenza-specific antibody titres against all vaccinated and circulated strains during the 2016/2017 season from healthy individuals, allowing to monitor herd immunity across urban quarters. Survey data and PCR-confirmed cases are linked to data from the Statistics Office of the Canton Basel-City and visualised using geo-information system mapping. WGS data will be analysed in the context of patient epidemiological data using phylodynamic analyses, and the obtained herd immunity for each quarter. Profound knowledge on the key geographical, epidemiological and immunological factors influencing urban influenza transmission will help to develop effective counter measurements. Ethics and dissemination The study is registered and approved by the regional ethics committee as an observational study (EKNZ project ID 2015–363 and 2016–01735). It is planned to present the results at conferences and publish the data in scientific journals.
Interruptions of biological and targeted synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: a descriptive cohort study assessing trends in patient characteristics in Switzerland
Burkard, Theresa; Vallejo-Yagüe, Enriqueta; Hügle, Thomas; et al. (2022)
BMJ Open
Objectives To identify differing patient characteristics at the time of stop and restart of biological or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in rheumatoid arthritis (RA), stratified by stop reason. Design Explorative descriptive cohort study. Setting Swiss Clinical Quality Management in Rheumatic Diseases (1999–2018). Participants Patients with RA who stopped their first b/tsDMARD. Outcome measures We assessed patient characteristics at b/tsDMARD stop and restart, stratified by stop reason (non-response, adverse event, remission, other). Results Among 2526 eligible patients, most patients (38%) stopped their b/tsDMARD due to non-response. At treatment stop, most characteristics did not differ by stop reason, yet some differed significantly (p<0.0001, those stopping due to remission had lowest median Health Assessment Questionnaire measurements (0.1) and were least likely to use leflunomide combination therapy (3.9%) and to have fibromyalgia (6.7%)). The majority of patients restarted b/tsDMARDs without changes in patient characteristics at restart. However, among the 48% of patients who restarted a b/tsDMARD after having previously stopped due to remission or other reasons, disease activity measurements were significantly worse compared with treatment stop date (mean disease activity score-erythrocyte sedimentation rate score of 2.0 at b/tsDMARD restart vs 3.5 at treatment stop (p<0.0001)). Furthermore, we observed non-significant trends in several patient characteristics (eg, higher proportion of women (75% at b/tsDMARD restart vs 70% at treatment stop, p=0.38), patients with seropositivity (anti-citrullinated protein antibody positive 67% vs 58%, p=0.25), with family history of rheumatic diseases (24% vs 20%, p=0.15), osteoarthritis/arthroplasty (25% vs 20%, p=0.34) and the metabolic syndrome (11% vs 6%, p=0.15). Conclusion Differences among patient characteristics across b/tsDMARD cessation strata were few. However, differences between stop and restart may have identified an RA phenotype that is challenging to treat. Further research on identifying the patient characteristics predictive of successful drug holidays and the optimal time to initiate and stop a drug holiday is warranted.
Defining ‘therapeutic value’ of medicines: a scoping review
Glaus, Camille E.G.; Kloeti, Andrina; Vokinger, Kerstin Noëlle (2023)
BMJ Open
Objectives: In recent years, discussions on the importance and scope of therapeutic value of new medicines have intensified, stimulated by the increase of prices and number of medicines entering the market. This study aims to perform a scoping review identifying factors contributing to the definition of the therapeutic value of medicines. Design: Scoping review. Data sources: We searched the MEDLINE, CINAHL, Embase, Business Source Premier, EconLit, Regional Business News, Cochrane, Web of Science, Scope and Pool databases through December 2020 in English, German, French, Italian and Spanish. Eligibility criteria: Studies that included determinants for the definition of therapeutic value of medicines were included. Data extraction and synthesis: Data were extracted using the mentioned data sources. Two reviewers independently screened and analysed the articles. Data were analysed from April 2021 to May 2022. Results: Of the 1883 studies screened, 51 were selected and the identified factors contributing to the definition of therapeutic value of medicines were classified in three categories: patient perspective, public health perspective and socioeconomic perspective. More than three-quarters of the included studies were published after 2014, with the majority of the studies focusing on either cancer disorders (14 of 51, 27.5%) or rare diseases (11 of 51, 21.6%). Frequently mentioned determinants for value were quality of life, therapeutic alternatives and side effects (all patient perspective), prevalence/incidence and clinical endpoints (all public health perspective), and costs (socioeconomic perspective). Conclusions: Multiple determinants have been developed to define the therapeutic value of medicines, most of them focusing on cancer disorders and rare diseases. Considering the relevance of value of medicines to guide patients and physicians in decision-making as well as policymakers in resource allocation decisions, a development of evidence-based factors for the definition of therapeutic value of medicines is needed across all therapeutic areas.

Publications1 - 10 of 35

Journal: BMJ Open

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