bluuebunny/crossref_metadata_2025 huggingface dataset:
Alcohol related disorders among elite male football players in Sweden: nationwide cohort study
Authors: Ueda Peter , Pasternak Björn , Svanström Henrik , Lim Carl-Emil , Neovius Martin , Forssblad Magnus , Ludvigsson Jonas F , Kader Manzur
Published: December 2022

Objectives

To assess whether male elite football players are at increased risk of alcohol related disorders compared with men from the general population, and whether such an increased risk would vary on the basis of calendar year of the first playing season in the top tier of competition, age, career length, and goal scoring abilities.

Design

Nationwide cohort study.

Setting

Sweden, 1924-2020.

Participants

6007 male football players who had played in the Swedish top division, Allsvenskan, from 1924 to 2019 and 56 168 men from the general population matched to players based on age and region of residence.

Main outcome measures

Primary outcome was alcohol related disorders (diagnoses recorded in death certificates, during hospital admissions and outpatient visits, or use of prescription drugs for alcohol addiction); secondary outcome was disorders related to misuse of other drugs.

Results

During follow-up up to 31 December 2020, 257 (4.3%) football players and 3528 (6.3%) men from the general population received diagnoses of alcohol related disorders. In analyses accounting for age, region of residence, and calendar time, risk of alcohol related disorders was lower among football players than among men from the general population (hazard ratio 0.71, 95% confidence interval 0.62 to 0.81). A reduced risk of alcohol related disorders was observed for football players who played their first season in the top tier in the early 1960s and later, while no significant difference versus men from the general population was seen in the risk for football players from earlier eras. The hazard ratio was lowest at around age 35 years, and then increased with age; at around age 75 years, football players had a higher risk of alcohol related disorders than men from the general population. No significant association was seen between goal scoring, number of games, and seasons played in the top tier and the risk of alcohol related disorders. Risk of disorders related to other drug misuse was significantly lower among football players than the general population (hazard ratio 0.22, 95% confidence interval 0.15 to 0.34).

Conclusions

In this nationwide cohort study, male football players who had played in the Swedish top tier of competition had a significantly lower risk of alcohol related disorders than men from the general population.
Learning from electronic prescribing errors: a mixed methods study of junior doctors’ perceptions of training and individualised feedback data
Authors: Chu Ann , Kumar Arika , Depoorter Geraldine , Franklin Bryony Dean , McLeod Monsey
Published: December 2022

Objectives

To explore the views of junior doctors towards (1) electronic prescribing (EP) training and feedback, (2) readiness for receiving individualised feedback data about EP errors and (3) preferences for receiving and learning from EP feedback.

Design

Explanatory sequential mixed methods study comprising quantitative survey (phase 1), followed by interviews and focus group discussions (phase 2).

Setting

Three acute hospitals of a large English National Health Service organisation.

Participants

25 of 89 foundation year 1 and 2 doctors completed the phase 1 survey; 5 participated in semi-structured interviews and 7 in a focus group in phase 2.

Results

Foundation doctors in this mixed methods study reported that current feedback provision on EP errors was lacking or informal, and that existing EP training and resources were underused. They believed feedback about prescribing errors to be important and were keen to receive real-time, individualised EP feedback data. Feedback needed to be in manageable amounts, motivational and clearly signposting how to learn or improve. Participants wanted feedback and better training on the EP system to prevent repeating errors. In addition to individualised EP error data, they were positive about learning from general prescribing errors and aggregated EP data. However, there was a lack of consensus about how best to learn from statistical data. Potential limitations identified by participants included concern about how the data would be collected and whether it would be truly reflective of their performance.

Conclusions

Junior doctors would value feedback on their prescribing, and are keen to learn from EP errors, develop their clinical prescribing skills and use the EP interface effectively. We identified preferences for EP technology to enable provision of real-time data in combination with feedback to support learning and potentially reduce prescribing errors.
Validity of algorithms for identifying mild traumatic brain injury in the French national emergency department database OSCOUR: a retrospective multicentre validation study protocol
Authors: Paget Louis-Marie , Forgeot Cécile , Lorton Fleur , Aghakhani Nozar , Raphael Maurice , Gallay Anne , Beltzer Nathalie
Published: December 2022

Introduction

The French emergency department (ED) surveillance network OSCOUR transmits data on ED visits to Santé publique France (the national public health agency). As these data are collected daily and are almost exhaustive at a national level, it would seem relevant to use them for national epidemiological surveillance of mild traumatic brain injury (mTBI). This article presents the protocol of a planned study to validate algorithms for identifying mTBI in the OSCOUR database. Algorithms to be tested will be based on International Classification of Diseases (ICD)-10 codes.

Methods and analysis

We will perform a multicentre validation study of algorithms for identifying mTBI in OSCOUR. Different combinations of ICD-10 codes will be used to identify cases of mTBI in the OSCOUR database. A random sample of mTBI cases and non-cases will be selected from four EDs. Medical charts will serve as the reference standard to validate the algorithms. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the different algorithms, as well as their 95% CIs, will be calculated and compared.

Ethics and dissemination

The ethics committee of the French National Data Protection Authority (CNIL) approved this study (n° 921152, 1 August 2021). Results will be submitted to national and international peer-reviewed journals and presented at conferences dedicated to trauma and to methodologies for the construction and validation of algorithms.
Effect of free medicine distribution on ability to make ends meet: post hoc quantitative subgroup analysis and qualitative thematic analysis
Authors: Hess Margaret , Wang Ri , Workentin Aine , Woods Hannah , Persaud Nav
Published: December 2022

Objectives

Out-of-pocket medication costs can contribute to financial insecurity and many Canadians have trouble affording medicines. This study aimed to determine if the effect of eliminating out-of-pocket medication costs on individual’s financial security varied by gender, racialisation, income and location.

Design

In this post hoc subgroup analysis of the CLEAN Meds trial, a binary logistic regression model was fitted and a qualitative inductive thematic analysis of comments related to participant’s ability to make ends meet was carried out.

Setting

Primary care patients in Ontario, Canada.

Participants

Adult patients (786) who reported not being able to afford medicines during the previous 12 months.

Intervention

Free access to a comprehensive list of essential medicines for 24 months.

Primary outcome measure

Ability to make ends meet or afford basic necessities.

Results

There were no significant differences in the effect of free medicine distribution by gender (OR for male 0.82; 95% CI 0.51 to 1.33, p=0.76), age (older than 65 years OR 1.28; 95 % CI 0.62 to 2.64, p=0.73), racialisation (OR 0.85; 95 % CI 0.51 to 1.45, p=0.66), household income level (above US$30 000 per year OR 1.08; 95 % CI 0.64 to 1.80, p=0.99) or location (urban OR 0.47; 95 % CI 0.23 to 0.96, p=0.10). The main theme in the qualitative analysis was insufficient income, and there were three related themes: out-of-pocket medication expenses, cost-related non-adherence and the importance of medication coverage. In the intervention group, additional themes identified included improved health, functioning and access to basic needs.

Conclusions

Providing free essential medications improved financial security across subgroups in a trial population who all had trouble affording medicines. Free access to medicines could improve health directly by improving medicine adherence and indirectly by making other necessities more accessible to people who have an insufficient income.

Trial registration number

NCT02744963.
Effectiveness of short, personalised student assistantships: an evaluative study across eight London hospitals
Authors: Fung Chee Yeen , Kearney Lesa , Hatfield Emma , Martin Niamh M , Halse Omid , Jensen-Martin James , Hughes Elizabeth , Sam Amir H
Published: December 2022

Objectives

Student assistantships are recommended to prepare medical graduates for clinical practice. Traditionally, assistantships have consisted of longer placements, often up to 15 weeks. However, within the constraints of the final year, medical schools need to carefully balance the time required for specialty placements, assessments and the risk of student burnout. We set out to evaluate the effectiveness of shorter, personalised student assistantships.

Design

An evaluative study on the changes in final year student confidence in preparedness for practice after a 3-week assistantship with defined learning objectives and learning needs assessment.

Setting

Eight hospitals affiliated with Imperial College School of Medicine.

Outcomes

Student confidence in 10 learning outcomes including organising ward rounds, documentation, communication with colleagues, communication with patients and relatives, patient handover, practical procedures, patient management, acute care, prioritisation and out-of-hours clinical work.

Results

Two hundred and twenty final year medical students took part in the student assistantship, of whom 208 completed both the pre-assistantship and post-assistantship confidence rating questionnaires (95% completion rate). After the assistantship, 169 (81%) students expressed increased confidence levels in one or more learning objectives. For each individual learning objective, there was a significant change in the proportion of students who agreed or strongly agreed after the assistantship (p<0.0001).

Conclusion

Overall, the focused 3-week, personalised student assistantships led to significant improvement across all learning objectives related to preparedness for practice. The use of the pre-assistantship confidence rating questionnaire allowed students to identify and target areas of learning needs during their assistantship.
Responsive evaluation: an innovative evaluation methodology for workplace health promotion interventions
Authors: van Heijster Hanneke , van Berkel Jantien , Boot Cécile RL , Abma Tineke , de Vet Emely
Published: December 2022

Background:Workplace health promotion (WHP) interventions have limited effects on the health of employees with low socioeconomic position (SEP). This paper argues that this limited effectiveness can be partly explained by the methodology applied to evaluate the intervention, often a randomised controlled trial (RCT). Frequently, the desired outcomes of traditional evaluations may not match employees’—and in particular employees with low SEP—needs and lifeworld. Furthermore, traditional evaluation methodologies do not function well in work settings characterised by change resulting from internal and external developments.Objective:In this communication, responsive evaluation is proposed as an alternative approach to evaluating WHP interventions. Responsive evaluation’s potential added value for WHP interventions for employees with low SEP in particular is described, as well as how the methodology differs from RCTs. The paper also elaborates on the different scientific philosophies underpinning the two methodologies as this allows researchers to judge the suitability and quality of responsive evaluation in light of the corresponding criteria for good science.
Randomised clinical trial using Coronary Artery Calcium Scoring in Australian Women with Novel Cardiovascular Risk Factors (CAC-WOMEN Trial): study protocol
Authors: Marschner Simone , Wing-Lun Edwina , Chow Clara , Maple-Brown Louise , Graham Sian , Nicholls Stephen J , Brown Alex , Wood Anna , Ihdayhid Abdul , Von Huben Amy , Zaman Sarah
Published: December 2022

Introduction

Cardiovascular disease (CVD) is the leading cause of death in women around the world. Aboriginal and Torres Strait Islander women (Australian Indigenous women) have a high burden of CVD, occurring on average 10–20 years earlier than non-Indigenous women. Traditional risk prediction tools (eg, Framingham) underpredict CVD risk in women and Indigenous people and do not consider female-specific ‘risk-enhancers’ such as hypertensive disorders of pregnancy (HDP), gestational diabetes mellitus (GDM) and premature menopause. A CT coronary artery calcium score (‘CT-calcium score’) can detect calcified atherosclerotic plaque well before the onset of symptoms, being the single best predictor for future cardiac events. A CT-calcium score may therefore help physicians intensify medical therapy in women with risk-enhancing factors.

Methods and analysis

This multisite, single-blind randomised (1:1) controlled trial of 700 women will assess the effectiveness of a CT-calcium score-guided approach on cardiovascular risk factor control and healthy lifestyle adherence, compared with standard care. Women without CVD aged 40–65 (35–65 for Aboriginal and Torres Strait Islander women) at low-intermediate risk on standard risk calculators and with at least one risk-enhancing factor (eg, HDP, GDM, premature menopause) will be recruited. Aboriginal and Torres Strait Islander women will be actively recruited, aiming for ~10% of the sample size. The 6-month coprimary outcomes will be low-density lipoprotein cholesterol and systolic blood pressure. Barriers and enablers will be assessed, and a health economic analysis performed.

Ethics and dissemination

Western Sydney Local Health District Research Ethics Committee (HREC 2021/ETH11250) provided ethics approval. Written informed consent will be obtained before randomisation. Consent will be sought for access to individual participant Medicare Benefits Schedule, Pharmaceutical Benefits Scheme claims usage through Medicare Australia and linked Admitted Patient Data Collection. Study results will be disseminated via peer-reviewed publications and presentations at national and international conferences.

Trial registration number

ACTRN12621001738819p.
Cohort profile: Biomarkers related to folate-dependent one-carbon metabolism in colorectal cancer recurrence and survival – the FOCUS Consortium
Authors: Gigic Biljana , van Roekel Eline , Holowatyj Andreana N , Brezina Stefanie , Geijsen Anne J M R , Ulvik Arve , Ose Jennifer , Koole Janna L , Damerell Victoria , Kiblawi Rama , Gumpenberger Tanja , Lin Tengda , Kvalheim Gry , Koelsch Torsten , Kok Dieuwertje E , van Duijnhoven Franzel J , Bours Martijn J , Baierl Andreas , Li Christopher I , Grady William , Vickers Kathy , Habermann Nina , Schneider Martin , Kampman Ellen , Ueland Per Magne , Ulrich Alexis , Weijenberg Matty , Gsur Andrea , Ulrich Cornelia
Published: December 2022

Purpose

The overarching goal of the FOCUS (biomarkers related to folate-dependent one-carbon metabolism in colorectal cancer (CRC) recurrence and survival) Consortium is to unravel the effect of folate and folate-mediated one-carbon metabolism (FOCM) biomarkers on CRC prognosis to provide clinically relevant advice on folate intake to cancer patients and define future tertiary prevention strategies.

Participants

The FOCUS Consortium is an international, prospective cohort of 2401 women and men above 18 years of age who were diagnosed with a primary invasive non-metastatic (stages I–III) CRC. The consortium comprises patients from Austria, two sites from the Netherlands, Germany and two sites from the USA. Patients are recruited after CRC diagnosis and followed at 6 and 12 months after enrolment. At each time point, sociodemographic data, data on health behaviour and clinical data are collected, blood samples are drawn.

Findings to date

An increased risk of cancer recurrences was observed among patients with higher compared with lower circulating folic acid concentrations. Furthermore, specific folate species within the FOCM pathway were associated with both inflammation and angiogenesis pathways among patients with CRC. In addition, higher vitamin B6status was associated with better quality of life at 6 months post-treatment.

Future plans

Better insights into the research on associations between folate and FOCM biomarkers and clinical outcomes in patients with CRC will facilitate the development of guidelines regarding folate intake in order to provide clinically relevant advice to patients with cancer, health professionals involved in patient care, and ultimately further tertiary prevention strategies in the future. The FOCUS Consortium offers an excellent infrastructure for short-term and long-term research projects and for combining additional biomarkers and data resulting from the individual cohorts within the next years, for example, microbiome data, omics and multiomics data or CT-quantified body composition data.
Stakeholder perspectives on the demand and supply factors driving substandard and falsified blood pressure lowering medications in Nigeria: a qualitative study
Authors: Shedul Grace , Sanuade Olutobi Adekunle , Ugwuneji Eugenia N , Ojo Tunde M , Vijay Aishwarya , Ponzing Patrick , Okpe Inuwa , Shedul Gabriel Lamkur , Huffman Mark D , Ojji Dike , Hirschhorn Lisa R
Published: December 2022

Objectives

Although substandard and falsified (SF) blood pressure (BP) lowering medications are a global problem, qualitative research exploring factors driving this in Nigeria has not been reported. This study provides information on factors driving demand for and supply of low-quality BP lowering medications in Nigeria and potential strategies to address these factors.

Methods

This was a cross-sectional qualitative study. Between August 2020 and September 2020, we conducted 11 in-depth interviews and 7 focus group discussions with administrators of health facilities, major manufacturers and distributors of BP lowering medications, pharmacists, drug regulators, patients and primary care physicians purposively sampled from the Federal Capital Territory, Nigeria. Data were analysed using directed content analysis, with the aid of Dedoose.

Results

We found that demand for SF BP lowering medications in Nigeria was driven by high out-of-pocket expenditure and stockouts of quality-assured BP lowering medications. Supply of low-quality BP lowering medications was driven by limited in-country manufacturing capacity, non-adherence to good manufacturing and distribution practices, under-resourced drug regulatory systems, ineffective healthcare facility operations, poor distribution practices, limited number of trained pharmacists and the COVID-19 pandemic which led to stockouts. Central medicine store procurement procedures, active pharmaceutical ingredient quality check and availability of trained pharmacists were existing strategies perceived to lower the risk of supply and demand of SF BP lowering medications.

Conclusion

Our findings suggest that demand for and supply of SF BP lowering medications in Nigeria are driven by multi-level, interrelated factors. Multi-pronged strategies need to target stakeholders and systems involved in drug production, distribution, prescription, consumption, regulation and pricing.
How soon should patients be eligible for differentiated service delivery models for antiretroviral treatment? Evidence from a retrospective cohort study in Zambia
Authors: Jamieson Lise , Rosen Sydney , Phiri Bevis , Grimsrud Anna , Mwansa Muya , Shakwelele Hilda , Haimbe Prudence , Mukumbwa-Mwenechanya Mpande , Lumano-Mulenga Priscilla , Chiboma Innocent , Nichols Brooke E
Published: December 2022

Objectives

Patient attrition is high the first 6 months after antiretroviral therapy (ART) initiation. Patients with <6 months of ART are systematically excluded from most differentiated service delivery (DSD) models, which are intended to support retention. Despite DSD eligibility criteria requiring ≥6 months on ART, some patients enrol earlier. We compared loss to follow-up (LTFU) between patients enrolling in DSD models early with those enrolled according to guidelines, assessing whether the ART experience eligibility criterion is necessary.

Design

Retrospective cohort study using routinely collected electronic medical record data.

Setting

Participants

Adults (≥15 years) who initiated ART between 1 January 2019 and 31 December 2020.

Outcomes

LTFU (>30 days late for scheduled visit) at 18 months for ‘early enrollers’ (DSD enrolment after <6 months on ART) and ‘established enrollers’ (DSD enrolment after ≥6 months on ART). We used a log-binomial model to compare LTFU risk, adjusting for age, sex, location, ART refill interval and DSD model.

Results

For 6340 early enrollers and 25 857 established enrollers, there were no differences in sex (61% female), age (median 37 years) or location (65% urban). ART refill intervals were longer for established versus early enrollers (72% vs 55% were given 4–6 months refills). LTFU at 18 months was 3% (192 of 6340) for early enrollers and 5% (24 646 of 25 857) for established enrollers. Early enrollers were 41% less likely to be LTFU than established patients (adjusted risk ratio 0.59, 95% CI 0.50 to 0.68).

Conclusions

Patients enrolled in DSD after <6 months of ART were more likely to be retained than patients established on ART prior to DSD enrolment. A limitation is that early enrollers may have been selected for DSD due to providers’ and patients’ expectations about future retention. Offering DSD models to ART patients soon after ART initiation may help address high attrition during the early treatment period.

Trial registeration number

NCT04158882.
Associations and mitigations: an analysis of the changing risk factor landscape for chronic kidney disease in primary care using national general practice level data
Authors: Stedman Mike , Heald Adrian , Robinson Adam , Davies Mark , Harnett Patrick
Published: December 2022

Objectives

Early recognition of chronic kidney disease (CKD) should be achieved by every modern healthcare system. The objective of this study was to investigate CKD risk factor trends in England using general practice level data.

Design

Observational analysis of data at practice level for all general practices in England. Practice characteristics identified as potential CKD risk factors included comorbidities and local demography. Data were analysed using both univariate and multivariate analysis to identify significant factors that were associated with CKD diagnosis for the period 1 April 2019 to 31 March 2020.

Setting

Publicly available data from UK primary care sources including Primary Care Quality and Outcomes Framework database, practice-level prescribing data from the British National Formulary and Public Health England health outcome data.

Participants

All data submitted from 6471 medium to large practices in England were included (over 46 million patients).

Risk factor analysis

Potential risk factors were grouped into four classes based on existing literature: demographic factors, comorbidities, service and practice outcome factors, and prescribing data effects.

Results

The original model’s prediction of CKD improved from r20.38 to an r2of 0.66 when updated factors were included. Positive associations included known risk factors with higher relative risk such as hypertension and diabetes, along with less recognised factors such as depression and use of opiates. Negative associations included NSAIDs which are traditionally associated with increased CKD risk, and prescribing of antibiotics, along with more northerly locations.

Conclusions

CKD is a preventable disease with high costs and consequences. These data and novel analysis give clearer relative risk values for different patient characteristics with some unexpected findings such as potential harmful association between CKD and opiates, and a more benign association with NSAIDs. A deeper understanding of CKD risk factors is important to update and implement local and national management strategies. Further research is required to establish the causal nature of these associations and to refine location appropriate actions to minimise harm from CKD on regional and local levels.
Pre-eclampsia and cardiovascular risk: a long-term nationwide cohort study on over 120 000 Finnish women
Authors: Venetkoski Minttu , Joensuu Johanna , Gissler Mika , Ylikorkala Olavi , Mikkola Tomi Sakari , Savolainen-Peltonen Hanna
Published: December 2022

Objectives

To investigate the impact of pre-eclampsia on the future cardiovascular risk in Finnish women

Design

A registry-based nationwide controlled cohort study.

Setting

Women hospitalised for pre-eclampsia in 1969–1993 and control women with a history of normotensive pregnancies followed from the pre-eclampsia diagnosis until 2019 for cardiovascular outcomes.

Participants

31 688 women with and 91 726 control women without a history of pre-eclampsia.

Primary outcome measures

Incidences of and deaths from ischaemic heart disease (IHD), myocardial infarction (MI) and stroke.

Results

In total, 25 813 (81.5%) women had pre-eclampsia without severe features, 4867 (15.4%) had pre-eclampsia with severe features and 1006 (3.2%) women developed eclampsia. Women with a history of pre-eclampsia showed elevated risks for IHD (HR 1.52, 95% CI 1.44 to 1.59), MI (HR 1.66, 95% CI 1.52 to 1.81) and stroke (HR 1.40, 95% CI 1.32 to 1.48). The risks for death from IHD (HR 1.50, 95% CI 1.28 to 1.75), MI (1.63, 95% CI 1.30 to 2.05) and stroke (1.44, 95% CI 1.03 to 2.01) were also elevated. Pre-eclampsia with severe features or eclampsia was accompanied with 15% higher IHD risk, 19% higher MI risk and 26% higher stroke risk than pre-eclampsia without severe features. The highest risk elevations of 30% for IHD, 32% for MI and 30% for stroke were observed in women with recurrent pre-eclampsia (n=4180).

Conclusion

Pre-eclampsia-related significant elevations in CVD risks of Finnish women with inherently high risk for these diseases were of the same magnitude as reported previously from other countries. Thus, women with a history of pre-eclampsia should be screened and treated early for modifiable cardiovascular risk factors.
Accuracy of self-perceived risk of falls among hospitalised adults in China: an observational study
Authors: Bao Guanjun , Liu Yuanfei , Zhang Wei , Luo Ye , Zhu Lin , Jin Jingfen
Published: December 2022

Objective

To evaluate the accuracy of self-perceived risk of falls in hospitalised adults and explore factors associated with the differences.

Design

Cross-sectional study.

Setting

We conducted the study in two tertiary general hospitals located in Zhejiang province and Shandong province in China.

Participants

339 patients were recruited using convenient sampling. The majority of them were men (54%), aged 61–70 (40.1%) and had received secondary school education or lower (82%).

Outcome measures

The Fall Risk Perception Questionnaire and the Morse Fall Scale (MFS) were used to measure patients’ self-perceived risk of falls and nurses’ assessment. Other risk factors of falls were assessed to identify the determinants of disparities.

Results

Most patients (74.6%) had a high risk of falls according to MFS. Only 61.9% of the patients’ perceived risk matched with the assessment of nurses. Nearly one-third (27.5%) underestimated their fall risk, while the remaining (10.6%) overestimated. Multivariable logistic regression analyses revealed that older age, lower number of comorbidities, not having fear of falling and emergency department were the significant factors associated with underestimated risk of falls (p<0.05). Besides, endocrine department and having fall-related injuries were significantly associated with overestimated risk of falls (p<0.05).

Conclusion

Hospitalised patients were proven to be poor at recognising their risk of falls. Measurement of patients’ self-perceived and health professionals’ assessment of fall risk should be conducted to evaluate the disparity. This study provides a solid foundation to raise medical staff’s awareness of the targeted population, identify the underlying factors and implement tailored fall prevention strategies and education.
Why medicines are used differently from prescribed: a protocol for a prospective patient-oriented observational case study to investigate reasons for non-adherence in primary care
Authors: Kvarnström Kirsi , Westerholm Aleksi , Airaksinen Marja SA , Liira Helena
Published: December 2022

Introduction

Patients do not always tell the physician if they have used medicines differently from prescribed. The challenges that patients experience in medication self-management and adherence have been prioritised globally as among the most crucial factors influencing the effectiveness and safety of pharmacotherapies.

Methods and analysis

This study protocol presents a new patient-oriented method to investigate reasons for non-adherence using pharmacist-conducted medication reconciliation in a primary care clinic as data collection point. By interviewing, the pharmacist will learn how the patient has been taking the prescribed medicines and whether any non-prescription medicines and food supplements have been used for self-medication. The pharmacist will document the findings of the conversation to the electronic patient record in a structured format. The pharmacist will collect data related to the characteristics of the patients and outpatient clinics, patients’ diseases and medications, and medication discrepancies. These data will be analysed for descriptive statistics to identify (1) the number of discrepancies between the physician’s prescription orders and the patient’s self-reported use of the medicines, (2) what kind of discrepancies there are, (3) which are high-risk medicines in terms of non-adherence and (4) why medicines were taken differently from prescribed; based on the results, (5) a preliminary conceptual model of patient-reported reasons for non-adherence will be constructed.

Trial registration number

NCT05167578.
Heath policy guiding the identification, analysis and management of secondary findings for individuals undergoing genomic sequencing: a systematic review protocol
Authors: Majeed Safa , Mighton Chloe , Malkin David , Bombard Yvonne
Published: December 2022

Introduction

Genomic sequencing is increasingly enabling precision care across medical specialties; however, the discovery of genomic ‘secondary findings’ (SFs) unrelated to the patient’s primary indication remains a profuse, unintended consequence. Existing practices within the continuum of SF identification, analysis and management are numerous, inconsistent and sometimes contradictory across health conditions and regions. Final decisions are often at the discretion of the genomic sequencing laboratory, bioinformatician or treating physician. This difference in healthcare delivery causes inconsistent information, disclosure and downstream impacts required to manage SFs and patient outcomes. Improving our understanding of the SF health policy landscape can determine components of the SF policy continuum spanning generation through to management that are in conflict, limitations of current guidance and existing needs across clinical settings.

Methods and analysis

We will carry out a systematic review to catalogue and appraise current guidance directing the identification, analysis and management of SFs for participants receiving genomic sequencing globally. We will conduct a comprehensive search of Medline (Medline R, Medline Epub Ahead of Print and Medline-In-Process & In-Data-Review Citations), Embase and Cochrane databases (n=5, inception to Feb 2022) and a grey literature search of international genomics websites (n=64; inception to May 2022). Key inclusion criteria include: guidance produced by health organisations, bioethics committees and professional associations, outlining recommendations for: (1) SF identification, (2) SF analysis or (3) SF management. Non-English language articles and conference abstracts will be excluded. Guidance will be critically appraised with the Appraisal of Guidelines for Research & Evaluation Instrument (AGREE) II tool. We will interpret our findings by process and across populations using a qualitative descriptive approach.

Ethics and dissemination

Our systematic review evaluates published data and does not require ethics review. Our findings will be disseminated through peer-reviewed publications, conference presentations and workshops with precision medicine stakeholders.

PROSPERO registration number

CRD42022316079.
Association of short poor work ability measure with increased mortality risk: a prospective multicohort study
Authors: Elovainio Marko , Laaksonen Mikko , Sakari Kainulainen , Aalto Anna-Mari , Jääskeläinen Tuija , Rissanen Harri , Koskinen Seppo
Published: December 2022

Objectives

To examine whether a single-item measure of self-rated work ability predicts all-cause mortality in three large population-based samples collected in 1978–1980, 2000 and 2017.

Setting

A representative sample of the population of Finland.

Participants

The study population comprised 17 178 participants aged 18 to 65 from the population-based Mini-Finland, Health 2000 and FinHealth 2017 cohort studies, pooled together. In all cohorts, self-rated work ability was assessed at baseline (1978–80, 2000–2001 and 2017) using three response alternatives: completely fit (good work ability), partially disabled (limited work ability) and completely disabled (poor work ability) for work.

Primary and secondary outcome measures

All-cause mortality from national registers. Cox proportional hazards models were adjusted for socioeconomic characteristics, lifestyle factors, self-rated health and mental health problems.

Results

Of the participants, 2219 (13%) were classified as having limited and 991 (5.8%) poor work ability and 246 individuals died during the 4 year follow-up. The age- and sex-adjusted HR for mortality risk was 7.20 (95% CI 5.15 to 10.08) for participants with poor vs good work ability and 3.22 (95% CI 2.30 to 4.43) for participants with limited vs good work ability. The excess risk associated with poor work ability was seen in both genders, all age groups, across different educational levels, self-rated health levels and in those with and without mental health problems. The associations were robust to further adjustment for education, health behaviours, self-rated health and mental health problems. In the multivariable analyses, the HR for mortality among those with poor vs good work ability was 5.75 (95% CI 3.59 to 9.20).

Conclusions

One-item poor self-rated work ability -measure is a strong predictor of increased risk of all-cause mortality and may be a useful survey-measure in predicting severe health outcomes in community-based surveys.
Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa
Authors: Pascoe Sophie , Fox Matthew , Kane Jeremy , Mngadi Sithabile , Manganye Pertunia , Long Lawrence C , Metz Kristina , Allen Taylor , Sardana Srishti , Greener Ross , Zheng Amy , Thea Donald M , Murray Laura K
Published: December 2022

Introduction

Intimate partner violence (IPV) is a barrier to consistent HIV treatment in South Africa. Previous trials have established that the Common Elements Treatment Approach (CETA), a cognitive-behavioural-based intervention, is effective in reducing mental and behavioural health problems but has not been trialled for effectiveness in improving HIV outcomes. This paper describes the protocol for a randomised trial that is testing the effectiveness of CETA in improving HIV treatment outcomes among women experiencing IPV in South Africa.

Methods and analysis

We are conducting a randomised trial among HIV-infected women on antiretroviral therapy, who have experienced sexual and/or physical IPV, to test the effect of CETA on increasing retention and viral suppression and reducing IPV. Women living with HIV who have an unsuppressed viral load or are at high risk for poor adherence and report experiencing recent IPV, defined as at least once within in the last 12 months, will be recruited from HIV clinics and randomised 1:1 to receive CETA or an active attention control (text message reminders). All participants will be followed for 24 months. Follow-up HIV data will be collected passively using routinely collected medical records. HIV outcomes will be assessed at 12 and 24 months post-baseline. Questionnaires on violence, substance use and mental health will be administered at baseline, post-CETA completion and at 12 months post-baseline. Our primary outcome is retention and viral suppression (<50 copies/mL) by 12 months post-baseline. We will include 400 women which will give us 80% power to detect an absolute 21% difference between arms. Our primary analysis will be an intention-to-treat comparison of intervention and control by risk differences with 95% CIs.

Ethics and dissemination

Ethics approval provided by University of the Witwatersrand Human Research Ethics Committee (Medical), Boston University Institutional Review Board and Johns Hopkins School Institutional Review Board. Results will be published in peer-reviewed journals.

Trial registration number

NCT04242992.
Cannabis Use in Pregnancy and Downstream effects on maternal and infant health (CUPiD): a protocol for a birth cohort pilot study
Authors: Ramlawi Serine , Murphy Malia S Q , Dingwall-Harvey Alysha L J , Rennicks White Ruth , Gaudet Laura M , McGee Amy , DeGrace Amanda , Cantin Christina , El-Chaâr Darine , Walker Mark C , Corsi Daniel J
Published: December 2022

Introduction

Cannabis use in pregnancy and post partum is increasing. Accessibility to cannabis has expanded due to the legalisation of cannabis in Canada. Therefore, there is a critical need to monitor the impact of cannabis on pregnancy outcomes and infant neurodevelopment. This pilot study will assess the feasibility of modern recruitment and data collection strategies adapted to the current cannabis environment and inform the design of a multicentre prospective birth cohort.

Methods and analysis

We will establish a pregnancy and birth cohort of 50 cannabis users and 50 non-users recruited before delivery. We will follow the participants at regular visits from recruitment to 12 weeks post partum. Participants will provide demographic and socioeconomic data, report their cannabis use patterns, and provide biological samples. Biological samples include maternal and infant urine and blood, breastmilk/chestmilk, cord blood, cord tissue, placenta and meconium. All samples will be processed and stored at −80°C until analysis by immunoassay or liquid chromatography-tandem mass spectrometry to determine the presence of cannabis metabolites. In addition, partners will be invited to provide additional socioeconomic and substance use data.

Ethics and dissemination

Ethics was obtained from Ottawa Health Science Network Research Ethics Board through Clinical Trials Ontario (3791). Our findings will be published in peer-reviewed journals, presented at scientific conferences and shared broadly with patients, healthcare decision-makers, and project partners online and through social media.

Trial registration number

NCT05309226.Cite Now
Recording of patients’ mental health and quality of life-related outcomes in primary care: a cross-sectional study in the UK
Authors: Carreira Helena , Williams Rachael , Dempsey Harley , Bhaskaran Krishnan
Published: December 2022

Objective

To compare patient-reported anxiety, depression and quality-of-life (QoL) outcomes, with data registered in patients’ primary care electronic health record (EHR).

Design

Cross-sectional study.

Setting

Primary care in the UK.

Participants

A convenience sample of 608 women registered in the Clinical Practice Research Datalink GOLD primary care database (data from a previous study on 356 breast cancer survivors (8.1 years postdiagnosis) and 252 women with no prior cancer).

Outcome measures

Patient-reported data on anxiety, depression and QoL, collected through postal questionnaires, and compared with coded information in EHR up to 2 years prior.

Results

Abnormal anxiety symptoms were reported by 118 of 599 women who answered the relevant questions (21%); 59/118 (50%) had general practitioner (GP)-recorded anxiolytic/antidepressant use, and 2 (1.6%) had anxiety coded in the EHR. 26/601 women (11%) reported depression symptoms, of whom 17 (65.4%) had GP-recorded antidepressant use and none had depression coded. 65 of 123 women reporting distress on the pain QoL domain (52.8%) had a corresponding record in the EHR <3 months before and 92 (74.8%) <24 months before. No patients reporting fatigue (n=157), sexual health problems (156), social avoidance (82) or cognitive problems (93) had corresponding codes in the EHR. There were no meaningful differences in the concordance results between breast cancer survivors and women with no history of cancer.

Conclusion

Many patients reporting mental health and QoL problems had no record of this in coded primary care data. This finding suggests that coded data does not fully reflect the burden of disease. Further research is needed to understand whether or not GPs are aware of patient distress in cases where codes have not been recorded.
Protocol for the PLAYshop randomised controlled trial: examining efficacy of a virtually delivered parent-focused physical literacy intervention for early childhood on child-specific and family-specific outcomes
Authors: Carson Valerie , Boyd Madison , Potter Morgan , Rhodes Ryan , Liu Sam , Naylor Patti-Jean
Published: December 2022

Introduction

The PLAYshop programme is a novel, brief, theory-based, parent-focused physical literacy intervention in early childhood designed to address the major public health issue of childhood physical inactivity. The primary objective of this study is to examine the efficacy of the virtually delivered PLAYshop programme in increasing preschool-aged children’s physical literacy, including fundamental movement skills and motivation and enjoyment.

Methods and analysis

This study aims to recruit 130 families with preschool-aged children (3–5 years) from Alberta and British Columbia, Canada who will be randomised to an intervention or control group. The PLAYshop programme is informed by the Capability, Opportunity, Motivation, Behavior (COM-B) model and includes four intervention strategies: (1) educational training via a 60 min virtual synchronous workshop, (2) educational resources via handouts, (3) material resources via a goody bag of basic active play equipment and (4) follow-up support via access to a digital app with an online toolkit and four biweekly booster lessons (1-week, 3-week, 5-week and 7-week follow-up). To assess the primary outcome of physical literacy, five fundamental movement skills (overhand throw, underhand throw, horizontal jump, hop, one leg balance) will be measured virtually at baseline and 2-month follow-up using the Test of Gross Motor Development (TGMD) and the Movement Assessment Battery for Children-Second Edition (MABC-2) tools. Additionally, children’s motivation and enjoyment will also be assessed at baseline and 2-month follow-up by: (1) parental-report using items from the Preschool Physical Literacy Assessment (PrePLAy) and (2) self-report using an adapted Five Degrees of Happiness Likert scale for children. The control group will receive the PLAYshop programme after the 2-month follow-up.

Ethics and dissemination

The protocol was approved by the University of Alberta (00093764) and University of Victoria (16-444) Research Ethics Boards. Findings will be disseminated through peer-reviewed publications, conference presentations, social and traditional media and a circulated infographic.

Trial registration number

NCT05255250.
Using participatory action research to reimagine community mental health services in Colombia: a mixed-method study protocol
Authors: Burgess Rochelle , Dedios Sanguineti María Cecilia , Maldonado-Carrizosa Darío , Fonseca Laura , Vera San Juan Norha , Lucumí Diego , González-Gort Mónica , Melgar Mónica Carreño , Gaviria María Fanny , Tovar Diego Ferney , Jovchelovitch Sandra
Published: December 2022

Introduction

Mental healthcare systems are challenged by how they hear and respond to what marginalised communities experience as drivers of mental distress. In Colombia, this challenge intersects with wider challenges facing post-conflict reconstruction. Our pilot study will explore the feasibility and acceptability of a participatory approach to developing community-led participatory interventions for community mental health systems strengthening and mental health improvement, in two sites in Caquetá, Colombia.

Methods and analysis

The project is divided into three distinct phases aligned with community participatory action research cycles: diagnostic, intervention and evaluation. This allows us to use a participatory approach to design a community-led, bottom-up intervention for mental health systems strengthening and the promotion of mental health and well-being.

The diagnostic phase explores local understandings of mental health, mental distress and access to mental health services from community members and health providers. The intervention stage will be guided by a participatory Theory of Change process. Community priorities will inform the development of a participatory, learning and action (PLA) informed group intervention, with a community linkage forum. The pilot of the PLA intervention will be evaluated using MRC process evaluation guidelines.

Ethics and dissemination

This project has received ethical approval from two sources. Universidad de Los Andes (2021–1393) and the University College London (16127/005). Dissemination of findings will include academic publications, community forums, policy briefs and visual media (cartoons, pod casts and short films).