Professional paediatrics associations play an important role in promoting the highest standard of care for women and children. Education and guidelines must be made in the best interests of patients. Given the importance of breastfeeding for the health, development and survival of infants, children and mothers, paediatric associations have a particular responsibility to avoid conflicts of interest with companies that manufacture breast-milk substitutes (BMSs). The objective of this study was to investigate the extent to which national and regional paediatric associations are sponsored by BMS companies.Data were collected on national paediatric associations based on online searches of websites and Facebook pages. Sites were examined for evidence of financial sponsorship by the BMS industry, including funding of journals, newsletters or other publications, conferences and events, scholarships, fellowship, grants and awards. Payment for services, such as exhibitor space at conferences or events and paid advertisements in publications, was also noted.Overall, 68 (60%) of the 114 paediatric associations with a website or Facebook account documented receiving financial support from BMS companies. Sponsorship, particularly of conferences or other events, was the most common type of financial support. The prevalence of conference sponsorship is highest in Europe and the Americas, where about half of the associations have BMS company-sponsored conferences. Thirty-one associations (27%) indicated that they received funding from BMS companies as payment for advertisements or exhibitor space. Only 18 associations (16%) have conflict of interest policies, guidelines, or criteria posted online.Despite the well-documented importance of breastfeeding and the widespread recognition that commercial influences can shape the behaviours of healthcare professionals, national and regional paediatric associations commonly accept funding from companies that manufacture and distribute BMS. Paediatric associations should function without the influence of commercial interests. This is the first study to systematically document the extent of conflicts of interest in national paediatric associations with regard to manufacturers of breast-milk substitutes.Data from websites were available for 75% of national paediatric associations.Data were objectively collected and analysed based on online documentation.Funding that has not been documented on websites was not captured, potentially leading to an underestimate of the extent of industry funding.This study was not able to capture information on the amount of funding received or on how it compares to funding from other sources.Breastfeeding is critical for the health, development and survival of infants, children and mothers. Recent analyses have concluded that an estimated 820 000 infant and child deaths still occur each year from substandard breastfeeding practices or non-breastfeeding.2Marketing of breast-milk substitutes (BMSs) has effectively reduced rates of breastfeeding. Globally, sales of BMSs are growing almost eight times as quickly as the world’s population.The widespread involvement of BMS companies in healthcare has long been recognised and documented.11The International Code of Marketing of Breast-milk Substitutes, adopted by the World Health Assembly in 1981, delineates a number of steps to limit the ways in which industry uses healthcare workers to promote its products.Although anecdotal information exists about the relationship between the BMS industry and paediatric associations, it has not yet been examined in a systematic way. The objective of this study was to investigate the extent to which national and regional paediatric associations are sponsored by BMS companies.Data were collected on national (n=146) or regional (n=6) paediatric associations listed on the webpage of the International Paediatric Association.17Online searches were conducted for evidence of funding of paediatric associations by the BMS industry. This involved first determining which associations had official websites or, in the absence of official websites, Facebook accounts. Searches were then conducted within the online presence for these associations. For associations with a website, searches were conducted on the main website, as well as any associated journal websites, conference websites, and charity or non-profit branch or foundation websites, as available.In addition, the Facebook accounts of 10 randomly selected associations that also had official websites were searched. As this process did not render any information in addition to that which was found on the website itself, no additional Facebook accounts were searched.Data were collected by two research assistants in June–August 2017. Reliability was assessed by having both research assistants conduct searches for the same 10 member associations and compare results. Minor discrepancies were encountered as to where on the website certain information was encountered, but in no case was the overall assessment of receipt of funding from BMS companies different. After this process, the remaining associations were divided and assigned to each research assistant. Some websites were in a language that was familiar to one research assistant or the other and were therefore assigned accordingly. Websites in languages other than English, French, German, Italian, Portuguese or Spanish were translated using online translators and additional interpretation was sometimes provided by other WHO staff or interns. The rest were divided randomly.The websites were examined for any logos or names of BMS companies found in acknowledgments, funding sources, advertisements and lists of exhibitors or sponsors of conferences. Where funders or sponsors were unknown, additional web searches were conducted to fully understand the nature of the donor. Home pages and all sub-pages, PowerPoint presentations, event photos and online documents, such as pamphlets, education sheets, newsletters and publicly accessible journals were included in the search. Content that required a membership to access, such as subscription journals, were not reviewed.Searches were also conducted on the websites of BMS companies. Due to the high number of such companies , it was impossible to identify or search the websites of all. In order to be systematic, the websites of ‘infant formula’ companies listed on the Baby Milk Action website were searched.18Information was collected on the purpose of funding  and clasData were entered into a spreadsheet and checked by both research assistants to verify the relevance of the information. For each category of funding, ‘sponsorship’ or ‘payment for services’, the association was counted as ‘yes’ if there was evidence of financial contribution from BMS companies in that category. In addition to funding, information was collected on whether the association had policies or criteria on conflicts of interest available online.No patients were involved in the study.Of the 152 paediatric associations, websites were identified for 109 and an additional five had Facebook pages, yielding a total of 114 associations with an online presence (75%). Overall, 68 of the paediatric associations with an online presence (60%) documented receipt of some kind of financial support from BMS companies, either in the form of sponsorship or payment for services . This waSponsorship was the most common type of funding received by paediatric associations. Overall, 60 of 114 (53%) websites of paediatric associations indicated sponsorship by BMS companies. Forty-three associations (38%) have conferences or other events sponsored by BMS companies. The prevalence of conference sponsorship is highest in Europe and the Americas, where about half of the associations have BMS company-sponsored conferences.In addition to conferences, paediatric associations may receive other types of sponsorship from BMS companies, though less frequently. Fifteen associations (13%) receive general sponsorship of the association or its website, 10 associations (9%) receive sponsorship for scholarships, awards, grants or fellowships and 4 (4%) have publications that are sponsored.Thirty-one associations (27%) indicated that they received funding from BMS companies as payment for services . This was highest in the Americas, with 14 of 28 (50%), and in Europe, with 10 of 21 (31%). Fourteen (12%) were found to have BMS company advertising in their online publications . Worldwide, only one-fifth (22 of 114) of the associations had exhibitions by the BMS industry at conferences.Documentation of association sponsorship was also found on BMS company websites, although most of this information was captured on the association websites. While 16 associations were identified as recipients of funding on BMS company websites, only 3 of these associations did not already have documentation of this on their own website. In general, it was not possible to determine the purpose of the sponsorship on the BMS company websites.Only 18 (16%) associations published conflict of interest policies, guidelines or criteria. Many of these address conflicts of interest among individuals in leadership positions or the need to declare interests when making presentations. Policies on sponsorship or funding typically gave general criteria that donors cannot compromise the vision, mission or values of the association but did not specify how this would be determined. Two associations listed specific industries that they would not work with , but in neither case were BMS manufacturers on that list.Associations that receive financial sponsorship from BMS companies are more likely to have a conflict of interest policy  than those that are not sponsored .Despite the well-documented importance of breastfeeding and the widespread recognition of how commercial influences shape the behaviours of healthcare professionals, national and regional paediatric associations commonly accept funding from companies that make BMS. This study found that 53% of association websites acknowledge receiving sponsorship from BMS companies. In addition, when payment for advertisements or exhibitor space is included, it can be seen that 60% of associations receive financial support from BMS companies.A conflict of interest occurs when a set of conditions in which professional judgement concerning a primary interest  tends to be unduly influenced by a secondary interest .et alEach type of sponsorship presents its own challenges and has the potential to create a conflict of interest. Perhaps of greatest concern is the widespread sponsorship of conferences and other events at which paediatricians meet and disseminate research. The impact of the BMS industry at these events—either as direct sponsors, sponsors of symposia or presenters of information—is not to be underestimated. For example, as Fabbri Furthermore, accepting any kind of support from the industry ‘creates a sense of obligation and loyalty to the company in question’.Industry sponsorship of medical journals is concerning in that it may shape the content that is presented to health professionals. Funding for scholarships and grants has the potential to impact what topics are researched, thus influencing the field for years to come.This study was unable to document the actual amount of funding provided by the BMS companies, as this information is rarely posted on public websites. Professional medical associations are not required to share their financial records.et al29Although refusing sponsorship from the BMS industry may reduce paediatric associations’ budgets, there are alternatives that could lessen the impact of the financial relationships. Schofferman et al,Only 18 associations (16%) had posted online some sort of policy to manage conflicts of interest. Interestingly, associations with a conflict of interest policy are actually more likely to accept sponsorship from BMS companies than those that do not have such policies. This finding is consistent with previous research by Fabbri This is the first time that the sponsorship of national and regional paediatric associations by BMS companies has been documented in a systematic way. Out of 152 known associations, we found online information about 114 of them, allowing for a regional breakdown of patterns. Data were objectively collected and analysed. We were able to document the purpose of the funding received and examine the existence and content of policies about funding and conflicts of interest.As the research was limited to associations’ online presence, some information was likely missed. The associations were not contacted directly to confirm the completeness of the website documentation. No information was available for the 38 associations with neither a website nor Facebook page, although these associations were generally in small countries and may be quite small associations. Review of websites not in English, French, German, Italian, Portuguese or Spanish may not have been entirely complete. Not all funding may be acknowledged on websites. It was outside of the scope of this project to investigate print versions of publications, which may be more likely to display advertisements than online versions of journals. As a result, the extent of industry funding is likely underestimated.This study was not able to capture information on the amount of funding received or on how it compares to funding from other sources.This study has documented that paediatric associations regularly receive funding from BMS companies, particularly through sponsorship of conferences and meetings, as well as publications, scholarships, fellowship, grants and awards. Paediatric associations are tasked above all else with safeguarding the health of infants, children and mothers and promoting the highest standard of care, including the protection, promotion and support of breastfeeding. WHO recommends that this should be without influence from industry. Policies on conflicts of interest are relatively rare and do not appear to limit the decision to accept funds from the BMS industry. In accordance with the World Health Assembly Resolution 69.9, paediatric associations should refuse sponsorship from the BMS industry and identify alternative funding models especially with respect to the management and style of conferences.


Real-world implementation of psychological interventions for psychosis is poor. Barriers include therapy being insufficiently usable and useful for a diverse range of people. User-centered, inclusive design approaches could improve the usability of therapy, which may increase uptake, adherence, and effectiveness.This study aimed to optimize the usability of an existing psychological intervention, Thinking Well, which targets reasoning processes in paranoia using a basic digital interface.extreme users from the margins of groups, ethnographic investigation of the problem context, and iterative prototyping of solutions. The UK Design Council’s double diamond method was used. This consisted of 4 phases: discover, including a case series of Thinking Well, stakeholder interviews, desk research, user profiling, system mapping, and a mood board; define, consisting of workshops to synthesize findings and generate the design brief; develop, involving concept workshops and prototype testing; and deliver, in which the final minimal viable product was storyboarded and iteratively coded.We conducted inclusive, user-centered design research characterized by purposive sampling of discover phase confirmed that usability was challenged by information complexity and poor accessibility. Participants were generally positive about the potential of technology to be enjoyable, help manage paranoia, and provide tailored interpersonal support from therapists and peers, although they reported privacy and security concerns. The define phase highlighted that the therapy redesign should support monitoring, simplify information processing, enhance enjoyment and trust, promote personalization and normalization, and offer flexible interpersonal support. During the develop phase over 60 concepts were created, with 2 key concepts of thoughts visualized as bubbles and therapy as a journey selected for storyboarding. The output of the deliver phase was a minimal viable product of an innovative digital therapy, SlowMo. SlowMo works by helping people to notice their worries and fast thinking habits, and encourages them to slow down for a moment to find ways of feeling safer. A Web app supports the delivery of 8 face-to-face sessions, which are synchronized to a native mobile app.Consistent with our previous work, the Thinking Well case series showed medium to large effects on paranoia and well-being and small effects on reasoning. These were maintained at follow-up despite some participants reporting difficulties with the therapy interface. Insights from the SlowMo makes use of personalization, ambient information, and visual metaphors to tailor the appeal, engagement, and memorability of therapy to a diversity of needs. Feasibility testing has been promising, and the efficacy of SlowMo therapy is now being tested in a multicentered randomized controlled trial. The study demonstrates that developments in psychological theory and techniques can be enhanced by improving the usability of the therapy interface to optimize its impact in daily life. The development of psychological interventions for psychosis has accelerated in the last 2 decades, particularly with the second- and third-wave cognitive behavioral therapies (CBT) . Althougslow down for a moment to find ways of feeling safer. SlowMo is currently being tested in a multicenter randomized controlled trial [We propose that enhancing the usability (or ease-of-use) of therapy will address implementation barriers and thereby improve effectiveness. To the best of our knowledge, this study is the first to focus on optimizing the usability of an existing therapy (Thinking Well) by conducting inclusive, user-centered design (UCD) research. Thinking Well is a brief protocol-based therapy that targets jumping-to-conclusions and belief inflexibility, the reasoning styles that contribute to paranoia . We haveed trial .SlowMo reflects the rapid growth of digital technology in mental health care, given its potential to improve access, outcomes, and costs -26. In pDesign thinking is a process whereby challenges to therapy access, uptake, and adherence can be addressed. It involves developing a rich understanding of the problem area and its context to identify valued outcomes. From this, themes are derived to develop possible new ways of framing the problem by highlighting its paradoxes, and solutions are then generated to resolve them [lve them ,39. For Participatory design, or codesign, is a UCD technique that emphasizes direct user involvement and has its roots in activism and shared decision making. It is increasingly used in digital mental health research, based on ethnographic and qualitative methods [think aloud usability tests [UCD methods address this limitation as they privilege the empathic understanding of end users and their contexts, thereby ensuring solutions are relevant to the diverse needs of people involved -41. Part methods -44. To dty tests -53. Howediscover phase) and using insights from this phase to reframe the problem and generate a design brief (the define phase). From this, solutions are generated and iteratively tested with users (the develop phase), with feedback determining the optimal design for development (the deliver phase). Our strategy for involving people in the design process, inclusive UCD, is different from conventional participatory design. It involves purposive sampling of people at the margins of a normal distribution (extreme users) to ensure the design solution is suitable for the widest range of people. This purposive sampling of extreme users can help to ensure the needs of marginalized groups are considered [Our multidisciplinary collaboration of people with lived experience, clinicians, researchers, industrial designers, and software developers aimed to integrate the best practice principles of design thinking and participatory design. This involved using the Design Council’s  double dnsidered . On the In summary, we anticipated that the inclusive, UCD research methods employed would support the development of an improved version of the Thinking Well intervention tailored to meet a diversity of needs. Our intention was that the design thinking approach would result in a redesign of the therapy that was more accessible, appealing, memorable, and easy to use, both within sessions and in daily life.Thinking Well therapy. This was done to support the discovery phase of the double diamond. The case series will first be described, followed by an overview of the double diamond method. The design research was conducted from October 2014 to May 2017.We conducted our design research alongside a case series of the previous version of the Fourteen participants were recruited from community mental health teams in a National Health Service (NHS) Trust between March 2014 and May 2015 , and at follow-up (12 weeks).slowing down for a moment as a means of managing worries [The case series used the fourth version of Thinking Well, which built on earlier iterations and aimed to incorporate the participant feedback from our previous trial   is a 34-The GPTS  is a 32-Participants were asked to rate their current distress and preoccupation regarding their main paranoia belief using a 100-point Visual Analog Scale (VAS) ranging from 0  to 100 .Using a VAS, participants were asked to provide a rating between 0  and 100 (believe absolutely) of their current conviction in their main paranoia belief.Two items were employed to assess belief flexibility. Possibility of being mistaken was assessed using an item from the Maudsley Assessment of Delusions Scale , with paThe Warwick-Edinburgh Mental Well-Being Scale  was usedA semistructured interview schedule was used after each therapy session and at the end of therapy to elicit feedback regarding acceptability, usefulness, and usability.d standardized effect sizes for continuous outcomes, calculated as the difference in the mean between 2 time points divided by the SD of the change.Feedback interviews are summarized descriptively. As this case series was primarily conducted to support the design research and not powered to detect significant effects, the focus of the results is not on significance testing. However, to support comparison with our previous work, we report Cohen An overview of the design research methods used at each phase of the double diamond is shown in divergent in its approach as it explores the subject matter from a variety of viewpoints. It started with desk research covering empirical studies, self-help books, therapy manuals, lived experience narratives, computer games, and gamification. The lead designer (AW) did live and taped observations of the Thinking Well case series and, for comparison, taped observations of 2 cases of a therapy targeting anxiety processes in paranoia. In total, 6 service users were interviewed about topics, including their daily habits, therapy experiences, attitudes toward therapy, and technology preferences. Therapists were shadowed in their service contexts to gain insight into their roles and service user journeys through the system. Following these tasks, user profiles of prototypical service users and therapists were created, together with mapping of the contexts in which therapy is delivered. Methods for illustrating and visualizing thoughts and emotions were also explored to identify the most intuitive ways of communicating them. This included research into areas such as art, visual communication, symbolism, music, movement, and dyslexia.The aim of this phase was to develop a shared understanding of psychological therapy, behavior change, psychosis, and technology use from the perspective of service users, carers, therapists, and clinicians. This phase is convergent in its approach, aiming to refine and reframe the breadth of insights emerging from the discover phase. This consisted of workshops to synthesize the research insights into themes and identify the most salient areas for improving mental health care in psychosis. A matrix of service users’ and clinicians’ needs in relation to the therapy was developed, with each need rated according to potential impact and ease of implementation. On the basis of these insights, a design brief was developed, specifying the desired area of impact and aims for the redesign.The define phase is The develop phase resumed a divergent process, which focused on creating a wide range of ideas for addressing the design brief. At the beginning of the develop phase, concepts to address the design brief were generated, developed, evaluated, and refined by the project designers, technologists, and psychologists. Prototypes of the selected concepts were then made and validated with service users. Prototypes for different modalities of monitoring worries were also explored.convergent deliver phase consisted of refining the breadth of concepts generated in the develop phase. The selected concepts for therapy redesign were finalized and storyboards were developed. The new version of the design was iteratively produced through rapid prototyping in software code, with user testing of a low fidelity version of the therapy redesign. This resulted in the final minimal viable product.The Forty-five service users were referred: 12 were unsuitable before screening, 4 declined to meet, 5 did not meet the cut-off score for paranoia, and 24 were suitable. Four service users disengaged between screening and consent, and 20 service users consented to participate. Of those consented, 6 disengaged during the baseline assessment. Fourteen participants were included in the case series, 2 dropped out, and 12 completed the intervention. One of the participants who dropped out experienced a relapse in mental state that was assessed as unrelated to participation in the study and the other disengaged from therapy. No other adverse events were reported. All participants who completed the intervention did the posttherapy assessment and 10 completed the 12-week follow-up assessment. One participant was not contactable as they had moved out of the area and the other was not able to attend because of new personal commitments.The case series sample demographics are presented in All participants were offered the opportunity to register to the website, which hosted the therapy Web pages. Of the 12 participants in the case series, all expressed an initial interest and 4 completed registration. Of these, 3 never accessed the Web pages and 1 person logged on once, with support from their therapist. Participants were asked about their reasons for not accessing the Web pages at the posttherapy assessment see . ResponsThe key insights and outputs from each phase of the double diamond will be described below. There were 18 participants in the design research sample. The sample included all the participants who completed the case series, the participants who disengaged from the case series, and 5 participants who were purposively recruited to improve the extent to which the sample represented the extremes of our target sampling characteristics . The sample included 9  men and 9  women (age range 23-62 years). Seven  participants were white British, 3 were black Caribbean , 2 were black African , 2 were black British , 2 were white British and black Caribbean , 1 was white British and black African , and 1 was white British and black Caribbean . On the basis of their self-report and presentation during the design research tasks, 2  participants appeared to have above-average cognitive abilities, 7  participants had average cognitive abilities, 5  participants had mild difficulties with attention, reasoning, and memory (often because of psychotic experiences), and 4  participants had moderate to severe difficulties in these areas. In relation to digital literacy, 2  participants had minimal experience of using technology, of whom 1 was interested in developing their skills and 1 was not. Seven  participants used a basic mobile phone, of whom 3 were not confident in using. Nine  participants had experience with smartphones and laptops, including 7 frequent and competent users and 2 who were not confident in using and wished to improve their skills. With regard to attitudes to therapy, 11  participants viewed therapy as both supportive and useful. In addition, 4 of these reported no difficulty in applying insights to daily life and 7 reported struggling to generalize strategies outside of therapy because of the intensity of their distress, memory problems, motivation, social stressors, and physical health problems. The remaining 7  participants were ambivalent about therapy usefulness either because they were unsure of its relevance to their problems or struggled with its reliance on verbal material and paper tools. Involvement in the design research tasks varied across participants, 6 participants were interviewed, 15 had either live or taped observations of their therapy sessions, and 4 participants were involved in prototype testing.The first theme concerned challenges to the usability of therapy. Service users and therapists struggled to manage information processing and communication demands, given the amount and complexity of the therapy materials. This limited the potential impact of therapy on people’s lives. As a result, adaptations were made to make the materials more concise and accessible, such as personalizing the content and using mobile phones to record therapy strategies. The second theme related to technology use. Concerns about digital literacy and privacy were frequent, although these often occurred alongside a desire to integrate technology into therapy and improve digital skills. A wish to progress and to document achievements using technology was also highlighted. Enjoyment was the focus of the third theme, with a consensus that interactive, gamified tasks and visual materials were the most enjoyable aspects of therapy. The next theme related to the therapy relationship. Feedback in this area reflected some people valuing the support from their therapist, with others being less committed to or avoidant within the relationship. The final theme was about interpersonal support from others experiencing similar difficulties. Service users varied as to what level of support they would find useful, ranging from accessing previously recorded stories and suggestions to more active involvement in digital or face-to-face support groups.The define phase involved defining the design brief based on the insights from the discover work. A number of possibilities for the therapy redesign were identified, including family and carer involvement, social inclusion, peer support, and self-help. The areas of impact that appeared most relevant to improving usability were optimizing therapists’ and service users’ time within and between sessions and improving self-monitoring and self-management in daily life. The design brief was then generated by identifying the factors that could limit how useful the therapy was during and outside of therapy sessions . The design brief, therefore, specified that we aimed to develop a digital platform to support the therapy process by:Supporting people to notice their thoughts and thinking habitsPresenting information in a simple and memorable wayBeing enjoyable and trustworthyPromoting personalization and normalizationand independent.Helping people feel more supported The selected concepts were prototyped digitally and validated by presenting them to participants on a tablet. The validation process focused on both participants’ verbal reports and their behavior in relation to the prototypes. The concept of illustrating thoughts as bubbles resonated strongly. Participants displayed positive affect and approach behavior responses. Importantly, with regard to the aims of psychological therapy, the metaphor helped them see their thoughts as transient and separate from the self. They noted that bubbles could have different sizes depending on their intensity and that their movement, speed, and color could reflect different thinking patterns and styles. Participants also liked the idea of therapy represented as a journey, where each session is characterized by new experiences guided by their digital avatar who interacts with other characters along the way. The interaction prototype was less appealing to users who had a neutral or confused affective response and commented that it felt too abstract and oversimplified their problems. Bubbles and journey were therefore selected as the design concepts for framing the therapy redesign.The second prototype testing explored the uptake and usability of different modalities for monitoring thoughts  using a design probe. Participants were given a basic smartphone with the prototype installed for them to use over a week. They were told to use the prototype as they wished to explore if and how they engaged in using the smartphone to monitor their worries. At the end of the testing period, daily data indicated 87% (24/28) usage for the text questions, 50% usage for the voice recorder and counter (14/28), and 34% (10/28) for the camera. This suggested a preference for simple text as the main monitoring modality, although it was notable that the voice recorder and counter were also used, despite being considerably harder to access on the phone’s interface. In addition, participants reported a mean rating of 73% for enjoyment, 61% for usability, and 85% for acceptability on a 10-item User Experience Survey (adapted from ) designenext buttons were made more visually salient than back or exit buttons so that users were more likely to tap them and sustain their engagement.In the deliver phase, wireframe storyboards of the session and out-of-session content were developed based on the selected concepts and then iteratively coded alongside user testing. All the session content from Thinking Well was incorporated, with a redesigned interface and functionality. An analogue aesthetic  was used throughout to provide an accessible and friendly design for people less willing and able to use technology. The use of written text was significantly reduced and replaced with short audio files or simple visual displays. Haptic interactions were used, where possible, to promote engagement, enjoyment, and memorability. The mobile app was designed so that people could use it without the keyboard if they wished, improving accessibility for those less digitally literate. The flow through the interface was designed to increase the likelihood of sustained engagement and completion of therapeutic tasks. For example, slowed down are given a colored halo. A finger tap was chosen for selecting a thought and its color, with scaling used to alter the bubble size or spinning speed.Rapid prototyping and testing also explored the aesthetic of the bubbles used to visualize thoughts and thinking habits, given that they represented a unifying visual language in the therapy. On the basis of the design research insights, a balance was sought between an appealing appearance that increased the likelihood of people wanting to use it and a wish not to invalidate their concerns. It was anticipated this would help people to see their thoughts as less threatening and separate from themselves. Visual attributes  and ways of interacting with the bubbles  were investigated as a way of communicating information about the nature of thoughts and how we can relate to them. It was decided that the size of the bubble would reflect the intensity of the thought, whereas the speed at which it spins would illustrate the associated thinking habit. Worries are shown as gray bubbles, safer thoughts or other strategies for feeling safer are displayed as colored bubbles, and worries that the person has care and compassion, feeling safe and calm, and tools and superpowers. Over 200 concepts were developed; each participant selected their favorites, which were then reviewed. SlowMo was selected, supported by the tagline slow down for a moment.The therapy name, SlowMo, was the product of a brainstorming workshop with designers, psychologists, and software developers. Workshop participants were given the aim of finding a name that would appeal to both service users and therapists, that communicated the essence of the therapy, that was phonetically engaging and memorable, and that could function within the clinical context . Popular digital brand names were reviewed for inspiration, and name concepts were generated based on the themes of The main screens from the SlowMo Web app and mobile app are shown in slow down for a moment tip. The topics from sessions 1 to 8 are notice your thoughts; notice your thinking habits; slow down for a moment; slow down: what is your safer thought; use a safety strategy; slow down: past experiences; slow down: pop the worry; and making a habit of slowing down. With some exceptions in sessions 1 and 8 for initial and final tasks, sessions follow a consistent format of monitoring progress, reviewing the formulation , collaborative agreement of session aims, psychoeducation, normalization, experiential tasks to personalize learning, recording of key learning, practice with the SlowMo native app, and documenting a goal for the week.The Web app has a fixed structure to support fidelity and adherence, although content can be skipped to allow tailoring of the material to the person’s cognitive needs. The journey concept is used to anchor the therapy. During set-up, people select an avatar to represent them on their therapy journey and input a chosen name. The home screen then displays the person’s journey through therapy from which individual sessions can be accessed. The journey home screen also contains a destination signpost where people enter their personal valued goal for the therapy. As with previous versions of the therapy, initial sessions involve building the meta-cognitive skill of noticing thoughts and thinking habits. People learn that although fast thinking is common and can be useful, slow thinking can be helpful in dealing with stress and worries about other people. This principle is expanded in subsequent sessions by covering a new topic area and a related The interface for these tasks was developed in line with the design brief. Progress is monitored through scaling the visual appearance of bubbles  to be more appealing and reduce the reliance on numerical rating and graphs. A formulation of people’s difficulties detailing triggers, worries, impact on life, and helpful thoughts and strategies is developed in session 1 using the visual language of bubbles. This is pulled through to remaining sessions and can be easily updated as new insights, difficulties, and ways of coping emerge. The potential aims are communicated through interactive boxes that are tapped to reveal their content to be more engaging and memorable and provide a shared understanding of the session structure. Psychoeducation information is presented with brief audio messages paired with illustrative animations. Three characters with prototypical experiences of paranoia share their stories as the therapy progresses. Their function is to provide normalizing messages about fears of harm from others  and to model how the SlowMo tips can be used to make sense of worries and feel safer. Experiential learning tasks are designed to optimize personalization and implementation in daily life, for example, by exploring the impact of fast thinking on daily life or by practicing the application of the SlowMo tips to worries selected from the formulation. Text or audio recordings are then made of the most important learning points from the session and of a note outlining a goal or key message for the week to support the person in making use of the therapy strategies. The learning messages are pulled through to the final session to support a personalized review of the therapy, from which the individual can choose a customized selection of the SlowMo tips for use after the end of therapy.feeling safer thoughts and strategies. In the first session, the home screens automatically populate from the data inputted to the Web app formulation, which consists of the person’s worry bubbles. People are then encouraged to use the app to identify their worries over the next week. When they experience a worry, they tap the associated bubble to record its occurrence and then size the bubble to indicate how distressing it is. An additional screen is unlocked on the app during session 2, where the thinking habit associated with the worry is rated by spinning the bubble faster or slower. From session 3, a slow down screen is added to the process, which displays a spinning bubble. This slows down when tapped, to act as a cue to slow down for a moment to manage worries. From session 4 onward, additional strategy prompts or tips are provided on this screen based on the topic covered in the session. When a user selects a tip, a halo corresponding to the tip color appears around the gray worry bubble, providing visual feedback that a helpful slowing down idea has been identified. Following the slow down screen, there is an option to record useful new information by way of audio or text and then select an alternative safer thought or strategy. The user finally rerates the distress associated with the worry to evaluate the impact of slowing down.There is an emphasis throughout the intervention on practicing skills inside and outside sessions, with the SlowMo native app providing a bridge between the therapy meetings and everyday life. The app works by unlocking new content toward the end of each session, based on the learning topic covered in the Web app. This new content is reviewed in session, and where possible, the therapist supports the person to practice the use of the app outside the consulting room. The home screen has 2 viewing modes, one displaying worries and the other thought profile page from which users can either enter the slowing down process or see a summary of previous occasions when they have slowed the thought down . Another option is to access a list of all the tips that have been liked in relation to the thought. In addition, the burger menu of the app sequentially unlocks a brief summary of each session (under a My journey option) to act as an aide memoire for session content . The burger menu also consists of settings, where the offline mode can be selected, and at the end of therapy, an option is unlocked to allow the selection of slowing down tips. The burger menu also contains an About SlowMo section that briefly details the background to the development of SlowMo and privacy and security information. A My safety plan section advises users what to do in a crisis and provides an option to insert crisis contact numbers. Finally, optional notifications are available if people wish the app to provide prompts to encourage slowing down.Data are stored in a format whereby, when experiencing recurrent concerns, people can readily access what was previously helpful. When a worry is tapped on the home screen, this will initially access a The software development work was done by Evolyst Ltd, a user-centered and evidence-based health care software development company, informed by the British Standards Institute quality criteria and code of practice for health care apps . SlowMo This study is the first to employ inclusive UCD methods within a design thinking approach to optimize the usability of an existing therapy for psychosis, Thinking Well. In the case series of a newly extended version of Thinking Well, we found indications of sustained medium to large effects on paranoia and well-being and small effects on reasoning post therapy and at 12-week follow-up. However, obstacles to the intervention interface were noted, underscoring the need for the design research. The inclusive UCD research identified the importance of therapy being usable, memorable, trustworthy, enjoyable, personalized, and normalizing, and of it offering flexible interpersonal support -39,42-44An important limitation of the study is the lack of integration of an implementation strategy within the therapy design. This is critical, given that most health technologies fail to be adopted, scaled-up, spread, and sustained, even where they are efficacious in randomized controlled trials . The taiWe therefore do not consider SlowMo to be a finished product, but rather a nascent behavioral intervention technology  or technIn conclusion, this study is the first to demonstrate how an inclusive UCD method  can enhance the usability of therapy and augment developments in psychological theory and interventions. We hope that our study may serve as a prototypical example of how design thinking can challenge skeuomorphism in digital health, whereby therapy features made redundant by technology are unnecessarily replicated  instead of facilitating psychological mechanisms of change through innovative digital means. Notwithstanding the hugely valuable progress made over the past 2 decades in psychological therapy for psychosis , we echo


We estimated the affordability of food and beverages by energy density and nutrient quality in Mexico and tested for differential trends in affordability over time and by income quintile. We used the National Income and Expenditures Survey from 1994 to 2016, and information on the caloric and nutrient content of food and beverages from Mexican food composition tables. We estimated food energy density  and nutrient quality of food and beverages using the nutrient-rich food index (NRFI). Affordability of food and beverages was defined as household monthly income needed to purchase 1000 kcal. The affordability index was expressed by quintiles of energy density and quintiles of the NRFI and by income quintile over time. We found that more energy-dense foods and food and beverages with lower nutrient quality were more affordable compared to healthier food and beverages. Food categories with lower energy density and a higher NRFI became less affordable over time for most income groups, but the burden was higher for lower-income households. A comprehensive national strategy should be implemented to make healthier options more affordable and discretional foods and beverages with lower nutrient quality less affordable. Urbanization and economic development have driven major transformations in dietary habits and physical activity worldwide. Dietary patterns have shifted to higher consumption of refined carbohydrates, vegetable fats, added sugars, processed food, and meat, along with reductions in fiber intake from legumes, vegetables, and coarse grains ,2. TheseIn Mexico, along with a high prevalence of overweight and obesity affecting over 70% of adults and more than one third of children and adolescents ,6, consuOne of the main drivers of food choice is price ,10. SeveTo our knowledge, there are few studies from less developed countries on the affordability of food and beverages  as well as how the affordability of food and beverages has changed over time and by income. A study conducted in 18 countries from all continents showed that fruits and vegetables are less affordable in low-income countries and in rural areas, but the paper did not show the affordability of other food and beverages and Mexico was not included .The objective of this study was to estimate the affordability of food and beverages by energy density and nutrient quality in Mexico from 1994 to 2016. We also tested for differential trends in affordability over time and by income quintile.We used thirteen rounds of the National Income and Expenditure Surveys (ENIGH for its acronym in Spanish) from 1994 to 2016 . The ENIThe energy content of foods was obtained from a dataset created by the National Council for the Evaluation of Social and Development Policies for the construction of the basic food basket in Mexico for 2009 . The datThe content of protein, fiber, vitamins A, C, and E, calcium, iron, potassium, magnesium, saturated fat, added sugar, and sodium of food and beverages was obtained from a food composition table compiled by the National Institute of Public Health . The datWe estimated energy density as the amount of energy measured in calories per kilogram for each food as purchased. Energy density was estimated only for solid foods; we excluded all caloric and noncaloric beverages from the estimation of energy-dense food, since water dilutes energy density values .Since some high energy-dense foods may not be of low quality in terms of nutrient content—such as nuts—we also estimated the nutrient-rich food index (NRFI) developed by Drewnowski et al. . The advThe affordability index was estimated as the ratio of the cost per 1000 kcal relative to monthly household income for each food and beverage category. Household income includes all sources of income received by members of the household as reported in the ENIGH.i purchased at the household level as reported in the ENIGH, expressed as calories per kilogram  using the data set that contained calories. The cost per kg was approximated by deriving unit values (UV)—household expenditures for a specific food or beverage category i divided by the quantity purchased from the ENIGH. Unit values were aggregated at the municipality level to reduce potential household recall biases; therefore, the cost per 1000 kcal for each food and beverage was estimated at the municipality level. The cost per 1000 kcal is the result of dividing, for each food and beverage, the UV per kilogram by energy density , multiplied by 1000, as defined in Equation (1),To estimate the affordability index, we first calculated the cost of purchasing 1000 kcal for each food or beverage The ENIGH collects information on household daily purchases of food and beverages for a week, but households may not purchase all food and beverages from the list of all categories in the survey. For example, some households may have purchased blackberries but others not. Because the affordability index measures how much income is needed to purchase 1000 kcal of a food or beverage category in the ENIGH, regardless of whether a household purchased it, we imputed within each municipality the energy costs of food and beverage categories not purchased by a household . If within a municipality, none of the households purchased a specific food or beverage, the energy cost would not be imputed, as energy costs were aggregated at the municipality level. The higher the affordability index is, the less affordable a food or beverage is.Given the complexity of showing the affordability index for each of the 222 food and beverage categories, we expressed the index by quintiles of energy density  and quintiles of the NRFI. We first estimated the energy density for each of the 222 food categories (except for beverages) from the sample of households and then created quintiles of energy density. The same method was used for the NFRI but including beverages. Since the sources of data used to estimate the NRFI and energy density were time-invariant, the quintile to which each food or beverage belongs did not vary over time. In descriptive analyses, we show the average affordability index by quintile of energy density and the same for the NFRI.To test for differential trends in the overall affordability index over time and by income quintile, we ran a linear regression where the dependent variable was the affordability index for each food and beverage category at the household level. The independent variables were: binary variables for each round of the ENIGH survey, household income quintiles, interactions between income quintiles and this binary time variable to test if changes in the affordability index over time were different by income level. We adjusted the model for quintiles of energy density and of the NRFI. We controlled for household place of residence to account for differences in energy costs between urban and rural dwellers. We included education of the head of the household to adjust for the possibility that more educated individuals have greater abilities to find better products at lower prices, as described by Zhen . We thenAll estimations were weighted based on the ENIGH survey design. Monetary values were expressed as constant Mexican pesos (MXN) 2017 = 100, using the national consumer price index . All anaThe analytical sample between 1994 and 2016 were 247,164 households.In Descriptive statistics of the sample in 2016 are presented in The results from the regression model are presented in We estimated the affordability of foods and beverages by energy density and by the NRFI. We also tested for differences in overall affordability of food and beverages over time and by household income quintile. We found that more energy-dense foods and food and beverages with lower nutrient quality were more affordable, as less income is needed to purchase these food and beverages. Food categories with lower energy density and higher NRFI were less affordable for all income groups, but the poorest households had to spend significantly more of their income to purchase healthier products. Overall, food and beverages became less affordable over time, which can be explained by the increase in the affordability index of high nutritional quality and low density. The decrease in the affordability of food and beverages is seen for all income quintiles, but the difference over time was higher for the lowest income groups.Between 2004 and 2016, food and beverages became less affordable, particularly among lower-income households . This coBased on the results of the cost per 1000 kcal , our finWe showed that nutrient-poor foods and beverages that provide the same number of calories are more affordable than foods higher in nutrient quality. The cost per calories or energy cost has been used as an indicator for comparing the cost of food and beverages in the last 100 years , althougOur results are similar to other studies showing that high energy-dense food costs less, which represents a barrier to healthy eating ,36,37,38The study had some limitations. We acknowledge that, as in most household expenditure surveys, purchases of food and beverages in the ENIGH may be underreported. However, as methods for data collection in the ENIGH have not changed over time so the results and trends over time are comparable. We also recognize that we are missing all food and beverages purchased away from home that include meals consumed at restaurants, cafeterias, or any other food outlet, which increased from 14.6% in 1994 to 19.7% in 2016 . Given tAlthough the NRFI provides a score for each food and beverage based on the quality of the nutrients, results for some food and beverages deserve more discussion. For instance, juices and nectars with added sugars are classified in the fourth quintile of the NRFI because they have vitamins. Given the evidence that sugar-sweetened beverages are associated with weight gain, diabetes, and other chronic diseases ,27, futuWe decided to calculate quintiles of NRFI because it is very complex to show the affordability index for each score of the 222 food and beverage categories and for each round of the ENIGH. We recognize that one quintile could include foods of higher or lower quality, but quintiles differentiate well between low versus high quality. Additionally, Fulgoni  recommenDespite these limitations, to our knowledge, this is the first study on the costs and affordability of food and beverages in Mexico. We relied on a nationally representative survey with 13 rounds that guarantees comparability and consistency of the data over time.If healthier food and beverages are and have become less affordable, particularly for lower income households, our findings suggest that poor families have been pushed to purchase more energy-dense food of lower nutritional quality. To revert this adverse scenario, a comprehensive national strategy should be implemented to make healthier options more affordable and discretional foods and sugar-sweetened beverages, which are of low nutrient quality, less affordable. Taxes on unhealthy food and beverages can be used to reduce purchases though increases in prices. The taxes on sugar-sweetened beverages and nonessential energy-dense food implemented in Mexico have shown reductions in consumption ,43, but


Obtaining consistent spectra by using different spectrometers is of critical importance to the fields that rely heavily on Raman spectroscopy. The quality of both qualitative and quantitative analysis depends on the stability of specific Raman peak shifts across instruments. Non-linear drifts in the Raman shifts can, however, introduce additional complexity in model building, potentially even rendering a model impractical. Fortunately, various types of shift correction methods can be applied in data preprocessing in order to address this problem. In this work, a moving window fast Fourier transform cross-correlation is developed to correct non-linear shifts for synchronization of spectra obtained from different Raman instruments. The performance of this method is demonstrated by using a series of Raman spectra of pharmaceuticals as well as comparing with data obtained by using an existing standard Raman shift scattering procedure. The results show that after the removal of shift displacements, the spectral consistency improves significantly, i.e., the spectral correlation coefficient of the two Raman instruments increased from 0.87 to 0.95. The developed standardization method has, to a certain extent, reduced instrumental systematic errors caused by measurement, while enhancing spectral compatibility and consistency through a simple and flexible moving window procedure. Over the last few decades, the use of Raman spectroscopy in combination with chemometric methods has increased significantly for analysis of pharmaceutical products  were provided by the National Institute for the Control of Pharmaceutical and Biological Products. Pharmaceutical tablets  was used in subsequent data analysis.The integration times of the standards and drugs were of 2 and 3 s, respectively. Unless stated otherwise, six Raman spectra were collected for each drug during the experiment. It is worth noting that the final spectrum of each drug was calculated as the average of spectra collected from a variety of positions. Moreover, only the spectral region containing the most abundant information  . The correlation coefficient of each drug's spectrum was calculated, and the results are summarized in Table Here, XAs can be seen in Table A wide application of the MWFFT method necessitates the selection of an appropriate reference spectrum. When a drug sample is measured on a secondary instrument to obtain an average spectrum for synchronization, its corresponding standard spectrum contained in the existing spectral library can be certainly used as the reference to correct shift displacements. However, when the spectral library does not contain the required reference spectrum, it would be preferable to use the reference spectra of existing drugs with the same generic name in the database in order to obtain a new matrix of shift points. As a result, the shift profile of the new drug can be calculated from the mode of each column of the matrix. Through this profile, one can obtain a new reference spectrum by shift correction, which can be subsequently applied. Otherwise, one can regard the new sample spectrum directly as a reference, and save it in the database for subsequent analysis. The entire procedure is depicted in Figure The existing peak detection methods, e.g., the wavelet and ridge line peak picking method, need idealized line profiles of the corresponding peaks in order to detect the displacements accurately, which is not practical for the spectroscopic analysis of real samples. Moreover, several parameters need to be specified with a priori knowledge, which largely influence the final results and can be difficult to implement in C programming language. By contrast, the use of the moving window strategy can allow an estimation of non-linear shifts between spectra flexibly and without peak detection for peak synchronization. With a window that moves from the beginning to the end of two spectra, one can obtain an N-dimensional matrix of shift points, where the data points of a Raman spectrum are N. In this case, the shift profile can be calculated from the mode of each column of the matrix, while the mean and median of the matrix can outline the paths of the shifts. The Raman shift profile of metronidazole tablet is shown in Figure 2) time complexity for a Raman spectrum of length N, which is time-consuming for spectra with thousands of data points. Fortunately, cross-correlation can be calculated by using FFT much more efficiently since it can significantly decrease the time complexity of cross-correlation from O (N2) to O (NlogN). The use of the moving window strategy with FFT cross-correlation, with a window size w, leads to a time complexity of one window wlogw. Accordingly, the time complexity of MWFFT is Nwlogw, where N represents the number of data points in a Raman spectrum.The MWFFT method has several distinctive advantages when compared to the traditional methods as a result of the continuity and redundancy of the moving window procedure. Usually, the direct evaluation of cross-correlation requires O  is calculated as follows:Generally, Raman spectra will become more consistent, exhibit higher correlation coefficients, and be more similar to each other after a successful synchronization. The correlation coefficient can be used as a criterion for assessing the synchronization quality between the primary and secondary spectra. The synchronized spectra are commonly used to perform library-based searches and are further analyzed by chemometric algorithms. Usually, distance and Euclidean distance in particular Juday, , can alsn), while the columns correspond to variables (k). ith primary (reference) spectrum and secondary spectrum, respectively. It is worth mentioning at this stage that the normalization algorithm , which may be well-suited to solving the Raman shift displacements between spectrometers in the fields that rely heavily on the use of Raman spectrometers.Methods for the synchronization of spectra are indispensable for successful applications using different spectrometers. In the present work, we used the moving window strategy in combination with FFT cross-correlation to synchronize Raman spectra. This technique, abbreviated as MWFFT, was shown to eliminate accurately and effectively non-linear shift displacements between Raman spectra. Owing to the continuity of the moving window technique, non-linear shifts are corrected and shift profiles are obtained for each spectrum. In general, the use of the FFT cross-correlation methodology is time-saving and results in a significant improvement in speed. Moreover, this method can reduce or even remove systematic differences between Raman spectrometers (a dramatic increase in similarity from 0.87 to 0.95 after synchronization of the spectra between master (primary) and slave (secondary) spectrometers), as well as the compatibility with Raman spectral library. It is better than the SSS method in terms of correcting non-linear shifts and does not require the use of Raman shift standards. These advantages make MWFFT a promising shift correction method that addresses the demand for automated, flexible, rapid, and reliable data preprocessing, which plays an important role in Raman spectroscopy analysis using different spectrometers. Finally, MWFFT can be easily implemented with C and C++ programming languages (available as open source package at The experimental protocol was approved by the Research Ethics Committee of The Second Medical University and Shanghai University of Traditional Chinese Medicine, The findings and conclusions in this article have not been formally disseminated by the State Food and Drug Administration and should not be construed to represent any agency determination or policy.HC designed and carried out experiments. Z-MZ and YL assisted with analyzing the results and discussions. HC and Z-MZ wrote the manuscript. FL reviewed and edited the manuscript. YC reviewed and checked our manuscript, gave constructive amendments to the text, and also approved the version to be published.HC is employed by the company Shanghai Diracarta Biomedical Technology Co., Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


General Practitioners (GPs) in the Netherlands routinely register all patient contacts electronically. These records include longitudinally gathered clinical information of the patient contacts in coded data and free text.Diagnoses are coded according to the International Coding of Primary Care (ICPC). Drug prescriptions are labelled with the Anatomical Therapeutic Chemical Classification (ATC), and letters of hospital specialists and paramedic health care professionals are linked or directly incorporated in the electronic medical files. A network of a large group of GPs collecting routine care data on an ongoing basis can be used for answering various research questions.The Julius General Practitioners’ Network (JGPN) database consists of routine care data from over ten years of a dynamic cohort of around 370,000 individuals registered with the participating GPs from the city of Utrecht and its vicinity. Health care data are extracted anonymously every quartile of a year and these data are used by researchers.We describe the content and usability of our JGPN database, and how a wide variety of research questions could be answered, as illustrated with examples of published articles. The Dutch health system is based upon a gatekeeper system, in which patients only have access to hospital care after consulting the general practitioner (GP). All Dutch residents are registered with a GP, and all have mandatory health care insurance. GPs provide basic care for all health problems for all patient categories; emergency care, chronic disease, and mental health problems. GP care is completely insured and is not subject to initial payment; therefore the threshold for consultation is low. GP registries therefore adequately reflect morbidity patterns of the Dutch population, as far as it results in a contact with a healthcare provider.General Practice has a long-standing history of registering routine healthcare data. In the early days of general practice, some GPs in the UK presented joint patients records as practice overviews to study morbidity patterns in primary care , 2. In tRoutine care databases are widely used for research. Primary care research networks originated from local initiatives, but in recent years they merged to large-scale registration databases in many countries , 9–11. IAcademic research in routine primary care databases in the Netherlands has a longstanding tradition. In the 1960s a number of dedicated general practitioners in the Nijmegen area started the Continuous Morbidity Registration (CMR), which at present has more than 40 years of follow-up registration data of 15,000 patients , 13. In In the Utrecht region, six general practice groups collaborating with the University Medical Centre started in 1996 a registration network, with the mission to make their routine care data accessible for research . With deIn this paper we describe the organisation and data content of the Julius General Practitioners’ Network (JGPN), the different types of research that have been performed with the data and the potential of the networks for future innovation and how the data can be supportive in education in general practice.The main aims of JGPN are to facilitate clinically relevant research, the development of health care innovations and to support quality management by using routine care data. The network infrastructure brings together routine care registration data from all participating practices. After obtaining consent from a scientific board, the anonymised database can be used for scientific research. The network can generate key indicators of clinical performance of participating practices that can be benchmarked with the rest of the network. The network also supports innovative disease management programs, such as panel management of frail elderly and early identification of patients at risk of depression and cardiovascular disease. In the near future, the network data will be used to monitor the educational progress of GP trainees working in the network practices.N = 67) of 8.6 years (IQR 7.4–11.8). Minimum follow-up time is 0 years, maximum 87.8 years. The mean loss to follow-up in the network over the years is 5.3% annually, mainly caused by moving as a result of enlistment to another GP who is not participating in the JGPN network. In 2015, the average number of diagnoses and prescriptions per patient was 2.3 (range 0–45), and 2.5 (range 0–96), respectively. Patients contacted their GP on average 3.7 times per year (range 0–193), with 30% of patients not visiting their GP.The current composition of the patient database, and the geographical distribution of the participating practices in urban and (semi) rural regions make the JGPN population representative for the Dutch population. Gender, mean age, and age distribution of patients is comparable to the Dutch population  is entered in ATC . In addition, GP consultations are grouped in episodes, i.e. a series of consultations related to a single reason for encounter (a symptom or a diagnosis). In 2015, for example, the database contained 11,547 new episodes of diabetes mellitus and 22,330 new or recurrent episodes of upper respiratory tract infections  codes. In addition, linkage to national disease or mortality databases like the regional primary care laboratory, the National Cancer Registry or the National Mortality Registry, generates important complimentary sources of information . TechnicThe JGPN is subject to Dutch privacy law. The law on the medical consultation (Dutch: WGBO) states that the use of medical data for scientific research is allowed provided that i) results cannot be traced to individual patients, ii) and people are adequately informed beforehand allowing them an opt out option. As a consequence, all GPs participating in JGPN inform their patients by practice flyers and/or on their internet site about the anonymous use of their medical records for research purposes. Patients may opt out, and their routine care data will not be used for the JGPN database (opt-out regulation). The law on medical research (Dutch: WMO) states that medical research on patients requires individual consent if an intervention takes place. Research in JGPN is observational, without an intervention, and enlisted patients are not individually approached for participation. Therefore, the Medical Ethics Committees in the Netherlands do not rank such research as subject to the WMO conditions, but researcher need to confirm to the privacy legislation. The complete anonymised dataset is stored safely, and only copies of parts of it are delivered to researchers after they have requested it and JGPN has agreed on executing their research proposal. Such data sets are made only available under the strict condition of anonymity, and researchers have to give written consent to destruct the data at the end of their study. Only under very strict conditions free text is made available to researchers, after free text fields are anonymised by the computer program TM7 that is especially developed for this purpose . In the All participating GP practices have a longstanding relationship with the network. In return for their willingness to participate, they receive a small annual fee or benchmark information about their practice of the listed patient population and their medical management. The operational process of the network is run by a small team consisting of a coordinating and operational manager, a data-manager and secretarial support. The use of the database for research is monitored by a steering committee, consisting of representatives of the participating GPs in the network, the operational manager, and supplemented by research advisors of the Julius Centre. As yet, patients are not included on the steering committee. This steering committee also assesses requests for data submitted by researchers following a standard procedure. Research proposals should meet pre-set criteria, including sufficient quality of methodology, clinical relevance, and acceptable burden for practices and patients of JGPN. After consent of the steering committee and signing of the JGPN contract, data management of the JGPN prepares the requested dataset. Researchers pay a fee for each dataset, and thus contribute to the maintenance costs of the JGPN dataset. Most of the running costs are covered by institutional sponsoring of the University Medical Centre Utrecht.In the past 10 years the JGPN database has been used by researchers of the UMC Utrecht as well as by external research groups, which has resulted in 165 research projects and 105 peer reviewed publications. Data have been used for descriptive research and observational studies, such as trends in antibiotic prescriptions, but also for other types of epidemiological research –35.In etiological research, the causal relationship between a single determinant (i.e. risk factor) and a disease (or outcome) is assessed, but without randomisation the association is distorted by confounders. The most important potential confounders registered in the JGPN database include age, gender, lifestyle, socio-economic status, and co-morbidities. Additional patient characteristics can be obtained through linkage with other databases or through the use of proxy indicators. With supplementary data acquisition etiologic research is possible within the JGPN database.Rutten et al. assessed the long-term effect of beta-blocker use on survival and exacerbation in patients with COPD. After correction for multiple  confounders, the adjusted hazard ratios (HRs) for all-cause mortality and exacerbations were calculated with both propensity scores and Cox regression analyses. .Diagnostic studies usually aim to determine the diagnostic value of tests in patients suspected of a certain disease. For this type of research all suspected cases should have undergone the test(s) under investigation, but also the reference test to establish the disease (the outcome), without work-up bias. This is usually not the case in routine care data. Routine care data can however be used to identify potentially useful determinants that may be part of a diagnostic prediction model derived form a cohort with enough necessary information to perform such prediction research.Van de Pol et al. investigated the determinants of referral for recurrent respiratory tract infections (RTI) in young children aged between zero and two years old . In the Prognostic research focusses on prediction, answering the question; ‘which variables predict an outcome such as mortality in patients with a certain disease, irrespective of a possible causal relation . ConsequBertens et al. developed a prediction model for exacerbations in patients with COPD .Randomized controlled trials (RCTs) are difficult to perform within a cohort of observational routine care data, but as an alternative, a case-control design could be used to evaluate an intervention. Patients cannot be included through randomisation, but sampling techniques can be applied to limit selection bias while selecting controls. In addition, quasi-experimental designs can be used to evaluate interventions, including pre-post comparisons or stepped wedge designs for introduction of innovations in a ‘real life’ setting. To validate the effect, information on potential confounders is needed, otherwise, the validity of the outcomes of these types of studies is hampered.Venekamp et al. conducted a study in which a recent update of a primary care guideline on acute rhino sinusitis (ARS) was evaluated. The judicious use of antibiotics by consultation and prescription rates before and after the introduction of the guideline were compared .Routine primary care data also provide the opportunity for quality support and evaluation of health care innovations. For these ‘interventions’ it is essential the GP receives feedback information on patient level. To enable this, data need to be de-anonymised. The patient’s own GP is the only person having the key to identify his/her patients again.The principle of ‘panel management’ is that routine care data are used to preselect (symptomatic or asymptomatic) people at risk of a disease. Selected high-risk patients may subsequently be approached by the GP for preventive interventions. The selection frequently requires a priori prognostic research to identify which combination of risk factors optimally predicts the development of a disease . Once thIn the U profit study Drubbel et al. developed a frailty index (FI) for elderly patients that calculates the patient’s risk of frailty based on the patient’s health characteristics and health care consumption. To predict adverse health outcomes, survival curves were constructed and hazard ratios estimated. The FI for all elderly patients in the JGPN were calculated, and patients at risk were reported to the GP, who then could actively approach the patient for care interventions .JGPN can also be used to support daily clinical practice by adding (anonymously) new clinical information to the medical files of patients. The researcher may review the routine care data of the GP and (re)calculate the reliability of a particular diagnosis based on the characteristics and clinical data of a patient. Confirmation or cancellation of the diagnosis or new diagnosis is returned (in encrypted form) to the practice to enrich the GPs’ registration and to upgrade the patients’ records.Van Doorn cs. were focussing on the management of atrial fibrillation (AF). Patients with an ICPC code K78 ‘atrial fibrillation/flutter were checked for a confirmatory 12-lead electrocardiogram or heart rhythm registration, and the CHA2DS2-VASc risk score was calculated in every case with confirmed AF. This information was fed back to the GPs. With this information, the GP could re-consider the antithrombotic management of the patients with AF .The JGPN database can also be used for the evaluation of new disease managing care programmes. For example, the introduction of a new guideline may be evaluated by comparing pre and post outcomes such as referral patterns or prescription trends. To select a patient cohort that receives the guideline or managed care programme, arrangements must be made with the GPs concerned. In this type of study the effect on the outcome must be defined by the intervention components, after control for possible confounders such as practice variability. Studies monitoring antibiotic prescriptions are striking examples, such as the study evaluating the introduction of an update of the guideline on acute rhino sinusitis .Van den Broek d’Obrenan described the antibiotic management of infectious diseases in the JGPN. During 2007–2010 all contacts for infections and the rate and choice of antibiotics in 45 practices were analysed .If GP trainees are trained in one of the practices participating in JGPN the routine care data can be used for assessing educational progress by monitoring clinical performance. An important condition is that trainees have their own login code to register their patient contacts in the electronic medical files. Analysing these registrations provides excellent opportunities for monitoring the patient’s mix that GP trainees see, as well as their clinical performance, and trainees can evaluate their performance with their supervisors . The medRoutine-care primary care databases such as the JGPN offer excellent potential for different types of clinical research. In addition, the database can be used for feedback and monitoring purposes in support of quality of care programs in daily care. In future the dataset will also be used for educational purposes, to monitor the clinical performance of GP trainees and medical students in primary care practice. Important assets of the JGPN are the size of the data set, the length of the follow-up, the representativeness of its population, and the variety of clinical information that is registered. Much effort has been put in uniformity of the registration of the routine care, resulting in a high accuracy of the data over the years.Many primary care routine datasets exist; most are used only for research purposes. In the Netherlands, for example, all academic universities have such a (research) network. In the UK the General Practice Research Database is focused on facilitating larger scale observational research in primary care. Other networks have surveillance or monitoring purpose, such as the LINH sentinel network of NIVEL in the Netherlands that provides representative (monitoring) data on morbidity and clinical management in primary care. The content and the quality of the data vary between different databases. Some networks only store the coded information, and do not extract the qualitative text data, laboratory results, or the referral letters. The quality mainly depends upon the uniformity in coding, the training that participating GPs received, and the frequency of extractions. Some networks provide extensive training sessions, while others largely depend on routine data entry in the participating practices. The JGPN offers several advantages over other networks: it stores information on all aspects of clinical care; qualitative textual information on reason for encounter, diagnostic data, ICPC coded diagnoses and ATC coded prescription data, and referrals and return letters from specialists. Participating GPs are used to working with a structured coding program. The JGPN is based on a long-standing collaboration between regional participants and the academic department, and the practices actively participate in the management and exploitation of the database. Finally, the JGPN dataset is used for various objectives: not only for academic research, but also for regional surveillance, managed care programs and quality benchmarking purposes as well for educational purposes. This supports the feeling of joint ownership and creates a ‘win-win’ with participating practices.The JGPN database contains observational data, of the consultations that were registered by the GP, depending on the interpretation of the consultations by the GP and the way it was registered by the GP. This is also the limitation of the dataset. Because of the anonymous character, it is not possible to go back to the patient in order to collect additional information. Additional information becomes available only if the patient reappears on consultation, or if data are linked to other sources. Missing data for specific research questions are not retrievable.A second limitation of the data is that follow-up may be interrupted by both moving or by death. With the removal of patients from the database, the distinction between those who moved or those who passed away is no longer traceable. Through proxy indicators on morbidity or through linkage to the official death registry (CBS) this limitation can often be overcome.A third limitation is that the detailed data of the electronic chronic disease management programs, that many practice have introduced to monitor their patients with type 2 diabetes, chronic obstructive pulmonary disease, and cardiovascular risk management, were initially not automatically transferred to the routine care registration. Thus, these data were not available in JGPN. In recent years however, key indicators of chronic disease management programs are automatically copied to the routine care registration.Finally, data extraction takes place only four times a year, so the data are not always up to date. Given the progress in data capturing techniques, however, a system of real-time monitoring should be realistic in the future.prognostic studies. Diagnostic studies are more difficult to perform as test results are incompletely entered in the database. This can be overcome by linking individual data from laboratory databases. Interventions can be evaluated, but only in observational comparisons, with quasi experimental designs. This is particularly effective in the evaluation of healthcare innovations or guidelines after introduction on population level.The longitudinal character of the database provides the opportunity to perform observational analyses in different designs. Etiological studies can be achieved by splitting up the cohort and compare the positive and negative study-arm adjusting for the potential confounders. In addition, the database is large enough to analyse matched groups who are matched on important characteristics. The presence of additional determinants such as disease history, signs and test results make the data also attractive for One could argue that JGPN contains insufficient performance indicators for monitoring quality of care, since GP practices vary in the level of detail of information that is entered in the routine care registration. As a result, indicators of quality of care cannot always adequately be generated. These limitations, however, can be overcome in two ways. First, many clinical outcomes can be estimated by the use of proxy indicators, such as referrals (for treatment), or medication (for diagnosis). These proxy indicators have intrinsic limitations because of, for example, inter-physician variation in referrals or in individual health policies. Alternatively, clinical information can be enriched by linkage to other databases, such as those from hospitals, insurance companies or from disease-specific registries. Even when a deterministic or probabilistic linkage would result in a number of unidentified individuals, the number of patients in the JGPN is large enough to have adequate statistical power.The main future challenges for JGPN are the development of a regional data warehouse, the need to adequately address the medical ethical legislation for large-scale routine care data collection and the need to safeguard the commitment of partners such as GPs and patients. JGPN was initially setup as a mono disciplinary registration network. However, for optimal use of the data in future, structural linkage to other sources is essential to meet the ever- increasing demands of researchers, to continuously upgrade the quality of the data and to broaden the scope of the database. Recently, linkage to laboratory data, disease registries, and hospital data proved successful, but time consuming. In future, real-time linkage through a virtual regional data warehouse, connecting all relevant data sources in the region, should overcome these limitations.Legislation around medical databases is becoming more strict, to protect the privacy of patients and medical professionals. Many suggest that individual Informed consent is required for optimal protection, but experience has learnt that only a minority of patients do respond to requests for research participation. This would threaten both the size of the database as well as its representativeness. The present opt out procedure, with optimal information provision in the practices, a register of patients that refuse to participate, and shared governance over the data, adequately safeguards ethical use of the data. Ultimately, it is the patient, and not the professional or the researcher, that decides on the use of the individual health data, even though they are anonymised. Therefore not only researchers and GPs, but also patients should be actively involved in the JGPN steering committee. Patient participation is therefore one of the challenges for the near future.Routine-care primary care databases such as the JGPN offer excellent potential for different types of clinical research. Moreover, such databases can be used to support quality management in participating practices, thus optimizing individual patient care. This secures the balance between academic interest, and value for the participating GPs and patients, stimulating the concept of joint ownership, and turning a database into a solid instrument in regional health care developments.