Integrating international policy standards in the implementation of postnatal care: a rapid review.

INTRODUCTION: International legal and political documents can assist policy-makers and programme managers in countries to create an enabling environment to promote maternal and newborn health. This review aimed to map and summarise international legal and political documents relevant to the implementation of the WHO recommendations on maternal and newborn care for a positive postnatal experience. METHODS: Rapid review of relevant international legal and political documents, including legal and political commitments (declarations, resolutions and treaties) and interpretations (general comments, recommendations from United Nations human rights treaty bodies, joint United Nations statements). Documents were mapped to the domains presented in the WHO postnatal care (PNC) recommendations; relating to maternal care, newborn care, and health systems and health promotion interventions, and by type of human right implied and/or stated in the documents. RESULTS: Twenty-nine documents describing international legal and political commitments and interpretations were mapped, out of 45 documents captured. These 29 documents, published or entered into force between 1944 and 2020, contained content relevant to most of the domains of the PNC recommendations, most prominently the domains of breastfeeding and health systems interventions and service delivery arrangements. The most frequently mapped human rights were the right to health and the right to social security. CONCLUSION: Existing international legal and political documents can inform and encourage policy and programme development at the country level, to create an enabling environment during the postnatal period and thereby support the provision and uptake of PNC and improve health outcomes for women, newborns, children and families. Governments and civil society organisations should be aware of these documents to support efforts to protect and promote maternal and newborn health.

Smartphone apps for point-of-care information summaries: systematic assessment of the quality and content.

BACKGROUND: Clinicians need easy access to evidence-based information to inform their clinical practice. Point-of-care information summaries are increasingly available in the form of smartphone apps. However, the quality of information from the apps is questionable as there is currently no regulation on the content of the medical apps. OBJECTIVES: This study aimed to systematically assess the quality and content of the medical apps providing point-of-care information summaries that were available in two major app stores. We evaluated apps designed specifically for healthcare professionals and assessed their content development, editorial policy, coverage of medical conditions and trustworthiness. METHODS: We conducted a systematic assessment of medical apps providing point-of-care information summaries available in Google Play and Apple app stores. Apps launched or updated since January 2020 were identified through a systematic search using 42matters. Apps meeting the inclusion criteria were downloaded and assessed. The data extraction and app assessment were done in parallel and independently by at least two reviewers. Apps were evaluated against the adapted criteria: (1) general characteristics, (2) content presentation of the summaries, (3) editorial quality, (4) evidence-based methodology, (5) coverage (volume) of the medical conditions, (6) usability of apps and (7) trustworthiness of the app based on HONcode principles. HONcode principles are guidelines used to inform users about the credibility and reliability of health information online. The results were reported as a narrative review. RESULTS: Eight medical apps met the inclusion criteria and were systematically appraised. Based on our evaluation criteria, UpToDate supported 16 languages, and all other apps were English. Bullet points and brief paragraphs were used in all apps, and only DynaMed and Micromedex and Pathway-medical knowledge provided a formal grading system for the strength of recommendations for all the medical conditions in their apps. All the other apps either lacked a formal grading system altogether or offered one for some of the medical conditions. About 30% of the editorial quality assessment and 47.5% of the evidence-based methodology assessment were unclear or missing. UpToDate contained the most point-of-care evidence-based documents with >10 500 documents. All apps except 5-Minute Clinical Consult and DynaMed and Micromedex were available for offline access. Only Medscape complied with the HONcode principles. CONCLUSIONS: Future apps should report a more detailed evidence-based methodology, be accessible for offline use and support search in more than one language. There should be clearer information provided in future apps regarding the declaration of authorship and conflict of interest.

Recruitment of general practitioners in China: a scoping review of strategies and challenges.

BACKGROUND: China is rapidly expanding its general practitioner (GP) workforce as part of recent healthcare reform, with an extra 400,000 GPs by 2030. This scoping review identifies the published strategies for GP recruitment that are being implemented and the challenges encountered. METHODS: We searched six English and three Chinese databases from 2015 to April 2022, following Arksey and O'Malley's framework and the PRISMA ScR reporting guidelines. RESULTS: A total of 40 Chinese-language and 5 English-language records were included. We identified multiple policies, pathways and programmes focused on expanding GP recruitment. Twenty-two evaluations of these initiatives show varying degrees of effectiveness. Selecting general practice as a career is affected by many factors, including individual's background, remuneration and benefits, career prospects, working environment, self-fulfilment, and current national developments and reorganisations of primary care. The challenge most frequently reported was the adequate provision of qualified GP in rural regions. The targeting of students from rural areas and provision of free education in return for an obligatory six-years' working in their hometown upon graduation appears to be effective. Extracted records mostly studied views of trainees in a defined locality, and we identified a paucity of studies which explored the perspectives of organisations and institutions, similarly there were areas of China not contributing to the literature and there were no records taking a national perspective. CONCLUSIONS: Long-term monitoring is required to assess policy changes and to systematically evaluate the effectiveness of the interventions nationally. The monitoring of the challenges influencing GP recruitment can be used to inform the design of future initiatives. Development of a minimum agreed standardised set of outcomes used to measure and report evaluations will help assess the relative contributions and cost effectiveness of different approaches being used to boost GP numbers. We provide suggestions for improving the benefits and rewards for GPs and how to promote recruitment to the more rural or less attractive areas.

Lay perceptions of diabetes mellitus and prevention costs and benefits among adults undiagnosed with the condition in Singapore: a qualitative study.

BACKGROUND: Therapeutic lifestyle changes can reduce individual risk of type 2 diabetes (T2D) by up to 58%. In Singapore, rates of preventive practices were low, despite a high level of knowledge and awareness of T2D risk and prevention. The study explored the context of the discrepancy between knowledge and practices in T2D prevention among adults undiagnosed with the condition. METHODS: In-depth interviews with 41 adults explored lay beliefs of T2D and the sources of these perceptions, subjective interpretation of how T2D may impact lives, and perceived costs and benefits of practising preventative behaviours. Purposive sampling was used to maximise the variability of participants in demographic characteristics. Thematic analysis was conducted to identify themes related to the domains of inquiry. RESULTS: Participants' risk perceptions were influenced by familial, social, and cultural contexts of the representation and management of T2D conditions. The adverse effects of T2D were often narrated in food culture. The cost of adopting a healthy diet was perceived at a high cost of life pleasure derived from food consumption and social interactions. Inconveniences, loss of social functions, dependency and distress were the themes related to T2D management. Participants' motivation to preventive practices, such as exercise and weight loss, were influenced by short-term observable benefits. CONCLUSIONS: T2D risk communication needs to be addressed in emotionally impactful and interpersonally salient ways to increase the urgency to adopt preventative behaviours. Shifting perceived benefits from long-term disease prevention to short-term observable wellbeing could reduce the response cost of healthy eating.

Disease burden of primary biliary cholangitis and associated pruritus based on a cross-sectional US claims analysis.

OBJECTIVE: In order to identify areas of unmet need in patients with primary biliary cholangitis (PBC), this study sought to use real-world observational healthcare data to characterise the burden in patients with PBC and in PBC patients with a recorded diagnosis of pruritus. DESIGN: This retrospective, cross-sectional database study compared prevalence of prespecified comorbidities and medications in the PBC population and PBC-pruritus subpopulation with non-cases using an indirect standardisation approach. The PBC population was identified from the US IBM MarketScan Commercial Claims and Medicare Supplemental Database during 2016 using International Classification of Diseases 10th Revision, Clinical Modification codes (≥2 claims for PBC); the PBC-pruritus subpopulation additionally had ≥1 claim for pruritus during this period. Non-cases had no claims for PBC. Indirect age-sex standardised prevalence ratios (iSPR) and 95% confidence intervals (CIs) were calculated for prespecified comorbidities and medications recorded during 2017. RESULTS: The PBC population (N=1963) and PBC-pruritus subpopulation (N=139) had significantly higher prevalence of fatigue (19.9%, iSPR (95% CI): 1.51 (1.36 to 1.66); 26.6%, 2.10 (1.48 to 2.90)), depression/anxiety (21.3%, 1.09 (0.99 to 1.20); 28.1%, 1.46 (1.04 to 2.00)) and sleep-related issues (6.9%, 1.18 (0.99 to 1.40); 14.4%, 2.58 (1.58 to 3.99)) compared with non-cases. Bile acid sequestrants were prescribed in 5.8% and 18.0% of the PBC and PBC-pruritus populations, respectively. In general, a higher prevalence of comorbidities and medication use was observed in the PBC-pruritus subpopulation compared with the PBC population and non-cases. CONCLUSION: Despite availability of treatments for PBC, the PBC population had a higher burden of comorbidities than non-cases. This burden was even greater among the PBC-pruritus subpopulation, with a particularly high prevalence of sleep disorders and depression/anxiety. Despite this, pruritus remains undertreated highlighting a need for treatments specifically indicated for cholestatic pruritus.

Multicentre randomised controlled trial: protocol for Plasma-Lyte Usage and Assessment of Kidney Transplant Outcomes in Children (PLUTO).

INTRODUCTION: Acute electrolyte and acid-base imbalance is experienced by many children following kidney transplantation. When severe, this can lead to complications including seizures, cerebral oedema and death. Relatively large volumes of intravenous fluid are administered to children perioperatively in order to establish perfusion to the donor kidney, the majority of which are from living and deceased adult donors. Hypotonic intravenous fluid is commonly used in the post-transplant period due to clinicians' concerns about the sodium, chloride and potassium content of isotonic alternatives when administered in large volumes.Plasma-Lyte 148 is an isotonic, balanced intravenous fluid that contains sodium, chloride, potassium and magnesium with concentrations equivalent to those of plasma. There is a physiological basis to expect that Plasma-Lyte 148 will reduce the incidence of clinically significant electrolyte and acid-base abnormalities in children following kidney transplantation compared with current practice.The aim of the Plasma-Lyte Usage and Assessment of Kidney Transplant Outcomes in Children (PLUTO) trial was to determine whether the incidence of clinically significantly abnormal plasma electrolyte levels in paediatric kidney transplant recipients will be different with the use of Plasma-Lyte 148 compared with intravenous fluid currently administered. METHODS AND ANALYSIS: PLUTO is a pragmatic, open-label, randomised controlled trial comparing Plasma-Lyte 148 to current care in paediatric kidney transplant recipients, conducted in nine UK paediatric kidney transplant centres.A total of 144 children receiving kidney transplants will be randomised to receive either Plasma-Lyte 148 (the intervention) intraoperatively and postoperatively, or current fluid. Apart from intravenous fluid composition, all participants will receive standard clinical transplant care.The primary outcome measure is acute hyponatraemia in the first 72 hours post-transplant, defined as laboratory plasma sodium concentration of <135 mmol/L. Secondary outcomes include symptoms of acute hyponatraemia, other electrolyte and acid-base imbalances and transplant kidney function.The primary outcome will be analysed using a logistic regression model adjusting for donor type (living vs deceased donor), patient weight (<20 kg vs ≥20 kg pretransplant) and transplant centre as a random effect. ETHICS AND DISSEMINATION: The trial received Health Research Authority approval on 20 January 2020. Findings will be presented to academic groups via national and international conferences and peer-reviewed journals. The patient and public involvement group will play an important part in disseminating the study findings to the public domain. TRIAL REGISTRATION NUMBERS: 2019-003025-22 and 16586164.

Examining the Trends in Online Health Information-Seeking Behavior About Chronic Obstructive Pulmonary Disease in Singapore: Analysis of Data From Google Trends and the Global Burden of Disease Study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is the third leading cause of death globally, and timely health care seeking is imperative for its prevention, early detection, and management. While online health information-seeking behavior (OHISB) is increasingly popular due to widespread internet connectivity, little is known about how OHISB for COPD has changed in comparison with the COPD disease burden, particularly at a country-specific level. OBJECTIVE: This study aimed to examine the trends in OHISB for COPD and how that compared with the estimates of COPD disease burden in Singapore, a highly wired country with a steadily increasing COPD disease burden. METHODS: To examine the trends in OHISB for COPD, we performed Prais-Winsten regression analyses on monthly search volume data for COPD from January 2004 to June 2020 downloaded from Google Trends. We then conducted cross-correlational analyses to examine the relationship between annualized search volume on COPD topics and estimates of COPD morbidity and mortality reported in the Global Burden of Disease study from 2004 to 2017. RESULTS: From 2004 to 2020, the trend in COPD search volume was curvilinear (ß=1.69, t194=6.64, P<.001), with a slope change around the end of 2006. There was a negative linear trend (ß=-0.53, t33=-3.57, P=.001) from 2004 to 2006 and a positive linear trend (ß=0.51, t159=7.43, P<.001) from 2007 to 2020. Cross-correlation analyses revealed positive associations between COPD search volume and COPD disease burden indicators: positive correlations between search volume and prevalence, incidence, years living with disability (YLD) at lag 0, and positive correlations between search volume and prevalence, YLD at lag 1. CONCLUSIONS: Google search volume on COPD increased from 2007 to 2020; this trend correlated with the upward trajectory of several COPD morbidity estimates, suggesting increasing engagement in OHISB for COPD in Singapore. These findings underscore the importance of making high-quality, web-based information accessible to the public, particularly COPD patients and their carers.

Cost-effectiveness of specialist eating disorders services for children and adolescents with anorexia nervosa: a national surveillance study.

BACKGROUND: Evidence suggests specialist eating disorders services for children and adolescents with anorexia nervosa have the potential to improve outcomes and reduce costs through reduced hospital admissions. This study aimed to evaluate the cost-effectiveness of assessment and diagnosis in community-based specialist child and adolescent mental health services (CAMHS) compared to generic CAMHS for children and adolescents with anorexia nervosa. METHOD: Observational, surveillance study of children and adolescents aged 8 to 17, in contact with community-based CAMHS in the UK or Republic of Ireland for a first episode of anorexia nervosa. Data were reported by clinicians at baseline, 6 and 12-months follow-up. Outcomes included the Children's Global Assessment Scale (CGAS) and percentage of median expected body mass for age and sex (%mBMI). Service use data included paediatric and psychiatric inpatient admissions, outpatient and day-patient attendances. A joint distribution of incremental mean costs and effects for each group was generated using bootstrapping to explore the probability that each service is the optimal choice, subject to a range of values a decision-maker might be willing to pay for outcome improvements. Uncertainty was explored using cost-effectiveness acceptability curves. RESULTS: Two hundred ninety-eight children and adolescents met inclusion criteria. At 12-month follow-up, there were no significant differences in total costs or outcomes between specialist eating disorders services and generic CAMHS. However, adjustment for pre-specified baseline covariates resulted in observed differences favouring specialist services, due to significantly poorer clinical status of the specialist group at baseline. Cost-effectiveness analysis using CGAS suggests that the probability of assessment in a specialist service being cost-effective compared to generic CAMHS ranges from 90 to 50%, dependent on willingness to pay for improvements in outcome. CONCLUSIONS: Assessment in a specialist eating disorders service for children and adolescents with anorexia nervosa may have a higher probability of being cost-effective than assessment in generic CAMHS. TRIAL REGISTRATION: ISRCTN12676087 . Date of registration 07/01/2014.

Specialist eating disorders services may improve outcomes and reduce hospitalisations for children and adolescents with anorexia nervosa. Reductions in hospitalisation could save money for the NHS and are better for young people because hospitalisation disrupts their home life, social life and education. This study evaluated outcomes and costs of specialist eating disorders services compared to general child and adolescent mental health services (CAMHS) for children and adolescents with anorexia nervosa.Children and adolescents were identified by contacting child and adolescent psychiatrists in the UK and Ireland and asking them to report any new cases of anorexia nervosa. These psychiatrists identified 298 young people aged 8 to 17 with an anorexia nervosa diagnosis for the first time. The psychiatrists provided information on the health services these young people used and how they were doing when they were first diagnosed and 6 months and 1 year later.Children and adolescents in specialist services were more severely ill than those in CAMHS when they were first diagnosed. Despite this, care for the young people in specialist services cost about the same as for those diagnosed in CAMHS, and their outcomes after 1 year were similar. This work showed that specialist services may be better value for money than CAMHS.

Clinical and Economic Outcomes of Erythropoiesis-Stimulating Agent Hyporesponsiveness in the Post-Bundling Era.

RATIONALE & OBJECTIVE: Since the change in erythropoiesis-stimulating agent (ESA) labeling and bundling of dialysis services in the United States, few studies have addressed the clinical importance of ESA hyporesponsiveness and none have considered health care resource use in this population. We aimed to further explore ESA hyporesponsiveness and its consequences. STUDY DESIGN: Retrospective observational cohort study. SETTING & PARTICIPANTS: US Renal Data System Medicare participants receiving dialysis with a minimum 6 months of continuous ESA use from 2012 to 2014. PREDICTORS: Erythropoietin resistance index (≥2.0 U/kg/wk/g/L) and ESA dose were used to identify ESA hyporesponders and hyporesponsive subgroups: isolated, intermittent, and chronic. OUTCOMES: Associations between ESA responsiveness and mortality, cardiovascular hospitalization rates, and health care resource use were evaluated and compared across subgroups. ANALYTICAL APPROACH: Baseline characteristics were compared using Wilcoxon rank sum tests for continuous variables and χ2 tests for categorical variables. Incidence rates of health care resource use were modeled using an unadjusted and adjusted generalized linear model. RESULTS: Of 834,115 dialysis patients in the CROWNWeb database, 38,891 ESA hyporesponders and 59,412 normoresponders met all inclusion criteria. Compared with normoresponders, hyporesponders were younger women, weighed less, and had longer durations of dialysis (all P < 0.001). Hyporesponders received 3.8-fold higher ESA doses (mean, 94,831 U/mo) and erythropoietin resistance index was almost 5 times higher than in normoresponders. Hyporesponders had lower hemoglobin levels and parathyroid hormone levels > 800 pg/mL, and iron deficiency was present in 26.5% versus 10.9% in normoresponders. One-year mortality was higher among hypo- compared with normoresponders (25.3% vs 22.6%). Hyporesponders also had significantly higher rates of hospitalization for cardiovascular events, emergency department visits, inpatient stays, home health agency visits, skilled nursing facility, and hospice days. LIMITATIONS: Only US Medicare patients were included and different hyporesponder definitions may have influenced the results. CONCLUSIONS: This study explored ESA hyporesponsiveness using new definitions and incorporated clinical and economic outcomes. It established that ESA-hyporesponsive dialysis patients had higher mortality, cardiovascular hospitalization rates, and health care costs as compared with ESA-normoresponsive patients.

The Economic Burden of Chronic Obstructive Pulmonary Disease in the Asia-Pacific Region: A Systematic Review.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a significant and disabling condition that entails high economic burden for society. OBJECTIVE: The aim of this article is to assess cost studies of COPD and analyze cross-country cost comparisons in Asia-Pacific. METHODS: A systematic literature search from October 2000 to October 2018 was conducted using PubMed, MEDLINE, and EMBASE to identify relevant studies. Costs reported by the different studies were converted to 2017 US dollars using the consumer price index for medical care. The quality of the studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards. RESULTS: Ten studies (6 countries and 11 estimates) were identified and included for full review after consideration of the inclusion and exclusion criteria. Annual total societal costs of COPD ranged from $4398 to $23 049 per capita in Japan and $453 to $12 167 in South Korea. There were no intracountry comparison estimates for the remaining countries (Singapore: $2700; Taiwan: $4000; China: $3942; and Thailand: $1105). In addition, there were estimates of partial costs in Singapore and Taiwan. CONCLUSIONS: Results of this review showed high cost variations between countries, with estimates in 2 countries (Japan and South Korea) exceeding those in UK and USA. Wide variation in disease cost estimates will continue to exist as long as there are differences in cost methodologies, disease severities included, and data limitation. We propose that researchers conducting burden-of-illness studies use standard methods and reporting formats to support cross-country comparisons.

Size and shape matter: A preliminary analysis of microplastic sampling technique in seawater studies with implications for ecological risk assessment.

Microplastic particles (MPs) are widely distributed in seawater. Fibrous MPs (microfibres) are often reported as the most commonly encountered shape of particle. To estimate MP concentrations in seawater, samples are often collected using towed nets (generally 300-350-µm mesh) and may underestimate the amount of microfibres present, which may pass through the mesh due to their narrow width. We compared the potential microplastic particle (PMP) concentration estimates provided by two different seawater sampling methods conducted at three commercial shellfish farms and three unfarmed sites in Baynes Sound, British Columbia, Canada. The methods were: 10-L bucket samples sieved through 63-µm mesh in situ and subsequently filtered through an 8-µm polycarbonate membrane; and 1-L bulk samples collected in jars and subsequently filtered to 8 µm. The jar samples yielded PMP concentrations averaging approximately 8.5 times higher than the bucket samples per L of water (at the site level), largely driven by differences in the number of microfibres. There was no significant difference in PNP concentration between shellfish farms and unfarmed sites. An analysis of MP concentrations and mesh sizes reported in the literature suggests that using a 300-350-µm mesh may underestimate total MP concentrations by one to four orders of magnitude compared with samples that are filtered through much smaller mesh sizes (e.g. <100 µm), despite the effect of sample volume. Particles <300 µm in diameter make up a large component of MPs commonly found in fish and invertebrates. As such, common sampling practices fail to adequately measure a biologically relevant class of MPs, thereby undermining the ability to quantify ecological risk. We suggest that seawater sampling methods be designed to filter to <10 µm (the approximate width of many microfibres), either using pressurized pumps for large-volume samples, or by using sufficient replication of small-volume discrete samples.

New indicators and indexes for benchmarking university-industry-government innovation in medical and life science clusters: results from the European FP7 Regions of Knowledge HealthTIES project.

BACKGROUND: While the European Union is striving to become the 'Innovation Union', there remains a lack of quantifiable indicators to compare and benchmark regional innovation clusters. To address this issue, a HealthTIES (Healthcare, Technology and Innovation for Economic Success) consortium was funded by the European Union's Regions of Knowledge initiative, research and innovation funding programme FP7. HealthTIES examined whether the health technology innovation cycle was functioning differently in five European regional innovation clusters and proposed regional and joint actions to improve their performance. The clusters included BioCat (Barcelona, Catalonia, Spain), Medical Delta (Leiden, Rotterdam and Delft, South Holland, Netherlands), Oxford and Thames Valley (United Kingdom), Life Science Zürich (Switzerland), and Innova Észak-Alföld (Debrecen, Hungary). METHODS: Appreciation of the 'triple helix' of university-industry-government innovation provided the impetus for the development of two quantifiable innovation indexes and related indicators. The HealthTIES H-index is calculated for disease and technology platforms based on the h-index proposed by Hirsch. The HealthTIES Innovation Index is calculated for regions based on 32 relevant quantitative and discriminative indicators grouped into 12 categories and 3 innovation phases, namely 'Input' (n = 12), 'Innovation System' (n = 9) and 'Output' (n = 11). RESULTS: The HealthTIES regions had developed relatively similar disease and technology platform profiles, yet with distinctive strengths and weaknesses. The regional profiles of the innovation cycle in each of the three phases were surprisingly divergent. Comparative assessments based on the indicators and indexes helped identify and share best practice and inform regional and joint action plans to strengthen the competitiveness of the HealthTIES regions. CONCLUSION: The HealthTIES indicators and indexes provide useful practical tools for the measurement and benchmarking of university-industry-government innovation in European medical and life science clusters. They are validated internally within the HealthTIES consortium and appear to have a degree of external prima facie validity. Potentially, the tools and accompanying analyses can be used beyond the HealthTIES consortium to inform other regional governments, researchers and, possibly, large companies searching for their next location, analyse and benchmark 'triple helix' dynamics within their own networks over time, and to develop integrated public-private and cross-regional research and innovation strategies in Europe and beyond.

A randomised controlled trial of an exercise intervention promoting activity, independence and stability in older adults with mild cognitive impairment and early dementia (PrAISED) - A Protocol.

BACKGROUND: People with dementia progressively lose cognitive and functional abilities. Interventions promoting exercise and activity may slow decline. We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia. We successfully undertook a feasibility randomised controlled trial (RCT) to refine the intervention and research delivery. We are now delivering a multi-centred RCT to evaluate its clinical and cost-effectiveness. METHODS: We will recruit 368 people with MCI or early dementia (Montreal Cognitive Assessment score 13-25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research). Participants will be randomised to an individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control). The intervention will be delivered in participants' homes by trained physiotherapists, occupational therapists and therapy assistants. We will measure disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use. We will use a mixed methods approach to conduct a process evaluation to assess staff training and delivery of the intervention, and to identify individual- and context-level mechanisms affecting intervention engagement and activity maintenance. We will undertake a health economic evaluation to determine if the intervention is cost-effective. DISCUSSION: We describe the protocol for a multi-centre RCT that will evaluate the clinical and cost-effectiveness of a therapy programme designed to promote activity and independence amongst people living with dementia. TRIAL REGISTRATION: ISRCTN, ISRCTN15320670. Registered on 4 September 2018.

A development study and randomised feasibility trial of a tailored intervention to improve activity and reduce falls in older adults with mild cognitive impairment and mild dementia.

BACKGROUND: People with dementia progressively lose abilities and are prone to falling. Exercise- and activity-based interventions hold the prospect of increasing abilities, reducing falls, and slowing decline in cognition. Current falls prevention approaches are poorly suited to people with dementia, however, and are of uncertain effectiveness. We used multiple sources, and a co-production approach, to develop a new intervention, which we will evaluate in a feasibility randomised controlled trial (RCT), with embedded adherence, process and economic analyses. METHODS: We will recruit people with mild cognitive impairment or mild dementia from memory assessment clinics, and a family member or carer. We will randomise participants between a therapy programme with high intensity supervision over 12 months, a therapy programme with moderate intensity supervision over 3 months, and brief falls assessment and advice as a control intervention. The therapy programmes will be delivered at home by mental health specialist therapists and therapy assistants. We will measure activities of daily living, falls and a battery of intermediate and distal health status outcomes, including activity, balance, cognition, mood and quality of life. The main aim is to test recruitment and retention, intervention delivery, data collection and other trial processes in advance of a planned definitive RCT. We will also study motivation and adherence, and conduct a process evaluation to help understand why results occurred using mixed methods, including a qualitative interview study and scales measuring psychological, motivation and communication variables. We will undertake an economic study, including modelling of future impact and cost to end-of-life, and a social return on investment analysis. DISCUSSION: In this study, we aim to better understand the practicalities of both intervention and research delivery, and to generate substantial new knowledge on motivation, adherence and the approach to economic analysis. This will enable us to refine a novel intervention to promote activity and safety after a diagnosis of dementia, which will be evaluated in a definitive randomised controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02874300; ISRCTN 10550694.

Establishing partnership with traditional birth attendants for improved maternal and newborn health: a review of factors influencing implementation.

BACKGROUND: Recent World Health Organization recommendations recognize the important role Traditional Birth Attendants (TBAs) can play in supporting the health of women and newborns. This paper provides an analysis of key factors that affect the implementation of interventions to develop partnerships with TBAs to promote improved access to skilled care at birth. METHODS: We conducted a secondary analysis of 20 papers identified through two systematic reviews that examined the effectiveness of interventions to find new roles for TBAs on maternal and newborn health outcomes, as well as papers identified through a systematic mapping of the maternal health literature. The Supporting the Use of Research Evidence framework (SURE) guided the thematic analysis to explore the perceptions of various stakeholders and implementation barriers and facilitators, as well as other contextual issues. RESULTS: This analysis identified countries that have implemented interventions to support the transition from birth with a TBA to birth with a skilled birth attendant. Drawing on the experiences of these countries, the analysis highlights factors that are important to consider when designing and implementing such interventions. Barriers to implementation included resistance to change in more traditional communities, negative attitudes between TBAs and skilled attendants and TBAs concerns about the financial implications of assuming new roles. Facilitating factors included stakeholder involvement in devising and implementing interventions, knowledge sharing between TBAs and skilled birth attendants, and formalised roles and responsibilities and remuneration for TBAs. CONCLUSIONS: The implementation barriers identified in this analysis could, if not addressed, prevent or discourage TBAs from carrying out newly defined roles supporting women in pregnancy and childbirth and linking them to the formal health system. This paper also identifies the factors that seem critical to success, which new programmes could consider adopting from the outset. In most cases a multi-faceted approach is needed to prepare TBAs and others for new roles, including the training of TBAs to strengthen their knowledge and skills to enable them to be able to assume new roles, alongside the sensitization of healthcare providers, communities, women and their families. Further research is required to map the transition process and stakeholder experiences in more detailed ways and to provide longer-term monitoring of existing interventions.

Developing global indicators for quality of maternal and newborn care: a feasibility assessment.

OBJECTIVE: To assess the feasibility of applying the World Health Organization's proposed 15 indicators of quality of care for maternal and newborn health at health-facility level in low- and middle-income settings. METHODS: Six of the indicators are about maternal health, five are for newborn health and four are general cross-cutting indicators. We used data collected routinely in facility registers and obtained as part of facility assessments from 963 health-care facilities specializing in maternity services in 10 countries in Africa and Asia. We made a feasibility assessment of the availability of data and the clarity of indicator definitions and identified additional information and data collection processes needed to apply the proposed indicators in real-life settings. FINDINGS: Of the indicators evaluated, 10 were clearly defined, of which four could be applied directly in the field and six would require revisions to operationalize them. The other five indicators require further development, with one of them being ready for implementation by using information readily available in registers and four requiring further information before deployment. For indicators that measure coverage of care or availability of services or products, there is a need to further strengthen measurement. Information on emergency obstetric complications was not recorded in a standard manner, thus limiting the reliability of the information. CONCLUSION: While some of the proposed indicators can already be applied, other indicators need to be refined or will need additional sources and methods of data collection to be applied in real-world settings.

UK healthcare professionals' uncertainties, barriers and facilitators to the introduction of targeted human papillomavirus vaccination for men who have sex with men.

BACKGROUND: Female-only human papillomavirus (HPV) vaccination will fail to protect men who have sex with men (MSM) against HPV and its sequelae (i.e. genital warts and anal cancers). In the absence of gender-neutral HPV vaccination, targeted vaccination at sexual health clinics for MSM offers a valuable preventive opportunity. This study aimed to identify sexual healthcare professionals' (HCPs) perceived barriers and facilitators for MSM-targeted HPV vaccination. METHODS: Nineteen telephone interviews with UK-based self-referred HCPs (13 doctors, three nurses, three health advisers) were conducted in October and November 2014. The interviews were recorded and transcribed verbatim. Data were analysed thematically by two researchers. RESULTS: HCPs were unsure about selection criteria, acceptable healthcare settings and the source of vaccination funding for the introduction of MSM-targeted HPV vaccination. Lack of political and public support, MSMs' limited access to HPV vaccination and disclosure of sexual orientation to HCPs, identification of eligible MSM, patients' poor HPV awareness and motivation to complete HPV vaccination were perceived as significant barriers. HCPs believed that the introduction of official guidelines on HPV vaccination for MSM, awareness campaigns and integrated clinic procedures could improve vaccination coverage. CONCLUSION: HCPs recognised a need to protect MSM against HPV. However, several challenges and obstacles associated with the introduction of MSM-targeted HPV vaccination in the UK were reported. HCPs' perspectives and concerns need to be addressed when developing policies and guidelines for a potential MSM-targeted HPV vaccination. Future research needs to examine whether negative views of HCPs towards MSM-targeted HPV vaccination are associated with lower HPV vaccine uptake and completion rates in MSM.

Frameworks to assess health systems governance: a systematic review.

Governance of the health system is a relatively new concept and there are gaps in understanding what health system governance is and how it could be assessed. We conducted a systematic review of the literature to describe the concept of governance and the theories underpinning as applied to health systems; and to identify which frameworks are available and have been applied to assess health systems governance. Frameworks were reviewed to understand how the principles of governance might be operationalized at different levels of a health system. Electronic databases and web portals of international institutions concerned with governance were searched for publications in English for the period January 1994 to February 2016. Sixteen frameworks developed to assess governance in the health system were identified and are described. Of these, six frameworks were developed based on theories from new institutional economics; three are primarily informed by political science and public management disciplines; three arise from the development literature and four use multidisciplinary approaches. Only five of the identified frameworks have been applied. These used the principal-agent theory, theory of common pool resources, North's institutional analysis and the cybernetics theory. Governance is a practice, dependent on arrangements set at political or national level, but which needs to be operationalized by individuals at lower levels in the health system; multi-level frameworks acknowledge this. Three frameworks were used to assess governance at all levels of the health system. Health system governance is complex and difficult to assess; the concept of governance originates from different disciplines and is multidimensional. There is a need to validate and apply existing frameworks and share lessons learnt regarding which frameworks work well in which settings. A comprehensive assessment of governance could enable policy makers to prioritize solutions for problems identified as well as replicate and scale-up examples of good practice.

Development of a Report Card for Identifying Local Sublingual Immunotherapy Events in Clinical Trials.

BACKGROUND: The sublingual immunotherapy (SLIT) Report Card was developed to capture patient-reported local reactions from the administration of SLIT, based on the World Allergy Organization side-effect grading system. The objective was to evaluate understandability, usability, and translatability of the paper and electronic versions of the SLIT Report Card. METHODS: Adults (aged 18+ years), adolescents (aged 12-17 years), and parents/caregivers and their children (aged 5-11 years) participated in two rounds of interviews, testing the paper version in Round 1, and both the paper and electronic versions in Round 2. Interviews assessed comprehension and usability by subjects. Translatability identified potential issues related to translation or cultural relevance. RESULTS: Ten adults, ten adolescents, and ten parent/child dyads were interviewed. In general, subjects demonstrated a clear understanding of the instrument's content. However, some subjects were uncertain of or suggested clarifying the meaning of certain terms, including tablet, ulcer, taste alteration, uvula, nausea, and itching in the ear. The translatability assessment also identified uvula and nausea as potentially problematic for translation. Subjects could use the electronic device and found navigation 'easy', with only a few minor suggestions made to improve usability. Some wording and formatting changes were made based on subjects' feedback and the translatability assessment. CONCLUSION: The SLIT Report Card was refined following best practices for instrument development, including cognitive interviewing, usability, and translatability assessment. The refined SLIT Report Card is appropriate for comprehensively and systematically collecting SLIT-related local reactions directly from subjects in a clinical trial setting, taking into account the World Allergy Organization grading system.