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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.

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.

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.

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.

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.

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.

COVID outcome prediction in the emergency department (COPE): using retrospective Dutch hospital data to develop simple and valid models for predicting mortality and need for intensive care unit admission in patients who present at the emergency department

Por: van Klaveren · D. · Rekkas · A. · Alsma · J. · Verdonschot · R. J. C. G. · Koning · D. T. J. J. · Kamps · M. J. A. · Dormans · T. · Stassen · R. · Weijer · S. · Arnold · K.-S. · Tomlow · B. · de Geus · H. R. H. · van Bruchem-Visser · R. L. · Miedema · J. R. · Verbon · A. · van Nood
Objectives

Develop simple and valid models for predicting mortality and need for intensive care unit (ICU) admission in patients who present at the emergency department (ED) with suspected COVID-19.

Design

Retrospective.

Setting

Secondary care in four large Dutch hospitals.

Participants

Patients who presented at the ED and were admitted to hospital with suspected COVID-19. We used 5831 first-wave patients who presented between March and August 2020 for model development and 3252 second-wave patients who presented between September and December 2020 for model validation.

Outcome measures

We developed separate logistic regression models for in-hospital death and for need for ICU admission, both within 28 days after hospital admission. Based on prior literature, we considered quickly and objectively obtainable patient characteristics, vital parameters and blood test values as predictors. We assessed model performance by the area under the receiver operating characteristic curve (AUC) and by calibration plots.

Results

Of 5831 first-wave patients, 629 (10.8%) died within 28 days after admission. ICU admission was fully recorded for 2633 first-wave patients in 2 hospitals, with 214 (8.1%) ICU admissions within 28 days. A simple model—COVID outcome prediction in the emergency department (COPE)—with age, respiratory rate, C reactive protein, lactate dehydrogenase, albumin and urea captured most of the ability to predict death. COPE was well calibrated and showed good discrimination for mortality in second-wave patients (AUC in four hospitals: 0.82 (95% CI 0.78 to 0.86); 0.82 (95% CI 0.74 to 0.90); 0.79 (95% CI 0.70 to 0.88); 0.83 (95% CI 0.79 to 0.86)). COPE was also able to identify patients at high risk of needing ICU admission in second-wave patients (AUC in two hospitals: 0.84 (95% CI 0.78 to 0.90); 0.81 (95% CI 0.66 to 0.95)).

Conclusions

COPE is a simple tool that is well able to predict mortality and need for ICU admission in patients who present to the ED with suspected COVID-19 and may help patients and doctors in decision making.

Quick-Wee versus bladder stimulation to collect midstream urine from precontinent infants under 1 year of age: a study protocol for a randomised controlled trial (ES.Stimquick.U)

Por: Marchal · S. · Janicot · J. · Salicis · J. · Demonchy · D. · Herisse · A.-L. · Olla · M. · Rancurel · A. · Haas · H. · Berard · E. · Breaud · J. · Bernardor · J. · Ribet · C. · Freyssinet · E. · Donzeau · D. · Desmontils · J. · Schori-Fortier · C. · Fontas · E. · Tran · A.
Introduction

Urinary tract infections occur in around 1%–4% of boys and 3%–8% of girls under 2 years old. Diagnosis is difficult because of non-specific symptoms and the risk of urine analysis contamination depending on the sampling method used for precontinent infants. The American Academy of Pediatrics recommend transurethral catheterisation and suprapubic aspiration because of a low contamination rate but these techniques are invasive. On the other hand, while the National Institute for Health and Care Excellence advocate clean catch urine for its minimal invasiveness and acceptable contamination rate, it is difficult to accomplish in precontinent infants. Two recent methods have been described: the Quick-Wee method by Kaufman et al (suprapubic stimulation with cold saline-soaked gauze); and bladder stimulation by Herreros et al then by Tran et al (pubic tapping alternating with lumbar massage). This study aims to compare the effectiveness in collecting midstream urine by bladder stimulation vs the Quick-Wee method in infants under 1 year, before walking.

Methods and analysis

This study is a multicentre randomised controlled trial of 230 infants under 1 year and before walking who need urine analysis, conducted in four paediatric emergency departments in France. Patients will be randomised into two groups: bladder stimulation and Quick-Wee method.

The primary endpoint will be the success rate of voiding at least 2 mL of urine in less than 5 min.

Secondary outcomes are the time to collect at least 2 mL of urine, comfort, quality of urine and the risk factors associated with failure of the two techniques.

Ethics and dissemination

The study protocol was approved by the French national ethic committee (consultative committee of the protection of persons). The results of the study will be published in a peer-reviewed journal.

Trial registration number

Clinical Trials Registry - NCT04587999.

Date and protocol version identifier

October 2020, V.1.

Ross for Valve replacement In AduLts (REVIVAL) pilot trial: rationale and design of a randomised controlled trial

Por: Whitlock · R. · Belley-Cote · E. · Rega · F. · Chu · M. W. A. · McClure · G. R. · Hronyecz · H. · Verbrugghe · P. · Devereaux · P. · Bangdiwala · S. · Eikelboom · J. · Brady · K. · Sharifulin · R. · Bogachev-Prokophiev · A. · Stoica · S.
Introduction

In non-elderly adults, aortic valve replacement (AVR) with conventional prostheses yield poor long-term outcomes. Recent publications suggest a benefit of the Ross procedure over conventional AVR and highlight the need for high-quality randomised controlled trial (RCTs) on the optimal AVR. We have initiated a pilot trial assess two feasibility criteria and one assumption: (1) evaluate the capacity to enrol six patients per centre per year in at least five international centre, (2) validate greater than 90% compliance with allocation and (3) to validate the proportion of mechanical (≥65%) vs biological (≤35%) valves in the conventional arm.

Methods and analysis

Ross for Valve replacement In AduLts (REVIVAL) is a multinational, expertise-based RCT in adults aged 18–60 years undergoing AVR, comparing the Ross procedure versus one of the alternative approaches (mechanical vs stented or stentless bioprosthesis). The feasibility objectives will be assessed after randomising 60 patients; we will then make a decision regarding whether to expand the trial with the current protocol. We will ultimately examine the impact of the Ross procedure as compared with conventional AVR in non-elderly adults on survival free of valve-related life-threatening complications (major bleeding, systemic thromboembolism, valve thrombosis and valve reoperation) over the duration of follow-up. The objectives of the pilot trial will be analysed using descriptive statistics. In the full trial, the intention-to-treat principle will guide all primary analyses. A time-to-event analysis will be performed and Kaplan-Meier survival curves with comparison between groups using a log rank test will be presented.

Ethics and dissemination

REVIVAL will answer whether non-elderly adults benefit from the Ross procedure over conventional valve replacement. The final results at major meetings, journals, regional seminars, hospital rounds and via the Reducing Global Perioperative Risk Multimedia Resource Centre.

Trial registration number

ClinicalTrials.gov Identifier: NCT03798782

Protocol version

January 29, 2019 (Final Version 1.0)

Safety, feasibility and efficacy of metformin and sitagliptin in patients with a TIA or minor ischaemic stroke and impaired glucose tolerance

Por: Osei · E. · Zandbergen · A. · Brouwers · P. J. A. M. · Mulder · L. J. M. M. · Koudstaal · P. · Lingsma · H. · Dippel · D. W. J. · den Hertog · H.
Introduction

Impaired glucose tolerance (IGT) is highly prevalent after stroke and is associated with recurrent stroke and unfavourable outcome.

Objectives

We aimed to assess the feasibility, safety and effects on glucose metabolism of metformin or sitagliptin in patients with transient ischaemic attack (TIA) or minor ischaemic stroke and IGT.

Design

We performed a multicentre, randomised, controlled, open-label phase II trial with blinded outcome assessment.

Interventions

Patients were randomised in a 2:1:1 ratio to ‘no medication’, sitagliptin or metformin.

Primary and secondary outcome measures

Primary outcome measures were baseline adjusted differences of 2-hour postload glucose; secondary outcome measures fasting glucose, glycosylated haemoglobin 1c (HbA1c) levels, tolerability and safety of metformin and sitagliptin at 6 months. Patients on metformin or sitagliptin were contacted by telephone for recording of possible adverse events and to support continuation of treatment at 2 weeks, 6 weeks and 3 months after inclusion. These events were not analysed as outcome measures.

Results

Fifty-three patients were randomised to control group, 26 to metformin and 22 to sitagliptin. We found no significant differences in 2-hour postload glucose between patients on antidiabetic drugs and controls ((–0.04 mmol/L (95% CI –0.53 to 0.45)). Patients in the treatment arms had reduced fasting glucose: ((–0.21 mmol/L (95% CI –0.36 to –0.06)) and HbA1c levels ((–1.16 mmol/mol (95% CI –1.84 to –0.49)). Thirteen patients (50%) on metformin and 7 (32%) on sitagliptin experienced side effects. Sixteen patients (61%) in the metformin and 13 (59%) in the sitagliptin group were still on treatment after 6 months.

Conclusions

Metformin and sitagliptin were both effective in reducing fasting glucose and HbA1c levels in patients with recent TIA or minor ischaemic stroke and IGT. However, the reduction of glucose levels and sample size was relatively small. The clinical relevance, therefore, needs to be tempered. A phase III trial is needed to investigate whether medical treatment, compared with lifestyle intervention or a combination of both, not only improves glucose metabolism in IGT, but also leads to reduction of recurrent TIA or ischaemic stroke in these patients.

Trial registration number

NL3048.

Protocol for implementation of the 'AusPROM recommendations for elective surgery patients: a mixed-methods cohort study

Por: Morris · M. E. · Brusco · N. · Woods · J. · Myles · P. S. · Hodge · A. · Jones · C. · Lloyd · D. · Rovtar · V. · Clifford · A. · Atkinson · V.
Introduction

Incorporating patient-reported outcome measures (PROMs) into usual care in hospitals can improve safety and quality. Gaps exist in electronic PROM (ePROM) implementation recommendations, including for elective surgery. The aims are to: (1) understand barriers and enablers to ePROM implementation in hospitals and develop Australian ePROM implementation recommendations (AusPROM); (2) test the feasibility and acceptability of the Quality of Recovery 15 item short-form (QoR-15) PROM for elective surgery patients applying the AusPROM and (3) establish if the QoR-15 PROM has concurrent validity with the EQ-5D-5L.

Methods and analysis

Phase I will identify staff barriers and facilitators for the implementation of the AusPROM recommendations using a Delphi technique. Phase II will determine QoR-15 acceptability for elective surgery patients across four pilot hospitals, using the AusPROM recommendations. For phase II, in addition to a consumer focus group, patients will complete brief acceptability surveys, incorporating the QoR-15, in the week prior to surgery, in the week following surgery and 4 weeks postsurgery. The primary endpoint will be 4 weeks postsurgery. Phase III will be the national implementation of the AusPROM (29 hospitals) and the concurrent validity of the QoR-15 and generic EQ-5D-5L. This protocol adopts the Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trials Protocols guidelines.

Ethics and dissemination

The results will be disseminated via public forums, conferences and peer-reviewed journals. Ethics approval: La Trobe University (HEC20479).

Trial registration number

ACTRN12621000298819 (Phase I and II) and ACTRN12621000969864 (Phase III)

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