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Hoy — Abril 19th 2024Tus fuentes RSS

Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis

Por: Natarajan · P. · Menounos · S. · Harris · L. · Monuja · M. · Gorelik · A. · Karjalainen · T. · Buchbinder · R. · Harris · I. A. · Naylor · J. M. · Adie · S.
Objective

To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls.

Design

Meta-epidemiological study.

Data sources

Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018.

Study selection

Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis.

Outcome measures

Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up.

Results

Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p

Conclusions

Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout.

PROSPERO registration number

CRD42019117364.

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Hierarchy of demographic and social determinants of mental health: analysis of cross-sectional survey data from the Global Mind Project

Por: Bala · J. · Newson · J. J. · Thiagarajan · T. C.
Objectives

To understand the extent to which various demographic and social determinants predict mental health status and their relative hierarchy of predictive power in order to prioritise and develop population-based preventative approaches.

Design

Cross-sectional analysis of survey data.

Setting

Internet-based survey from 32 countries across North America, Europe, Latin America, Middle East and North Africa, Sub-Saharan Africa, South Asia and Australia, collected between April 2020 and December 2021.

Participants

270 000 adults aged 18–85+ years who participated in the Global Mind Project.

Outcome measures

We used 120+ demographic and social determinants to predict aggregate mental health status and scores of individuals (mental health quotient (MHQ)) and determine their relative predictive influence using various machine learning models including gradient boosting and random forest classification for various demographic stratifications by age, gender, geographical region and language. Outcomes reported include model performance metrics of accuracy, precision, recall, F1 scores and importance of individual factors determined by reduction in the squared error attributable to that factor.

Results

Across all demographic classification models, 80% of those with negative MHQs were correctly identified, while regression models predicted specific MHQ scores within ±15% of the position on the scale. Predictions were higher for older ages (0.9+ accuracy, 0.9+ F1 Score; 65+ years) and poorer for younger ages (0.68 accuracy, 0.68 F1 Score; 18–24 years). Across all age groups, genders, regions and language groups, lack of social interaction and sufficient sleep were several times more important than all other factors. For younger ages (18–24 years), other highly predictive factors included cyberbullying and sexual abuse while not being able to work was high for ages 45–54 years.

Conclusion

Social determinants of traumas, adversities and lifestyle can account for 60%–90% of mental health challenges. However, additional factors are at play, particularly for younger ages, that are not included in these data and need further investigation.

Forecasting disease trajectories in critical illness: comparison of probabilistic dynamic systems to static models to predict patient status in the intensive care unit

Por: Duggal · A. · Scheraga · R. · Sacha · G. L. · Wang · X. · Huang · S. · Krishnan · S. · Siuba · M. T. · Torbic · H. · Dugar · S. · Mucha · S. · Veith · J. · Mireles-Cabodevila · E. · Bauer · S. R. · Kethireddy · S. · Vachharajani · V. · Dalton · J. E.
Objective

Conventional prediction models fail to integrate the constantly evolving nature of critical illness. Alternative modelling approaches to study dynamic changes in critical illness progression are needed. We compare static risk prediction models to dynamic probabilistic models in early critical illness.

Design

We developed models to simulate disease trajectories of critically ill COVID-19 patients across different disease states. Eighty per cent of cases were randomly assigned to a training and 20% of the cases were used as a validation cohort. Conventional risk prediction models were developed to analyse different disease states for critically ill patients for the first 7 days of intensive care unit (ICU) stay. Daily disease state transitions were modelled using a series of multivariable, multinomial logistic regression models. A probabilistic dynamic systems modelling approach was used to predict disease trajectory over the first 7 days of an ICU admission. Forecast accuracy was assessed and simulated patient clinical trajectories were developed through our algorithm.

Setting and participants

We retrospectively studied patients admitted to a Cleveland Clinic Healthcare System in Ohio, for the treatment of COVID-19 from March 2020 to December 2022.

Results

5241 patients were included in the analysis. For ICU days 2–7, the static (conventional) modelling approach, the accuracy of the models steadily decreased as a function of time, with area under the curve (AUC) for each health state below 0.8. But the dynamic forecasting approach improved its ability to predict as a function of time. AUC for the dynamic forecasting approach were all above 0.90 for ICU days 4–7 for all states.

Conclusion

We demonstrated that modelling critical care outcomes as a dynamic system improved the forecasting accuracy of the disease state. Our model accurately identified different disease conditions and trajectories, with a

Is the quality of public health facilities always worse compared to private health facilities: Association between birthplace on neonatal deaths in the Indian states

by Priyanka Dixit, Thiagarajan Sundararaman, Shiva Halli

Background

The role of place of delivery on the neonatal health outcomes are very crucial. Although the quality of care is being improved, there is no consensus about who is the better healthcare provider in low and middle-income countries (LMICs), public or private facilities. The aim of this study is to assess the differentials in neonatal mortality by the type of healthcare providers in India and its states.

Methods

We used the data from the fourth wave of the National Family Health Survey 2015–16 (NFHS-4). Information on 259,627 live births to women within the five years preceding the survey was examined. Neonatal mortality rates for state and national levels were calculated using DHS methodology. Multi-variate logistics regression was performed to find the effect of birthplace on neonatal deaths. Propensity score matching (PSM) was used to evaluate the relationship between place of delivery and neonatal deaths to account for the bias attributable to observable covariates.

Results

The rise in parity of the women and purchasing power influences the choice of healthcare providers. Increased neonatal mortality was found in private hospital delivery compared to public hospitals in Punjab, Rajasthan, Chhattisgarh, Madhya Pradesh, Bihar, Jharkhand, Odisha, Goa, Maharashtra, Andhra Pradesh and Karnataka states using propensity score matching analysis. However, analysis on the standard of pre-natal and post-natal care indicates that private hospitals generally outperformed public hospitals.

Conclusions

The study observed a significant variation in neonatal mortality among public and private health care systems in India. Findings of the study urges that more attention be paid to the improve care at the place of delivery to improve neonatal health. There is a need of strengthened national health policy and public-private partnerships in order to improve maternal and child health care in both private and public health facilities.

Using Gaussian process for velocity reconstruction after coronary stenosis applicable in positron emission particle tracking: An <i>in-silico</i> study

by Hamed Keramati, Adelaide de Vecchi, Ronak Rajani, Steven A. Niederer

Accurate velocity reconstruction is essential for assessing coronary artery disease. We propose a Gaussian process method to reconstruct the velocity profile using the sparse data of the positron emission particle tracking (PEPT) in a biological environment, which allows the measurement of tracer particle velocity to infer fluid velocity fields. We investigated the influence of tracer particle quantity and detection time interval on flow reconstruction accuracy. Three models were used to represent different levels of stenosis and anatomical complexity: a narrowed straight tube, an idealized coronary bifurcation with stenosis, and patient-specific coronary arteries with a stenotic left circumflex artery. Computational fluid dynamics (CFD), particle tracking, and the Gaussian process of kriging were employed to simulate and reconstruct the pulsatile flow field. The study examined the error and uncertainty in velocity profile reconstruction after stenosis by comparing particle-derived flow velocity with the CFD solution. Using 600 particles (15 batches of 40 particles) released in the main coronary artery, the time-averaged error in velocity reconstruction ranged from 13.4% (no occlusion) to 161% (70% occlusion) in patient-specific anatomy. The error in maximum cross-sectional velocity at peak flow was consistently below 10% in all cases. PEPT and kriging tended to overestimate area-averaged velocity in higher occlusion cases but accurately predicted maximum cross-sectional velocity, particularly at peak flow. Kriging was shown to be useful to estimate the maximum velocity after the stenosis in the absence of negative near-wall velocity.

Barriers and facilitators for developing a prehospital emergency care system evaluation tool (PEC-SET) for low-resource settings: a qualitative analysis

Por: Joiner · A. · Blewer · A. L. · Pek · P. P. · Ostbye · T. · Staton · C. A. · Silvalila · M. · Ong · M. · Nadarajan · G. D.
Objectives

Strengthening of emergency care systems, including prehospital systems, can reduce death and disability. We aimed to identify perspectives on barriers and facilitators relating to the development and implementation of a prehospital emergency care system assessment tool (PEC-SET) from prehospital providers representing several South and Southeast (SE) Asian countries.

Design

We conducted a qualitative study using focus group discussions (FGD) informed by the Consolidated Framework for Implementation Research (CFIR). FGDs were conducted in English, audioconferencing/videoconferencing was recorded, transcribed verbatim and coded using an inductive and deductive approach. Participants suggested specific elements to be measured within three main ‘pillars’ of disease conditions proposed by the research team of the tool being developed (cardiovascular, trauma and perinatal emergencies).

Setting

We explored the perspectives of medical directors in six low-income and middle-income countries (LMICs) in South and SE Asia.

Participants

A total of 16 participants were interviewed (1 Vietnam, 4 Philippines, 4 Thailand, 5 Malaysia, 1 Indonesia and 1 Pakistan) as a part of 4 focus groups.

Results

Themes identified within the four CFIR constructs included: (1) Intervention characteristics: importance of developing an contextually specific tool, need for generalisability, trialling in one geographical area or with one pillar before expanding; (2) Inner setting: data transfer barriers, workforce shortages; (3) Outer setting: underdevelopment of EMS nationally; need for further EMS system development prior to implementing a tool and (4) Individual characteristics: lack of buy-in by prehospital personnel. Elements proposed by participants included both process and outcome measures.

Conclusions

Through the CFIR framework, we identified several themes which can provide a basis for codeveloping a PEC-SET for LMICs with local stakeholders. This work may inform development of quality improvement tools in LMIC PEC systems.

Overview of the role of different conservative interventions as first-line treatment in the management of urinary incontinence in women

Por: Rajan · K. · Nambiar · A. K.

Commentary on: Todhunter-Brown A, Hazelton C, Campbell P, Elders A, Hagen S, McClurg D. Conservative interventions for treating urinary incontinence in women: an Overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2022 Sep 2;9(9):CD012337. doi: 10.1002/14651858.CD012337.pub2.

Implications for practice and research

  • Pelvic floor muscle training is an effective conservative treatment option for managing all types of urinary incontinence (UI) in women in isolation or combined with other measures and should be considered first-line treatment in women with UI.

  • Further research is needed on long-term outcomes of conservative interventions and their impact on quality of life.

  • Context

    Urinary incontinence (UI) is a highly prevalent condition affecting nearly 25% of women, especially in older age groups.1 It is characterised by involuntary leakage of urine and can have a significant impact on quality of life, leading to psychological distress and placing a financial burden...

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