FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
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.

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.

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.

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)

'NOPAIN-ROP trial: Intravenous fentanyl and intravenous ketamine for pain relief during laser photocoagulation for retinopathy of prematurity (ROP) in preterm infants: A randomised trial

Por: Madathil · S. · Thomas · D. · Chandra · P. · Agarwal · R. · Sankar · M. J. · Thukral · A. · Deorari · A.
Objectives

To investigate if intravenous fentanyl or intravenous ketamine can provide adequate analgesia in preterm infants undergoing laser photocoagulation for retinopathy of prematurity (ROP).

Design

Open-label randomised trial.

Setting

Tertiary care institution.

Participants

Preterm infants who underwent laser photocoagulation for ROP.

Interventions

Infants were randomised to receive fentanyl as intravenous bolus dose of 2 µg/kg, followed by an intravenous infusion of 1 µg/kg/hour increased to a maximum of 3 µg/kg/hour or intravenous ketamine as bolus dose of 0.5 mg/kg, followed by further intermittent intravenous bolus doses of 0.5 mg/kg to a maximum of 2 mg/kg in the initial phase and intravenous fentanyl (bolus of 2 µg/kg followed by infusion of 2 µg/kg/hour to a maximum of 5 µg/kg/hour) or intravenous ketamine (bolus dose of 1 mg/kg followed by intermittent bolus doses of 0.5 mg/kg to a maximum of 4 mg/kg) in the revised regimen phase.

Main outcome measures

Proportion of infants with adequate analgesia defined as the presence of both: (1) all the Premature Infant Pain Profile-Revised scores measured every 15 min less than seven and (2) proportion of the procedure time the infant spent crying less than 5%.

Secondary outcomes included apnoea, cardiorespiratory or haemodynamic instability, feed intolerance and urinary retention requiring catheterisation during and within 24 hours following the procedure.

Results

A total of 97 infants were randomised (fentanyl=51, ketamine=46). The proportions of infants with adequate analgesia were 16.3% (95% CI 8.5% to 29%) with fentanyl and 4.5% (95% CI 1.3% to 15.1%) with ketamine. Ten infants (19.6%) in the fentanyl group and seven infants (15.2%) in the ketamine group had one or more side effects. In view of inadequate analgesia with both the regimens, the study steering committee recommended using a higher dose of intravenous fentanyl and intravenous ketamine. Consequently, we enrolled 27 infants (fentanyl=13, ketamine=14). With revised regimens, the proportions of infants with adequate analgesia were higher: 23.1% (95% CI 8.2% to 50.2%) with fentanyl and 7.1% (95% CI 1.3% to 31.5%) with ketamine. However, higher proportions of infants developed apnoea (n=4; 30.7%), need for supplemental oxygen (n=5, 38.4%) and change in cardiorespiratory scores (n=7; 53.8%) with fentanyl but none with ketamine.

Conclusions

Fentanyl-based and ketamine-based drug regimens provided adequate analgesia only in a minority of infants undergoing laser photocoagulation for ROP. More research is needed to find safe and effective regimens that can be employed in resource constrained settings.

Trial registration number

CTRI/2018/03/012878.

Experiences of trial participants and site staff of participating in and running a large randomised trial within fertility (the endometrial scratch trial): a qualitative interview study

Por: Chatters · R. · White · D. · Pye · C. · Petrovic · A. · Sizer · A. · Kumar · P. · Metwally · M.
Objectives

To explore the experiences of endometrial scratch (ES) trial participants and site staff of trial recruitment and participation, in order to improve the experience of participants in future trials.

Design

Qualitative study of a subset of participants in the ES randomised controlled trial and a subset of trial site staff.

Setting

A purposeful sample of 9 of the 16 UK Fertility Units that participated in the trial.

Participants

A purposeful sample of 27 trial participants and 7 site staff.

Results

Participants were largely happy with the recruitment practices, however, some were overwhelmed with the amount of information received. Interviewees had positive preconceptions regarding the possible effect of the ES on the outcome of their in vitro fertilisation (IVF) cycle, which often originated from their own internet research and seemed to be exacerbated by how site staff described the intervention. Some participants appeared to not understand that receiving the ES could potentially reduce their chances of a successful IVF outcome. Those randomised to the control arm discussed feeling discontent; site staff developed mechanisms of dealing with this.

Conclusions

A lack of equipoise in both study participants and the recruiting site staff led to trial participants having positive preconceptions of the potential impact of the ES on their upcoming IVF cycle. Trial participants may not have understood the potential harms of participating in a randomised trial. The trial information sheet did not clearly state this; further research should assess how such information should be presented to potential participants, to proportionately present the level of risk, but to not unduly discourage participation. The amount of information fertility patients require about a research study should also be investigated, in order to avoid participants feeling overwhelmed by the amount of information they receive prior to starting IVF.

Trial registration number

ISRCTN23800982.

Cancer symptom experience and help-seeking behaviour during the COVID-19 pandemic in the UK: a cross-sectional population survey

Por: Quinn-Scoggins · H. D. · Cannings-John · R. · Moriarty · Y. · Whitelock · V. · Whitaker · K. L. · Grozeva · D. · Hughes · J. · Townson · J. · Osborne · K. · Goddard · M. · McCutchan · G. M. · Waller · J. · Robling · M. · Hepburn · J. · Moore · G. · Gjini · A. · Brain · K.
Objectives

To understand self-reported potential cancer symptom help-seeking behaviours and attitudes during the first 6 months (March–August 2020) of the UK COVID-19 pandemic.

Design

UK population-based survey conducted during August and September 2020. Correlates of help-seeking behaviour were modelled using logistic regression in participants reporting potential cancer symptoms during the previous 6 months. Qualitative telephone interviews with a purposeful subsample of participants, analysed thematically.

Setting

Online UK wide survey.

Participants

7543 adults recruited via Cancer Research UK online panel provider (Dynata) and HealthWise Wales (a national register of ‘research ready’ participants) supplemented with social media (Facebook and Twitter) recruitment. 30 participants were also interviewed.

Main outcome measures

Survey measures included experiences of 15 potential cancer symptoms, help-seeking behaviour, barriers and prompts to help-seeking.

Results

Of 3025 (40.1%) participants who experienced a potential cancer symptom, 44.8% (1355/3025) had not contacted their general practitioner (GP). Odds of help-seeking were higher among participants with disability (adjusted OR (aOR)=1.38, 95% CI 1.11 to 1.71) and who experienced more symptoms (aOR=1.68, 95% CI 1.56 to 1.82), and lower among those who perceived COVID-19 as the cause of symptom(s) (aOR=0.36, 95% CI 0.25 to 0.52). Barriers included worries about wasting the doctor’s time (1158/7543, 15.4%), putting strain on healthcare services (945, 12.6%) and not wanting to make a fuss (907, 12.0%). Interviewees reported reluctance to contact the GP due to concerns about COVID-19 and fear of attending hospitals, and described putting their health concerns on hold.

Conclusions

Many people avoided healthcare services despite experiencing potential cancer symptoms during the COVID-19 pandemic. Alongside current help-seeking campaigns, well-timed and appropriate nationally coordinated campaigns should signal that services are open safely for those with unusual or persistent symptoms.

Trial registration number

ISRCTN17782018.

BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial

Por: Schop · S. S. J. · Hommes · J. E. · Krastev · T. K. · Derks · D. · Larsen · M. · Rakhorst · H. · Schmidbauer · U. · Smit · J. M. · Tan · T. · Wehrens · K. · de Wit · T. · van der Hulst · R. R. W. J. · Piatkowski de Grzymala · A. A.
Introduction

Pioneers have shown that it is possible to reconstruct a full breast using just autologous fat harvested by liposuction or autologous fat transfer (AFT). This study describes the first multicentre randomised study protocol to thoroughly investigate the effectiveness of AFT to reconstruct full breasts following mastectomy procedures (primarily and delayed).

Methods and analysis

This study is designed as a multicentre, randomised controlled clinical superiority trial with a 1:1 allocation ratio. A total of 196 patients (98 patients per treatment arm) are aimed to be included. Patients who wish to undergo breast reconstruction with either one of the two techniques are randomly allocated into the AFT group (intervention) or the tissue-expander/prosthesis group (control). The primary outcome measure for the quality of life is measured by the validated BREAST-Q questionnaire.

Ethics and dissemination

Approval for this study was obtained from the medical ethics committee of Maastricht University Medical Centre/Maastricht University; the trial has been registered at ClinicalTrials.gov. The results of this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peer-reviewed journals.

Trial status

Enrolment into the trial has started in October 2015. Data collection and data analysis are expected to be completed in December 2021.

Trial registration number

NCT02339779.

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.

Route of oxytocin administration for preventing blood loss at caesarean section: a systematic review with meta-analysis

Por: Torloni · M. R. · Siaulys · M. · Riera · R. · Martimbianco · A. L. C. · Pacheco · R. L. · Latorraca · C. d. O. C. · Widmer · M. · Betran · A. P.
Objectives

Assess the effects of different routes of prophylactic oxytocin administration for preventing blood loss at caesarean section (CS).

Design

Systematic review and meta-analysis.

Methods

Medline, EMBASE, CINAHL, Cochrane Library, BVS, SciELO and Global Index Medicus were searched through 24 May 2020 for randomised controlled trials (RCTs) comparing different routes of prophylactic oxytocin administration during CS. Study selection, data extraction and quality assessment were conducted by two investigators independently. We pooled results in fixed effects meta-analyses and calculated average risk ratio (RR), mean difference (MD) and 95% CI. We used GRADE to assess the overall quality of evidence for each outcome.

Results

Three trials (180 women) were included in the review. All studies compared intramyometrial (IMY) versus intravenous oxytocin in women having prelabour CS. IMY compared with intravenous oxytocin administration may result in little or no difference in the incidence of postpartum haemorrhage (RR 0.14, 95% CI 0.01 to 2.70; N=100 participants; 1 RCT), hypotension (RR 1.00, 95% CI 0.29 to 3.45; N=40; 1 RCT), headache (RR 3.00, 95% CI 0.13 to 69.52; N=40; 1 RCT) or facial flushing (RR 0.50, 95% CI 0.05 to 5.08; N=40; 1 RCT); IMY oxytocin may reduce nausea/vomiting (RR 0.13, 95% CI 0.02 to 0.69; N=140; 2 RCTs). We are very uncertain about the effect IMY versus intravenous oxytocin on the need for additional uterotonics (RR 0.82; 95% CI 0.25 to 2.69; N=140; 2 RCTs). IMY oxytocin may reduce blood loss slightly (MD –57.40 mL, 95% CI –101.71 to –13.09; N=40; 1 RCT).

Conclusions

There is limited, low to very low certainty evidence on the effects of IMY versus intravenous oxytocin at CS for preventing blood loss. The evidence is insufficient to support choosing one route over another. More trials, including studies that assess intramuscular oxytocin administration, are needed on this relevant question.

PROSPERO registration number

CRD42020186797.

Development and presentation of an objective risk stratification tool for healthcare workers when dealing with the COVID-19 pandemic in the UK: risk modelling based on hospitalisation and mortality statistics compared with epidemiological data

Por: Strain · W. D. · Jankowski · J. · Davies · A. P. · English · P. · Friedman · E. · McKeown · H. · Sethi · S. · Rao · M.
Objectives

Healthcare workers have greater exposure to SARS-CoV-2 and an estimated 2.5-fold increased risk of contracting COVID-19 than the general population. We wished to explore the predictive role of basic demographics to establish a simple tool that could help risk stratify healthcare workers.

Setting

We undertook a review of the published literature (including multiple search strategies in MEDLINE with PubMed interface) and critically assessed early reports on preprint servers. We explored the relative risk of mortality from readily available demographics to identify the population at the highest risk.

Results

The published studies specifically assessing the risk of healthcare workers had limited demographics available; therefore, we explored the general population in the literature. Clinician demographics: Mortality increased with increasing age from 50 years onwards. Male sex at birth, and people of black and minority ethnicity groups had higher susceptibility to both hospitalisation and mortality. Comorbid disease. Vascular disease, renal disease, diabetes and chronic pulmonary disease further increased risk. Risk stratification tool: A risk stratification tool was compiled using a white female aged

Conclusions

We generated a tool that provides a framework for objective risk stratification of doctors and healthcare professionals during the COVID-19 pandemic, without requiring disclosure of information that an individual may not wish to share with their direct line manager during the risk assessment process. This tool has been made freely available through the British Medical Association website and is widely used in the National Health Service and other external organisations.

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.

Assessing health-related quality of life and health utilities in patients with chronic hepatitis B-related diseases in China: a cross-sectional study

Por: Zhang · M. · Li · Y. · Fan · Z. · Shen · D. · Huang · X. · Yu · Q. · Liu · M. · Ren · F. · Wang · X. · Dai · L. · Wang · P. · Ye · H. · Shi · J. · Yang · X. · Zhang · S. · Zhang · J.
Objectives

The health-related quality of life (HRQoL) and utilities of patients with chronic hepatitis B (CHB) virus infection, including compensated cirrhosis (CC), decompensated cirrhosis (DC) and different stages of hepatocellular carcinoma (HCC), have not been well described in China. This study aimed to evaluate HRQoL and utilities and provide parameters for the economic evaluation of CHB-related diseases.

Methods

We conducted a multicentre cross-sectional and study to measure the HRQoL of patients with CHB, CC, DC and HCC using the Chinese short form (SF) 36 health survey V.2. The utilities were extracted based on the SF-six dimension scoring model. Multivariable regression analyses identified the effects on HRQoL.

Results

A total of 1071 patients (639 with CHB, 125 with CC, 85 with DC and 222 with HCC) were invited to complete the questionnaire. Physical HRQoL was not impaired in the CHB stage, while mental HRQoL was significantly impaired. Physical composite summary scores have a more significant decrease than mental composite summary scores at the advanced stages (CC, DC and HCC). The utility scores of CHB only, CC, DC and HCC were 0.773, 0.750, 0.683 and 0.640, respectively. The utility scores in the early, middle and terminal stages of HCC were 0.656, 0.635 and 0.615, respectively.

Conclusion

Slowing the progress of CHB-related diseases and providing psychological support early are the key points to improving the quality of life with the diseases. The utility values estimated in this study can provide a vital instrument for cost-effectiveness studies on CHB-related diseases.

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.

Economic burden of road traffic injuries in sub-Saharan Africa: a systematic review of existing literature

Por: Ryan-Coker · M. F. D. · Davies · J. · Rinaldi · G. · Hasselberg · M. · Marke · D. H. · Necchi · M. · Haghparast-Bidgoli · H.
Objective

This systematic review aims to explore and synthesise existing literature on the direct and indirect costs from road traffic injuries (RTIs) in sub-Saharan Africa (SSA), the quality of existing evidence, methods used to estimate and report these costs, and the factors that drive the costs.

Methodology

MEDLINE, SCOPUS, ProQuest Central, Web of Science, Global Index Medicus, Embase, World Bank Group e-Library, Econlit, Google Scholar and WHO webpages were searched for relevant literature. References of selected papers were also examined for related articles. Screening was done following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Articles were included in this review if they were published by March 2019, written in English, conducted in SSA and reported original findings on the cost of illness or economic burden of RTIs. The results were systematically examined, and the quality assessed by two reviewers using a modified Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist.

Results

Eleven studies met the inclusion criteria. RTIs can cost between INT$119 and 178 634 per injury and INT$486 and 12 845 per hospitalisation. Findings show variability in costing methods and inadequacies in the quality of existing evidence. Prolonged hospital stays, surgical sundries and severity of injury were the most common factors associated with cost.

Conclusion

While available data are limited, evidence shows that the economic burden of RTIs in SSA is high. Poor quality of existing evidence and heterogeneity in costing methods limit the generalisability of costs reported.

❌