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Identifying womens preferences for treatment of urinary tract infection: a discrete choice experiment

Por: van der Worp · H. · Brandenbarg · D. · Boek · P. A. · Braams · J. H. W. · Brink · L. J. F. · Keupers · J. · Blanker · M. H.
Objective

To identify the preferences of women regarding management of urinary tract infections (UTIs).

Design

A discrete choice experiment of the preferences for certain treatment attributes was conducted by survey. Attributes included treatment duration, time to complaint resolution, complication risk, side effect risk and contribution to antimicrobial resistance.

Setting

General population in the Netherlands, recruited via social media.

Participants

Women aged 18 years or older.

Primary and secondary outcome measures

The primary outcome was the relative importance of the attributes for treatment choice, using a conditional logit model. The secondary outcome was the heterogeneity in these preferences.

Results

The discrete choice experiment was completed by 833 women. Most attributes were important to decisions for UTI treatment. Women were willing to accept management with, for example, a higher chance of complications or longer time to resolution, if it could help avoid antimicrobial resistance. However, there was heterogeneity in the preferences. Women who had one previous UTI had a stronger preference for faster symptom resolution compared with those who had no previous UTI. Younger women also preferred faster symptom resolution. Finally, women with a low or middle education level gave less importance to preventing antimicrobial resistance than women with a high education level.

Conclusions

The current study indicated that a considerable part of women valued alternatives to antimicrobial treatment and were prepared to tolerate management that was less optimal in certain respects to avoid antimicrobial treatment.

Study protocol: a multicentre, open-label, parallel-group, phase 2, randomised controlled trial of autologous macrophage therapy for liver cirrhosis (MATCH)

Por: Brennan · P. N. · MacMillan · M. · Manship · T. · Moroni · F. · Glover · A. · Graham · C. · Semple · S. · Morris · D. M. · Fraser · A. R. · Pass · C. · McGowan · N. W. A. · Turner · M. L. · Lachlan · N. · Dillon · J. F. · Campbell · J. D. M. · Fallowfield · J. A. · Forbes · S. J.
Introduction

Liver cirrhosis is a growing global healthcare challenge. Cirrhosis is characterised by severe liver fibrosis, organ dysfunction and complications related to portal hypertension. There are no licensed antifibrotic or proregenerative medicines and liver transplantation is a scarce resource. Hepatic macrophages can promote both liver fibrogenesis and fibrosis regression. The safety and feasibility of peripheral infusion of ex vivo matured autologous monocyte-derived macrophages in patients with compensated cirrhosis has been demonstrated.

Methods and analysis

The efficacy of autologous macrophage therapy, compared with standard medical care, will be investigated in a cohort of adult patients with compensated cirrhosis in a multicentre, open-label, parallel-group, phase 2, randomised controlled trial. The primary outcome is the change in Model for End-Stage Liver Disease score at 90 days. The trial will provide the first high-quality examination of the efficacy of autologous macrophage therapy in improving liver function, non-invasive fibrosis markers and other clinical outcomes in patients with compensated cirrhosis.

Ethics and dissemination

The trial will be conducted according to the ethical principles of the Declaration of Helsinki 2013 and has been approved by Scotland A Research Ethics Committee (reference 15/SS/0121), National Health Service Lothian Research and Development department and the Medicine and Health Care Regulatory Agency-UK. Final results will be presented in peer-reviewed journals and at relevant conferences.

Trial registration numbers

ISRCTN10368050 and EudraCT; reference 2015-000963-15

Cost-effectiveness of household contact investigation for detection of tuberculosis in Pakistan

Por: Hussain · H. · Malik · A. · Ahmed · J. F. · Siddiqui · S. · Amanullah · F. · Creswell · J. · Tylleskär · T. · Robberstad · B.
Objectives

Despite WHO guidelines recommending household contact investigation, and studies showing the impact of active screening, most tuberculosis (TB) programmes in resource-limited settings only carry out passive contact investigation. The cost of such strategies is often cited as barriers to their implementation. However, little data are available for the additional costs required to implement this strategy. We aimed to estimate the cost and cost-effectiveness of active contact investigation as compared with passive contact investigation in urban Pakistan.

Methods

We estimated the cost-effectiveness of ‘enhanced’ (passive with follow-up) and ‘active’ (household visit) contact investigations compared with standard ‘passive’ contact investigation from providers and the programme’s perspective using a simple decision tree. Costs were collected in Pakistan from a TB clinic performing passive contact investigation and from studies of active contact tracing interventions conducted. The effectiveness was based on the number of patients with TB identified among household contacts screened.

Results

The addition of enhanced contact investigation to the existing passive mode detected 3.8 times more cases of TB per index patient compared with passive contact investigation alone. The incremental cost was US$30 per index patient, which yielded an incremental cost of US$120 per incremental patient identified with TB. The active contact investigation was 1.5 times more effective than enhanced contact investigation with an incremental cost of US$238 per incremental patient with TB identified.

Conclusion

Our results show that enhanced and active approaches to contact investigation effectively identify additional patients with TB among household contacts at a relatively modest cost. These strategies can be added to the passive contact investigation in a high burden setting to find the people with TB who are missed and meet the End TB strategy goals.

Comparison of three different exercise training modalities (aerobic, strength and mixed) in patients with schizophrenia: study protocol for a multicentre randomised wait-list controlled trial

Por: Garcia-Garces · L. · Lacamara Cano · S. · Cebolla Melia · Y. · Sanchez-Lopez · M. I. · Marques Azcona · D. · Lison · J. F. · Peyro-Gregori · L.
Introduction

Numerous studies support the practice of different physical exercise modalities as an effective treatment to address the problems associated with schizophrenia, reporting that they result in improvements in patient symptoms and quality of life. Given the lack of studies comparing different types of training in controlled environments, the aim of this proposed study will be to compare the effects of three physical exercise programmes (strength, aerobic and mixed) on the symptoms, body composition, level of physical activity and health-related quality of life of patients with schizophrenia.

Methods and analysis

A multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. The participants will be randomised into three 16-week training groups comprising 48 sessions lasting 1 hour each, or to the wait-list control group. The training groups will complete aerobic, strength or mixed (aerobic+strength) training. The participants will be assessed before, immediately after and 6 months after the end of the intervention. The patients in the wait-list control group (n=15) will receive one of the three trainings immediately after the intervention. The study variables will include positive, negative and general symptomology (Positive and Negative Syndrome Scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (International Physical Activity Questionnaire-Short Form) and quality of life (abbreviated WHO Quality of Life questionnaire).

Ethics and dissemination

This study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia, Spain (CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained. The results from this study will be published in peer-reviewed journals and presented in scientific conferences.

Trial registration number

NCT04987151.

Trends in high deductible health plan enrolment and spending among commercially insured members with and without chronic conditions: a Natural Experiment for Translation in Diabetes (NEXT-D2) Study

Por: Garabedian · L. F. · Zhang · F. · LeCates · R. · Wallace · J. · Ross-Degnan · D. · Wharam · J. F.
Objectives

To examine trends in high deductible health plan (HDHP) enrolment among members with diabetes and cardiovascular disease (CVD) compared with healthy members and compare out-of-pocket (OOP) and total spending for members with chronic conditions in HDHPs versus low deductible plans.

Design

Descriptive study with time trends.

Setting

A large national commercial insurance database.

Participants

1.2 million members with diabetes, 4.5 million members with CVD (without diabetes) and 18 million healthy members (defined by a low comorbidity score) under the age of 65 years and insured between 2005 and 2013.

Outcome measures

Percentage of members in an HDHP (ie, annual deductible ≥$1000) by year, annual mean OOP and total spending, adjusted for member sociodemographic and employer characteristics.

Results

Enrolment in HDHPs among members in all disease categories increased by 5 percentage points a year and was over 50% by 2013. On average, over the study period, HDHP enrolment among members with diabetes and CVD was 2.84 (95% CI: 2.78 to 2.90) and 2.02 (95% CI: 1.98 to 2.05) percentage points lower, respectively, than among healthy members. HDHP members with diabetes, CVD and low morbidity had higher annual OOP costs ($636 (95% CI: 630 to 642), $539 (95% CI: 537 to 542) and $113 (95% CI: 112 to 113)) and lower total costs (–$529 (95% CI: –597 to –461), –$364 (95% CI: –385 to –342) and –$79 (95% CI: –81 to –76)), respectively, than corresponding low deductible members when averaged over the study period. Members with chronic diseases had yearly OOP expenditures that were five to seven times higher than healthier members.

Conclusion

High HDHP enrolment coupled with the high OOP costs associated with HDHPs may be particularly detrimental to the financial well-being of people with diabetes and CVD, who have more healthcare needs than healthier populations.

Non-communicable diseases, sociodemographic vulnerability and the risk of mortality in hospitalised children and adolescents with COVID-19 in Brazil: a cross-sectional observational study

Por: Sousa · B. L. A. · Brentani · A. · Costa Ribeiro · C. C. · Dolhnikoff · M. · Grisi · S. J. F. E. · Ferrer · A. P. S. · Ferraro · A. A.
Objectives

To analyse how previous comorbidities, ethnicity, regionality and socioeconomic development are associated with COVID-19 mortality in hospitalised children and adolescents.

Design

Cross-sectional observational study using publicly available data from the Brazilian Ministry of Health.

Setting

Nationwide.

Participants

5857 patients younger than 20 years old, all of them hospitalised with laboratory-confirmed COVID-19, from 1 January 2020 to 7 December 2020.

Main outcome measure

We used multilevel mixed-effects generalised linear models to study in-hospital mortality, stratifying the analysis by age, region of the country, presence of non-communicable diseases, ethnicity and socioeconomic development.

Results

Individually, most of the included comorbidities were risk factors for mortality. Notably, asthma was a protective factor (OR 0.4, 95% CI 0.24 to 0.67). Having more than one comorbidity increased almost tenfold the odds of death (OR 9.67, 95% CI 6.89 to 13.57). Compared with white children, Indigenous, Pardo (mixed) and East Asian had significantly higher odds of mortality (OR 5.83, 95% CI 2.43 to 14.02; OR 1.93, 95% CI 1.48 to 2.51; OR 2.98, 95% CI 1.02 to 8.71, respectively). We also found a regional influence (higher mortality in the North—OR 3.4, 95% CI 2.48 to 4.65) and a socioeconomic association (lower mortality among children from more socioeconomically developed municipalities—OR 0.26, 95% CI 0.17 to 0.38)

Conclusions

Besides the association with comorbidities, we found ethnic, regional and socioeconomic factors shaping the mortality of children hospitalised with COVID-19 in Brazil. Our findings identify risk groups among children that should be prioritised for public health measures, such as vaccination.

Illness scripts in nursing: Directed content analysis

Abstract

Aims

To explore the possible extension of the illness script theory used in medicine to the nursing context.

Design

A qualitative interview study.

Methods

The study was conducted between September 2019 and March 2020. Expert nurses were asked to think aloud about 20 patient problems in nursing. A directed content analysis approach including quantitative data processing was used to analyse the transcribed data.

Results

Through the analysis of 3912 statements, scripts were identified and a nursing script model is proposed; the medical illness script, including enabling conditions, fault and consequences, is extended with management, boundary, impact, occurrence and explicative statements. Nurses often used explicative statements when pathophysiological causes are absent or unknown. To explore the applicability of Illness script theory we analysed scripts’ richness and maturity with descriptive statistics. Expert nurses, like medical experts, had rich knowledge of consequences, explicative statements and management of familiar patient problems.

Conclusion

The knowledge of expert nurses about patient problems can be described in scripts; the components of medical illness scripts are also relevant in nursing. We propose to extend the original illness script concept with management, explicative statements, boundary, impact and occurrence, to enlarge the applicability of illness scripts in the nursing domain.

Impact

Illness scripts guide clinical reasoning in patient care. Insights into illness scripts of nursing experts is a necessary first step to develop goals or guidelines for student nurses’ development of clinical reasoning. It might lay the groundwork for future educational strategies.

Combined association of obesity and other cardiometabolic diseases with severe COVID-19 outcomes: a nationwide cross-sectional study of 21 773 Brazilian adult and elderly inpatients

Por: Silva · N. d. J. · Ribeiro-Silva · R. d. C. · Ferreira · A. J. F. · Teixeira · C. S. S. · Rocha · A. S. · Alves · F. J. O. · Falcao · I. R. · Pinto · E. d. J. · Santos · C. A. d. S. T. · Fiaccone · R. L. · Ichihara · M. Y. T. · Paixao · E. S. · Barreto · M. L.
Objectives

To investigate the combined association of obesity, diabetes mellitus (DM) and cardiovascular disease (CVD) with severe COVID-19 outcomes in adult and elderly inpatients.

Design

Cross-sectional study based on registry data from Brazil’s influenza surveillance system.

Setting

Public and private hospitals across Brazil.

Participants

Eligible population included 21 942 inpatients aged ≥20 years with positive reverse transcription-PCR test for SARS-CoV-2 until 9 June 2020.

Main outcome measures

Severe COVID-19 outcomes were non-invasive and invasive mechanical ventilation use, intensive care unit (ICU) admission and death. Multivariate analyses were conducted separately for adults (20–59 years) and elders (≥60 years) to test the combined association of obesity (without and with DM and/or CVD) and degrees of obesity with each outcome.

Results

A sample of 8848 adults and 12 925 elders were included. Among adults, obesity with DM and/or CVD showed higher prevalence of invasive (prevalence ratio 3.76, 95% CI 2.82 to 5.01) and non-invasive mechanical ventilation use (2.06, 1.58 to 2.69), ICU admission (1.60, 1.40 to 1.83) and death (1.79, 1.45 to 2.21) compared with the group without obesity, DM and CVD. In elders, obesity alone (without DM and CVD) had the highest prevalence of ICU admission (1.40, 1.07 to 1.82) and death (1.67, 1.00 to 2.80). In both age groups, obesity alone and combined with DM and/or CVD showed higher prevalence in all outcomes than DM and/or CVD. A dose–response association was observed between obesity and death in adults: class I 1.32 (1.05 to 1.66), class II 1.41 (1.06 to 1.87) and class III 1.77 (1.35 to 2.33).

Conclusions

The combined association of obesity, diabetes and/or CVD with severe COVID-19 outcomes may be stronger in adults than in elders. Obesity alone and combined with DM and/or CVD had more impact on the risk of COVID-19 severity than DM and/or CVD in both age groups. The study also supports an independent relationship of obesity with severe outcomes, including a dose–response association between degrees of obesity and death in adults.

EndoVAscular treatment and ThRombolysis for Ischemic Stroke Patients (EVA-TRISP) registry: basis and methodology of a pan-European prospective ischaemic stroke revascularisation treatment registry

Por: Nordanstig · A. · Curtze · S. · Gensicke · H. · Zinkstok · S. M. · Erdur · H. · Karlsson · C. · Karlsson · J.-E. · Martinez-Majander · N. · Sibolt · G. · Lyrer · P. · Traenka · C. · Baharoglu · M. I. · Scheitz · J. F. · Bricout · N. · Henon · H. · Leys · D. · Eskandari · A. · Michel · P.
Purpose

The Thrombolysis in Ischemic Stroke Patients (TRISP) collaboration was a concerted effort initiated in 2010 with the purpose to address relevant research questions about the effectiveness and safety of intravenous thrombolysis (IVT). The collaboration also aims to prospectively collect data on patients undergoing endovascular treatment (EVT) and hence the name of the collaboration was changed from TRISP to EVA-TRISP. The methodology of the former TRISP registry for patients treated with IVT has already been published. This paper focuses on describing the EVT part of the registry.

Participants

All centres committed to collecting predefined variables on consecutive patients prospectively. We aim for accuracy and completeness of the data and to adapt local databases to investigate novel research questions. Herein, we introduce the methodology of a recently constructed academic investigator-initiated open collaboration EVT registry built as an extension of an existing IVT registry in patients with acute ischaemic stroke (AIS).

Findings to date

Currently, the EVA-TRISP network includes 20 stroke centres with considerable expertise in EVT and maintenance of high-quality hospital-based registries. Following several successful randomised controlled trials (RCTs), many important clinical questions remain unanswered in the (EVT) field and some of them will unlikely be investigated in future RCTs. Prospective registries with high-quality data on EVT-treated patients may help answering some of these unanswered issues, especially on safety and efficacy of EVT in specific patient subgroups.

Future plans

This collaborative effort aims at addressing clinically important questions on safety and efficacy of EVT in conditions not covered by RCTs. The TRISP registry generated substantial novel data supporting stroke physicians in their daily decision making considering IVT candidate patients. While providing observational data on EVT in daily clinical practice, our future findings may likewise be hypothesis generating for future research as well as for quality improvement (on EVT). The collaboration welcomes participation of further centres willing to fulfill the commitment and the outlined requirements.

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