Iodine deficiency disorders (IDDs) refer to a series of diseases caused by the human body's insufficient iodine intake. Edible salt became iodized in China in 1996, which yielded remarkable results. We have known that IDDs is associated with iodine in the human body, but it is not clear whether IDDs is related to medical resource level.We collected the number of IDDs cases and an index for the level of medical resource from 31 provinces, autonomous regions and municipalities directly under the central government in China. All data came from the China Statistical Yearbook of Health and Family Planning issued in 2013 by the Peking Union Medical College Publishing House. Data standardization and linear regression analysis were used.P < 0.01). In a multiple linear regression, IDDs was most significantly associated with the number of beds in hospitals, the number of rural health personnel, the number of basic medical and health institutions and government health expenditure for these institutions.The results showed that IDDs correlated with the number of beds in medical and health institutions, number of medical health personnel, number of medical and health institutions, total health expenditure, average health expenditure per capita, medical insurance for urban resident and new rural cooperative medical rural residents (Based on the experimental data, we concluded that IDDs had a positive connection with the medical resource level, and basic and rural areas had a more significant association with IDDs. This analysis provides new and explicit ideas for iodine prevention and control work in China. Iodine deficiency disorders (IDDs) is the most widely distributed endemic disease and end angers the largest number of people in the world. One-third of the world’s population lives in iodine-deficient areas, and 32 countries have a low level of iodine intake , 2. In tIodine is an indispensable microelement of the human body and plays a key role in metabolism, including enhancing protein synthesis, promoting growth and maintaining normal brain function . AdditioIn view of the most important problem, in 1995, the Chinese government started to implement a universal salt iodization (USI) campaign , which aIn previous studies, environmental and genetic factors were identified as the most important factors for IDDs but could not be quantified. To further improve IDDs prevention, treatment plans and continuous elimination and to achieve the ultimate goal of entirely eliminating IDDs, not only should we research iodine in a scientific manner, but we should also find other related factors for these diseases. We wanted to research the secondary factors and discover what were the most correlated with IDDs. As we all know, the local medical resource level determines the popularity rate of USI and the early diagnosis of the disease. We usually diagnose goiter by touch and visual inspection. Many years ago, WHO and the International Council classified IDDs into grades 0, 1, and 2; because of the limitations of diagnosis, levels 0 and 1 of IDDs were usually missed, which was contrary to the aim of early diagnosis and treatment of IDDs. Now, with improvement in the level of medical resources, B-ultrasounds and fine-needle aspiration (FNA) are used for the early diagnosis of IDDs . In addiWe collected the number of IDDs cases ;in summary, we collected a total of 5,126,941 patients with IDDs, which included 4,800,287 patients with goiter, 224,834 patients with two degrees of goiter, and 101,820 patients with cretinism. The number of beds in medical and health institutions, the number of medical health personnel, the number of medical and health institutions, total health expenditure, the average health expenditure per capita (not including Tibet in the abovementioned two indexes), medical insurance for urban residents, new rural cooperative medical rural residents (not including Tianjin) and other relevant information were collected from 31 provinces, autonomous regions and municipalities directly under the central government  in China in 2013. All data came from the China Statistical Yearbook of Health and Family Planning issued in 2013 by the Peking Union Medical College Publishing House. The data in the China Statistical Yearbook of Health and Family Planning issued in 2013 are excerpted for annual health statistics; a part of data came from sample surveys; data on the population and community economy came from the China Statistical Yearbook issued in 2013 by China Statistics Press; statistical information came from the Ministry of Public Security, Ministry of Education and Ministry of Civil Affairs; and medical insurance data for urban residents came from the Ministry of Human Resources and Social Security in China.Using Microsoft Office Excel 2007 software, we conducted a data analysis of the respective correlation between IDDs cases and the seven indicators and their concrete indexes Table . To guarF, namely, the value of P. We considered P < 0.05 to be statistically significant. The numbers of IDDs cases were defined as dependent variables, and the seven indicators were defined as independent variables. First, we used linear regression to analyze the relationship between the number of IDDs cases and the seven indicators. Second, there were four concrete indexes for the number of beds in medical and health institutions,two concrete indexes for the number of medical health personnel, four concrete indexes for the number of medical and health institutions and two concrete indexes for total health expenditure; we can see these in the support table. A multiple regression was preformed: the number of IDDs cases were defined as the dependent variable, and for total health expenditure, government expenditure on health and social health expenditure were the concrete indexes defined as independent variables. We used the same method to analyze the other three indicators. We adopted a multiple linear regression equation and specifically determined which concrete indexes had the greatest impact on IDDs by comparing the value of the standardized regression coefficient Beta with sig. The standardized regression coefficient  was used to compare the importance among variables in multiple regressions [We used SPSS 13.0 software to conduct a regression analysis of the above data. Regression analysis is a statistical analysis technique that we use to confirm the quantitative relation of which two or more variables depend. After the result was determined, we analyzed the value of significance (sig.), which was the significance coefficient of the regression relation and the actual significance probability of the value of ressions . When thThe data were standardized and are shown in line graphs Figs. , 2 and 3P < 0.001), the number of medical health personnel , the number of medical and health institutions , total health expenditure , the average health expenditure per capita , medical insurance for urban residents , and new rural cooperative medical for rural residents . All groups exhibited statistical significance. Correlations between the number of IDDs cases and the concrete indexes are shown in Table P = 0.086). In Table P = 0.002) and the number of beds in basic medical and health institutions  were statistically significant; the number of beds in professional medical and health institutions  was not significantly associated with IDDs. City medical personnel and rural health personnel had a remarkable correlation with IDDs . There was only one related factor: basic medical and health institutions were statistically and significantly correlated with IDDs ; hospitals, professional medical and health institutions and other medical and health institutions were not significantly associated with IDDs. Government expenditure on health , social health expenditure , and personal health expenditure  were all statistically and significantly correlated with IDDs.Correlations between the number of IDDs cases and possible influencing factors are shown in Table P < 0.01).In previous studies, researchers focused more on genetic and environmental factors, believing that those were the main factors causing IDDs. Additionally, researchers focused on the extremely low content of iodine in the soil, various chemical compounds in water , insuffiWe attempted to analyze the fundamental reasons for why higher levels of medical resource were associated with greater numbers of IDDs cases. First, local people had a high level of health care awareness and paid comparatively more attention to prevention and control of the disease when the level of medical resource was higher, which enabled publicity efforts regarding the disease to go more smoothly. As people gradually developed IDDs, they would go to hospitals as long as there were clinical manifestations. Thus, with the clinic rate increasing, the number of cases of IDDs will increase, which comprehensively and accurately provides data about this epidemic situation. These data are critical for the prevention and treatment of IDDs in the next step of the plan. Second, a high level of medical resources represents more advanced detection techniques and a higher overall quality of doctors than in low-level medical resource areas, which are also convenient for diagnosing the disease; Reinhardt et al.  also repAfter further multiple linear regression analyses, it could be observed that primary-level medical and health institutions, the number of the rural health personnel, the number of beds in healthcare institutions, and the health expenditure of the government had the highest degree of correlation with the number of IDDs cases. In addition, the number of IDDs cases in rural areas represents a larger proportion, and these results were consistent with the actual situation in China. In fact, there were many difficulties in prevention and treatment of IDDs in rural areas in China. First, affected by traditional habits and economic conditions, the extension of the USI was not sufficient in outlying and poverty-stricken areas  and someConclusively, our study demonstrated that the IDDs diagnosis was closely correlated with the medical level in China, as a larger number of IDDs cases were present in some provinces with a high level of medical resources; we conjecture that this phenomenon is associated with a low visiting rate, a difference in population bases and so on. Governments should pay more attention to the provinces with a low level of medical resources, increasing government expenditure on health and attaching importance to propaganda in order to get comprehensive and accurate data about an epidemic situation; these data are critical for the prevention and treatment of IDDs in the next step of the plan. On the other hand, prevention and treatment of IDDs in rural areas is momentous; improving the level of medical resources in rural areas and enhancing local residents’ awareness of IDDs is essential.There were some limitations to this experiment. First, the data were not complete: we lacked data about total health expenditure in Tibet and new rural cooperative medical rural residents in Tianjin. Complete data would be preferable in the future to accurately evaluate the influence of the medical and health levels further. Second, the data are cross-sectional and not experimental, which lacks persuasive ability, so the results and conclusions should be further confirmed. Additionally, it would be more accurate to collect the data from each city for the linear regression. A large sample size would be more persuasive.Based on the experimental data, we concluded that IDDs had a positive correlation with the medical resource level, and basic and rural areas had a more significant association with IDDs. This analysis provides new and explicit ideas for iodine prevention and control work in China.


Purpose. Effectiveness of nonpharmacological multicomponent prevention delivered by trained volunteers , targeted at delirium risk factors in geriatric inpatients, was assessed at an internal medicine ward in Poland. Patients and Methods. Participants were recruited to intervention and control groups at the internal medicine ward . Every day trained volunteers delivered a multicomponent standardized intervention targeted at risk factors of in-hospital complications to the intervention group. The control group, selected using a retrospective individual matching strategy , received standard care. Outcome Measures. Hospitalization time, deaths, falls, delirium episodes, and antipsychotic prescriptions were assessed retrospectively from medical documentation. Results. 130 patients  participated in the study, with 65 in the intervention group. Antipsychotic medications were initiated less frequently in the intervention group compared to the control group. There was a trend towards a shorter hospitalization time and a not statistically significant decrease in deaths in the intervention group. Conclusion. Nonpharmacological multicomponent intervention targeted at delirium risk factors effectively reduced length of hospitalization and need for initiating antipsychotic treatment in elderly patients at the internal medicine ward. Health complications among elderly inpatients are an increasing problem worldwide, resulting in a growing need for the implementation of effective preventive strategies . One of The development of delirium may give rise to other adverse outcomes in individuals, such as falls, cognitive and functional decline with loss of independency, prolonged hospital stay, increased risk of death, rehospitalization, and institutionalization –5. Most Recognizing this evidence, comprehensive nonpharmacological intervention programs preventing delirium have been launched in several medical centers in the United States  and spread worldwide , 9, 11. Taking into account the encouraging results of ongoing delirium prevention programs, the nonpharmacological multicomponent volunteer-based interventional program “The Wholesome Contact” has been developed as a translation of evidence-based guidelines into practice. It was designed and introduced to prevent in-hospital complications among old patients of internal medicine ward. Medical and psychology students were recruited as volunteers providing the intervention and then trained to implement the protocol. With different approaches being considered, a prevention strategy employed in the present study was mostly inspired by the REVIVE program from Australia  that wasThe aim of our pilot study was to assess the effectiveness of a set of tailored interventions, targeted at specific delirium risk factors, delivered to elderly inpatients by trained volunteers. Additionally, we have determined the feasibility and safety of the forthcoming prospective project on nonpharmacological prevention of delirium. It has been hypothesized that the implementation of a structured delirium prevention program would reduce the incidence of in-hospital complications, shorten the length of hospitalization, and contribute to lower mortality rates in older hospital inpatients when compared to those in the usual care group. To the best of the authors' knowledge, this is the first project of its kind in Central-Eastern Europe.The participants for the study were recruited from the patients of the Department of Internal Medicine and Geriatrics of the University Hospital in Krakow, Poland, from October 2013 to May 2015. The Department of Internal Medicine and Geriatrics is a 47-bed acute care, tertiary teaching hospital that provides general medical care for part of the aged population of one of the biggest Polish cities.The inclusion criteria were as follows: patients at the age of 75 and older, being admitted for acute conditions and transferred directly from the emergency department, who were alert at the time of admission .The following exclusion criteria were employed: life expectancy < 24 hours, being admitted due to surgical reasons or transferred from other wards, isolation due to infectious disease, and a lack of consent. We only included the patients who were discharged home . The criteria were applied to both the intervention and the control group. All medical data was obtained from the patients' medical records retrospectively.The patients who fulfilled the criteria and agreed to participate in the study were included in a standardized multicomponent intervention. The intervention was delivered daily for 5 initial days of the hospitalization, beginning within the first 48 hours from admission, by trained volunteers.In order to select a control group with similar characteristics to the aged patients included in the project, a retrospective individual matching strategy was used. The controls were matched to the patients in a 1 : 1 ratio, with regard to variables such as age (within five years), gender, and time of hospitalization (within 21 days). Inclusion and exclusion criteria were the same for the control group and for the intervention group. The patients included in the control group received the usual medical care that consisted of standard Evidence-Based Medicine (EBM) guided treatment of acute conditions. Additionally, each patient received physiotherapy, nutritional counseling, and psychological and social support individually, if needed.The group of eighteen volunteers was recruited from medical and psychology students at the Jagiellonian University in Krakow. The recruitment process started with posters and social media announcements within the university and with an introductory meeting. It was necessary for a student to have at least the first year of his/her studies completed and to sign the consent in order to be a volunteer. Since active participation in the program was a great opportunity for the volunteers to experience and practice contact with aged patients in the context of a hospital setting and to train their competences and soft skills in the interdisciplinary teams, we met a sufficient interest at the stage of recruitment.All the volunteers participated in a structured training period (12 hours), covering theoretical knowledge and practical skills necessary to provide the intervention, before they undertook the first contact with patient. The education concerned delirium  and detailed protocol of the multifactorial intervention. Volunteers were instructed about the importance of adhering to the protocol. Finally, they were informed about hospital ward organization rules, health and safety, and ethical issues. They had many opportunities to address any initial questions and concerns.https://doi.org/10.1155/2017/1297164). The Form listed all risk factors addressed by the intervention and some possible ways to manage them. Volunteers followed the list and reported on the actions aimed at the risk factors every time they met a patient.The Volunteer-Patient Contact Form was introduced to the volunteers as a tool to support and to ensure adherence to the protocol  with a minimum level of involvement (visiting 1 patient a month) was established to ensure a balance between resources invested and effects acceptable both for volunteers and for coordinators.The aim of the regular reporting and commitment of participation in two-hour monthly meetings of supervision and training was to maintain skills and adherence to the intervention protocol. The meetings were led by a medical doctor and a psychologist to support the volunteers and to avoid overwhelming burden of care and dropouts from the program. Additionally, single training sessions were delivered by a nurse, a physiotherapist, and a social worker in order to address all the important issues concerning the hospitalization of elderly patients. Through the whole period of the project the volunteers were coordinated, supervised, and supported by an interdisciplinary team of health-care professionals employed at the Jagiellonian University. A practicing psychologist (WK) was involved in the project, worked as a supervisor, and was accessible on call when needed. The opportunity to acquire medical knowledge and experience useful for their future profession worked as an additional reward and source of motivation for the volunteers. The volunteers were as follows: eight medical students  and ten psychology students .The volunteers visited patients in pairs to support each other and to minimize the workload and the burden of care. Two volunteers—a medical student and a psychology student—were assigned to a single patient at a time in order to avoid patient's disorientation related to the volunteers' turnover and to enable them to establish a trusted relationship which was recognized as crucial for successful intervention.Contact with a particular patient was initiated by the pair of volunteers during the first visit at a patient's bedside. Afterwards, they visited the patient separately (they took turns): daily, usually in the afternoon, for five days. However, they discussed the patient's condition and needs and shared the details of the visit with the partner to provide a regular, uninterrupted, and adequate care. During the visit, lasting approximately one hour (depending on the patient's needs and condition), they performed the intervention according to the protocol and afterwards reported in the Volunteer-Patient Contact Form. Volunteers were also encouraged to share their experiences and to discuss with the rest of teams and supervisors during and between their monthly meetings. Our rationale to conduct the multifactorial nonpharmacological intervention to prevent delirium during the first five days of patients' hospital stay was based on data showing that elderly patients are most vulnerable to develop delirium at that time , 15. WhaThe details of a multicomponent, standardized intervention, comprising seven components, targeted at risk factors for in-hospital complications (esp. delirium) were presented in Four surrogate markers of in-hospital complications were analyzed as outcome measures: the length of stay (LOS), need for prescription of antipsychotic drugs during hospitalization, falls' occurrence, and in-hospital deaths. As delirium incidence was not assessed in a standardized way, by blinded investigators unaware of the study outcomes, it could not have been analyzed as a primary outcome and surrogate markers were necessary to apply. Nevertheless, we searched for the Polish words denoting the following: “delirium”, “delirious”, and/or “agitated” and/or “confusion” in patients' medical records retrospectively.All outcomes were assessed retrospectively on the basis of patients' medical charts and doctors' and nurses' daily reports. Considered antipsychotic drugs included haloperidol, risperidone, perazine, and quetiapine. A fall was defined as an unexpected event when the patient came to the floor unintentionally. Patients' medical diagnoses were obtained from their medical records with the Charlson Comorbidity Index (CCI) and the Age-Adjusted Charlson Comorbidity Index (ACCI) being calculated , 17. The t-test and categorical variables were compared using Chi2 test. A p value < 0.05 was considered significant.All statistical analyses were performed with Statistica 10 . Continuous variables were expressed as mean (±standard deviation); categorical data was expressed as percentages. Normality of distribution was checked by the Shapiro–Wilk test. In the case of skewed distribution data were logarithmized. Continuous variables were compared using Student'sp = 0.05) . There was no difference with respect to baseline characteristics between the intervention and the control group . The mos = 0.05) .p = 0.040) (p = 0.47). No statistically significant differences in the number of in-hospital deaths  and the number of falls during hospitalization  were noticed. No adverse effects related to patients and volunteers were reported. One of the students discontinued her participation in the project after the patient, whom she was taking care of, passed away. Prompt psychological support was offered to the student.Antipsychotic medications were initiated less frequently in those in the intervention group  . There wOur study demonstrated that the nonpharmacological, multicomponent intervention targeted at delirium risk factors, delivered by volunteers, could be effective in reducing the length of hospital stay and the need for antipsychotic treatment initiated during hospitalization in the group of aged patients hospitalized in internal medicine ward.The effectiveness of multicomponent nonpharmacological interventions in reducing the time of hospital stays was studied in several trials , 18–20. Reducing LOS in the intervention group might reflect better quality of care. It may be related to a reduced number of in-hospital complications, including delirium. In the analysis conducted by Bo et al., patients who developed delirium stayed at hospital almost twice as long as those who did not experience delirium . ReducinAt the time of our pilot study, both in the intervention and in the control group, a formal diagnosis of delirium has not been carried out, which is a weakness of the study. Instead, we searched for the Polish words denoting the following: “delirium”, “delirious”, and/or “agitated” and/or “confusion” in patients' medical records retrospectively. We also decided to evaluate the need for initiation of antipsychotic medication  as a surrogate outcome measure for hyperactive delirium incidence. Although significant reduction in the incidences of antipsychotic drugs initiation was observerved in the intervention group, relative to the control group, this effect should be further verified in our planned prospective study, encompassing formal diagnosis of delirium. According to the obtained data, it was assumed that delirium is experienced in about 20% of patients who met the inclusion criteria for the study. These results are consistent with previously published data . The numA statistically nonsignificant reduction of mortality in the patients in the intervention group was shown. Although our preliminary outcomes need to be confirmed in a larger, randomized trial, which is planned to be performed, the results are comparable to those presented in the recent meta-analysis by Martinez et al. Martinez and colleagues pooled 3 studies with a total number of 582 patients , 20, 23 There was no difference detected in the number of falls in the intervention and in the control group. Still, results on the impact of multicomponent interventions on the number of falls in aged patients are inconclusive. Stenvall et al., in their study of 199 patients, demonstrated a significantly lower incidence of falls in the intervention group. However, the trial was performed in a different setting and with a different scope of patients when compared to our study  . In the To the best of our knowledge, our study is the first from Central and Eastern Europe to assess the impact of a nonpharmacological intervention targeted at delirium risk factors on the short-term outcomes in hospitalized older patients. What is more, it is also the first report in Europe on a trial in which trained volunteers were employed to deliver the intervention. The idea of the volunteer-based nonpharmacological intervention to prevent or treat in-hospital complications was put into action in medical settings in the USA and Australia , 13. AltApart from substantial benefits for patients, it provides a great opportunity for future medical and health-care professionals to gain valuable experience, thus creates a win-win situation. Furthermore, as mentioned above, no adverse outcomes related to patients were noted. The innovative nature of our project also covers the successful implementation of state-of-the-art research and guidelines for prevention of in-hospital complications, despite serious cultural, economic, and organizational differences being present in Poland.We are fully aware of some weaknesses of our study. First of all, our preliminary results are based on retrospective data analysis. Secondly, there was no formal delirium assessment being performed at the time of our study. We decided to present the surrogate outcome measures  instead, but at the same time detailed medical charts review was conducted. Inconsistent results obtained (higher number of those in whom antipsychotic drugs were initiated than those diagnosed with delirium) are in line with the study of van Zyl and Davidson who showed that delirium was underreported in patients' medical records . ThirdlyOur pilot study supports the use of multifactorial volunteer-based nonpharmacological intervention to prevent in-hospital complications in an internal medicine ward. Medical and psychology students should be considered as potential volunteers in some other similar projects.The Volunteer-Patient Contact Form was designed to aid the voluteers' adherence to the intervention protocol. The form includes a list of risk factors and some suggestions and examples how they can be addressed. An open space for the voluteers' post-visit impressions allows description for any subjective evaluations of the volunteer-patient contact, encountered difficulties or concerns, and importants observations not listed in the table. The dedicated space is to be completed after each consecutive visit.


Biobanks are collections of donations of biological material  and related data which are very valuable for research into human diseases. A variety of biobanks exist for example within hospitals, research institutes, pharmaceutical companies and patient organisations. The role of patients in biobanking is changing from being seen simply as donors, to actual collaborators in the design, development and the running of biobanks. In this article, we provide a number of examples of patients acting as partners at the heart of biobanking, where their voice and perspective is being seen and used as a valuable resource for the biobank. Our aim is that these examples can be used by those who work with patients in biobank-based research, to design future strategies for patient and public involvement in all biobanks.Biobanks and biobanking research plays an increasingly important role in healthcare research and delivery as health systems become more patient-centred and medicine becomes more personalised. There is also growing acceptance and appreciation of the value that patients, patient advocacy organisations and the public can bring as stakeholders in biobanking and more generally in research. Therefore, the importance of active, early and sustained engagement and involvement of patient and public representatives in biobanks will become increasingly relevant.Organising and facilitating patient and public involvement in biobanking takes considerable time and effort for all stakeholders involved. Therefore, for any biobank operator considering involving patients and the public in their biobanking activities, consideration of best practices, current guidance, ethical issues and evaluation of involvement will be important.In this article, we demonstrate that patients are much more than donors to biobanks—they are collaborators at the heart of biobanking with an important voice to identify perspective, which can be an extremely valuable resource for all biobanks to utilise. The case studies herein provide examples of good practice of patient involvement in biobanking as well as outcomes from these practices, and lessons learned. Our aim is to provide useful insights from these efforts and potential future strategies for the multiple stakeholders that work with patients and the public involved in biobank-based research. Biobanks collect, process, store and distribute biological material and related data to research organisations. These “biospecimens” and data are used by scientists to learn more about human diseases, their causes and their effects and to develop better prevention measures, better diagnostic tests and better therapies . DiffereBiobanks do not operate in isolation. They exist within a diverse “ecosystem” of stakeholders which includes the public, patients, healthcare workers, scientists, government, funders, healthcare providers, ethicists, regulators and others. The sheer variety of stakeholders involved in maintaining biobanks reflects the diversity of biobanks themselves . BiobankThe role of patients and the public in biobanking activities has been viewed traditionally as biobank participants rather than as collaborators in the design, development and ongoing operation and governance of biobanks. However, there is growing acceptance and appreciation of the value that patients, patient advocacy organisations and the public can bring as stakeholders in biobanking and more generally in research , 4.This article demonstrates the wealth of experience that now exists within patient communities which makes them valuable partners and sources of input in biobanking research. We demonstrate that patients are much more than donors—they are collaborators at the heart of biobanking with an important voice and a unique perspective, which can be an extremely valuable resource for all biobanks to utilise. The case studies herein provide examples of good practice of patient involvement in biobanking as well as outcomes from these practices, and lessons learned. Our aim is to provide useful insights from these efforts and potential future strategies for the multiple stakeholders that work with patients and the public involved in biobank-based research.The term “patient” in this article refers to the patient, his/her relatives or patient advocates as collaborative or representative voice of patients.The term “patient involvement” in this article refers to “involvement in research” .The term “patient organisation” in this article refers to not-for-profit organisations which are patient focused, and whereby patients and/or carers (the latter when patients are unable to represent themselves) represent a majority of members in governing bodies. These could be either general umbrella organisations  or disease-specific organisations .Population biobanks: whose primary goal is to obtain biomarkers of population identity and susceptibility, typically from the DNA of large numbers of healthy donors, representative of a country/region/ethnic cohort.Disease-oriented biobanks for epidemiology: whose activity is focused on biomarkers of exposure, using large numbers of samples, usually following a healthy exposed cohort/case-control design, and studying germ-line DNA or serum markers and large amounts of specifically designed and collected data.Disease-oriented general biobanks (e.g. tumour banks): where their goals correspond to biomarkers of disease through collections of biosamples and their derivates (DNA/RNA/proteins), usually associated to clinical data and sometimes associated to clinical trials. The amount of clinical data linked to the sample determinate the availability and biological value of the sample.The term “biobank” generally refers to a service whereby biological materials and the data associated with those materials are collected, stored, processed and distributed for the purposes of scientific research and/or medical treatment. Typically, those “biological materials” are human samples—such as tissue, blood, body fluids etc., and the “data” is any information, including medical information pertaining to the donor of that sample. Biobanks exist within a variety of institutions, including academic medical institutions, and pharmaceutical and biotechnology companies. They can also be stand-alone organisations, including independent companies (both for profit and non-profit) that can provide biobanking services and access to samples as a service to the research community or patients. There are multiple designs according to different possible goals. Briefly, human sample-related biobanks include three major types:Unless otherwise stated, the term “biobank” in this article refers to disease-oriented general biobanks, comprising of human tissue, cell or DNA biosamples and associated clinical data.Directly involving patients and the public in shaping both the organisation and delivery of healthcare services is central to current health reform agendas around the world. Realigning public services based on evidence from service user’s experiences, and designed with and by the public rather than on their behalf, is challenging national healthcare systems, with particular examples emerging in the USA and UK , 6. It iDeveloping in parallel to patient-centred healthcare is the concept of personalised medicine . In ordeMost health research would be impossible without the active involvement of patients. Traditionally, patients have been involved “passively” as subjects/participants in research, with patients and their representative organisations only rarely seen as partners in research practices. However, the last 20 years has seen a growing interest and activity at a local, national and international level in patient engagement and in particular a focused interest in patient and public involvement (PPI) in research, with projects in the European Union , 12, AusActually, it’s surprising that it has taken us this long to focus on patient engagement because the results we have thus far are nothing short of astounding. If patient engagement were a drug, it would be the blockbuster drug of the century and malpractice not to use it.Leonard Kish—Principal and Co-Founder of VivaPhiMany people describe public involvement in research as research that is done with or by the public, and not to, about, or for them . PatientFor most patients and patient organisations, the primary objective for their involvement in biobanking activities is to find the cause of their disease or to improve their diagnosis and treatment options . The degAlthough an ever-increasing number of patient organisations are establishing their own biobank, the emergence of patient-led and patient-run biobanks began only relatively recently. Individual patients, and representative patient organisations, many unsatisfied with the speed of research into their respective conditions, established their own biobank, primarily to enable them to provide a greater contribution and influence on research in their disease area. Three case studies of patient-led biobanks in the USA (Chordoma Foundation Biobank), Germany (Patients’ Tumor Bank of Hope (PATH) Biobank) and Italy  are provided in this article as examples in this regard. Another example worth highlighting is the Généthon DNA and Cell Bank driven by the French patient organisation Association Française contre les Myopathies (AFM). AFM become active in genetic research in the 1980s to help find a cure for neuromuscular diseases and founded the biobank in the mid-1990s . The orgPatient-led initiatives were also among the first to develop networked biobanking activities. The European network of DNA, cell and tissue biobanks for rare diseases (EuroBiobank) was the first pan-European network of biobanks—established in 2001 by the EURORDIS  and AFM A further example is the patient-led “Genetic Alliance Biobank”, established in the USA in 2003 based on the organisational strategies of PXE International, an advocacy group set up by two parents whose children were diagnosed with the incurable condition PXE. The Genetic Alliance uses a cooperative, cost-sharing model that translates into a tightly controlled infrastructure for patient organisations to conduct biobanking activities. Genetic Alliance sets high standards for patient involvement in research, exceeding the requirements of applicable US federal, state and local laws, rules and regulations .A number of European-wide initiatives have been able to develop “representative” patient positions on biobanking. The first clear recommendation was in 2006 by the European platform for patients’ organisations, science and industry (EPPOSI)—an EU patient-driven partnership between patient organisations, industry and academic science and clinicians. In the first conference to bring these different stakeholders together to discuss the future of biobanks, representatives of several patient organisations demonstrated i) how their self-developed biobanks contribute to progress to effective therapies for their diseases, ii) what key role patient groups play in promoting the need for biobanks and iii) how they contribute to raise awareness about the usefulness of biobanks and to accelerate the collection of precious biomaterial .Inclusion, Engagement and Communication. Translating these key principles into practice involves:Inclusion of patients and patient organisations as partners in the research effort, especially in the areas of communication, advocacy and recruitment .When establishing sample, tissue and databanks, the experience, knowledge and expertise of patients, families and carers should be considered.Listening to patients’ voices/expectations on research needs from their experience from participating in biobanking as donors.Regular, general and reasonable feedback to patients regarding use, sharing and transfer of samples.In 2010, patient representatives of the stakeholders’ forum of Biological and Biomolecular Resource Infrastructure (BBMRI) produced a “consultation document on patient perspectives” which was subsequently endorsed by a number of major pan-European patient organisations . The docIn particular, the document recommends that patient involvement should be extended to ethical aspects such as informing Research Ethics Committees (RECs) of patients’ interests, patient rights over their donation, access to samples from research groups out of the country, possible new use of existing samples and/or discontinuation of the biobank.In 2012, the EU-FP7 PatientPartner project identified a number of patients’ needs for partnership in the context of clinical trials, including for biobanking activities. The project consulted extensively with patient organisations through a number of different engagement mechanisms and made recommendations on the role that patient organisations have in biobanking, including a need to educate patient organisations on how to start and structure a biobank .Biobanks create a number of ethical and legal issues related to research governance, privacy, informed consent , controlthe nature of consent when agreeing to participatethe confidentiality of the tissue and of data being compromisedaccess to the tissue and data after donationhow their information might be usedtheir access rights to results from research performed using their tissue and dataThe findings from a plethora of public consultations have shown that the public response to biobanking activities is varied, diffuse and highly context-specific , 38. In A common recommendation resulting from public and patient consultations is the principle of transparency—that operators of biobanks should actively communicate relevant information to patients in a clear and transparent fashion, thus striving to build a relationship of trust with participants and the wider public . TranspaTo secure the trust of patients and the public, more recently established population-based biobanks , 40 haveIt is commonly accepted that in order to ensure that biobanks are developed and used to their full potential, it is essential that both researchers and other stakeholders associated with biobanking have access to the best possible training and career development opportunities at all stages of their professional life. Therefore, in order to facilitate active participation of patients and patient organisations in biobanking activities, appropriate training in partnership with healthcare professionals and researchers is and will be necessary.A number of ongoing patient-led training initiatives in this area are helping to raise awareness of the contribution that patients can make as partners in research. The European Patients’ Academy (EUPATI), an EU-wide, public-private partnership that is led by the European Patients’ Forum and is funded by the Innovative Medicines Initiative (IMI), provides in-depth training of patient advocates as well as educational material on all aspects of medicines research and development (R&D) including key topics relevant to patient involvement in biobanking . EUPATI’s Expert Patient Training Courses are currently training 50 patient advocates, and its Internet Library will provide this information in the form of web-based educational resources to the health-interested general public in seven languages in 2016 .The Vision On Information, Confidence and Engagement (VOICE) patient training course in the UK trains patient advocates in basic cancer biology, research terminology and study design, and the critical evaluation of research proposals and scientific papers . The GenEquipping research professionals with the understanding to start involving patients and public as partners in biobanking and to develop practice is a distinct challenge in this area. However, there remains a potential for this training to be provided in connection with leading universities/training sites/course providers in the field . In addition, possible topics for patient seminars, summer schools, and short/long-term fellowships in the field of biobanking research could be a valuable addition to current training programmes in biobanking .There are many examples, predominantly from the rare disease patient community, of patient stakeholders who have invested their own resources in the establishment of new biobanks and biobank infrastructures. Below are three case studies which capture the levels of involvement and the resulting value to the biobank itself.Case study 1:The current PATH board consists of three breast cancer survivors, which according to its statutes, at least two members have to be former patients. In addition to the representation (e.g. at conferences and towards scientific partners), the board guides the activities and direction of PATH Biobank. As breast cancer survivors, all board members have an inherent motivation to contribute to the cure of this disease.PATH respects the proprietary right of the breast cancer patient. The patient donates their blood and tumour, and in return, PATH reserves one aliquot of both blood serum and tumour tissue, for the donor. The donor may request these samples at any time, free of charge. This way, the breast cancer patient is directly involved in the biobanking process and may benefit from the storage of her biospecimens.PATH patients provide their follow-up data. In a follow-up study, PATH patients were re-contacted by telephone. More than 75 % of contacted patients provided data about their disease course and medical treatments. The extraordinarily high response rate reflects the patients’ trust and interest in PATH’s work .http://www.path-biobank.org). This way, PATH patients can directly see what PATH samples have achieved. Additionally, PATH biospecimen donors receive a yearly newsletter. The newsletter covers topics like clinical studies, new therapeutics and progresses in research and development. The patients’ feedback indicates that they appreciate the newsletter. Importantly, only 31 % of all PATH patients use the internet as a source of information highlighting the important role of biobanks like PATH in patient information [PATH is transparent. PATH publishes the results of studies performed with PATH samples on the PATH website  at high ethical standards and under uniform SOPs. PATH  aims to Case study 2:Chordoma is a rare bone cancer that can occur anywhere along the spine. The Chordoma Foundation was founded in 2007 by Josh Sommer, a then 17-year-old patient, and is a small, volunteer-run patient organisation. The Chordoma Foundation decided in 2010 to establish its own biobank  with theThe patient-led biobank team works closely with hospitals to coordinate chordoma tissue collection from patients, providing the first centralized source of chordoma samples and data to the research community. The foundation also developed a standardized kit to make it easy for any hospital to provide tissue samples, thus ensuring the quality of sample collection and preservation during transport.As the condition is very rare, and the tissue so scarce, the foundation has made specific efforts to liaise closely with hospitals to collect any chordoma tissue remaining from surgical procedures that is not needed for patient care. The foundation has also set up partnership networks with hospitals that are centres of excellence for the treatment of chordoma patients to routinely collect chordoma tissue. Expanding the biobank network to Europe and exploring “virtual” biobank solutions  are currently being investigated. A major goal for the near future is to acquire more frozen samples suitable for genetic research.Volunteers and patients are also involved in promoting the biobank to the public through the foundation’s online  and offline  tools and channels. Because the patient organisation is in the driver’s seat, chordoma patients are very easily convinced about the necessity of tissue donation. This has all been achieved with the support of chordoma patients and their families, acting as volunteers, and a small staff (<5). The Foundation board consists of patients or relatives of patients, in the majority. The message from the Chordoma Foundation is that patient/volunteer-led biobanking can be performed very effectively, even by very small organisations, and may be the only solution for some rare diseases.Case study 3:Alternating Hemiplegia of Childhood (AHC) is a very rare, progressive and debilitating neurological disease, characterized by an early onset. The Italian Association for Alternating Hemiplegia of Childhood (AISEA) is actively involved in their Italian Biobank AHC (I.B.AHC), an open repository by which the clinical information and the biological material of AHC patients with a validated diagnosis are collected and made usable for any research project on AHC . The I.BI.B.AHC is composed of two linked repositories—a clinical registry of patient data and a biobank of DNA samples from participating patients. AISEA defined both the biobank and registry protocols together with its scientific committee and with the ethics committee of the scientific institute hosting the biobank . The informed consent forms for patients and the Material and Data Transfer Agreement (MDTA) for the researchers applying for access were also defined by the patient organisation in collaboration with the MEDEA Ethics Committee.AISEA has a primary responsibility for the recruitment of AHC patients and plays a vital role in active communication with patients, particularly about the process of sample/data collection, as well as information on the communication of individual results obtained by the research projects that used their sample/data. According to conditions stated in the MDTA, AISEA enters the individual results of the research projects accessing I.B.AHC into the clinical registry, so that they can be seen and used by any other future study accessing I.B.AHC. In this way, the patients, by donating their data and samples to I.B.AHC, obtain the maximum return of their investment for the progress of research on AHC. AISEA also communicates the individual results of the studies accessing I.B.AHC to the patients and to their treating physicians.The I.B.AHC was the largest case series included in an international collaborative research project that in July 2012 identified mutations in the ATP1A3 gene as the major cause for AHC. The I.B.AHC organisational and information model, in compliance with the model developed by ENRAH, the European Network for the Research on AHC, is now being used to create an international network of homogeneous clinical registries with linked biobanks as a supporting infrastructure for the International Consortium for the Research on AHC (IAHCRC). In this initiative, the AISEA together with other national patient associations for AHC are playing an essential role in its governance, not only for guaranteeing the sustainability of this infrastructure and the recruitment of the patients but also for the definition of rules for sharing of the data and samples inside IAHCRC.Biobanks are increasingly incorporating patient involvement as an important part of their governance structures. Three case studies are presented below.Case study 4:The Wales Cancer Bank (WCB) is funded by the Welsh Government and Cancer Research Wales and is hosted by Cardiff University . PatientA steering group was convened when the biobank was founded to ensure all relevant stakeholders were able to input into the formation and initiation of the WCB. Of the 38 steering group members, four were “lay members” recruited either through personal contact or via the local patient support groups and/or networks. Three lay members were patients, and one was a caregiver for a cancer patient. These four lay members went on to form the core of the patient and ethics committee, which drafted the ethics application, the patient information sheet and consent form and advised on the proposed patient pathways. They were instrumental in keeping the discussions grounded, ensuring the language and content of the patient documentation was suitable and giving invaluable advice regarding the timing and method of consent.The patient and ethics committee was later reconfigured and revitalised to become the Lay Liaison and Ethics group (LLEG). The group expanded its lay membership further to include a public relations expert, a fundraising expert and additional patients. Mr. Neil Formstone, who was one of the original three patients involved in the steering group and who remained heavily involved as a committed patient advocate until his death in December 2012, initially chaired the new group. The Chair of the LLEG committee is a full member of the WCB Executive group, which is the central pillar of the governance structure responsible for the operational decisions. The Executive group reports to an overarching Advisory Board with a remit to oversee the progression and future strategy of the WCB. The lay voice is, therefore, an integral part of the Executive group and is also heard at Advisory Board meetings where the Executive group is in attendance. The Chair of the Advisory Board is also currently a lay member.The Lay Liaison and Ethics group has expanded further with three new patient members and has concentrated on raising the profile of the biobank through their interactions with patient groups, hospital groups and other organisations, such as Rotary. The members regularly review the communication strategy and are the first port of call for WCB to explore any proposed new processes. The value WCB places on the views and advice of the members of the LLEG committee was recently demonstrated when two suggested new procedures were first presented to the group prior to higher level discussion at the Advisory Board. Electronic consenting and volunteer consenting were both  submitted to the group and only with their support have both schemes been progressed further for more detailed investigation and potential implementation.A sub-committee of members of the Lay Liaison and Ethics group has started to review the lay summaries on the applications that the WCB receives for samples to ensure that they are understandable to a general audience. Researchers will not receive samples until the reviewing LLEG member is satisfied that the content and structure of the lay summary describes the proposed research in terminology suitable for a lay audience. These summaries are uploaded onto the WCB website and feature in the annual report to publicise the projects supported by the collection.Case study 5:Following a deliberate community engagement event in September 2007, patient and public participants created recommendations for the design of the Mayo Clinic Biobank . The hopCase study 6:The Nottingham Health Science Biobank (NHSB) has pioneered an innovative model of patient-led consent which is being piloted and developed with the help of the Biobank PPI Advisory Group, comprising volunteer patients, carers and the public . In thisreceived full mandatory training and induction by the Hospital Trustwere given an Honorary Trust contracthad to sign a confidentiality agreementwere required to have a Criminal Records Bureau (CRB) check and engage with the Independent Safeguarding Authority (ISA) to carry out the Disclosure and Barring Service (DBS)were provided with Hospital badgeswere given free car parking permitswere reimbursed for travel expensesNottingham University Hospitals have 1500 PPI members on their database. To engage the volunteers, an expression of interest was sent to 200 PPI members outlining what the NHSB did, why it was set up and the activities that would be requested for PPI members to become involved in. These activities included the design development and delivery of innovative, effective and user-friendly consenting processes to encourage improved donation activity, delivery of easy-to-understand information for patients and the public, and provision of greater opportunities to share biobank-related news with patients and the public via various media sources on a local, regional and national level. As part of the process, a comprehensive job description was created including the nature of the role for a person consenting, time commitment, support and reporting, confidentiality, probationary period and length of membership. A comprehensive “person specification” also outlined the essential and desirable skills for experience, special attributes and communication skills. From this process, 25 people who were interested in the NHSBs’ activities were identified and invited to a face-to-face meeting. After further consultation with the PPI advocates, nine wished to take part in the consent process for the NHSB. PPI members who wished to take part:a presentation followed by role playshand-holding in the clinic for a minimum of six clinics. This aspect of the training was tailored to the individual and no time limits were setshadowing and reviewdirect observation and final competency sign offsIn addition, the NHSB also produced a comprehensive consent training package which included:Each advocate was also provided with one-to-one training and taken through the full life cycle of biobanking. As part of their ongoing professional development, the PPI advocates are also offered annual appraisals. NHSB have now recruited five PPI Advocates, all of whom have had breast cancer or are the partners of people with a history of breast cancer, to lead the process of consent in this specialist area. Since August 2012, the PPI advocates have been responsible for consenting in five out-patient breast clinics. The new role has had excellent feedback from both patient and the advocates and has led to increases in the rates of consent.The use of PPI advocates to take consent is cost-effective and embeds the patient perspective at the core of the biobanking process. According to NHSB, this is the first description of a novel and broadly applicable approach to consent for biobanking. In addition, the current PPI advocates have expressed an enthusiasm to be involved in training of future biobank volunteers. The NHSB continues to promote PPI and patient and public engagement (PPE) through regular group meetings, open days and speciality targeted workshops.Reflecting a “cultural revolution” in health research over the last two decades, we believe that PPI in biobanking practices and research is here to stay. PPI represents an ideological shift within which patients can take a more central, driving role in research that affects their health and healthcare.This article provides examples of the variety of ways that active patient involvement has been conducted to date. It also provides evidence to support the importance of early and sustained engagement and involvement of patient representatives in biobanks. As more and more biobanks are created in the future, so too will the number of patients and patient organisations that get involved in biobanking, as donors, as active participants and collaborators in research.To facilitate this increased role as collaborators in biobanking, appropriate training is necessary and more information should be disseminated as to how patients can concretely contribute to biobank-based research.In-depth training and educational resources are now available, for example, through the EUPATI’s Expert Patient Training Courses, the EUPATI Internet Library—becoming available in 2016 in seven languages, as well as the Cochrane’s “Consumers for Evidence-Based Healthcare” initiative . In addiOrganising and facilitating PPI activity in biobanking takes considerable time and effort for all stakeholders involved. Therefore, for any biobank operator considering involving patients in their biobanking activities, consideration of best practices, current guidance, ethical issues and evaluation of involvement will be important. To act as reference guide in this regard, the examples of involvement outlined in this article are summarized and illustrated in Fig.


To determine the barriers and enablers to behavioural change to reduce free sugar intake related to dental caries in a sample of UK adults who identify their ethnicity as White.Qualitative study comprising semi-structured interviews of 27 participants. Interviews were recorded, transcribed and analysed using thematic analysis methods. The Capability-Opportunity-Motivation-Behaviour model (COM-B) and the Theoretical Domains Framework (TDF) were used to guide the derivation of themes.Data saturation occurred at 27 interviews. The COM-B Model and TDF domains captured various factors that may influence the consumption of free sugar. TDF elements which are reflected in the study are: Knowledge; Psychological skills; Memory, attention, and decision processes; Behavioural regulation; Physical skills; Social influence; Environmental context and resources; Social and professional role and identity; Beliefs about capabilities; Beliefs about consequence; Intentions and goals reinforcement; and Emotions. COM-B Model elements which are reflected in the study are: psychological capabilities, physical capabilities, social opportunities, physical opportunities, reflective motivation, and automatic motivation.The COM-B model and TDF framework provided a comprehensive account of the barriers and facilitators of reducing sugar intake among white ethnic groups. In addition, the free sugar intake of most ethnic groups in the UK exceeds the goal of <5% of total energy intake; however, the Defra report9–15 indicates that people who identify their ethnicity as White have the highest free sugar intake compared with other ethnic groups in the UK.The rate of free sugar intake among adults in the UK, however, is consistently higher than the WHO recommendation. According to the National Diet and Nutrition Survey UK,16–24 Examples of psychological factors include the perception of sugary beverages; individual choice; knowledge level. Examples of physical factors are the intake of fast food and being passive, e.g., watching TV for long period.23–25 Finally an example of social factor is parental control practices.20Many studies have reported on the factors that contribute to the intake of free sugar, including environmental and context, psychological, physical and social factors. Examples of environmental and context factors include: sources of sugar, prices, food content, availability, accessibility and the advertising of sugary foods, low household income; cultural commitments.17 reducing the availability of beverages,19 educational strategies for both children and parents and develop a policy at both the government and school levels to reduce the intake of beverages.20In addition, there have been several suggestions for interventions to reduce sugar intake including deliver shocking educational messages,26 The participants included 2500 adults  aged 18–75 years old from five European counties, including the UK. The survey identified factors, such as monitoring sugary food intake, searching for foods with low sugar, individuals' perceptions about artificial sweeteners, and their influence on the choice of buying, as factors related to sugar intake.26 While this report highlighted some of the factors that need to be understood in order to encourage individuals to make healthy choices in relation to their sugar intake, the published report did not include details about how the research was conducted, nor how the variables that influence sugar intake were identified.A recent survey conducted in Europe sought to identity consumers' attitudes towards healthy eating.27–30 Interventions based on such models have been shown to be more effective than non-theory based interventions.31 Behaviour change theories and models, such as the theory of planned behaviour and social cognitive theory, have been developed to understand behaviours and achieve behavioural change.32 In many cases, however, these theories and models of behavioural change have failed to facilitate change due to major limitations, such as a lack of focus on the circumstances of how a behaviour occurs or a lack of coherence.34 In contrast, more recently a new model known as the capability-opportunity-motivation-behaviour (COM-B) model has been proposed. The COM-B model aims to understand or analyse behaviours and provide a ‘behavioural diagnosis’.34 According to the COM-B model, an individual's behaviour is the result of an interaction between three main conditions: the individual's capability to perform the behaviour, the opportunity that facilitates the behaviour, and the motivation that promotes the behaviour at a given moment.34–36 The Theoretical Domains Framework (TDF) is a system that consists of 14 domains (constructs) that can be used along with the COM-B model for further analysis of behaviour.37 Both models can be used in conjunction to analyse factors that enhance or prevent the practice of any behaviour.32 Both frameworks have been used in different fields related to health including: assessing barriers and enablers to delivery of the Healthy Kids Check;38 assessing barriers of doctors toward appropriate prescription of older hospitalised patients;39 and development of resource linkage and an IT-enabled health coaching program for disadvantaged Latina moms with recent gestational diabetes.40 In these studies, the TDF framework and COM-B Model, have shown to be useful tools in diagnosing behaviour  and developing interventions that meet the need of individuals in the society.Much of the previous research in this area has not been informed by a theoretical framework of behaviour change, which is essential in the design of effective behaviour change strategies.To date, no studies have employed the COM-B model and/ or TDF to understand the barriers and facilitating factors to the reduction of the intake of free sugar to <5% of the total energy intake among White ethnic adults in the UK. To achieve this a qualitative descriptive method was adopted that provides an in-depth identification of facilitating factors and barriers related to the reduction of free sugar intake to <5% of the total energy intake among White ethnic adults in the UK.What are the potential barriers and facilitators to behavioural change to reduce free sugar intake related to dental caries in a sample of UK adults who identify their ethnicity as White.?41 which were then analysed using Thematic analysis.42Qualitative data were collected through a series of semi-structured interviewsThe sample comprised White ethnic adults aged 18 and over.For the purposes of this study, the White ethnic adults invited to take part were those individuals who live in the UK, spoke English, and identified themselves as White.43 In this study, the sample frame was the staff and students of King’s College London, because this location was more practical than other sites in terms of accessibility. Also, students and staff are from different White ethnic background in the UK, possibly leading to a varied sample population.The sample frame for this study was based on the ‘flow population’ method, which involves a process where samples are purposefully selected from a particular site or setting.43 The selection of the purposive sampling is based on age and ethnicity criteria.For this study, purposive sampling was used as the aim of the study is associated with particular ethnicity and age. For purposive sampling in this study, maximum variation and snowballing methods were used, as these methods allow sampling of participants or individuals based on the selection criteria but in a widely varied manner.Participants were recruited through King’s College London based on the sample criteria. Participants who voluntarily agreed to take part in the study were asked to sign the consent form and fill out an application describing their demographic data. In addition, participants were contacted through email and telephone to provide further details about the study and to arrange an interview appointment.A topic guide was used to guide the interviews. The objectives of the interviews were provided to each participant at the beginning of each session. Privacy and anonymity was emphasised at the commencement of the interviews. The duration of the interviews ranged from 15 to 90 min. One interviewer conducted all of the interviews, which were audio recorded. Participants were informed about the interview taping both in the consent form and before commencing the interview.36 and mapped to the COM-B and TDF elements.The questions were developed based on established guidelinesThe study was approved by the King’s College London Research Ethics Committee Reference: LRS15/16 2651. All participants provided written informed consent.An Amazon voucher valued at £20 was given to participants in appreciation of their time after the interview. The purpose of incentives is to encourage the participants to contribute to the study.42 based on the categories/themes of the TDF and COM-B model. First, the audio file for each interview was imported into the MAXQDA 12 qualitative analysis software for analysis. Second, a theme guide was developed from the already published definitions of the constructs related to the TDF domains and COM-B model elements. In addition, a general criterion related to sugar intake was considered before codes were collated under the themes of TDF. This stage helped to assign all the themes with factors related to sugar intake. Third, after import of the audio files, each file was converted to a transcript for review by the interviewer (SHAR) to ensure consistency of the transcripts with the audio files. A second investigator (JTN) then reviewed a subsample of transcripts and was in agreement with the interviewer. Fourth, excerpts from the transcripts were coded, and relevant codes were collated under a single subtheme and each subtheme was defined. Fifth, each subtheme was mapped to a domain of the TDF. Sixth, the codes, subthemes, and themes were reviewed three times to ensure the validity of the content of each theme. Review of the coding again took place during the mapping and writing stages.The data were analysed thematically44 A similar number of males and females and of staff and students were included. Data saturation occurred at 27 participants. Most were from English, British, Irish, Scottish, and other White ethnic groups. These different categories of white ethnicity are based on ethnicity classifications of Office for National Statistics, UK.The factors that were reported to influence the sugar intake fitted well within the framework of the TDF themes. No comments could be coded to the TDF Optimism theme, which is associated with the Automatic and Reflection elements of COM-B. The following sections describe some of the facilitators and barriers identified in each theme. Please refer to In the context of this study, knowledge can be seen as both a facilitator and a barrier to change in terms of sugar intake behaviour. For example, awareness of healthy and unhealthy foods, including drinks and acidic foods, which can cause caries, as well as awareness of the amount of sugar in food and the time to eat sweets can help to increase the possibility of reducing sugar intake. Please refer to quotes number 1–2 in However, knowledge can be act as barrier to reduce sugar intake. For example lack of knowledge about the term free sugar and sugar and lack of understanding of the recommended free sugar intake per day. Please refer to quotes number 3-4 in The psychological skills identified in this study included the ability to calculate the amount of sugar consumed per day, interpreting the labelling of foods, and assessing the sugar content of foods or meals. Please refer to quotes number 5–6 in However, some of the participants stated that they do not perform sugar assessment when they eat meals. This can act as a barrier towards reducing free sugar intake. Please refer to quote number 7 in Memory, attention, and decision processes include remembering sugar intake advice and the amount of sugar in foods or meals and choosing food with lower sugar or natural sugar increases the possibility of reducing free sugar intake. Please refer to quotes number 8, 9, 10 in In contrast, memory, attention, and decision processes can also act as barriers towards change. For example, some participants indicated that they do not pay attention to or are less focused on sugar intake and identifying sugar content in foods. Instead, attention is paid to food that has been reduced in price or is part of a special offer. Also, some of these participants indicated that when they eat sweet food they think of their body weight rather than their teeth and other participants indicated that they prioritise taste over health. Moreover, some of the participants prioritise frequency of eating free sugar over the amount of free sugar and other participants choose food with low calories instead of food low free sugar. In addition, some of the participants raised concerns about their trust of the labelling system and stating that these concerns influence their decision process to reduce sugar intake. Please refer to quotes number 11–19 in Behavioural regulation factors play an important role in minimising sugar intake. Setting of an action plan for daily sugar intake, selecting small size portions of sweets, and prioritising fresh food can help in reducing sugar intake. Please refer to quotes number 20–21 in Such skills include the selection of cheap and healthy foods, selection of small portions of sweets, cooking/preparing healthy food, not adding sugar to foods or drinks, and the ability to determine the sugar content on food labels. Please refer to quotes number 24–26 in However, some of the participants stated that they add sugar in food. Please refer to quotes number 27 in Parents and friends offer both positive support for the reduction of sugar consumption and a possible negative influence. The participants indicated that parents, for example, can limit the purchase of sweets or sugary foods. Also, trusted members of the family or society can encourage individuals to consume less sugar. Please refer to quotes number 28–29 in In contrast, family members and friends may encourage the purchase of sweets or unhealthy food. Also, individuals can be influenced by a friend’s health condition. Please refer to quotes number 30–31 in The environmental context and resources have a major influence on the consumption of free sugar. The cost of food may promote the consumption of cheap high sugar content foods. Also, the participants stated that social media can promote healthy food choices. Please refer to quotes number 32–33 in Social and professional identities including part experiences, can play an important role in influencing sugar intake. Please refer to quotes number 37–38 in Information 1.However, some participants stated that identities inherited from their parents and culture can increase the consumption of sugar. Also, an individual who was a student or on low-income may buy cheaper unhealthy foods. Please refer to quotes number 39–40 in A belief in your own ability to cook food, that it is easy to identify the amount of sugar in foods, that one is able to quantify sugar intake, that one is able to know sugar content by labels, that sugar content can be found on packaging, and that one can calculate the amount of sugar consumed per day can contribute to the reduction of free sugar intake. Please refer to quotes number 41–42 in In contrast, if the beliefs about individual capabilities are weak or the individual is less confident, these beliefs can easily prevent behaviour change to reduce sugar intake. The following are examples of beliefs that were mentioned by the participants during the interviews: the difficulty of controlling sugar consumption or reducing sugar intake, feeling unable to reduce sweet snacks, the ease of getting sweets, laziness, hard to know the sugar content of meals, difficult to control the influence of advertisements, difficult or impossible to read the labels, and unable to understand the labels. Please refer to quotes number 43–47 in Examples of beliefs about the consequences of sugar intake that will facilitate the reduction in free sugar consumption include the beliefs that sweets have unhealthy consequences and that naturally occurring sugars in fruits and vegetables and cooking food have healthy consequences. Also, the participants believed that placing a picture of tooth decay on food packaging would help them to reduce sugar intake and ultimately would prevent the need for dental treatment. Please refer to quotes number 48–50 in In contrast, the following examples of such beliefs were expressed by the participants act as a barrier to reduce free sugar intake: the belief that exercise alone is sufficient to control weight without a reduction in food intake, the belief that performing exercise to burn energy means that the individual can eat sugary snacks, the belief that fizzy drinks boost energy. In addition, the selection of food with low calorie content can easily prevent behaviour change to reduce sugar intake. Please refer to quotes number 51–53 in Examples of intentions that were expressed by the participants include the intention not to buy sugary foods, to reduce sugar intake; to eat healthy food, and to exercise. The participants indicated that their goals were to improve their fitness level and to reduce body weight. Please refer to quotes number 54–56 in Social and professional roles and identities may influence free sugar intake unconsciously through automatic processes and choices. Routine cooking habits and parents’ modelling of cooking meals consisting of low-sugar foods can promote the reduction of free sugar intake to <5% of the total energy intake. Please refer to quotes number 59–60 in However, habits can act as barriers toward reduce for sugar intake. For instance, the habit of sharing food with others and annual holidays can also increase the risk of consuming more sugar. Please refer to quotes number 61–62 in Reinforcement is thought to have a crucial role in facilitating reduced sugar intake. In the context of this study, reinforcement was associated with interventions as a facilitator of reduced free sugar consumption. Colour-coded labelling reinforces the selection of healthy food. Another example of positive reinforcement is the perceived reward of burning off energy through exercise and education about the effects of sugar reinforcing decisions about healthy food selection. Please refer to quotes number 64–65 in Participants reported both negative and positive emotions associated with the consumption of sweet foods, for example feelings of guilt after eating sweets, enjoying the taste of fruits and drinks without artificial sugar, love of having fruits with a main meal or as a snack, and dislike of sugary foods. Please refer to quotes number 66–67 in In contrast, emotions can also drive individuals towards increased sugar consumption, serving as a strong barrier towards behaviour change. The following are examples of emotions that can prevent reduction of sugar intake to <5% of the total energy intake: cravings for fizzy drinks and sweets, love of Coca-Cola, enjoyment of tasty foods, consideration of sweets as treats, the love of a bargain, and no interest in counting sugars in foods. Please refer to quotes number 68–71 in In Summary, 12 TDF elements are identified as being relevant to reducing free sugar intake to <5% of the total energy: Knowledge; Psychological Skills; Memory, Attention, and Decision Processes; Behavioural Regulation; Physical Skills; Social influence; Environmental context and resources; Social and professional role and identity; Beliefs about Capabilities; Beliefs about Consequence; Intentions and Goals; Reinforcement; and Emotions. Six of the COM-B Model elements which are relevant to reducing free sugar intake to <5% of the total energy: Psychological capabilities Physical capabilities Social Opportunities Physical Opportunities; Reflective Motivation; and Automatic Motivation.38–40 This comprehensiveness of the COM-B model and the TDF domains has enabled the research to capture more factors related to free sugar intake than have been reported by previous studies.16–25 The factors are related to the following domains of TDF: Knowledge; Psychological Skills; Memory, Attention, and Decision Processes; Behavioural Regulation; Physical Skills; Social influence; Environmental context and resources; Social and professional role and identity; Beliefs about Capabilities; Beliefs about Consequence; Intentions and Goals; Reinforcement; and Emotions. From all 14 domains of TDF, the only exception to the framework, was that none of the participants’ comments could be mapped to the Optimism theme of Motivation. Altogether, these findings clearly indicated that the six elements of the COM-B model and the 14 domains of the TDF are relevant to behaviour change to reduce sugar intake.The aim of this study was to explore the barriers and enablers to behavioural change to reduce free sugar intake related to dental caries in a sample of UK adults who identify their ethnicity as White. The findings from the study indicated that the COM-B model and the TDF domains provided a comprehensive framework for the description of the facilitators of and barriers to behaviour change to reducing sugar intake. This has been reported by other studies in different fields.In this study there were some limitations. one of the anticipated limitations in the study was the possible recruitment of participants from a middle-class academic setting only and that these participants would have little or no caries. Such a population would not reflect the full social range of the White ethnic groups in the UK, though some of the student participants reported coming from the lower social classes. Another limitation was that the authors were unable to assess the sugar content of the participants’ daily meals, as the brands and types of food were not verified in most of the cases. Despite these limitations, we conclude that this study highlighted many crucial factors that influence sugar intake in this population.The COM-B model and TDF framework provided an inclusive account of the barriers and facilitators of reducing sugar intake among white ethnic groups. Although the study had some limitations, we believe that the COM-B model and TDF can be useful for the development of strategies to address specific facilitators and barriers of the implementation of interventions that aim to reduce sugar intake to <5% of the total energy intake in relation to dental caries.