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Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses

Por: Wasmann · K. A. · Wijsman · P. · van Dieren · S. · Bemelman · W. · Buskens · C.
Objective

Randomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients’ preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined.

Design

Systematic review and meta-analyses.

Data sources

MEDLINE, Embase, PsycINFO and the Cochrane Library.

Eligibility criteria for selecting studies

RPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included.

Data extraction and synthesis

Two independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed.

Results

In total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%–100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%–99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI –0.178 to 0.364, p=0.502).

Conclusions

Patients’ preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs.

PROSPERO registration number

CRD42019094438.

Health outcomes, utility and costs of returning incidental results from genomic sequencing in a Canadian cancer population: protocol for a mixed-methods randomised controlled trial

Por: Shickh · S. · Clausen · M. · Mighton · C. · Gutierrez Salazar · M. · Zakoor · K.-R. · Kodida · R. · Reble · E. · Elser · C. · Eisen · A. · Panchal · S. · Aronson · M. · Graham · T. · Armel · S. R. · Morel · C. F. · Fattouh · R. · Glogowski · E. · Schrader · K. A. · Hamilton · J. G. · Offit
Introduction

Genomic sequencing has rapidly transitioned into clinical practice, improving diagnosis and treatment options for patients with hereditary disorders. However, large-scale implementation of genomic sequencing faces challenges, especially with regard to the return of incidental results, which refer to genetic variants uncovered during testing that are unrelated to the primary disease under investigation, but of potential clinical significance. High-quality evidence evaluating health outcomes and costs of receiving incidental results is critical for the adoption of genomic sequencing into clinical care and to understand the unintended consequences of adoption of genomic sequencing. We aim to evaluate the health outcomes and costs of receiving incidental results for patients undergoing genomic sequencing.

Methods and analysis

We will compare health outcomes and costs of receiving, versus not receiving, incidental results for adult patients with cancer undergoing genomic sequencing in a mixed-methods randomised controlled trial. Two hundred and sixty patients who have previously undergone first or second-tier genetic testing for cancer and received uninformative results will be recruited from familial cancer clinics in Toronto, Ontario. Participants in both arms will receive cancer-related results. Participants in the intervention arm have the option to receive incidental results. Our primary outcome is psychological distress at 2 weeks following return of results. Secondary outcomes include behavioural consequences, clinical and personal utility assessed over the 12 months after results are returned and health service use and costs at 12 months and 5 years. A subset of participants and providers will complete qualitative interviews about utility of incidental results.

Ethics and dissemination

This study has been approved by Clinical Trials Ontario Streamlined Research Ethics Review System that provides ethical review and oversight for multiple sites participating in the same clinical trial in Ontario.

Results from the trial will be shared through stakeholder workshops, national and international conferences, and peer-reviewed journals.

Trial registration number

NCT03597165.

Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery patients

Por: McLean · K. A. · Mountain · K. E. · Shaw · C. A. · Drake · T. M. · Ots · R. · Knight · S. R. · Fairfield · C. J. · Sgro · A. · Skipworth · R. J. E. · Wigmore · S. J. · Potter · M. A. · Harrison · E. M.
Introduction

National data suggest that surgical site infection (SSI) complicates 2%–10% of general surgery cases, although the patient-reported incidence is much higher. SSIs cause significant patient morbidity and represent a significant burden on acute healthcare services, in a cohort predominantly suitable for outpatient management. Over three-quarters of UK adults now own smartphones, which could be harnessed to improve access to care. We aim to investigate if a smartphone-delivered wound assessment tool results in earlier treatment.

Methods and analysis

This is a randomised controlled trial aiming to recruit 500 patients across National Health Service (NHS) hospitals. All emergency abdominal surgery patients over the age of 16 who own smartphones will be considered eligible, with the exclusion of those with significant visual impairment. Participants will be randomised in a 1:1 ratio between standard postoperative care and the intervention – use of the smartphone tool in addition to standard postoperative care. The main outcome measure will be time-to-diagnosis of SSI with secondary outcome measures considering use of emergency department and general practitioner services and patient experience. Follow-up will be conducted by clinicians blinded to group allocation. Analysis of time-to-diagnosis will be by comparison of means using an independent two sample t-test.

Ethics and dissemination

This is the first randomised controlled trial on the use of a smartphone-delivered wound assessment tool to facilitate the assessment of SSI and the impact on time-to-diagnosis. The intervention is being used in addition to standard postoperative care. The study design and protocol were reviewed and approved by Southeast Scotland Research and Ethics Committee (REC Ref: 16/SS/0072 24/05/2016). Study findings will be presented at academic conferences, published in peer-reviewed journals and are expected in 2020. A written lay summary will be available to study participants on request.

Trial registration number

NCT02704897; Pre-results.

Using population-wide administrative and laboratory data to estimate type- and subtype-specific influenza vaccine effectiveness: a surveillance protocol

Por: Scott · A. N. · Buchan · S. A. · Kwong · J. C. · Drews · S. J. · Simmonds · K. A. · Svenson · L. W.
Introduction

The appropriateness of using routinely collected laboratory data combined with administrative data for estimating influenza vaccine effectiveness (VE) is still being explored. This paper outlines a protocol to estimate influenza VE using linked laboratory and administrative data which could act as a companion to estimates derived from other methods.

Methods and analysis

We will use the test-negative design to estimate VE for each influenza type/subtype and season. Province-wide individual-level records of positive and negative influenza tests at the Provincial Laboratory for Public Health in Alberta will be linked, by unique personal health numbers, to administrative databases and vaccination records held at the Ministry of Health in Alberta to determine covariates and influenza vaccination status, respectively. Covariates of interests include age, sex, immunocompromising chronic conditions and healthcare setting. Cases will be defined based on an individual’s first positive influenza test during the season, and potential controls will be defined based on an individual’s first negative influenza test during the season. One control for each case will be randomly selected based on the week the specimen was collected. We will estimate VE using multivariable logistic regression.

Ethics and dissemination

Ethics approval was obtained from the University of Alberta’s Health Research Ethics Board—Health Panel under study ID Pro00075997. Results will be disseminated by public health officials in Alberta.

Prospective longitudinal study of tobacco company adaptation to standardised packaging in the UK: identifying circumventions and closing loopholes

Por: Evans-Reeves · K. A. · Hiscock · R. · Lauber · K. · Gilmore · A. B.
Objectives

UK standardised packaging legislation was introduced alongside pack size and product descriptor restrictions of the European Union Tobacco Products Directive to end tobacco marketing and misinformation via the pack. This paper aims to assess compliance with the restrictions and identify attempts to continue to market tobacco products and perpetuate misperceptions of harm post legislation.

Design, setting and intervention

A prospective study of the introduction of standardised packaging of tobacco products to the UK.

Participants and outcomes

We analysed commercial sales data to assess whether the legally required changes in pack branding, size and name were implemented. To explore any adaptations to products and packaging we analysed sales data, monthly pack purchases of factory-made (FM) cigarettes and roll-your-own (RYO) tobacco, tobacco advertisements from retail trade magazines and articles on tobacco from commercial literature (retail trade, market analyst and tobacco company publications).

Results

One month after full implementation of the UK and European Union policies, 97% FM and 98% RYO was sold in compliant packaging. Nevertheless, tobacco companies made adaptations to tobacco products which enabled continued brand differentiation after the legislation came into force. For example, flavour names previously associated with low tar were systematically changed to colour names arguably facilitating continued misperceptions about the relative harms of products. Tobacco companies used the 1-year sell-through to their advantage by communicating brand name changes and providing financial incentives for retailers to buy large volumes of branded packs. In addition, tobacco companies continued to market their products to retailers and customers by innovating exemptions to the legislation, namely, filters, packaging edges, seals, multipack outers, RYO accessories, cigars and pipe tobacco.

Conclusions

Tobacco companies adapted to packaging restrictions by innovating their tobacco products and marketing activities. These findings should enable policy makers globally to close loopholes and increase the potential efficacy of standardised packaging policies.

Biobanking for discovery of novel cardiovascular biomarkers using imaging-quantified disease burden: protocol for the longitudinal, prospective, BioHEART-CT cohort study

Por: Kott · K. A. · Vernon · S. T. · Hansen · T. · Yu · C. · Bubb · K. J. · Coffey · S. · Sullivan · D. · Yang · J. · O'Sullivan · J. · Chow · C. · Patel · S. · Chong · J. · Celermajer · D. S. · Kritharides · L. · Grieve · S. M. · Figtree · G. A.
Introduction

Coronary artery disease (CAD) persists as a major cause of morbidity and mortality worldwide despite intensive identification and treatment of traditional risk factors. Data emerging over the past decade show a quarter of patients have disease in the absence of any known risk factor, and half have only one risk factor. Improvements in quantification and characterisation of coronary atherosclerosis by CT coronary angiography (CTCA) can provide quantitative measures of subclinical atherosclerosis—enhancing the power of unbiased ‘omics’ studies to unravel the missing biology of personal susceptibility, identify new biomarkers for early diagnosis and to suggest new targeted therapeutics.

Methods and analysis

BioHEART-CT is a longitudinal, prospective cohort study, aiming to recruit 5000 adult patients undergoing clinically indicated CTCA. After informed consent, patient data, blood samples and CTCA imaging data are recorded. Follow-up for all patients is conducted 1 month after recruitment, and then annually for the life of the study. CTCA data provide volumetric quantification of total calcified and non-calcified plaque, which will be assessed using established and novel scoring systems. Comprehensive molecular phenotyping will be performed using state-of-the-art genomics, metabolomics, proteomics and immunophenotyping. Complex network and machine learning approaches will be applied to biological and clinical datasets to identify novel pathophysiological pathways and to prioritise new biomarkers. Discovery analysis will be performed in the first 1000 patients of BioHEART-CT, with validation analysis in the following 4000 patients. Outcome data will be used to build improved risk models for CAD.

Ethics and dissemination

The study protocol has been approved by the human research ethics committee of North Shore Local Health District in Sydney, Australia. All findings will be published in peer-reviewed journals or at scientific conferences.

Trial registration number

ACTRN12618001322224.

Passive versus active intra-abdominal drainage following pancreatic resection: does a superior drainage system exist? A protocol for systematic review

Por: Park · L. · Baker · L. · Smith · H. · Davies · A. · Abou Khalil · J. · Martel · G. · Balaa · F. · Bertens · K. A.
Background

Clinically relevant postoperative pancreatic fistula (CR-POPF) is the most common cause of major morbidity following pancreatic resection. Intra-abdominal drains are frequently positioned adjacent to the pancreatic anastomosis or transection margin at the time of surgery to aid in detection and management of CR-POPF. Drains can either evacuate fluid by passive gravity (PG) or be attached to a closed suction (CS) system using negative pressure. There is controversy as to whether one of these two systems is superior. The objective of this review is to identify and compare the incidence of adverse events (AEs) and resource utilisation associated with PG and CS drainage following pancreatic resections.

Methods and analysis

MEDLINE, EMBASE, CINAHL and Cochrane Central Registry of Controlled Trials will be searched from inception to April 2019, to identify interventional and observational studies comparing PG and CS drains following pancreatic resection. The primary outcome is POPF as defined by the International Study Group for Pancreatic Fistula in 2017. Secondary outcomes include postoperative AE, resource utilisation (length of stay, return to emergency department, readmission and reintervention), time to drain removal and quality of life. Study selection, data extraction and risk of bias assessment will be performed independently, by two reviewers. A meta-analysis will be conducted if deemed statistically appropriate. Subgroup analysis by study design will be performed. Study heterogeneity will be calculated with the 2 test and reported as I2 statistics. Statistical analyses will be conducted and displayed using RevMan V.5.3

Ethics and dissemination

Ethics approval is not required. The results of this study will be submitted to relevant conferences for presentation and peer-reviewed journals for publication.

PROSPERO registration number

CRD42019123647.

Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial

Por: Collins · K. A. · Ouedraogo · A. · Guelbeogo · W. M. · Awandu · S. S. · Stone · W. · Soulama · I. · Ouattara · M. S. · Nombre · A. · Diarra · A. · Bradley · J. · Selvaraj · P. · Gerardin · J. · Drakeley · C. · Bousema · T. · Tiono · A.
Introduction

A large proportion of malaria-infected individuals in endemic areas do not experience symptoms that prompt treatment-seeking. These asymptomatically infected individuals may retain their infections for many months during which sexual-stage parasites (gametocytes) are produced that may be transmissible to mosquitoes. Reductions in malaria transmission could be achieved by detecting and treating these infections early. This study assesses the impact of enhanced community case management (CCM) and monthly screening and treatment (MSAT) on the prevalence and transmissibility of malaria infections.

Methods and analysis

This cluster-randomised trial will take place in Sapone, an area of intense, highly seasonal malaria in Burkina Faso. In total, 180 compounds will be randomised to one of three interventions: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced CCM, comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus MSAT using RDTs. The study will be conducted over approximately 18 months covering two high-transmission seasons and the intervening dry season. The recruitment strategy aims to ensure that overall transmission and force of infection is not affected so we are able to continuously evaluate the impact of interventions in the context of ongoing intense malaria transmission. The main objectives of the study are to determine the impact of enhanced CCM and MSAT on the prevalence and density of parasitaemia and gametocytaemia and the transmissibility of infections. This will be achieved by molecular detection of infections in all study participants during start and end season cross-sectional surveys and routine sampling of malaria-positive individuals to assess their infectiousness to mosquitoes.

Ethics and dissemination

The study has been reviewed and approved by the London School of Hygiene and Tropical Medicine (LSHTM) (Review number: 14724) and The Centre National de Recherche et de Formation sur le Paludisme institutional review board (IRB) (Deliberation N° 2018/000002/MS/SG/CNRFP/CIB) and Burkina Faso national medical ethics committees (Deliberation N° 2018-01-010).

Findings of the study will be shared with the community via local opinion leaders and community meetings. Results may also be shared through conferences, seminars, reports, theses and peer-reviewed publications; disease occurrence data and study outcomes will be shared with the Ministry of Health. Data will be published in an online digital repository.

Trial registration number

NCT03705624.

Evaluation of the impact of the GRACE risk score on the management and outcome of patients hospitalised with non-ST elevation acute coronary syndrome in the UK: protocol of the UKGRIS cluster-randomised registry-based trial

Por: Everett · C. C. · Fox · K. A. · Reynolds · C. · Fernandez · C. · Sharples · L. · Stocken · D. D. · Carruthers · K. · Hemingway · H. · Yan · A. T. · Goodman · S. G. · Brieger · D. · Chew · D. P. · Gale · C. P.
Introduction

For non-ST-segment elevation acute coronary syndrome (NSTEACS) there is a gap between the use of class I guideline recommended therapies and clinical practice. The Global Registry of Acute Coronary Events (GRACE) risk score is recommended in international guidelines for the risk stratification of NSTEACS, but its impact on adherence to guideline-indicated treatments and reducing adverse clinical outcomes is unknown. The objective of the UK GRACE Risk Score Intervention Study (UKGRIS) trial is to assess the effectiveness of the GRACE risk score tool and associated treatment recommendations on the use of guideline-indicated care and clinical outcomes.

Methods and analysis

The UKGRIS, a parallel-group cluster randomised registry-based controlled trial, will allocate hospitals in a 1:1 ratio to manage NSTEACS by standard care or according to the GRACE risk score and associated international guidelines. UKGRIS will recruit a minimum of 3000 patients from at least 30 English National Health Service hospitals and collect healthcare data from national electronic health records. The co-primary endpoints are the use of guideline-indicated therapies, and the composite of cardiovascular death, non-fatal myocardial infarction, new onset heart failure hospitalisation or cardiovascular readmission at 12 months. Secondary endpoints include duration of inpatient hospital stay over 12 months, EQ-5D-5L responses and utilities, unscheduled revascularisation and the components of the composite endpoint over 12 months follow-up.

Ethics and dissemination

The study has ethical approval (North East - Tyne & Wear South Research Ethics Committee reference: 14/NE/1180). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the funder’s open access policy.

Trial registration number

ISRCTN29731761; Pre-results.

Comparison of ventilatory modes to facilitate liberation from mechanical ventilation: protocol for a systematic review and network meta-analysis

Por: Lewis · K. A. · Chaudhuri · D. · Guyatt · G. · Burns · K. E. A. · Bosma · K. · Ge · L. · Karachi · T. · Piraino · T. · Fernando · S. M. · Ranganath · N. · Brochard · L. · Rochwerg · B.
Introduction

Timely liberation from invasive mechanical ventilation is important to reduce the risk of ventilator-associated complications. Once a patient is deemed ready to tolerate a mode of partial ventilator assist, clinicians can use one of multiple ventilatory modes. Despite multiple trials, controversy regarding the optimal ventilator mode to facilitate liberation remains. Herein, we report the protocol for a systematic review and network meta-analysis comparing modes of ventilation to facilitate the liberation of a patient from invasive mechanical ventilation.

Methods and analysis

We will search MEDLINE, EMBASE, PubMed, the Cochrane Library from inception to April 2019 for randomised trials that report on critically ill adults who have undergone invasive mechanical ventilation for at least 24 hours and have received any mode of assisted invasive mechanical ventilation compared with an alternative mode of assisted ventilation. Outcomes of interest will include: mortality, weaning success, weaning duration, duration of mechanical ventilation, duration of stay in the acute care setting and adverse events. Two reviewers will independently screen in two stages, first titles and abstracts, and then full texts, to identify eligible studies. Independently and in duplicate, two investigators will extract all data, and assess risk of bias in all eligible studies using the Modified Cochrane Risk of Bias tool. Reviewers will resolve disagreement by discussion and consultation with a third reviewer as necessary. Using a frequentist framework, we will perform random-effect network meta-analysis, including all ventilator modes in the same model. We will calculate direct and indirect estimates of treatment effect using a node-splitting procedure and report effect estimates using OR and 95% CI. We will assess certainty in effect estimates using Grading of Recommendations Assessment, Development and Evaluation methodology.

Ethics and dissemination

Research ethics board approval is not necessary. The results will be disseminated through publication in a peer-reviewed journals.

PROSPERO registration number

CRD42019137786

Drink driving and speeding in Sao Paulo, Brazil: empirical cross-sectional study (2015-2018)

Por: Andreuccetti · G. · Leyton · V. · Carvalho · H. B. · Sinagawa · D. M. · Bombana · H. S. · Ponce · J. C. · Allen · K. A. · Vecino-Ortiz · A. I. · Hyder · A. A.
Objectives

To evaluate the prevalence of drink driving and speeding during 2015–2018 in Sao Paulo, Brazil.

Design

Cross-sectional observational study.

Setting

Roads representing the five main regions of the city of Sao Paulo in Brazil, one of the world’s largest urban areas.

Participants

Drivers (N=10 294) stopped at routine roadside breath testing checkpoints and those driving in selected roads for speeding measurement (N=414 664).

Primary and secondary outcome measures

Microwave radar guns were used to measure the speed of vehicles, while the prevalence of drivers under the influence of alcohol was observed in police checkpoints. Data were collected during three consecutive years (2016–2018) following a baseline study established in 2015 using a city-level representative sample of observational data representing all days of the week.

Results

Alcohol-related fatalities kept at a constantly high percentage, with 39% of road traffic deaths involving alcohol in 2016. Drivers testing above the legal breath alcohol concentration limit showed a decreasing trend, from 4.1% (95% CI 2.9% to 5.5%) at baseline to 0.6% (95% CI 0.2% to 1.2%) in the end of 2018 (p

Conclusions

Drink driving rates have reduced, likely due to an increase in drivers refusing breath alcohol tests, while speeding rates have increased significantly by the end of the study period, particularly among motorcycles. Future strategies aiming at reducing road traffic injuries in the major Brazilian city should tailor drink driving and speeding enforcement based on the new evidence provided here.

Autologous platelet‐rich plasma for healing chronic venous leg ulcers: Clinical efficacy and potential mechanisms

The overall quality of evidence of autologous platelet‐rich plasma (PRP) for treating chronic wounds remains low. While further well‐designed clinical studies are clearly required to convincingly demonstrate the efficacy of autologous PRP in improved healing of venous leg ulcers (VLUs) and other chronic wounds, there is also an increasing need to better define the underlying mechanisms of action and whether positive outcomes can be predicted based on the analysis of PRP. This brief review will discuss the current understanding of autologous PRP in VLUs and whether molecular evaluation of PRP at the time of collection could potentially be informative to clinical outcomes. Benefits of the autologous PRP treatment strategy include that PRP is easily accessible and is relatively inexpensive and safe. Better understanding of the mechanisms involved could improve treatment, enable supplementation, and/or lead to gains in product development. Analysis of PRP could also add value to future clinical trials on efficacy and potentially personalised treatment regimens.

Enhancing intrinsic motivation for physical activity among adolescents with cystic fibrosis: a qualitative study of the views of healthcare professionals

Objective

To explore the views of healthcare professionals from cystic fibrosis (CF) multidisciplinary teams (MDT) on physical activity for adolescents with CF, the specific strategies used for physical activity promotion and associated challenges.

Design

In this exploratory study, in-depth qualitative interviews were conducted with 15 healthcare professionals from CF MDTs to explore their views surrounding physical activity promotion for adolescents with CF.

Participants

Eleven physiotherapists (nine female), two consultants (both male) and two dieticians (both female) provided written informed consent and participated in the study.

Setting

CF clinics in the UK.

Results

While healthcare professionals highlighted the importance of physical activity in the management of CF, they noted that very few patients were motivated solely by (CF or general) health reasons. Healthcare professionals discussed the need for physical activity to be an enjoyable and routine part of their life, undertaken with significant others, outside the clinic whenever possible. Adopted approaches for physical activity promotion focused on providing individualised recommendations that suit the patients’ individual needs and goals and enhance intrinsic motivation for physical activity.

Conclusion

Our research offers valuable information for those seeking to develop interventions to promote physical activity among adolescents with CF. Specifically, intervention developers should focus on developing individualised interventions that focus on enhancing intrinsic motivation and support the integration of physical activity into everyday life.

Spatial patterns and determinants of postnatal care use in Ethiopia: findings from the 2016 demographic and health survey

Por: Sisay · M. M. · Geremew · T. T. · Demlie · Y. W. · Alem · A. T. · Beyene · D. K. · Melak · M. F. · Gelaye · K. A. · Ayele · T. A. · Andargie · A. A.
Objective

Postnatal care (PNC) is essential for preventing maternal and newborn deaths; however, it still remains less well recognised in low-income and middle-income countries. This study was aimed to explore geographical patterns and identify the determinants of PNC usage among women aged 15–49 years in Ethiopia.

Methods

A secondary data analysis was conducted using the 2016 Ethiopian demographic and health survey data. A total of 7193 women were included in this analysis. We employed spatial scan statistics to detect spatial inequalities of PNC usage among women. A multilevel binary logistic regression model was fitted to identify factors associated with women’s PNC.

Results

The prevalence of PNC usage among women was 6.9% (95% CI 6.3% to 7.5%). The SaTScan spatial analysis identified three most likely clusters with low rates of PNC use namely southwestern Ethiopia (log likelihood ratio (LLR)=18.07, p

Conclusion

PNC usage remains a public health problem and has spatial variations at regional levels in the country. Low prevalence of PNC was detected in the Somali, Oromia, Gambella and Southern Nations, Nationalities, and People’s Region (SNNPR) regions. Women with low educational status, old age, being in poorest wealth quantile and history of ANC visits were significantly associated with PNC usage. Hence, it is better to strengthen maternal health programmes that give special emphasis on health promotion with a continuum of care during pregnancy.

Public, health professional and legislator perspectives on the concept of psychiatric disease: a population-based survey

Por: Tikkinen · K. A. O. · Rutanen · J. · Frances · A. · Perry · B. L. · Dennis · B. B. · Agarwal · A. · Maqbool · A. · Ebrahim · S. · Leinonen · J. S. · Järvinen · T. L. N. · Guyatt · G. H.
Objective

To assess which mental health-related states of being are perceived as diseases by psychiatrists, non-psychiatric physicians, nurses, parliament members and laypeople.

Design and setting

A population-based, mailed survey in Finland.

Participants

Respondents from a random sample of 3000 laypeople, 1500 physicians, 1500 nurses and all 200 members of the parliament (MPs) of Finland.

Primary outcome measures

Respondents’ perspectives on 20 mental health-related states of being as diseases, measuring the extent of agreement with the claim: ‘[This state of being] is a disease’.

Results

Of the 6200 people approached, we received 3259 eligible responses (53%). Two conditions (schizophrenia and autism) were considered to be diseases by at least 75% and two states (grief and homosexuality) were considered not to be diseases by at least 75% in each group. A majority (at least 50% in each group) considered seven states as diseases (anorexia, attention deficit hyperactivity disorder, bulimia, depression, generalised anxiety disorder, panic disorder and personality disorder) and three not to be diseases (absence of sexual desire, premature ejaculation and transsexualism). In six states, there was a wide divergence of opinion (alcoholism, drug addiction, gambling addiction, insomnia, social anxiety disorder and work exhaustion). Psychiatrists were significantly more inclined to considering states of being as diseases relative to other groups, followed by non-psychiatric physicians, nurses, MPs and laypeople.

Conclusions

Respondents agreed that some conditions, such as schizophrenia and autism, are diseases and other states, such as grief and homosexuality, are not; for others, there was considerable disagreement. Psychiatrists are more inclined to consider mental health-related states of being as diseases compared with other physicians, who, in turn, are more inclined than other constituencies. Understanding notions of disease may underlie important debates in public policy and practice in areas of mental health and behaviour, and have implications for resource allocation and stigma.

Food-insecure pregnant women in South Africa: a cross-sectional exploration of maternal depression as a mediator of violence and trauma risk factors

Por: Barnett · W. · Pellowski · J. · Kuo · C. · Koen · N. · Donald · K. A. · Zar · H. J. · Stein · D. J.
Objectives

Better understanding of psychosocial risk factors for food insecurity (FI) during pregnancy and how they interact is crucial, given long-term health implications for maternal and child health. We investigated the association between maternal childhood trauma as well as intimate partner violence (IPV) and FI among pregnant women in South Africa, in the Drakenstein Child Health Study, and whether maternal depression mediates these relationships.

Setting

Two primary care clinics in Paarl, South Africa.

Participants

992 pregnant women; inclusion criteria were clinic attendance and remaining in area for at least 1 year; women were excluded if a minor.

Methods

We examined psychosocial predictors of FI using multivariate regression. Mediation analyses investigated whether depression mediated the relationship between IPV and FI as well as between childhood trauma and FI, including disaggregation by two study communities. FI was assessed using an adapted US Department of Agriculture food security scale; households were coded as food insecure where 2 of 5 affirmative responses were recorded.

Results

Among 992 pregnant women, there were high rates of IPV (7%–27%), depression (24%) and childhood trauma (34%). In multivariate cross-sectional analysis, emotional IPV (adjusted OR [aOR] 1.60; 95% CI 1.04 to 2.46), depression (aOR 1.05; 95% CI 1.01 to 1.08) and childhood trauma (aOR 1.52; 95% CI 1.08 to 2.15) predicted FI. In mediation models, depression partially mediated the relationship between emotional IPV and FI as well as physical IPV and FI; depression partially mediated the relationship between childhood trauma and FI. Differing degrees of mediation were found when applied to communities.

Conclusions

Antenatal maternal depression, IPV and childhood trauma were highly prevalent and associated with FI. Depression, IPV and trauma screening services should be considered within routine antenatal care and may offer an opportunity to identify and intervene. Community-level differences in risk and in mediation analyses indicate that contextual tailoring of interventions may be important.

Patients and informal caregivers experiences of burden of treatment in lung cancer and chronic obstructive pulmonary disease (COPD): a systematic review and synthesis of qualitative research

Por: Lippiett · K. A. · Richardson · A. · Myall · M. · Cummings · A. · May · C. R.
Objective

To identify, characterise and explain common and specific features of the experience of treatment burden in relation to patients living with lung cancer or chronic obstructive pulmonary disease (COPD) and their informal caregivers.

Design

Systematic review and interpretative synthesis of primary qualitative studies. Papers were analysed using constant comparison and directed qualitative content analysis.

Data sources

CINAHL, EMBASE, MEDLINE, PsychINFO, Scopus and Web of Science searched from January 2006 to December 2015.

Eligibility criteria for selecting studies

Primary qualitative studies in English where participants were patients with lung cancer or COPD and/or their informal caregivers, aged >18 years that contain descriptions of experiences of interacting with health or social care in Europe, North America and Australia.

Results

We identified 127 articles with 1769 patients and 491 informal caregivers. Patients, informal caregivers and healthcare professionals (HCPs) acknowledged lung cancer’s existential threat. Managing treatment workload was a priority in this condition, characterised by a short illness trajectory. Treatment workload was generally well supported by an immediacy of access to healthcare systems and a clear treatment pathway. Conversely, patients, informal caregivers and HCPs typically did not recognise or understand COPD. Treatment workload was balanced with the demands of everyday life throughout a characteristically long illness trajectory. Consequently, treatment workload was complicated by difficulties of access to, and navigation of, healthcare systems, and a fragmented treatment pathway. In both conditions, patients’ capacity to manage workload was enhanced by the support of family and friends, peers and HCPs and diminished by illness/smoking-related stigma and social isolation.

Conclusion

This interpretative synthesis has affirmed significant differences in treatment workload between lung cancer and COPD. It has demonstrated the importance of the capacity patients have to manage their workload in both conditions. This suggests a workload which exceeds capacity may be a primary driver of treatment burden.

PROSPERO registration number

CRD42016048191.

Knowledge and practice of health workers about control and prevention of multidrug-resistant tuberculosis in referral hospitals, Ethiopia: a cross-sectional study

Por: Alene · K. A. · Adane · A. A. · Yifiru · S. · Bitew · B. D. · Adane · A. · Koye · D. N.
Objective

The aim of this study was to assess the knowledge and practice of health workers about multidrug-resistant tuberculosis (MDR-TB) prevention and control.

Study design and settings

A cross-sectional study was conducted at Gondar University Referral Hospital and Felege Hiwot Referral Hospital.

Participants

Randomly selected health workers (ie, medical doctor, nurse, health officer, pharmacy, medical laboratory and midwifery) were the study participants.

Outcome measures

The main outcomes were knowledge and self-reported practice of health workers about MDR-TB.

Results

A total of 377 health workers (with a response rate of 93.7%) participated in the study. The majority of respondents were nurses (52.5%, n=198) and medical doctors (15.6%, n=59). The mean knowledge score was seven out of 10; 149 (39.5%) of respondents scored seven or more which was considered as good knowledge. MDR-TB knowledge of health workers was significantly associated with having a postgraduate degree (adjusted odds ratio (AOR)=5.78; 95% CI 2.33 to 14.33), taking infection prevention training (AOR=1.79; 95% CI 1.00, to 3.17) and having a history of tuberculosis (TB) (AOR=1.85; 95% CI 1.12, to 3.03). The mean self-reported practice score was four out of seven; one-fifth (19.6%) of respondents scored four or more which was considered as good practice. Self-reported practice of health workers was significantly associated with working at internal medicine (AOR=4.64; 95% CI 1.99, to 10.81) and paediatrics (AOR=3.85; 95% CI 1.11, to 13.34) wards, being in the age groups of 26–30 years (AOR=2.70; 95% CI 1.27, to 5.76), and 30 years and above (AOR=4.42; 95% CI 1.77, to 11.00).

Conclusions

This study found low knowledge and self-reported practice score among health workers. MDR-TB knowledge of health workers was significantly associated with educational status, infection prevention training and previous history of TB. This finding highlights the potential of providing MDR-TB training for health workers to increase their knowledge about MDR-TB.

Effects of exercise interventions on cardiovascular health in individuals with chronic, motor complete spinal cord injury: protocol for a randomised controlled trial [Cardiovascular Health/Outcomes: Improvements Created by Exercise and education in SCI (C

Por: Krassioukov · A. V. · Currie · K. D. · Hubli · M. · Nightingale · T. E. · Alrashidi · A. A. · Ramer · L. · Eng · J. J. · Ginis · K. A. M. · MacDonald · M. J. · Hicks · A. · Ditor · D. · Oh · P. · Verrier · M. C. · Craven · B. C.
Introduction

Recent studies demonstrate that cardiovascular diseases and associated complications are the leading cause of morbidity and mortality in individuals with spinal cord injury (SCI). Abnormal arterial stiffness, defined by a carotid–to-femoral pulse wave velocity (cfPWV) ≥10 m/s, is a recognised risk factor for heart disease in individuals with SCI. There is a paucity of studies assessing the efficacy of conventional training modalities on arterial stiffness and other cardiovascular outcomes in this population. Therefore, this study aims to compare the efficacy of arm cycle ergometry training (ACET) and body weight-supported treadmill training (BWSTT) on reducing arterial stiffness in individuals with chronic motor complete, high-level (above the sixth thoracic segment) SCI.

Methods and analysis

This is a multicentre, randomised, controlled, clinical trial. Eligible participants will be randomly assigned (1:1) into either ACET or BWSTT groups. Sixty participants with chronic (>1 year) SCI will be recruited from three sites in Canada (Vancouver, Toronto and Hamilton). Participants in each group will exercise three times per week up to 30 min and 60 min for ACET and BWSTT, respectively, over the period of 6 months. The primary outcome measure will be change in arterial stiffness (cfPWV) from baseline. Secondary outcome measures will include comprehensive assessments of: (1) cardiovascular parameters, (2) autonomic function, (3) body composition, (4) blood haematological and metabolic profiles, (5) cardiorespiratory fitness and (6) quality of life (QOL) and physical activity outcomes. Outcome measures will be assessed at baseline, 3 months, 6 months and 12 months (only QOL and physical activity outcomes). Statistical analyses will apply linear-mixed modelling to determine the training (time), group (ACET vs BWSTT) and interaction (time x group) effects on all outcomes.

Ethics and dissemination

Ethical approval was obtained from all three participating sites. Primary and secondary outcome data will be submitted for publication in peer-reviewed journals and widely disseminated.

Trial registration number

NCT01718977; Pre-results.

Trial status

Recruitment for this study began on January 2013 and the first participant was randomized on April 2013. Recruitment stopped on October 2018.

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