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Does skin preparation alter suture strength characteristics? Assessing the effect of chlorhexidine and isopropyl alcohol on common skin closure suture material

Abstract

Sutures are essential to approximate tissues and enable healing by first intention until a wound regains its original tensile strength. The mechanical properties of sutures are well documented, but the effects of exposing sutures to skin preparation solutions used in surgery are not. This study was performed to investigate whether 2% chlorhexidine and 70% isopropyl alcohol skin preparation, commonly used prior to incision and prior to closure, has any effect on the mechanical properties of several commonly used surgical suture types. Four suture types were soaked in either 2% chlorhexidine and 70% isopropyl alcohol or Hartmann's solution for 5 minutes. All sutures were left to dry for 11 days before being tested to failure using an Instron 3367 tensile testing machine. Testing revealed significant differences in failure load, ultimate tensile stress, and Young's modulus between suture types (P < .05). No significant differences in failure load (P = .98), ultimate tensile stress (P = .21), or Young's modulus (P = .22) were observed between the test group and the control group when comparing sutures of the same type. This study demonstrates that chlorhexidine/isopropyl skin preparation solutions do not significantly change the mechanical properties of suture materials exposed to them.

Incubation period of COVID-19: a rapid systematic review and meta-analysis of observational research

Por: McAloon · C. · Collins · A. · Hunt · K. · Barber · A. · Byrne · A. W. · Butler · F. · Casey · M. · Griffin · J. · Lane · E. · McEvoy · D. · Wall · P. · Green · M. · O'Grady · L. · More · S. J.
Objectives

The aim of this study was to conduct a rapid systematic review and meta-analysis of estimates of the incubation period of COVID-19.

Design

Rapid systematic review and meta-analysis of observational research.

Setting

International studies on incubation period of COVID-19.

Participants

Searches were carried out in PubMed, Google Scholar, Embase, Cochrane Library as well as the preprint servers MedRxiv and BioRxiv. Studies were selected for meta-analysis if they reported either the parameters and CIs of the distributions fit to the data, or sufficient information to facilitate calculation of those values. After initial eligibility screening, 24 studies were selected for initial review, nine of these were shortlisted for meta-analysis. Final estimates are from meta-analysis of eight studies.

Primary outcome measures

Parameters of a lognormal distribution of incubation periods.

Results

The incubation period distribution may be modelled with a lognormal distribution with pooled mu and sigma parameters (95% CIs) of 1.63 (95% CI 1.51 to 1.75) and 0.50 (95% CI 0.46 to 0.55), respectively. The corresponding mean (95% CIs) was 5.8 (95% CI 5.0 to 6.7) days. It should be noted that uncertainty increases towards the tail of the distribution: the pooled parameter estimates (95% CIs) resulted in a median incubation period of 5.1 (95% CI 4.5 to 5.8) days, whereas the 95th percentile was 11.7 (95% CI 9.7 to 14.2) days.

Conclusions

The choice of which parameter values are adopted will depend on how the information is used, the associated risks and the perceived consequences of decisions to be taken. These recommendations will need to be revisited once further relevant information becomes available. Accordingly, we present an R Shiny app that facilitates updating these estimates as new data become available.

Impact of COVID-19 pandemic on surgical neuro-oncology multi-disciplinary team decision making: a national survey (COVID-CNSMDT Study)

Por: Price · S. J. · Joannides · A. · Plaha · P. · Afshari · F. T. · Albanese · E. · Barua · N. U. · Chan · H. W. · Critchley · G. · Flannery · T. · Fountain · D. M. · Mathew · R. K. · Piper · R. J. · Poon · M. T. · Rajaraman · C. · Rominiyi · O. · Smith · S. · Solomou · G. · Solth · A. · Suras
Objectives

Pressures on healthcare systems due to COVID-19 has impacted patients without COVID-19 with surgery disproportionally affected. This study aims to understand the impact on the initial management of patients with brain tumours by measuring changes to normal multidisciplinary team (MDT) decision making.

Design

A prospective survey performed in UK neurosurgical units performed from 23 March 2020 until 24 April 2020.

Setting

Regional neurosurgical units outside London (as the pandemic was more advanced at time of study).

Participants

Representatives from all units were invited to collect data on new patients discussed at their MDT meetings during the study period. Each unit decided if management decision for each patient had changed due to COVID-19.

Primary and secondary outcome measures

Primary outcome measures included number of patients where the decision to undergo surgery changed compared with standard management usually offered by that MDT. Secondary outcome measures included changes in surgical extent, numbers referred to MDT, number of patients denied surgery not receiving any treatment and reasons for any variation across the UK.

Results

18 units (75%) provided information from 80 MDT meetings that discussed 1221 patients. 10.7% of patients had their management changed—the majority (68%) did not undergo surgery and more than half of this group not undergoing surgery had no active treatment. There was marked variation across the UK (0%–28% change in management). Units that did not change management could maintain capacity with dedicated oncology lists. Low volume units were less affected.

Conclusion

COVID-19 has had an impact on patients requiring surgery for malignant brain tumours, with patients receiving different treatments—most commonly not receiving surgery or any treatment at all. The variations show dedicated cancer operating lists may mitigate these pressures.

Study registration

This study was registered with the Royal College of Surgeons of England’s COVID-19 Research Group (https://www.rcseng.ac.uk/coronavirus/rcs-covid-research-group/).

Implementing post-discharge care following acute kidney injury in England: a single-centre qualitative evaluation

Por: Elvey · R. · Howard · S. J. · Martindale · A.-M. · Blakeman · T.
Objectives

We sought to understand the factors influencing the implementation of a primary care intervention to improve post-discharge care following acute kidney injury (AKI).

Design

Qualitative study using semi-structured interviews and thematic analysis.

Setting

General practices in one Clinical Commissioning Group area in England.

Participants

A total of 18 healthcare staff took part in interviews. Participants were practice pharmacists, general practitioners, practice managers and administrators involved in implementing the intervention.

Results

We identified three main factors influencing implementation: differentiation of the new intervention from other practice work; development of skill mix and communication across organisations. Overall, post-AKI processes of care were deemed straightforward to embed into existing practice. However, it was also important to separate the intervention from other work in general practice. Dedicating staff time to proactively identify AKI on discharge summaries and to coordinate the provision of care enabled implementation of the intervention. The post-AKI intervention provided an opportunity for practice pharmacists to expand their primary care role. Working in a new setting also brought challenges; time to develop trusting relationships including an understanding of boundaries of clinical expertise influenced pharmacists’ roles. Unclear and inconsistent information on discharge summaries contributed to concerns about additional work in primary care.

Conclusions

The research highlights challenges around post-discharge management in the primary care context. Coordination and communication were key factors for improving follow-up care following AKI. Further consideration is required to understand patient experiences of the interface between secondary and primary care. The issues pertaining to discharge care following AKI are relevant to practitioners and commissioners as they work to improve transitions of care for vulnerable patient populations.

Association between health indicators of maternal adversity and the rate of infant entry to local authority care in England: a longitudinal ecological study

Por: Pearson · R. J. · Jay · M. A. · Wijlaars · L. P. M. M. · De Stavola · B. · Syed · S. · Bedston · S. J. · Gilbert · R.
Objective

Infants enter care at varying rates across local authorities (LAs) in England, but evidence is lacking on what is driving these differences. With this ecological study, we aimed to explore the extent to which adversity indicated within women’s hospitalisation histories, predelivery, explained the rate of infant entry into care.

Methods

We used two longitudinal person-level data sets on hospitalisations and entries to care to create annual measures for 131 English LAs, between 2006/2007 and 2013/2014 (April–March). We combined these measures by LA and financial year, along with other publicly available data on LA characteristics. We used linear mixed-effects models to analyse the relationship between the outcome—LA-specific rate of infant entry into care (per 10 000 infants in the LA population) — and LA-specific percentage of live births with maternal history of adversity-related hospital admissions (ie, substance misuse, mental health problems or violence-related admissions in the 3 years before delivery), adjusted for other predictors of entry into care.

Results

Rate of infant entry into care (mean: 85.16 per 10 000, SD: 41.07) and percentage of live births with maternal history of adversity-related hospital admissions (4.62%, 2.44%) varied greatly by LA. The prevalence of maternal adversity accounted for 24% of the variation in rate of entry (95% CI 14% to 35%). After adjustment, a percentage point increase in prevalence of maternal adversity—both within and between LAs—was associated with an estimated 2.56 (per 10 000) more infants entering care (1.31–3.82).

Conclusions

The prevalence of maternal adversity before birth helped to explain the variation in LA rates of infant entry into care. Preventive interventions are needed to improve maternal well-being before and during pregnancy, and potentially reduce risk of child maltreatment and therefore entries to care. Evidence on who to target and data to evaluate change require linkage between parent–child healthcare data and administrative data from children’s social care.

Inferred duration of infectious period of SARS-CoV-2: rapid scoping review and analysis of available evidence for asymptomatic and symptomatic COVID-19 cases

Por: Byrne · A. W. · McEvoy · D. · Collins · A. B. · Hunt · K. · Casey · M. · Barber · A. · Butler · F. · Griffin · J. · Lane · E. A. · McAloon · C. · O'Brien · K. · Wall · P. · Walsh · K. A. · More · S. J.
Objectives

Our objective was to review the literature on the inferred duration of the infectious period of COVID-19, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, and provide an overview of the variation depending on the methodological approach.

Design

Rapid scoping review. Literature review with fixed search terms, up to 1 April 2020. Central tendency and variation of the parameter estimates for infectious period in (A) asymptomatic and (B) symptomatic cases from (1) virological studies (repeated testing), (2) tracing studies and (3) modelling studies were gathered. Narrative review of viral dynamics.

Information sources

Search strategies developed and the following searched: PubMed, Google Scholar, MedRxiv and BioRxiv. Additionally, the Health Information Quality Authority (Ireland) viral load synthesis was used, which screened literature from PubMed, Embase, ScienceDirect, NHS evidence, Cochrane, medRxiv and bioRxiv, and HRB open databases.

Results

There was substantial variation in the estimates, and how infectious period was inferred. One study provided approximate median infectious period for asymptomatic cases of 6.5–9.5 days. Median presymptomatic infectious period across studies varied over

Conclusions

There are limitations of inferring infectiousness from repeated diagnosis, viral loads and viral replication data alone and also potential patient recall bias relevant to estimating exposure and symptom onset times. Despite this, available data provide a preliminary evidence base to inform models of central tendency for key parameters and variation for exploring parameter space and sensitivity analysis.

Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial

Por: Ma · J. · Zhang · J. w. · Li · H. · Zhao · L. s. · Guo · A. y. · Chen · Z. h. · Yuan · W. · Gao · T. m. · Li · Y. m. · Li · C. h. · Wang · H. w. · Song · B. · Lu · Y. l. · Cui · M. z. · Wei · Q. y. · Lyu · S. j. · Yin · H. c.
Introduction

Preliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme.

Methods and analysis

We propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1 month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed.

Ethics and dissemination

This study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People’s Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results.

Trial registration number

NCT03936504.

Persistence of patient and family experiences of critical illness

Por: Hirshberg · E. L. · Butler · J. · Francis · M. · Davis · F. A. · Lee · D. · Tavake-Pasi · F. · Napia · E. · Villalta · J. · Mukundente · V. · Coulter · H. · Stark · L. · Beesley · S. J. · Orme · J. F. · Brown · S. M. · Hopkins · R. O.
Objective

To investigate: (1) patient and family experiences with healthcare and the intensive care unit (ICU); (2) experiences during their critical illness; (3) communication and decision making during critical illness; (4) feelings about the ICU experience; (5) impact of the critical illness on their lives; and (6) concerns about their future after the ICU.

Design

Four semistructured focus group interviews with former ICU patients and family members.

Settings

Multicultural community group and local hospitals containing medical/surgical ICUs.

Participants

Patients and family who experienced a critical illness within the previous 10 years.

Interventions

None.

Measurements and main results

Four separate focus groups each lasting a maximum of 150 min and consisting of a total of 21 participants were held. Focus groups were conducted using a semistructured script including six topics relating to the experience of critical illness that facilitated deduction and the sorting of data by thematic analysis into five predominant themes. The five main themes that emerged from the data were: (1) personalised stories of the critical illness; (2) communication and shared decision making, (3) adjustment to life after critical illness, (4) trust towards clinical team and relevance of cultural beliefs and (5) end-of-life decision making. Across themes, we observed a misalignment between the medical system and patient and family values and priorities.

Conclusions

The experience of critical illness of a diverse group of patients and families can remain vivid for years after ICU discharge. The identified themes reflect the strength of memory of such pivotal experiences and the importance of a narrative around those experiences. Clinicians need to be aware of the lasting effects of critical illness has on patients and families.

Influence of trust on two different risk perceptions as an affective and cognitive dimension during Middle East respiratory syndrome coronavirus (MERS-CoV) outbreak in South Korea: serial cross-sectional surveys

Por: Jang · W. M. · Kim · U.-N. · Jang · D. H. · Jung · H. · Cho · S. · Eun · S. J. · Lee · J. Y.
Objectives

This study aimed to assess the affective and cognitive risk perceptions in the general population of Middle East respiratory syndrome (MERS) during the 2015 MERS coronavirus (MERS-CoV) outbreak in South Korea and the influencing factors.

Design

Serial cross-sectional design with four consecutive surveys.

Setting

Nationwide general population in South Korea.

Participants

Overall 4010 respondents (aged 19 years and over) from the general population during the MERS-CoV epidemic were included.

Primary and secondary outcome measures

The main outcome measures were (1) affective risk perception, (2) cognitive risk perception, and (3) trust in the government. Multivariate logistic regression models were used to identify factors (demographic, socioeconomic, area and political orientation) associated with risk perceptions.

Results

Both affective and cognitive risk perceptions decreased as the MERS-CoV epidemic progressed. Proportions of affective risk perception were higher in all surveys and slowly decreased compared with cognitive risk perception over time. Females (adjusted OR (aOR) 1.72–2.00; 95% CI 1.14 to 2.86) and lower self-reported household economic status respondents were more likely to perceive the affective risk. The older the adults, the higher the affective risk perception, but the lower the cognitive risk perception compared with younger adults. The respondents who had low trust in the government had higher affective (aOR 2.19–3.11; 95 CI 1.44 to 4.67) and cognitive (aOR 3.55–5.41; 95 CI 1.44 to 9.01) risk perceptions.

Conclusions

This study suggests that even if cognitive risk perception is dissolved, affective risk perception can continue during MERS-CoV epidemic. Risk perception associating factors (ie, gender, age and self-reported household economic status) appear to be noticeably different between affective and cognitive dimensions. It also indicates that trust in the government influences affective risk perception and cognitive risk perception. There is a need for further efforts to understand the mechanism regarding the general public’s risk perception for effective risk communication.

Trial protocol: preoperative administration of tranexamic acid in sleeve gastrectomy (PATAS) to reduce haemorrhage rates. A randomised controlled trial

Por: Leeman · M. · Huisbrink · J. · Wijnand · J. M. A. · Biter · L. U. · Verbrugge · S. J. C. · Dunkelgrun · M. · Apers · J. A.
Introduction

Fast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates of venous thromboembolic events (VTEs) have decreased, while there seems to be an increase in the occurrence of postoperative haemorrhage. Tranexamic acid (TXA) can potentially lower the incidence of postoperative haemorrhage. This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG).

Methods and analysis

This is a single centre double-blind randomised placebo-controlled trial. Patients undergoing an LSG are included after obtaining informed consent. Patients are randomised between two groups: (1) administration of placebo infusion and (2) administration of 1500 mg TXA. In both groups, the infusions will be administered during the induction phase of the procedure. Primary outcome measures are preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage. Secondary outcome measure is the rates of VTE.

Ethics and dissemination

The protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations.

Trial registration number

The Netherlands Trial Registry (NL8029); Pre-results.

Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach

Por: Bowden · J. L. · Egerton · T. · Hinman · R. S. · Bennell · K. L. · Briggs · A. M. · Bunker · S. J. · Kasza · J. · French · S. D. · Pirotta · M. · Schofield · D. J. · Zwar · N. A. · Hunter · D. J.
Introduction

This protocol outlines the rationale, design and methods for the process and feasibility evaluations of the primary care management on knee pain and function in patients with knee osteoarthritis (PARTNER) study. PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against ‘usual care’. PARTNER is designed to encourage greater uptake of key evidence-based non-surgical treatments for knee osteoarthritis (OA) in primary care. The intervention supports general practitioners (GPs) to gain an understanding of the best management options available through online professional development. Their patients receive telephone advice and support for OA management by a centralised, multidisciplinary ‘Care Support Team’. We will conduct concurrent process and feasibility evaluations to understand the implementation of this new complex health intervention, identify issues for consideration when interpreting the effectiveness outcomes and develop recommendations for future implementation, cost effectiveness and scalability.

Methods and analysis

The UK Medical Research Council Framework for undertaking a process evaluation of complex interventions and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks inform the design of these evaluations. We use a mixed-methods approach including analysis of survey data, administrative records, consultation records and semistructured interviews with GPs and their enrolled patients. The analysis will examine fidelity and dose of the intervention, observations of trial setup and implementation and the quality of the care provided. We will also examine details of ‘usual care’. The semistructured interviews will be analysed using thematic and content analysis to draw out themes around implementation and acceptability of the model.

Ethics and dissemination

The primary and substudy protocols have been approved by the Human Research Ethics Committee of The University of Sydney (2016/959 and 2019/503). Our findings will be disseminated to national and international partners and stakeholders, who will also assist with wider dissemination of our results across all levels of healthcare. Specific findings will be disseminated via peer-reviewed journals and conferences, and via training for healthcare professionals delivering OA management programmes. This evaluation is crucial to explaining the PARTNER study results, and will be used to determine the feasibility of rolling-out the intervention in an Australian healthcare context.

Trial registration number

ACTRN12617001595303; Pre-results.

Resilience, burnout and coping mechanisms in UK doctors: a cross-sectional study

Por: McKinley · N. · McCain · R. S. · Convie · L. · Clarke · M. · Dempster · M. · Campbell · W. J. · Kirk · S. J.
Aims

This cross-sectional study aimed to assess resilience, professional quality of life and coping mechanisms in UK doctors. It also aimed to assess the impact of demographic variables, such as sex, grade and specialty on these factors.

Methods

During October and November 2018, medical doctors in the UK were eligible to complete an online survey made up of validated psychological instruments. Royal Colleges and other medical organisations invited their membership to participate via newsletters, email invitations, websites and social media.

Results

1651 doctors participated from a wide range of specialties and grades across the UK. The mean resilience score was 65.01 (SD 12.3), lower than population norms. Of those who responded, 31.5% had high burnout (BO), 26.2% had high secondary traumatic stress and 30.7% had low compassion satisfaction (CS). Doctors who responded from emergency medicine were more burned out than any other specialty group (F=2.62, p=0.001, df 14). Those who responded from general practice scored lowest for CS (F=6.43, p

Conclusions

One-third of UK doctors who responded are burned out and suffering from STS. Those who responded from emergency medicine and general practice appear to be suffering the most. Over 100 doctors fell into the at-risk category of high BO, high STS and low CS. Future analysis of the free text responses from doctors may help to identify factors that are playing a role in the high levels of BO and STS being reported by medical staff.

Impact of adult weight management interventions on mental health: a systematic review and meta-analysis protocol

Por: Jones · R. A. · Lawlor · E. R. · Griffin · S. J. · van Sluijs · E. M. F. · Ahern · A. L.
Introduction

The effects of interventions targeting weight loss on physical health are well described, yet the evidence for mental health is less clear. It is essential to better understand the impact of weight management interventions on mental health to optimise care and minimise risk of harm. We will assess the effect of behavioural weight management interventions on mental health in adults with overweight and obesity.

Methods and analysis

The systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. We will include behavioural weight management interventions with a diet and/or physical activity component focusing on weight loss for adults with a body mass index ≥25 kg/m2. Randomised controlled trials (RCTs) and cluster RCTs will be the only eligible study designs. Outcomes of interest will be related to mental health. The following databases were searched from inception to 07 May 2019: MEDLINE, Embase, Cochrane database (CENTRAL), PsycINFO, ASSIA, AMED and CINAHL. The search strategy was based on four concepts: (1) adults, defined as ≥18 years, with overweight/obesity, defined as BMI ≥25kg/m², (2) weight management interventions, (3) mental health outcomes and (4) study design. The search was restricted to English-language published papers, with no other restrictions applied. Two stage screening for eligibility will be completed by two independent reviewers, with two independent reviewers completing data extraction and risk of bias assessment. Data permitting, a random-effects meta-analysis of outcomes, subgroup analyses and meta-regression will be conducted. If not appropriate, narrative synthesis and ‘levels of evidence’ assessment will be completed.

Ethics and dissemination

Ethical approval is not required as primary data will not be collected. The completed systematic review will be disseminated in a peer-reviewed journal, at conferences and contribute towards the lead author’s PhD thesis.

PROSPERO registration number

CRD42019131659.

KMBARC registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in Korea

Por: Lee · H. · Choi · H. · Sim · Y. S. · Park · S. · Kim · W. J. · Yoo · K. H. · Lee · S. J. · Kim · T.-H. · Yang · B. · Jeong · I. · Um · S.-J. · Kim · D. K. · Lee · J.-H. · Kwon · B. S. · Cho · Y.-J. · Park · H. Y. · Lee · C.-H. · Rhee · C. K. · Lee · S. H. · Na · J. O. · Jang · A.-S. · Jung · J. Y
Introduction

Despite the significant disease burden of bronchiectasis in Korea, no large-scale, representative prospective cohort studies have been conducted to evaluate the clinical characteristics of Korean patients with bronchiectasis, indicating an urgent need for cohort studies on bronchiectasis.

Methods and analysis

The Korean Multicenter Bronchiectasis Audit and Research Collaboration (KMBARC) is a prospective, non-interventional observational cohort study on bronchiectasis in Korea. The inclusion criteria of this registry are as follows: (1) adult patients (aged ≥18 years) with or without respiratory symptoms (cough, chronic sputum and/or recurrent respiratory infection) and chest computed tomography revealing bronchiectasis affecting one or more lobes and (2) stable status at the time of registration: patients with bronchiectasis who were admitted for a respiratory aetiology can be enrolled at least 4 weeks after hospital discharge. The exclusion criteria are as follows: (1) bronchiectasis due to cystic fibrosis; (2) traction bronchiectasis associated with interstitial lung disease; (3) patients actively being treated for pneumonia, pulmonary tuberculosis or non-tuberculous mycobacterial infection; (4) patients who are unable or unwilling to provide informed consent; and (5) pregnant patients. Although the KMBARC questionnaires for baseline and annual follow-up data are similar to the European Multicentre Bronchiectasis Audit and Research Collaboration questionnaires, KMBARC has distinctive features such as use of Bronchiectasis Health Questionnaires, measurement with fatigue and depression scales, blood tests, use of consensus definition of exacerbations and information on emergency room or hospitalisation.

We aim to recruit at least 1200 patients over the study period from more than 26 hospitals in South Korea. Patients will undergo a detailed baseline and yearly assessment for up to 5 years. The study objectives of the KMBARC registry are as follows: (1) uncovering the natural course of bronchiectasis; (2) aiding in establishing evidence-based bronchiectasis guidelines in Korea; and (3) encouraging and facilitating studies on bronchiectasis in Korea.

Ethics and dissemination

This study received necessary approval from the Institutional Review Boards of all participating institutions. The Asan Medical Center Institutional Review Board gave overall approval for the study. Results will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number

KCT0003088.

International phase 1 study protocol to develop a health state classification system for a preference-based measure for women with breast cancer: the BREAST-Q Utility module

Por: Kaur · M. · Pusic · A. L. · Cano · S. J. · Xie · F. · Bordeleau · L. · Zhong · T. · Klassen · A.
Introduction

Concerns unique to women with breast cancer can include impact of cancer on body image, sexual well-being and changes in breast appearance and sensation. These important issues are not captured by the existing generic preference-based measures (PBMs) and no breast cancer-specific PBM currently exists. This Phase 1 protocol describes a mixed-methods study to develop and validate the descriptive health state classification system for a breast cancer-specific PBM, called the BREAST-Q Utility module.

Methods and analysis

A heterogeneous sample of women aged 18 years and older diagnosed with breast cancer who are undergoing or have had treatment for breast cancer will be invited to participate in qualitative interviews. Participants will be asked to describe impact of their diagnosis and treatment(s) on their health-related quality of life (HRQOL). Interviews will be audio recorded, transcribed verbatim and coded using a line-by-line approach. At the end of each interview, based on each participant’s cancer treatment history, patients will complete the mastectomy, breast-conserving therapy or reconstruction module of BREAST-Q, with modified 5-point Likert scale to measure importance of the BREAST-Q concepts. Both sources of data will be analysed to identify the most important HRQOL concerns.

A conceptual framework and item pool will be developed from the qualitative dataset. Preliminary version of the BREAST-Q Utility module will be created and refined at an in-person meeting of multidisciplinary experts. Content validity of the Utility module will be examined (cognitive debriefing, expert feedback). Psychometric properties of Utility module will be evaluated in a large sample of women with breast cancer.

Ethics and dissemination

The study has been approved by Hamilton Integrated Research Ethics Board, Canada. Results of this study will be presented at international conferences and published in peer-reviewed journals.

Accelerometery as a measure of modifiable physical activity in high-risk elderly preoperative patients: a prospective observational pilot study

Por: Grimes · L. · Outtrim · J. G. · Griffin · S. J. · Ercole · A.
Objectives

To use wrist-worn accelerometers (Axivity AX3) to establish normative physical activity (PA) and acceptability data for the high-risk elderly preoperative population, to assess whether PA could be modified by a prehabilitation intervention as part of routine care, to assess any correlation between accelerometer-measured PA and self-reported PA and to assess the acceptability of wearing wrist-worn accelerometers in this population.

Study design

Prospective, observational, pilot study.

Setting

Single National Health Service Hospital.

Participants

Frail patients≥65 years awaiting major surgery referred to a multidisciplinary preoperative clinic at which they received a routine intervention aimed at improving their PA. 35 patients were recruited. Average age 79.9 years (SD=5.6).

Primary outcomes

Normative PA data measured as a mean daily Euclidean norm minus one (ENMO) in milli-gravitational units (mg).

Secondary outcomes

Measure PA levels (mg) following a routine preoperative intervention. Determine correlation between patient-reported PA (measured using the Physical Activity Scale for the Elderly) and accelerometer-measured PA (mg). Assess acceptability of wearing a wrist-worn accelerometer measured using Visual Analogue Scale (VAS) questionnaire and device wear time (hours).

Results

Median baseline daily PA was 14.3 mg (IQR 9.75–22.04) with an improvement in PA detected following the intervention (median ENMO post intervention 20.91 mg (IQR 14.83–27.53), p=0.022). There was no significant correlation between accelerometer-measured and self-reported PA (baseline =0.162 (p=0.4), post intervention =–0.144 (p=0.5)). We found high acceptability ratings (median score of 10/10 on VAS, IQR 8–10) and wear-time compliance (163.2 hours (IQR 150–167.5) preintervention and 166.1 hours (IQR 162.5–167) post intervention).

Conclusions

Accelerometery is acceptable to this population and increases in PA levels measured following an unoptimised routine clinical intervention which indicates that health behavioural change interventions may be successful during the preoperative period. Accelerometers may therefore be a useful tool to design and validate interventions for improving PA in this setting.

Trial registration number

NCT03737903.

Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study

Por: Keene · D. J. · Costa · M. L. · Tutton · E. · Hopewell · S. · Barber · V. S. · Dutton · S. J. · Redmond · A. C. · Willett · K. · Lamb · S. E.
Introduction

Ankle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.

The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6 month follow-up.

Methods and analysis

A multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.

Ethics and dissemination

Hampshire B Research Ethics Committee (18/SC/0281) gave approval on 2nd July 2018.

Trial registration number

ISRCTN16612336

Cohort profile: Korean Urban Rural Elderly (KURE) study, a prospective cohort on ageing and health in Korea

Por: Hong · N. · Kim · K.-J. · Lee · S. J. · Kim · C. O. · Kim · H. C. · Rhee · Y. · Youm · Y. · Choi · J.-Y. · Park · H.-Y.
Purpose

The Korean Urban Rural Elderly (KURE) cohort was initiated to study the epidemiologic characteristics, physical performance, laboratory and imaging biomarkers and incidence of age-related diseases in an elderly population with respect to both clinical and social aspects to develop preventive and therapeutic strategies for combatting age-related diseases.

Participants

A total of 3517 adults aged 65 or older participated in the cohort at baseline from 2012 to 2015, recruited from three urban districts and one rural district in Korea. The second-wave follow-up survey is now being conducted at a 4-year interval from baseline (2016–2019; follow-up rate 71.5%). The data set included detailed information on anthropometric and socioeconomic factors, functional assessments, image scans (plain radiography, dual-energy X-ray absorptiometry and CT), biospecimens (ie, serum, urine and DNA) and social support networks along with the feasibility of linkage to a national claims database.

Findings to date

Mean age of participants at entry was 71.9±4.6 years and 67% were women. From the KURE participants enrolled in baseline recruitment, several studies were published in the fields of cardiometabolic diseases, musculoskeletal health and the association between social support network and diseases in ageing.

Future plans

Participants will be observed actively and passively every 4–5 years and the first follow-up will be completed in 2020. The KURE data set has strength in comprehensive physical function assessments, quantifiable imaging data sets using CT and detailed information regarding the social support networks of participants from a large community-based elderly Korean population.

Factors associated with patient-reported likelihood of using online self-care interventions: a Scleroderma Patient-centered Intervention Network (SPIN) ohort study

Por: Kwakkenbos · L. · Cumin · J. · Carrier · M.-E. · Bartlett · S. J. · Malcarne · V. L. · Mouthon · L. · Nielson · W. R. · Rannou · F. · Welling · J. · Thombs · B. D. · the SPIN Investigators · Baron · Furst · Gottesman · Mayes · Riggs · Sauve · Wigley · Assassi · Boutron · Maia · Cronin
Objectives

The Scleroderma Patient-centered Intervention Network (SPIN) Cohort uses the cohort multiple randomised controlled trial design to embed trials of online self-care interventions for people living with systemic sclerosis (SSc; scleroderma). To offer interventions to patients interested in using them, participants complete signalling items that query about the likelihood that patients would agree to participate in nine different hypothetical online programmes addressing common SSc-related problems. It is not known what factors influence patient-reported interest in participating in a particular online intervention and if intervention-specific signalling questions provide unique information or replicate broader characteristics, such as overall willingness to participate or self-efficacy. This study assessed factors that explain responses to intervention-specific signalling items.

Design

Cross-sectional survey.

Setting

SPIN Cohort participants enrolled at 42 centres from Canada, the USA, the UK, France, Spain and Mexico who completed study questionnaires from March 2014 to January 2018 were included.

Measures

Demographic and disease characteristics, self-efficacy and symptoms related to each specific intervention were completed in addition to signalling items. General likelihood of using interventions was calculating by taking the mean score of the remaining signalling questions.

Participants

1060 participants with complete baseline data were included in the analyses.

Results

For all individual signalling questions, controlling for other variables, the mean of the remaining signalling questions was the strongest predictor (standardised regression coefficient β from 0.61 (sleep) to 0.80 (self-management)). Smaller, but statistically significant, associations were found with the symptom associated with the respective signalling question and with general self-efficacy for 7 of 9 signalling questions.

Conclusions

The main factor associated with patients’ interest in participating in a disease-specific online self-care intervention is their general interest in participating in online interventions. Factors that may influence this general interest should be explored and taken into consideration when inviting patients to try online interventions.

Effectiveness of a multicomponent safe surgery intervention on improving surgical quality in Tanzanias Lake Zone: protocol for a quasi-experimental study

Por: Alidina · S. · Kuchukhidze · S. · Menon · G. · Citron · I. · Lama · T. N. · Meara · J. · Barash · D. · Hellar · A. · Kapologwe · N. A. · Maina · E. · Reynolds · C. · Staffa · S. J. · Troxel · A. · Varghese · A. · Zurakowski · D. · Ulisubisya · M. · Maongezi · S.
Introduction

Effective, scalable strategies for improving surgical quality are urgently needed in low-income and middle-income countries; however, there is a dearth of evidence about what strategies are most effective. This study aims to evaluate the effectiveness of Safe Surgery 2020, a multicomponent intervention focused on strengthening five areas: leadership and teamwork, safe surgical and anaesthesia practices, sterilisation, data quality and infrastructure to improve surgical quality in Tanzania. We hypothesise that Safe Surgery 2020 will (1) increase adherence to surgical quality processes around safety, teamwork and communication and data quality in the short term and (2) reduce complications from surgical site infections, postoperative sepsis and maternal sepsis in the medium term.

Methods and analysis

Our design is a prospective, longitudinal, quasi-experimental study with 10 intervention and 10 control facilities in Tanzania’s Lake Zone. Participants will be surgical providers, surgical patients and postnatal inpatients at study facilities. Trained Tanzanian medical data collectors will collect data over a 3-month preintervention and postintervention period. Adherence to safety as well as teamwork and communication processes will be measured through direct observation in the operating room. Surgical site infections, postoperative sepsis and maternal sepsis will be identified prospectively through daily surveillance and completeness of their patient files, retrospectively, through the chart review. We will use difference-in-differences to analyse the impact of the Safe Surgery 2020 intervention on surgical quality processes and complications. We will use interviews with leadership and surgical team members in intervention facilities to illuminate the factors that facilitate higher performance.

Ethics and dissemination

The study has received ethical approval from Harvard Medical School and Tanzania’s National Institute for Medical Research. We will report results in peer-reviewed publications and conference presentations. If effective, the Safe Surgery 2020 intervention could be a promising approach to improve surgical quality in Tanzania’s Lake Zone region and other similar contexts.

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