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Digital Health Technologies Applied by the Pharmaceutical Industry to Improve Access to Noncommunicable Disease Care in Low- and Middle-Income Countries

Glob Health Sci Pract. 2022 Oct 31;10(5):e2200072. doi: 10.9745/GHSP-D-22-00072. Print 2022 Oct 31.

ABSTRACT

BACKGROUND: There is limited research on how digital health technologies (DHTs) are used to promote access to care for patients with noncommunicable diseases (NCDs), particularly in low- and middle-income countries (LMICs). We describe the use of DHTs in pharmaceutical industry-led access programs aimed at improving access to NCD care in LMICs.

METHODS: The Access Observatory is the largest publicly available repository containing detailed information about pharmaceutical industry-led access programs targeting NCDs. The repository includes 101 access program reports submitted by 19 pharmaceutical companies. From each report, we extracted data relating to geographic location, disease area, beneficiary population, use of DHTs, partnerships, strategies, and activities. Data were analyzed descriptively using SAS Statistical Software and categorized according to the World Health Organization Digital Health Classification Framework.

RESULTS: A total of 43 access programs (42.6%) included DHTs. The majority of programs using DHTs were clustered across sub-Saharan Africa (72.1%) and targeted cancer (60.5%) followed by metabolic disorders (39.5%). The applied DHTs mostly related to program strategies on health service strengthening (74.4%) and community awareness (41.9%) and were largely directed toward health providers, followed by data services and clients. Only a few DHTs were used for health system management. To promote access, most DHTs focused on improving data collection, management, and use (51.1%); building health provider capacity through training (37.2%); and providing targeted patient information (34.8%).

CONCLUSION: The range of DHTs applied by the pharmaceutical industry offers opportunities for more effective access to NCD care. Transparent reporting on DHT use and its contributions to access programs’ achievements may reduce duplicative and redundant efforts and provide learnings for private and public stakeholders that may contribute to greater access to NCD care in LMICs.

PMID:36316151 | DOI:10.9745/GHSP-D-22-00072

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A general framework for inferring Bayesian ideal observer models from psychophysical data

eNeuro. 2022 Oct 31:ENEURO.0144-22.2022. doi: 10.1523/ENEURO.0144-22.2022. Online ahead of print.

ABSTRACT

A central question in neuroscience is how sensory inputs are transformed into percepts. At this point, it is clear that this process is strongly influenced by prior knowledge of the sensory environment. Bayesian ideal observer models provide a key link between data and theory that can help researchers evaluate how prior knowledge is represented and integrated with incoming sensory information. However, the statistical prior employed by a Bayesian observer cannot be measured directly, and must instead be inferred from behavioral measurements. Here we review the general problem of inferring priors from psychophysical data, and the simple solution that follows from assuming a prior that is a Gaussian probability distribution. As our understanding of sensory processing advances, however, there is an increasing need for methods to flexibly recover the shape of Bayesian priors that are not well-approximated by elementary functions. To address this issue, we describe a novel approach that applies to arbitrary prior shapes, which we parameterize using mixtures of Gaussian distributions. After incorporating a simple approximation, this method produces an analytical solution for psychophysical quantities that can be numerically optimized to recover the shapes of Bayesian priors. This approach offers advantages in flexibility, while still providing an analytical framework for many scenarios. We provide a MATLAB toolbox implementing key computations described herein.Significance statementModels in neuroscience provide an essential tool for developing and testing hypotheses about how the brain works. Here, we review the canonical application of Bayesian ideal observer models for understanding sensory processing. We present a new mathematical generalization that will allow these models to be used for deeper investigations into how prior knowledge influences perception. We also provide a software toolkit for implementing the described models.

PMID:36316119 | DOI:10.1523/ENEURO.0144-22.2022

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Frequency and severity of respiratory infections prior to COPD diagnosis and risk of subsequent postdiagnosis COPD exacerbations and mortality: EXACOS-UK health care data study

Thorax. 2022 Oct 31:thoraxjnl-2022-219039. doi: 10.1136/thorax-2022-219039. Online ahead of print.

ABSTRACT

OBJECTIVE: Little is known about how lower respiratory tract infections (LRTIs) before chronic obstructive pulmonary disease (COPD) are associated with future exacerbations and mortality. We investigated this association in patients with COPD in England.

METHODS: Clinical Practice Research Datalink Aurum, Hospital Episode Statistics and Office of National Statistics data were used. Start of follow-up was patient’s first ever COPD diagnosis date and a 1-year baseline period prior to start of follow-up was used to find mild LRTIs (general practice (GP) events/no antibiotics), moderate LRTIs (GP events+antibiotics) and severe LRTIs (hospitalised). Patients were categorised as having: none, 1 mild only, 2+ mild only, 1 moderate, 2+ moderate and 1+ severe. Negative binomial regression modelled the association between baseline LRTIs and subsequent COPD exacerbations and Cox proportional hazard regression was used to investigate mortality.

RESULTS: In 215 234 patients with COPD, increasing frequency and severity of mild and moderate LRTIs were associated with increased rates of subsequent exacerbations compared with no recorded LRTIs (1 mild adjusted IRR 1.16, 95% CI 1.14 to 1.18, 2+ mild IRR 1.51, 95% CI 1.46 to 1.55, 1 moderate IRR 1.81, 95% CI 1.78 to 1.85, 2+ moderate IRR 2.55, 95% CI 2.48 to 2.63). Patients with 1+ severe LRTI (vs no baseline LRTIs) also showed an increased rate of future exacerbations (adjusted IRR 1.75, 95% CI, 1.70 to 1.80). This pattern of association was similar for risk of all-cause and COPD-related mortality; however, patients with 1+ severe LRTIs had the highest risk of all-cause and COPD mortality.

CONCLUSION: Increasing frequency and severity of LRTIs prior to COPD diagnosis were associated with increasing rates of subsequent exacerbations, and increasing risk of all-cause and COPD-related mortality.

PMID:36316117 | DOI:10.1136/thorax-2022-219039

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Cervical spine movements during laryngoscopy and orotracheal intubation: a systematic review and meta-analysis

Emerg Med J. 2022 Oct 31:emermed-2021-211160. doi: 10.1136/emermed-2021-211160. Online ahead of print.

ABSTRACT

BACKGROUND: Airway management is challenging in trauma patients because of the fear of worsening cervical spinal cord damage. Video-integrated and optic-integrated devices and intubation laryngeal mask airways have been proposed as alternatives to direct laryngoscopy with the Macintosh laryngoscope (MAC). We performed a meta-analysis to clarify which devices cause less cervical movement during airway management.

METHODS: We searched MEDLINE, Cochrane Central, Embase and LILACS from inception to January 2022. We selected randomised controlled trials comparing alternative devices with the MAC for cervical movement from C0 to C5 in adult patients, evaluated by radiological examination. Additionally, cervical spine immobilisation (CSI) techniques were evaluated. We used the Cochrane Risk of Bias Tool to evaluate the risk of bias, and the principles of the Grading of Recommendations, Assessment, Development, and Evaluations system to assess the quality of the body of evidence.

RESULTS: Twenty-one studies (530 patients) were included. Alternative devices caused statistically significantly less cervical movement than MAC during laryngoscopy with mean differences of -3.43 (95% CI -4.93 to -1.92) at C0-C1, -3.19 (-4.04 to -2.35) at C1-C2, -1.35 (-2.19 to -0.51) at C2-C3, and -2.61 (-3.62 to -1.60) at C3-C4; and during intubation: -3.60 (-5.08 to -2.12) at C0-C1, -2.38 (-3.17 to -1.58) at C1-C2, -1.20 (-2.09 to -0.31) at C2-C3. The Airtraq and the Intubation Laryngeal Mask Airway caused statistically significant less movement than MAC restricted to some cervical segments, as well as CSI. Heterogeneity was low to moderate in most results. The quality of the body of evidence was ‘low’ and ‘very low’.

CONCLUSIONS: Compared with the MAC, alternative devices caused less movement during laryngoscopy (C0-C4) and intubation (C0-C3). Due to the high risk of bias and the very low grade of evidence of the studies, further research is necessary to clarify the benefit of each device and to determine the efficacy of cervical immobilisation during airway management.

PMID:36316103 | DOI:10.1136/emermed-2021-211160

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Mechanical thrombectomy first versus direct angioplasty or stenting for the treatment of intracranial atherosclerotic stenosis-related large vessel occlusion: protocol for a systematic review and meta-analysis

BMJ Open. 2022 Oct 31;12(10):e060136. doi: 10.1136/bmjopen-2021-060136.

ABSTRACT

INTRODUCTION: Mechanical thrombectomy (MT) using stent retrievers or a direct aspiration first-pass technique has proven to yield better results over intravenous thrombolysis in treating acute ischaemic stroke caused by large vessel occlusion (LVO). However, the treatment of intracranial atherosclerotic stenosis-related LVO remains unclear and has been a critical problem in daily clinical practice, as it can cause a relatively high failure rate for MT. Whether direct angioplasty and/or stenting is clinically feasible and shows advantage in reducing delay to revascularisation with better functional outcome compared with MT with rescue angioplasty and/or stenting remains unclear. This study seeks to provide direct and practical clinical evidence for clinicians.

METHODS AND ANALYSIS: The main databases of PubMed, the Cochrane library, Embase and Web of Science will be screened for related studies published after1 January 2015. Primary outcomes include successful recanalisation and 90-day favourable outcome. Secondary outcomes include puncture to revascularisation time, vascular complication (perforation, dissection and vasospasm), intracerebral haemorrhage, hospital-related complications and 90-day mortality. The Newcastle-Ottawa Scale will be adopted to assess risk bias of observational studies. The I 2 statistic will be used to assess heterogeneity.

ETHICS AND DISSEMINATION: No primary data of patients are needed. Therefore, ethics approval is unnecessary. The results of this systematic review and meta-analysis will be published in a peer-reviewed journal.

PROSPERO REGISTRATION NUMBER: CRD42021268061.

PMID:36316082 | DOI:10.1136/bmjopen-2021-060136

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Complex multidisciplinary intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): mixed-methods process evaluation protocol

BMJ Open. 2022 Oct 31;12(10):e067468. doi: 10.1136/bmjopen-2022-067468.

ABSTRACT

INTRODUCTION: Medication non-initiation, or primary non-adherence, is a persistent public health problem that increases the risk of adverse clinical outcomes. The initial medication adherence (IMA) intervention is a complex multidisciplinary intervention to improve adherence to cardiovascular and diabetes treatments in primary care by empowering the patient and promoting informed prescriptions based on shared decision-making. This paper presents the development and implementation strategy of the IMA intervention and the process evaluation protocol embedded in a cluster randomised controlled trial (the IMA-cRCT) to understand and interpret the outcomes of the trial and comprehend the extent of implementation and fidelity, the active mechanisms of the IMA intervention and in what context the intervention is implemented and works.

METHODS AND ANALYSIS: We present the protocol for a mixed-methods process evaluation including quantitative and qualitative methods to measure implementation and fidelity and to explore the active mechanisms and the interactions between the intervention, participants and its context. The process evaluation will be conducted in primary care centres and community pharmacies from the IMA-cRCT, and participants include healthcare professionals (general practitioners, nurses and community pharmacists) as well as patients. Quantitative data collection methods include data extraction from the intervention operative records, patient clinical records and participant feedback questionnaires, whereas qualitative data collection involves semistructured interviews, focus groups and field diaries. Quantitative and qualitative data will be analysed separately and triangulated to produce deeper insights and robust results.

ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Research Ethics Comittee (CEIm) at IDIAP Jordi Gol (codeCEIm 21/051 P). Findings will be disseminated through publications and conferences, as well as presentations to healthcare professionals and stakeholders from healthcare organisations.

TRIAL REGISTRATION NUMBER: NCT05026775.

PMID:36316078 | DOI:10.1136/bmjopen-2022-067468

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NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise – study protocol for a multicentre randomised controlled trial

BMJ Open. 2022 Oct 31;12(10):e060242. doi: 10.1136/bmjopen-2021-060242.

ABSTRACT

INTRODUCTION AND AIM: Low socioeconomic position (SEP) has been shown to be strongly associated with impaired lung cancer survival. Barriers related to receiving recommended treatment among patients with lung cancer with low SEP may include adverse health behaviour and limited physical and psychosocial resources influencing the ability to react on high-risk symptoms and to navigate the healthcare system. To address the underlying factors that drive both decisions of treatment, adherence to treatment and follow-up in vulnerable patients with lung cancer, we developed the Navigate intervention. The aim of this randomised controlled trial is to investigate the effect of the intervention on survival (primary outcome), lung cancer treatment adherence, health-related quality of life and other psychosocial outcomes as well as health costs and process evaluation (secondary outcomes) in a study population of vulnerable patients with lung cancer.

METHODS AND ANALYSIS: This two-armed multicentre randomised trial will recruit patients from five lung cancer clinics in Denmark identified as vulnerable according to a screening instrument with nine clinical and patient-reported vulnerability criteria developed for the study. We will enrol 518 vulnerable patients >18 years old diagnosed with non-small cell lung cancer at all stages with a performance status <2. Participants will be randomly allocated to either standard treatment and intervention or standard treatment alone. The Navigate intervention is based on principles from motivational interviewing and includes three components of nurse navigation, systematic monitoring of patient-reported outcomes (PROs) and physical exercise in a person-centred delivery model. Data will be collected at baseline and 3, 6, 12 months after randomisation using questionnaires, clinical data and physical function tests.

ETHICS AND DISSEMINATION: Ethics Committee, Region Zealand (SJ-884/EMN-2020-37380) and the Data Protection Agency in Region Zealand (REG-080-2021) approved the trial. Participants will provide written informed consent. Results will be reported in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: NCT05053997.

PMID:36316074 | DOI:10.1136/bmjopen-2021-060242

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Canadian Anaphylaxis Network-Predicting Recurrence after Emergency Presentation for Allergic REaction (CAN-PREPARE): a prospective, cohort study protocol

BMJ Open. 2022 Oct 31;12(10):e061976. doi: 10.1136/bmjopen-2022-061976.

ABSTRACT

INTRODUCTION: Anaphylaxis is a severe, potentially fatal multiorgan system manifestation of an allergic reaction. The highest incidence of anaphylaxis is in children and adolescents. Biphasic anaphylaxis (BA) is defined as the recurrence of allergic symptoms after resolution of an initial reaction. It has been reported to occur in 10%-20% of cases within 1-48 hours from the onset of the initial reaction. The dilemma for physicians is determining which patients with resolved anaphylaxis should be observed for BA and for how long. Guidelines for duration of postanaphylaxis monitoring vary, are based on limited evidence and can have unintended negative impacts on patient safety, quality of life and healthcare resources. The objectives of this study are to derive a prognostic model for BA and to develop a risk-scoring system that informs disposition decisions of children who present to emergency departments (ED) with anaphylaxis.

METHODS AND ANALYSIS: This prospective multicentre cohort study will enrol 1682 patients from seven paediatric EDs that are members of the Paediatric Emergency Research Canada network. We will enrol patients younger than 18 years of age with an allergic reaction meeting anaphylaxis diagnostic criteria. Trained ED research assistants will screen, obtain consent and prospectively collect study data. Research assistants will follow patients during their ED visit and ascertain, in conjunction with the medical team, if the patient develops BA. A standardised follow-up survey conducted following study enrolment will determine if a biphasic reaction occurred after ED disposition. Model development will conform to the broad principles of the PROGRESS (Prognosis Research Strategy) framework and reporting will follow the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis Statement.

ETHICS AND DISSEMINATION: Ethics approval has been received from all participating centres. Our dissemination plan focuses on informing clinicians, policy makers and parents of the results through publication in peer-reviewed journals and broadcasting on multiple media platforms.

TRIAL REGISTRATION NUMBER: NCT05135377.

PMID:36316072 | DOI:10.1136/bmjopen-2022-061976

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Extent of disability among paediatric Japanese encephalitis survivors and predictors of poor outcome: a retrospective cohort study in North India

BMJ Open. 2022 Oct 31;12(10):e060795. doi: 10.1136/bmjopen-2022-060795.

ABSTRACT

OBJECTIVE: To determine the Japanese encephalitis (JE)-associated long-term functional and neurological outcomes, the extent of reduced social participation and predictors of poor outcomes among paediatric JE survivors.

DESIGN: A retrospective cohort study.

SETTING: Laboratory-confirmed JE-positive paediatric cases (<16 years of age) hospitalised at the paediatric ward of Baba Raghav Das Medical College, Gorakhpur, India, between 1 January 2017 and 31 December 2017, were followed up after 6-12 months of hospital discharge.

PARTICIPANTS: 126 patients were included in the study; median age was 7.5 years (range: 1.5-15 years), and 74 (58.73%) were male.

OUTCOME MEASURES: Functional outcome defined by Liverpool Outcome Score (LOS) dichotomised into poor (LOS=1-2) and good (LOS=3-5) outcome groups compared for demographic, clinical and biochemical parameters for prognostic factors of poor outcomes. Social participation of patients scaled on Child and Adolescent Scale of Participation score 2-5.

RESULTS: About 94 of 126 (74.6%) children developed neurological sequelae at different levels of severity. Age-expected social participation was compromised in 90 out of 118 children. In multivariate logistic regression analysis, a combination of parameters, JE unvaccinated status (OR: 61.03, 95% CI (14.10 to 264); p<0.001), low Glasgow Coma Score (GCS) at admission (≤8) (OR: 8.6, 95% CI (1.3 to 57.1); p=0.026), malnutrition (OR: 13.56, 95% CI (2.77 to 66.46); p=0.001) and requirement of endotracheal intubation (OR: 5.43, 95% CI (1.20 to 24.44); p=0.027) statistically significantly predicted the poor outcome with 77.8% sensitivity and 94.6% specificity. The goodness-of-fit test showed that the model fit well (Hosmer-Lemeshow goodness-of-fit test) (χ 2=3.13, p=0.988), and area under the receiver operating characteristic curve was 0.950.

CONCLUSION: This study estimates the burden of JE-presenting post-discharge deaths (15.4%) and disability (63.08%). Those who did not receive JE vaccine, were suffering from malnutrition, had GCS ≤8 at admission and required endotracheal intubation had poorer outcomes.

PMID:36316071 | DOI:10.1136/bmjopen-2022-060795

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Ticagrelor-Aspirin Versus Clopidogrel-Aspirin Among CYP2C19 Loss-of-Function Carriers With Minor Stroke or Transient Ischemic Attack in Relation to Renal Function: A Post Hoc Analysis of the CHANCE-2 Trial

Ann Intern Med. 2022 Nov 1. doi: 10.7326/M22-1667. Online ahead of print.

ABSTRACT

BACKGROUND: Evidence on the risk-benefit ratio of dual antiplatelet therapies among patients with stroke and impaired renal function is limited and inconsistent.

OBJECTIVE: To investigate the effect of renal function on the efficacy and safety of ticagrelor-aspirin versus clopidogrel-aspirin treatment.

DESIGN: Post hoc analysis of a multicenter, randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT04078737).

SETTING: 202 centers in China.

PATIENTS: CYP2C19 loss-of-function allele carriers with minor stroke or transient ischemic attack.

INTERVENTION: Ticagrelor-aspirin and clopidogrel-aspirin.

MEASUREMENTS: Renal function was evaluated by estimated glomerular filtration rate (eGFR) levels. The primary efficacy and safety outcomes were recurrent stroke and severe or moderate bleeding within 90 days, respectively.

RESULTS: Among 6378 patients, 4050 (63.5%) had normal (eGFR ≥90 mL/min/1.73 m2), 2010 (31.5%) had mildly decreased (eGFR 60 to 89 mL/min/1.73 m2), and 318 (5.0%) had moderately to severely decreased (eGFR <60 mL/min/1.73 m2) renal function. The corresponding differences in recurrent stroke between ticagrelor-aspirin and clopidogrel-aspirin for normal, mildly decreased, and moderately to severely decreased renal function was -2.8 percentage points (95% CI, -4.4 to -1.3 percentage points) (hazard ratio [HR], 0.63 [CI, 0.49 to 0.81]), -0.2 percentage point (CI, -2.4 to 2.0 percentage points) (HR, 0.98 [CI, 0.69 to 1.39]), and 3.7 percentage points (CI, -2.3 to 10.1 percentage points) (HR, 1.31 [CI, 0.48 to 3.55]), respectively. Rates of severe or moderate bleeding did not substantially differ by treatment assignments across eGFR categories.

LIMITATION: Renal function was only evaluated by using eGFR, and the proportion of patients with severely decreased renal function was low.

CONCLUSION: Patients with normal, rather than impaired, renal function received greater benefit from ticagrelor-aspirin versus clopidogrel-aspirin.

PRIMARY FUNDING SOURCE: Ministry of Science and Technology of the People’s Republic of China.

PMID:36315949 | DOI:10.7326/M22-1667