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Nevin Manimala Statistics

Assessing quality of direct-to-consumer telemedicine in China: a cross-sectional study using unannounced standardised patients

BMJ Qual Saf. 2024 Apr 30:bmjqs-2024-017072. doi: 10.1136/bmjqs-2024-017072. Online ahead of print.

ABSTRACT

Direct-to-onsumer telemedicine (DTCT) has become popular as an alternative to traditional care. However, uncertainties about the potential risks associated with the lack of comprehensive quality evaluation could influence its long-term development. This study aimed to assess the quality of care provided by DTCT platforms in China using unannounced standardised patients (USP) between July 2021 and January 2022. The study assessed consultation services on both hospital and enterprise-sponsored platforms using the Institute of Medicine quality framework. It employed 10 USP cases, covering conditions such as diabetes, asthma, common cold, gastritis, angina, low back pain, child diarrhoea, child dermatitis, stress urinary incontinence and postpartum depression. Descriptive and regression analyses were employed to examine platform characteristics and compare quality across platform types. The results showed that of 170 USP visits across 107 different telemedicine platforms, enterprise-sponsored platforms achieved a 100% success in access, while hospital-sponsored platforms had a success rate of only 47.5% (56/118). Analysis highlighted a low overall correct diagnosis rate of 45% and inadequate adherence to clinical guidelines across all platforms. Notably, enterprise-sponsored platforms outperformed in accessibility, response time and case management compared with hospital-sponsored platforms. This study highlights the suboptimal quality of DTCT platforms in China, particularly for hospital-sponsored platforms. To further enhance DTCT services, future studies should compare DTCT and in-person care, aiming to identify gaps and potential risks associated with using DTCT as alternatives or supplements to traditional care. The potential of future development in enhancing DTCT services may involve exploring the integration of hospital resources with the technology and market capabilities of enterprise-sponsored platforms.

PMID:38688711 | DOI:10.1136/bmjqs-2024-017072

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Incidence, prevalence and mortality of idiopathic pulmonary fibrosis in England from 2008 to 2018: a cohort study

Thorax. 2024 Apr 30:thorax-2023-220887. doi: 10.1136/thorax-2023-220887. Online ahead of print.

ABSTRACT

BACKGROUND: Owing to discrepancies in methodologies and how idiopathic pulmonary fibrosis (IPF) is diagnosed it is challenging to establish a consistent understanding of the disease burden In the UK, over 10 years ago, the incidence and prevalence of IPF were reported as 2.8-8.7 per 100 000 person-years (from 2000 to 2012) and 39 per 100 000 persons (in 2012), respectively. Here, we estimated the incidence and prevalence of IPF in England from 2008 to 2018 and investigated IPF mortality.

METHODS: Using Clinical Practice Research Datalink Aurum and Hospital Episode Statistics (HES) linked datasets, we estimated incidence and prevalence using four validated diagnostic-code-based algorithms. Using the registered number of deaths (from Office of National Statistics) with the underlying cause being recorded as IPF, we estimated IPF mortality for the same period.

RESULTS: Using Aurum-based definitions, incidence increased over time by 100% for Aurum narrow (3-6.1 per 100 000 person-years) and by 25% for Aurum broad (22.4-28.6 per 100 000 person-years). However, using HES-based definitions showed a decrease in incidence over the same period and lay between the two extremes derived for Aurum-based definition. IPF mortality in 2018 was 7.9 per 100 000 person-years and increased by 53% between 2008 and 2018.

INTERPRETATION: When using best-case definitions, incidence rose throughout the study period. Scaling this to England’s population (2018), our best estimate would be in the range of 8000-9000 new cases per year which is higher than previously reported estimates (5000-6000). This increased burden in the new cases of IPF each year impacts future health service planning and resource allocation.

PMID:38688708 | DOI:10.1136/thorax-2023-220887

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Risk of severe mood and anxiety disorders in the adult children of parents with alcohol use disorder: a nationwide cohort study

J Epidemiol Community Health. 2024 Apr 30:jech-2023-221720. doi: 10.1136/jech-2023-221720. Online ahead of print.

ABSTRACT

BACKGROUND: Growing up with parental alcohol use disorder (AUD) is a risk factor for psychiatric disorders. This study investigated the risk of mood disorders and of anxiety disorders in the adult children of parents with AUD, adjusted for sociodemographic factors.

METHODS: Individual-level register data on the total population were linked to follow children of parents with AUD from 1973 to 2018 to assess their risk of mood disorders and of anxiety disorders. AUD, mood disorders and anxiety disorders were defined with International Statistical Classification of Diseases and Related Health Problems codes from the National Patient Register. HRs of outcomes were calculated with Cox regression. Model 1 was adjusted for the child’s sex, parental education and death of a parent. Model 2 was adjusted for those factors and parental diagnosis of mood or anxiety disorder.

RESULTS: Those with ≥1 parent with AUD (99 723 of 2 421 479 children) had a higher risk of mood disorder and of anxiety disorder than those whose parents did not have AUD (HR mood 2.32, 95% CI 2.26 to 2.39; HR anxiety 2.66, 95% CI 2.60 to 2.72). The risk remained elevated after adjustment for sociodemographic factors and parental psychiatric diagnosis (HR mood 1.67, 95% CI 1.63 to 1.72; HR anxiety 1.74, 95% CI 1.69 to 1.78). The highest risks were associated with AUD in both parents, followed by AUD in mothers and then in fathers.

CONCLUSION: Adult children of parents with AUD have a raised risk of mood and anxiety disorders even after adjustment for sociodemographic factors and parental mood or anxiety disorder. These population-level findings can inform future policies and interventions.

PMID:38688702 | DOI:10.1136/jech-2023-221720

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Computable phenotype for real-world, data-driven retrospective identification of relapse in ANCA-associated vasculitis

RMD Open. 2024 Apr 30;10(2):e003962. doi: 10.1136/rmdopen-2023-003962.

ABSTRACT

OBJECTIVE: ANCA-associated vasculitis (AAV) is a relapsing-remitting disease, resulting in incremental tissue injury. The gold-standard relapse definition (Birmingham Vasculitis Activity Score, BVAS>0) is often missing or inaccurate in registry settings, leading to errors in ascertainment of this key outcome. We sought to create a computable phenotype (CP) to automate retrospective identification of relapse using real-world data in the research setting.

METHODS: We studied 536 patients with AAV and >6 months follow-up recruited to the Rare Kidney Disease registry (a national longitudinal, multicentre cohort study). We followed five steps: (1) independent encounter adjudication using primary medical records to assign the ground truth, (2) selection of data elements (DEs), (3) CP development using multilevel regression modelling, (4) internal validation and (5) development of additional models to handle missingness. Cut-points were determined by maximising the F1-score. We developed a web application for CP implementation, which outputs an individualised probability of relapse.

RESULTS: Development and validation datasets comprised 1209 and 377 encounters, respectively. After classifying encounters with diagnostic histopathology as relapse, we identified five key DEs; DE1: change in ANCA level, DE2: suggestive blood/urine tests, DE3: suggestive imaging, DE4: immunosuppression status, DE5: immunosuppression change. F1-score, sensitivity and specificity were 0.85 (95% CI 0.77 to 0.92), 0.89 (95% CI 0.80 to 0.99) and 0.96 (95% CI 0.93 to 0.99), respectively. Where DE5 was missing, DE2 plus either DE1/DE3 were required to match the accuracy of BVAS.

CONCLUSIONS: This CP accurately quantifies the individualised probability of relapse in AAV retrospectively, using objective, readily accessible registry data. This framework could be leveraged for other outcomes and relapsing diseases.

PMID:38688690 | DOI:10.1136/rmdopen-2023-003962

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The diagnostic pathway for patients with interstitial lung disease: a mixed-methods study of patients and physicians

BMJ Open Respir Res. 2024 Apr 30;11(1):e002333. doi: 10.1136/bmjresp-2024-002333.

ABSTRACT

OBJECTIVES: The diagnostic process for patients with interstitial lung diseases (ILD) remains complex. The aim of this study was to characterise the diagnostic care pathway and identify barriers and potential solutions to access a timely and accurate ILD diagnosis.

DESIGN: This mixed-method study was comprised of a quantitative chart review, patient and physician surveys and focus groups.

RESULTS: Chart review was completed for 97 patients. Median time from symptom onset to ILD diagnosis was 12.0 (IQR 20.5) months, with 46% diagnosed within 1 year. Time from first computed tomography (CT) scan to respirology referral was 2.4 (IQR 21.2) months. Referrals with a prior CT were triaged sooner than referrals without (1.7±1.6 months vs 3.9±3.3 months, p=0.013, 95% CI 0.48 to 2.94). On patient surveys (n=70), 51% felt that their lung disease was not recognised early enough. Commonly reported challenges to timely diagnosis included delayed presentation to primary care, initial misdiagnoses and long wait-times for specialists. Forty-five per cent of physicians (n=20) identified diagnostic delays, attributed to delayed presentations to primary care (58%), initial misdiagnoses (67%) and delayed chest imaging (75%). Themes from patient and respirologist focus groups included patient-related, healthcare provider-related and system-related factors leading to delays in diagnosis.

CONCLUSIONS: This mixed-methods study identified patient and system-related factors that contribute to diagnostic delays for patients with ILD, with most delays occurring prior to respirology referral. ILD awareness and education, earlier presentation to primary care, expedited access to chest imaging and earlier referral to respirology may expedite diagnosis.

PMID:38688689 | DOI:10.1136/bmjresp-2024-002333

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Regional versus general anesthesia for total hip and knee arthroplasty: a nationwide retrospective cohort study

Reg Anesth Pain Med. 2024 Apr 30:rapm-2024-105440. doi: 10.1136/rapm-2024-105440. Online ahead of print.

ABSTRACT

INTRODUCTION: We aimed to determine whether regional anesthesia (RA) has any advantages over general anesthesia (GA) in total joint arthroplasty (TJA) in terms of mortality and postoperative complications.

METHODS: This population-based retrospective cohort study included data of adults who underwent total knee or hip arthroplasty under RA or GA between 2016 and 2021 from the National Health Insurance Service of South Korea. RA included spinal or epidural anesthesia or a combination of both. Endpoints were 30-day mortality, 90-day mortality, and postoperative complications. Propensity score (PS) matching was used for statistical analysis.

RESULTS: We included 517 960 patients (RA, n=380 698; GA, n=137 262) who underwent TJA. After PS matching, 186 590 patients (93 295 in each group) were included in the final analysis. In the logistic regression analyses using the PS-matched cohort, the RA group compared with the GA group showed 31% (OR: 0.69; 95% CI, 0.60 to 0.80; p<0.001) and 22% (OR: 0.78; 95% CI, 0.72 to 0.85; p<0.001) lower 30-day and 90-day mortality rates, respectively. However, the total postoperative complication rate did not differ significantly between the two groups (p=0.105).

CONCLUSION: RA compared with GA was associated with improved 30-day and 90-day survival outcomes in patients who underwent TJA. However, the postoperative complication rate did not differ significantly. Therefore, our results should be interpreted with caution, and more well-designed future studies are needed to clarify the most appropriate type of anesthesia for TJA.

PMID:38688686 | DOI:10.1136/rapm-2024-105440

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Do athletic ECG changes predict athletic performance in Gurkha recruits?

BMJ Mil Health. 2024 Apr 30:e002576. doi: 10.1136/military-2023-002576. Online ahead of print.

ABSTRACT

INTRODUCTION: ECG changes are associated with regular long-term intensive exercise due to electrical manifestations of increased vagal tone, increased ventricular wall thickness and enlarged chamber size. The aim of this study was to further understand the relationship of athletic ECG changes and athletic performance in an athletic population.

METHODS: A retrospective cohort study was performed in 195 Nepali civilian males undergoing selection to the Gurkhas. V̇O2max (maximal oxygen consumption) was estimated from a 1.5-mile run time using Cooper’s formula and correlated with athletic ECG adaptations. Variables were explored with univariable and multivariable linear regression.

RESULTS: The median number of athletic changes on ECG was 2 (IQR 1-2). There was no significant correlation (p=0.46) between the number of ECG adaptations and the degree of cardiovascular fitness by estimated V̇O2max (estV̇O2max). We found a negligible but significant correlation between the presence of inferior T wave inversion (TWI) and estV̇O2max (R2=0.03, p=0.02). The multivariable-fitted regression model was: estV̇O2max~Intercept+presence of RVH (right ventricular hypertrophy) voltage criteria+absence of sinus arrhythmia+T wave axis+inferior TWI. The overall regression was statistically significant: R2=0.10, F(df=4, df=189)=[5.4], p=0.0004). All variables in the multivariable model significantly predicted estV̇O2max (p<0.04).

CONCLUSION: ECG changes of athleticism negligibly predict and differentiate athletic performance in our athletic population. The most predictive ECG markers being voltage criteria for left ventricular hypertrophy and RVH. Markers of increased vagal tone were not predictive. TWI, being a marker for disease, was also a marker for athletic performance in this cohort. The number of athletic ECG adaptations did not predict increased athletic performance.

PMID:38688679 | DOI:10.1136/military-2023-002576

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Relation between pre-existing quality management measures and prevention and containment of COVID-19 outbreaks in 159 nursing homes in Tuscany: a mixed methods study

BMJ Open Qual. 2024 Apr 30;13(2):e002560. doi: 10.1136/bmjoq-2023-002560.

ABSTRACT

BACKGROUND: Nursing homes were often the focus of COVID-19 outbreaks. Many factors are known to influence the ability of a nursing home to prevent and contain a COVID-19 outbreak. The role of an organisation’s quality management prior to the pandemic is not yet clear. In the Italian region of Tuscany nursing home performance indicators have been regularly collected since before the pandemic, providing the opportunity to better understand this relationship.

OBJECTIVES: To test if there is a difference in the results achieved by nursing homes in Tuscany on 13 quality management indicators, when grouped by severity of COVID-19 outbreaks; and to better understand how these indicators may be related to the ability to control COVID-19 outbreaks, from the perspective of nursing homes.

METHODS: We used a mixed methods sequential explanatory design. Based on regional and national databases, 159 nursing homes in Tuscany were divided into four groups by outbreak severity. We tested the significance of the differences between the groups with respect to 13 quality management indicators. The potential relation of these indicators to COVID-19 outbreaks was discussed with 29 managers and other nursing homes’ staff through four group interviews.

RESULTS: The quantitative analysis showed significant differences between the groups of nursing homes for 3 of the 13 indicators. From the perspective of nursing homes, the indicators might not be good at capturing important aspects of the ability to control COVID-19 outbreaks. For example, while staffing availability is seen as essential, the staff-to-bed ratio does not capture the turn-over of staff and temporary absences due to positive COVID-19 testing of staff.

CONCLUSIONS: Though currently collected indicators are key for overall performance monitoring and improvement, further refinement of the set of quality management indicators is needed to clarify the relationship with nursing homes’ ability to control COVID-19 outbreaks.

PMID:38688676 | DOI:10.1136/bmjoq-2023-002560

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Repurposing of dextromethorphan as an adjunct therapy in patients with major depressive disorder: a randomised, group sequential adaptive design, controlled clinical trial protocol

BMJ Open. 2024 Apr 30;14(4):e080500. doi: 10.1136/bmjopen-2023-080500.

ABSTRACT

BACKGROUND: Therapeutic latency, lack of efficacy and adverse drug reactions are the major concerns in current antidepressant therapies. To overcome these treatment hurdles, add-on therapy to conventional antidepressant medications may lead to better therapeutic outcomes. The present randomised controlled trial has been planned to evaluate the efficacy and safety of add-on dextromethorphan to selective serotonin reuptake inhibitors (SSRIs) in major depressive disorder (MDD).

METHODS AND ANALYSIS: A randomised, double-blind, add-on, placebo-controlled, group sequential design clinical trial will be conducted on patients with MDD who will be randomly assigned to the control and the test group in a 1:1 ratio. Patients in the test group will get dextromethorphan 30 mg once daily, whereas patients in the control group will receive a placebo once daily as an add-on to ongoing SSRI treatment for 8 weeks. All patients will be evaluated for the primary outcome (change in the Montgomery-Åsberg Depression Rating Scale score) and secondary outcomes (treatment response rate, remission rate, Clinical Global Impression, serum brain-derived neurotrophic factor, serum dextromethorphan and treatment-emergent adverse events) over the period of 8 weeks. Intention-to-treat analysis will be done for all parameters using suitable statistical tools.

ETHICS AND DISSEMINATION: This study was approved by the Institutional Ethics Committee of All India Institute of Medical Sciences, Bhubaneswar, India, and the study conformed to the provisions of the Declaration of Helsinki and ICMR’s ethical guidelines for biomedical research on human subjects (2017). Written informed consent will be obtained from the participants before recruitment. The results of this study will be published in peer-reviewed publications.

TRIAL REGISTRATION NUMBER: NCT05181527.

PMID:38688675 | DOI:10.1136/bmjopen-2023-080500

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Life skills and reproductive health empowerment intervention for newly married women and their families to reduce unintended pregnancy in India: protocol for the TARANG cluster randomised controlled trial

BMJ Open. 2024 Apr 30;14(4):e086778. doi: 10.1136/bmjopen-2024-086778.

ABSTRACT

INTRODUCTION: In South Asia, younger women have high rates of unmet need for family planning and low empowerment. Life skills interventions can equip young women with agency, but the effectiveness of these interventions in reproductive and sexual autonomy and contraception has not been examined.

METHODS AND ANALYSIS: A two-arm, parallel, cluster randomised controlled trial will evaluate the impact of TARANG (Transforming Actions for Reaching and Nurturing Gender Equity and Empowerment), a life skills and reproductive health empowerment group-based intervention for newly married women, compared with usual services in the community in rural and tribal Rajasthan, India. TARANG will also provide light-touch sessions to husbands and mothers-in-law of newly married women. We will test the impact of TARANG in 80 village clusters among 800 eligible households comprising newly married women aged 18-25 years who are at risk of pregnancy but do not want a pregnancy within 1 year at the time of enrolment, their husbands and mothers-in-law who consent to participate. Women in the intervention villages will receive 14 sessions over a 6-month period, while husbands and mothers-in-law will receive 1 and 4 sessions (respectively) each. Three rounds of surveys will be collected over 18 months. Control villages will receive the intervention after the endline surveys. Primary outcomes include rate of unintended pregnancy and modern contraceptive use. We plan to start recruitment of participants and data collection in April 2024. We will estimate unadjusted and adjusted intention-to-treat effects using survival analysis and mixed models.

ETHICS AND DISSEMINATION: Study protocols have been reviewed and approved by the human subjects review boards at the University of California, San Francisco, and the Centre for Media Studies, India (IRB00006230) and ACE Independent Ethics Committee, Bangalore (NET0062022). Results will be disseminated in international peer-reviewed journals and conferences, to stakeholders including local government and non-governmental organisations, and directly to the communities and individuals that participated in the intervention.

TRIAL REGISTRATION NUMBER: NCT06024616.

PMID:38688674 | DOI:10.1136/bmjopen-2024-086778