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What are common barriers and helpful solutions to colorectal cancer screening? A cross-sectional survey to develop intervention content for a planning support tool

Por: Kotzur · M. · Macdonald · S. · O'Carroll · R. E. · O'Connor · R. C. · Irvine · A. · Steele · R. J. C. · Robb · K. A.
Objective

Colorectal screening using faecal immunochemical tests (FITs) can save lives if the people invited participate. In Scotland, most people intend to complete a FIT but this is not reflected in uptake rates. Planning interventions can bridge this intention-behaviour gap. To develop a tool supporting people willing to do colorectal screening with planning to complete a FIT, this study aimed to identify frequently experienced barriers and solutions to these barriers.

Design

This is a cross-sectional study.

Setting

Participants were recruited through the Scottish Bowel Screening Programme to complete a mailed questionnaire.

Participants

The study included 2387 participants who had completed a FIT (mean age 65 years, 40% female) and 359 participants who had not completed a FIT but were inclined to do so (mean age 63 years, 39% female).

Outcome measures

The questionnaire assessed frequency of endorsement of colorectal screening barriers and solutions.

Results

Participants who had not completed a FIT endorsed significantly more barriers than those who had completed a FIT, when demographic, health and behavioural covariates were held constant (F(1,2053)=13.40, p2=0.01). Participants who completed a FIT endorsed significantly more solutions than those who did not (U=301 585.50, z=–3.21, p

Conclusion

This survey identified six barriers and seven solutions as key content to include in the development of a planning tool for colorectal screening using the FIT. Participatory research is required to codesign an engaging and accessible planning tool.

Systematic scoping review on moral distress among physicians

Por: Quek · C. W. N. · Ong · R. R. S. · Wong · R. S. M. · Chan · S. W. K. · Chok · A. K.-L. · Shen · G. S. · Teo · A. Y. T. · Panda · A. · Burla · N. · Wong · Y. A. · Chee · R. C. H. · Loh · C. Y. L. · Lee · K. W. · Tan · G. H. N. · Leong · R. E. J. · Koh · N. S. Y. · Ong · Y. T. · Chin · A. M
Background

Concepts of moral distress (MD) among physicians have evolved and extend beyond the notion of psychological distress caused by being in a situation in which one is constrained from acting on what one knows to be right. With many accounts involving complex personal, professional, legal, ethical and moral issues, we propose a review of current understanding of MD among physicians.

Methods

A systematic evidence-based approach guided systematic scoping review is proposed to map the current concepts of MD among physicians published in PubMed, Embase, PsycINFO, Web of Science, SCOPUS, ERIC and Google Scholar databases. Concurrent and independent thematic and direct content analysis (split approach) was conducted on included articles to enhance the reliability and transparency of the process. The themes and categories identified were combined using the jigsaw perspective to create domains that form the framework of the discussion that follows.

Results

A total of 30 156 abstracts were identified, 2473 full-text articles were reviewed and 128 articles were included. The five domains identified were as follows: (1) current concepts, (2) risk factors, (3) impact, (4) tools and (5) interventions.

Conclusions

Initial reviews suggest that MD involves conflicts within a physician’s personal beliefs, values and principles (personal constructs) caused by personal, ethical, moral, contextual, professional and sociocultural factors. How these experiences are processed and reflected on and then integrated into the physician’s personal constructs impacts their self-concepts of personhood and identity and can result in MD. The ring theory of personhood facilitates an appreciation of how new experiences create dissonance and resonance within personal constructs. These insights allow the forwarding of a new broader concept of MD and a personalised approach to assessing and treating MD. While further studies are required to test these findings, they offer a personalised means of supporting a physician’s MD and preventing burn-out.

Acupuncture versus massage for pain in patients living with advanced cancer: a protocol for the IMPACT randomised clinical trial

Por: Romero · S. A. D. · Emard · N. · Baser · R. E. · Panageas · K. · MacLeod · J. · Walker · D. · Barton-Burke · M. · Liou · K. · Deng · G. · Farrar · J. · Xiao · H. · Mao · J. J. · Epstein · A.
Introduction

Pain, comorbid fatigue and sleep disturbances are common and distressing symptoms for patients with advanced cancer, negatively impacting their quality of life. Clinical guidelines recommend non-pharmacological interventions, including acupuncture and massage, for pain management in adult patients with cancer in adjunct to conventional care. However, high-quality evidence about the comparative effectiveness and long-term durability of these therapies for symptom management is limited.

Methods and analysis

We describe the design of a two-arm, parallel group, multicentre randomised controlled trial that investigates the use of acupuncture versus massage for musculoskeletal pain among 300 patients with diverse types of advanced cancer. The primary aim is to evaluate the long-term effectiveness (26 weeks from randomisation) of acupuncture vs massage for pain (primary outcome) and comorbid symptoms (fatigue, sleep disturbance and quality of life). The secondary aim is to identify patient-level demographic characteristics (eg, sex, race, age), clinical factors (eg, insomnia, pain severity) and psychological attributes that are associated with a greater reduction in pain for either acupuncture or massage. Patients will receive weekly acupuncture or massage treatments for 10 weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint will be the change in worst pain intensity score from baseline to 26 weeks. We will collect validated patient-reported outcomes at multiple time points over 26 weeks.

Ethics and dissemination

The Institutional Review Board at Memorial Sloan Kettering Cancer Center in New York approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations. Our findings will help patients and healthcare providers make informed decisions about incorporating non-pharmacological treatments to manage pain for patients with advanced cancer.

Trial registration number

NCT04095234.

Global impact of COVID-19 on surgeons and team members (GlobalCOST): a cross-sectional study

Por: Jaffry · Z. · Raj · S. · Sallam · A. · Lyman · S. · Negida · A. · Yiu · C. F. A. · Sobti · A. · Bua · N. · Field · R. E. · Abdalla · H. · Hammad · R. · Qazi · N. · Singh · B. · Brennan · P. A. · Hussein · A. · Narvani · A. · Jones · A. · Imam · M. A. · The OrthoGlobe Collaborative · Abbas
Objectives

To investigate the impact of COVID-19 on the well-being of surgeons and allied health professionals as well as the support provided by their institutions.

Design

This cross-sectional study involved distributing an online survey through medical organisations, social media platforms and collaborators.

Setting

It included all staff based in an operating theatre environment around the world.

Participants

1590 complete responses were received from 54 countries between 15 July and 15 December 2020. The average age of participants was 30–40 years old, 64.9% were men and 32.5% of a white ethnic background. 79.5% were surgeons with the remainder being nurses, assistants, anaesthetists, operating department practitioners or classified other.

Main outcome measures

Participants that had experienced any physical illness, changes in mental health, salary or time with family since the start of the pandemic as well as support available based on published recommendations.

Results

32.0% reported becoming physically ill. This was more likely in those with reduced access to personal protective equipment (OR 4.62; CI 2.82 to 7.56; p

Conclusions

This work has highlighted a need and strategies to improve conditions for the healthcare workforce, ultimately benefiting patient care.

Primary Care Severe Asthma Registry and Education Project (PCSAR-EDU): Phase 1 - an e-Delphi for registry definitions and indices of clinician behaviour

Por: D'Urzo · K. A. · Tamari · I. E. · Chapman · K. R. · Maleki-Yazdi · M. R. · Greiver · M. · Upshur · R. E. · Biro · L. · O'Neill · B. · Moineddin · R. · Aliarzadeh · B. · Kulasegaram · K. · To · T. · D'Urzo · A. D.
Introduction

Although most asthma is mild to moderate, severe asthma accounts for disproportionate personal and societal costs. Poor co-ordination of care between primary care and specialist settings is recognised as a barrier to achieving optimal outcomes. The Primary Care Severe Asthma Registry and Education (PCSAR-EDU) project aims to address these gaps through the interdisciplinary development and evaluation of both a ‘real-world’ severe asthma registry and an educational programme for primary care providers. This manuscript describes phase 1 of PCSAR-EDU which involves establishing interdisciplinary consensus on criteria for the: (1) definition of severe asthma; (2) generation of a severe asthma registry and (3) definition of an electronic-medical record data-based Clinician Behaviour Index (CBI).

Methods and analysis

In phase 1, a modified e-Delphi activity will be conducted. Delphi panellists (n≥13) will be invited to complete a 30 min online survey on three separate occasions (i.e., three separate e-Delphi ‘rounds’) over a 3-month period. Expert opinion will be collected via an open-ended survey (‘Open’ round 1) and 5-point Likert scale and ranking surveys (‘Closed’ round 2 and 3). A fourth and final Delphi round will occur via synchronous meeting, whereby panellists approve a finalised ideal ‘core criteria list’, CBI and corresponding item weighting.

Ethics and dissemination

Ethical approval has been obtained for the activities involved in phase 1 from the University of Toronto’s Human Research Ethics Programme (approval number 39695). Future ethics approvals will depend on information gathered in the proceeding phase; thus, ethical approval for phase 2 and 3 of this study will be sought sequentially. Findings will be disseminated through conference presentations, peer-reviewed publications and knowledge translation tools.

Evaluation of a community-based performance arts programme for people who have experienced stroke in the UK: protocol for the SHAPER-Stroke Odysseys study

Por: Estevao · C. · Baldellou Lopez · M. · Davis · R. E. · Jarret · L. · Soukup · T. · Bakolis · I. · Healey · A. · Harrington · J. · Woods · A. · Crane · N. · Jones · F. · Pariante · C. · Fancourt · D. · Sevdalis · N.
Introduction

Stroke survivors, once in the community, face challenges with their long-term rehabilitation care and present higher levels of loneliness, depression and anxiety than the rest of the population. A community-based performance arts programme, Stroke Odysseys (SO), has been devised to tackle the challenges of living with stroke in the UK. In this study, we aim to evaluate the implementation, impact and experiences of SO for stroke survivors.

Methods and analysis

Scaling-up Health Arts Programmes: Implementation and Effectiveness Research (SHAPER)-SO aims to scale-up SO to 75 participants and 47 stakeholders, while simultaneously evaluating the effectiveness and implementation of the programme. The main research aim is to evaluate the implementation, effectiveness, impact and experiences of a community-based performance arts programme (SO for stroke survivors). This mixed-methods study will evaluate the experience and impact of SO on those participating using mixed methods (interviews, observations and surveys) before and after each stage and carry out non-participant observations during a percentage of the workshops, training and tour. Data will be analysed using quantitative and qualitative approaches. This is a study within the SHAPER programme.

Ethics and dissemination

Ethical approval has been granted by the King’s College London PNM Research Ethics Panel, REC reference: LRS/DP-20/21–21549. Written informed consent will be sought for participants and stakeholders. The results of the study will be reported and disseminated at international conferences and in peer-reviewed scientific journals.

Trial registration number

NCT04864470.

Validating risk models versus age alone for atrial fibrillation in a young Dutch population cohort: should atrial fibrillation risk prediction be expanded to younger community members?

Por: Himmelreich · J. C. L. · Harskamp · R. E. · Geelhoed · B. · Virdone · S. · Lucassen · W. A. M. · Gansevoort · R. T. · Rienstra · M.
Background

Advancing age is the primary selection criterion for community screening for atrial fibrillation (AF), with selection often restricted to those aged ≥65 years. If multivariable models were shown to have considerable additional value over age alone in predicting AF risk among younger individuals, AF screening could be expanded to patients with lower age, but with high AF risk as per a validated risk model.

Methods

We validated risk models CHARGE-AF (Cohorts for Heart and Aging Research in Genomic Epidemiology model for AF) and FHS-AF (Framingham Heart Study model for AF), and risk scores CHA2DS2-VASc and CHA2DS2-VA, and presented their predictive abilities for 5-year and 10-year AF risk versus that of age alone in a young Dutch population cohort (PREVEND) free from AF at baseline. We assessed discrimination by the C-statistic and calibration by the calibration plot and stratified Kaplan-Meier plot using survey-weighted Cox models.

Results

During 5-year and 10-year follow-up there were n=98 (2.46/1000 person-years) and n=249 (3.29/1000 person-years) new AF cases, respectively, among 8265 participants with mean age 49±13 years. CHARGE-AF and FHS-AF both showed good discrimination for 5-year and 10-year AF (C-statistic range 0.83–0.86) with accurate calibration for 5-year AF, but overestimation of 10-year AF risk in highest-risk individuals. CHA2DS2-VASc and CHA2DS2-VA relatively underperformed. Age alone showed similar discrimination to that of CHARGE-AF and FHS-AF both in the overall, young PREVEND cohort and in subgroups for lower age and lower stroke risk.

Conclusion

Multivariable models accurately discriminate for 5-year and 10-year AF risk among young European community-dwelling individuals. However, their additional discriminatory value over age alone was limited. Selection strategies for primary AF screening using multivariable models should not be expanded to younger individuals.

Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinsons disease

Por: Soukup · T. · Davis · R. E. · Baldellou Lopez · M. · Healey · A. · Estevao · C. · Fancourt · D. · Dazzan · P. · Pariante · C. · Dye · H. · Osborn · T. · Bind · R. · Sawyer · K. · Rebecchini · L. · Hazelgrove · K. · Burton · A. · Manoharan · M. · Perkins · R. · Podlewska · A. · Chaudhuri · R
Introduction

Research on the benefits of ‘arts’ interventions to improve individuals’ physical, social and psychological well-being is growing, but evidence on implementation and scale-up into health and social care systems is lacking. This protocol reports the SHAPER-Implement programme (Scale-up of Health-Arts Programmes Effectiveness-Implementation Research), aimed at studying the impact, implementation and scale-up of: Melodies for Mums (M4M), a singing intervention for postnatal depression; and Dance for Parkinson’s (PD-Ballet) a dance intervention for Parkinson’s disease. We examine how they could be embedded in clinical pathways to ensure their longer-term sustainability.

Methods and analysis

A randomised two-arm effectiveness-implementation hybrid type 2 trial design will be used across M4M/PD-Ballet. We will assess the implementation in both study arms (intervention vs control), and the cost-effectiveness of implementation. The design and measures, informed by literature and previous research by the study team, were refined through stakeholder engagement. Participants (400 in M4M; 160 in PD-Ballet) will be recruited to the intervention or control group (2:1 ratio). Further implementation data will be collected from stakeholders involved in referring to, delivering or supporting M4M/PD-Ballet (N=25–30 for each intervention).

A mixed-methods approach (surveys and semi-structured interviews) will be employed. ‘Acceptability’ (measured by the ‘Acceptability Intervention Measure’) is the primary implementation endpoint for M4M/PD-Ballet. Relationships between clinical and implementation outcomes, implementation strategies (eg, training) and outcomes will be explored using generalised linear mixed models. Qualitative data will assess factors affecting the acceptability, feasibility and appropriateness of M4M/PD-Ballet, implementation strategies and longer-term sustainability. Costs associated with implementation and future scale-up will be estimated.

Ethics and dissemination

SHAPER-PND (the M4M trial) and SHAPER-PD (the PD trial) are approved by the West London and GTAC (20/PR/0813) and the HRA and Health and Care Research Wales (REC Reference: 20/WA/0261) Research Ethics Committees. Study findings will be disseminated through scientific peer-reviewed journals and scientific conferences.

Trial registration numbers

Both trials are registered with NIH US National Library of Medicine, ClinicalTrials.gov. The trial registration numbers, URLs of registry records, and dates of registration are: (1) PD-Ballet: URL: NCT04719468 (https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fct2%2Fshow%2FNCT04719468%3Fterm%3DNCT04719468%26draw%3D2%26rank%3D1&data=04%7C01%7Crachel.davis%40kcl.ac.uk%7C11a7c5142782437919f808d903111449%7C8370cf1416f34c16b83c724071654356%7C0%7C0%7C6375441942616) (date of registration: 22 Jan 2021). (2) Melodies for Mums: NCT04834622 (https://clinicaltrials.gov/ct2/show/NCT04834622?term=shaper-pnd&draw=2&rank=1) (date of registration: 8 Apr 2021).

Psychological correlates of free colorectal cancer screening uptake in a Scottish sample: a cross-sectional observational study

Por: Fawns-Ritchie · C. · Miller · C. B. · van der Pol · M. · Douglas · E. · Bell · D. · O'Carroll · R. E. · Deary · I. J.
Objectives

Colorectal cancer (CRC) screening uptake in Scotland is 56%. This study examined whether psychological factors were associated with CRC screening uptake.

Design

Cross-sectional observational study.

Setting

This study used data from the Healthy AGeing In Scotland (HAGIS) pilot study, a study designed to be representative of Scottish adults aged 50 years and older.

Participants

908 (505 female) Scottish adults aged 50–80 years (mean age=65.85, SD=8.23), who took part in the HAGIS study (2016–2017).

Primary and secondary outcome measures

Self-reported participation in CRC screening was the outcome measure. Logistic regression was used to test whether scores on measures of health literacy, cognitive ability, risk aversion, time preference (eg, present oriented or future oriented) and personality were associated with CRC screening when these psychological factors were entered individually and simultaneously in the same model.

Results

Controlling for age, age-squared, sex, living arrangement, and sex*living arrangement, a one-point increase in risk aversion (OR=0.66, 95% CI 0.51 to 0.85) and present orientation (OR=0.86, 95% CI 0.80 to 0.94) was associated with reduced odds of screening. Higher scores on health literacy (OR per one-point increase=1.20, 95% CI 1.09 to 1.31), cognitive ability (OR per SD increase=1.51, 95% CI 1.25 to 1.81) and the intellect personality trait (OR per one-point increase=1.05, 95% CI 1.01 to 1.09) were associated with increased odds of screening. Higher risk aversion was the only psychological variable that was associated with CRC screening participation when all psychological variables were entered in the same model and remained associated with CRC screening when additionally adjusting for deprivation and education. A backward elimination model retained two psychological variables as correlates of CRC screening: risk aversion and cognitive ability.

Conclusion

Individuals who are more risk averse are less likely to participate in free, home CRC screening.

Investigating primary healthcare practitioners barriers and enablers to referral of patients with COPD to pulmonary rehabilitation: a mixed-methods study using the Theoretical Domains Framework

Por: Watson · J. S. · Jordan · R. E. · Adab · P. · Vlaev · I. · Enocson · A. · Greenfield · S.
Objectives

Pulmonary rehabilitation (PR) is a highly effective, recommended intervention for patients with chronic obstructive pulmonary disease (COPD). Using behavioural theory within mixed-methods research to understand why referral remains low enables the development of targeted interventions in order to improve future PR referral.

Design

A multiphase sequential mixed-methods study.

Setting

United Kingdom (UK).

Participants

252 multiprofessional primary healthcare practitioners (PHCPs).

Measures

Phase 1: semistructured interviews. Phase 2: a 54-item paper and online questionnaire, based on the Theoretical Domains Framework (TDF). Content and descriptive analysis utilised. Data mixed at two points: instrument design and interpretation.

Results

19 PHCPs took part in interviews and 233 responded to the survey. Integrated results revealed that PHCPs with a post qualifying respiratory qualification (154/241; 63.9%) referred more frequently (91/154; 59.1%) than those without (28/87; 32.2%). There were more barriers than enablers for referral in all 13 TDF domains. Key barriers included: infrequent engagement from PR provider to referrer, concern around patient’s physical ability and access to PR (particularly for those in work), assumed poor patient motivation, no clear practice referrer and few referral opportunities. These mapped to domains: belief about capabilities, social influences, environment, optimism, skills and social and professional role. Enablers to referral were observed in knowledge, social influences memory and environment domains. Many PHCPs believed in the physical and psychological value of PR. Helpful enablers were out-of-practice support from respiratory interested colleagues, dedicated referral time (annual review) and on-screen referral prompts.

Conclusions

Referral to PR is complex. Barriers outweighed enablers. Aligning these findings to behaviour change techniques will identify interventions to overcome barriers and strengthen enablers, thereby increasing referral of patients with COPD to PR.

Quantifying within-city inequalities in child mortality across neighbourhoods in Accra, Ghana: a Bayesian spatial analysis

Por: Bixby · H. · Bennett · J. E. · Bawah · A. A. · Arku · R. E. · Annim · S. K. · Anum · J. D. · Mintah · S. E. · Schmidt · A. M. · Agyei-Asabere · C. · Robinson · B. E. · Cavanaugh · A. · Agyei-Mensah · S. · Owusu · G. · Ezzati · M. · Baumgartner · J.
Objective

Countries in sub-Saharan Africa suffer the highest rates of child mortality worldwide. Urban areas tend to have lower mortality than rural areas, but these comparisons likely mask large within-city inequalities. We aimed to estimate rates of under-five mortality (U5M) at the neighbourhood level for Ghana’s Greater Accra Metropolitan Area (GAMA) and measure the extent of intraurban inequalities.

Methods

We accessed data on >700 000 women aged 25–49 years living in GAMA using the most recent Ghana census (2010). We summarised counts of child births and deaths by five-year age group of women and neighbourhood (n=406) and applied indirect demographic methods to convert the summaries to yearly probabilities of death before age five years. We fitted a Bayesian spatiotemporal model to the neighbourhood U5M probabilities to obtain estimates for the year 2010 and examined their correlations with indicators of neighbourhood living and socioeconomic conditions.

Results

U5M varied almost five-fold across neighbourhoods in GAMA in 2010, ranging from 28 (95% credible interval (CrI) 8 to 63) to 138 (95% CrI 111 to 167) deaths per 1000 live births. U5M was highest in neighbourhoods of the central urban core and industrial areas, with an average of 95 deaths per 1000 live births across these neighbourhoods. Peri-urban neighbourhoods performed better, on average, but rates varied more across neighbourhoods compared with neighbourhoods in the central urban areas. U5M was negatively correlated with multiple indicators of improved living and socioeconomic conditions among peri-urban neighbourhoods. Among urban neighbourhoods, correlations with these factors were weaker or, in some cases, reversed, including with median household consumption and women’s schooling.

Conclusion

Reducing child mortality in high-burden urban neighbourhoods in GAMA, where a substantial portion of the urban population resides, should be prioritised as part of continued efforts to meet the Sustainable Development Goal national target of less than 25 deaths per 1000 live births.

Defining CD4 T helper and T regulatory cell endotypes of progressive and remitting pulmonary sarcoidosis (BRITE): protocol for a US-based, multicentre, longitudinal observational bronchoscopy study

Por: Koth · L. L. · Harmacek · L. D. · White · E. K. · Arger · N. K. · Powers · L. · Werner · B. R. · Magallon · R. E. · Grewal · P. · Barkes · B. Q. · Li · L. · Gillespie · M. · Collins · S. E. · Cardenas · J. · Chen · E. S. · Maier · L. A. · Leach · S. M. · OConnor · B. P. · Hamzeh · N. Y.
Introduction

Sarcoidosis is a multiorgan granulomatous disorder thought to be triggered and influenced by gene–environment interactions. Sarcoidosis affects 45–300/100 000 individuals in the USA and has an increasing mortality rate. The greatest gap in knowledge about sarcoidosis pathobiology is a lack of understanding about the underlying immunological mechanisms driving progressive pulmonary disease. The objective of this study is to define the lung-specific and blood-specific longitudinal changes in the adaptive immune response and their relationship to progressive and non-progressive pulmonary outcomes in patients with recently diagnosed sarcoidosis.

Methods and analysis

The BRonchoscopy at Initial sarcoidosis diagnosis Targeting longitudinal Endpoints study is a US-based, NIH-sponsored longitudinal blood and bronchoscopy study. Enrolment will occur over four centres with a target sample size of 80 eligible participants within 18 months of tissue diagnosis. Participants will undergo six study visits over 18 months. In addition to serial measurement of lung function, symptom surveys and chest X-rays, participants will undergo collection of blood and two bronchoscopies with bronchoalveolar lavage separated by 6 months. Freshly processed samples will be stained and flow-sorted for isolation of CD4 +T helper (Th1, Th17.0 and Th17.1) and T regulatory cell immune populations, followed by next-generation RNA sequencing. We will construct bioinformatic tools using this gene expression to define sarcoidosis endotypes that associate with progressive and non-progressive pulmonary disease outcomes and validate the tools using an independent cohort.

Ethics and dissemination

The study protocol has been approved by the Institutional Review Boards at National Jewish Hospital (IRB# HS-3118), University of Iowa (IRB# 201801750), Johns Hopkins University (IRB# 00149513) and University of California, San Francisco (IRB# 17-23432). All participants will be required to provide written informed consent. Findings will be disseminated via journal publications, scientific conferences, patient advocacy group online content and social media platforms.

Manual QT interval measurement with a smartphone-operated single-lead ECG versus 12-lead ECG: a within-patient diagnostic validation study in primary care

Por: Beers · L. · van Adrichem · L. P. · Himmelreich · J. C. L. · Karregat · E. P. M. · de Jong · J. S. S. G. · Postema · P. G. · de Groot · J. R. · Lucassen · W. A. M. · Harskamp · R. E.
Objective

To determine the accuracy of QT measurement in a smartphone-operated, single-lead ECG (1L-ECG) device (AliveCor KardiaMobile 1L).

Design

Cross-sectional, within-patient diagnostic validation study.

Setting/participants

Patients underwent a 12-lead ECG (12L-ECG) for any non-acute indication in primary care, April 2017–July 2018.

Intervention

Simultaneous recording of 1L-ECGs and 12L-ECGs with blinded manual QT assessment.

Outcomes of interest

(1) Difference in QT interval in milliseconds (ms) between the devices; (2) measurement agreement between the devices (excellent agreement

Results

250 ECGs of 125 patients were included. The mean QTc interval, using Bazett’s formula (QTcB), was 393±25 ms (mean±SD) in 1L-ECGs and 392±27 ms in lead I of 12L-ECGs, a mean difference of 1±21 ms, which was not statistically different (paired t-test (p=0.51) and Bland Altman method (p=0.23)). In terms of agreement between 1L-ECGs and lead I, QTcB had excellent agreement in 66.9% and clinically acceptable agreement in 93.4% of observations. The sensitivity and specificity of detecting extreme QTc were 0% and 99.2%, respectively. The comparison of 1L-ECG QTcB with lead II of 12L-ECGs showed a significant difference (p=

Conclusion

Smartphone-operated 1L-ECGs can be used to accurately measure the QTc interval compared with simultaneously obtained 12L-ECGs in a primary care population. This may provide an opportunity for monitoring the effects of potential QTc-prolonging medications.

Minimal versus specialist equipment in the delivery of pulmonary rehabilitation: protocol for a non-inferiority randomised controlled trial

Por: Nolan · C. M. · Walsh · J. A. · Patel · S. · Barker · R. E. · Polgar · O. · Maddocks · M. · Gao · W. · Wilson · R. · Fiorentino · F. · Man · W.
Introduction

Pulmonary rehabilitation (PR), an exercise and education programme for people with chronic lung disease, aims to improve exercise capacity, breathlessness and quality of life. Most evidence to support PR is from trials that use specialist exercise equipment, for example, treadmills (PR-gym). However, a significant proportion of programmes do not have access to specialist equipment with training completed with minimal exercise equipment (PR-min). There is a paucity of robust literature examining the efficacy of supervised, centre-based PR-min. We aim to determine whether an 8-week supervised, centre-based PR-min programme is non-inferior to a standard 8-week supervised, centre-based PR-gym programme in terms of exercise capacity and health outcomes for patients with chronic lung disease.

Methods and analysis

Parallel, two-group, assessor-blinded and statistician-blinded, non-inferiority randomised trial. 436 participants will be randomised using minimisation at the individual level with a 1:1 allocation to PR-min (intervention) or PR-gym (control). Assessment will take place pre-PR (visit 1), post-PR (visit 2) and 12 months following visit 1 (visit 3). Exercise capacity (incremental shuttle walk test), dyspnoea (Chronic Respiratory Questionnaire (CRQ)-Dyspnoea), health-related quality of life (CRQ), frailty (Short Physical Performance Battery), muscle strength (isometric quadriceps maximum voluntary contraction), patient satisfaction (Global Rating of Change Questionnaire), health economic as well as safety and trial process data will be measured. The primary outcome is change in exercise capacity between visit 1 and visit 2. Two sample t-tests on an intention to treat basis will be used to estimate the difference in mean primary and secondary outcomes between patients randomised to PR-gym and PR-min.

Ethics and dissemination

London-Camden and Kings Cross Research Ethics Committee and Health Research Authority have approved the study (18/LO/0315). Results will be submitted for publication in peer-reviewed journals, presented at international conferences, disseminated through social media, patient and public routes and directly shared with stakeholders.

Trial registration number

ISRCTN16196765.

Womens acceptability of and experience with primary human papillomavirus testing for cervix screening: HPV FOCAL trial cross-sectional online survey results

Por: Smith · L. W. · Racey · C. S. · Gondara · L. · Krajden · M. · Lee · M. · Martin · R. E. · Stuart · G. · Peacock · S. · Coldman · A. J. · Franco · E. L. · van Niekerk · D. · Ogilvie · G. S.
Objective

To study participant’s acceptability of and attitudes towards human papillomavirus (HPV) testing compared with cytology for cervical cancer screening and what impact having an HPV positive result may have in future acceptability of screening.

Design

Cross-sectional online survey of clinical trial participants.

Setting

Primary care, population-based Cervix Screening Program, British Columbia, Canada.

Participants

A total of 5532 participants from the HPV FOCAL trial, in which women received HPV and cytology testing at study exit, were included in the analysis. Median age was 54 years. The median time of survey completion was 3 years after trial exit.

Outcome measures

Acceptability of HPV testing for primary cervical cancer screening (primary); attitudes and patient perceptions towards HPV testing and receipt of HPV positive screen results (secondary).

Results

Most respondents (63%) were accepting of HPV testing, with the majority (69%) accepting screening to begin at age 30 years with HPV testing. Only half of participants (54%) were accepting of an extended screening interval of 4–5 years. In multivariable logistic regression, women who received an HPV positive screen test result during the trial (OR=1.41 95% CI 1.11 to 1.80) or were older (OR=1.01, 95% CI 1.00 to 1.02) were more likely to report HPV testing as acceptable.

Conclusions

In this evaluation of acceptability and attitudes regarding HPV testing for cervix screening, most are accepting of HPV testing for screening; however, findings indicate heterogeneity in concerns and experiences surrounding HPV testing and receipt of HPV positive results. These findings provide insights for the development of education, information and communication strategies during implementation of HPV-based cervical cancer screening.

Trial registration numbers

ISRCTN79347302 and NCT00461760.

A pilot randomised controlled trial of a structured, home-based exercise programme on cardiovascular structure and function in kidney transplant recipients: the ECSERT study design and methods

Por: Billany · R. E. · Vadaszy · N. · Bishop · N. C. · Wilkinson · T. J. · Adenwalla · S. F. · Robinson · K. A. · Croker · K. · Brady · E. M. · Wormleighton · J. V. · Parke · K. S. · Cooper · N. J. · Webster · A. C. · Barratt · J. · McCann · G. P. · Burton · J. O. · Smith · A. C. · Graham-B
Background

Cardiovascular disease (CVD) is a major cause of morbidity and mortality in kidney transplant recipients (KTRs). CVD risk scores underestimate risk in this population as CVD is driven by clustering of traditional and non-traditional risk factors, which lead to prognostic pathological changes in cardiovascular structure and function. While exercise may mitigate CVD in this population, evidence is limited, and physical activity levels and patient activation towards exercise and self-management are low. This pilot study will assess the feasibility of delivering a structured, home-based exercise intervention in a population of KTRs at increased cardiometabolic risk and evaluate the putative effects on cardiovascular structural and functional changes, cardiorespiratory fitness, quality of life, patient activation, healthcare utilisation and engagement with the prescribed exercise programme.

Methods and analysis

Fifty KTRs will be randomised 1:1 to: (1) the intervention; a 12week, home-based combined resistance and aerobic exercise intervention; or (2) the control; usual care. Intervention participants will have one introductory session for instruction and practice of the recommended exercises prior to receiving an exercise diary, dumbbells, resistance bands and access to instructional videos. The study will evaluate the feasibility of recruitment, randomisation, retention, assessment procedures and the intervention implementation. Outcomes, to be assessed prior to randomisation and postintervention, include: cardiac structure and function with stress perfusion cardiac MRI, cardiorespiratory fitness, physical function, blood biomarkers of cardiometabolic health, quality of life and patient activation. These data will be used to inform the power calculations for future definitive trials.

Ethics and dissemination

The protocol was reviewed and given favourable opinion by the East Midlands-Nottingham 2 Research Ethics Committee (reference: 19/EM/0209; 14 October 2019). Results will be published in peer-reviewed academic journals and will be disseminated to the patient and public community via social media, newsletter articles and presentations at conferences.

Trial registration number

NCT04123951.

Introducing patient and public involvement practices to healthcare research in Austria: strategies to promote change at multiple levels

Por: Kaisler · R. E. · Kulnik · S. T. · Klager · E. · Kletecka-Pulker · M. · Schaden · E. · Stainer-Hochgatterer · A.
Background

Patient and public involvement (PPI) in research is well-established in the UK. However, it can be challenging to introduce PPI to research communities where there is limited prior knowledge, experience or appreciation of PPI. We aimed to explore current PPI practices, experiences and ethical and operational challenges with PPI within our own research community in Austria, to inform strategies for supporting PPI in Austria going forward.

Methods

We surveyed scientists at 21 research institutes of the Ludwig Boltzmann Gesellschaft (LBG) and representatives of 32 medical and university research ethics committees in Austria using online questionnaires. We analysed quantitative data using descriptive statistics, and we collated textual responses to open questions. We combined survey data with anecdotal evidence from our personal experience to summarise current challenges around implementing PPI in Austria.

Results

Nineteen scientists from nine research institutes indicated generally positive attitudes towards PPI. However, the majority reported they rarely or never involved patients and members of the public in roles of consultation, collaboration or control in research. Six of eight ethics committees were unfamiliar with PPI. We discern five current challenges to implementing PPI in Austria: lack of knowledge and skills for PPI among scientists, scepticism about the usefulness of PPI, conflation of PPI with qualitative research, uncertainty about ethical requirements for PPI and uncertainty about publishing PPI activities.

Discussion

We suggest that the provision of guidance about ethical requirements of PPI is a strategic priority. To address this, and following on from a recently introduced PPI training and grant scheme by the LBG, our surveys have initiated a dialogue with ethics committees and have informed the development of a checklist for ethical aspects of PPI.

Conclusion

Our experiences may provide useful examples to others who seek to introduce or strengthen PPI practices within their own research communities.

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