1
BMJ Open
. 2020 Jun 29;10(6):e037918. doi: 10.1136/bmjopen-2020-037918.
Comparison of Prevalence and Associated Factors of Depressive Disorder Between Patients With Head and Neck Cancer and Those With Lung Cancer at a Tertiary Hospital in Taiwan: A Cross-Sectional Study
Yu Lee 1, Chi-Fa Hung 1, Chih-Yen Chien 2, Pao-Yen Lin 1, Meng-Chih Lin 3, Chin-Chou Wang 3, Hung-I Lu 4, Yung-Che Chen 3, Mian-Yoon Chong 1, Liang-Jen Wang 5
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PMID: 32601116 DOI: 10.1136/bmjopen-2020-037918
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Abstract
Objective: Depression is a common comorbidity in cancer patients. This study aimed to compare the prevalence and associated factors of depressive disorder between patients with head and neck cancer (HNC) and those with lung cancer (LC).

Design: This study used a cross-sectional design with consecutive sampling.

Setting: A medical centre (Kaohsiung Chang Gung Memorial Hospital, Taiwan).

Participants: Patients for the study were recruited from the HNC and LC outpatient clinic and inpatient ward from March 2016 to February 2018. Patients with HNC and LC were enrolled and assessed using the Mini International Neuropsychiatric Interview (MINI).

Primary and secondary outcome measures: The primary outcome was psychiatric diagnoses assessed using the MINI. The secondary outcomes were psychological well-being assessed using the Beck Anxiety Inventory, Taiwanese Depression Questionnaire, Brief Fatigue Inventory, Numeric Pain Rating Scale and the List of Threatening Experiences Questionnaire.

Results: In total, 113 HNC patients and 104 LC patients were recruited for the study. The most common psychiatric comorbidity of HNC patients was alcohol use disorder (49.6%), followed by adjustment disorder (20.4%) and depressive disorder (11.5%). The most common psychiatric comorbidity of LC patients was depressive disorder (25.0%), followed by adjustment disorder (17.3%), alcohol use disorder (3.8%) and insomnia disorder (3.8%). Among HNC patients, a self-harm history was positively associated with depression (OR=11.91; 95% CI, 1.47 to 96.83), and a higher educational level was negatively associated with depression (OR=0.77; 95% CI, 0.66 to 0.91). Among LC patients, severity of stressor (OR=2.78; 95% CI, 1.50 to 5.15) and severity of anxiety (OR=1.18; 95% CI, 1.04 to 1.34) were two significant factors associated with depression.

Conclusion: We reported the prevalence and associated factors of depression between patients with HNC and those with LC. Clinicians should be aware of this comorbidity and the associated risk factors, and conduct intervention programmes to prevent these cancer patients from developing depression.

Keywords: depression & mood disorders; head & neck tumours; respiratory tract tumours.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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2
BMJ Open
. 2020 Jun 28;10(6):e035680. doi: 10.1136/bmjopen-2019-035680.
Investigating Foods and Beverages Sold and Advertised in Deprived Urban Neighbourhoods in Ghana and Kenya: A Cross-Sectional Study
Mark Alan Green 1, Rebecca Pradeilles 2, Amos Laar 3, Hibbah Osei-Kwasi 4, Nicolas Bricas 5, Nathaniel Coleman 6, Senam Klomegah 7, Milka Njeri Wanjohi 8, Akua Tandoh 6, Robert Akparibo 9, Richmond Nii Okai Aryeetey 6, Paula Griffiths 2, Elizabeth W Kimani-Murage 8, Kobby Mensah 10, Stella Muthuri 11, Francis Zotor 7, Michelle Holdsworth 12
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PMID: 32595155 DOI: 10.1136/bmjopen-2019-035680
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Abstract
Objectives: The aim of this study was to characterise the local foods and beverages sold and advertised in three deprived urban African neighbourhoods.

Design: Cross-sectional observational study. We undertook an audit of all food outlets (outlet type and food sold) and food advertisements. Descriptive statistics were used to summarise exposures. Latent class analysis was used to explore the interactions between food advertisements, food outlet types and food type availability.

Setting: Three deprived neighbourhoods in African cities: Jamestown in Accra, Ho Dome in Ho (both Ghana) and Makadara in Nairobi (Kenya).

Main outcome measure: Types of foods and beverages sold and/or advertised.

Results: Jamestown (80.5%) and Makadara (70.9%) were dominated by informal vendors. There was a wide diversity of foods, with high availability of healthy (eg, staples, vegetables) and unhealthy foods (eg, processed/fried foods, sugar-sweetened beverages). Almost half of all advertisements were for sugar-sweetened beverages (48.3%), with higher exposure to alcohol adverts compared with other items as well (28.5%). We identified five latent classes which demonstrated the clustering of healthier foods in informal outlets, and unhealthy foods in formal outlets.

Conclusion: Our study presents one of the most detailed geospatial exploration of the urban food environment in Africa. The high exposure of sugar-sweetened beverages and alcohol both available and advertised represent changing urban food environments. The concentration of unhealthy foods and beverages in formal outlets and advertisements of unhealthy products may offer important policy opportunities for regulation and action.

Keywords: nutrition & dietetics; public health; statistics & research methods.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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3
BMJ Open
. 2020 Jun 28;10(6):e032128. doi: 10.1136/bmjopen-2019-032128.
Comparison of Intravitreal Dexamethasone Implant and anti-VEGF Drugs in the Treatment of Retinal Vein Occlusion-Induced Oedema: A Meta-Analysis and Systematic Review
Shuai Ming 1 2, Kunpeng Xie 2, Mingzhu Yang 3, Huijuan He 2, Ya Li 2, Bo Lei 4 2 3
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PMID: 32595145 DOI: 10.1136/bmjopen-2019-032128
Free article
Abstract
Objective: To compare the efficacy and safety of intravitreal dexamethasone (DEX) implant and anti-vascular endothelial growth factor (anti-VEGF) agents in the treatment of macular oedema secondary to retinal vein occlusion (RVO).

Design: Systematic review and meta-analysis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE).

Data sources: PubMed, Cochrane Library and ClinicalTrials.gov registry were searched from inception to 10 December 2019, without language restrictions.

Eligibility criteria: Randomised controlled trials (RCTs) and real-world observation studies comparing the efficacy of DEX implant and anti-VEGF agents for the treatment of patients with RVO, naïve or almost naïve to both arms, were included.

Data extraction and synthesis: Two reviewers independently extracted data for mean changes in best-corrected visual acuity (BCVA), central subfield thickness (CST) and product safety. Review Manager V.5.3 and GRADE were used to synthesise the data and validate the evidence, respectively.

Results: Four RCTs and 12 real-world studies were included. An average lower letter gain in BCVA was determined for the DEX implant (mean difference (MD) = -6.59; 95% CI -8.87 to -4.22 letters) administered at a retreatment interval of 5-6 months. Results were similar (MD6 months=-12.68; 95% CI -21.98 to -3.37 letters; MD12 months=-9.69; 95% CI -12.01 to -7.37 letters) at 6 and 12 months. The DEX implant resulted in comparable or marginally less CST reduction at months 6 and 12 but introduced relatively higher risks of elevated intraocular pressure (RR=3.89; 95% CI 2.16 to 7.03) and cataract induction (RR=5.22; 95% CI 1.67 to 16.29). Most real-life studies reported an insignificant numerical gain in letters for anti-VEGF drugs relative to that for DEX implant. However, the latter achieved comparable efficacy with a 4-month dosage interval.

Conclusion: Compared with anti-VEGF agents, DEX implant required fewer injections but had inferior functional efficacy and safety. Real-life trials supplemented the efficacy data for DEX implant.

Keywords: anti-VEGF; dexamethasone; intravitreal implant; macular oedema; retinal vein occlusion.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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4
BMJ Open
. 2020 Jun 28;10(6):e037069. doi: 10.1136/bmjopen-2020-037069.
Monitoring TNM Stage of Female Breast Cancer and Survival Across the South Australian Population, With National and International TNM Benchmarking: A Population-Based Cohort Study
Ming Li 1, David Roder 2, Katina D'Onise 3, David Walters 4 5, Gelareh Farshid 5 6, Elizabeth Buckley 1, Chris Karapetis 7, Rohit Joshi 5 8, Timothy Price 5 9, Amanda Townsend 9 10, Caroline Louise Miller 5 11, David Currow 12, Kate Powell 11 13, Dianne Buranyi-Trevarton 13, Ian Olver 5
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PMID: 32595164 DOI: 10.1136/bmjopen-2020-037069
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Abstract
Objective: Using linked cancer registry and administrative data to monitor, tumour, node and metastases (TNM) stage and survival from female breast cancer in Australia.

Method: Analysis of 2000-2014 diagnoses with linked population-based data to investigate: (1) sociodemographic predictors of advanced stage (stages III and IV), using unadjusted and adjusted logistic regression; and (2) sociodemographic factors and stage as predictors of breast cancer survival using competing risk regression.

Design: Population-based registry cohort.

Setting and participants: 14 759 South Australian women diagnosed in 2000-2014.

Primary and secondary outcome measures: Stage and survival.

Results: At diagnosis, 46% of women were classified as stage I, 39% as stage II, 12% as stage III and 4% as stage IV. After adjusting for sociodemographic factors, advanced stage was more common: (1) for ages <50 years; and although not statistically significant, for ages 80+ years; and (2) in women from socioeconomically disadvantaged areas. Compared with 2000-2004 diagnoses, stage and sociodemographic adjusted risks (sub-HRs (SHRs)) of breast cancer death were lower in 2005-2009 (SHR 0.75, 95% CI 0.67 to 0.83) and 2010-2015 (SHR 0.57, 95% CI 0.48 to 0.67). Compared with stage I, the SHR was 3.87 (95% CI 3.32 to 4.53) for stage II, 10.87 (95% CI 9.22 to 12.81) for stage III, and 41.97 (95% CI 34.78 to 50.65) for stage IV. Women aged 70+ years at diagnosis and those living in the most socioeconomically disadvantaged areas were at elevated risk of breast cancer death, independent of stage and sociodemographic factors.

Conclusions: Stage varied by age, diagnostic period and socioeconomic status, and was a stronger predictor of survival than other statistically significant sociodemographic predictors. Achieving earlier diagnosis outside the original BreastScreen target of 50-69 years (as applying <2014) and in residents of socioeconomically disadvantaged areas likely would increase cancer survival at a population level.

Keywords: breast tumours; epidemiology; public health.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: DR reports grants from National Breast Cancer Foundation, grants from Cancer Council SA, during the conduct of the study.

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5
BMJ Open
. 2020 Jun 29;10(6):e037326. doi: 10.1136/bmjopen-2020-037326.
Study Protocol: Building an Evidence Base for Epidemiology Emergency Response, a Mixed-Methods Study
Amy Elizabeth Parry 1, Martyn D Kirk 2, David N Durrheim 3, Babatunde Olowokure 4, Tambri Housen 2
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PMID: 32601115 DOI: 10.1136/bmjopen-2020-037326
Free article
Abstract
Introduction: Determinants and drivers for emergencies, such as political instability, weak health systems, climate change and forcibly displaced populations, are increasing the severity, complexity and frequency of public health emergencies. As emergencies become more complex, it is increasingly important that the required skillset of the emergency response workforce is clearly defined. To enable essential epidemiological activities to be implemented and managed during an emergency, a workforce is required with the right mix of skills, knowledge, experience and local context awareness. This study aims to provide local and international responders with an opportunity to actively contribute to the development of new thinking around emergency response roles and required competencies. In this study, we will develop recommendations using a broad range of evidence to address identified lessons and challenges so that future major emergency responses are culturally and contextually appropriate, and less reliant on long-term international deployments.

Method and analysis: We will conduct a mixed-methods study using an exploratory sequential study design. The integration of four data sources, including key informant interviews, a scoping literature review, survey and semistructured interviews will allow the research questions to be examined in a flexible, semistructured way, from a range of perspectives. The study is unequally weighted, with a qualitative emphasis. We will analyse all activities as individual components, and then together in an integrated analysis. Thematic analysis will be conducted in NVivo V.11 and quantitative analysis will be conducted in Stata V.15.

Ethics and dissemination: All activities have been approved by the Science and Medical Delegated Ethics Review Committee at the Australian National University (protocol numbers 2018-521, 2018-641, 2019-068). Findings will be disseminated through international and local deployment partners, peer-reviewed publication, presentation at international conferences and through social media such as Twitter and Facebook.

Keywords: epidemiology; public health.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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6
BMJ Open
. 2020 Jun 28;10(6):e036645. doi: 10.1136/bmjopen-2019-036645.
Systematic Review Protocol Examining Sex Differences in Survival Among Low Birthweight Newborns and Infants in sub-Saharan Africa
Akalewold T Gebremeskel 1, Arone W Fantaye 2, Lena E Faust 3, Sanni Yaya 4 5
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PMID: 32595162 DOI: 10.1136/bmjopen-2019-036645
Free article
Abstract
Introduction: In sub-Saharan African countries, low birthweight (LBW) accounts for three-quarters of under-five mortality and morbidity. However, there is no systematic evidence of sex differences in LBW survival risk. The aim of this protocol is to outline the methodological process of a systematic review that will gather qualitative and quantitative data on sex differences in survival among LBW newborns and infants in sub-Saharan Africa.

Methods: This protocol adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols reporting guidelines. We will conduct a systematic review to retrieve all qualitative and quantitative studies. Electronic search strategies are being finalised on 24 February 2020 for Ovid Medline and EMBASE, and on 28 February 2020 for CINAHL, Scopus and Global Health in collaboration with a Health Sciences librarian. The primary outcome of interest is indicating sex differences in survival among LBW newborns and infants. Secondary outcomes are sex-disaggregated differences in morbidity among LBW newborns and infants. Screening, data extraction and assessments of risk of bias will be performed independently. Narrative synthesis and a meta-analysis will be conducted with studies that are compatible based on population and outcome. The systematic review is focused on the analysis of secondary data and does not require ethics approval.

Ethics and dissemination: As it will be a systematic review, without human participants' involvement, there will be no requirement for ethical approval. The systematic review will present key evidence of sex-disaggregated differences in mortality and morbidity among LBW newborns and infants in sub-Saharan Africa. Programme managers, policy-makers and researchers can use the findings to evaluate LBW health outcomes in different sexes. The final manuscript will be disseminated through a peer-reviewed journal and scientific conferences.

Prospero registration number: CRD42020163470.

Keywords: community child health; epidemiology; public health.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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7
BMJ Open
. 2020 Jun 28;10(6):e036787. doi: 10.1136/bmjopen-2020-036787.
Digital Epidemiological and Citizen Science Methodology to Capture Prospective Physical Activity in Free-Living Conditions: A SMART Platform Study
Tarun Reddy Katapally 1 2, Luan Manh Chu 3
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PMID: 32595163 DOI: 10.1136/bmjopen-2020-036787
Free article
Abstract
Objectives: The purpose of this study was to develop a replicable methodology of mobile ecological momentary assessments (EMAs) to capture prospective physical activity (PA) within free-living social and physical contexts by leveraging citizen-owned smartphones running on both Android and iOS systems.

Design: Data were obtained from the cross-sectional pilots of the SMART Platform, a citizen science and mobile health initiative.

Setting: The cities of Regina and Saskatoon, Canada.

Participants: 538 citizen scientists (≥18 years) provided PA data during eight consecutive days using a custom-built smartphone application, and after applying a rigid inclusion criteria, 89 were included in the final analysis.

Outcome measures: EMAs enabled reporting of light, moderate, and vigorous PA, as well as physical and social contexts of PA. Retrospective PA was reported using International Physical Activity Questionnaire (IPAQ). For both measures, PA intensities were categorised into mean minutes of light and moderate-to-vigorous PA per day. Wilcoxon signed ranks tests and Spearman correlation procedures were conducted to compare PA intensities reported via EMAs and IPAQ.

Results: Using EMAs, citizen scientists reported 140.91, 87.16 and 70.38 mean min/day of overall, light and moderate-to-vigorous PA, respectively, whereas using IPAQ they reported 194.39, 116.99 and 98.42 mean min/day of overall, light and moderate-to-vigorous PA, respectively. Overall (ρ=0.414, p<0.001), light (ρ=0.261, p=0.012) and moderate-to-vigorous PA (ρ=0.316, p=0.009) were fairly correlated between EMA and IPAQ. In comparison with EMAs, using IPAQ, citizen scientists reported significantly greater overall PA in active transportation (p=0.002) and recreation, sport and leisure-time domains (p=0.003).

Conclusions: This digital epidemiological and citizen science methodology adapted mobile EMAs to capture not only prospective PA, but also important physical and social contexts within which individuals accumulate PA. Ubiquitous tools can be leveraged via citizen science to capture accurate active living patterns of large populations in free-living conditions through innovative EMAs.

Keywords: epidemiology; public health; sports medicine.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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8
BMJ Open
. 2020 Jun 28;10(6):e034903. doi: 10.1136/bmjopen-2019-034903.
Mortality of Ethnic Minority Groups in the UK: A Systematic Review Protocol
Fiona Stanaway 1, Naomi Noguchi 2, Erin Mathieu 2, Saman Khalatbari-Soltani 2, Raj Bhopal 3
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PMID: 32595151 DOI: 10.1136/bmjopen-2019-034903
Free article
Abstract
Introduction: Growing ethnic diversity in the UK has made it increasingly important to determine the presence of ethnic health inequalities. There has been no systematic review that has drawn together research on ethnic differences in mortality in the UK.

Methods: All types of observational studies that compare all-cause mortality between major ethnic groups and the white majority population in the UK will be included. We will search Medline (OvidSP), Embase (OvidSP), Scopus and Web of Science and search the grey literature through conference proceedings and online thesis registries. Searches will be carried out from inception to 2 August 2019 with no language or other restrictions. Database searches will be repeated prior to publication to identify new articles published since the initial search. We will conduct forward and backward citation tracking of identified references and consult with experts in the field to identify further publications and ongoing or unpublished studies. Two reviewers will independently screen studies and extract data. Two reviewers will independently assess the quality of included studies using the Newcastle-Ottawa Scale. If at least two studies are located for each ethnic group and studies are sufficiently homogeneous, we will conduct a meta-analysis. If insufficient studies are located or if there is high heterogeneity we will produce a narrative summary of results.

Ethics and dissemination: As no primary data will be collected, formal ethical approval is not required. The findings of this review will be disseminated through publication in peer reviewed journals and conference presentations.

Prospero registration number: CRD42019146143.

Keywords: epidemiology; public health; statistics & research methods.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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9
BMJ Open
. 2020 Jun 28;10(6):e034247. doi: 10.1136/bmjopen-2019-034247.
Racial and Socioeconomic Disparities in Patient Experience of Clinician Empathy: A Protocol for Systematic Review and Meta-Analysis
Brian W Roberts 1 2, Christian J Trzeciak 3, Nitin K Puri 3 2, Anthony J Mazzarelli 3 2, Stephen Trzeciak 3 2
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PMID: 32595149 DOI: 10.1136/bmjopen-2019-034247
Free article
Abstract
Introduction: Clinician empathy is a vital component of high-quality healthcare. Healthcare disparities may reflect a societal lack of empathy for disadvantaged persons in general, and recent research suggests that socioeconomic disparities exist in patient satisfaction with clinicians. However, it is currently unclear if there are disparities in patient experience of empathy from clinicians. Our objective is to systematically analyse the scientific literature to test the hypothesis that racial and socioeconomic status (SES) disparities exist in patient-reported experience of clinician empathy.

Methods and analysis: In accordance with published methodological guidelines for conducting a systematic review, we will analyse studies reporting patient assessment of clinician empathy using the Consultation and Relational Empathy (CARE) measure, which to date is the most commonly used and well-validated methodology in clinical research for measuring clinician empathy from the patient's perspective. We will use a standardised data collection template and assess study quality (risk of bias) using the Newcastle-Ottawa Scale. We will abstract data for the CARE measure stratified by race and SES, and we will contact the corresponding authors to obtain stratified data by race/SES if not reported in the original manuscript. Where appropriate, we will pool the data and perform quantitative meta-analysis to test if non-white (compared to white) patients and low SES (compared to high SES) patients report lower scores for clinician empathy.

Ethics and dissemination: No individual patient-level data will be collected and thus the proposed systematic review does not require ethical approval. This systematic review will test if racial and SES differences exist in patient experience of clinician empathy, and will inform future research to help promote healthcare equity.

Prospero registration number: CRD42019142809.

Keywords: public health; quality in health care; social medicine.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: AM and ST are authors of a book on compassion science, entitled ‘Compassionomics’. None of the other authors have potential competing interests to disclose.

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10
BMJ Open
. 2020 Jun 28;10(6):e033652. doi: 10.1136/bmjopen-2019-033652.
Descriptive Study of Workplace Demand, Control and Bullying Among Migrant and Australian-born Workers by Gender: Does Workplace Support Make a Difference?
Alison Reid 1, Alison Daly 2, Anthony D LaMontagne 3, Allison Milner 4, Elena Ronda Pérez 5 6
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PMID: 32595148 DOI: 10.1136/bmjopen-2019-033652
Free article
Abstract
Objective: The objective of this study is to examine the relationship between bullying in migrants and Australians and types of workplace Iso-strain, by gender.

Design and setting: Two descriptive cross-sectional surveys of the Australian working population.

Participants: Australian-born workers of Caucasian ancestry (n=1051, participant response rate=87.3%) and workers born in New Zealand (n=566), India (n=633) and the Philippines (n=431) (participant response rate=79.5%).

Primary and secondary outcomes measures: Using logistic regression, we examined whether self-reported assessment of various forms of bullying in the workplace was associated with Iso-strain (job with high demands and low control and without social support), gender and migrant status.

Results: The prevalence of workplace bullying within the previous year was 14.5%. Sexual harassment, though rare (n=47, 1.8%), was reported by more women than men (83% vs 17%, χ2=19.3, p<0.0001) and more Australia or New Zealand born workers compared to India or the Philippines workers (75.5% vs 25.5%, χ2=4.6, p=0.032). Indian-born women had lower adjusted OR for being bullied and for being intimidated compared to other women. Independent of migrant status, Iso-strain (1), (low support from boss) and Iso-strain (2), (low support from colleagues) predicted being bullied. Women were more likely to be in an Iso-strain (1) job than men (18.7% vs 13.6%, p=0.013) and had twice the risk of being both verbally abused and intimidated compared to men (OR 9 vs OR 5.5, p<0.0001).

Conclusion: Workplace bullying was more likely for women than men. There were few differences between workers from different migrant groups. Iso-strain was the strongest predictor of workplace bullying. Workplaces should encourage supportive and collegiate work environments.

Keywords: bullying; epidemiology; migrants; occupational & industrial medicine; public health.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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11
BMJ Open
. 2020 Jun 29;10(6):e036367. doi: 10.1136/bmjopen-2019-036367.
Long-term Outcomes for Asian Patients With X-linked Hypophosphataemia: Rationale and Design of the SUNFLOWER Longitudinal, Observational Cohort Study
Takuo Kubota 1, Seiji Fukumoto 2, Hae Il Cheong 3, Toshimi Michigami 4, Noriyuki Namba 5, Nobuaki Ito 6, Shin Tokunaga 7, Yoshimi Gibbs 7, Keiichi Ozono 8
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PMID: 32601114 DOI: 10.1136/bmjopen-2019-036367
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Abstract
Introduction: X-linked hypophosphataemic rickets/osteomalacia (XLH) is a chronic, debilitating genetic disease characterised by skeletal abnormalities and growth disorder. The burden of XLH begins in childhood and continues throughout life. Conventional medical therapy with phosphate, active vitamin D and surgery do not address the underlying pathophysiology of the disease. While treatment during childhood may improve bone deformity and growth retardation, a large proportion of adult patients still fail to reach normal stature. Furthermore, adult patients with XLH report comorbidities associated with unresolved childhood disease, as well as newly developed disease-related complications and significantly impaired quality of life (QOL). Despite the multiple negative aspects of XLH, Asian consensus statements for diagnosis and management are lacking.

Methods and analysis: The Study of longitUdinal observatioN For patients with X-Linked hypOphosphataemic rickets/osteomalacia in collaboration With Asian partnERs study is a longitudinal observational cohort study of patients with XLH, designed to determine the medical characteristics and burdens (physical, emotional and financial) of this progressive disease and to evaluate the impact of treatment (including the use of burosumab) on clinical outcomes. The study was initiated in April 2018, and registration will remain open until 30 April 2022. The sample size planned for analyses is 160 patients, consisting of 100 patients in Japan and 60 patients in Korea. Up to 5 years of observation are planned per patient, from enrolment through to April 2023. Prospective and retrospective data will be collected to evaluate variables, including height/growth, rickets severity score, QOL, motor function and biomarkers for phosphate metabolism and bone turnover.

Ethics and dissemination: Ethics approval was obtained from the Ethics Committee of Osaka University, the Ethics Committee of Kyowa Kirin Co and by the Ethics Committee of each participating medical institution. Two interim analyses and associated publications are planned using retrospective and enrolment data at year 1 and results at year 3.

Trial registration numbers: NCT03745521; UMIN000031605.

Keywords: bone diseases; clinical trials; health economics; musculoskeletal disorders.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: TK has received personal fees from Kyowa Kirin Co for the submitted work and grants from Kyowa Kirin Co outside the submitted work. SF has received grants from Teijin Pharma and Astellas Pharma; and held an endowed chair position with Chugai Pharmaceutical Co, Ono Pharmaceutical Co, Taisho Pharmaceutical Co and Kyowa Kirin Co outside the submitted work. TM has received personal fees (honorarium) from Kyowa Kirin Co for serving as a member of the advisory board during the conduct of this study. NN has received personal fees from Kyowa Kirin Co for the submitted work; and grants from Kyowa Kirin Co outside the submitted work. NI has received research grants from Kyowa Kirin Co outside the submitted work. ST and YG are the employees of Kyowa Kirin Co. KO has received lecture fees from Kyowa Kirin Co, Alexion Pharmaceuticals and Novo Nordisk Pharma outside the submitted work.

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12
BMJ Open
. 2020 Jun 28;10(6):e031727. doi: 10.1136/bmjopen-2019-031727.
Implementation of Interventions Targeting the Uptake of Genetic Testing Services for Breast Cancer Risk: Protocol for a Systematic Review
Subash Thapa 1, Anja Leppin 2, Rikke Kristensen 2, Mette Just Bonde 2, Arja R Aro 2
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PMID: 32595144 DOI: 10.1136/bmjopen-2019-031727
Free article
Abstract
Introduction: The timely identification of breast cancer-related pathogenic variants can help to identify the risk of potential disease development and determine healthcare choices. However, the uptake rate of genetic testing services for breast cancer risk remains low in many countries. Interventions targeting the uptake of these services among individuals potentially at risk for inherited breast cancer are often complex and have multiple components, and are therefore difficult to implement, replicate and disseminate to new contexts. Our aim is to systematically review studies targeting the uptake of genetic testing services for breast cancer risk and critically assess the quality of implementation outcomes and the reporting of intervention descriptions.

Methods and analysis: PubMed, CINAHL, PsycINFO, Embase, Cochrane Library and all Campbell Coordinating Group databases will be searched for intervention studies that target individuals' participation in breast cancer genetic testing programmes. Papers published in English within the time period from January 2005 until October 2019 will be considered for inclusion. Titles, abstracts and full papers will be screened for eligibility by two pairs of reviewers independently. For data analysis and synthesis, study-level and intervention-level characteristics will be abstracted. We will present all implementation outcomes that are mentioned in each of the studies and register the number of studies that do not at all look at or report implementation outcomes. The quality of implementation will be checked using a 5-point rubric item, and the quality and completeness of reporting of intervention description will be evaluated using the 12-item Template for Intervention Description and Replication (TIDieR).

Ethics and dissemination: Ethical approval is not required to conduct this review. Review findings will be disseminated to academic and non-specialist audiences via peer-reviewed academic journals and presented at appropriate conferences, workshops and meetings to policymakers, practitioners and organisations that work with our population of interest.

Prospero registration number: CRD42018105732.

Keywords: cancer genetics; international health services; quality in health care.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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13
BMJ Open
. 2020 Jun 28;10(6):e035809. doi: 10.1136/bmjopen-2019-035809.
Biomarkers Versus Traditional Risk Factors to Predict Cardiovascular Events in Very Old Adults: Cross-Validated Prospective Cohort Study
Bert Vaes 1, Paulien Indestege 2, Tinne Serneels 2, Eralda Hegendörfer 2 3, Petra G van Peet 4, Rosalinde K E Poortvliet 4, Pierre Wallemacq 5, Jacobijn Gussekloo 4 6, Jan Degryse 2 3
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PMID: 32595156 DOI: 10.1136/bmjopen-2019-035809
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Abstract
Objectives: To test new cardiovascular (CV) risk models in very old adults with and without a history of CV disease (CVD), based on traditional risk factors and biomarkers.

Design: Cross-validated prospective cohort study. The models were tested in the BELFRAIL Study and externally validated in the Leiden 85-plus Study.

Setting: General practice, Belgium and The Netherlands.

Participants: The BELFRAIL cohort consisted of 266 patients aged 80 years or older without a history of CVD and 260 with a history of CVD. The Leiden 85-plus Study consisted of 264 patients aged 85 years without a history of CVD and 282 with a history of CVD.

Outcome measures: The model with traditional risk factors and biomarkers, as well as the model using only biomarkers, was compared with the model with only traditional risk factors to predict 3-year CV morbidity and mortality. A competing-risk analysis was performed, and the continuous net reclassification improvement (NRI), integrated discrimination improvement (IDI) and net benefit were used to compare the predictive value of the different models.

Results: Traditional risk factors poorly predicted CV mortality and morbidity. In participants without a history of CVD, adding N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) improved the prediction (NRI 0.56 (95% CI 0.16 to 0.99) and relative IDI 4.01 (95% CI 2.19 to 6.28)). In participants with a history of CVD, the NRI with the addition of NT-pro-BNP and high-sensitivity C reactive protein was 0.38 (95% CI 0.09 to 0.70), and the relative IDI was 0.53 (95% CI 0.23 to 0.90). Moreover, in participants without a history of CVD, NT-pro-BNP performed well as a stand-alone predictor (NRI 0.32 (95% CI -0.12 to 0.74) and relative IDI 3.44 (95% CI 1.56 to 6.09)).

Conclusions: This study tested new risk models to predict CV morbidity and mortality in very old adults. Especially, NT-pro-BNP showed a strong added predictive value. This opens perspectives for clinicians who are in need of an easily applicable strategy for CV risk prediction in very old adults.

Keywords: cardiac epidemiology; epidemiology; geriatric medicine.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Competing interests: None declared.

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14
BMJ Open
. 2020 Jun 28;10(6):e036166. doi: 10.1136/bmjopen-2019-036166.
Protocol for Creating New Warnings on Cigarette Packs and Evaluating Their Efficacy in a Randomised Experimental Setting
Christian Ben Lakhdar 1, Antoine Deplancke 2, Fabrice Le Lec 2, Sophie Massin 3, Anthony Piermatteo 2, Nicolas Vaillant 4 2
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PMID: 32595160 DOI: 10.1136/bmjopen-2019-036166
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Abstract
Introduction: Tobacco smoking is one of the leading causes of preventable death. This is not inevitable as tobacco control tools have become more powerful and more effective. Among these, warnings on cigarette packs have proven to be somewhat effective. Our objective is to increase the efficacy of antismoking warnings by using innovative psychological approaches and to create an experimental setting for the evaluation of these new warnings based on behavioural indicators.

Methods and analysis: First, we created new warnings based on three categories of motivational leverage and on harm reduction. New warnings with innovative texts and pictures were designed for each category and inserted on plain packs. We will then use standard indicators to compare their effect to that of control packs: plain pack without warning, plain pack with conventional warning and branded pack with conventional warning. Second, the novelty of our approach will consist in designing an experimental protocol that uses monetary incentives to evaluate the effect of warnings. Subjects will be able to 'sacrifice' part of their participation defrayal to purchase a good whose subjective value is related to one's attitude towards smoking. These monetarily incentivised measures are designed to assess smokers' immediate/mid-term intention to quit and non-smokers' aversion to smoking. In both cases, the monetary amounts individuals accept to sacrifice may be a more reliable measure than declarative responses, which may be distorted by several hypothetical biases. In the end, we should be able to robustly measure the impact of our new warnings between intervention and control groups by using both traditional indicators and our new monetarily incentivised measure.

Ethics and dissemination: The ethics committee of the Groupement des Hôpitaux de l'Institut Catholique de Lille approved the research protocol on 5 July 2019 (CIER 2019-22). Results will be presented at scientific meetings and published.

Keywords: health economics; public health; statistics & research methods.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Competing interests: None declared.

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15
BMJ Open
. 2020 Jun 28;10(6):e039154. doi: 10.1136/bmjopen-2020-039154.
Development of a Core Outcome Set to Use in the Research and Assessment of Malignant Bowel Obstruction: Protocol for the RAMBO Study
Elin Baddeley 1, Alison Bravington 2, Miriam Johnson 2, David C Currow 2 3, Fliss Em Murtagh 2, Elaine Boland 4, George Obita 5, Annmarie Nelson 6, Kathy Seddon 6, Alfred Oliver 7 8, Simon Noble 6, Jason Boland 2
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PMID: 32595168 DOI: 10.1136/bmjopen-2020-039154
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Abstract
Introduction: Studies regarding the management of malignant bowel obstruction (MBO) report conflicting findings. This is partly due to different outcome measures being used to evaluate severity of MBO and the response to treatments. Furthermore, current outcome measures focus mainly on measurable physiological parameters which may not correlate strongly with patient-defined quality of life. The development of core outcome sets allows a consistent approach to evaluating clinical conditions taking into consideration patient, healthcare professional and researcher viewpoints. It follows an internationally recognised standard methodology. We present a protocol for the development of a core outcome set for Research and Assessment of MBO (RAMBO).

Methods: RAMBO is a multicentre study, comprising of four phases: a systematic review to examine current scope of outcome measures associated with MBO (phase I). Interviews with patients, companions and healthcare professionals will explore priorities and preferences for care and outcomes (phase II). An expert panel meeting will collate the findings into a set of outcomes (phase III), refined by consensus through a Delphi survey with key stakeholders (phase IV). The final set of outcomes will be ratified at a consensus meeting. Each step will actively include patient partners. Thematic analysis and descriptive statistics will be used to analyse qualitative and quantitative data, respectively.

Ethics and dissemination: Ethical approval was obtained (Wales REC 5, REF: 19/LO/1876). Study participants and relevant stakeholders will be updated with newsletters and a lay summary at the end of the study. Abstracts will be submitted to national and international conferences, result papers will be submitted to peer-reviewed, open access journals.

Trial and prospero registration numbers: Core Outcome Measures in Effectiveness Trials (1402); Systematic Literature Review (CRD42019150648); Rapid Review (CRD42020176393).

Keywords: adult palliative care; gastroenterology; oncology; qualitative research.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Competing interests: None declared.

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16
BMJ Open
. 2020 Jun 28;10(6):e035207. doi: 10.1136/bmjopen-2019-035207.
Patient, Physiotherapist and Surgeon Endorsement of the Core Domain Set for Total Hip and Total Knee Replacement in Germany: A Study Protocol for an OMERACT Initiative
Robert Prill 1, Jasvinder A Singh 2 3, Gesine H Seeber 4, Sabrina Mai Nielsen 5, Susan Goodman 6, Sven Michel 7, Christian Kopkow 7, Robert Schulz 7, Peter Choong 8, Hagen Hommel 9
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PMID: 32595152 DOI: 10.1136/bmjopen-2019-035207
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Abstract
Introduction: There is a lack of harmonising measures for clinical trials on total joint replacement (TJR) that would allow for results from TJR studies to be compared or pooled. The Outcome Measures in Rheumatology (OMERACT) TJR core domain set is already endorsed among patients and physicians in the USA and Australia. Physiotherapists use different types of measurements compared to orthopaedic surgeons while both make substantial contributions to research in the field of TJR. To achieve consensus on core measurements sets, patients, physiotherapists and orthopaedic surgeons need to achieve consensus on the core domains for TJR trials.

Methods and analysis: For this multistage study, first, the OMERACT TJR core domain set survey will be translated to German and validated according to WHO guidelines. Next, the TJR core domain set will be considered for endorsement in different German stakeholder groups including patients, physiotherapists and orthopaedic surgeons.

Ethics and dissemination: Ethical approval for this protocol was given by the ethics committee of the Brandenburg University of Technology Cottbus-Senftenberg (BTU-CS, EK 2019-2). This article is based on the protocol version 2.5 from 6 May 2020. Anonymous data will be presented only. We will publish the results in peer-reviewed publications and at international conferences.

Trial registration number: German Clinical Trials Registry (DRKS00016015).

Keywords: hip; knee; protocols & guidelines; statistics & research methods.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: RP, GHS, SMN, SG, SM, CK, RS and HH do not have competing interests. JAS has received consultant fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Medscape, WebMD, Clinical Care options, Clearview healthcare partners, Putnam associates, Spherix, the National Institutes of Health and the American College of Rheumatology. JAS owns stock options in Amarin pharmaceuticals and Viking therapeutics. JAS is a member of the executive of OMERACT, an organisation that develops outcome measures in rheumatology and receives arms-length funding from 36 companies. JAS serves on the FDA Arthritis Advisory Committee. JAS is a member of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. JAS previously served as a member of the following committees: member, the American College of Rheumatology's (ACR) Annual Meeting Planning Committee (AMPC) and Quality of Care Committees, the Chair of the ACR Meet-the-Professor, Workshop and Study Group Subcommittee and the cochair of the ACR Criteria and Response Criteria subcommittee. PC received institutional support from Medacta. PC also received consultancies from Johnson & Johnson and Stryker. PC received royalties from Johnson and Johnson as part of an instrument design team. PC is part of a Federal Government (Australian) funded industry led consortium (Innovative Manufacturing Cooperative Research Centre) investigating advanced manufacturing in prosthetic design and manufacture. PC is a recipient of National Health and Medical Research Council grants, as well as Australian Research Council grants.

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17
BMJ Open
. 2020 Jun 28;10(6):e035590. doi: 10.1136/bmjopen-2019-035590.
Social Factors Associated With Chronic Non-Communicable Disease and Comorbidity With Mental Health Problems in India: A Scoping Review
Saju Madavanakadu Devassy 1 2, Anuja Maria Benny 2, Lorane Scaria 2, Anjana Nannatt 1, Meredith Fendt-Newlin 3, Jacques Joubert 4, Lynette Joubert 5, Martin Webber 6
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PMID: 32595154 DOI: 10.1136/bmjopen-2019-035590
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Abstract
Objectives: The purpose of this study is to examine the existing literature of the major social risk factors which are associated with diabetes, hypertension and the comorbid conditions of depression and anxiety in India.

Design: Scoping review.

Data sources: Scopus, Embase, CINAHL Plus, PsycINFO, Web of Science and MEDLINE were searched for through September 2019.

Eligibility criteria for selecting studies: Studies reporting data on social risk factors for diabetes or hypertension and depression or anxiety in community-based samples of adults from India, published in English in the 10 years to 2019, were included. Studies that did not disaggregate pooled data from other countries were excluded.

Data extraction and synthesis: Two independent reviewers extracted study aims; methods; sample size and description; demographic, social and behavioural risk factors and a summary of findings from each paper. Risk factors were synthesised into six emergent themes.

Results: Ten studies were considered eligible and included in this review. Nine presented cross-sectional data and one was a qualitative case study. Six themes emerged, that is, demographic factors, economic aspects, social networks, life events, health barriers and health risk behaviours.

Conclusions: Literature relating to the major social risk factors associated with diabetes, hypertension and comorbid depression and anxiety in India is sparse. More research is required to better understand the interactions of social context and social risk factors with non-communicable diseases and comorbid mental health problems so as to better inform management of these in the Indian subcontinent.

Keywords: cardiology; general diabetes; hypertension; mental health.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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18
BMJ Open
. 2020 Jun 29;10(6):e034567. doi: 10.1136/bmjopen-2019-034567.
Assessing Palliative Care Education in Undergraduate Medical Students: Translation and Validation of the Self-Efficacy in Palliative Care and Thanatophobia Scales for Brazilian Portuguese
Guilherme Gryschek 1, Dario Cecilio-Fernandes 2, Stephen Mason 3, Marco Antonio de Carvalho-Filho 4 5
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PMID: 32601112 DOI: 10.1136/bmjopen-2019-034567
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Abstract
Background: As the global population ages, palliative care is ever more essential to provide care for patients with incurable chronic conditions. However, in many countries, doctors are not prepared to care for dying patients. Palliative care education should be an urgent concern for all medical schools all around the world, including Latin America and Brazil. Advances in palliative care education require robust assessment tools for constant evaluation and improvement of educational programmes. Bandura's social cognitive theory proposes that active learning processes are mediated by self-efficacy and associated outcome expectancies, both crucial elements of developing new behaviour. The Self-Efficacy in Palliative Care (SEPC) and Thanatophobia Scales were developed using Bandura's theory to assess the outcomes of palliative care training.

Objectives: We aimed to translate and validate these scales for Brazilian Portuguese to generate data on how well doctors are being prepared to meet the needs of their patients.

Design: Cross-sectional study.

Setting: One Brazilian medical school.

Participants: Third-year medical students.

Methods: The authors translated the scales following the European Organisation for Research and Treatment of Cancer's recommendations and examined their psychometric properties using data collected from a sample of 111 students in a Brazilian medical school in 2017.

Results: The Brazilian versions of SEPC and Thanatophobia Scales showed good psychometric properties, including confirmatory factor analysis, replicating the original factors (factor range: 0.51-0.90), and acceptable values of reliability (Cronbach's alpha: 0.82-0.97 and composite reliability: 0.82-0.96). Additionally, the Brazilian versions of the scales showed concurrent validity, demonstrated through a significant negative correlation.

Conclusions: The Brazilian version of the scales may be used to assess the impact of current undergraduate training and identify areas for improvement within palliative care educational programmes. The data generated allow Brazilian researchers to join international conversations on this topic and educators to develop tailored pedagogical approaches.

Keywords: attitude to death; palliative care; psychometrics; self-efficacy; undergraduate medical education.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Competing interests: None declared.

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19
BMJ Open
. 2020 Jun 29;10(6):e034530. doi: 10.1136/bmjopen-2019-034530.
Realist Evaluation of a Theory-Based Life Skills Programme Aiming to Prevent Addictive Behaviours in Adolescents: The ERIEAS Study Protocol
Judith Martin-Fernandez 1 2, Aurelie Affret 3 2, Emma Martel 4, Romain Gallard 2 4, Laurence Merchadou 5, Laetitia Moinot 5, Monique Termote 5, Vincent Dejarnac 6, François Alla 3 7, Linda Cambon 5 8
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PMID: 32601111 DOI: 10.1136/bmjopen-2019-034530
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Abstract
Introduction: Adolescence is a sensitive life stage during which tobacco, alcohol and cannabis are used as ways to learn and adopt roles. There is a great deal of interest in substance use (SU) prevention programmes for young people that work to change representations of these products and help with mobilisation of life skills. Unfortunately, few existing programmes are evidence-based.In France, a programme called Expériences Animées (EA, Animated Experiences) has been developed, inspired by life skills development programmes that have been proven to be successful. The EA programme uses animated short movies and talks with high school and secondary school pupils about the use of psychoactive substances and addictions. By allowing life skills mobilisation and modifying representations and beliefs about SU, it is aimed at delaying initiation of use of psychoactive substances, preventing adolescents from becoming regular consumers, reducing the risks and harms related to the use of these substances and opening the way for adapted support measures.We are interested in understanding how, under what circumstances, through which mechanisms and among which adolescents the EA programme works. Therefore, we have developed the ERIEAS study ('Evaluation Réaliste de l'Intervention Expériences Animées en milieu Scolaire'; Realist Evaluation of the EA Intervention in Schools).

Methods and analysis: EA will be conducted in 10 schools. A multi-case approach will be adopted with the aim of developing and adjusting an intervention theory. The study comes under the theory-driven evaluation framework. The investigation methodology will include four stages: (i) elaboration of a middle-range theory; (ii) data collection for validating/adjusting the theory; (iii) data analysis; and (iv) refinement and adjustment of the middle-range theory and definition of the programme's key functions.

Ethics and dissemination: The study will provide evidence-based results to health authorities to help in the rollout of health promotion strategies in schools. It will provide knowledge about the strategic configurations most suitable for leading to life skills mobilisation and change young people's representations about SU. The project will be carried out with full respect of current relevant legislation (eg, the Charter of Fundamental Rights of the European Union) and international conventions (eg, Helsinki Declaration). It follows the relevant French legislation of the research category on interventional research protocol involving the human person. The protocol was approved by the Comité et Protection des Personnes (CPP), that is, Committee for the Protection of Persons CPP SUD-EST VI n°: AU 1525 and was reported to the Agence Française de Sécurité Sanitaire des Produits de Santé (ANSM) that is, the French National Agency for the Safety of Health Products. It is in conformity with reference methodology MR003 of Bordeaux University Hospital (CNIL n° 2 026 779 v0).Trial registration detailsThis research has been registered on ClinicalTrials.gov (No. NCT04110626).The research project is registered in the European database ID-RCB (No. 2019-A01003-54).

Keywords: addictions; life skills; preventive medicine; realist evaluation.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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20
BMJ Open
. 2020 Jun 28;10(6):e036326. doi: 10.1136/bmjopen-2019-036326.
Service Users' Experiences of Contacting NHS Patient Medicines Helpline Services: A Qualitative Study
Matt Williams 1, Abbie Jordan 2, Jennifer Scott 1, Matthew D Jones 3
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PMID: 32595161 DOI: 10.1136/bmjopen-2019-036326
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Abstract
Objectives: Patient medicines helpline services (PMHS) are available from some National Health Service (NHS) Trusts in the UK to provide medicines information to hospital patients and carers. To date, studies of PMHS have examined the views of service users via satisfaction surveys. This study used qualitative methods to explore service users' experiences of using a PMHS, including perceived benefits and areas for improvement.

Design: Qualitative, using semi-structured interviews.

Setting: This study was conducted across seven NHS Trusts in England.

Participants: Forty users of PMHS were individually interviewed over the telephone. Interviews were audio-recorded, transcribed verbatim and analysed using Braun and Clarke's inductive reflexive thematic analysis. Ethical approval was obtained before study commencement.

Results: Participants predominantly called a PMHS for themselves (82%; carers: 18%). Two main themes were generated. Theme 1: timeliness-PMHS provide support during the uncertain transition of care period from hospital to home, when patients and carers often feel vulnerable because support is less available. PMHS met service users' needs for timely and easily accessible support, and quick resolution of their issues. PMHS could be improved with staffing beyond typical work week hours, and by having staff available to answer calls instead of using an answerphone. Theme 2: PMHS are best-placed to help-PMHS were perceived as best-placed to answer enquiries that arose from hospital care. Service users felt reassured from speaking to pharmacy professionals, and PMHS were perceived as the optimal service in terms of knowledge and expertise regarding medicines-related questions. However, several participants were initially unaware that their PMHS existed.

Conclusions: PMHS are perceived to be a valuable means of accessing timely medicines-related support when patients and carers may be feeling particularly vulnerable. However, their availability and promotion could be improved. We recommend that providers of PMHS consider whether this is achievable, in order to better meet the needs of service users.

Keywords: National Health Service; carers; drug information services; hospital discharge; medicines information; patient medicines helpline services; patients; qualitative; service users; thematic analysis.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Competing interests: None declared.

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21
BMJ Open
. 2020 Jun 29;10(6):e031708. doi: 10.1136/bmjopen-2019-031708.
Effects of Adding Adjunctive Hyperbaric Oxygen Therapy to Standard Wound Care for Diabetic Foot Ulcers: A Protocol for a Systematic Review With Meta-Analysis and Trial Sequential Analysis
Julie Vinkel 1, Niels Frederich Rose Holm 2, Janus C Jakobsen 3 4 5 6, Ole Hyldegaard 2
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PMID: 32601110 DOI: 10.1136/bmjopen-2019-031708
Free article
Abstract
Introduction: Diabetic foot ulcer represents a major health problem globally. Preliminary studies have indicated that systemic treatment of diabetic foot ulcer patients with hyperbaric oxygen therapy have beneficial effects on wound healing, risk of amputation, glycaemic control, atherosclerosis, inflammatory markers and other clinical and laboratory parameters. This protocol for a systematic review aims at identifying the beneficial and harmful effects of adding hyperbaric oxygen therapy to standard wound care for diabetic foot ulcers.

Methods and analysis: This protocol was performed following the recommendations of the Cochrane Collaboration and the eight-step assessment procedure suggested by Jakobsen and colleagues. We plan to include all relevant randomised clinical trials assessing the effects of hyperbaric oxygen therapy in the treatment of diabetic foot ulcer versus any control group with any intervention defined as standard wound care or similar, together with sham interventions. Our primary outcome will be: all-cause mortality, serious adverse events and quality of life. Our secondary outcomes will be: healing of index wound, major amputation and wound infection. Any eligible trial will be assessed and classified as either high risk of bias or low risk of bias, and our conclusions will be based on trials with low risk of bias. The analyses of the extracted data will be performed using Review Manager 5 and Trial Sequential Analysis. For both our primary and secondary outcomes, we will create a 'Summary of Findings' table and use GRADE (Grading of Recommendations Assessment, Development and Evaluation) assessment to assess the quality of the evidence.

Ethics and dissemination: We use publicly accessible documents as evidence, there is no participant involvement at an individual level and an institutional ethics approval is not required. The results of the review will be sought published in a peer-reviewed journals, also in the event of insignificant results or null results, and thereby it will be disseminated to clinicians and public available.

Prospero registration number: CRD42019139256.

Keywords: diabetic foot; hyperbaric oxygen therapy; meta-analysis; systematic review; trial sequential analysis.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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22
BMJ Open
. 2020 Jun 28;10(6):e031461. doi: 10.1136/bmjopen-2019-031461.
Pain Associated With Psoriasis: Systematic Scoping Review Protocol
Ana Sanader Vucemilovic 1, Danijela Nujic 2, Livia Puljak 3
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PMID: 32595143 DOI: 10.1136/bmjopen-2019-031461
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Abstract
Introduction: Psoriasis is a common chronic skin inflammatory disease. Its presentation, apart from affected skin areas, involves other unpleasant symptoms, such as pain. Pain deteriorates the patient's quality of life, impairing their daily behaviour and functioning. Therefore, the alleviation of pain in patients with psoriasis should be one of the most desired outcomes of successful treatment. The aim of this study is to summarise available evidence about pain in patients with psoriasis using systematic scoping review methodology in order to map the relevant literature.

Methods and analyses: Our scoping systematic review will provide evidence synthesis of the literature, both quantitative and qualitative, about the pain associated with psoriasis, including pain associated with psoriatic arthritis. Any types of studies will be eligible for inclusion, and we will not have any time, language or publication status restrictions. We will search MEDLINE, Embase and PsycINFO via OVID, as well as Cochrane Central Register of Clinical Trials, Cochrane Database of Systematic Reviews via Cochrane Library, CINAHL via EBSCO, OpenGrey and ProQuest Dissertations and Theses Global. All databases will be searched from the date of their inception. Retrieved bibliographic records and potentially relevant full texts will be screened by two authors independently. Two researchers will extract data independently. Any discrepancies will be resolved via discussion or consultation of the third author, if necessary. To appraise studies, we will use a Mixed Methods Appraisal Tool, AMSTAR 2, Cochrane risk of bias tool and ROBINS. Our findings will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews.

Ethics and dissemination: The proposed study will not be conducted with human participants. We will only use published data and therefore ethics approval is not required. Our findings will be disseminated via peer-reviewed manuscript and conference reports.

Keywords: evidence; pain management; psoriasis; systematic review.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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23
BMJ Open
. 2020 Jun 28;10(6):e033493. doi: 10.1136/bmjopen-2019-033493.
Hospitalisation at the End of Life Among Cancer and Non-Cancer Patients in Denmark: A Nationwide Register-Based Cohort Study
Anne Høy Seemann Vestergaard 1, Mette Asbjoern Neergaard 2, Christian Fynbo Christiansen 1, Henrik Nielsen 1, Thomas Lyngaa 1, Kristina Grønborg Laut 1, Søren Paaske Johnsen 3
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PMID: 32595146 DOI: 10.1136/bmjopen-2019-033493
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Abstract
Objectives: End-of-life hospitalisations may not be associated with improved quality of life. Studies indicate differences in end-of-life care for cancer and non-cancer patients; however, data on hospital utilisation are sparse. This study aimed to compare end-of-life hospitalisation and place of death among patients dying from cancer, heart failure or chronic obstructive pulmonary disease (COPD).

Design: A nationwide register-based cohort study.

Setting: Data on all in-hospital admissions obtained from nationwide Danish medical registries.

Participants: All decedents dying from cancer, heart failure or COPD disease in Denmark between 2006 and 2015.

Outcome measures: Data on all in-hospital admissions within 6 months and 30 days before death as well as place of death. Comparisons were made according to cause of death while adjusting for age, sex, comorbidity, partner status and residential region.

Results: Among 154 235 decedents, the median total bed days in hospital within 6 months before death was 19 days for cancer patients, 10 days for patients with heart failure and 11 days for patients with COPD. Within 30 days before death, this was 9 days for cancer patients, and 6 days for patients with heart failure and COPD. Compared with cancer patients, the adjusted relative bed day use was 0.65 (95% CI, 0.63 to 0.68) for heart failure patients and 0.68 (95% CI, 0.66 to 0.69) for patients with COPD within 6 months before death. Correspondingly, this was 0.65 (95% CI, 0.63 to 0.68) and 0.70 (95% CI, 0.68 to 0.71) within 30 days before death.Patients had almost the same risk of dying in hospital independently of death cause (46.2% to 56.0%).

Conclusion: Patients with cancer, heart failure and COPD all spent considerable part of their end of life in hospital. Hospital use was highest among cancer patients; however, absolute differences were small.

Keywords: chronic disease; death; hospital; neoplasms; palliative care; terminal care.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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24
BMJ Open
. 2020 Jun 28;10(6):e035400. doi: 10.1136/bmjopen-2019-035400.
Concurrent Validity of the Alcohol Purchase Task in Relation to Alcohol Involvement: Protocol for a Systematic Review and Meta-Analysis
Alba González-Roz 1, Víctor Martínez-Loredo 2, Roberto Secades-Villa 1, Michael Amlung 3, James MacKillop 3
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PMID: 32595153 DOI: 10.1136/bmjopen-2019-035400
Free article
Abstract
Introduction: Alcohol demand, as measured by an alcohol purchase task (APT), provides a multidimensional assessment of the relative reinforcing efficacy of alcohol. The objective of this meta-analysis is to critically appraise the existing literature on the concurrent validity of the APT by meta-analysing the cross-sectional relationships between indices of the APT (ie, breakpoint, Omax, Pmax, elasticity and intensity) and alcohol-related measures. It also aims to examine methodological procedures used to obtain APT indices and individual variables as potential moderators on the assessed estimations.

Methods and analysis: A comprehensive literature search conducted from inception to April 2020 will be conducted in the PubMed, PsycINFO, Web of Science and Scopus databases. Two authors will independently screen and extract data from articles using a predefined protocol search and extraction forms. Disagreements will be resolved through discussion with two additional reviewers. All results will be tabulated, and a random-effect meta-analysis will be conducted. Participants' sex, number of prices and APT methodological procedures will be examined as potential moderators on the observed effect sizes.

Ethics and dissemination: Results of this meta-analysis will characterise the concurrent validity of the APT in the existing literature. Further, the results are anticipated to provide evidence on which index (or indices) is most robustly associated with alcohol use and severity. Ethics approval was not required for this study and the results will be published in a peer-reviewed journal.

Prospero registration number: CRD42019137512.

Keywords: mental health; public health; substance misuse.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: JM is a principal in a private company, BEAM Diagnostics, but no commercial products will fall within the scope of the review.

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25
BMJ Open
. 2020 Jun 28;10(6):e035087. doi: 10.1136/bmjopen-2019-035087.
Evaluation of the General Practice Pharmacist (GPP) Intervention to Optimise Prescribing in Irish Primary Care: A Non-Randomised Pilot Study
Karen Cardwell 1, Susan M Smith 1, Barbara Clyne 1 2, Laura McCullagh 3 4, Emma Wallace 1, Ciara Kirke 5, Tom Fahey 1, Frank Moriarty 6, General Practice Pharmacist (GPP) Study Group
Collaborators, Affiliations expand
PMID: 32595137 DOI: 10.1136/bmjopen-2019-035087
Free article
Abstract
Objective: Limited evidence suggests integration of pharmacists into the general practice team could improve medicines management for patients, particularly those with multimorbidity and polypharmacy. This study aimed to develop and assess the feasibility of an intervention involving pharmacists, working within general practices, to optimise prescribing in Ireland.

Design: Non-randomised pilot study.

Setting: Primary care in Ireland.

Participants: Four general practices, purposively sampled and recruited to reflect a range of practice sizes and demographic profiles.

Intervention: A pharmacist joined the practice team for 6 months (10 hours/week) and undertook medication reviews (face to face or chart based) for adult patients, provided prescribing advice, supported clinical audits and facilitated practice-based education.

Outcome measures: Anonymised practice-level medication (eg, medication changes) and cost data were collected. Patient-reported outcome measure (PROM) data were collected on a subset of older adults (aged ≥65 years) with polypharmacy using patient questionnaires, before and 6 weeks after medication review by the pharmacist.

Results: Across four practices, 786 patients were identified as having 1521 prescribing issues by the pharmacists. Issues relating to deprescribing medications were addressed most often by the prescriber (59.8%), compared with cost-related issues (5.8%). Medication changes made during the study equated to approximately €57 000 in cost savings assuming they persisted for 12 months. Ninety-six patients aged ≥65 years with polypharmacy were recruited from the four practices for PROM data collection and 64 (66.7%) were followed up. There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life.

Conclusions: This non-randomised pilot study demonstrated that an intervention involving pharmacists, working within general practices is feasible to implement and has potential to improve prescribing quality. This study provides rationale to conduct a randomised controlled trial to evaluate the clinical and cost-effectiveness of this intervention.

Keywords: health economics; organisation of health services; primary care; quality in health care.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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26
BMJ Open
. 2020 Jun 28;10(6):e034713. doi: 10.1136/bmjopen-2019-034713.
Duration of Sick Leave After Same-Day Discharge for Lower Extremity Arterial Disease and Varicose Vein Interventions in Active Population of French Patients, 2013-2016: Observational Study
Asma Hamid 1, Guillaume Lamirault 2 3, Yann Gouëffic 4, Nolwenn Le Meur 5
Affiliations expand
PMID: 32595150 DOI: 10.1136/bmjopen-2019-034713
Free article
Abstract
Objective: To assess whether disparities in rates of same-day discharge for lower extremities arterial disease (5%) and varicose vein interventions (90%) are associated with the burden of postprocedural rehabilitation process, measured through the duration of sick leave.

Design: Retrospective observational study using French National Health Insurance data in 2012-2016.

Setting: The French National Health Data System (Système National des Données de Santé), which covers 98.8% of the 66 million people in the French population.

Participants: French workforce population aged 18 to 65 years old who underwent a first angioplasty with stent placement for lower extremities arterial disease (LEAD, n=30 238) or a first varicose vein intervention (n=265 670) between 2013 and 2016.

Main outcome measures: Duration and renewals of sick leave within 180 days after endovascular intervention, continuity of care and prescription indices to assess coordination among healthcare professionals after intervention associated with specific intervention settings: conventional (inpatient) or same-day discharge (outpatient). Association was estimated by multivariate negative binomial regressions adjusting for age, gender and comorbidities.

Results: Outpatient settings decrease the incidence rate ratio (IRR) of the number of cumulated days of sick leave by 14% in both interventions. The increasing variety of prescribers decreases the IRR of cumulated days of sick leave and prescription renewals for varicose interventions by 25% and 21%, respectively, but increases them for LEAD interventions by 240% and 106%. Less coordination between healthcare specialists increases the IRR of cumulative days of sick leave and renewals by 37% and 29% for varicose, and 11% and 9% for LEAD interventions.

Conclusions: Low rates of outpatients in LEAD angioplasty does not seem related to the duration of sick leave. Outpatient setting reduces the duration of sick leave and their renewals, whatever the intervention. Coordination of healthcare professionals is a key element of interventions follow-up with pathology specificities.

Keywords: organisation of health services; public health; vascular medicine; vascular surgery.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: The authors declare that they have no competing interests.

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27
BMJ Open
. 2020 Jun 28;10(6):e035863. doi: 10.1136/bmjopen-2019-035863.
Barriers in Care for Children With Life-Threatening Conditions: A Qualitative Interview Study in the Netherlands
Marije Brouwer 1, Els L M Maeckelberghe 2, Agnes van der Heide 3, Irma Hein 4, Eduard Verhagen 5
Affiliations expand
PMID: 32595157 DOI: 10.1136/bmjopen-2019-035863
Free article
Abstract
Objective: To identify barriers, as perceived by parents, to good care for children with life-threatening conditions.

Design: In a nationwide qualitative study, we held in-depth interviews regarding end-of-life care with parents of children (aged 1 to 12 years) who were living with a life-threatening illness or who had died after a medical trajectory (a maximum of 5 years after the death of the child). Sampling was aimed at obtaining maximum variety for a number of factors. The interviews were transcribed and analysed.

Setting: The Netherlands.

Participants: 64 parents of 44 children.

Results: Parents identified six categories of difficulties that create barriers in the care for children with a life-threatening condition. First, parents wished for more empathetic and open communication about the illness and prognosis. Second, organisational barriers create bureaucratic obstacles and a lack of continuity of care. Third, parents wished for more involvement in decision-making. Fourth, parents wished they had more support from the healthcare team on end-of-life decision-making. Fifth, parents experienced a lack of attention for the family during the illness and after the death of their child. Sixth, parents experienced an overemphasis on symptom-treatment and lack of attention for their child as a person.

Conclusions: The barriers as perceived by parents focussed almost without exception on non-medical aspects: patient-doctor relationships; communication; decision-making, including end-of-life decision-making; and organisation. The perceived barriers indicate that care for children with a life-threatening condition focusses too much on symptoms and not enough on the human beings behind these symptoms.

Keywords: medical ethics; paediatric palliative care; palliative care.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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28
BMJ Open
. 2020 Jun 28;10(6):e035993. doi: 10.1136/bmjopen-2019-035993.
Investigating the Relationship Between Changes in Social Security Benefits and Mental Health: A Protocol for a Systematic Review
Julija Simpson 1, Heather Brown 2, Zoe Bell 2, Viviana Albani 2, Clare Bambra 2
Affiliations expand
PMID: 32595158 DOI: 10.1136/bmjopen-2019-035993
Free article
Abstract
Introduction: Poor mental health is one of the greatest causes of disability in the world. Evidence increasingly shows that population mental health may be influenced by national social security policies. This systematic review aims to establish the relationship between social security and mental health in order to help inform recommendations for policy-makers, practitioners and future research.

Methods and analysis: A systematic review of quantitative observational studies investigating mental health outcomes related to changes in social security policies will be conducted. Six major databases, including Medline, PsychInfo, Embase, Cumulative Index to Nursing and Allied Health Literature, Applied Social Sciences Index Abstracts and Scopus, as well as Research Papers in Economics will be searched from January 1979 to April 2020. The electronic database searches will be supplemented by reference and citation searches as well as hand-searching of key journals. The outcomes of interest are objective or subjective mental health outcomes, including stress, anxiety, depression, self-reported mental health scores, subjective well-being and suicide. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and the quality of the studies will be assessed by the validity assessment framework designed for appraising econometric studies. A narrative synthesis will be conducted for all included studies. If data permit, study findings will be synthesised by conducting a meta-analysis.

Ethics and dissemination: As it will be a systematic review, without primary data collection, there will be no requirement for ethical approval. Findings will be disseminated through peer-reviewed publications and in various media, for example, conferences or symposia.

Prospero registration number: CRD42019154733.

Keywords: mental health; public health; social medicine.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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29
BMJ Open
. 2020 Jun 28;10(6):e033625. doi: 10.1136/bmjopen-2019-033625.
The Problem-Solving Decision-Making Scale-Translation and Validation for the Portuguese Language: A Cross-Sectional Study
Micaela Gregório 1, Andreia Teixeira 1 2, Rosália Páscoa 1 2, Sofia Baptista 1, Rosa Carvalho 3, Carlos Martins 4 2
Affiliations expand
PMID: 32595147 DOI: 10.1136/bmjopen-2019-033625
Free article
Abstract
Objectives: To translate and validate the Problem-Solving Decision-Making scale instrument into the Portuguese language.

Design: Cross-sectional study.

Setting participants: The Problem-Solving Decision-Making scale was translated from English to Portuguese and then back-translated to obtain a final version. The questionnaire was then applied face-to-face from January to March 2019 in a representative sample of the Portuguese population (n=301 people aged 20 years or more) to validate the Problem-Solving Decision-Making scale in a Portuguese population.

Outcomes: Principal component analysis and Cronbach's alpha.

Results: Principal component analysis was used to evaluate the validity of the internal structure of the scale. The results identified two components: problem-solving and decision-making with an explained variance of 65.9%. For internal consistency, three different techniques were used and applied to the two components. All of the items have very good internal consistency (problem-solving Cronbach's alpha=0.931 and decision-making Cronbach's alpha=0.951).

Conclusions: The validation of the Portuguese scale agreed well with the existing literature. The scale can be divided into two components: the problem-solving component and the decision-making component. The translated scale demonstrated good internal consistency and can therefore be used in future studies.

Keywords: Problem-Solving Decision-Making scale; translation; validation.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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30
BMJ Open
. 2020 Jun 28;10(6):e038164. doi: 10.1136/bmjopen-2020-038164.
Appreciative Inquiry in Evaluating Integrated Primary Oral Health Services in Quebec Cree Communities: A Qualitative Multiple Case Study
Richa Shrivastava 1, Yves Couturier 2, Felix Girard 1, Christophe Bedos 3, Mary Ellen Macdonald 3, Jill Torrie 4, Elham Emami 5
Affiliations expand
PMID: 32595166 DOI: 10.1136/bmjopen-2020-038164
Free article
Abstract
Objective: The Strategic Regional Plan of the Cree Board of Health and Social Services of James Bay (CBHSSJB), serving the Quebec Cree communities, mandates the objective of integrating oral health within primary healthcare. Emerging evidence suggests that the integration of oral health into primary healthcare can decrease oral health disparities. This research study aimed to answer the following research question: how and to what extent does the integration of oral health into primary healthcare address the oral health needs of the Cree communities?

Design: We used a multiple-case study design within a qualitative approach and developmental evaluation methodology. The Discovery, Dream, Design and Destiny model of appreciative inquiry was selected as a study framework among existing frameworks of the developmental evaluation.

Setting: Four purposefully selected Cree communities.

Participants: Healthcare providers, administrators and patients at the community wellness centres and hospital.

Outcome measures: Integration of oral health into primary healthcare.

Results: A total of 36 interviews and 6 focus group discussions were conducted. We identified ten themes in discovery and dream phases. The Discovery phase identified the strengths of the organisation in facilitating enablers of integration including strategic planning, organisational structure, cultural integration, coordinated networks and colocation. In the Dream phase, participants' oral healthcare stories expressed various dimensions of integration and their wish for strengthening integration via extending public oral healthcare programmes, increasing resources and improving organisational management. In the Design phase, recommendations were formulated for a future action plan within the CBHSSJB.

Conclusion: This study results suggested that the CBHSSJB has been successful in implementing oral health integration into primary care following its strategic planning. At present, the organisation could extend the level of integration into full integration by following study recommendations derived from the perspective of local stakeholders.

Keywords: health services administration and management; primary care; public health; qualitative research.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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31
BMJ Open
. 2020 Jun 28;10(6):e038145. doi: 10.1136/bmjopen-2020-038145.
Generic Outcome Set for the International Registry on Laser trEAtments in Dermatology (LEAD): A Protocol for a Delphi Study to Achieve Consensus on what to Measure
Frederike Fransen 1, Phyllis Spuls 2 3, Murad Alam 4 5, Ashraf Badawi 6, Pablo Boixeda 7, Merete Haedersdal 8 9, Iltefat Hamzavi 10, Lene Hedelund 11, Kristen M Kelly 12, Tara Kono 13, Hans Joachim Laubach 14, Woraphong Manuskiatti 15, Leonardo Marini 16, Keyvan Nouri 17, Uwe Paasch 18, Thierry Passeron 19, Cecilia A C Sanna Prinsen 20, Ines Verner 21, Albert Wolkerstorfer 2
Affiliations expand
PMID: 32595165 DOI: 10.1136/bmjopen-2020-038145
Free article
Abstract
Introduction: While laser technology has expanded the armamentarium of treatment for various skin diseases during the past years, heterogeneity in study outcomes hampers comparability and appropriate evidence synthesis. Part of these issues can be addressed by developing a generic outcome set. Using the Delphi method, this study aims to seek consensus between key stakeholders on relevant generic outcomes (what to measure) for implementation in the international registry on Laser trEAtments in Dermatology (LEAD). The registry is focused on collecting research data on various laser treatments for skin disorders.

Methods and analysis: By reviewing the literature and involvement of key stakeholder groups and adult patients in need or after laser surgery and health professionals, a preliminary list of outcomes will be generated and categorised into domains. Using these outcomes, an international three-round Delphi study will be performed to rate the importance of outcomes in the selection of a generic outcome set. Participants are allowed to provide new outcomes to the preliminary list for revisions during the first Delphi round. Finally, results will be discussed during a consensus meeting to agree on generic outcomes to be used in the LEAD registry.

Ethics and dissemination: An ethics approval was not applicable (W19_290 # 18.336). The study is registered with the Cochrane Skin Core OUtcome Set INitiative) and the Core Outcome Measures in Effectiveness Trials initiative. Procedures will be conducted according to the Declaration of Helsinki. The findings will be disseminated through peer-reviewed publications and conference presentations.

Keywords: dermatology; laser therapy; surgical dermatology.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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32
BMJ Open
. 2020 Jun 28;10(6):e036047. doi: 10.1136/bmjopen-2019-036047.
Economic Evaluation Alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (E-PROSPECT): Study Protocol
Vincent Issac Lau 1 2, Deborah J Cook 2 3, Robert Fowler 4, Bram Rochwerg 2 3, Jennie Johnstone 5, François Lauzier 6, John C Marshall 7, John Basmaji 8, Diane Heels-Ansdell 2 9, Lehana Thabane 2 9, Feng Xie 2 9, PROSPECT Collaborators
Collaborators, Affiliations expand
PMID: 32595159 DOI: 10.1136/bmjopen-2019-036047
Free article
Abstract
Introduction: Ventilator-associated pneumonia (VAP) is a common healthcare-associated infection in the intensive care unit (ICU). Probiotics are defined as live microorganisms that may confer health benefits when ingested. Prior randomised trials suggest that probiotics may prevent infections such as VAP and Clostridioides difficile-associated diarrhoea (CDAD). PROSPECT (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial) is a multicentre, double-blinded, randomised controlled trial comparing the efficacy of the probiotic Lactobacillus rhamnosus GG with usual care versus usual care without probiotics in preventing VAP and other clinically important outcomes in critically ill patients admitted to the ICU.

Methods and analysis: The objective of E-PROSPECT is to determine the incremental cost-effectiveness of L. rhamnosus GG plus usual care versus usual care without probiotics in critically ill patients. E-PROSPECT will be performed from the public healthcare payer's perspective over a time horizon from ICU admission to hospital discharge.We will determine probabilities of in-ICU and in-hospital events from all patients alongside PROSPECT. We will retrieve unit costs for each resource use item using jurisdiction-specific public databases, supplemented by individual site unit costs if such databases are unavailable. Direct costs will include medications, personnel costs, radiology/laboratory testing, operative/non-operative procedures and per-day hospital 'hoteling' costs not otherwise encompassed. The primary outcome is the incremental cost per VAP prevented between the two treatment groups. Other clinical events such as CDAD, antibiotic-associated diarrhoea and in-hospital mortality will be included as secondary outcomes. We will perform pre-specified subgroup analyses (medical/surgical/trauma; age; frailty status; antibiotic use; prevalent vs no prevalent pneumonia) and probabilistic sensitivity analyses for VAP, then generate confidence intervals using the non-parametric bootstrapping approach.

Ethics and dissemination: Study approval for E-PROSPECT was granted by the Hamilton Integrated Research Ethics Board of McMaster University on 29 July 2019. Informed consent was obtained from the patient or substitute decision-maker in PROSPECT. The findings of this study will be published in peer-reviewed journals.

Trial registration number: NCT01782755; Pre-results.

Keywords: adult intensive & critical care; health economics; infectious diseases; microbiology; preventive medicine; statistics & research methods.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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33
BMJ Open
. 2020 Jun 28;10(6):e025818. doi: 10.1136/bmjopen-2018-025818.
Randomised, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery: A Study Protocol
Amer Jarrar 1, Adele Budiansky 2, Naveen Eipe 2, Caolan Walsh 3, Nicole Kolozsvari 3, Amy Neville 3, Joseph Mamazza 3
Affiliations expand
PMID: 32595142 DOI: 10.1136/bmjopen-2018-025818
Free article
Abstract
Introduction: Evaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery.

Methods: 150 patients Living with obesity undergoing elective laparoscopic Roux-En-Y gastric bypass for obesity will be recruited to this double-blinded, placebo-controlled randomised controlled trial from a Bariatric Centre of Excellence over a period of 6 months. Patients will be electronically randomised on a 1:1 basis to either an intervention or placebo group. Those on the intervention arm will receive a total of 60 mL 0.25% ropivacaine, divided into four injections: two for TAP and two for RS block under laparoscopic visualisation. The placebo arm will receive normal saline in the same manner. A standardised surgical and anaesthetic protocol will be followed, with care in adherence to the Enhanced Recovery after Bariatric Surgery guidelines.

Analysis: Demographic information and relevant medical history will be collected from the 150 patients enrolled in the study. Our primary efficacy endpoint is cumulative postoperative narcotic use. Secondary outcomes are peak expiratory flow, postoperative pain score and the 6 min walk test. Quality of recovery (QoR) will be assessed using a validated questionnaire (QoR-40). Statistical analysis will be conducted to assess differences within and between the two groups. The repeated measures will be analysed by a mixed modelling approach and results reported through publication.

Ethics and dissemination: Ethics approval was obtained (20170749-01H) through our institutional research ethics board (Ottawa Health Science Network Research Ethics Board) and the study results, regardless of the outcome, will be reported in a manuscript submitted for a medical/surgical journal.

Trial registration number: Pre-results NCT03367728.

Keywords: ERAS; TAP block; gastric bypass; morbid obesity; opioid sparring; pain management.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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34
BMJ Open
. 2020 Jun 29;10(6):e035024. doi: 10.1136/bmjopen-2019-035024.
Patients' Experiences of Using an e-Health Tool for Self-Management Support After Prostate Cancer Surgery: A Deductive Interview Study Explained Through the FITT Framework
Lina Nilsson 1, Amanda Hellström 2, Camilla Wennerberg 3, Mirjam Ekstedt 4 2 5, Kristina Schildmeijer 2
Affiliations expand
PMID: 32601113 DOI: 10.1136/bmjopen-2019-035024
Free article
Abstract
Objective: To evaluate patients' experiences of using a web-based application, especially its usability as support for self-care activities after prostate cancer surgery.

Design: A deductive content analysis was used, stemming from the Fit between Individuals, Task and Technology (FITT) framework.

Setting: One surgical department in south of Sweden between October 2015 and April 2016 and between September 2017 and July 2018.

Participants: Fifteen men who had undergone radical prostatectomy for prostate cancer.

Results: By organising data in accordance with the FITT model, three main categories with ten subcategories were identified. Patients gave feedback on functions that suited them and their needs, as well as potential adjustments and improvements. Patients experienced that ePATH gave them easy access to reliable information regarding their rehabilitation. Directed information about ePATH at enrolment was seen as important. ePATH was perceived to have a logical structure that was easy to follow. However, when the structure was unclear, patients became less motivated to use a function.

Conclusions: Patients experienced ePATH as satisfactorily user-friendly and useful as a complementary self-management support after prostate cancer surgery, especially when the information and tasks were tailored to their preferences and the system design features supported individual autonomy.

Keywords: oncology; qualitative research; quality in health care.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Conflict of interest statement
Competing interests: None declared.

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35
BMJ Open
. 2020 Jun 29;10(6):e037974. doi: 10.1136/bmjopen-2020-037974.
Observational Study on the Current Status of Thalassaemia in Malaysia: A Report From the Malaysian Thalassaemia Registry
Hishamshah Mohd Ibrahim 1 2, Zulaiha Muda 2, Ida Shahnaz Othman 2, Mohamed Najib Mohamed Unni 2, Kok Hoi Teh 2, Asohan Thevarajah 3, Kogilavani Gunasagaran 3, Gek Bee Ong 4, Seoh Leng Yeoh 5, Aisyah Muhammad Rivai 6, Che Hadibiah Che Mohd Razali 7, Nazzlin Dizana Din 8, Zarina Abdul Latiff 9, Rahman Jamal 10, Norsarwany Mohamad 11, Hany Mohd Ariffin 12, Hamidah Alias 13
Affiliations expand
PMID: 32601117 DOI: 10.1136/bmjopen-2020-037974
Free article
Abstract
Objective: Thalassaemia is the most common inherited blood disorder in Malaysia. This study aims to report the current status of thalassaemia in Malaysia and provide a comprehensive understanding of the disease through data obtained from the Malaysian Thalassaemia Registry.

Design: Data were extracted from the Malaysian Thalassaemia Registry, a web-based system accessible to enrolled users through www.mytalasemia.net.my.

Setting: The Malaysian Thalassaemia Registry data was recorded from reports obtained from 110 participating government and university hospitals in Malaysia.

Participants: The patients were those attending the 110 participating hospitals for thalassaemia treatment.

Intervention: Data were collected from the Malaysian Thalassaemia Registry from 2007 until the fourth quarter of 2018.

Primary outcome measure: 7984 out of 8681 patients with thalassaemia registered in the Malaysian Thalassaemia Registry were reported alive.

Results: Majority of the patients were reported in the state of Sabah (22.72%); the largest age group affected was 5.0-24.9 years old (64.45%); the largest ethnic group involved was Malay (63.95%); and the major diagnosis was haemoglobin E/β-thalassaemia (34.37%). From the 7984 patients, 56.73% were on regular blood transfusions and 61.72% were on chelation therapy. A small fraction (14.23%) has undergone splenectomy, while the percentage of patients with severe iron overload (serum ferritin ≥5000 µg/L) reduced over time. However, cardiac complications are still the main cause of death in patients with thalassaemia.

Conclusion: Data gathered into the registry can be used to understand the progression of the disorder, to monitor iron overload management and to improve the outcomes of treatment, to enhance preventive strategies, reduce healthcare burden and improve the quality of life. Sustainability of the Malaysian Thalassaemia Registry is important for surveillance of thalassaemia management in the country and help the national health authorities to develop more effective policies.

Keywords: Malaysia; database; haemoglobinopathy; healthcare burden; registry; thalassaemia.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Competing interests: None declared.

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BMJ Open
. 2020 Jun 28;10(6):e038826. doi: 10.1136/bmjopen-2020-038826.
Alcohol-related Mortality Following the Loss of a Child: A Register-Based Follow-Up Study From Norway
Solveig Glestad Christiansen 1, Anne Reneflot 2, Kim Stene-Larsen 2, Lars Johan Hauge 2
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PMID: 32595167 DOI: 10.1136/bmjopen-2020-038826
Free article
Abstract
Objectives: The death of one's child is one of the most stressful events a person can experience. Research has shown that bereaved parents have a higher mortality than non-bereaved parents. This increased mortality might partly be caused directly by long-term stress. However, changes in health behaviour such as an increase in alcohol consumption might also play a role. This study examines the association between losing a child and alcohol-related mortality. In addition to Cox regression models using data covering the entire Norwegian adult population, we employ sibling fixed-effect models in order to partly control for genes and childhood experiences that might be associated with both losing a child and alcohol-related mortality.

Design: A follow-up study between 1986 and 2014 based on Norwegian register data.

Setting: Norway.

Participants: The entire Norwegian adult population.

Primary outcome measure: Alcohol-related mortality.

Results: An increased alcohol-related mortality was found among parents who had experienced the death of a child. The HR of alcohol-related mortality among those bereaved of a child was 1.59 (95% CI 1.48 to 1.71) compared with non-bereaved parents, for women 2.03 (95% CI 1.78 to 2.32) and for men 1.46 (95% CI 1.34 to 1.59). After including sibling fixed effects, the HR of alcohol-related mortality among parents who had lost a child was 1.30 (95% CI 1.03 to 1.64).

Conclusions: This study provides evidence of an elevated alcohol-related mortality among parents who have lost a child compared with non-bereaved parents. Although strongly attenuated, there is still an association when adjusting for genetic predisposition for alcohol problems as well as childhood environment using sibling fixed-effect models.

Keywords: epidemiology; public health; substance misuse.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Competing interests: None declared.

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Published Erratum BMJ Open
. 2020 Jun 25;10(6):e026806corr1. doi: 10.1136/bmjopen-2018-026806corr1.
Correction: Correction for Prison Cell Spatial Density and Infectious and Communicable Diseases: A Systematic Review
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PMID: 32586915 DOI: 10.1136/bmjopen-2018-026806corr1
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Erratum for
Prison cell spatial density and infectious and communicable diseases: a systematic review.
Simpson PL, Simpson M, Adily A, Grant L, Butler T.
BMJ Open. 2019 Jul 23;9(7):e026806. doi: 10.1136/bmjopen-2018-026806.
PMID: 31340959 Free PMC article.
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Published Erratum BMJ Open
. 2020 Jun 25;10(6):e035171corr1. doi: 10.1136/bmjopen-2019-035171corr1.
Correction: Health-related Quality of Life in Patients With Advanced Soft TIssue Sarcomas Treated With Chemotherapy (The HOLISTIC Study): Protocol for an International Observational Cohort Study
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PMID: 32586916 DOI: 10.1136/bmjopen-2019-035171corr1
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Erratum for
Health-related quality Of Life In patients with advanced Soft TIssue sarcomas treated with Chemotherapy (The HOLISTIC study): protocol for an international observational cohort study.
Younger E, Jones RL, Desar IME, Peckitt C, van der Graaf WTA, Husson O.
BMJ Open. 2020 Jun 1;10(6):e035171. doi: 10.1136/bmjopen-2019-035171.
PMID: 32487574 Free PMC article.
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