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Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness-implementation randomised controlled trial

Por: Kastner · M. · Makarski · J. · Hayden · L. · Hamid · J. S. · Holroyd-Leduc · J. · Twohig · M. · Macfarlane · C. · Hynes · M. T. · Prasaud · L. · Sklar · B. · Honsberger · J. · Wang · M. · Kramer · G. · Hobden · G. · Armson · H. · Ivers · N. · Leung · F.-H. · Liu · B. · Marr · S. · Greiver · M
Introduction

In response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called ‘KeepWell’ that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.

Methods and analysis

We will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness–implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.

Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.

Ethics and dissemination

Ethics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.

Trial registration number

NCT04437238.

Population-based otoscopic and audiometric assessment of a birth cohort recruited for a pneumococcal vaccine trial 15-18 years earlier: a protocol

Por: Chan · K. · Carosone-Link · P. · Bautista · M. T. G. · Sanvictores · D. · Uhler · K. · Tallo · V. · Lucero · M. G. · De Jesus · J. · Simoes · E. A. F.
Introduction

A cohort of 12 000 children in the Philippines who had enrolled in a 2000–2004 (current ages 16 to 20 years) Phase 3 11-valent pneumococcal conjugate vaccine for the prevention of radiographically confirmed pneumonia are now being asked to participate in a separate study (expected completion date September 2021) to assess the cohort’s current long-term audiometric and otologic status. This new study would allow assessments of the utility of the pneumococcal vaccine in conferring its protective effects on the long-term sequelae of otitis media (OM), if any. Lack of trained local healthcare providers in otolaryngology/audiology and testing equipment in Bohol, Philippines, necessitates the development of a distinct methodology that would lead to meaningful data analysis.

Methods and analysis

Reliable data collection and transfer are achieved by a US otolaryngologist/audiologist team training local nurses on all procedures in a didactic and hands-on process. An assortment of portable otolaryngologic and audiologic equipment suitable for field testing has been acquired, including an operating otoscope (Welch-Allyn), a video-otoscope (JedMed), a tympanometer with distortion product otoacoustic emission measurements (Path Sentiero) and a screening audiometer (HearScreen). Data will then be uploaded to a Research Electronic Data Capture database in the USA.

Tympanometric and audiologic data will be codified through separate conventional algorithms. A team of paediatric otolaryngology advanced practice providers (APPs) have been trained and validated in interpreting video otoscopy. The protocol for classification of diagnostic outcome variables based on video otoscopy and tympanometry has been developed and is being used by APPs to evaluate all otoscopy data.

Ethics and dissemination

The study was approved by the Research Institute of Tropical Medicine, Alabang, Manila, Philippines, and the institutional review board and the Colorado Multiple Institutional Review Board of the University of Colorado School of Medicine, Aurora, Colorado, USA.

Research results will be made available to children and their caregivers with abnormal audiologic outcomes, the funders and other researchers.

Trial registration number

ISRCTN 62323832; Post-results.

Protocol for a quasi-experimental study to assess the feasibility, acceptability and costs of multiple first-lines artemisinin-based combination therapies for uncomplicated malaria in the Kaya health district, Burkina Faso

Por: SIRIBIE · M. · Tchouatieu · A.-M. · Soulama · I. · Kabore · J. M. T. · Nombre · Y. · Hien · D. · Kiba Koumare · A. · Barry · N. · Baguiya · A. · Hema · A. · Dianda · F. · Savadogo · Y. · Kouanda · S. · Tiono · A. B. · Sirima · S. B.
Introduction

As demonstrated in mathematical models, the simultaneous deployment of multiple first-line therapies (MFT) for uncomplicated malaria, using artemisinin-based combination therapies (ACTs), may extend the useful therapeutic life of the current ACTs. This is possible by reducing drug pressure and slowing the spread of resistance without putting patients’ life at risk. We hypothesised that a simultaneous deployment of three different ACTs is feasible, acceptable and can achieve high coverage rate if potential barriers are properly identified and addressed.

Methods and analysis

We plan to conduct a quasi-experimental study in the Kaya health district in Burkina Faso. We will investigate a simultaneous deployment of three ACTs, artemether–lumefantrine, pyronaridine–artesunate, dihydroartesinin–piperaquine, targeting three segments of the population: pregnant women, children under five and individuals aged five years and above. The study will include four overlapping phases: the formative phase, the MFT deployment phase, the monitoring and evaluation phase and the post-evaluation phase. The formative phase will help generate baseline information and develop MFT deployment tools. It will be followed by the MFT deployment phase in the study area. The monitoring and evaluation phase will be conducted as the deployment of MFT progresses. Cross-sectional surveys including desk reviews as well as qualitative and quantitative research methods will be used to assess the study outcomes. Quantitatives study outcomes will be measured using univariate, bivariate and multivariate analysis, including logistic regression and interrupted time series analysis approach. Content analysis will be performed on the qualitative data.

Ethics and dissemination

The Health Research Ethics Committee in Burkina Faso approved the study (Clearance no. 2018-8-113). Study findings will be disseminated through feedback meetings with local communities, national workshops, oral presentations at congresses, seminars and publications in peer-reviewed scientific journals.

Trial registration number

NCT04265573.

Retrospective cohort study evaluating clinical, biochemical and pharmacological prognostic factors for prostate cancer progression using primary care data

Por: Merriel · S. W. D. · Ingle · S. M. · May · M. T. · Martin · R. M.
Objectives

To confirm the association of previously reported prognostic factors with future progression of localised prostate cancer using primary care data and identify new potential prognostic factors for further assessment in prognostic model development and validation.

Design

Retrospective cohort study, employing Cox proportional hazards regression controlling for age, prostate specific antigen (PSA), and Gleason score, was stratified by diagnostic stage.

Setting

Primary care in England.

Participants

Males with localised prostate cancer diagnosedbetween 01/01/1987 and 31/12/2016 within the Clinical Practice ResearchDatalink database, with linked data from the National Cancer Registration andAnalysis Service and Office for National Statistics.

Primary and secondary outcomes

Primary outcome measure was prostate cancer mortality. Secondary outcome measures were all-cause mortality and commencing systemic therapy. Up-staging after diagnosis was not used as a secondary outcome owing to significant missing data.

Results

10 901 men (mean age 74.38±9.03 years) with localised prostate cancer were followed up for a mean of 14.12 (±6.36) years. 2331 (21.38%) men underwent systemic therapy and 3450 (31.65%) died, including 1250 (11.47%) from prostate cancer. Factors associated with an increased risk of prostate cancer mortality included age; high PSA; current or ex-smoker; ischaemic heart disease; high C reactive protein; high ferritin; low haemoglobin; high blood glucose and low albumin.

Conclusions

This study identified several new potential prognostic factors for prostate cancer progression, as well as confirming some known prognostic factors, in an independent primary care data set. Further research is needed to develop and validate a prognostic model for prostate cancer progression.

Burn-out syndrome in Spanish internists during the COVID-19 outbreak and associated factors: a cross-sectional survey

Objectives

The objective of this study is to evaluate the impact of the COVID-19 outbreak on mental health and burn-out syndrome in Spanish internists and the factors that could be related to its appearance.

Design

We performed an observational, cross-sectional, descriptive study for which we designed a survey that was distributed in May 2020.

Setting

We included internists who worked in Spain during the COVID-19 outbreak.

Participants

A total of 1015 internists responded to the survey. Of those 62.9% were women.

Results

Of 1015 people, 58.3% presented with high emotional exhaustion, 61.5% had a high level of depersonalisation and 67.6% reported low personal fulfilment. 40.1% presented with the 3 criteria described, and therefore burn-out syndrome.

Burn-out syndrome was independently related to the management of patients with SARS-CoV-2 (HR: 2.26; 95% CI 1.15 to 4.45), the lack of availability of personal protective equipment (HR: 1.41; 95% CI 1.05 to 1.91), increased responsibility (HR: 2.13; 95% CI 1.51 to 3.01), not having received financial compensation for overtime work (HR: 0.43; 95% CI 0.31 to 0.62), not having rested after 24-hour shifts (HR: 1.61; 95% CI 1.09 to 2.38), not having had holidays in the previous 6 months (HR: 1.36; 95% CI 1.01 to 1.84), consumption of sleeping pills (HR: 1.83; 95% CI 1.28 to 2.63) and higher alcohol intake (HR: 1.95; 95% CI 1.39 to 2.73).

Conclusions

During the COVID-19 outbreak, 40.1% of Internal Medicine physicians in Spain presented with burn-out syndrome, which was independently related to the assistance of patients with SARS-CoV-2, overworking without any compensation and the fear of being contagious to their relatives. Therefore, it is imperative to initiate programmes to prevent and treat burn-out in front-line physicians during the COVID-19 outbreak.

National, clinical cohort study of late effects among survivors of acute lymphoblastic leukaemia: the ALL-STAR study protocol

Por: Andres-Jensen · L. · Skipper · M. T. · Mielke Christensen · K. · Hedegaard Johnsen · P. · Aagaard Myhr · K. · Kaj Fridh · M. · Grell · K. · Pedersen · A. M. L. · Leisgaard Morck Rubak · S. · Ballegaard · M. · Horlyck · A. · Beck Jensen · R. · Lambine · T.-L. · Gjerum Nielsen · K.
Introduction

More than 90% of patients diagnosed with childhood acute lymphoblastic leukaemia (ALL) today will survive. However, half of the survivors are expected to experience therapy-related chronic or late occurring adverse effects, reducing quality of life. Insight into underlying risk trajectories is warranted. The aim of this study is to establish a Nordic, national childhood ALL survivor cohort, to be investigated for the total somatic and psychosocial treatment-related burden as well as associated risk factors, allowing subsequent linkage to nation-wide public health registers.

Methods and analysis

This population-based observational cohort study includes clinical follow-up of a retrospective childhood ALL survivor cohort (n=475), treated according to a common Nordic ALL protocol during 2008–2018 in Denmark. The study includes matched controls. Primary endpoints are the cumulative incidence and cumulative burden of 197 health conditions, assessed through self-report and proxy-report questionnaires, medical chart validation, and clinical examinations. Secondary endpoints include organ-specific outcome, including cardiovascular and pulmonary function, physical performance, neuropathy, metabolic disturbances, hepatic and pancreatic function, bone health, oral and dental health, kidney function, puberty and fertility, fatigue, and psychosocial outcome. Therapy exposure, acute toxicities, and host genome variants are explored as risk factors.

Ethics and dissemination

The study is approved by the Regional Ethics Committee for the Capital Region in Denmark (H-18035090/H-20006359) and by the Danish Data Protection Agency (VD-2018–519). Results will be published in peer-reviewed journals and are expected to guide interventions that will ameliorate the burden of therapy without compromising the chance of cure.

Coping with multiple morbidities: Asian perspectives to inform culturally appropriate caregiving

Por: Zhan · X. · Wenchung · W. · Lin · H. · Jingran · L. · Li · B. · Li · M. T. · Tian Fu · R. · Wu · Y. · Wu · X. · Shi · X. · Lee · A. J. · Shengxiao · X.

Commentary on: Cheng Cheng, Bai Jie, Yang Cong-Yan et al. Patients' experiences of coping with multiple chronic conditions: a qualitative descriptive study. J Clin Nurs, 2019, 28: 4400–11.

Implications for practice and research

  • Healthcare professionals must acknowledge cultural differences in coping strategies and must communicate effectively to inform caregiving.

  • Further qualitative, descriptive studies are required to explore the needs of patients so this information can inform culturally sensitive and appropriate care.

  • Context

    As prevalence of multiple chronic conditions (MCC) increases, financial, personal and institutional burdens will rise.1 Complexities require more information on polypharmacy, disease management and assessments of impact on service provision.2 This qualitative study3 evaluates how patients cope with their diagnoses and manage their own symptoms. It offers a cultural perspective on the burdens of chronic disease management and presents guidance on coping strategies used in Chinese...

    Health care professionals’ competence in stroke care pathways: a mixed‐method systematic review

    Abstract

    Background

    The challenges of caring for stroke patients are growing due to population ageing and improved survival rates. Health care professionals’ competence development in stroke care is a necessity to ensure high‐quality patient care.

    Objectives

    To identify and describe the competence areas of health care professionals working in the stroke patient care pathway and factors influencing these competences.

    Design

    A mixed‐method systematic review.

    Methods

    The review was conducted according to the JBI guidelines and registered in the PROSPERO database (CRD42020204062). PRISMA checklist guided the review process. Relevant original studies were identified by searching four databases – CINAHL (EBSCO), PubMed, Scopus and Medic. After researcher consensus was reached, 32 studies were selected for inclusion and subjected to content analysis and data tabulation.

    Results

    Competence in care processes, clinical competence, competence in using self‐management strategies, interaction skills, skills in acknowledging family and competence in integrating the available evidence base into patient care were identified as key competence areas. Organisation of services, specialization in stroke care, continuous development and education, family and carer and training in oral care and cognitive rehabilitation were identified as factors that influence health care professionals’ competence.

    Conclusions

    Diverse clinical and interaction competencies are needed throughout the stroke care pathway and various factors affect health care professionals’ competence. Further research on health care professionals’ stroke care competence will be needed to respond to changing healthcare demand.

    Relevance to clinical practice

    We recommend organizational support and formulation of stroke care patient guidelines in line with health care competence requirements. Focus should be added for nursing professions in developing interactive communication competence since nurses spend the majority of the time providing individual patient care. Also, organizations should integrate continuing training in specialized stroke care for health care professionals' competence development.

    Caregiver autonomy support: A systematic review of interventions for adults with chronic illness and their caregivers with narrative synthesis

    Abstract

    Chronic illnesses cause significant mortality in adults. Caregivers (spouses, adult children, friends) support adults with chronic illness in multiple ways, for instance through support of their autonomous decisions about how and why to engage in self‐care.

    Aim

    To examine interventions designed to improve the health and well‐being of adults with chronic illness by enhancing the autonomy supportive behaviours of caregivers.

    Design

    Systematic review of randomized controlled trials with narrative synthesis.

    Data sources

    All available dates of publication through August 2020 conducted in PubMed, Medline, Ageline, PsychInfo, and CINAHL.

    Methods

    Randomized controlled interventions of adults with chronic illness and their caregivers with content to enhance caregiver autonomy support were included. Interventions involving healthcare personnel, adults without self‐care capacity, or not published in English were excluded. Quality was appraised using Joanna Briggs Institute recommendations. Common themes in autonomy support and associated outcomes (e.g., self‐care, social support) were synthesized.

    Results

    Search identified 1,426 studies with 16 included in review (N = 2,486 dyads). Methodological quality was moderate. Successful interventions were skills‐based, targeted various communication styles, contained in‐person elements, and involved nurses. Half of the interventions assessed autonomy support outcomes; 63% (5 of 8) of these improved autonomy support. Results were generally positive for social support, mixed for self‐care, and null for caregiver burden. Heterogeneity and complexity of studies limited attribution of effects.

    Conclusion

    Behavioural interventions designed to enhance dyadic caregiver interpersonal communication to be autonomy supportive may positively influence caregiver skills and chronic illness outcomes. Future studies of autonomy support are needed to identify core intervention components.

    Impact

    This is the first systematic review examining interventions promoting caregiver to care‐receiver autonomy support. Modifying interpersonal communication to be autonomy supportive has potential to improve chronic illness outcomes. Findings can inform how clinicians and investigators enlist caregiver autonomy support to encourage behaviour change.

    Multidimensional assessment of women after severe maternal morbidity: the COMMAG cohort study

    Por: Ferreira · E. C. · Costa · M. L. · Pacagnella · R. C. · Silveira · C. · Andreucci · C. B. · Zanardi · D. M. T. · Santos · J. P. · Angelini · C. R. · Souza · R. T. · Parpinelli · M. A. · Sousa · M. H. · Cecatti · J. G.
    Objectives

    To perform a multidimensional assessment of women who experienced severe maternal morbidity (SMM) and its short-term and medium-term impact on the lives and health of women and their children.

    Design

    A retrospective cohort study.

    Setting

    A tertiary maternity hospital from the southeast region of Brazil.

    Participants

    The exposed population was selected from intensive care unit admissions if presenting any diagnostic criteria for SMM. Controls were randomly selected among women without SMM admitted to the same maternity and same time of childbirth.

    Primary and secondary outcome variables

    Validated tools were applied, addressing post-traumatic stress disorder (PTSD) and quality of life (SF-36) by phone, and then general and reproductive health, functioning (WHO Disability Assessment Schedule), sexual function (Female Sexual Function Index (FSFI)), substance abuse (Alcohol, Smoking and Substance Involvement Screening Test 2.0) and growth/development (Denver Developmental Screening Test) of children born in the index pregnancy in a face-to-face interview.

    Results

    All instruments were applied to 638 women (315 had SMM; 323 were controls, with the assessment of 264 and 307 children, respectively). SF-36 score was significantly lower in the SMM group, while PTSD score was similar between groups. Women who had SMM became more frequently sterile, had more abnormal clinical conditions after the index pregnancy and a higher score for altered functioning, while proportions of FSFI score or any drug use were similar between groups. Furthermore, children from the SMM group were more likely to have weight (threefold) and height (1.5 fold) for age deficits and also impaired development (1.5-fold).

    Conclusion

    SMM impairs some aspects of the lives of women and their children. The focus should be directed towards monitoring these women and their children after birth, ensuring accessibility to health services and reducing short-term and medium-term repercussions on physical, reproductive and psychosocial health.

    Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort

    Por: Zaghloul · H. · Chagoury · O. · Elhadad · S. · Hayder Ahmed · S. · Suleiman · N. · Al Naama · A. · El Nahas · K. · Al Hamaq · A. · Charlson · M. · Wells · M. T. · Al Abdulla · S. · Abou-Samra · A. B. · Taheri · S.
    Objectives

    Diabetes Intervention Accentuating Diet and Enhancing Metabolism-I (DIADEM-I) is the first randomised controlled trial (RCT) in the Middle East and North Africa (MENA) region testing the effectiveness of an intensive lifestyle intervention (ILI) for weight loss and diabetes remission. We report on the recruitment process and baseline characteristics of the DIADEM-I cohort based on origin (Middle East vs North Africa), and waist circumference.

    Design

    DIADEM-I is an open-label randomised, controlled, parallel group RCT recruiting young individuals (18–50 years) with early type 2 diabetes (≤3 years since diagnosis) originating from MENA. Individuals from primary care were randomised to usual medical care or ILI (total dietary replacement phase using meal replacement products, followed by staged food reintroduction and physical activity support). The primary outcome is weight loss at 12 months. Other outcomes are glycaemic control and diabetes remission.

    Setting

    Primary care, Qatar.

    Participants

    147 (73% men) randomised within DIADEM-I who were included in the final trial data analysis.

    Outcome measures

    Recruitment metrics, and baseline clinical and metabolic characteristics.

    Results

    Of 1498 people prescreened, 267 (18%) were invited for screening and 209 (78%) consented. 173 (83%) were eligible. 15 (7%) withdrew before randomisation and the remaining 158 were randomised. Mean age was 42.1 (SD 5.6) years and mean body mass index was: 36.3 (5.5) kg/m2 (women) and 34.4 (5.4) kg/m2 (men). Mean diabetes duration was 1.8 (1.0) years and mean glycosylated haemoglobin (HbA1c) was 7.0% (1.30) (52.5 mmol/mol (SD 14.3)). Participants originated from 13 countries. Those from North Africa reported greater physical activity and had lower family history of diabetes. 90% of subjects were taking diabetes medications and 31% antihypertensives. Those with greater waist circumference had significantly higher insulin resistance and lower quality of life.

    Conclusion

    Recruitment of participants originating from the MENA region into the RCT was successful, and study participation was readily accepted. While DIADEM-I participants originated from 13 countries, there were few baseline differences amongst participants from Middle East versus North Africa, supporting generalisability of RCT results.

    Trial registration number

    ISRCTN20754766; NCT03225339

    Cost-effectiveness analysis of PET/CT surveillance imaging to detect systemic recurrence in resected stage III melanoma: study protocol

    Por: Dieng · M. · Khanna · N. · Nguyen · M. T. H. · Turner · R. · Lord · S. J. · Menzies · A. M. · Allen · J. · Saw · R. · Nieweg · O. E. · Thompson · J. · Morton · R. L.
    Introduction

    In the new era of effective systemic therapies for advanced melanoma, early detection of lower volume recurrent disease using surveillance imaging can improve survival. However, intensive imaging follow-up strategies are likely to increase costs to health systems and may pose risks to patients. The objective of this study is to estimate from the Australian health system perspective the cost-effectiveness of four follow-up strategies in resected stage III melanoma over a 5-year period following surgical treatment with curative intent.

    Methods and analysis

    A decision-analytic model will be built to estimate the costs and benefits of (1) 12 monthly, (2) 6 monthly, (3) 3–4 monthly positron emission tomography/CT imaging for 5 years, compared with (4) no imaging follow-up. The model will be populated with probabilities of disease recurrence, test performance measures using data from >1000 consecutive resected stage III melanoma patients from Melanoma Institute Australia diagnosed between 2000 and 2017. Healthcare resource use, including surveillance imaging, doctor’s visits, subsequent tests and procedures to investigate suspicious findings, will be quantified from detailed patient records and valued using Australian reference pricing. Economic outcomes include cost per new distant melanoma recurrence detected and cost per diagnostic error avoided, for no imaging compared with the other strategies.

    Deterministic sensitivity analyses will examine the robustness of model results.

    Ethics and dissemination

    This study was approved by the Sydney Local Health District, Sydney Local Health District Ethics Review Committee (RPAH Zone), AU/1/830638 and the Australian Institute of Health and Welfare (EO2019-1-454). The results of this study will be published in peer-reviewed medical and health economics journals and will inform melanoma management guidelines.

    Respiratory function and respiratory complications in spinal cord injury: protocol for a prospective, multicentre cohort study in high-income countries

    Por: Raab · A. M. · Brinkhof · M. W. G. · Berlowitz · D. J. · Postma · K. · Gobets · D. · Hirschfeld · S. · Hopman · M. T. E. · Huber · B. · Hund-Georgiadis · M. · Jordan · X. · Schubert · M. · Wildburger · R. · Mueller · G.
    Introduction

    Pneumonia is one of the leading complications and causes of death after a spinal cord injury (SCI). After a cervical or thoracic lesion, impairment of the respiratory muscles decreases respiratory function, which increases the risk of respiratory complications. Pneumonia substantially reduces patient’s quality of life, may prolong inpatient rehabilitation time, increase healthcare costs or at worse, lead to early death. Respiratory function and coughing can be improved through various interventions after SCI, but the available evidence as to which aspect of respiratory care should be optimised is inconclusive. Furthermore, ability of respiratory function parameters to predict pneumonia risk is insufficiently established. This paper details the protocol for a large-scale, multicentre research project that aims to evaluate the ability of parameters of respiratory function to predict and understand variation in inpatient risk of pneumonia in SCI.

    Methods and analysis

    RESCOM, a prospective cohort study, began recruitment in October 2016 across 10 SCI rehabilitation centres from Australia, Austria, Germany, the Netherlands and Switzerland. Inpatients with acute SCI, with complete or incomplete cervical or thoracic lesions, 18 years or older and not/no more dependent on 24-hour mechanical ventilation within the first 3 months after injury are eligible for inclusion. The target sample size is 500 participants. The primary outcome is an occurrence of pneumonia; secondary outcomes include pneumonia-related mortality and quality of life. We will use the longitudinal data for prognostic models on inpatient pneumonia risk factors.

    Ethics and dissemination

    The study has been reviewed and approved by all local ethics committees of all participating centres. Study results will be disseminated to the scientific community through peer-reviewed journals and conference presentations, to the SCI community, other stakeholders and via social media, newsletters and engagement activities.

    Trial registration details

    ClinicalTrials.gov NCT02891096.

    Puff or pass: do social media and social interactions influence smoking behaviour of university students? A cross-sectional mixed methods study from Dhaka, Bangladesh

    Por: Roby · N. U. · Hasan · M. T. · Hossain · S. · Christopher · E. · Ahmed · M. K. · Chowdhury · A. B. · Hasan · S. · Ashraf · F.
    Objective

    To determine whether the odds of being a smoker differ based on social media use and social interactions among urban university students in Bangladesh.

    Hypothesis

    Social media use and social interactions influence the smoking behaviour of Bangladeshi university students, particularly in starting and maintaining cigarette smoking.

    Design and setting

    A cross-sectional study using mixed methods on 600 student smokers and non-smokers recruited from two public and two private universities in Dhaka, Bangladesh, a lower middle-income country with limited resources. Exclusion criteria were those who did not use any form of social media and PhD students.

    Results

    Odds of smoking were significantly higher for those who socialised more than 4 hours/day (p

    Conclusion

    This study suggests social media and social interactions may influence smoking behaviour in university students in Dhaka, Bangladesh. Future research should continue to investigate the roles social media and social interaction have on smoking in order to explore social media-based smoking cessation interventions or dissemination of smoking health hazards through social media.

    Pronounced haemodynamic changes during and after robotic-assisted laparoscopic prostatectomy: a prospective observational study

    Por: Pawlik · M. T. · Prasser · C. · Zeman · F. · Harth · M. · Burger · M. · Denzinger · S. · Blecha · S.
    Objectives

    Robotic-assisted laparoscopic prostatectomy (RALP) is typically conducted in steep Trendelenburg position (STP). This study investigated the influence of permanent 45° STP and capnoperitoneum on haemodynamic parameters during and after RALP.

    Design

    Prospective observational study.

    Setting

    Haemodynamic changes were recorded with transpulmonary thermodilution and pulse contour analysis in men undergoing RALP under standardised anaesthesia.

    Participants

    Informed consent was obtained from 51 patients scheduled for elective RALP in a University Medical Centre in Germany.

    Interventions

    Heart rate, mean arterial pressure, central venous pressure (CVP), Cardiac Index (CI), systemic vascular resistance (SVR), Global End-Diastolic Volume Index (GEDI), global ejection fraction (GEF), Cardiac Power Index (CPI) and stroke volume variation (SVV) were recorded at six time points: 20 min after induction of anaesthesia (T1), after insufflation of capnoperitoneum in supine position (T2), after 30 min in STP (T3), when controlling Santorini’s plexus in STP (T4), before awakening in supine position (T5) and after 45 min in the recovery room (T6). Adverse cardiac events were registered intraoperatively and postoperatively.

    Results

    All haemodynamic parameters were significantly changed by capnoperitoneum and STP during RALP and partly normalised at T6. CI, GEF and CPI were highest at T6 (CI: 3.9 vs 2.2 L/min/m²; GEF: 26 vs 22%; CPI: 0.80 vs 0.39 W/m²; p

    Conclusions

    RALP led to pronounced perioperative haemodynamic changes. The combination of increased cardiac contractility and heart rate reflects a hyperdynamic situation during and after RALP. Anaesthesiologists should be aware of unnoticed pre-existing heart failure to worsen during STP in patients undergoing RALP.

    Cohort profile: Oxford Pain, Activity and Lifestyle (OPAL) Study, a prospective cohort study of older adults in England

    Por: Sanchez Santos · M. T. · Williamson · E. · Bruce · J. · Ward · L. · Mallen · C. D. · Garrett · A. · Morris · A. · Lamb · S. E. · on behalf of the OPAL study team · Conway · Darton · Dutton · Hagan · Haywood · Hewitt · Marian · Nevay · Nicolson · Slark · Vadher · Watson · Williamson
    Purpose

    The ‘Oxford Pain, Activity and Lifestyle’ (OPAL) Cohort is a longitudinal, prospective cohort study of adults, aged 65 years and older, living in the community which is investigating the determinants of health in later life. Our focus was on musculoskeletal pain and mobility, but the cohort is designed with flexibility to include new elements over time. This paper describes the study design, data collection and baseline characteristics of participants. We also compared the OPAL baseline characteristics with nationally representative data sources.

    Participants

    We randomly selected eligible participants from two stratified age bands (65–74 and 75 and over years). In total, 5409 individuals (42.1% of eligible participants) from 35 general practices in England agreed to participate between 2016 and 2018. The majority of participants (n=5367) also consented for research team to access their UK National Health Service (NHS) Digital and primary healthcare records.

    Findings to date

    Mean participant age was 74.9 years (range 65–100); 51.5% (n=2784/5409) were women. 94.9% of participants were white, and 28.8% lived alone. Over 83.0% reported pain in at least one body area in the previous 6 weeks. Musculoskeletal symptoms were more prevalent in women (86.4%). One-third of participants reported having one or more falls in the last year. Most participants were confident in their ability to walk outside. The characteristics of OPAL Cohort participants were broadly similar to the general population of the same age.

    Future plans

    Postal follow-up of the cohort is being undertaken at annual intervals, with data collection ongoing. Linkage to NHS hospital admission data is planned. This English prospective cohort offers a large and rich resource for research on the longitudinal associations between demographic, clinical, and social factors and health trajectories and outcomes in community-dwelling older people.

    Psychological distress among refugees in Germany: a cross-sectional analysis of individual and contextual risk factors and potential consequences for integration using a nationally representative survey

    Por: Walther · L. · Kröger · H. · Tibubos · A. N. · Ta · T. M. T. · von Scheve · C. · Schupp · J. · Hahn · E. · Bajbouj · M.
    Objectives

    Responding to the mental health needs of refugees remains a pressing challenge worldwide. We estimated the prevalence of psychological distress in a large refugee population in Germany and assessed its association with host country factors amenable to policy intervention and integration indicators.

    Design

    A cross-sectional and population-based secondary analysis of the 2017 wave of the IAB-BAMF-SOEP refugee survey.

    Setting

    Germany.

    Participants

    2639 adult refugees who arrived in Germany between 2013 and 2016.

    Main outcome measures

    Psychological distress involving symptoms of depression, anxiety and post-traumatic stress disorder was measured using the Refugee Health Screener-13.

    Results

    Almost half of the population surveyed (41.2% (95% CI: 37.9% to 44.6%)) was affected by mild, moderate or severe levels of psychological distress. 10.9% (8.4% to 13.5%) of the population screened positive for severe distress indicative of an urgent need for care. Prevalence of distress was particularly high for females (53.0% (47.2% to 58.8%)), older refugees (aged ≥55, 70.4% (58.5% to 82.2%)) and Afghans (61.5% (53.5% to 69.5%)). Individuals under threat of deportation were at a greater risk of distress than protection status holder (risk ratio: 1.55 (95% CI: 1.14 to 2.10)), single males at a greater risk than males with nuclear families living in Germany (1.34 (1.04 to 1.74)) and those in refugee housing facilities at a greater risk than those in private housing (1.21 (1.02 to 1.43)). Distressed males had a lower likelihood of employment (0.67 (0.52 to 0.86)) and reduced participation in integration courses (0.90 (0.81 to 0.99)). A trend of reduced participation in educational programmes was observed in affected females (0.42 (0.17 to 1.01)).

    Conclusion

    The finding that a substantial minority of refugees in Germany exhibits symptoms of distress calls for an expansion of mental health services for this population. Service providers and policy-makers should consider the increased prevalence among female, older and Afghan refugees, as well as among single males, residents in housing facilities and those under threat of deportation. The associations between mental health and integration processes such as labour market, educational programme and integration course participation also warrant consideration.

    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/).

    Cohort profile: the Oxford Parkinsons Disease Centre Discovery Cohort MRI substudy (OPDC-MRI)

    Por: Griffanti · L. · Klein · J. C. · Szewczyk-Krolikowski · K. · Menke · R. A. L. · Rolinski · M. · Barber · T. R. · Lawton · M. · Evetts · S. G. · Begeti · F. · Crabbe · M. · Rumbold · J. · Wade-Martins · R. · Hu · M. T. · Mackay · C.
    Purpose

    The Oxford Parkinson’s Disease Centre (OPDC) Discovery Cohort MRI substudy (OPDC-MRI) collects high-quality multimodal brain MRI together with deep longitudinal clinical phenotyping in patients with Parkinson’s, at-risk individuals and healthy elderly participants. The primary aim is to detect pathological changes in brain structure and function, and develop, together with the clinical data, biomarkers to stratify, predict and chart progression in early-stage Parkinson’s and at-risk individuals.

    Participants

    Participants are recruited from the OPDC Discovery Cohort, a prospective, longitudinal study. Baseline MRI data are currently available for 290 participants: 119 patients with early idiopathic Parkinson’s, 15 Parkinson’s patients with pathogenic mutations of the leucine-rich repeat kinase 2 or glucocerebrosidase (GBA) genes, 68 healthy controls and 87 individuals at risk of Parkinson’s (asymptomatic carriers of GBA mutation and patients with idiopathic rapid eye movement sleep behaviour disorder-RBD).

    Findings to date

    Differences in brain structure in early Parkinson’s were found to be subtle, with small changes in the shape of the globus pallidus and evidence of alterations in microstructural integrity in the prefrontal cortex that correlated with performance on executive function tests. Brain function, as assayed with resting fMRI yielded more substantial differences, with basal ganglia connectivity reduced in early Parkinson’sand RBD. Imaging of the substantia nigra with the more recent adoption of sequences sensitive to iron and neuromelanin content shows promising results in identifying early signs of Parkinsonian disease.

    Future plans

    Ongoing studies include the integration of multimodal MRI measures to improve discrimination power. Follow-up clinical data are now accumulating and will allow us to correlate baseline imaging measures to clinical disease progression. Follow-up MRI scanning started in 2015 and is currently ongoing, providing the opportunity for future longitudinal imaging analyses with parallel clinical phenotyping.

    Psychological distress among mountainous farmers in Vietnam: a cross-sectional study of prevalence and associated factors

    Por: Hoang · M. T. · Do · K. N. · Pham · H. Q. · Nguyen · C. T. · Ha · G. H. · Vu · G. T. · Tran · B. X. · Latkin · C. · Ho · R. C. M. · Ho · C. S.
    Background

    Psychological distress has been known as a major health problem among farmers across the world. In Vietnam, approximately 50% of farmers have lived in rural and mountainous areas. Yet, little has been known about how psychological distress impacts mountainous farmers’ health.

    Objectives

    This study aimed to examine the prevalence and risk factors related to psychological distress among mountainous farmers in Vietnam.

    Design and setting

    A cross-sectional study was performed from August to September 2018 in Moc Chau district, Vietnam. A structured questionnaire and face-to-face interviews were used for data collection.

    Participants

    A random sample of 197 farmers aged at least 18 years, spoke Vietnamese, was not suffering from severe diseases and residing in Moc Chau at the time of the survey were recruited.

    Primary and secondary outcome measures

    The Kessler Psychological Distress Scale (K6) was employed to measure psychological distress. The tobit and logistic regressions were applied to indicate associated factors.

    Results

    The prevalence of psychological distress was 38.2% (95% CI 31.3% to 45.5%). Having a greater comorbidities (OR=6.17; 95% CI 1.44 to 26.43), drinking alcohol (OR=3.86; 95% CI 1.02 to 14.59) and obtaining health information from health workers (OR=3.77; 95% CI 1.22 to 11.66) were positively associated with the prevalence of psychological distress. By contrast, being overweight (OR=0.29; 95% CI 0.09 to 0.93), adopting books as the primary source of health information (OR=0.11; 95% CI 0.01 to 0.8), and receiving a higher number of home visits by community health workers (CHWs) (OR=0.38; 95% CI 0.14 to 0.99) were negatively associated with the prevalence of psychological distress.

    Conclusion

    This study highlighted a high prevalence of psychological distress among mountainous farmers. Providing routine psychological and physical health screening, developing CHWs to provide clinical support and raising health awareness are critical implications for reducing psychological distress in this population.

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