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Hoy — Septiembre 18th 2021Tus fuentes RSS

Predicting pain and function outcomes in people consulting with shoulder pain: the PANDA-S clinical cohort and qualitative study protocol

Por: Wynne-Jones · G. · Myers · H. · Hall · A. · Littlewood · C. · Hennings · S. · Saunders · B. · Bucknall · M. · Jowett · S. · Riley · R. · Wathall · S. · Heneghan · C. · Cook · J. · Pincus · T. · Mallen · C. · Roddy · E. · Foster · N. · Beard · D. · Lewis · J. · Rees · J. L. · Higginbottom · A.
Introduction

People presenting with shoulder pain considered to be of musculoskeletal origin is common in primary care but diagnosing the cause of the pain is contentious, leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (1) to investigate the short-term and long-term outcomes (overall prognosis) of shoulder pain, (2) estimate costs of care, (3) develop a prognostic model for predicting individuals’ level and risk of pain and disability at 6 months and (4) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis and management of shoulder pain.

Methods and analysis

The Prognostic And Diagnostic Assessment of the Shoulder (PANDA-S) study is a longitudinal clinical cohort with linked qualitative study. At least 400 people presenting to general practice and physiotherapy services in the UK will be recruited. Participants will complete questionnaires at baseline, 3, 6, 12, 24 and 36 months. Short-term data will be collected weekly between baseline and 12 weeks via Short Message Serevice (SMS) text or software application. Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with 15 dyads of patients and their healthcare professional (general practitioner or physiotherapist).

Short-term and long-term trajectories of Shoulder Pain and Disability Index (using SPADI) will be described, using latent class growth analysis. Health economic analysis will estimate direct costs of care and indirect costs related to work absence and productivity losses. Multivariable regression analysis will be used to develop a prognostic model predicting future levels of pain and disability at 6 months using penalisation methods to adjust for overfitting. The added predictive value of prespecified physical examination tests and ultrasound findings will be examined. For the qualitative interviews an inductive, exploratory framework will be adopted using thematic analysis to investigate decision making, perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options.

Ethics and dissemination

The PANDA-S study has ethical approval from Yorkshire and The Humber-Sheffield Research Ethics Committee, UK (18/YH/0346, IRAS Number: 242750). Results will be disseminated through peer-reviewed publications, social and mainstream media, professional conferences, and the patient and public involvement and engagement group supporting this study, and through newsletters, leaflets and posters in participating sites.

Trial registration number

ISRCTN46948079.

The United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers (UK-REACH): protocol for a prospective longitudinal cohort study of healthcare and ancillary workers in UK healthcare settings

Por: Woolf · K. · Melbourne · C. · Bryant · L. · Guyatt · A. L. · McManus · I. C. · Gupta · A. · Free · R. C. · Nellums · L. · Carr · S. · John · C. · Martin · C. A. · Wain · L. V. · Gray · L. J. · Garwood · C. · Modhwadia · V. · Abrams · K. R. · Tobin · M. D. · Khunti · K. · Pareek · M. · on beh
Introduction

The COVID-19 pandemic has resulted in significant morbidity and mortality and devastated economies globally. Among groups at increased risk are healthcare workers (HCWs) and ethnic minority groups. Emerging evidence suggests that HCWs from ethnic minority groups are at increased risk of adverse COVID-19-related outcomes. To date, there has been no large-scale analysis of these risks in UK HCWs or ancillary workers in healthcare settings, stratified by ethnicity or occupation, and adjusted for confounders. This paper reports the protocol for a prospective longitudinal questionnaire study of UK HCWs, as part of the UK-REACH programme (The United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers).

Methods and analysis

A baseline questionnaire will be administered to a national cohort of UK HCWs and ancillary workers in healthcare settings, and those registered with UK healthcare regulators, with follow-up questionnaires administered at 4 and 8 months. With consent, questionnaire data will be linked to health records with 25-year follow-up. Univariate associations between ethnicity and clinical COVID-19 outcomes, physical and mental health, and key confounders/explanatory variables will be tested. Multivariable analyses will test for associations between ethnicity and key outcomes adjusted for the confounder/explanatory variables. We will model changes over time by ethnic group, facilitating understanding of absolute and relative risks in different ethnic groups, and generalisability of findings.

Ethics and dissemination

The study is approved by Health Research Authority (reference 20/HRA/4718), and carries minimal risk. We aim to manage the small risk of participant distress about questions on sensitive topics by clearly participant information that the questionnaire covers sensitive topics and there is no obligation to answer these or any other questions, and by providing support organisation links. Results will be disseminated with reports to Government and papers submitted to pre-print servers and peer reviewed journals.

Trial registration number

ISRCTN11811602; Pre-results.

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.

Moderate to severe OSA screening based on support vector machine of the Chinese population faciocervical measurements dataset: a cross-sectional study

Por: Zhang · L. · Yan · Y. R. · Li · S. Q. · Li · H. P. · Lin · Y. N. · Li · N. · Sun · X. W. · Ding · Y. J. · Li · C. X. · Li · Q. Y.
Objectives

Obstructive sleep apnoea (OSA) has received much attention as a risk factor for perioperative complications and 68.5% of OSA patients remain undiagnosed before surgery. Faciocervical characteristics may screen OSA for Asians due to smaller upper airways compared with Caucasians. Thus, our study aimed to explore a machine-learning model to screen moderate to severe OSA based on faciocervical and anthropometric measurements.

Design

A cross-sectional study.

Setting

Data were collected from the Shanghai Jiao Tong University School of Medicine affiliated Ruijin Hospital between February 2019 and August 2020.

Participants

A total of 481 Chinese participants were included in the study.

Primary and secondary outcome

(1) Identification of moderate to severe OSA with apnoea–hypopnoea index 15 events/hour and (2) Verification of the machine-learning model.

Results

Sex-Age-Body mass index (BMI)-maximum Interincisal distance-ratio of Height to thyrosternum distance-neck Circumference-waist Circumference (SABIHC2) model was set up. The SABIHC2 model could screen moderate to severe OSA with an area under the curve (AUC)=0.832, the sensitivity of 0.916 and specificity of 0.749, and performed better than the STOP-BANG (snoring, tiredness, observed apnea, high blood pressure, BMI, age, neck circumference, and male gender) questionnaire, which showed AUC=0.631, the sensitivity of 0.487 and specificity of 0.772. Especially for asymptomatic patients (Epworth Sleepiness Scale

Conclusion

The SABIHC2 machine-learning model provides a simple and accurate assessment of moderate to severe OSA in the Chinese population, especially for those without significant daytime sleepiness.

Effectiveness and safety of ivermectin in the treatment of COVID-19: protocol for a systematic review and meta-analysis

Introduction

Ivermectin is a drug with antiviral properties and has been proposed as an alternative treatment for patients with COVID-19, in some countries; however, there is limited evidence to support its clinical use. Accordingly, the aim of this review and meta-analysis is to obtain superior evidence on the effectiveness and safety of ivermectin in treatment of COVID-19.

Methods and analysis

We will search in the medical databases and International Clinical Trials Registry Platform databases for randomised clinical trials and quasi-randomised trials published from December 2019. The criteria for inclusion are that infection needs to be confirmed by a real-time PCR or serology test, and the effect of ivermectin has been compared with placebo, symptomatic treatment or no treatment. We will exclude observational studies and clinical trials that involved patients with symptoms suggestive of COVID-19, but without a laboratorial diagnosis. Outcomes of interest include mortality, time to symptom resolution, time of hospitalisation, frequency of invasive mechanical ventilation and extracorporeal membrane oxygenation, incidence of severe acute respiratory syndrome, admission to intensive care unit, viral load, PCR-negative status, percentage of infection after prophylactic use, and total incidence of adverse and side effects. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Two reviewers will independently select the studies and assess their eligibility. Two other reviewers will independently extract data from each study. Meta-analysis will then be carried out using fixed-effects or random-effects model, using the mean difference for continuous outcomes and the relative risk for dichotomous outcomes. Bias risk will be assessed using the Cochrane risk-of-bias tool. The quality of evidence for each outcome will be assessed using GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. Review Manager V.5.3.5 will be used for synthesis and subgroup analysis.

Ethics and dissemination

Owing to the nature of the review, ethical approval is not required. The results will be disseminated through peer-reviewed publications.

PROSPERO registration number

CRD42020197395.

Surveillance of indeterminate pulmonary nodules detected with CT in a Swedish population-based study (SCAPIS): psychosocial consequences and impact on health-related quality of life--a multicentre prospective cross-sectional study

Por: Andersson · E. · Dai Ydrefelt · Y. · Johannesson · M. · Lundbäck · M. · Mannila · M. · Persson · M. · Swahn · E. · Bolejko · A.
Objectives

To investigate whether surveillance of pulmonary nodules detected with low-dose CT (LDCT) impacted health-related quality of life and psychosocial consequences in the Swedish population-based study, Swedish CArdioPulmonary bioImage Study (SCAPIS).

Design

A prospective cross-sectional study.

Settings and participants

This multicentre (five sites) observational study, which included a cohort from SCAPIS, consisted of 632 participants with indeterminate pulmonary nodules detected with LDCT. These participants continued surveillance for up to 36 months, during which lung cancer was not detected (surveillance group). Additionally, 972 participants with a negative pulmonary LDCT scan were included as a control group. Matching criteria were LDCT date (±2 weeks), gender and site.

Outcome measures

All participants completed a health-related quality of life questionnaire (RAND-36) and the Consequences of Screening (COS) questionnaire, an average of 3 years after LDCT was conducted at entry into SCAPIS.

Results

Participants were 51–70 years old at study commencement. Overall, the two groups did not differ in demographic or psychosocial variables, smoking habits or pulmonary medical history. Individuals from countries other than Sweden and those with low socioeconomic status were less likely to participate (p

Conclusions

Lung surveillance with LDCT contributed to significant experiences of sense of dejection, anxiety about lung cancer and development of thoughts about existential values among participants in the surveillance group compared with the controls. The risk of side effects should be communicated for informed decision-making about (non-)attendance in lung cancer screening.

Identification and comparison of key criteria of feedback of funding decisions: mixed-methods analysis of funder and applicant perspectives

Por: Fackrell · K. · Meadmore · K. · Recio-Saucedo · A. · Bull · A. · Fraser · S. · Blatch-Jones · A.
Objective

This study investigated the content, quality and value of feedback given to applicants who applied to one of four research programmes in the UK funded (or jointly funded) by the National Institute for Health Research (NIHR).

Methods

A mixed-method phased approach was conducted using document analysis and an online survey. Phase 1 examined 114 NIHR applicant feedback documents comprised written feedback from funding committees and external peer-reviewers and a conceptual framework of the key components of feedback was developed using content analysis. Phase 2 was an online survey completed by 113 NIHR applicants. Frequencies of responses to closed questions were calculated. Perceptions of quality and value of feedback were identified using content analysis of open-text responses.

Results

In phase 1, a conceptual framework was developed with seven overarching categories: ‘Study structure and quality’; ‘Team and infrastructure’; ‘Acceptability to patients and professionals’; ‘Study justification and design’; ‘Risks and contingencies’; ‘Outputs’; ‘Value for money’. A higher frequency of feedback was provided at stage 2 and for successful applications across the majority of components. In phase 2, frequency data showed that opinion on feedback was dependent on funding outcome. Content analysis revealed four main themes: ‘Committee transparency’; ‘Content validity and reliability’; ‘Additional support’; Recognition of effort and constraints’.

Conclusions

This study provides key insights and understanding into the quality, content and value of feedback provided to NIHR applicants. The study identified key areas for improvement that can arise in NIHR funding applications, as well as in the feedback given to applicants that are applicable to other funding organisations. These findings could be used to inform funding application guidance documents to help researchers strengthen their applications and used more widely by other funders to inform their feedback processes.

Longitudinal prospective study examining the effects of the timing of prenatal stress on infant and child regulatory functioning: the Michigan Prenatal Stress Study protocol

Por: Levendosky · A. A. · Bogat · G. A. · Lonstein · J. · Muzik · M. · Nuttall · A. K.
Introduction

A considerable literature implicates prenatal stress as a critical determinant of poor psychological functioning in childhood and beyond. However, knowledge about whether the timing of prenatal stress differentially influences the development of child outcomes, including psychopathology, is virtually unknown. The primary aim of our study is to examine how the timing of prenatal stress differentially affects early childhood regulatory functioning as a marker of psychopathology. Our second aim is to examine the mediating effects of maternal physiological and psychological factors during pregnancy. Our third aim is to examine the moderating effects of postnatal factors on child regulatory functioning. Our project is the first longitudinal, prospective, multimethod study addressing these questions.

Methods and analysis

Our ongoing study recruits pregnant women, oversampled for intimate partner violence (a common event-based stressor allowing examination of timing effects), with data collection starting at pregnancy week 15 and concluding 4 years post partum. We aim to have n=335 mother–child dyads. We conduct a granular assessment of pregnancy stress (measured weekly by maternal report) in order to reveal sensitive periods during fetal life when stress particularly derails later functioning. Pattern-based statistical analyses will be used to identify subgroups of women who differ in the timing of their stress during pregnancy and then test whether these patterns of stress differentially predict early childhood self-regulatory outcomes.

Ethics and dissemination

Due to the high-risk nature of our sample, care is taken to ensure protection of their well-being, including a safety plan for suicidal ideation and a safety mechanism (exit button in the online weekly survey) to protect participant data privacy. This study was approved by Michigan State University Institutional Review Board. Dissemination will be handled by data sharing through National Institute of Child Health and Human Development Data and Specimen Hub (DASH), as well as through publishing the findings in journals spanning behavioural neuroendocrinology to clinical and developmental psychology.

Delirium and neuropsychological outcomes in critically Ill patients with COVID-19: a cohort study

Por: Ragheb · J. · McKinney · A. · Zierau · M. · Brooks · J. · Hill-Caruthers · M. · Iskander · M. · Ahmed · Y. · Lobo · R. · Mentz · G. · Vlisides · P. E.
Objective

To characterise the clinical course of delirium for patients with COVID-19 in the intensive care unit, including postdischarge neuropsychological outcomes.

Design

Retrospective chart review and prospective survey study.

Setting

Intensive care units, large academic tertiary-care centre (USA).

Participants

Patients (n=148) with COVID-19 admitted to an intensive care unit at Michigan Medicine between 1 March 2020 and 31 May 2020 were eligible for inclusion.

Primary and secondary outcome measures

Delirium was the primary outcome, assessed via validated chart review method. Secondary outcomes included measures related to delirium, such as delirium duration, antipsychotic use, length of hospital and intensive care unit stay, inflammatory markers and final disposition. Neuroimaging data were also collected. Finally, a telephone survey was conducted between 1 and 2 months after discharge to determine neuropsychological function via the following tests: Family Confusion Assessment Method, Short Blessed Test, Patient-Reported Outcomes Measurement Information System Cognitive Abilities 4a and Patient-Health Questionnaire-9.

Results

Delirium was identified in 108/148 (73%) patients, with median (IQR) duration lasting 10 (4–17) days. In the delirium cohort, 50% (54/108) of patients were African American and delirious patients were more likely to be female (76/108, 70%) (absolute standardised differences >0.30). Sedation regimens, inflammation, delirium prevention protocol deviations and hypoxic-ischaemic injury were likely contributing factors, and the most common disposition for delirious patients was a skilled care facility (41/108, 38%). Among patients who were delirious during hospitalisation, 4/17 (24%) later screened positive for delirium at home based on caretaker assessment, 5/22 (23%) demonstrated signs of questionable cognitive impairment or cognitive impairment consistent with dementia and 3/25 (12%) screened positive for depression within 2 months after discharge.

Conclusion

Patients with COVID-19 commonly experience a prolonged course of delirium in the intensive care unit, likely with multiple contributing factors. Furthermore, neuropsychological impairment may persist after discharge.

Changes in benzodiazepine use in the French general population after November 2015 terrorist attacks in Paris: an interrupted time series analysis of the national CONSTANCES cohort

Por: Gouraud · C. · Airagnes · G. · Kab · S. · Courtin · E. · Goldberg · M. · Limosin · F. · Lemogne · C. · Zins · M.
Objectives

To determine whether the terrorist attacks occurring in Paris on November 2015 have changed benzodiazepine use in the French population.

Design

Interrupted time series analysis.

Setting

National population-based cohort.

Participants

90 258 individuals included in the population-based CONSTANCES cohort from 2012 to 2017.

Outcome measures

Benzodiazepine use was evaluated according to two different indicators using objective data from administrative registries: weekly number of individuals with a benzodiazepine delivered prescriptions (BDP) and weekly number of defined daily dose (DDD). Two sets of analyses were performed according to sex and age (≤50 vs >50). Education, income and area of residence were additional stratification variables to search for at-risk subgroups.

Results

Among women, those with younger age (incidence rate ratios (IRR)=1.18; 95% CI=1.05 to 1.32 for BDP; IRR=1.14; 95% CI=1.03 to 1.27 for DDD), higher education (IRR=1.23; 95% CI=1.03 to 1.46 for BDP; IRR=1.23; 95% CI=1.01 to 1.51 for DDD) and living in Paris (IRR=1.27; 95% CI=1.05 to 1.54 for BDP) presented increased risks for benzodiazepine use. Among participants under 50, an overall increase in benzodiazepine use was identified (IRR=1.14; 95% CI=1.02 to 1.28 for BDP and IRR=1.12; 95% CI=1.01 to 1.25 for DDD) and in several strata. In addition to women, those with higher education (IRR=1.22; 95% CI=1.02 to 1.47 for BDP), lower income (IRR=1.17; 95% CI=1.02 to 1.35 for BDP) and not Paris residents (IRR=1.13; 95% CI=1.02 to 1.26 for BDP and IRR=1.13; 95% CI=1.03 to 1.26 for DDD) presented increased risks for benzodiazepine use.

Conclusion

Terrorist attacks might increase benzodiazepine use at a population level, with at-risk subgroups being particularly concerned. Information and prevention strategies are needed to provide appropriate care after such events.

Effect of ethnicity and other sociodemographic factors on attendance at diabetic eye screening: a 12-month retrospective cohort study

Por: Olvera-Barrios · A. · Seltene · M. · Heeren · T. F. C. · Chambers · R. · Bolter · L. · Tufail · A. · Owen · C. G. · Rudnicka · A. R. · Egan · C. · Anderson · J.
Objectives

To examine the association of sociodemographic characteristics with attendance at diabetic eye screening in a large ethnically diverse urban population.

Design

Retrospective cohort study.

Setting

Screening visits in the North East London Diabetic Eye Screening Programme (NELDESP).

Participants

84 449 people with diabetes aged 12 years or older registered in the NELDESP and scheduled for screening between 1 April 2017 and 31 March 2018.

Main outcome measure

Attendance at diabetic eye screening appointments.

Results

The mean age of people with diabetes was 60 years (SD 14.2 years), 53.4% were men, 41% South Asian, 29% White British and 17% Black; 83.4% attended screening. Black people with diabetes had similar levels of attendance compared with White British people. However, South Asian, Chinese and 'Any other Asian' background ethnicities showed greater odds of attendance compared with White British. When compared with their respective reference group, high levels of deprivation, younger age, longer duration of diabetes and worse visual acuity, were all associated with non-attendance. There was a higher likelihood of attendance per quintile improvement in deprivation (OR, 1.06; 95% CI, 1.03 to 1.08), with increasing age (OR per decade, 1.17; 95% CI, 1.15 to 1.19), with better visual acuity (OR per Bailey-Lovie chart line 1.12; 95% CI, 1.11 to 1.14) and with longer time of NELDESP registration (OR per year, 1.02; 95% CI, 1.01 to 1.03).

Conclusion

Ethnic differences in diabetic eye screening uptake, though small, are evident. Despite preconceptions, a higher likelihood of screening attendance was observed among Asian ethnic groups when compared with the White ethnic group. Poorer socioeconomic profile was associated with higher likelihood of non-attendance for screening. Further work is needed to understand how to target individuals at risk of non-attendance and reduce inequalities.

Characteristics of older adults with back pain associated with choice of first primary care provider: a cross-sectional analysis from the BACE-N cohort study

Por: Vigdal · O. N. · Storheim · K. · Munk Killingmo · R. · Smastuen · M. C. · Grotle · M.
Objectives

To describe characteristics of older adults with back pain in primary care, and to assess associations between patient characteristics and type of first primary care provider (general practitioner (GP), physiotherapist (PT) or chiropractor).

Design

Cross-sectional analysis from the Back Complaints in the Elders-Norway cohort study.

Setting

Norwegian GP, PT and chiropractic primary care centres.

Participants

Patients aged ≥55 years seeking Norwegian primary care with a new episode of back pain were invited to participate. Between April 2015 and February 2020, we included 452 patients: 127 first visited a GP, 130 first visited a PT and 195 first visited a chiropractor.

Primary and secondary outcome measures

For the first objective, the outcome measure was descriptive statistics of patient characteristics, covering the following domains: sociodemographic, general health, current and previous back pain, psychological and clinical factors. For the second objective, first primary care provider was the outcome measure. Associations between patient characteristics and visiting a GP or PT compared with a chiropractor were assessed with multiple multinomial regression analyses.

Results

Median (IQR) age was 66 (59–72) years. Levels of back-related disability was moderate to severe, with a median (IQR) Roland-Morris Disability Questionnaire (range 0–24) score of 9 (5–13). Recurring episodes were common, 301 (67%) patients had monthly or yearly recurrences. Patients with worse back-related disability, longer duration of symptoms, lower expectations for full recovery and worse physical performance measured with the Back Performance Scale had higher odds of visiting a GP or PT compared with a chiropractor (p

Conclusion

Older back pain patients in primary care had moderate to severe levels of back-related disability, and most had recurring episodes. Our results suggest that older adult’s choice of first primary care provider was associated with important patient characteristics, which highlights the need for caution with generalisations of study results across primary care populations.

Trial registration number

NCT04261309.

Impact of pulse oximetry on hospital referral acceptance in children under 5 with severe pneumonia in rural Pakistan (district Jamshoro): protocol for a cluster randomised trial

Por: Mir · F. · Ali Nathwani · A. · Chanar · S. · Hussain · A. · Rizvi · A. · Ahmed · I. · Memon · Z. A. · Habib · A. · Soofi · S. · Bhutta · Z. A.
Background

Pneumonia is a leading cause of death among children under 5 specifically in South Asia and sub-Saharan Africa. Hypoxaemia is a life-threatening complication among children under 5 with pneumonia. Hypoxaemia increases risk of mortality by 4.3 times in children with pneumonia than those without hypoxaemia. Prevalence of hypoxaemia varies with geography, altitude and severity (9%–39% Asia, 3%–10% African countries). In this protocol paper, we describe research methods for assessing impact of Lady Health Workers (LHWs) identifying hypoxaemia in children with signs of pneumonia during household visits on acceptance of hospital referral in district Jamshoro, Sindh.

Methods and analysis

A cluster randomised controlled trial using pulse oximetry as intervention for children with severe pneumonia will be conducted in community settings. Children aged 0–59 months with signs of severe pneumonia will be recruited by LHWs during routine visits in both intervention and control arms after consent. Severe pneumonia will be defined as fast breathing and/or chest in-drawing, and, one or more danger sign and/or hypoxaemia (Sa02

Ethics and dissemination

Ethical approval was granted by the Ethics Review Committee of the Aga Khan University (4722-Ped-ERC-17), Karachi. Study results will be shared with relevant government and non-governmental organisations, presented at national and international research conferences and published in international peer-reviewed scientific journals.

Trial registration number

NCT03588377.

Effectiveness of a customised mobile phone text messaging intervention supported by data from activity monitors for improving lifestyle factors related to the risk of type 2 diabetes among women after gestational diabetes: protocol for a multicentre rando

Por: Marschner · S. · Chow · C. · Thiagalingam · A. · Simmons · D. · McClean · M. · Pasupathy · D. · Smith · B. J. · Flood · V. · Padmanabhan · S. · Melov · S. · Ching · C. · Cheung · N. W.
Introduction

Gestational diabetes (GDM) contributes substantially to the population burden of type 2 diabetes (T2DM), with a high long-term risk of developing T2DM. This study will assess whether a structured lifestyle modification programme for women immediately after a GDM pregnancy, delivered via customised text messages and further individualised using data from activity monitors, improves T2DM risk factors, namely weight, physical activity (PA) and diet.

Methods and analysis

This multicentre randomised controlled trial will recruit 180 women with GDM attending Westmead, Campbelltown or Blacktown hospital services in Western Sydney. They will be randomised (1:1) on delivery to usual care with activity monitor (active control) or usual care plus activity monitor and customised education, motivation and support delivered via text messaging (intervention). The intervention will be customised based on breastfeeding status, and messages including their step count achievements to encourage PA. Messages on PA and healthy eating will encourage good lifestyle habits. The primary outcome of the study is healthy lifestyle composed of weight, dietary and PA outcomes, to be evaluated at 6 months. The secondary objectives include the primary objective components, body mass index, breastfeeding duration and frequency, postnatal depression, utilisation of the activity monitor, adherence to obtaining an oral glucose tolerance test post partum and the incidence of dysglycaemia at 12 months. Relative risks and their 95% CIs will be presented for the primary objective and the appropriate regression analysis, adjusting for the baseline outcome results, will be done for each outcome.

Ethics and dissemination

Ethics approval has been received from the Western Sydney Local Health District Human Research Ethics Committee (2019/ETH13240). All patients will provide written informed consent. Study results will be disseminated via the usual channels including peer-reviewed publications and presentations at national and international conferences.

Trial registration number

ACTRN12620000615987; Pre-results.

Facilitators and barriers to using telepresence robots in aged care settings: a scoping review protocol

Por: Smith · C. · Gregorio · M. · Hung · L.
Introduction

Social isolation is a significant issue in aged care settings (eg, long-term care (LTC) and hospital) and is associated with adverse outcomes such as reduced well-being and loneliness. Loneliness is linked with depression, anxiety, cognitive decline, weakened immune system, poor physical health, poor quality of life and mortality. The use of robotic assistance may help mitigate social isolation and loneliness. Although telepresence robots have been used in healthcare settings, a comprehensive review of studies focusing on their use in aged care for reducing social isolation requires further investigation. This scoping review will focus on the use of telepresence robots to support social connection of older people in care settings.

Methods and analysis

This scoping review will follow Joanna Briggs Institute scoping review methodology. The review team consists of patient partners and family partners, a nurse researcher and a group of students. In the scoping review, we will search the following databases: MEDLINE (Ovid), CINAHL, PsycINFO (EBSCO), Web of Science and ProQuest Dissertations & Theses Global. Google and Google Scholar will be used to search for additional literature. A handsearch will be conducted using the reference lists of included studies to identify additional relevant articles. The scoping review will consider studies of using a telepresence robotic technology with older adults in care settings (ie, LTC and hospital), published in English.

Ethics and dissemination

Since the methodology of the study consists of collecting data from publicly available articles, it does not require ethics approval. By examining the current state of using telepresence to support older people in care settings, this scoping review can offer useful insight into users’ needs (eg, patients’ and care providers’ needs) and inform future research and practice. We will share the scoping review results through conference presentations and an open access publication in a peer-reviewed journal.

Identifying persistent somatic symptoms in electronic health records: exploring multiple theory-driven methods of identification

Por: Kitselaar · W. M. · Numans · M. E. · Sutch · S. P. · Faiq · A. · Evers · A. W. · van der Vaart · R.
Objective

Persistent somatic symptoms (PSSs) are defined as symptoms not fully explained by well-established pathophysiological mechanisms and are prevalent in up to 10% of patients in primary care. The present study aimed to explore methods to identify patients with a recognisable risk of having PSS in routine primary care data.

Design

A cross-sectional study to explore four identification methods that each cover part of the broad spectrum of PSS was performed. Cases were selected based on (1) PSS-related syndrome codes, (2) PSS-related symptom codes, (3) PSS-related terminology and (4) Four-Dimensional Symptom Questionnaire scores and all methods combined.

Setting

Coded electronic health record data were extracted from 76 general practices in the Netherlands.

Participants

Patients who were registered for at least 1 year during 2014–2018, were included (n=169 138).

Outcome measures

Identification methods were explored based on (1) PSS sample sizes and demographics, (2) presence of chronic conditions and (3) healthcare utilisation (HCU) variables. Overlap between methods and practice specific differences were examined.

Results

The percentage of cases identified varied between 0.3% and 7.0% across the methods. Over 58.1% of cases had chronic physical condition(s) and over 33.8% had chronic mental condition(s). HCU was generally higher for cases selected by any method compared with the total cohort. HCU was higher for method B compared with the other methods. In 26.7% of cases, cases were selected by multiple methods. Overlap between methods was low.

Conclusions

Different methods yielded different patient samples which were general practice specific. Therefore, for the most comprehensive data-based selection of PSS cases, a combination of methods A, C and D would be recommended. Advanced (data-driven) methods are needed to create a more sensitive algorithm for identifying the full spectrum of PSS. For clinical purposes, method B could possibly support screening of patients who are currently missed in daily practice.

Safety and effectiveness of dose-sparing strategies for intramuscular seasonal influenza vaccine: a rapid scoping review

Por: Lunny · C. · Antony · J. · Rios · P. · Williams · C. · Ramkissoon · N. · Straus · S. E. · Tricco · A. C.
Background

The objective of this rapid scoping review was to identify studies of dose-sparing strategies for administration of intramuscular seasonal influenza vaccines in healthy individuals of all ages.

Methods

Comprehensive literature searches were executed in MEDLINE, Embase and the Cochrane library. The grey literature was searched via international clinical trial registries for relevant studies published in English in the last 20 years. We included studies in healthy humans of any age that used any dose-sparing strategy to administer intramuscular seasonal influenza vaccines. Title/abstract and full-text screening were carried out by pairs of reviewers independently. Data extraction was conducted by a single reviewer and verified by a second reviewer. Our outcomes were influenza infections, intensive care unit admission, pneumonia, hospitalisations, adverse events and mortality. Results were summarised descriptively.

Results

A total of 13 studies with 10 351 participants were included in the review and all studies were randomised controlled trials (RCTs) conducted between 2006 and 2019. The most common interventions were the trivalent influenza vaccine (n=10), followed by the quadrivalent influenza vaccine (n=4). Nine studies included infants/toddlers 6–36 months old and one of these studies also included children and adolescents. In these nine studies, no clinical effectiveness outcomes were reported. Of the four adult studies (≥18 years), two studies reported on effectiveness outcomes, however, only one RCT reported on laboratory-confirmed influenza.

Conclusions

Due to the low number of studies in healthy adults and the lack of studies assessing confirmed influenza and influenza-like illness, there remains a need for further evaluation.

Comparison of FORTA, PRISCUS and EU(7)-PIM lists on identifying potentially inappropriate medication and its impact on cognitive function in multimorbid elderly German people in primary care: a multicentre observational study

Por: Krüger · C. · Schäfer · I. · van den Bussche · H. · Bickel · H. · Dreischulte · T. · Fuchs · A. · König · H.-H. · Maier · W. · Mergenthal · K. · Riedel-Heller · S. G. · Schön · G. · Weyerer · S. · Wiese · B. · von Renteln-Kruse · W. · Langebrake · C. · Scherer · M.
Objectives

Our study aimed to assess the frequency of potentially inappropriate medication (PIM) use (according to three PIM lists) and to examine the association between PIM use and cognitive function among participants in the MultiCare cohort.

Design

MultiCare is conducted as a longitudinal, multicentre, observational cohort study.

Setting

The MultiCare study is located in eight different study centres in Germany.

Participants

3189 patients (59.3% female).

Primary and secondary outcome measures

The study had a cross-sectional design using baseline data from the German MultiCare study. Prescribed and over-the-counter drugs were classified using FORTA (Fit fOR The Aged), PRISCUS (Latin for ‘time-honoured’) and EU(7)-PIM lists. A mixed-effect multivariate linear regression was performed to calculate the association between PIM use patients’ cognitive function (measured with (LDST)).

Results

Patients (3189) used 2152 FORTA PIM (mean 0.9±1.03 per patient), 936 PRISCUS PIM (0.3±0.58) and 4311 EU(7)-PIM (1.4±1.29). The most common FORTA PIM was phenprocoumon (13.8%); the most prevalent PRISCUS PIM was amitriptyline (2.8%); the most common EU(7)-PIM was omeprazole (14.0%). The lists rate PIM differently, with an overall overlap of 6.6%. Increasing use of PIM is significantly associated with reduced cognitive function that was detected with a correlation coefficient of –0.60 for FORTA PIM (p=0.002), –0.72 for PRISCUS PIM (p=0.025) and –0.44 for EU(7)-PIM (p=0.005).

Conclusion

We identified PIM using FORTA, PRISCUS and EU(7)-PIM lists differently and found that PIM use is associated with cognitive impairment according to LDST, whereby the FORTA list best explained cognitive decline for the German population. These findings are consistent with a negative impact of PIM use on multimorbid elderly patient outcomes.

Trial registration number

ISRCTN89818205.

Association between tissue oxygenation and myocardial injury in patients undergoing major spine surgery: a prospective cohort study

Por: Bernholm · K. F. · Meyhoff · C. S. · Bickler · P.
Objective

To describe the association between intraoperative tissue oxygenation and postoperative troponin elevation in patients undergoing major spine surgery. We hypothesised that a decrease in intraoperative skeletal muscle tissue oxygenation (SmO2) was associated with the peak postoperative cardiac troponin value.

Design

This is a prospective cohort study.

Setting

Single-centre, University of California San Francisco Medical Center.

Participants

Seventy adult patients undergoing major elective spine surgery.

Primary and secondary outcome measures

High-sensitivity troponin T (hsTnT) was measured in plasma preoperatively and on the first and second day after surgery to assess the primary outcome of peak postoperative hsTnT. Secondary outcomes included MINS and intensive care unit (ICU) admission within 30 days. Skeletal cerebral tissue oxygenation and SmO2 was measured continuously with near-infrared spectroscopy during surgery. The primary exposure variable was time-weighted area under the curve (TW AUC) for SmO2.

Results

Mean age was 65 (33–85) years and 59% were female. No significant association was found between TW AUC for SmO2 and peak hsTnT (Spearman’s correlation, rs=0.17, p=0.16). A total of 28 (40%) patients had MINS. ICU admission occurred in 14 (40%) in lower vs 25 (71%) in upper half of patients based on TW AUC for SmO2, p=0.008.

Conclusions

Decrease in SmO2 was not a statistically significant predictor for peak troponin value following major spine surgery but is a potential predictor for other postoperative complications.

Trial registration number

NCT03518372.

Prevalence and related factors of hyperuricaemia in Shanghai adult women of different ages: a multicentre and cross-sectional study

Por: Tao · M. · Ma · X. · Pi · X. · Shi · Y. · Tang · L. · Hu · Y. · Chen · H. · Zhou · X. · Du · L. · Chi · Y. · Zhuang · S. · Liu · N.
Objective

Women in different age phases have different metabolism and hormone levels that influence the production and excretion of uric acid. We aimed to investigate the prevalence and related factors of hyperuricaemia among women in various age phases.

Study design

Observational, cross-sectional study.

Setting

Data were obtained from women at three health check-up centres in Shanghai.

Participants

Adult women from three health check-up centres were recruited. Exclusion criteria were individuals with pregnancy, cancer, incomplete information. Finally, 11 601 participants were enrolled.

Results

The prevalence rates of hyperuricaemia of total subjects were 11.15% (95% CIs 10.57% to 11.72%). The prevalence of hyperuricaemia in 18–29, 30–39, 40–49, 50–59, 60–69 and ≥70 years old was 6.41% (95% CI 4.97% to 7.86%), 5.63% (4.71% to 6.55%), 6.02% (5.01%% to 7.03%), 11.51% (10.19% to 12.82%), 16.49% (15.03% to 17.95%) and 23.98% (21.56% to 26.40%), respectively. Compared with 18–29 years old, the ORs for hyperuricaemia in other age phases were 0.870 (95% CI 0.647 to 1.170, p=0.357), 0.935 (0.693 to 1.261, p=0.659), 1.898 (1.444 to 2.493, p

Conclusion

After 50 years old, the prevalence of hyperuricaemia in Shanghai women has increased significantly and reaches the peak after 70. Obesity and dyslipidaemia are two main related factors for hyperuricaemia during all ages, while diabetes mellitus and nephrolithiasis have no relationship with hyperuricaemia throughout. CKD is an independent impact factor for hyperuricaemia after 30 years old.

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