bluuebunny/crossref_metadata_2025 huggingface dataset:
Analysis of Space Manipulation in an Informal Urban Settlement: The Case of Ng’ombe in Lusaka, Zambia
Authors: Mwamba Jonathan Simbeya
Published: October 2020

Urban informality remains a consistent challenge and matter of debate by planners and policymakers in the urbanising cities of sub-Saharan Africa. A common manifestation of urban informality in African cities is the sprawling informal settlements that constitute the only available housing option for the majority of the urban poor. The analysis of informal urban settlement’s environmental composition, physical modelling and socio-economic and policy analysis have been areas of recent study. However there is limited literature on how the urban poor communities in Zambia manipulate their social, spatial and economic environments to meet their needs. This article seeks to broaden the knowledge base on the way informal urban settlement communities manipulate their urban space. The built environment provides the setting for human interaction and the explanatory theory of Environment-Behaviour Relations provides a suitable analytical framework for the identification of useful parameters for developing future settlement interventions. The study employs a case study method of research to analyse the informal urban settlement settings. Ng’ombe, a peri-urban informal settlement in Lusaka, Zambia is the case study location for this research. Analysis of social, spatial and economic environment at neighbourhood level provides vital information about the informal urban settlement conditions. The study in particular addresses the question of how the social-spatial circumstances of the informal urban population in the developing world influence and defines their built environment. The study shows that systems of settings and system of activities in Ng’ombe offer a suitable analytical framework for studying the settlement characteristics that can guide in formulating strategies for settlement regularisation. Residents devise means of adapting and manipulating their informal urban space to suit their immediate needs and they also devise livelihood coping strategies in the midst of their informal settings. The paper likewise contributes to the growing body of knowledge in urban informality.
Parathyroid cyst: differential diagnosis
Authors: Silva Rita , Cavadas Daniela , Vicente Carla , Coutinho Jose
Published: October 2020

Parathyroid cysts are rare lesions of the cervical region and less frequently of the mediastinum. They occur mostly in women and are usually asymptomatic. They generally occur in the fourth and fifth decades of life and mainly are non-functioning. They commonly present as a neck mass that is found incidentally during surgery or in imaging test. Its importance lies in the difficulty in diagnosis, often confusing itself with thyroid pathology. The diagnosis is usually made intraoperatively, confirmed by histopathological examination.

The aim of this paper is to report a case of parathyroid cyst that mimics a thyroid nodule.
Aphasia and confusion – influenza encephalopathy: atypical presentation of influenza
Authors: Obata Reiichiro , Ernst Kristina
Published: October 2020

Influenza encephalopathy, a rare manifestation of influenza infection in the adult population which is not widely recognised, can present with confusion and focal neurological symptoms, including aphasia. The aim of this report is to illustrate the unique presentation of influenza encephalopathy and discuss the need for close attention to and monitoring of this rare but highly fatal disease.

A 28-year-old woman was admitted with acute-onset confusion and incoherent speech. CT of the head was unremarkable. Cerebrospinal fluid analysis showed elevation of protein, but was otherwise unremarkable. A detailed history revealed recent upper respiratory symptoms which prompted a rapid influenza test which was positive and oseltamivir was started. The patient’s confusion and aphasia gradually improved and her speech was back to her baseline by the next day.
Oro-facial fibrosis in systemic sclerosis: a reconstructive journey
Authors: Jeon Faith Hyun Kyung , Griffin Michelle , Varghese Jajini , Butler Peter Edward Michael
Published: October 2020

Oro-facial fibrosis presents a significant disease burden in patients with systemic sclerosis, but there remains no established treatment modality. Autologous fat grafting is a minimally invasive surgical procedure that is now increasingly recognised for its regenerative capacity, propagating an expansion of heterogeneous indications beyond volume restoration, including fibrotic diseases such as systemic sclerosis. We present a 42-year-old woman with oro-facial involvement of systemic sclerosis leading to severe limitation in mouth opening and closure, with marked retraction of the lower lip and gingival display. We describe the reconstructive journey over a 12-year period, where the antifibrotic effect of autologous fat grafting served as the basis on which a series of surgical procedures were performed to achieve functional and aesthetic improvement. Autologous fat grafting provides a novel treatment modality for oro-facial skin fibrosis, previously considered a non-treatable disease manifestation of systemic sclerosis.
An unusual ischaemic presentation of thrombosed intracranial mycotic aneurysm with subsequent subarachnoid haemorrhage
Authors: Brown Patrick , Fulks Daniel
Published: October 2020

We present an unusual case of acute ischaemic stroke secondary to thrombosed mycotic aneurysm with subsequent early aneurysmal rupture and subarachnoid haemorrhage, successfully treated with endovascular coil embolisation of the thrombosed segment. Imaging correlates are presented demonstrating successful endovascular management despite vessel occlusion precluding angiographic visualisation of the aneurysmal segment. Imaging and clinical follow-up is provided demonstrating durable occlusion and excellent clinical outcome with full functional recovery.
Late presentation of ‘Lemierre’s syndrome’: how a delay in seeking healthcare and reduced access to routine services resulted in widely disseminatedFusobacterium necrophoruminfection during the global COVID-19 pandemic
Authors: Howley Fergal , O'Doherty Laura , McEniff Niall , O'Riordan Ruth
Published: October 2020

The SARS-CoV-2 outbreak has disrupted the delivery of routine healthcare services on a global scale. With many regions suspending the provision of non-essential healthcare services, there is a risk that patients with common treatable illnesses do not receive prompt treatment, leading to more serious and complex presentations at a later date. Lemierre’s syndrome is a potentially life-threatening and under-recognised sequela of an oropharyngeal or dental infection. It is characterised by septic embolisation of the gram-negative bacillusFusobacterium necrophorumto a variety of different organs, most commonly to the lungs. Thrombophlebitis of the internal jugular vein is frequently identified. We describe an atypical case of Lemierre’s syndrome involving the brain, liver and lungs following a dental infection in a young male who delayed seeking dental or medical attention due to a lack of routine services and concerns about the SARS-CoV-2 outbreak.
Effects of walkability on physical activity and obesity: a prospective observational study protocol
Authors: Zhang Yalan , Chen Siyu , Shi Jiayang , Chen Zongtao
Published: October 2020

Introduction

The prevalence of overweight and obesity is increasing worldwide, which could lead to a set of chronic and metabolic diseases. Physical activity is a modifiable factor for obesity, which was reported to be correlated with the built environment. However, the effects of the built environment on physical activity are not consistent. Walkability is a convenient way to assess the built environment. We aim to prospectively explore the relationship among walkability, physical activity and obesity in Chinese participants in Chongqing, a hilly city and provide evidence for future urban planning.

Methods and analysis

Participants will be recruited from people who receive health examination in the Health Management Centre, the First Affiliated Hospital to Army Medical University. Exposure variables are WalkScores calculated within the areas around workplace and residential addresses of participants. The primary outcomes are body mass index measured through health examination at baseline and follow-ups, and daily walking steps recorded by WeChat mini application for 30 days after every time of health examination. Other health-related data of the participants will also be collected. Multivariate regression analysis will be performed to examine the relationship between exposure variables and outcomes.

Ethics and dissemination

The Protocol is approved by the Ethics Committee of the First Affiliated Hospital to Army Medical University (KY201839). The results will be actively disseminated through peer-review journals and conference publications.

Registration number

Chinese Clinical Trial Registry (ChiCTR1800017680).
Evidence for Better Lives Study: a comparative birth-cohort study on child exposure to violence and other adversities in eight low- and middle-income countries - foundational research (study protocol)
Authors: Valdebenito Sara , Murray Aja , Hughes Claire , Băban Adriana , Fernando Asvini D , Madrid Bernadette J. , Ward Catherine , Osafo Joseph , Dunne Michael , Sikander Siham , Walker Susan P , Thang Vo Van , Tomlinson Mark , Fearon Pasco , Shenderovich Yulia , Marlow Marguerite , Chathurika Deshanie , Taut Diana , Eisner Manuel
Published: October 2020

Introduction

Violence against children is a health, human rights and social problem affecting approximately half of the world’s children. Its effects begin at prenatal stages with long-lasting impacts on later health and well-being. The Evidence for Better Lives Study (EBLS) aims to produce high-quality longitudinal data from cities in eight low- and middle-income countries—Ghana, Jamaica, Pakistan, the Philippines, Romania, South Africa, Sri Lanka and Vietnam—to support effective intervention to reduce violence against children. EBLS-Foundational Research (EBLS-FR) tests critical aspects of the planned EBLS, including participant recruitment and retention, data collection and analysis. Alongside epidemiological estimates of levels and predictors of exposure to violence and adversity during pregnancy, we plan to explore mechanisms that may link exposure to violence to mothers’ biological stress markers and subjective well-being.

Methods and analyses

EBLS-FR is a short longitudinal study with a sample of 1200 pregnant women. Data are collected during the last trimester of pregnancy and 2 to 6 months after birth. The questionnaire for participating women has been translated into nine languages. Measures obtained from mothers will include, among others, mental and physical health, attitudes to corporal punishment, adverse childhood experiences, prenatal intimate partner violence, substance use and social/community support. Hair and dry blood spot samples are collected from the pregnant women to measure stress markers. To explore research participation among fathers, EBLS-FR is recruiting 300 fathers in the Philippines and Sri Lanka.

Ethics and dissemination

The study received ethical approvals at all recruiting sites and universities in the project. Results will be disseminated through journal publications, conferences and seminar presentations involving local communities, health services and other stakeholders. Findings from this work will help to adjust the subsequent stages of the EBLS project.
Non-pharmacological approaches to procedural anxiety reduction for patients undergoing radiotherapy for cancer: systematic review protocol
Authors: Forbes Erin , Baker Amanda L , Britton Ben , Clover Kerrie , Skelton Eliza , Oultram Sharon , Oldmeadow Christopher , McCarter Kristen
Published: October 2020

Introduction

Procedural anxiety relates to an affective state of anxiety or fear in relation to a medical procedure. Various treatment-related factors may elicit anxiety among oncology patients, including fear of diagnostic imaging (such as MRI scans) and impending treatment and medical procedures (such as chemotherapy and radiotherapy). It is common in oncology settings to manage acute anxiety relating to medical procedures with anxiolytic medication. However, pharmacological approaches are not suitable for many patients. Despite this, non-pharmacological interventions are infrequently used. The aim of this systematic review is to determine whether non-pharmacological interventions delivered prior to, or during, radiotherapy are effective in reducing procedural anxiety.

Methods and analysis

Data sources will include the bibliographic databases CINAHL, MEDLINE, EMBASE, PsycINFO and Cochrane Central Register of Controlled trials (CENTRAL) (from inception onward). Eligible studies will include adult patients with cancer undergoing radiotherapy treatment. Included studies will be those which employ a non-pharmacological intervention, delivered within existing radiotherapy appointments, with the aim of reducing procedural anxiety related to radiotherapy. All research designs with a control or other comparison group will be included. The primary outcome will be change in levels of self-reported procedural anxiety. Secondary outcomes will be changes in scores on physiological measures of anxiety and/or changes in treatment completion and/or changes in treatment duration and/or changes in psychological distress. Two investigators will independently complete title and abstract screening, full-text screening, data extraction and assessment of methodological quality. If appropriate, a meta-analyses will be performed. Any important amendments to this protocol will be updated in the PROSPERO registration and documented in the resulting review publication.

Ethics and dissemination

No ethical issues are anticipated from this review. The findings will be disseminated through peer-reviewed publication and at conferences by presentation.

Systematic review registration

CRD42019112941.
Early indicators of disease progression in Fabry disease that may indicate the need for disease-specific treatment initiation: findings from the opinion-based PREDICT-FD modified Delphi consensus initiative
Authors: Hughes Derralynn A , Aguiar Patricio , Deegan Patrick B , Ezgu Fatih , Frustaci Andrea , Lidove Olivier , Linhart Aleš , Lubanda Jean-Claude , Moon James C , Nicholls Kathleen , Niu Dau-Ming , Nowak Albina , Ramaswami Uma , Reisin Ricardo , Rozenfeld Paula , Schiffmann Raphael , Svarstad Einar , Thomas Mark , Torra Roser , Vujkovac Bojan , Warnock David G , West Michael L , Johnson Jack , Rolfe Mark J , Feriozzi Sandro
Published: October 2020

Objectives

The PRoposing Early Disease Indicators for Clinical Tracking in Fabry Disease (PREDICT-FD) initiative aimed to reach consensus among a panel of global experts on early indicators of disease progression that may justify FD-specific treatment initiation.

Design and setting

Anonymous feedback from panellists via online questionnaires was analysed using a modified Delphi consensus technique. Questionnaires and data were managed by an independent administrator directed by two non-voting cochairs. First, possible early indicators of renal, cardiac and central/peripheral nervous system (CNS/PNS) damage, and other disease and patient-reported indicators assessable in routine clinical practice were compiled by the cochairs and administrator from panellists’ free-text responses. Second, the panel scored indicators for importance (5-point scale: 1=not important; 5=extremely important); indicators scoring ≥3 among >75% of panellists were then rated for agreement (5-point scale: 1=strongly disagree; 5=strongly agree). Indicators awarded an agreement score ≥4 by >67% of panellists achieved consensus. Finally, any panel-proposed refinements to consensus indicator definitions were adopted if >75% of panellists agreed.

Results

A panel of 21 expert clinicians from 15 countries provided information from which 83 possible current indicators of damage (kidney, 15; cardiac, 15; CNS/PNS, 13; other, 16; patient reported, 24) were compiled. Of 45 indicators meeting the importance criteria, consensus was reached for 29 and consolidated as 27 indicators (kidney, 6; cardiac, 10; CNS/PNS, 2; other, 6; patient reported, 3) including: (kidney) elevated albumin:creatinine ratio, histological damage, microalbuminuria; (cardiac) markers of early systolic/diastolic dysfunction, elevated serum cardiac troponin; (CNS/PNS) neuropathic pain, gastrointestinal symptoms suggestive of gastrointestinal neuropathy; (other) pain in extremities/neuropathy, angiokeratoma; (patient-reported) febrile crises, progression of symptoms/signs. Panellists revised and approved proposed chronologies of when the consensus indicators manifest. The panel response rate was >95% at all stages.

Conclusions

PREDICT-FD captured global opinion regarding current clinical indicators that could prompt FD-specific treatment initiation earlier than is currently practised.
Association between 7-day serum β-hCG levels after frozen–thawed embryo transfer and pregnancy outcomes: a single-centre retrospective study from China
Authors: Yuan Lihua , Yu Lingyu , Sun Zhengao , Song Jingyan , Xiao Jimei , Jiang Huaying , Sa Yuanhong
Published: October 2020

Objective

Early monitoring of plasma human chorionic gonadotropin (β-hCG) level is vital in predicting pregnancy outcome. This study investigated the predictive value of serum β-hCG level on the seventh day after frozen–thawed embryo transfer (FET) for ongoing pregnancy (OP) and adverse pregnancy (AP).

Design

Retrospective study.

Setting

The Reproductive and Genetic Center of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, China.

Participants

1061 pregnant women who underwent FET between January 2014 and January 2017.

Primary and secondary outcome measures

Pregnancy outcome.

Results

Serum β-hCG levels on the seventh day after FET were higher in the single OP group compared with the biochemical pregnancy group (p<0.001). Besides, the serum β-hCG cut-off level at 4.34 mIU/mL on the seventh day showed high predictive value (area under the curve (AUC)=0.852). Serum β-hCG levels on the seventh day after FET were higher in the twin OP group compared with the single OP group (p<0.001). Also, the serum β-hCG cut-off level at 17.95 mIU/mL on the seventh day showed high predictive value (AUC=0.903). Serum β-hCG levels on the seventh day after FET were lower in the ectopic pregnancy group compared with the single OP group (p<0.001) whereas, serum β-hCG cut-off level at 4.53 mIU/mL on the seventh day exhibited a high predictive value (AUC=0.860). Further, the serum β-hCG levels on the seventh day after FET were lower in the single early spontaneous abortion group compared with the single OP group (p<0.001) while the serum β-hCG cut-off level at 5.34 mIU/mL on the seventh day exhibited high predictive value (AUC=0.738).

Conclusion

Serum β-hCG on the seventh day after FET has good clinical significance for the prediction of OP and AP.
Cost-effectiveness of new MDR-TB regimens: study protocol for the TB-PRACTECAL economic evaluation substudy
Authors: Sweeney Sedona , Gomez Gabriela , Kitson Nichola , Sinha Animesh , Yatskevich Natalia , Staples Suzanne , Moodliar Ronelle , Motlhako Sharon , Maloma Matshepo , Rassool Mohammed , Ngubane Nosipho , Ndlovu Ella , Nyang'wa Bern-Thomas
Published: October 2020

Introduction

Current treatment regimens for multidrug-resistant tuberculosis (MDR-TB) are long, poorly tolerated and have poor outcomes. Furthermore, the costs of treating MDR-TB are much greater than those for treating drug-susceptible TB, both for health service and patient-incurred costs. Urgent action is needed to identify short, effective, tolerable and cheaper treatments for people with both quinolone-susceptible and quinolone-resistant MDR-TB. We present the protocol for an economic evaluation (PRACTECAL-EE substudy) alongside an ongoing clinical trial (TB-PRACTECAL) aiming to assess the costs to patients and providers of new regimens, as well as their cost-effectiveness and impact on participant poverty levels. This substudy is based on data from the three countries participating in the main trial.

Methods and analysis

Primary cost data will be collected from the provider and patient perspectives, following economic best practice. We will estimate the probability that new MDR-TB regimens containing bedaquiline, pretomanid and linezolid are cost-effective from a societal perspective as compared with the standard of care for MDR-TB patients in Uzbekistan, South Africa and Belarus. Analysis uses a Markov model populated with primary cost and outcome data collected at each study site. We will also estimate the impact of new regimens on prevalence of catastrophic patient costs due to TB.

Ethics and dissemination

Ethical approval has been obtained from the London School of Hygiene & Tropical Medicine and Médecins Sans Frontières. Local ethical approval will be sought in each study site. The results of the economic evaluation will be shared with the country health authorities and published in a peer-reviewed journal.

Trial registration number

ClinicalTrials.gov Registry (NCT04207112); Pre-results.
Barriers to uptake of reproductive information and contraceptives in rural Tanzania: an intersectionality informed qualitative enquiry
Authors: Carroll Allison , Kapilashrami Anuj
Published: October 2020

Objectives

Access to reproductive information and contraception (RIC) continues to be a critical unmet need in Tanzania and impedes the realisation of reproductive health rights. This study examined key sources of RIC and the factors influencing their uptake by women in Mbeya region of Tanzania.

Setting

This qualitative study was undertaken in a rural ward in a district in the south of the Mbeya region

Participants

In-depth interviews were undertaken with 48 women users and 2 nurses working in a public health facility, and focus group discussions with 16 home-based care workers in the district. Participants were recruited through a local non-governmental organisation (NGO) in the region, and via snowball sampling. All interactions were recorded, translated and transcribed and sought to identify the available resources and barriers in using them.

Results

Participants reported six main sources of reproductive information and contraceptives: public health facilities, NGO mobile clinics, other women, Mganga wa Asili (witchdoctors/traditional doctors) and Duka la Dawa (pharmacy). Women users and healthcare workers identified a range of individual (age, marital status and geography) and health system-wide factors shaping women’s reproductive choices and preventing uptake of contraceptives. The study also revealed structural factors such as gender, ethnicity, indigeneity as key determinants of access and health seeking, placing women from Sukuma and Maasai communities is the most disadvantageous position. Historical social disadvantage, patriarchal social controls and the pressure to preserve sociocultural traditions that women experience in the Maasai and Sukuma tribes underpin their disconnect from mainstream services.

Conclusion

Women’s reproductive choices and their uptake of contraceptives are shaped by the interaction of a range of individual, household, institutional and structural factors. An intersectional lens enables examination of the ways in which these factors interact and mutually constitute disadvantage and privilege.
Effects of interorganisational information technology networks on patient safety: a realist synthesis
Authors: Keen Justin , Abdulwahid Maysam Ali , King Natalie , Wright Judy M , Randell Rebecca , Gardner Peter , Waring Justin , Longo Roberta , Nikolova Silviya , Sloan Claire , Greenhalgh Joanne
Published: October 2020

Objective

Health services in many countries are investing in interorganisational networks, linking patients’ records held in different organisations across a city or region. The aim of the systematic review was to establish how, why and in what circumstances these networks improve patient safety, fail to do so, or increase safety risks, for people living at home.

Design

Realist synthesis, drawing on both quantitative and qualitative evidence, and including consultation with stakeholders in nominal groups and semistructured interviews.

Eligibility criteria

The coordination of services for older people living at home, and medicine reconciliation for older patients returning home from hospital.

Information sources

17 sources including Medline, Embase, CINAHL, Cochrane Library, Web of Science, ACM Digital Library, and Applied Social Sciences Index and Abstracts.

Outcomes

Changes in patients’ clinical risks.

Results

We did not find any detailed accounts of the sequences of events that policymakers and others believe will lead from the deployment of interoperable networks to improved patient safety. We were, though, able to identify a substantial number of theory fragments, and these were used to develop programme theories.

There is good evidence that there are problems with the coordination of services in general, and the reconciliation of medication lists in particular, and it indicates that most problems are social and organisational in nature. There is also good evidence that doctors and other professionals find interoperable networks difficult to use. There was limited high-quality evidence about safety-related outcomes associated with the deployment of interoperable networks.

Conclusions

Empirical evidence does not currently justify claims about the beneficial effects of interoperable networks on patient safety. There appears to be a mismatch between technology-driven assumptions about the effects of networks and the sociotechnical nature of coordination problems.

PROSPERO registration number

CRD42017073004.
Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol
Authors: Hu Tingting , Li Shunrong , Huang Heng , Huang Hui , Tan Luyuan , Chen Yanbo , Deng Heran , Wu Jiannan , Zhu Liling , Zhang Jian , Su Fengxi , Chen Kai
Published: October 2020

Introduction

The ideal treatment for idiopathic granulomatous mastitis (IGM) remains unclear. In a prospective, single-centre, pilot study, we reported that ductal lavage treatment for non-lactational mastitis patients had a 1-year clinical complete response (cCR) rate of >90%, without any significant adverse events. Thus, in this multicentre, randomised, open-label, non-inferiority trial, we will aim to compare the effectiveness and safety of ductal lavage vs oral corticosteroids as the first-line treatment for patients with IGM.

Methods and analysis

The trial will be conducted at the Breast Tumor Center of Sun Yat-sen Memorial Hospital in China and at least at one participating regional centre. We plan to recruit 140 eligible IGM patients who will be randomised into the ductal lavage group or oral corticosteroid group with a 1:1 ratio. The patients in the oral corticosteroid group will receive Methylprednisolone or prednisone for 6 months. The patients in the ductal lavage group will receive ductal lavage and breast massage, as previously reported. All the participants will be followed up at the clinic for 1 year post randomisation. The primary endpoint of this trial will be the 1-year cCR rate, and the secondary endpoints will include the time to cCR, treatment failure rate, relapse rate and protocol compliance rate. The trial was designed to determine whether ductal lavage is non-inferior to oral corticosteroids (1-year cCR rate assumed to be 90%), with a non-inferiority margin of 15%.

Ethics and dissemination

The ethics committee of Sun Yat-sen Memorial Hospital at Sun Yat-sen University approved the study (2018-Lun-Shen-Yan-No. 30). The results of the trial will be communicated to the participating primary care practices, published in international journals and presented at international clinical and scientific conferences.

Trial registration number

ClinicalTrials.gov Registry (NCT03724903); Pre-results.
Adherence to lipid-lowering guidelines for secondary prevention and potential reduction in CVD events in Swedish primary care: a cross-sectional study
Authors: Ödesjö Helena , Björck Staffan , Franzén Stefan , Hjerpe Per , Manhem Karin , Rosengren Annika , Thorn Jörgen , Adamsson Eryd Samuel
Published: October 2020

Objectives

The protective effect of lipid-lowering treatment for secondary prevention after coronary heart disease (CHD) has been well documented. Current guidelines recommend a target level for low-density lipoprotein cholesterol (LDL-C) of ≤1.8 mmol/L. The aim was to describe lipid-lowering treatment patterns and to provide an estimate of the potential reductions in cardiovascular disease (CVD) events with improved adherence to guidelines.

Design

Cross-sectional.

Setting

Primary care in a large Swedish region.

Participants

37 120 patients with CHD in a Swedish regional primary care quality register (QregPV), by 31 December 2015.

Primary and secondary outcome measures

Proportion of patients on statin treatment and proportion of patients achieving LDL-C ≤1.8 mmol/L. Estimated number of CVD events calculated for (1) current treatment, (2) improved treatment and (3) lowered LDL-C, based on applying rate reductions from meta-analyses of randomised trials to the potentially undertreated population. Risk estimation modelling was based on 52 042 patients in the same register on January 2011 followed for 5 years.

Results

Of 37 120 patients, 18% reached LDL-C ≤1.8 mmol/L and 32% were not on statin treatment. Based on individual risks, the estimated number of CVD events in the study group over 5 years was 9209/37 120. If all patients without a statin or with less potent statin treatment were given atorvastatin 80 mg, an estimated reduction of CVD events by 14% (7901 vs 9209) was seen. If all patients achieved LDL-C ≤1.8 mmol/L, the number of events was estimated to be reduced by 18% (7577 vs 9209).

Conclusion

One-third of patients with CHD in primary care were not on lipid-lowering treatment. Based on the assumption that included patients would react to statin therapy the same way as the patients in randomised trials, improved adherence to treatment guidelines could lead to a substantial reduction in new CVD events.
Early Parenting Acceptance and Commitment Therapy ‘Early PACT’ for parents of infants with cerebral palsy: a study protocol of a randomised controlled trial
Authors: Whittingham Koa , Sheffield Jeanie , Mak Catherine , Dickinson Corrine , Boyd Roslyn N
Published: October 2020

Introduction

New international clinical practice guidelines exist for identifying infants at high risk of cerebral palsy (CP) earlier: between 12 to 24 weeks corrected age, significantly earlier than previous diagnosis windows in Australia at 19 months. The earlier detection of infants at high risk of CP creates an opportunity for earlier intervention. The quality of the parent-infant relationship impacts various child outcomes, and is leveraged in other forms of intervention. This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP. We predict that participating in the Early PACT programme will be associated with improvements in the parent-infant relationship, in parent mental health and well-being as well as infant behaviour and quality of life.

Methods and analysis

This study aims to recruit 60 parents of infants (0 to 2 years old corrected age) diagnosed with CP or identified as at high risk of having CP. Participants will be randomly allocated to one of two groups: Early PACT or waitlist control (1:1). Early PACT is an online parent support programme grounded in Acceptance and Commitment Therapy (ACT). It is delivered as a course on an open source course management system called edX. Early PACT is designed to support parental adjustment and parent-infant relationship around the time of early diagnosis. Assessments will be conducted at baseline, following completion of Early PACT and at 6-month follow-up (retention). The primary outcome will be the quality of parent-child interactions as measured by the Emotional Availability Scale. Standard analysis methods for randomised controlled trial will be used to make comparisons between the two groups (Early PACT and waitlist control). Retention of effects will be examined at 6-month follow-up.

Ethics and dissemination

This study is approved through appropriate Australian and New Zealand ethics committees (see in text) with parents providing written informed consent. Findings from this trial will be disseminated through peer-reviewed journal publications and conference presentations.

Trial registration details

This trial has been prospectively registered on 12 June 2018 to present (ongoing) with the Australian New Zealand Clinical Trials Registry (ACTRN12618000986279); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=3 74 896
Healthcare experiences of patients with chronic heart failure in Germany: a scoping review
Authors: Dieckelmann Mirjam , Petersen Juliana J , Güthlin Corina , Reinhardt Felix , Plath Jasper , Jeitler Klaus , Semlitsch Thomas , Gerlach Ferdinand M , Siebenhofer Andrea
Published: October 2020

Objectives

To review systematically the past 10 years of research activity into the healthcare experiences (HCX) of patients with chronic heart failure (CHF) in Germany, in order to identify research foci and gaps and make recommendations for future research.

Design

In this scoping review, six databases and grey literature sources were systematically searched for articles reporting HCX of patients with CHF in Germany that were published between 2008 and 2018. Extracted results were summarised using quantitative and qualitative descriptive analysis.

Results

Of the 18 studies (100%) that met the inclusion criteria, most were observational studies (60%) that evaluated findings quantitatively (60%). HCX were often concerned with patient information, global satisfaction as well as relationships and communication between patients and providers and generally covered ambulatory care, hospital care and rehabilitation services. Overall, the considerable heterogeneity of the included studies’ outcomes only permitted relatively trivial levels of synthesis.

Conclusion

In Germany, research on HCX of patients with CHF is characterised by missing, inadequate and insufficient information. Future research would benefit from qualitative analyses, evidence syntheses, longitudinal analyses that investigate HCX throughout the disease trajectory, and better reporting of sociodemographic data. Furthermore, research should include studies that are based on digital data, reports of experiences gained in under-investigated yet patient-relevant healthcare settings and include more female subjects.
Trends in national pharmaceutical expenditure on diabetes in Ireland 2011–2015: a repeated cross-sectional study
Authors: O Neill Kate N , Bennett Kathleen E , Mc Hugh Sheena M , Fitzgerald Anthony P , Kearney Patricia M
Published: October 2020

Objectives

To explore trends in pharmaceutical expenditure on diabetes between 2011 and 2015, describing trends in expenditure on blood glucose-lowering medications and estimating the effect of cost-containment measures implemented during this time.

Design

Repeated cross-sectional study of national pharmacy claims data in Ireland.

Participants

Patients’ dispensed items used in the treatment or management of diabetes.

Primary and secondary outcomes

Total expenditure associated with diabetes was calculated by extracting data on all diabetes-related items dispensed to eligible patients. Costs were categorised into two groups. Diabetes-specific items include items used directly in diabetes treatment (WHO-Anatomical Therapeutic Chemical (ATC): A10, V07, V04) and diabetes-related include all other condition-related items (WHO-ATC: B01, C, H04, N03, N06). The impacts of two specific cost-containment measures, co-payments and reference pricing, were assessed using segmented linear regression analyses of interrupted time-series.

Results

Total expenditure varied over the study period, peaking at €216 994 441 in 2012. Expenditure on diabetes-specific items increased steadily by 18% reaching €153 621 477 in 2015, with blood glucose-lowering medications accounting for 73% of this increase. During the same period, expenditure on diabetes-related items decreased by 32% to €50 835 856. The introduction of reference pricing for atorvastatin in November 2013 resulted in immediate costs savings of €2.4 million per yearly quarter (level-change p<0.001).

Conclusions

The increasing expenditure on blood glucose-lowering medications negates the effect of recent cost-containment measures, presenting a significant challenge for the provision of diabetes care. Innovative policies are required to ensure high-quality diabetes care can be provided at an equitable, affordable and sustainable rate.
Comparing patients’ and other stakeholders’ preferences for outcomes of integrated care for multimorbidity: a discrete choice experiment in eight European countries
Authors: Rutten-van Mölken Maureen , Karimi Milad , Leijten Fenna , Hoedemakers Maaike , Looman Willemijn , Islam Kamrul , Askildsen Jan E , Kraus Markus , Ercevic Darija , Struckmann Verena , Gyorgy Pitter János , Cano Isaac , Stokes Jonathan , Jonker Marcel
Published: October 2020

Objectives

To measure relative preferences for outcomes of integrated care of patients with multimorbidity from eight European countries and compare them to the preferences of other stakeholders within these countries.

Design

A discrete choice experiment (DCE) was conducted in each country, asking respondents to choose between two integrated care programmes for persons with multimorbidity.

Setting

Preference data collected in Austria (AT), Croatia (HR), Germany (DE), Hungary (HU), the Netherlands (NL), Norway (NO), Spain (ES), and UK.

Participants

Patients with multimorbidity, partners and other informal caregivers, professionals, payers and policymakers.

Main outcome measures

Preferences of participants regarding outcomes of integrated care described as health/well-being, experience with care and cost outcomes, that is, physical functioning, psychological well-being, social relationships and participation, enjoyment of life, resilience, person-centredness, continuity of care and total costs. Each outcome had three levels of performance.

Results

5122 respondents completed the DCE. In all countries, patients with multimorbidity, as well as most other stakeholder groups, assigned the (second) highest preference to enjoyment of life. The patients top-three most frequently included physical functioning, psychological well-being and continuity of care. Continuity of care also entered the top-three of professionals, payers and policymakers in four countries (AT, DE, HR and HU). Of the five stakeholder groups, preferences of professionals differed most often from preferences of patients. Professionals assigned lower weights to physical functioning in AT, DE, ES, NL and NO and higher weights to person-centredness in AT, DE, ES and HU. Payers and policymakers assigned higher weights than patients to costs, but these weights were relatively low.

Conclusion

The well-being outcome enjoyment of life is the most important outcome of integrated care in multimorbidity. This calls for a greater involvement of social and mental care providers. The difference in opinion between patients and professionals calls for shared decision-making, whereby efforts to improve well-being and person-centredness should not divert attention from improving physical functioning.
Making shared decision-making (SDM) a reality: protocol of a large-scale long-term SDM implementation programme at a Northern German University Hospital
Authors: Danner Marion , Geiger Friedemann , Wehkamp Kai , Rueffer Jens Ulrich , Kuch Christine , Sundmacher Leonie , Skjelbakken Tove , Rummer Anne , Novelli Anna , Debrouwere Marie , Scheibler Fueloep
Published: October 2020

Introduction

Shared decision-making (SDM) is not yet widely used when making decisions in German hospitals. Making SDM a reality is a complex task. It involves training healthcare professionals in SDM communication and enabling patients to actively participate in communication, in addition to providing sound, easy to understand information on treatment alternatives in the form of evidence-based patient decision aids (EbPDAs). This project funded by the German Innovation Fund aims at designing, implementing and evaluating a multicomponent, large-scale and integrative SDM programme—called SHARE TO CARE (S2C)—at all clinical departments of a University Hospital Campus in Northern Germany within a 4-year time period.

Methods and analysis

S2C tackles the aforementioned components of SDM: (1) training physicians in SDM communication, (2) activating and empowering patients, (3) developing EbPDAs in the most common/relevant diseases and (4) training other healthcare professionals in SDM coaching. S2C is designed together with patients and providers. The physicians’ training programme entails an online and an in situ training module. The decision coach training is based on a similar but less comprehensive approach. The development of online EbPDAs follows the International Patient Decision Aid Standards and includes written, graphical and video-based information. Validated outcomes of SDM implementation are measured in a preintervention and postintervention evaluation design. Process evaluation accompanies programme implementation. Health economic impact of the intervention is investigated using a propensity-score-matched approach based on potentially preference-sensitive hospital decisions.

Ethics and dissemination

Ethics committee review approval has been obtained from Medical Ethics Committee of the Medical Faculty of the Christian-Albrechts-University Kiel. Project information and results will be disseminated at conferences, on project-hosted websites at University Hospital Medical Center Schleswig Holstein and by S2C as well as in peer-reviewed and professional journals.
What are the prevalence and predictors of psychosocial healthcare among patients with heart disease? A nationwide population-based cohort study
Authors: Zinckernagel Line , Ersbøll Annette Kjær , Holmberg Teresa , Pedersen Susanne S , Timm Helle Ussing , Zwisler Ann-Dorthe
Published: October 2020

Objectives

Psychosocial healthcare is recommended, but little is known about how patients perceive the level of care and whether subgroups of patients experience less psychosocial healthcare than others. We examined the prevalence of patient-reported psychosocial healthcare and factors predicting patient-reported lack of psychosocial healthcare among patients with heart disease.

Design

A cohort study.

Setting

Denmark, nationwide.

Participants

A registry-based random sample of 5000 patients with incident heart disease in 2013.

Measures

Patient-reported psychosocial healthcare was obtained from a survey and potential predictors before disease onset from registries. We used multivariable logistic regression analysis to determine predictors of patient-reported lack of care.

Results

We received responses from 56%; 40% reported lacking information on psychosocial aspects, 51% lacking psychosocial rehabilitation and support and 32% reported lacking both types of psychosocial healthcare. The type of heart disease was the strongest predictor of patient-reported lack of psychosocial healthcare, especially among patients with atrial fibrillation (OR: 3.11–3.98). Older age (OR: 1.48–2.05), female gender (OR: 1.27–1.53) and no contact with general practitioner (OR: 1.47–1.84) also predicted patient-reported lack of psychosocial healthcare. Patients outside the labour force (OR: 1.29) and living in the capital region (OR: 1.50) more frequently reported lacking psychosocial rehabilitation and support, and patients with recent (OR: 1.63) or past (OR: 1.33) anxiety or depression and severe comorbidities (OR: 1.34) more frequently reported lacking both types of psychosocial healthcare.

Conclusions

Many patients with heart disease reported lacking psychosocial healthcare. Importantly, patients who most need psychosocial healthcare are not those who report receiving it. Our results call for action to translate guidelines into clinical practice.
Clinical effectiveness of manipulation and mobilisation interventions for the treatment of non-specific neck pain: protocol for a systematic review and meta-analysis
Authors: Bailey Elizabeth , Heneghan Nicola R , Cassidy Natasha J , Falla Deborah , Rushton Alison B
Published: October 2020

Introduction

Non-specific neck pain (NSNP) is a common musculoskeletal condition resulting in pain, physical limitations and associated functional disability. Current guidelines recommend manipulation and/or mobilisation as part of the multimodal management of NSNP. This study focuses on intervention at the articular level and aims to identify whether joint mobilisation or joint manipulation has a greater effect on function, range of movement or pain outcomes in the management of NSNP.

Methods and analysis

A systematic review protocol has been designed and is reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. A targeted search strategy will enable searching of key databases from inception to 31 March 2020: CINAHL, PEDro, AMED, EMBASE, OVID, MEDLINE, Web of Science, PubMed and Google Scholar. Key journals will be searched using predefined keywords determined from preliminary scoping searches for randomised controlled trials of manipulation and mobilisation modalities for adults with NSNP in the absence of radiculopathy or whiplash, published in English. Grey literature and unpublished studies will also be searched. Studies will be screened by title and abstract and full text. Two independent reviewers will conduct the searches independently, extract data, assess risk of bias (Cochrane Risk of Bias Tool 2) and assess overall strength of evidence (Grading of Recommendations, Assessment, Development and Evaluation). Meta-analysis will be performed where individual studies measure comparable outcomes including performance-based outcome measures such as range of movement or patient reported outcome measures such as Neck Disability Index; and where interventions are comparable in their delivery such as number of oscillations and Maitland grading. Where not possible, data will be presented descriptively.

Ethics and dissemination

This study does not require ethical approval. Findings will be submitted for publication to relevant peer-reviewed journals and will be presented at profession-specific conferences.

PROSPERO registration number

CRD42020164457.