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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.

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.

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.

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.

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.

Perceived barriers to care for migrant children and young people with mental health problems and/or neurodevelopmental differences in high-income countries: a meta-ethnography

Por: Place · V. · Nabb · B. · Gubi · E. · Assel · K. · Ahlen · J. · Hagström · A. · Bäärnhielm · S. · Dalman · C. · Hollander · A.-C.
Objectives

To develop conceptual understanding of perceived barriers to seeking care for migrant children and young people (aged 0–25 years) with mental health problems and/or neurodevelopmental differences in high-income countries.

Design

Qualitative evidence synthesis using meta-ethnography methodology. We searched four electronic databases (Medline, PsycINFO, Global Health and Web of Science) from inception to July 2019 for qualitative studies exploring barriers to care (as perceived by migrant communities and service providers) for migrant children and young people in high-income countries with neurodevelopmental differences and/or mental health problems. The quality of included studies was explored systematically using a quality assessment tool.

Results

We screened 753 unique citations and 101 full texts, and 30 studies met our inclusion criteria. We developed 16 themes representing perceived barriers to care on the supply and demand side of the care-seeking process. Barriers included: stigma; fear and mistrust of services; lack of information on mental health and service providers lacking cultural responsiveness. Themes were incorporated into Levesque et al’s conceptual framework of patient-centred access to healthcare, creating a version of the framework specific to migrant children and young people’s mental health and neurodevelopmental differences.

Conclusions

This is the first qualitative evidence synthesis on barriers to care for mental health problems and/or neurodevelopmental differences in migrant children and young people in high-income countries. We present an adapted conceptual framework that will help professionals and policy-makers to visualise the complex nature of barriers to care, and assist in improving practice and designing interventions to overcome them. Similar barriers were identified across study participants and migrant populations. While many barriers were also similar to those for children and young people in general populations, migrant families faced further, specific barriers to care. Interventions targeting multiple barriers may be required to ensure migrant families reach care.

Comparing lung ultrasound: extensive versus short in COVID-19 (CLUES): a multicentre, observational study at the emergency department

Por: Kok · B. · Schuit · F. · Lieveld · A. · Azijli · K. · Nanayakkara · P. W. · Bosch · F.
Background

Bedside lung ultrasound (LUS) is an affordable diagnostic tool that could contribute to identifying COVID-19 pneumonia. Different LUS protocols are currently used at the emergency department (ED) and there is a need to know their diagnostic accuracy.

Design

A multicentre, prospective, observational study, to compare the diagnostic accuracy of three commonly used LUS protocols in identifying COVID-19 pneumonia at the ED.

Setting/patients

Adult patients with suspected COVID-19 at the ED, in whom we prospectively performed 12-zone LUS and SARS-CoV-2 reverse transcription PCR.

Measurements

We assessed diagnostic accuracy for three different ultrasound protocols using both PCR and final diagnosis as a reference standard.

Results

Between 19 March 2020 and 4 May 2020, 202 patients were included. Sensitivity, specificity and negative predictive value compared with PCR for 12-zone LUS were 91.4% (95% CI 84.4 to 96.0), 83.5% (95% CI 74.6 to 90.3) and 90.0% (95% CI 82.7 to 94.4). For 8-zone and 6-zone protocols, these results were 79.7 (95% CI 69.9 to 87.6), 69.0% (95% CI 59.6 to 77.4) and 81.3% (95% CI 73.8 to 87.0) versus 89.9% (95% CI 81.7 to 95.3), 57.5% (95% CI 47.9 to 66.8) and 87.8% (95% CI 79.2 to 93.2). Negative likelihood ratios for 12, 8 and 6 zones were 0.1, 0.3 and 0.2, respectively. Compared with the final diagnosis specificity increased to 83.5% (95% CI 74.6 to 90.3), 78.4% (95% CI 68.8 to 86.1) and 65.0% (95% CI 54.6 to 74.4), respectively, while the negative likelihood ratios were 0.1, 0.2 and 0.16.

Conclusion

Identifying COVID-19 pneumonia at the ED can be aided by bedside LUS. The more efficient 6-zone protocol is an excellent screening tool, while the 12-zone protocol is more specific and gives a general impression on lung involvement.

Trial registration number

NL8497.

Health service utilisation among African migrants in China: a nationwide cross-sectional study

Por: Xiong · M. Z. · Zhao · P. · Zou · X. · Hall · B. · Cao · H. · Wang · C.
Objectives

To assess the health utilisation status and associated factors among African migrants in China.

Design

A national cross-sectional study was conducted among African migrants in China in 2019.

Setting

Participants were recruited online and offline to participate in a self-report survey. Online participants were recruited through WeChat across China, and offline participants were recruited in Guangzhou.

Participants

We recruited participants who were from an African country; had spent at least 1 month cumulatively in China; were at least 18 years old; were willing to provide informed consent. A total of 1025 participants were recruited online and offline, 19 of them were excluded due to invalid response and 1006 people were finally included in the analysis.

Outcome measures

The primary outcome was health service utilisation and associated factors among African migrants during their stay in China in the past 12 months. The potential factors include the predisposing factors (demographic characteristics and social structure variables), enabling factors (annual income, health insurance in China) and need factors (non-communicable chronic and infectious diseases, depression) which determined by Anderson framework were measured.

Results

Eight hundred and seven online and 218 offline participants completed the survey, including 624 males and 382 females, with an average age of 26.4±8.9 years. Around 28.5% reported health utilization in the past 12 months. Results showed that longer duration in China, migration to China for business (aOR=2.23, 95% CI:1.13-4.40) and study (aOR=5.00, 95% CI:2.74-9.11), living in apartment (aOR=2.59, 95% CI:1.62-4.14) or dormitory (aOR=3.22, 95% CI:2.17-4.80) in China, suffering from chronic diseases, communicable diseases, and greater depressive symptoms (aOR=1.91, 95% CI:1.42-2.56) facilitated health service utilization.

Conclusions

The healthcare service that African migrants received in China is low. The existing public health policies and intervention measures need to be improved to make health utilisation more accessible and feasible for African migrants.

Insights into the association of ACEIs/ARBs use and COVID-19 prognosis: a multistate modelling study of nationwide hospital surveillance data from Belgium

Por: Penalvo · J. L. · Genbrugge · E. · Mertens · E. · Sagastume · D. · van der Sande · M. A. B. · Widdowson · M.-A. · Van Beckhoven · D.
Objectives

The widespread use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) by patients with chronic conditions raised early concerns on the potential exacerbation of COVID-19 severity and fatality. Previous studies addressing this question have used standard methods that may lead to biased estimates when analysing hospital data because of the presence of competing events and event-related dependency. We investigated the association of ACEIs/ARBs’ use with COVID-19 disease outcomes using time-to-event data in a multistate setting to account for competing events and minimise bias.

Setting

Nationwide surveillance data from 119 Belgian hospitals.

Participants

Medical records of 10 866 patients hospitalised from 14 March 2020to 14 June 2020 with a confirmed SARS-CoV-19 infection and information about ACEIs/ARBs’ use.

Primary outcome measure

Multistate, multivariate Cox-Markov models were used to estimate the hazards of patients transitioning through health states from admission to discharge or death, along with transition probabilities calculated by combining the baseline cumulative hazard and regression coefficients.

Results

After accounting for potential confounders, there was no discernable association between ACEIs/ARBs’ use and transfer to intensive care unit (ICU). Contrastingly, for patients without ICU transfer, ACEIs/ARBs’ use was associated with a modest increase in recovery (HR 1.07, 95% CI 1.01 to 1.13, p=0.027) and reduction in fatality (HR 0.83, 95% CI 0.75 to 0.93, p=0.001) transitions. For patients transferred to ICU admission, no evidence of an association between ACEIs/ARBs’ use and recovery (HR 1.16, 95% CI 0.97 to 1.38, p=0.098) or in-hospital death (HR 0.91, 95% CI 0.73 to 1.12, p=0.381) was observed. Male gender and older age were significantly associated with higher risk of ICU admission or death. Chronic cardiometabolic comorbidities were also associated with less recovery.

Conclusions

For the first time, a multistate model was used to address magnitude and direction of the association of ACEIs/ARBs’ use on COVID-19 progression. By minimising bias, this study provided a robust indication of a protective, although modest, association with recovery and survival.

Impact of bed height on the biomechanics of healthcare professionals during chest compressions on the neonate: a descriptive pilot study

Por: Parent-Nichols · J. · Perez · J. · Witherell · B. · McWilliam · P. · Halamek · L. P. · Kent · N. · Varnum · W. · Yamada · N. K.
Objectives

The biomechanics of the healthcare professionals (HCPs) performing the life-saving intervention of chest compressions in the neonatal population is poorly understood. The aim of this pilot study was to describe the variations in body position at a self-selected and a predetermined bed height during neonatal chest compressions. Measures of joint angles, time to postural sway and number of postural adjustments were chosen as indices for the stability of the HCP’s position.

Setting

Data were collected at a simulation-based research centre in which the patient care environment was replicated.

Participants

HCPs with varying roles working in the neonatal intensive care unit and holding a current Neonatal Resuscitation Program Provider certification were recruited for this study.

Interventions

Fifteen HCPs performed two trials of chest compressions, each lasting 2 min, at a predetermined bed height and a self-selected bed height. Trials were video recorded, capturing upper and lower body movements. Videos were analysed for time to postural sway and number of postural adjustments. Joint angles were measured at the start and end of each trial.

Results

A statistically significant difference was found between the two bed height conditions for number of postural adjustments (p=0.02). While not statistically significant, time postural sway was increased in the choice bed height condition (85 s) compared with the predetermined bed height (45 s). After 30 s of chest compressions, mean shoulder and knee angles were smaller for choice bed height (p=0.03, 95% CI Lower=–12.14, Upper=–0.68 and p=0.05, 95% CI Lower=3.43, Upper=0.01, respectively). After 1 min and 45 s of chest compressions, mean wrist angles were smaller in the choice bed height condition (p=0.01, 95% CI Lower=–9.20, Upper=–1.22), stride length decreased between the 30 s and 1 min 45 s marks of the chest compressions in the predetermined height condition (p=0.02).

Cohort profile: a migratory cohort study of US Marines who train in Australia

Por: Chan-Cuzydlo · A. · Harrison · D. J. · Pike · B. L. · Currie · B. J. · Mayo · M. · Salvador · M. G. · Hulsey · W. R. · Azzarello · J. · Ellis · J. · Kim · D. · King-Lewis · W. · Smith · J. N. · Rodriguez · B. · Maves · R. C. · Lawler · J. V. · Schully · K. L.
Purpose

In 2012, US Marines and Sailors began annual deployments to Australia to participate in joint training exercises with the Australian Defence Force and other partners in the region. During their training, US service members are exposed to a variety of infectious disease threats not normally encountered by American citizens. This paper describes a cohort of US Marines and Sailors enrolled during five rotations to Australia between 2016 and 2020.

Participants

Study participation is strictly voluntary. Group informational sessions are held prior to deployment to describe the study structure and goals, as well as the infectious disease threats that participants may encounter while in Australia. All participants provided written informed consent. Consented participants complete a pre-deployment questionnaire to collect data including basic demographic information, military occupational specialty, travel history, family history, basic health status and personal habits such as alcohol consumption. Blood is collected for serum, plasma and peripheral blood mononuclear cells (PBMC) processing. Data and specimen collection is repeated up to three times: before, during and after deployment.

Findings to date

From the five rotations that comprised the 2016–2020 Marine Rotational Force-Darwin, we enrolled 1289 volunteers. Enrolments during this period were overwhelmingly white male under the age of 24 years. Most of the enrollees were junior enlisted and non-commissioned officers, with a smaller number of staff non-commissioned officers and commissioned officers, and minimal warrant officers. Over half of the enrollees had occupational specialty designations for infantry.

Future plans

In the future, we will screen samples for serological evidence of infection with Burkholderia pseudomallei, Coxiella burnetii, Ross River virus, SARS-CoV-2 and other operationally relevant pathogens endemic in Australia. Antigenic stimulation assays will be performed on PBMCs collected from seropositive individuals to characterise the immune response to these infections in this healthy American population.

Potential solutions for screening, triage, and severity scoring of suspected COVID-19 positive patients in low-resource settings: a scoping review

Por: Hirner · S. · Pigoga · J. L. · Naidoo · A. V. · Calvello Hynes · E. J. · Omer · Y. O. · Wallis · L. A. · Bills · C. B.
Objectives

Purposefully designed and validated screening, triage, and severity scoring tools are needed to reduce mortality of COVID-19 in low-resource settings (LRS). This review aimed to identify currently proposed and/or implemented methods of screening, triaging, and severity scoring of patients with suspected COVID-19 on initial presentation to the healthcare system and to evaluate the utility of these tools in LRS.

Design

A scoping review was conducted to identify studies describing acute screening, triage, and severity scoring of patients with suspected COVID-19 published between 12 December 2019 and 1 April 2021. Extracted information included clinical features, use of laboratory and imaging studies, and relevant tool validation data.

Participant

The initial search strategy yielded 15 232 articles; 124 met inclusion criteria.

Results

Most studies were from China (n=41, 33.1%) or the United States (n=23, 18.5%). In total, 57 screening, 23 triage, and 54 severity scoring tools were described. A total of 51 tools–31 screening, 5 triage, and 15 severity scoring—were identified as feasible for use in LRS. A total of 37 studies provided validation data: 4 prospective and 33 retrospective, with none from low-income and lower middle-income countries.

Conclusions

This study identified a number of screening, triage, and severity scoring tools implemented and proposed for patients with suspected COVID-19. No tools were specifically designed and validated in LRS. Tools specific to resource limited contexts is crucial to reducing mortality in the current pandemic.

Searching for a technology-driven acute rheumatic fever test: the START study protocol

Por: Ralph · A. P. · Webb · R. · Moreland · N. J. · McGregor · R. · Bosco · A. · Broadhurst · D. · Lassmann · T. · Barnett · T. C. · Benothman · R. · Yan · J. · Remenyi · B. · Bennett · J. · Wilson · N. · Mayo · M. · Pearson · G. · Kollmann · T. · Carapetis · J. R.
Introduction

The absence of a diagnostic test for acute rheumatic fever (ARF) is a major impediment in managing this serious childhood condition. ARF is an autoimmune condition triggered by infection with group A Streptococcus. It is the precursor to rheumatic heart disease (RHD), a leading cause of health inequity and premature mortality for Indigenous peoples of Australia, New Zealand and internationally.

Methods and analysis

‘Searching for a Technology-Driven Acute Rheumatic Fever Test’ (START) is a biomarker discovery study that aims to detect and test a biomarker signature that distinguishes ARF cases from non-ARF, and use systems biology and serology to better understand ARF pathogenesis. Eligible participants with ARF diagnosed by an expert clinical panel according to the 2015 Revised Jones Criteria, aged 5–30 years, will be recruited from three hospitals in Australia and New Zealand. Age, sex and ethnicity-matched individuals who are healthy or have non-ARF acute diagnoses or RHD, will be recruited as controls. In the discovery cohort, blood samples collected at baseline, and during convalescence in a subset, will be interrogated by comprehensive profiling to generate possible diagnostic biomarker signatures. A biomarker validation cohort will subsequently be used to test promising combinations of biomarkers. By defining the first biomarker signatures able to discriminate between ARF and other clinical conditions, the START study has the potential to transform the approach to ARF diagnosis and RHD prevention.

Ethics and dissemination

The study has approval from the Northern Territory Department of Health and Menzies School of Health Research ethics committee and the New Zealand Health and Disability Ethics Committee. It will be conducted according to ethical standards for research involving Indigenous Australians and New Zealand Māori and Pacific Peoples. Indigenous investigators and governance groups will provide oversight of study processes and advise on cultural matters.

Clinical evaluation of enhanced recovery after surgery protocol for anterior cervical decompression and fusion (ACDF): study protocol for a multicentre randomised controlled trial

Por: Zhong · G. Q. · Lin · B. H. · Lin · R. Q. · Liang · Z. Y. · Lin · Y. J. · Chen · C. M.
Introduction

To improve the efficacy of anterior cervical decompression and fusion (ACDF) and reduce postoperative complications in degenerative cervical myelopathy, our team established a set of perioperative care of enhanced recovery guidelines of ACDF based on the concept of enhanced recovery after surgery. In addition, a prospective, multicentre, randomised clinical trial was designed.

Methods and analysis

A total of 260 patients aged 18–65 years will be included. Preoperative MRI and CT will be used to confirm the typical manifestations of cervical spondylosis, such as cervical disc herniation and spinal cord compression. The patient presents with neck and shoulder pain, numbness of upper limbs, weakened grip strength and cotton sense of foot tread. Patients received normal conservative treatment for 3 months with no obvious relief or even aggravation of symptoms. Patients will be assigned to the group in strict accordance with the random allocation table. Patients in groups A and B will receive conventional perioperative care and perioperative care for enhanced recovery, respectively. The main outcome indicators are the Karnofsky Performance Scale score and the Japanese Orthopaedic Association scale. Secondary outcome indicators are pain assessment by Numeric Rating Scale, Neck Disability Index, quality of life index (QL-Index) and postoperative complications. Follow-up will be conducted at 3, 6 and 12 months postoperatively.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Fujian Medical University Union Hospital, Fuzhou, China (2020YF034-01). Results of the research will be published in an international peer-reviewed scientific journal and disseminated through presentation at scientific conferences.

Trial registration number

ChiCTR2000040508.

Responses of physicians to an objective safety and quality knowledge test: a cross-sectional study

Por: Burke · H. B. · King · H. B.
Objective

For physicians to practice safe high quality medicine they must have sufficient safety and quality knowledge. Although a great deal is known about the safety and quality perceptions, attitudes and beliefs of physicians, little is known about their safety and quality knowledge. This study tested the objective safety and quality knowledge of practicing US primary care physicians.

Design

Cross-sectional objective test of safety and quality knowledge.

Setting

Primary care physicians practicing in the USA.

Participants

Study consisted of 518 US practicing primary care physicians who answered an email invitation. Fifty-four percent were family medicine and 46% were internal medicine physicians.The response rate was 66%.

Intervention

The physicians took a 24-question multiple-choice test over the internet.

Outcome

The outcome was the percent correct.

Results

The average number of correct answers was 11.4 (SD, 2.69), 48% correct. Three common clinical vignettes questions were answered correctly by 45% of the physicians. Five common radiation exposures questions were answered correctly by 40% of the physicians. Seven common healthcare quality and safety questions were answered correctly by 43% of the physicians. Seven Donabedian’s model of structure, process and outcome measure questions were answered correctly by 67% of the physicians. Two Institute of Medicine’s definitions of quality and safety questions were answered correctly by 19.5% of the physicians.

Conclusion

Forty-eight per cent of the physicians’ answers to the objective safety and quality questions were correct. To our knowledge, this is the first assessment of the objective safety and quality knowledge of practicing US primary care physicians.

Falls: a marker of preclinical Alzheimer disease: a cohort study protocol

Por: Bollinger · R. M. · Keleman · A. · Thompson · R. · Westerhaus · E. · Fagan · A. M. · Benzinger · T. L. · Schindler · S. E. · Xiong · C. · Balota · D. · Morris · J. C. · Ances · B. M. · Stark · S. L.
Introduction

Progression to symptomatic Alzheimer disease (AD) occurs slowly over a series of preclinical stages. Declining functional mobility may be an early indicator of loss of brain network integration and may lead to an increased risk of experiencing falls. It is unknown whether measures of functional mobility and falls are preclinical markers of AD. The purpose of this study is to examine (1) the relationship between falls and functional mobility with AD biomarkers to determine when falls occur within the temporal progression to symptomatic Alzheimer disease, and (2) the attentional compared with perceptual/motor systems that underlie falls and functional mobility changes seen with AD.

Methods and analysis

This longitudinal cohort study will be conducted at the Knight Alzheimer Disease Research Center. Approximately 350 cognitively normal participants (with and without preclinical AD) will complete an in-home visit every year for 4 years. During each yearly assessment, functional mobility will be assessed using the Performance Oriented Mobility Assessment, Timed Up and Go, and Timed Up and Go dual task. Data regarding falls (including number and severity) will be collected monthly by self-report and confirmed through interviews. This study will leverage ongoing neuropsychological assessments and neuroimaging (including molecular imaging using positron emission tomography and MRI) performed by the Knight Alzheimer Disease Research Center. Relationships between falls and biomarkers of amyloid, tau and neurodegeneration will be evaluated.

Ethics and dissemination

This study was approved by the Washington University in St. Louis Institutional Review Board (reference number 201807135). Written informed consent will be obtained in the home prior to the collection of any study data. Results will be published in peer-reviewed publications and presented at national and international conferences.

Trial registration number

NCT04949529; Pre-results.

Prognostic significance of dipstick proteinuria in heart failure with preserved ejection fraction: insight from the PURSUIT-HFpEF registry

Por: Oeun · B. · Hikoso · S. · Nakatani · D. · Mizuno · H. · Suna · S. · Kitamura · T. · Okada · K. · Dohi · T. · Sotomi · Y. · Kida · H. · Sunaga · A. · Sato · T. · Nakagawa · A. · Nakagawa · Y. · Hayashi · T. · Yano · M. · Tamaki · S. · Yasumura · Y. · Yamada · T. · Sakata · Y. · The OCVC-Heart F
Objective

The semiquantitative urine dipstick test is a simple and convenient method that is available in the smallest community-based healthcare clinics. We sought to clarify the prognostic significance of dipstick proteinuria in patients with heart failure (HF) with preserved ejection fraction (HFpEF).

Design

A Prospective mUlticenteR obServational stUdy of patIenTs with Heart Failure with preserved Ejection Fraction (PURSUIT-HFpEF) registry.

Participants and setting

We assessed 851 discharged-alive patients in the PURSUIT-HFpEF registry who were initially hospitalised due to an acute decompensated HFpEF (EF≥50%) and elevated N-terminal-pro-brain natriuretic peptide (≥400 ng/L) at Osaka University Hospital and other 30 affiliated hospitals in the Kansai region of Japan. Patients received a urine dipstick test, and were divided into two groups according to the absence or presence of proteinuria. A trace or more of dipstick proteinuria was defined as the presence of proteinuria.

Main outcome measures

A composite of cardiac death or HF rehospitalisation.

Results

Median age was 83 years and 473 patients (55.6%) were female. Five hundred and two patients (59%) were proteinuria (–) and 349 patients (41%) were proteinuria (+). The composite endpoint and HF rehospitalisation occurred more often in proteinuria (+) individuals than proteinuria (–) individuals (log-rank p=0.006 and p=0.007, respectively); but cardiac death did not (log-rank p=0.139). Multivariable Cox regression analysis showed that the presence of proteinuria was associated with the composite endpoint (HR: 1.47, 95% CI 1.07 to 2.01, p=0.016), and HF rehospitalisation (HR: 1.48, 95% CI 1.07 to 2.05, p=0.020), but not with cardiac death (HR: 1.52, 95% CI 0.83 to 2.76, p=0.172).

Conclusions

Dipstick proteinuria may be a prognostic marker in patients with HFpEF. Evaluation of proteinuria by a urine dipstick test may be a simple but useful method for risk stratification in HFpEF.

UMIN-CTR ID

UMIN000021831.

Protocol for the economic evaluation of COVID-19 pandemic response policies

Por: Chua · B. W. B. · Huynh · V. A. · Lou · J. · Goh · F. T. · Clapham · H. · Teerawattananon · Y. · Wee · H. L.
Introduction

Several treatment options are available for COVID-19 to date. However, the use of a combination of non-pharmaceutical interventions (NPIs) is necessary for jurisdictions to contain its spread. Although the implementation cost of NPIs may be low from the healthcare system perspective, it can be costly when considering the indirect costs from the societal perspective. COVID-19 vaccination campaigns have begun in several countries worldwide. Nonetheless, the quantity of vaccines available remain limited over the next 1 to 2 years. A tool for informing vaccine prioritisation that considers both cost and effectiveness will be highly useful. This study aims to identify the most cost-effective combination of COVID-19 response policies, using Singapore as an example.

Methods and analysis

An age-stratified Susceptible-Exposed-Infectious-Recovered model will be used to generate the number of infections stratified by disease severity under different intervention scenarios. Polices of interest include test-trace-isolate, travel restriction, compulsory face mask and hygiene practices, social distancing, dexamethasone/remdesivir therapy and vaccination. The latest phase 3 trial results and the WHO Target Product Profiles for COVID-19 vaccines will be used to model vaccine characteristics. A cost (expected resource utilisation and productivity losses) and quality-adjusted life years (QALYs) will be attached to these outputs for a cost-utility analysis. The primary outcome measure will be the incremental cost-effectiveness ratio generated from the incremental cost of policy alternatives expressed as a ratio of the incremental benefits (QALYs gained). Efficacy of policy options will be gathered from literature review and from its observed impacts in Singapore. Cost data will be gathered from healthcare institutions, Ministry of Health and published data. Sensitivity analysis such as threshold analysis and scenario analysis will be conducted.

Ethics and dissemination

Ethics approval was not required for this study. The study findings will be disseminated through peer-reviewed journals.

Barriers to follow-up after an abnormal cervical cancer screening result and the role of male partners: a qualitative study

Por: Chapola · J. · Lee · F. · Bula · A. · Mapanje · C. · Phiri · B. R. · Kamtuwange · N. · Tsidya · M. · Tang · J. H. · Chinula · L.
Introduction

Cervical cancer is the leading cause of cancer deaths among women in Malawi, but preventable through screening. Malawi primarily uses visual inspection with acetic acid (VIA) for screening, however, a follow-up for positive screening results remains a major barrier, in rural areas. We interviewed women who underwent a community-based screen-and-treat campaign that offered same-day treatment with thermocoagulation, a heat-based ablative procedure for VIA-positive lesions, to understand the barriers in accessing post-treatment follow-up and the role of male partners in contributing to, or overcoming these barriers.

Methods

We conducted in-depths interviews with 17 women recruited in a pilot study that evaluated the safety and acceptability of community-based screen-and-treat programme using VIA and thermocoagulation for cervical cancer prevention in rural Lilongwe, Malawi. Ten of the women interviewed presented for post-treatment follow-up at the healthcare facility and seven did not. The interviews were analysed for thematic content surrounding barriers for attending for follow-up and role of male partners in screening.

Results

Transportation was identified as a major barrier to post-thermocoagulation follow-up appointment, given long distances to the healthcare facility. Male partners were perceived as both a barrier for some, that is, not supportive of 6-week post-thermocoagulation abstinence recommendation, and as an important source of support for others, that is, encouraging follow-up attendance, providing emotional support to maintaining post-treatment abstinence and as a resource in overcoming transportation barriers. Regardless, the majority of women desired more male partner involvement in cervical cancer screening.

Conclusion

Despite access to same-day treatment, long travel distances to health facilities for post-treatment follow-up visits remained a major barrier for women in rural Lilongwe. Male partners were identified both as a barrier to, and an important source of support for accessing and completing the screen-and-treat programme. To successfully eliminate cervical cancer in Malawi, it is imperative to understand the day-to-day barriers women face in accessing preventative care.

European knowledge alliance for innovative measures in prevention of work-related musculoskeletal pain disorders (Prevent4Work Project): protocol for an international mixed-methods longitudinal study

Por: Bellosta-Lopez · P. · Domenech-Garcia · V. · Palsson · T. S. · Christensen · S. W. · Silva · P. d. B. · Langella · F. · Berjano · P. · Jensen · P. S. · Riis · A. · Baroncini · A. · Blasco-Abadia · J. · Jimenez-Sanchez · C. · Calvo · S. · Jaen-Carrillo · D. · Herrero · P. · Hoegh · M.
Introduction

Work-related musculoskeletal (MSK) pain is a highly prevalent condition and one of the main contributors to disability and loss of work capacity. Current approaches to the management and prevention of work-related MSK pain do not consistently integrate current evidence-based knowledge and seem to be outdated. The Prevent4Work (P4W) Project aims to collect and spread evidence-based information to improve the management and prevention of work-related MSK pain. P4W will longitudinally investigate (1) risk factors associated with the prevalence of work-related MSK pain, (2) predictive factors for new events of work-related MSK pain in the short term and (3) the modification of pain beliefs after participating in evidence-based e-learning courses.

Methods and analysis

This project employs a mixed-methods design with international cohorts of workers from Spain, Italy and Denmark. All participants will be assessed using self-reported variables at baseline (ie, cross-sectional design) with follow-up after 3 and 6 months (ie, prospective–predictive design). Throughout the first phase (0–3 months), all participants will be offered to self-enrol in e-learning courses on work-related MSK pain. Changes in pain beliefs (if any) will be assessed. The dataset will include sociodemographic characteristics, physical and psychological job demands, lifestyle-related factors, MSK pain history and pain beliefs. At baseline, all participants will additionally complete the P4W questionnaire developed to detect populations at high risk of suffering work-related MSK pain.

Descriptive statistics, binary logistic regression, and analysis of variance will be used to identify the significant factors that influence the history of work-related MSK pain, evaluate the short-term prediction capacity of the P4W questionnaire, and investigate whether workers’ participation in e-learning courses will modify their pain beliefs.

Ethics and dissemination

The study received ethical approval from the Ethical Committee of San Jorge University (USJ011-19/20). The results will be made available via peer-reviewed publications, international conferences and P4W official channels.

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