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☐ ☆ ✇ BMJ Open

Assessing Australian womens knowledge and knowledge preferences about long-term health after hypertensive disorders of pregnancy: a survey study

Por: Roth · H. · Homer · C. S. E. · LeMarquand · G. · Roberts · L. M. · Hanley · L. · Brown · M. · Henry · A. — Diciembre 17th 2020 at 16:27
Objectives

To (1) assess women’s current knowledge regarding long-term cardiovascular health after hypertensive disorders of pregnancy (2) elicit women’s preferred educational content and format regarding health after hypertensive disorders of pregnancy.

Design and setting

A custom-created online survey exploring Australian women’s knowledge about long-term health after hypertensive disorders of pregnancy, distributed through consumer groups and social media.

Participants

266 women with (n=174) or without (n=92) a history of hypertensive disorders of pregnancy.

Primary and secondary outcome measures

(1) Proportion of women identifying long-term health risks after hypertensive disorder of pregnancy using a 10-point risk knowledge score with 0–4 ‘low’, 4.1–7.0 ‘moderate’ and 7.1–10 ‘high’. (2) Exploration of preferred content, format and distribution of educational material post hypertensive disorder of pregnancy.

Results

Knowledge scores about health after hypertensive disorder of pregnancy were moderate in groups with and without a history of the disorder. Knowledge was highest regarding risk of recurrent hypertensive disorders in a subsequent pregnancy, ‘moderate’ for chronic hypertension and heart attack, ‘moderate’ and ‘low’ regarding risk of heart disease and ‘low’ for diabetes and renal disease. Only 36% of all participants were aware that risks start within 10 years after the affected pregnancy. The majority of respondents with a history of hypertensive disorder of pregnancy (76%) preferred receiving information about long-term health 0–6 months post partum from a healthcare provider (80%), key organisations (60%), social media (47%) and brochures/flyers (43%).

Conclusions

Women’s knowledge regarding health risks after hypertensive disorder of pregnancy was ‘moderate’, although with important disease-specific gaps such as increased risk of diabetes. Most women wanted to be informed about their long-term health from a healthcare provider.

☐ ☆ ✇ BMJ Open

Retirement age and type as predictors of frailty: a retrospective cohort study of older businessmen

Por: Haapanen · M. J. · von Bonsdorff · M. B. · Perttilä · N. M. · Törmäkangas · T. · von Bonsdorff · M. E. · Strandberg · A. Y. · Strandberg · T. E. — Diciembre 17th 2020 at 16:27
Objectives

To study the association between retirement characteristics and frailty in a homogenous population of former business executives.

Design

Cross-sectional cohort study using data from the Helsinki Businessmen Study.

Setting

Helsinki, Finland.

Participants

1324 Caucasian men, born in 1919–1934, who had worked as business executives and managers and of whom 95.9% had retired by the year 2000. Questions on age at and type of retirement, lifestyle and chronic conditions were embedded in questionnaires.

Primary and secondary outcome measures

Frailty assessed according to a modified phenotype definition at mean age 73.3 years.

Results

Mean age at retirement was 61.3 years (SD 4.3) and 37.1% had retired due to old age. The prevalence of frailty was lowest among men retiring at ages 66–67 years but increased among those who worked up to age 70 years or older. Compared with men who retired before age 55 years, those retiring at ages 58–69 years were at decreased risk of frailty in old age relative to non-frailty (adjusted ORs 0.07–0.29, p

Conclusion

Exiting working life early and continuing to be occupationally active until age 70 years and older were both associated with increased risk of frailty among the men. Promotion of longer work careers could, however, promote healthier ageing, as the lowest prevalence of frailty was observed in former business executives who retired at ages 66–67 years.

☐ ☆ ✇ BMJ Open

Rehabilitation for ataxia study: protocol for a randomised controlled trial of an outpatient and supported home-based physiotherapy programme for people with hereditary cerebellar ataxia

Por: Milne · S. C. · Corben · L. A. · Roberts · M. · Szmulewicz · D. · Burns · J. · Grobler · A. C. · Williams · S. · Chua · J. · Liang · C. · Lamont · P. J. · Grootendorst · A. C. · Massey · L. · Sue · C. · Dalziel · K. · LaGrappe · D. · Willis · L. · Freijah · A. · Gerken · P. · Delatycki · M. — Diciembre 17th 2020 at 16:27
Introduction

Emerging evidence indicates that rehabilitation can improve ataxia, mobility and independence in everyday activities in individuals with hereditary cerebellar ataxia. However, with the rarity of the genetic ataxias and known recruitment challenges in rehabilitation trials, most studies have been underpowered, non-randomised or non-controlled. This study will be the first, appropriately powered randomised controlled trial to examine the efficacy of an outpatient and home-based rehabilitation programme on improving motor function for individuals with hereditary cerebellar ataxia.

Methods and analysis

This randomised, single-blind, parallel group trial will compare a 30-week rehabilitation programme to standard care in individuals with hereditary cerebellar ataxia. Eighty individuals with a hereditary cerebellar ataxia, aged 15 years and above, will be recruited. The rehabilitation programme will include 6 weeks of outpatient land and aquatic physiotherapy followed immediately by a 24- week home exercise programme supported with fortnightly physiotherapy sessions. Participants in the standard care group will be asked to continue their usual physical activity. The primary outcome will be the motor domain of the Functional Independence Measure. Secondary outcomes will measure the motor impairment related to ataxia, balance, quality of life and cost-effectiveness. Outcomes will be administered at baseline, 7 weeks, 18 weeks and 30 weeks by a physiotherapist blinded to group allocation. A repeated measures mixed-effects linear regression model will be used to analyse the effect of the treatment group for each of the dependent continuous variables. The primary efficacy analysis will follow the intention-to-treat principle.

Ethics and dissemination

The study has been approved by the Monash Health Human Research Ethics Committee (HREC/18/MonH/418) and the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (2019/3503). Results will be published in peer-reviewed journals, presented at national and/or international conferences and disseminated to Australian ataxia support groups.

Trial registration number

ACTRN12618000908235.

☐ ☆ ✇ BMJ Open

Optimising antimicrobial stewardship interventions in English primary care: a behavioural analysis of qualitative and intervention studies

Por: Borek · A. J. · Wanat · M. · Atkins · L. · Sallis · A. · Ashiru-Oredope · D. · Beech · E. · Butler · C. C. · Chadborn · T. · Hopkins · S. · Jones · L. · McNulty · C. A. M. · Roberts · N. · Shaw · K. · Taborn · E. · Tonkin-Crine · S. — Diciembre 17th 2020 at 16:27
Objective

While various interventions have helped reduce antibiotic prescribing, further gains can be made. This study aimed to identify ways to optimise antimicrobial stewardship (AMS) interventions by assessing the extent to which important influences on antibiotic prescribing are addressed (or not) by behavioural content of AMS interventions.

Settings

English primary care.

Interventions

AMS interventions targeting healthcare professionals’ antibiotic prescribing for respiratory tract infections.

Methods

We conducted two rapid reviews. The first included qualitative studies with healthcare professionals on self-reported influences on antibiotic prescribing. The influences were inductively coded and categorised using the Theoretical Domains Framework (TDF). Prespecified criteria were used to identify key TDF domains. The second review included studies of AMS interventions. Data on effectiveness were extracted. Components of effective interventions were extracted and coded using the TDF, Behaviour Change Wheel and Behaviour Change Techniques (BCTs) taxonomy. Using prespecified matrices, we assessed the extent to which BCTs and intervention functions addressed the key TDF domains of influences on prescribing.

Results

We identified 13 qualitative studies, 41 types of influences on antibiotic prescribing and 6 key TDF domains of influences: ‘beliefs about consequences’, ‘social influences’, ‘skills’, ‘environmental context and resources’, ‘intentions’ and ‘emotions’. We identified 17 research-tested AMS interventions; nine of them effective and four nationally implemented. Interventions addressed all six key TDF domains of influences. Four of these six key TDF domains were addressed by 50%–67% BCTs that were theoretically congruent with these domains, whereas TDF domain 'skills' was addressed by 24% of congruent BCTs and 'emotions' by none.

Conclusions

Further improvement of antibiotic prescribing could be facilitated by: (1) national implementation of effective research-tested AMS interventions (eg, electronic decision support tools, training in interactive use of leaflets, point-of-care testing); (2) targeting important, less-addressed TDF domains (eg, 'skills', 'emotions'); (3) using relevant, under-used BCTs to target key TDF domains (eg, ‘forming/reversing habits’, ‘reducing negative emotions’, ‘social support’). These could be incorporated into existing, or developed as new, AMS interventions.

☐ ☆ ✇ BMJ Open

Study protocol for SPARED trial: randomised non-inferiority phase III trial comparing dexamethasone on day 1 with dexamethasone on days 1-4, combined with neurokinin-1 receptor antagonist, palonosetron and olanzapine (5 mg) in patients receiving cisplatin

Por: Minatogawa · H. · Izawa · N. · Kawaguchi · T. · Miyaji · T. · Shimomura · K. · Kazunori · H. · Iihara · H. · Ohno · Y. · Inada · Y. · Arioka · H. · Morita · H. · Hida · N. · Sugawara · M. · Katada · C. · Nawata · S. · Ishida · H. · Tsuboya · A. · Tsuda · T. · Yamaguchi · T. · Nakajima · T. E. — Diciembre 17th 2020 at 16:27
Introduction

Dexamethasone (DEX) is administered for multiple days to prevent chemotherapy-induced nausea and vomiting for patients receiving highly emetogenic chemotherapy (HEC); however, its notorious side effects have been widely reported. Although our multicentre randomised double-blind comparative study verified non-inferiority of sparing DEX after day 2 of chemotherapy when combined with neurokinin-1 receptor antagonist (NK1-RA) and palonosetron (Palo) for patients receiving HEC regimen, DEX sparing was not non-inferior in patients receiving cisplatin (CDDP)-based HEC regimens in subgroup analysis. Recently, the efficacy of the addition of olanzapine (OLZ) to standard triple antiemetic therapy on HEC has been demonstrated by several phase III trials. This study aims to confirm non-inferiority of DEX sparing when it is combined with NK-1RA, Palo and OLZ in patients receiving CDDP-based HEC regimens.

Methods and analysis

This is a randomised, double-blind, phase III trial. Patients who are scheduled to receive CDDP ≥50 mg/m2 as initial chemotherapy are eligible. Patients are randomly assigned to receive either DEX on days 1–4 or DEX on day 1 combined with NK1-RA, Palo and OLZ (5 mg). The primary endpoint is complete response (CR) rate, defined as no emesis and no rescue medications during the delayed phase (24–120 hours post-CDDP administration). The non-inferiority margin is set at –15.0%. We assume that CR rates would be 75% in both arms. Two hundred and sixty-two patients are required for at least 80% power to confirm non-inferiority at a one-sided significance level of 2.5%. After considering the possibility of attrition, we set our final required sample size of 280.

Ethics and dissemination

The institutional review board approved the study protocol at each of the participating centres. The trial result will be presented at international conferences and published in peer-reviewed journals.

Trial registration number

UMIN000032269.

☐ ☆ ✇ BMJ Open

Trauma-focused psychodynamic therapy and STAIR Narrative Therapy of post-traumatic stress disorder related to childhood maltreatment: trial protocol of a multicentre randomised controlled trial assessing psychological, neurobiological and health economic

Por: Leichsenring · F. · Steinert · C. · Beutel · M. E. · Feix · L. · Gündel · H. · Hermann · A. · Karabatsiakis · A. · Knaevelsrud · C. · König · H.-H. · Kolassa · I. T. · Kruse · J. · Niemeyer · H. · Nöske · F. · Palmer · S. · Peters · E. · Reese · J.-P. · Reuss · A. · Salzer · S. · Sch — Diciembre 17th 2020 at 16:27
Introduction

Success rates of psychotherapy in post-traumatic stress disorder related to childhood maltreatment (PTSD-CM) are limited.

Methods and analysis

Observer-blind multicentre randomised clinical trial (A-1) of 4-year duration comparing enhanced methods of STAIR Narrative Therapy (SNT) and of trauma-focused psychodynamic therapy (TF-PDT) each of up to 24 sessions with each other and a minimal attention waiting list in PTSD-CM. Primary outcome is severity of PTSD (Clinician-Administered PTSD Scale for DSM-5 total) assessed by masked raters. For SNT and TF-PDT, both superiority and non-inferiority will be tested. Intention-to-treat analysis (primary) and per-protocol analysis (secondary). Assessments at baseline, after 10 sessions, post-therapy/waiting period and at 6 and 12 months of follow-up. Adult patients of all sexes between 18 and 65 years with PTSD-CM will be included. Continuing stable medication is permitted. To be excluded: psychotic disorders, risk of suicide, ongoing abuse, acute substance related disorder, borderline personality disorder, dissociative identity disorder, organic mental disorder, severe medical conditions and concurrent psychotherapy. To be assessed for eligibility: n=600 patients, to be e randomly allocated to the study conditions: n=328. Data management, randomisation and monitoring will be performed by an independent European Clinical Research Infrastructure Network (ECRIN)-certified data coordinating centre for clinical trials (KKS Marburg). Report of AEs to a data monitoring and safety board. Complementing study A-1, four inter-related add-on projects, including subsamples of the treatment study A-1, will examine (1) treatment integrity (adherence and competence) and moderators and mediators of outcome (B-1); (2) biological parameters (B-2, eg, DNA damage, reactive oxygen species and telomere shortening); (3) structural and functional neural changes by neuroimaging (B-3) and (4) cost-effectiveness of the treatments (B-4, costs and utilities).

Ethics and dissemination

Approval by the institutional review board of the University of Giessen (AZ 168/19). Following the Consolidated Standards of Reporting Trials statement for non-pharmacological trials, results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media.

Trial registration number

DRKS 00021142.

☐ ☆ ✇ BMJ Open

Patient characteristics associated with COVID-19 positivity and fatality in Nigeria: retrospective cohort study

Por: Elimian · K. O. · Ochu · C. L. · Ebhodaghe · B. · Myles · P. · Crawford · E. E. · Igumbor · E. · Ukponu · W. · Olayinka · A. · Aruna · O. · Dan-Nwafor · C. · Olawepo · O. A. · Ogunbode · O. · Atteh · R. · Nwachukwu · W. · Venkatesan · S. · Obagha · C. · Ngishe · S. · Suleiman · K. · Usman — Diciembre 17th 2020 at 16:27
Objective

Despite the increasing disease burden, there is a dearth of context-specific evidence on the risk factors for COVID-19 positivity and subsequent death in Nigeria. Thus, the study objective was to identify context-specific factors associated with testing positive for COVID-19 and fatality in Nigeria.

Design

Retrospective cohort study.

Setting

COVID-19 surveillance and laboratory centres in 36 states and the Federal Capital Territory reporting data to the Nigeria Centre for Disease Control.

Participants

Individuals who were investigated for SARS-CoV-2 using real-time PCR testing during the study period 27 February–8 June 2020.

Methods

COVID-19 positivity and subsequent mortality. Multivariable logistic regression analyses were performed to identify factors independently associated with both outcome variables, and findings are presented as adjusted ORs (aORs) and 95% CIs.

Results

A total of 36 496 patients were tested for COVID-19, with 10 517 confirmed cases. Of 3215 confirmed cases with available clinical outcomes, 295 died. Factors independently associated with COVID-19 positivity were older age (p value for trend

Conclusion

The significant risk factors associated with COVID-19 positivity and subsequent mortality in the Nigerian population are similar to those reported in studies from other countries and should guide clinical decisions for COVID-19 testing and specialist care referrals.

☐ ☆ ✇ BMJ Open

Reporting of methodological studies in health research: a protocol for the development of the MethodologIcal STudy reportIng Checklist (MISTIC)

Por: Lawson · D. O. · Puljak · L. · Pieper · D. · Schandelmaier · S. · Collins · G. S. · Brignardello-Petersen · R. · Moher · D. · Tugwell · P. · Welch · V. A. · Samaan · Z. · Thombs · B. D. · Norskov · A. K. · Jakobsen · J. C. · Allison · D. B. · Mayo-Wilson · E. · Young · T. · Chan · A.-W. — Diciembre 17th 2020 at 16:27
Introduction

Methodological studies (ie, studies that evaluate the design, conduct, analysis or reporting of other studies in health research) address various facets of health research including, for instance, data collection techniques, differences in approaches to analyses, reporting quality, adherence to guidelines or publication bias. As a result, methodological studies can help to identify knowledge gaps in the methodology of health research and strategies for improvement in research practices. Differences in methodological study names and a lack of reporting guidance contribute to lack of comparability across studies and difficulties in identifying relevant previous methodological studies. This paper outlines the methods we will use to develop an evidence-based tool—the MethodologIcal STudy reportIng Checklist—to harmonise naming conventions and improve the reporting of methodological studies.

Methods and analysis

We will search for methodological studies in the Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Embase, MEDLINE, Web of Science, check reference lists and contact experts in the field. We will extract and summarise data on the study names, design and reporting features of the included methodological studies. Consensus on study terms and recommended reporting items will be achieved via video conference meetings with a panel of experts including researchers who have published methodological studies.

Ethics and dissemination

The consensus study has been exempt from ethics review by the Hamilton Integrated Research Ethics Board. The results of the review and the reporting guideline will be disseminated in stakeholder meetings, conferences, peer-reviewed publications, in requests to journal editors (to endorse or make the guideline a requirement for authors), and on the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and reporting guideline websites.

Registration

We have registered the development of the reporting guideline with the EQUATOR Network and publicly posted this project on the Open Science Framework (www.osf.io/9hgbq).

☐ ☆ ✇ BMJ Open

Association between duration of residence and prevalence of type 2 diabetes among male South Asian expatriate workers in the United Arab Emirates: a cross-sectional study

Por: Shah · S. M. · Jaacks · L. M. · Al-Maskari · F. · Al-Kaabi · J. · Aziz · F. · Soteriades · E. · Loney · T. · Farooqi · H. · Memon · A. · Ali · R. — Diciembre 17th 2020 at 16:27

Expatriates account for about 80% of the total population in the United Arab Emirates (UAE). This study aimed to evaluate the hypothesis that prevalence of type 2 diabetes in male South Asian expatriates increases with increased length of residence in the UAE.

Design, settings and participants

This cross-sectional study recruited a representative sample (n=1375) of male South Asian expatriates aged ≥18 years in Al Ain, UAE. Sociodemographic, anthropometric and lifestyle data were obtained using a pilot-tested adapted version of the WHO STEPS instrument.

Main outcome measures

Duration of residence was used as a marker for acculturation. Type 2 diabetes was defined as a self-reported physician diagnosis of diabetes or a glycosylated haemoglobin blood level ≥6.5%.

Results

Mean (±SD) age of participants was 34.0±9.9 years. Overall, the prevalence of type 2 diabetes was 8.3% (95% CI 6.8% to 9.8%). Diabetes prevalence was positively associated with longer duration of residence in the UAE, 2.7%, 10 years. After adjusting for age, nationality, and income and age, expatriates were more likely to develop diabetes if residing in the UAE for 5–10 years (OR=2.18; 95% CI 1.02 to 4.67) or >10 years (OR=3.23; 95% CI 1.52 to 6.85) compared with those residing for

Conclusions

After controlling for potential confounding factors, longer duration of residence was significantly associated with a higher prevalence of type 2 diabetes in male South Asian expatriate workers in the UAE.

☐ ☆ ✇ BMJ Open

Is the time of calling helpful for differentiating transient ischaemic attack and stroke from mimics in primary care out-of-hours services? A cross-sectional study

Por: Erkelens · D. C. · Zwart · D. L. · van der Meer · G. H. · Wouters · L. T. · De Groot · E. · Damoiseaux · R. A. · Hoes · A. W. · Rutten · F. H. — Diciembre 17th 2020 at 16:27
Objectives

Telephone triage of patients suspected of transient ischaemic attack (TIA) or stroke is challenging. Both TIA and stroke more likely occur during daytime, with a peak in the morning hours. Thus, the time of calling might be a helpful determinant during telephone triage. We assessed the time of calling in patients with stroke-like symptoms who called the out-of-hours services in primary care (OHS-PC), and evaluated whether the time of calling differed between patients with TIA or stroke compared with those with mimics.

Design

Cross-sectional study.

Setting

Six OHS-PC locations in the Netherlands.

Participants

1269 telephone triage recordings of patients calling the OHS-PC because of stroke-like symptoms. We collected information on patient characteristics, symptoms, time of calling and urgency allocation. The final diagnosis related to each triage call was based on letters from the neurologist (retrieved from the patient’s general practitioner).

Primary and secondary outcome measures

The primary outcome measures were the time of calling hourly and 4 hourly, and the risk of TIA or stroke/hour. The secondary outcome measure was the risk ratio of TIA or stroke in the morning (08:00—12:00h) versus other hours.

Results

Mean age was 68.6 (SD±18.5) years, 56.9% were women and 50.0% had a TIA or stroke. The risk ratio of TIA or stroke among people calling with stroke-like symptoms between 08:00—12:00h versus other hours was 1.13 (95% CI 1.00 to 1.28, p=0.070). After correction for age and sex, the adjusted risk ratio was 0.94 (95% CI 0.80 to 1.10, p=0.434).

Conclusion

In patients who called the OHS-PC because of stroke-like symptoms, the time of calling did not differ between patients with TIA or stroke and patients with mimics.

Trial registration number

The Netherlands National Trial Registry (NTR7331).

☐ ☆ ✇ BMJ Open

Development and validation of a prognostic nomogram for myocardial infarction patients in intensive care units: a retrospective cohort study

Por: Guo · Q. · Wu · M. · Li · H. · Ouyang · H. · Sun · R. · Wang · J. · Liu · Z. · Wang · J. · Zhang · Y. — Diciembre 17th 2020 at 16:27
Objectives

We aimed to develop and validate a prognostic nomogram and evaluate the discrimination of the nomogram model in order to improve the prediction of 30-day survival of critically ill myocardial infarction (MI) patients.

Design

A retrospective cohort study.

Setting

Data were collected from the Medical Information Mart for Intensive Care (MIMIC)-III database, consisting of critically ill participants between 2001 and 2012 in the USA.

Participants

A total of 2031 adult critically ill patients with MI were enrolled from the MIMIC-III database.

Primary and secondary outcome

Thirty-day survival.

Results

Independent prognostic factors, including age, heart rate, white blood cell count, blood urea nitrogen and bicarbonate, were identified by Cox regression model and used in the nomogram. Good agreement between the prediction and observation was indicated by the calibration curve for 30-day survival. The nomogram exhibited reasonably accurate discrimination (area under the receiver operating characteristic curve, 0.765, 95% CI, 0.716 to 0.814) and calibration (C-index, 0.758, 95% CI, 0.712 to 0.804) in the validation cohort. Decision curve analysis demonstrated that the nomogram was clinically beneficial. Additionally, participants could be classified into two risk groups by the nomogram, and the 30-day survival probability was significantly different between them (p

Conclusion

This five-factor nomogram can achieve a reasonable degree of accuracy to predict 30-day survival in critically ill MI patients and might be helpful for risk stratification and decision-making for MI patients.

☐ ☆ ✇ BMJ Open

Incidence and risk factors for hospital-acquired infection among paediatric patients in a teaching hospital: a prospective study in southeast Ethiopia

Por: Sahiledengle · B. · Seyoum · F. · Abebe · D. · Geleta · E. N. · Negash · G. · Kalu · A. · Woldeyohannes · D. · Tekalegn · Y. · Zenbaba · D. · Edward Quisido · B. J. — Diciembre 17th 2020 at 16:27
Objectives

In order to maximise the prevention of hospital-acquired infections (HAIs) and antimicrobial resistance, data on the incidence of HAIs are crucial. In Ethiopia, data about the occurrence of HAIs among hospitalised paediatric patients are lacking. We aim to determine the incidence and risk factors of HAIs among paediatric patients in Ethiopia.

Design

A prospective cohort study.

Setting

A teaching hospital in southeast Ethiopia.

Participants

448 hospitalised paediatric patients admitted between 1 November 2018 and 30 June 2019.

Primary and secondary outcome measures

Incidence and risk factors of hospital-acquired infections.

Results

A total of 448 paediatric patients were followed for 3227 patient days. The median age of the patients was 8 months (IQR: 2–26 months). The incidence rate of HAIs was 17.7 per 1000 paediatric days of follow-up; while the overall cumulative incidence was 12.7% (95% CI 9.8% to 15.8%) over 8 months. Children who stayed greater than 6 days in the hospital (median day) (adjusted risk ratio (RR): 2.58, 95% CI 1.52 to 4.38), and children with underlying disease conditions of severe acute malnutrition (adjusted RR: 2.83, 95% CI 1.61 to 4.97) had higher risks of developing HAIs.

Conclusions

The overall cumulative incidence of HAIs was about 13 per 100 admitted children. Length of stay in the hospital and underlying conditions of severe acute malnutrition were found to be important factors associated with increased risk of HAIs.

☐ ☆ ✇ BMJ Open

ED to EPI: protocol for a pragmatic randomised controlled trial of an SMS (text) messaging intervention to improve the transition from the emergency department to early psychosis intervention for young people with psychosis

Por: Polillo · A. · Foussias · G. · Wong · A. H. C. · Ampofo · A. · Stergiopoulos · V. · Anderson · K. K. · Bromley · S. · D'Arcey · J. · de Oliveira · C. · Duda · L. · Henderson · J. · Kidd · S. · Kurdyak · P. · Wang · W. · Zaheer · J. · Voineskos · A. N. · Kozloff · N. — Diciembre 17th 2020 at 16:27
Introduction

While nearly half of all new psychotic disorders are diagnosed in the emergency department (ED), most young people who present to the ED with psychosis do not receive timely follow-up with a psychiatrist, and even fewer with evidence-based early psychosis intervention (EPI) services. We aim to test an intervention delivered using short message service (SMS), a low-cost, low-complexity, youth-friendly approach, to improve transitions from the ED to EPI services.

Methods and analysis

This is a protocol for a pragmatic randomised, single blind, controlled trial with accompanying economic and qualitative evaluations conducted at the Centre for Addiction and Mental Health (CAMH) in Toronto, Canada. A consecutive series of 186 participants aged 16–29 referred by the ED to CAMH’s EPI programme will be recruited for a trial of a two-way intervention involving reminders, psychoeducation and check-ins delivered via SMS. The primary outcome will be attendance at the first consultation appointment within 30 days of study enrolment assessed through chart reviews in the electronic health record. We will also extract routine clinical measures, including the Brief Psychiatric Rating Scale, Clinical Global Impression and Service Engagement Scale, and link with provincial health administrative data to examine system-level outcomes, including ED visits and psychiatric hospitalisations, 6 months and up to 2 years after baseline. We will perform a cost-effectiveness analysis of the primary study outcome and costs incurred, calculating an incremental cost effectiveness ratio. Web-based surveys and qualitative interviews will explore intervention user experience. Patients and families with lived experience will be engaged in all aspects of the project.

Ethics and dissemination

Research Ethics Board approval has been obtained. Findings will be reported in scientific journal articles and shared with key stakeholders including youth, family members, knowledge users and decision makers.

Trial registration number

NCT04298450.

☐ ☆ ✇ BMJ Open

Familial and socio-cultural barriers in maintaining tobacco-free homes in Bangladesh: a comparative cross-sectional study

Por: Haque · M. I. · Zafar Ullah · A. N. · Akter · T. · Chowdhury · A. A. · Mamun · A. a. · Tamanna · T. I. · Hossain · M. K. · Khan · H. T. · Harun · M. G. D. — Diciembre 17th 2020 at 16:27
Objectives

Children, pregnant women and the elderly at a global level are all being dangerously exposed to tobacco use in the household (HH). However, there is no understanding of the familial and socio-cultural factors that provide barriers to ensuring tobacco-free homes in Bangladesh either in urban or rural areas (U&RAs). This study therefore investigates those barriers to help enable a move towards tobacco-free homes in Bangladesh.

Design

Comparative cross-sectional study.

Settings

Data were collected from both urban and rural settings in Bangladesh.

Participants

A probability proportional sampling procedure was used to select 808 participants in U&RAs out of a total of 3715 tobacco users. Semi-structured interviews through the use of a questionnaire were conducted with the participants followed by a multivariate logistic regression analysis of the data in order to explore the familial and socio-cultural factors associated with tobacco use at home.

Results

The prevalence of tobacco use at home was 25.7% in urban areas and 47.6% in rural areas. In urban areas: marital status (adjusted OR (AOR)=3.23, 95% CI 1.37 to 6.61), education (AOR=2.14, 95% CI 1.15 to 3.99), the smoking habits of elderly family members (AOR=1.81, 95% CI 0.91 to 2.89), offering tobacco as a traditional form of leisure activity at home (AOR=1.85, 95% CI 0.94 to 2.95) and lack of religious practices (AOR=2.39, 95% CI 1.27 to 4.54) were identified as significant socio-cultural predictors associated with tobacco use at home. In rural areas: age (AOR=5.11, 95% CI 2.03 to 12.83), extended family (AOR=3.08, 95% CI 1.28 to 7.38), lack of religious practices (AOR=4.23, 95% CI 2.32 to 7.72), using children to buy or carry tobacco (AOR=3.33, 95% CI 1.11 to 9.99), lack of family guidance (AOR=4.27, 95% CI 2.45 to 7.42) and offering tobacco as a traditional form of leisure activity at home (AOR=3.81, 95% CI 2.23 to 6.47) were identified as significant determinants for tobacco use at home.

Conclusion

This study concludes that socio-cultural traditions and familial norms in Bangladesh provide significant barriers for enabling tobacco-free homes. The identification of these barriers can aid policymakers and programme planners in Bangladesh in devising appropriate measures to mitigate the deadly consequences of tobacco use in the home. The consequences also include the dangers involved in family members being exposed to secondhand smoke.

☐ ☆ ✇ BMJ Open

OPTIMUM study protocol: an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule

Por: Perez Chacon · G. · Estcourt · M. J. · Totterdell · J. · Campbell · D. E. · Perrett · K. P. · Marsh · J. A. · Richmond · P. C. · Wood · N. · Gold · M. S. · Holt · P. G. · Waddington · C. S. · Snelling · T. L. — Diciembre 17th 2020 at 16:27
Introduction

Combination vaccines containing whole-cell pertussis antigens were phased out from the Australian national immunisation programme between 1997 and 1999 and replaced by the less reactogenic acellular pertussis (aP) antigens. In a large case–control study of Australian children born during the transition period, those with allergist diagnosed IgE-mediated food allergy were less likely to have received whole-cell vaccine in early infancy than matched population controls (OR: 0.77 (95% CI, 0.62 to 0.95)). We hypothesise that a single dose of whole-cell vaccine in early infancy is protective against IgE-mediated food allergy.

Methods and analysis

This adaptive double-blind randomised controlled trial is investigating whether a mixed whole-cell/aP vaccine schedule prevents allergic disease in the first year of life. The primary outcome is IgE-mediated food allergy by 12 months of age. Secondary outcomes include new onset of atopic dermatitis by 6 or 12 months of age; sensitisation to at least one allergen by 12 months of age; seroconversion in anti-pertussis toxin IgG titres after vaccination with aP booster at 18 months of age; and solicited systemic and local adverse events following immunisation with pertussis-containing vaccines. Analyses will be performed using a Bayesian group sequential design.

Ethics and dissemination

This study has been approved by the Child and Adolescent Health Service Human Research Ethics Committee, Perth, Western Australia (RGS 00019). The investigators will ensure that this trial is conducted in accordance with the principles of the Declaration of Helsinki and with the International Conference on Harmonisation Guidelines for Good Clinical Practice. Individual consent will be requested. Parents will be reimbursed reasonable travel and parking costs to attend the study visits. The dissemination of these research findings will follow the National Health and Medical Research Council of Australia Open Access Policy.

Trial registration number

ACTRN12617000065392p.

☐ ☆ ✇ BMJ Open

Towards biomarkers for outcomes after pancreatic ductal adenocarcinoma and ischaemic stroke, with focus on (co)-morbidity and ageing/cellular senescence (SASKit): protocol for a prospective cohort study

Por: Henze · L. · Walter · U. · Murua Escobar · H. · Junghanss · C. · Jaster · R. · Köhling · R. · Lange · F. · Salehzadeh-Yazdi · A. · Wolkenhauer · O. · Hamed · M. · Barrantes · I. · Palmer · D. · Möller · S. · Kowald · A. · Heussen · N. · Fuellen · G. — Diciembre 17th 2020 at 16:27
Introduction

Ageing-related processes such as cellular senescence are believed to underlie the accumulation of diseases in time, causing (co)morbidity, including cancer, thromboembolism and stroke. Interfering with these processes may delay, stop or reverse morbidity. The aim of this study is to investigate the link between (co)morbidity and ageing by exploring biomarkers and molecular mechanisms of disease-triggered deterioration in patients with pancreatic ductal adenocarcinoma (PDAC) and (thromboembolic) ischaemic stroke (IS).

Methods and analysis

We will recruit 50 patients with PDAC, 50 patients with (thromboembolic) IS and 50 controls at Rostock University Medical Center, Germany. We will gather routine blood data, clinical performance measurements and patient-reported outcomes at up to seven points in time, alongside in-depth transcriptomics and proteomics at two of the early time points. Aiming for clinically relevant biomarkers, the primary outcome is a composite of probable sarcopenia, clinical performance (described by ECOG Performance Status for patients with PDAC and the Modified Rankin Scale for patients with stroke) and quality of life. Further outcomes cover other aspects of morbidity such as cognitive decline and of comorbidity such as vascular or cancerous events. The data analysis is comprehensive in that it includes biostatistics and machine learning, both following standard role models and additional explorative approaches. Prognostic and predictive biomarkers for interventions addressing senescence may become available if the biomarkers that we find are specifically related to ageing/cellular senescence. Similarly, diagnostic biomarkers will be explored. Our findings will require validation in independent studies, and our dataset shall be useful to validate the findings of other studies. In some of the explorative analyses, we shall include insights from systems biology modelling as well as insights from preclinical animal models. We anticipate that our detailed study protocol and data analysis plan may also guide other biomarker exploration trials.

Ethics and dissemination

The study was approved by the local ethics committee (Ethikkommission an der Medizinischen Fakultät der Universität Rostock, A2019-0174), registered at the German Clinical Trials Register (DRKS00021184), and results will be published following standard guidelines.

☐ ☆ ✇ BMJ Open

Prevalence of domestic violence against women in informal settlements in Mumbai, India: a cross-sectional survey

Por: Daruwalla · N. · Kanougiya · S. · Gupta · A. · Gram · L. · Osrin · D. — Diciembre 16th 2020 at 17:04
Objectives

Domestic violence against women harms individuals, families, communities and society. Perpetrated by intimate partners or other family members, its overlapping forms include physical, sexual and emotional violence, control and neglect. We aimed to describe the prevalence of these forms of violence and their perpetrators in informal settlements in Mumbai.

Design

Cross-sectional survey.

Setting

Two large urban informal settlement areas.

Participants

5122 women aged 18–49 years.

Primary and secondary outcome measures

Prevalence and perpetrators in the last year of physical, sexual and emotional domestic violence, coercive control and neglect. For each of these forms of violence, responses to questions about individual acts and composite estimates.

Results

In the last year, 644 (13%) women had experienced physical domestic violence, 188 (4%) sexual violence and 963 (19%) emotional violence. Of ever-married women, 13% had experienced physical or sexual intimate partner violence in the last year. Most physical (87%) and sexual violence (99%) was done by partners, but emotional violence equally involved marital family members. All three forms of violence were more common if women were younger, in the lowest socioeconomic asset quintile or reported disability. 1816 women (35%) had experienced at least one instance of coercive control and 33% said that they were afraid of people in their home. 10% reported domestic neglect of their food, sleep, health or children’s health.

Conclusions

Domestic violence against women remains common in urban informal settlements. Physical and sexual violence were perpetrated mainly by intimate partners, but emotional violence was attributed equally to partners and marital family. More than one-third of women described controlling behaviours perpetrated by both intimate partners and marital family members. We emphasise the need to include the spectrum of perpetrators and forms of domestic violence—particularly emotional violence and coercive control—in data gathering.

Trial registration number

ISRCTN84502355; Pre-results.

☐ ☆ ✇ BMJ Open

COVID-19 mortality effects of underlying health conditions in India: a modelling study

Por: Novosad · P. · Jain · R. · Campion · A. · Asher · S. — Diciembre 16th 2020 at 17:04
Objective

To model how known COVID-19 comorbidities affect mortality rates and the age distribution of mortality in a large lower-middle-income country (India), and to identify which health conditions drive differences with high-income countries.

Design

Modelling study.

Setting

England and India.

Participants

Individual data were obtained from the fourth round of the District Level Household Survey and Annual Health Survey in India, and aggregate data were obtained from the Health Survey for England and the Global Burden of Disease, Risk Factors and Injuries Studies.

Main outcome measures

The primary outcome was the modelled age-specific mortality in each country due to each COVID-19 mortality risk factor (diabetes, hypertension, obesity and respiratory illness, among others). The change in overall mortality and in the share of deaths under age 60 from the combination of risk factors was estimated in each country.

Results

Relative to England, Indians have higher rates of diabetes (10.6% vs 8.5%) and chronic respiratory disease (4.8% vs 2.5%), and lower rates of obesity (4.4% vs 27.9%), chronic heart disease (4.4% vs 5.9%) and cancer (0.3% vs 2.8%). Population COVID-19 mortality in India, relative to England, is most increased by uncontrolled diabetes (+5.67%) and chronic respiratory disease (+1.88%), and most reduced by obesity (–5.47%), cancer (–3.65%) and chronic heart disease (–1.20%). Comorbidities were associated with a 6.26% lower risk of mortality in India compared with England. Demographics and population health explain a third of the difference in share of deaths under age 60 between the two countries.

Conclusions

Known COVID-19 health risk factors are not expected to have a large effect on mortality or its age distribution in India relative to England. The high share of COVID-19 deaths from people under age 60 in low- and middle-income countries (LMICs) remains unexplained. Understanding the mortality risk associated with health conditions prevalent in LMICs, such as malnutrition and HIV/AIDS, is essential for understanding differential mortality.

☐ ☆ ✇ BMJ Open

Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations

Por: Roennow · A. · Sauve · M. · Welling · J. · Riggs · R. J. · Kennedy · A. T. · Galetti · I. · Brown · E. · Leite · C. · Gonzalez · A. · Portales Guiraud · A. P. · Houÿez · F. · Camp · R. · Gilbert · A. · Gahlemann · M. · Moros · L. · Luna Flores · J. L. · Schmidt · F. · Sauter · W. · Finne — Diciembre 16th 2020 at 17:04

Introduction Transparent collaborations between patient organisations (POs) and clinical research sponsors (CRS) can identify and address the unmet needs of patients and caregivers. These insights can improve clinical trial participant experience and delivery of medical innovations necessary to advance health outcomes and standards of care. We share our experiences from such a collaboration undertaken surrounding the SENSCIS® clinical trial (NCT02597933), and discuss its impact during, and legacy beyond, the trial.

Summary We describe the establishment of a community advisory board (CAB): a transparent, multiyear collaboration between the scleroderma patient community and a CRS. We present shared learnings from the collaboration, which is split into three main areas: (1) the implementation and conduct of the clinical trial; (2) analysis and dissemination of the results; and (3) aspects of the collaboration not related to the trial.

1. The scleroderma CAB reviewed and provided advice on trial conduct and reporting. This led to the improvement and optimisation of trial procedures; meaningful, patient-focused adaptations were made to address challenges relevant to scleroderma-associated interstitial lung disease patients.

2. To ensure that results of the trial were accessible to lay audiences and patients, written lay summaries were developed by the trial sponsor with valuable input from the CAB to ensure that language and figures were understandable.

3. The CAB and the CRS also collaborated to co-develop opening tools for medication blister packs and bottles. In addition, to raise disease awareness among physicians, patients and caregivers, educational materials to improve diagnosis and management of scleroderma were co-created and delivered by the CAB and CRS.

Conclusions This collaboration between POs and a CRS, in a rare disease condition, led to meaningful improvements in patient safety, comfort and self-management and addressed information needs. This collaboration may serve as a template of best practice for future collaborations between POs, research sponsors and other healthcare stakeholders.

☐ ☆ ✇ BMJ Open

COVID-19 confessions: a qualitative exploration of healthcare workers experiences of working with COVID-19

Por: Bennett · P. · Noble · S. · Johnston · S. · Jones · D. · Hunter · R. — Diciembre 16th 2020 at 17:04
Objectives

To gain insight into the experiences and concerns of front-line National Health Service (NHS) workers while caring for patients with COVID-19.

Design

Qualitative analysis of data collected through an anonymous website (www.covidconfidential) provided a repository of uncensored COVID-19 experiences of front-line NHS workers, accessed via a link advertised on the Twitter feed of two high profile medical tweeters and their retweets.

Setting

Community of NHS workers who accessed this social media.

Participants

54 healthcare workers, including doctors, nurses and physiotherapists, accessed the website and left a ‘story’.

Results

Stories ranged from 1 word to 10 min in length. Thematic analysis identified common themes, with a central aspect being the experience and psychological consequence of trauma. Specific themes were: (1) the shock of the virus, (2) staff sacrifice and dedication, (3) collateral damage ranging from personal health concerns to the long-term impact on, and care of, discharged patients and (4) a hierarchy of power and inequality within the healthcare system.

Conclusions

COVID-19 confidential gave an outlet for unprompted and uncensored stories of healthcare workers in the context of COVID-19. In addition to personal experiences of trauma, there were perceptions that many operational difficulties stemmed from inequalities of power between management and front-line workers. Learning from these experiences will reduce staff distress and improve patient care in the face of further waves of the pandemic.

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