An age-old problem or an old-age problem? A UK survey of attitudes, historical use and recommendations by healthcare professionals to use healthcare apps.

BACKGROUND: The coronavirus pandemic has exacerbated barriers to accessing face-to-face care. Consequently, the potential for digital health technologies (DHTs) to address unmet needs has gained traction. DHTs may circumvent several barriers to healthy independent living, resulting in both socioeconomic and clinical benefits. However, previous studies have demonstrated these benefits may be disproportionately realised among younger populations while excluding older people. METHODS: We performed a prospective survey using the One Poll market research platform among 2000 adults from the United Kingdom. To mitigate against self-selection bias, participants were not informed of the topic of the survey until they had completed recruitment. We compared willingness to use and historical use of health-apps, in addition to recommendations to use health-apps from healthcare professionals; comparing outcomes across all age groups, including a reference group (n = 222) of those aged 18-24. Outcomes were analysed using multivariate logistic regression and reported as odds ratios (OR) with respondent age, ethnicity, gender, and location as covariates. RESULTS: Willingness to use health-apps decreased significantly with age, reaching a minimum (OR = 0.39) among those aged 65 and over compared to the reference group of 18-24 year olds. Despite this, more than 52% of those aged 65 and over were willing to use health-apps. Functions and features most cited as useful by older populations included symptom self-monitoring and surgery recovery assistance. The likelihood of never having used a health-app also increased consistently with age, reaching a maximum among those aged 65 and over (OR = 18.3). Finally, the likelihood of being recommended health-apps by a healthcare professional decreased significantly with age, (OR = 0.09) for those aged 65 and over. In absolute terms, 33.8% of those aged 18-24, and 3.9% of those aged 65 and over were recommended health-apps by their healthcare professionals. CONCLUSION: Although absolute utilisation of health-apps decreases with age, the findings of this study suggest that the gap between those willing to use health-apps, and those being recommended health-apps by healthcare professionals increases with age. Given the increasing availability of evidence-based health-apps designed for older populations, this may result in entirely avoidable unmet needs, suggesting that more should be done by healthcare professionals to recommend health-apps to older persons who are generally positive about their use. This may result in considerable improvements in healthy and independent ageing.

Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders.

BACKGROUND: Medical device certification has undergone significant changes in recent years. However, exploration of stakeholder experiences remains relatively limited, particularly in the context of software as a medical device. This study sought to explore stakeholder experiences of medical device certification across both the UK and EU. METHODS: Semi-structured interviews (n = 22) analysed using inductive-thematic analysis, synthesised using activity theory. RESULTS: Innovators, consultants and notified bodies share more similarities than differences when discussing barriers and enablers to achieving medical device certification. Systemic tensions between existing rules, tools, community understanding and division of labour currently undermine the intended aim of certification processes. Existing rules are considered complex, with small and medium-sized enterprises considered disproportionality affected, resulting in several unintended outcomes including the perceived 'killing' of innovation. Existing certification processes are described as unfit for purpose, unethical and unsustainable. CONCLUSION: Stakeholder experiences suggest that the intention of establishing a robust and sustainable regulatory framework capable of ensuring a high level of safety whilst also supporting innovation is not yet being realised. Failure to enact desired changes may further jeopardise future innovations, outcomes and care quality.

A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors.

BACKGROUND: Many cancer survivors following primary treatment have prolonged poor quality of life. AIM: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. DESIGN: Pragmatic parallel open randomised trial. SETTING: UK general practices. METHODS: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. RESULTS: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. CONCLUSION: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.

The effectiveness of digital health technologies for patients with diabetes mellitus: A systematic review.

Introduction: Diabetes mellitus (DM) is a leading cause of morbidity and mortality worldwide. At the same time, digital health technologies (DHTs), which include mobile health apps (mHealth) have been rapidly gaining popularity in the self-management of chronic diseases, particularly following the COVID-19 pandemic. However, while a great variety of DM-specific mHealth apps exist on the market, the evidence supporting their clinical effectiveness is still limited. Methods: A systematic review was performed. A systematic search was conducted in a major electronic database to identify randomized controlled trials (RCTs) of mHealth interventions in DM published between June 2010 and June 2020. The studies were categorized by the type of DM and impact of DM-specific mHealth apps on the management of glycated haemoglobin (HbA1c) was analysed. Results: In total, 25 studies comprising 3,360 patients were included. The methodological quality of included trials was mixed. Overall, participants diagnosed with T1DM, T2DM and Prediabetes all demonstrated greater improvements in HbA1c as a result of using a DHT compared with those who experienced usual care. The analysis revealed an overall improvement in HbA1c compared with usual care, with a mean difference of -0.56% for T1DM, -0.90% for T2DM and -0.26% for Prediabetes. Conclusion: DM-specific mHealth apps may reduce HbA1c levels in patients with T1DM, T2DM and Prediabetes. The review highlights a need for further research on the wider clinical effectiveness of diabetes-specific mHealth specifically within T1DM and Prediabetes. These should include measures which go beyond HbA1c, capturing outcomes including short-term glycemic variability or hypoglycemic events.

Optimising an intervention to support home-living older adults at risk of malnutrition: a qualitative study.

BACKGROUND: In the UK, about 14% of community-dwelling adults aged 65 and over are estimated to be at risk of malnutrition. Screening older adults in primary care and treating those at risk may help to reduce malnutrition risk, reduce the resulting need for healthcare use and improve quality of life. Interventions are needed to raise older adults' risk awareness, offer relevant and meaningful strategies to address risk and support general practices to deliver treatment and support. METHODS: Using the Person-based Approach and input from Patient and Public Involvement representatives, we developed the 'Eat well, feel well, stay well' intervention. The intervention was optimised using qualitative data from think aloud and semi-structured process evaluation interviews with 23 and 18 older adults respectively. Positive and negative comments were extracted to inform rapid iterative modifications to support engagement with the intervention. Data were then analysed thematically and final adjustments made, to optimise the meaningfulness of the intervention for the target population. RESULTS: Participants' comments were generally positive. This paper focuses predominantly on participants' negative reactions, to illustrate the changes needed to ensure that intervention materials were optimally relevant and meaningful to older adults. Key factors that undermined engagement included: resistance to the recommended nutritional intake among those with reduced appetite or eating difficulties, particularly frequent eating and high energy options; reluctance to gain weight; and a perception that advice did not align with participants' specific personal preferences and eating difficulties. We addressed these issues by adjusting the communication of eating goals to be more closely aligned with older adults' beliefs about good nutrition, and acceptable and feasible eating patterns. We also adjusted the suggested tips and strategies to fit better with older adults' everyday activities, values and beliefs. CONCLUSIONS: Using iterative qualitative methods facilitated the identification of key behavioural and contextual elements that supported engagement, and issues that undermined older adults' engagement with intervention content. This informed crucial revisions to the intervention content that enabled us to maximise the meaningfulness, relevance and feasibility of the key messages and suggested strategies to address malnutrition risk, and therefore optimise engagement with the intervention and the behavioural advice it provided.

Web-based internet searches for digital health products in the United Kingdom before and during the COVID-19 pandemic: a time-series analysis using app libraries from the Organisation for the Review of Care and Health Applications (ORCHA).

OBJECTIVES: To explore if consumer interest in digital health products (DHPs), changed following the COVID-19 pandemic and the lockdown measures that ensued. DESIGN: Retrospective time-series analysis of web-based internet searches for DHPs in the UK, split over two periods, pre-COVID-19 lockdown (January 2019-23 March 2020) and post-COVID-19 lockdown (24 March 2020-31 December 2020). SETTING: The UK. PARTICIPANTS: Members of the UK general population using health-app libraries provided by the Organisation for the Review of Care and Health Applications. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was volume of searches for DHPs. Secondary outcomes considered search volumes for 25 different therapeutic areas. Outcomes were assessed for significance using a two-stage Poisson test. RESULTS: There were 126 640 searches for DHPs over the study period. Searches for DHPs increased by 343% from 2446 per month prior to COVID-19 lockdown measures being introduced to 8996 per month in the period following the first COVID-19 lockdown in the UK. In total, 23/25 (92%) of condition areas experienced a significant increase in searches for DHPs, with the greatest increases occurring in the first 2 months following lockdown. Musculoskeletal conditions (2.036%), allergy (1.253%) and healthy living DHPs (1.051%) experienced the greatest increases in searches compared with pre-lockdown. Increased search volumes for DHPs were sustained in the 9 months following the introduction of lockdown measures, with 21/25 (84%) of condition areas experiencing monthly search volumes at least 50% greater than pre-lockdown levels. CONCLUSIONS: The COVID-19 pandemic has profoundly disrupted the routine delivery of healthcare, making face-to-face interaction difficult, and contributing to unmet clinical needs. This study has demonstrated significant increases in internet searches for DHPs by members of the UK population since COVID-19, signifying an increased interest in this potential therapeutic medium. Future research should clarify whether this increased interest has resulted in increased acceptance and utilisation of these technologies also.

Barriers and Facilitators to the Adoption of Mobile Health Among Health Care Professionals From the United Kingdom: Discrete Choice Experiment.

BACKGROUND: Despite the increasing availability of mobile health services, clinical engagement remains minimal. OBJECTIVE: This study aims to identify and weight barriers to and drivers of health app use among health care professionals (HCPs) from the United Kingdom. METHODS: A discrete choice experiment was conducted with 222 HCPs using a web-based survey between March 2019 and June 2019. Participants were recruited to take part via social media and asked to choose their preferred option of 2 hypothetical health apps to prescribe to a hypothetical patient or to prescribe neither. Choices were characterized by differing levels of patient age, cost, published evidence bases, whether they had a National Health Service (NHS) stamp of approval, personal familiarity with the technology, and whether they were recommended by a fellow HCP. The results were analyzed using a mixed logit model, with subgroup analyses to account for heterogeneity. RESULTS: We received 230 responses, a total of 96.5% (n=222/230) of respondents understood the survey task and passed the test of rationality. The median age was between 36 and 45 years, and 62.6% (n=139/222) of the health care providers responding to the survey had previously recommended the use of health apps to patients. Health apps were most likely to be prescribed to patients if they had an NHS stamp of approval or if they were recommended by another HCP (both P<.001). Published studies detailing clinical effectiveness were important (P<.001), but it would take five published studies to have the same impact on prescribing behavior as an NHS stamp of approval and two studies to be as convincing as having used the technology personally. Increasing patient age and costs resulted in significant reductions in digital health prescribing (P<.001), none more so than among allied health professionals. Willingness-to-pay for health apps increased by £124.61 (US $151.14) if an NHS stamp of approval was present and by £29.20 (US $35.42) for each published study. Overall, 8.1% (n=18/222) of respondents were reluctant to use health apps, always choosing the I would prescribe neither option, particularly among older HCPs, nurses, and those who do not use health apps personally. Subgroup analyses revealed significant differences in preferences among HCPs of differing ages and clinical backgrounds. CONCLUSIONS: An NHS stamp of approval, published studies, and recommendations from fellow HCPs are significant facilitators of digital prescribing, whereas increasing costs and patient age are significant barriers to engagement. These findings suggest that demonstrating assurances of health apps and supporting both the dissemination and peer-to-peer recommendation of evidence-based technologies are critical if the NHS is to achieve its long-term digital transformation ambitions.

Developing a digital intervention for cancer survivors: an evidence-, theory- and person-based approach.

This paper illustrates a rigorous approach to developing digital interventions using an evidence-, theory- and person-based approach. Intervention planning included a rapid scoping review that identified cancer survivors' needs, including barriers and facilitators to intervention success. Review evidence (N = 49 papers) informed the intervention's Guiding Principles, theory-based behavioural analysis and logic model. The intervention was optimised based on feedback on a prototype intervention through interviews (N = 96) with cancer survivors and focus groups with NHS staff and cancer charity workers (N = 31). Interviews with cancer survivors highlighted barriers to engagement, such as concerns about physical activity worsening fatigue. Focus groups highlighted concerns about support appointment length and how to support distressed participants. Feedback informed intervention modifications, to maximise acceptability, feasibility and likelihood of behaviour change. Our systematic method for understanding user views enabled us to anticipate and address important barriers to engagement. This methodology may be useful to others developing digital interventions.

Barriers and facilitators to screening and treating malnutrition in older adults living in the community: a mixed-methods synthesis.

BACKGROUND: Malnutrition (specifically undernutrition) in older, community-dwelling adults reduces well-being and predisposes to disease. Implementation of screen-and-treat policies could help to systematically detect and treat at-risk and malnourished patients. We aimed to identify barriers and facilitators to implementing malnutrition screen and treat policies in primary/community care, which barriers have been addressed and which facilitators have been successfully incorporated in existing interventions. METHOD: A data-base search was conducted using MEDLINE, Embase, PsycINFO, DARE, CINAHL, Cochrane Central and Cochrane Database of Systematic Reviews from 2012 to June 2016 to identify relevant qualitative and quantitative literature from primary/community care. Studies were included if participants were older, community-dwelling adults (65+) or healthcare professionals who would screen and treat such patients. Barriers and facilitators were extracted and mapped onto intervention features to determine whether these had addressed barriers. RESULTS: Of a total of 2182 studies identified, 21 were included (6 qualitative, 12 quantitative and 3 mixed; 14 studies targeting patients and 7 targeting healthcare professionals). Facilitators addressing a wide range of barriers were identified, yet few interventions addressed psychosocial barriers to screen-and-treat policies for patients, such as loneliness and reluctance to be screened, or healthcare professionals' reservations about prescribing oral nutritional supplements. CONCLUSION: The studies reviewed identified several barriers and facilitators and addressed some of these in intervention design, although a prominent gap appeared to be psychosocial barriers. No single included study addressed all barriers or made use of all facilitators, although this appears to be possible. Interventions aiming to implement screen-and-treat approaches to malnutrition in primary care should consider barriers that both patients and healthcare professionals may face. REVIEW REGISTRATIONS: PROSPERO: CRD42017071398 . The review protocol was registered retrospectively.

Understanding acceptability of and engagement with Web-based interventions aiming to improve quality of life in cancer survivors: A synthesis of current research.

OBJECTIVE: This review sought to summarize existing knowledge to inform the development of an online intervention that aims to improve quality of life after cancer treatment. METHODS: To inform our intervention, we searched for studies relating to Web-based interventions designed to improve quality of life in adults who have completed primary treatment for breast, prostate, and colorectal cancer (as these are 3 of the most common cancers and impact a large number of cancer survivors). We included a variety of study designs (qualitative research, feasibility/pilot trials, randomized trials, and process evaluations) and extracted all available information regarding intervention characteristics, experiences, and outcomes. Data were synthesized as textual (qualitative) data and analyzed by using thematic analysis. RESULTS: Fifty-seven full text articles were assessed for eligibility, and 16 papers describing 9 interventions were analyzed. Our findings suggest that cancer survivors value interventions that offer content specific to their changing needs and are delivered at the right stage of the cancer trajectory. Social networking features do not always provide added benefit, and behavior change techniques need to be implemented carefully to avoid potential negative consequences for some users. CONCLUSIONS: Future work should aim to identify appropriate strategies for promoting health behavior change, as well as the optimal stage of cancer survivorship to facilitate intervention delivery. CLINICAL IMPLICATIONS: The development of Web-based interventions for cancer survivors requires further exploration to better understand how interventions can be carefully designed to match this group's unique needs and capabilities. User involvement during development may help to ensure that interventions are accessible, perceived as useful, and appropriate for challenges faced at different stages of the cancer survivorship trajectory.

Placental growth factor (alone or in combination with soluble fms-like tyrosine kinase 1) as an aid to the assessment of women with suspected pre-eclampsia: systematic review and economic analysis.

BACKGROUND: Pre-eclampsia (PE) prediction based on blood pressure, presence of protein in the urine, symptoms and laboratory test abnormalities can result in false-positive diagnoses. This may lead to unnecessary antenatal admissions and preterm delivery. Blood tests that measure placental growth factor (PlGF) or the ratio of soluble fms-like tyrosine kinase 1 (sFlt-1) to PlGF could aid prediction of PE if either were added to routine clinical assessment or used as a replacement for proteinuria testing. OBJECTIVES: To evaluate the diagnostic accuracy and cost-effectiveness of PlGF-based tests for patients referred to secondary care with suspected PE in weeks 20-37 of pregnancy. DESIGN: Systematic reviews and an economic analysis. DATA SOURCES: Bibliographic databases including MEDLINE, EMBASE, Web of Science and The Cochrane Library and Database of Abstracts of Reviews of Effects were searched up to July 2015 for English-language references. Conferences, websites, systematic reviews and confidential company submissions were also accessed. REVIEW METHODS: Systematic reviews of test accuracy and economic studies were conducted to inform an economic analysis. Test accuracy studies were required to include women with suspected PE and report quantitatively the accuracy of PlGF-based tests; their risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) criteria. The economic studies review had broad eligibility criteria to capture any types of economic analysis; critical appraisal employed standard checklists consistent with National Institute for Health and Care Excellence criteria. Study selection, critical appraisal and data extraction in both reviews were performed by two reviewers. ECONOMIC ANALYSIS: An independent economic analysis was conducted based on a decision tree model, using the best evidence available. The model evaluates costs (2014, GBP) from a NHS and Personal Social Services perspective. Given the short analysis time horizon, no discounting was undertaken. RESULTS: Four studies were included in the systematic review of test accuracy: two on Alere's Triage® PlGF test (Alere, Inc., San Diego, CA, USA) for predicting PE requiring delivery within a specified time and two on Roche Diagnostics' Elecsys® sFlt-1 to PlGF ratio test (Roche Diagnostics GmbH, Mannheim, Germany) for predicting PE within a specified time. Three studies were included in the systematic review of economic studies, and two confidential company economic analyses were assessed separately. Study heterogeneity precluded meta-analyses of test accuracy or cost-analysis outcomes, so narrative syntheses were conducted to inform the independent economic model. The model predicts that, when supplementing routine clinical assessment for rule-out and rule-in of PE, the two tests would be cost-saving in weeks 20-35 of gestation, and marginally cost-saving in weeks 35-37, but with minuscule impact on quality of life. Length of neonatal intensive care unit stay was the most influential parameter in sensitivity analyses. All other sensitivity analyses had negligible effects on results. LIMITATIONS: No head-to-head comparisons of the tests were identified. No studies investigated accuracy of PlGF-based tests when used as a replacement for proteinuria testing. Test accuracy studies were found to be at high risk of clinical review bias. CONCLUSIONS: The Triage and Elecsys tests would save money if added to routine clinical assessment for PE. The magnitude of savings is uncertain, but the tests remain cost-saving under worst-case assumptions. Further research is required to clarify how the test results would be interpreted and applied in clinical practice. STUDY REGISTRATION: This study is registered as PROSPERO CRD42015017670. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Accuracy of fundus autofluorescence imaging for the diagnosis and monitoring of retinal conditions: a systematic review.

BACKGROUND: Natural fluorescence in the eye may be increased or decreased by diseases that affect the retina. Imaging methods based on confocal scanning laser ophthalmoscopy (cSLO) can detect this 'fundus autofluorescence' (FAF) by illuminating the retina using a specific light 'excitation wavelength'. FAF imaging could assist the diagnosis or monitoring of retinal conditions. However, the accuracy of the method for diagnosis or monitoring is unclear. OBJECTIVE: To conduct a systematic review to determine the accuracy of FAF imaging using cSLO for the diagnosis or monitoring of retinal conditions, including monitoring of response to therapy. DATA SOURCES: Electronic bibliographic databases; scrutiny of reference lists of included studies and relevant systematic reviews; and searches of internet pages of relevant organisations, meetings and trial registries. Databases included MEDLINE, EMBASE, The Cochrane Library, Web of Science and the Medion database of diagnostic accuracy studies. Searches covered 1990 to November 2014 and were limited to the English language. REVIEW METHODS: References were screened for relevance using prespecified inclusion criteria to capture a broad range of retinal conditions. Two reviewers assessed titles and abstracts independently. Full-text versions of relevant records were retrieved and screened by one reviewer and checked by a second. Data were extracted and critically appraised using the Quality Assessment of Diagnostic Accuracy Studies criteria (QUADAS) for assessing risk of bias in test accuracy studies by one reviewer and checked by a second. At all stages any reviewer disagreement was resolved through discussion or arbitration by a third reviewer. RESULTS: Eight primary research studies have investigated the diagnostic accuracy of FAF imaging in retinal conditions: choroidal neovascularisation (one study), reticular pseudodrusen (three studies), cystoid macular oedema (two studies) and diabetic macular oedema (two studies). Sensitivity of FAF imaging using an excitation wavelength of 488 nm was generally high (range 81-100%), but was lower (55% and 32%) in two studies using longer excitation wavelengths (514 nm and 790 nm, respectively). Specificity ranged from 34% to 100%. However, owing to limitations of the data, none of the studies provide conclusive evidence of the diagnostic accuracy of FAF imaging. LIMITATIONS: No studies on the accuracy of FAF imaging for monitoring the progression of retinal conditions or response to therapy were identified. Owing to study heterogeneity, pooling of diagnostic outcomes in meta-analysis was not conducted. All included studies had high risk of bias. In most studies the patient spectrum was not reflective of those who would present in clinical practice and no studies adequately reported how FAF images were interpreted. CONCLUSIONS: Although already in use in clinical practice, it is unclear whether or not FAF imaging is accurate, and whether or not it is applied and interpreted consistently for the diagnosis and/or monitoring of retinal conditions. Well-designed prospective primary research studies, which conform to the paradigm of diagnostic test accuracy assessment, are required to investigate the accuracy of FAF imaging in diagnosis and monitoring of inherited retinal dystrophies, early age-related macular degeneration, geographic atrophy and central serous chorioretinopathy. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014014997. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Self-catalyzed degradable cationic polymer for release of DNA.

The controlled release of siRNA or DNA complexes from cationic polymers is an important parameter design in polymer-based delivery carriers. In this work, we use the self-catalyzed degradable poly(2-dimethylaminoethyl acrylate) (PDMAEA) to strongly bind, protect, and then release oligo DNA (a mimic for siRNA) without the need for a cellular or external trigger. This self-catalyzed hydrolysis process of PDMAEA forms poly(acrylic acid) and N,N'-dimethylamino ethyl ethanol, both of which have little or no toxicity to cells, and offers the advantage of little or no toxicity to off-target cells and tissues. We found that PDMAEA makes an ideal component of a delivery carrier by protecting the oligo DNA for a sufficiently long period of time to transfect most cells (80% transfection after 4 h) and then has the capacity to release the DNA inside the cells after ~10 h. The PDMAEA formed large nanoparticle complexes with oligo DNA of ~400 nm that protected the oligo DNA from DNase in serum. The nanoparticle complexes showed no toxicity for all molecular weights at a nitrogen/phosphorus (N/P) ratio of 10. Only the higher molecular weight polymers at very high N/P ratios of 200 showed significant levels of cytotoxicity. These attributes make PDMAEA a promising candidate as a component in the design of a gene delivery carrier without the concern about accumulated toxicity of nanoparticles in the human body after multiadministration, an issue that has become increasingly more important.

The adaptation of health technology assessment reports: identification of the need for, and development of, a toolkit to aid the process.

OBJECTIVES: Europe has many health technology assessment (HTA) agencies, each producing their own HTA reports. Adapting HTA reports for different contexts could reduce the need for multiple reports on the same health technology with resultant saving of time and resources. This study aims to examine and understand the process of adaptation, and to develop a toolkit that would help the adaptation of reports produced by other countries. METHODS: The methods used were a review of the literature; a survey of twenty-nine European HTA organizations, two rounds of a Delphi survey, a face-to-face meeting of twenty-one European network for Health Technology Assessment (EUnetHTA) representatives, iterative rounds of review, and two rounds of quality assurance testing (termed applicability testing). RESULTS: Descriptions of previous examples of adaptation in the literature are sparse. Most respondents had previous experience in adapting reports, and all believed that adaptation was useful, and there was the ability to benefit from the use of a toolkit to aid in the process. EUnetHTA Partners developed and tested an adaptation toolkit. The toolkit is composed of a series of checklists and resources that identify or clarify the relevance, reliability, and transferability of data and information from existing reports. CONCLUSIONS: Consensus of opinion from twenty-nine European organizations/networks has indicated that the adaptation of HTA reports would be desirable and beneficial. A toolkit was developed to help with the adaptation of HTA reports produced in other settings. This collection of resources is available for use by all HTA agencies and can be accessed at: http://www.eunethta.net/upload/WP5/EUnetHTA_HTA_Adaptation_Toolkit_October08.pdf.

The health technology assessment adaptation toolkit: description and use.

OBJECTIVES: Adapting health technology assessment (HTA) reports for different contexts could reduce the need for multiple reports on the same health technology with resultant saving of time and resources. This article describes an instrument, the adaptation toolkit, which has been developed to aid in the process of adaptation of HTA reports. METHODS: The toolkit was developed by a partnership of HTA agencies and networks from across Europe. The role of the toolkit is to guide the user through the process of selecting possible relevant material from these report(s), assessing the relevance, reliability, and transferability of the material, and adapting it for the desired context. RESULTS: The adaptation toolkit has been developed, it comprises a collection of resources that help the user assess whether data and information in existing HTA reports should and could be adapted for their own setting. The toolkit contains two sections: a preliminary speedy sifting section and the main toolkit. The main toolkit includes five domains: (i) technology use and development, (ii) safety, (iii) effectiveness (including efficacy), (iv) economic evaluation, and (v) organizational aspects. Legal, ethical, and social aspects are beyond the scope of the toolkit. The toolkit is designed for the adaptation of evidence synthesis rather than primary research. CONCLUSIONS: The completed current version of the toolkit contains checklists and resources to aid in the adaptation of HTA reports. This collection of resources is available for use by all HTA agencies and can be accessed at: http://www.eunethta.net/upload/WP5/EUnetHTA_HTA_Adaptation_Toolkit_October08.pdf..

So many filters, so little time: the development of a search filter appraisal checklist.

OBJECTIVES: The authors developed a tool to assess the quality of search filters designed to retrieve records for studies with specific research designs (e.g., diagnostic studies). METHODS: The UK InterTASC Information Specialists' Sub-Group (ISSG), a group of experienced health care information specialists, reviewed the literature to evaluate existing search filter appraisal tools and determined that existing tools were inadequate for their needs. The group held consensus meetings to develop a new filter appraisal tool consisting of a search filter appraisal checklist and a structured abstract. ISSG members tested the final checklist using three published search filters. RESULTS: The detailed ISSG Search Filter Appraisal Checklist captures relevance criteria and methods used to develop and test search filters. The checklist includes categorical and descriptive responses and is accompanied by a structured abstract that provides a summary of key quality features of a filter. DISCUSSION: The checklist is a comprehensive appraisal tool that can assist health sciences librarians and others in choosing search filters. The checklist reports filter design methods and search performance measures, such as sensitivity and precision. The checklist can also aid filter developers by indicating information on core methods that should be reported to help assess filter suitability. The generalizability of the checklist for non-methods filters remains to be explored.

Setting the future policy agenda for health technology assessment: a specialty mapping approach.

BACKGROUND: There is a need for innovative methodologies to identify and prioritize topics for health technology assessment (HTA). A pilot project to evaluate the methodology for specialty mapping was undertaken in the area of child and adolescent health. Two case studies are presented, in the area of sexually transmitted infections and acute pain. METHODS: The methodology comprised sequential stages, based on principles of systematic review. A "stakeholder model" encouraged wider participation. Key stages included identifying the topic area and setting the scope; developing a care pathway; searching for clinical guidelines/guidance, and evaluation literature; synthesis and mapping of literature to the "nodes" of the care pathway to highlight gaps; prioritizing the topics with stakeholders; and referring priorities to the appropriate agencies. RESULTS: A total of thirty guidelines/guidance documents and sixteen evaluation studies were mapped across the two case studies. In some nodes of the care pathway, more literature was mapped than others, suggesting important gaps in research and policy guidance. Sixty-two policy questions were identified and were rated by stakeholders in prioritization workshops. The highest priorities have been considered by senior committees for likely commissioning as research or guidelines/guidance. CONCLUSIONS: This is one of the few published examples of innovative methodology to identify and prioritize topics for HTA. Specialty mapping can make a positive contribution to the policy agenda, with several research and policy gaps being fed into existing prioritization channels. Adequate time, resources, and capacity is required particularly in engaging stakeholders and developing a care pathway. Implementation of specialty mapping in other topic areas with on-going evaluation is recommended.

Are infant size and growth related to burden of disease in adulthood? A systematic review of literature.

BACKGROUND: Slower rates of infant growth are associated with increased rates of death from ischaemic heart disease (IHD) in later life. We carried out a systematic review to assess the association between infant size or growth and leading causes of adult burden of disease to contribute to the debate on the potential of the promotion of infant growth to prevent ischaemic heart disease. METHODS: We searched Medline, Embase, CINAHL, PsycINFO, and bibliographies of included studies. First authors of included studies and other experts were contacted to locate unpublished analyses. Outcome measures for the review were leading causes of adult burden of disease selected from the Global Burden of Disease study. We included studies that assessed the relationship between infant size or growth during the first 2 years and the leading causes of adult burden of disease. RESULTS: Nineteen studies relating to 10 causes of burden of disease met inclusion criteria. Most studies reported data on infant size. Larger size in infancy was associated with increased risk of insulin-dependent diabetes. Larger infant size was associated with reduced rates of IHD in men but not in women. There were considerable gaps in the evidence and many conditions that account for a high burden of disease, such as cancer, mental illness, stroke, chronic obstructive pulmonary disease, and non-insulin-dependent diabetes, had few or no studies associating them with infant size or growth. CONCLUSIONS: Our findings suggest that there is no single optimal pattern of infant growth that is associated with beneficial adult health outcomes. There is insufficient evidence to recommend prevention of adult disease through strategies to alter infant growth.