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Objectives: Dysfunction after transient ischaemic attack (TIA) and minor stroke is often underestimated by clinical measures. Patient-reported outcome measures used in value-based healthcare may help in detecting these problems. The Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health) is a concise patient-centred outcome measuring tool proposed for assessing health status in patients who had stroke. This study aims to address the validity of the Dutch PROMIS-10 in patients who had stroke in the Netherlands and also aims to compare telephone versus on-paper assessment., Design: Observational cohort study., Setting: Single-centre hospital in the Netherlands., Participants: 75 patients who were diagnosed with TIA or minor stroke and discharged without rehabilitation treatment 1 year ago (between December 2014 and January 2016) completed the study., Primary and Secondary Outcome Measures: PROMIS-10 physical (PH) and mental health (MH) scores assessed 1 year poststroke on paper (n=37) and by telephone (n=38) was compared with RAND-36 physical and mental component scores assessed on paper., Results: PROMIS-10 and RAND-36 correlated significantly in PH, r=0.81 (95% CI 0.69 to 0.88), and MH, r=0.76 (95% CI 0.64 to 0.85). Paper-and-pencil assessed correlations were r=0.87 and 0.79 for PH and MH, respectively. Telephone assessed correlations were r=0.76 and 0.73 for PH and MH, respectively. Internal consistency analysis indicated high reliabilities for both health components of the PROMIS-10, all Cronbach's α>0.70., Conclusions: The Dutch PROMIS-10 was found to strongly correlate with the RAND-36. Paper-and-pencil assessment was found to have a higher correlation than telephone assessment. This study provides support for the use of the Dutch PROMIS-10 in assessing health status in patients after TIA and minor stroke., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The predominant provider payment models in healthcare, particularly fee-for-service, hinder the delivery of high-value care and can encourage healthcare providers to prioritise the volume of care over the value of care. To address these issues, healthcare providers, payers and policymakers are increasingly experimenting with alternative payment models (APMs), such as shared savings (SS) and bundled payment (BP). Despite a growing body of literature on APMs, there is still limited insight into what works in developing and implementing successful APMs, as well as how, why and under what circumstances. This paper presents the protocol for a study that aims to (1) identify these circumstances and reveal the underlying mechanisms through which outcomes are achieved and (2) identify transferrable lessons for successful APMs in practice., Methods and Analysis: Drawing on realist evaluation principles, this study will employ an iterative three-step approach to elicit a programme theory that describes the relationship between context, mechanisms and outcomes of APMs. The first step involves a literature review to identify the initial programme theory. The second step entails empirical testing of this theory via a multiple case study design including seven SS and BP initiatives in Dutch hospital care. We will use various qualitative and quantitative methods, including interviews with involved stakeholders, document analysis and difference-in-differences analyses. In the final step, these data and the applicable formal theories will be combined to test and refine the (I)PT and address the research objectives., Ethics and Dissemination: Ethical approval has been granted by the Research Ethics Review Committee of Erasmus School of Health Policy and Management (Project ID ETH2122-0170). Where necessary, informed consent will be obtained from study participants. Among other means, study results will be disseminated through a publicly available manual for stakeholders (eg, healthcare providers and payers), publications in peer-reviewed scientific journals and (inter)national conference presentations., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The liberal use of blood cultures in emergency departments (EDs) leads to low yields and high numbers of false-positive results. False-positive, contaminated cultures are associated with prolonged hospital stays, increased antibiotic usage and even higher hospital mortality rates. This trial aims to investigate whether a recently developed and validated machine learning model for predicting blood culture outcomes can safely and effectively guide clinicians in withholding unnecessary blood culture analysis., Methods and Analysis: A randomised controlled, non-inferiority trial comparing current practice with a machine learning-guided approach. The primary objective is to determine whether the machine learning based approach is non-inferior to standard practice based on 30-day mortality. Secondary outcomes include hospital length-of stay and hospital admission rates. Other outcomes include model performance and antibiotic usage. Participants will be recruited in the EDs of multiple hospitals in the Netherlands. A total of 7584 participants will be included., Ethics and Dissemination: Possible participants will receive verbal information and a paper information brochure regarding the trial. They will be given at least 1 hour consideration time before providing informed consent. Research results will be published in peer-reviewed journals. This study has been approved by the Amsterdam University Medical Centers' local medical ethics review committee (No 22.0567). The study will be conducted in concordance with the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act, General Data Privacy Regulation and Medical Device Regulation., Trial Registration Number: NCT06163781., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: The majority of adolescents do not meet guidelines for healthy behaviours, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway. How to develop and implement sustainable and effective interventions focused on adolescent health and well-being in urban vulnerable life situations is a key challenge. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions., Methods and Analysis: In diverse urban environments in Denmark, the Netherlands, Nigeria and South Africa, we will engage a dynamic group of 15-20 adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (eg, policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system; tailoring; implementing and evaluating interventions during participatory meetings over the course of 3 years. YoPA applies a participatory mixed methods design guided by a novel Systems, User perspectives, Participatory co-creation process, Effects, Reach, Adoption, Implementation and Maintenance framework assessing: (i) the local systems, (ii) user perspectives, (iii) the participatory co-creation process, (iv) effects, (v) reach, (vi) adoption, (vii) implementation and (viii) maintenance of interventions. Through a realist evaluation, YoPA will explore why and how specific outcomes were reached (or not) in each setting (n=800-1000 adolescents in total)., Ethics and Dissemination: This study received approval from the ethics committees in Denmark, the Netherlands, Nigeria and South Africa and will be disseminated via various collaborative dissemination activities targeting multiple audiences. We will obtain informed consent from all participants. We envision that our YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally., Trial Registration Number: NCT06181162., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Ageing in place (AIP) for persons with dementia is encouraged by European governments and societies. Healthcare packages may need reassessment to account for the preferences of care funders, patients and informal caregivers. By providing insight into people's preferences, discrete choice experiments (DCEs) can help develop consensus between stakeholders. This protocol paper outlines the development of a Dutch national study to cocreate a healthcare package design methodology built on DCEs that is person-centred and helps support informal caregivers and persons with dementia to AIP. A subpopulation analysis of persons with dementia with a migration background is planned due to their high risk for dementia and under-representation in research and care., Methods and Analysis: The DCE is designed to understand how persons with dementia and informal caregivers choose between different healthcare packages. Qualitative methods are used to identify and prioritise important care components for persons with dementia to AIP. This will provide a list of care components that will be included in the DCE, to quantify the care needs and preferences of persons with dementia and informal caregivers. The DCE will identify individual and joint preferences to AIP. The relative importance of each attribute will be calculated. The DCE data will be analysed with the use of a random parameters logit model., Ethics and Dissemination: Ethics approval was waived by the Amsterdam University Medical Center (W23_112 #23.137). A study summary will be available on the websites of Alzheimer Nederland, Pharos and Amsterdam Public Health institute. Results are expected to be presented at (inter)national conferences, peer-reviewed papers will be submitted, and a dissemination meeting will be held to bring stakeholders together. The study results will help improve healthcare package design for all stakeholders., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: Hashimoto's thyroiditis (HT) is a common endocrine autoimmune disease affecting roughly 5% of the general population and involves life-long treatment with levothyroxine, as no curative treatment yet exists. Over the past decade, the crosstalk between gut microbiota and the host immune system has been well-recognised, identifying the gut microbiome as an important factor in host health and disease, including susceptibility to autoimmune diseases. Previous observational studies yielded a link between disruption of the gut microbiome composition and HT. This is the first study that investigates the potential of restoring a disrupted gut microbiome with faecal microbiota transplantations (FMTs) to halt disease progression and dampen autoimmunity., Methods and Analysis: The IMITHOT trial is a randomised, double-blinded, placebo-controlled study evaluating either autologous or allogenic FMTs in medication-naïve patients with subclinical autoimmune hypothyroidism. In total, 34 patients will be enrolled to receive either three allogenic or autologous FMTs. FMT will be made of fresh stool and directly administered into the duodenum. Patients will be evaluated at baseline before the first FMT is administered and at 6, 12 and 24 months post-intervention to assess efficacy and adverse events. The primary outcome measure will be the net incremental increase (incremental area under the curve) on thyrotropin-stimulated free thyroxine and free triiodothyronine release at 6 and 12 months compared with baseline. Results will be disseminated via peer-reviewed journals and international conferences. The recruitment of the first patient and donor occurred on 18 December 2019., Ethics and Dissemination: Ethics approval was obtained from the hospital Ethics Committee (Medical Ethics Committee) at Amsterdam University Medical Center. The trial's outcomes offer high-quality evidence that aids in unveiling distinct patterns within the gut microbiota potentially associated with improved thyroid function. Consequently, this may open avenues for the future clinical applications of microbial-targeted therapy in individuals at risk of developing overt HT., Trial Registration Number: NL7931., Competing Interests: Competing interests: MN is co-founder and member of the Scientific Advisory Board of Caelus Pharmaceuticals, the Netherlands. None of these are directly relevant to the current paper. There are no patents, products in development or marketed products to declare. The other authors declare no competing financial interests., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Chest pain is a common reason for consultation in primary care. To rule out acute coronary syndrome (ACS), general practitioners (GP) refer 40%-70% of patients with chest pain to the emergency department (ED). Only 10%-20% of those referred, are diagnosed with ACS. A clinical decision rule, including a high-sensitive cardiac troponin-I point-of-care test (hs-cTnI-POCT), may safely rule out ACS in primary care. Being able to safely rule out ACS at the GP level reduces referrals and thereby alleviates the burden on the ED. Moreover, prompt feedback to the patients may reduce anxiety and stress., Methods and Analysis: The POB HELP study is a clustered randomised controlled diagnostic trial investigating the (cost-)effectiveness and diagnostic accuracy of a primary care decision rule for acute chest pain, consisting of the Marburg Heart Score combined with a hs-cTnI-POCT (limit of detection 1.6 ng/L, 99th percentile 23 ng/L, cut-off value between negative and positive used in this study 3.8 ng/L). General practices are 2:1 randomised to the intervention group (clinical decision rule) or control group (regular care). In total 1500 patients with acute chest pain are planned to be included by GPs in three regions in The Netherlands. Primary endpoints are the number of hospital referrals and the diagnostic accuracy of the decision rule 24 hours, 6 weeks and 6 months after inclusion., Ethics and Dissemination: The medical ethics committee Leiden-Den Haag-Delft (the Netherlands) has approved this trial. Written informed consent will be obtained from all participating patients. The results of this trial will be disseminated in one main paper and additional papers on secondary endpoints and subgroup analyses., Trial Registration Numbers: NL9525 and NCT05827237., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Purpose: The Netherlands Longitudinal Study on Hearing (NL-SH) was set up to examine associations of hearing ability with psychosocial, work and health outcomes in working age adults., Participants: Inclusion started in 2006 and is ongoing. Currently the sample comprises 2800 adults with normal and impaired hearing, aged 18-70 years at inclusion. Five-year follow-up started in 2011, 10-year follow-up in 2016 and 15-year follow-up in 2021. All measurements are web-based. Participants perform a speech-in-noise recognition test to measure hearing ability and fill out questionnaires about their hearing status, hearing aid use, self-reported hearing disability and coping, work status and work-related outcomes (work performance, need for recovery), physical and psychosocial health (depression, anxiety, distress, somatisation, loneliness), healthcare usage, lifestyle (smoking, alcohol), and technology use., Findings to Date: The NL-SH has shown the vast implications of reduced hearing ability for the quality of life and health of working-age adults. A selection of results published in 27 papers is presented. Age-related deterioration of hearing ability accelerates after the age of 50 years. Having a history of smoking is associated with a faster decline in hearing ability, but this relationship is not found for other cardiovascular risk factors. Poorer hearing ability is associated with increased distress, somatisation, depression and loneliness. Adults with impaired hearing ability are more likely to be unemployed or unfit for work, and need more time to recuperate from work effort., Future Plans: Participant data will be linked to a national database to enable research on the association between hearing ability and mortality. Linking to environmental exposure data will facilitate insight in relations between environmental factors, hearing ability and psychosocial outcomes. The unique breadth of the NL-SH data will also allow for further research on other functional problems, for instance, hearing ability and fall risk., Trial Registration Number: NL12015.029.06., Competing Interests: Competing interests: MFvW, LAJ, TG, MS, JN, JHMvB, JRA, BIL-W, CS and SEK none. UL is affiliated with Sonova AG, one of the funding entities., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The medical field is facing a clinician-scientist shortage. Medical schools could foster the clinician-scientist workforce by offering students research opportunities. Most medical schools offer elective research programmes. Subsequently, a subset of doctors graduates without any research experience. Mandatory research projects may be more sufficient to develop clinician-scientist, but take more supervision and curricular time. There is limited insight in the scientific outcomes of mandatory research experiences. This study aims to examine publication rates of a mandatory research experience, identify factors associated with publication, and includes postgraduate research engagement., Design and Setting: Prospective follow-up study involving 10 cohorts of medical students' mandatory research projects from Leiden University Medical Center., Participants: All medical students who conducted their research project between 2008 and 2018 (n=2329) were included., Main Outcome Measure: Publication rates were defined as peer-reviewed scientific publications, including research papers, reviews, and published meeting abstracts. Postgraduate research engagement was defined as research participation and dissemination of research at scientific conferences or in journals., Results: In total, 644 (27.7%) of all mandatory research experiences resulted in publication, with students mainly as first (n=984, 42.5%) or second author (n=587, 25.3%) and above world average citation impact (mean normalised journal score 1.29, mean normalised citation score 1.23). Students who conducted their research in an academic centre (adjusted OR 2.82; 95% CI 2.10 to 3.77), extended their research (adjusted OR 1.73; 95% CI 1.35 to 2.20), were involved in an excellency track (adjusted OR 2.08; 95% CI 1.44 to 3.01), or conducted clinical (adjusted OR 2.08; 95% CI 1.15 to 3.74) or laboratory (adjusted OR 2.16; 95% CI 1.16 to 4.01) research published their research more often. Later as junior doctors, this group significantly more often disseminate their research results at scientific conferences (adjusted OR 1.89; 95% CI 1.11 to 3.23) or in journals (adjusted OR 1.98; 95% CI 1.14 to 3.43)., Conclusions: Our findings suggest that a significant subset of hands-on mandatory research projects with flexible learning pathways result in tangible research output with proper impact and that such successful experiences can be considered as diving board towards a research-oriented career., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: While the uptake of value-based health care (VBHC) is remarkable, uncertainty prevails regarding the most important actions and practices in establishing a value-based healthcare system. In this paper, we generate expert consensus on the most important aspects of VBHC., Design: The Delphi technique was used to reach consensus on the most important practices in moving towards a value-based healthcare system., Setting and Participants: A Dutch expert panel consisting of nine members participated in a two-round survey., Primary and Secondary Outcome Measures: We developed 39 initial items based on the pioneering literature on VBHC and recent health policies in the Netherlands. Experts rated the importance of each item on a 4-point Likert scale. Experts could change items or add new ones as they saw fit. We retained items that were rated (very) important by ≥80% of the panel., Results: After two survey rounds, 32 items (72%) were included through expert consensus. Experts unanimously agree on the importance of shared decision-making, with this item uniquely obtaining the maximum score. Experts also reached consensus on the importance of outcome measurements, a focus on medical conditions, and full cycles of care. No consensus was reached on the importance of benchmarking., Conclusion: This paper provides new insight into the most important actions and practices for establishing a value-based healthcare system in the Netherlands. Interestingly, several of our findings contrast with the pioneering literature on VBHC. This raises the question whether VBHC's widespread international uptake indicates its actual implementation, or rather that the original concept primarily serves as an inspiring idea., Competing Interests: Competing interests: The fourth author, DD, is professor at the Erasmus University Rotterdam while also employed at Zorginstituut Nederland (National Health Care Institute), which partially funds this research., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Introduction: This paper outlines the study protocol for the Dutch Young People (YP) Face IT Study. Adolescents with a visible difference (ie, disfigurement) often experience challenging social situations such as being stared at, receiving unwanted questions or being teased. As a consequence, some of these adolescents experience adverse psychosocial outcomes and appearance-related distress. To address this appearance-related distress, an online psychotherapeutic intervention, YP Face IT, has been developed. YP Face IT uses social interaction skills training and cognitive-behavioural therapy. The Dutch YP Face IT Study tests whether this intervention is effective in reducing social anxiety and improving body esteem., Methods and Analysis: Participants are adolescents aged 12-18 with a visible difference and experiencing appearance-related distress. In this two-armed randomised controlled trial, 224 adolescents will be randomised to care as usual or YP Face IT. Adolescents will complete questionnaires at baseline, at 13 weeks and at 25 weeks. Primary outcomes are differences in social anxiety and body esteem between YP Face IT and care as usual. Secondary outcomes are differences in aspects of self-worth, perceived stigmatisation, health-related quality of life, life engagement, appearance-related distress and depressive symptoms between the two groups., Ethics and Dissemination: Research ethics approval was obtained from the medical ethics review committee in Rotterdam (reference number MEC-2018-052/NL63955.078.18). Findings will be disseminated through academic peer-reviewed publications, conferences and newsletters to patient associations and participants of the study., Trial Registration Number: The Netherlands Trial Register (NL7626)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Introduction: The number of people that have one or multiple condition(s) with a chronic course is rising, which consequently challenges healthcare systems. Healthcare geared to long-term care should focus on patient-centredness, shared decision making and self-management. The Assessment of Burden of Chronic Conditions (ABCC) tool was developed to integrate these elements in daily healthcare practice. The ABCC tool assesses and visualises burden of disease(s), helps to make shared decisions and stimulates self-management. The present paper documents a protocol for a quasi-experimental study investigating the effectiveness and cost-effectiveness of the ABCC tool for people with chronic obstructive pulmonary disease, asthma, type 2 diabetes mellitus and/or heart failure., Methods and Analysis: The study has a pragmatic clustered quasi-experimental design and will be conducted in the Netherlands. The intervention will be allocated at the level of general practice. The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care. Outcomes include change in quality of care (Patient Assessment of Chronic Illness Care), quality of life (EuroQol-5D-5L), capability well-being (ICEpop CAPability measure for Adults), patients' activation (Patient Activation Measure) and costs. Follow-up time will be 18 months. Outcomes will be analysed using linear mixed models., Ethics and Dissemination: Ethical approval was obtained from the Medical Ethics Committee Zuyderland-Zuyd Heerlen, the Netherlands (METCZ20180131). Results will be published in peer-reviewed journals and will be presented at national and international conferences., Trial Registration Number: ClinicalTrials.gov Registry (NCT04127383)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The course of the disease in SARS-CoV-2 infection in mechanically ventilated patients is unknown. To unravel the clinical heterogeneity of the SARS-CoV-2 infection in these patients, we designed the prospective observational Maastricht Intensive Care COVID cohort (MaastrICCht). We incorporated serial measurements that harbour aetiological, diagnostic and predictive information. The study aims to investigate the heterogeneity of the natural course of critically ill patients with a SARS-CoV-2 infection., Methods and Analysis: Mechanically ventilated patients admitted to the intensive care with a SARS-CoV-2 infection will be included. We will collect clinical variables, vital parameters, laboratory variables, mechanical ventilator settings, chest electrical impedance tomography, ECGs, echocardiography as well as other imaging modalities to assess heterogeneity of the course of a SARS-CoV-2 infection in critically ill patients. The MaastrICCht is also designed to foster various other studies and registries and intends to create an open-source database for investigators. Therefore, a major part of the data collection is aligned with an existing national intensive care data registry and two international COVID-19 data collection initiatives. Additionally, we create a flexible design, so that additional measures can be added during the ongoing study based on new knowledge obtained from the rapidly growing body of evidence. The spread of the COVID-19 pandemic requires the swift implementation of observational research to unravel heterogeneity of the natural course of the disease of SARS-CoV-2 infection in mechanically ventilated patients. Our study design is expected to enhance aetiological, diagnostic and prognostic understanding of the disease. This paper describes the design of the MaastrICCht., Ethics and Dissemination: Ethical approval has been obtained from the medical ethics committee (Medisch Ethische Toetsingscommissie 2020-1565/3 00 523) of the Maastricht University Medical Centre+ (Maastricht UMC+), which will be performed based on the Declaration of Helsinki. During the pandemic, the board of directors of Maastricht UMC+ adopted a policy to inform patients and ask their consent to use the collected data and to store serum samples for COVID-19 research purposes. All study documentation will be stored securely for fifteen years after recruitment of the last patient. The results will be published in peer-reviewed academic journals, with a preference for open access journals, while particularly considering deposition of the manuscripts on a preprint server early., Trial Registration Number: The Netherlands Trial Register (NL8613)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Chemotherapy is the mainstay of treatment for patients with advanced soft tissue sarcomas (STS). Treatment intent is usually palliative, aiming to improve symptoms, stabilise or reduce tumour burden and extend life. Clinical trials have traditionally used radiological response, time to progression and survival as measures of treatment efficacy. Health-related quality of life (HRQoL) is at least equally important or more important than survival for many patients with advanced cancer. Systematically collecting HRQoL data during chemotherapy can provide greater insight into treatment efficacy from the patient perspective.The primary aims of this study are to evaluate HRQoL in patients with advanced STS treated with chemotherapy over time, explore the decision-making process and patient reflection post-treatment., Methods and Analysis: This is an observational, international cohort study for 132 patients aged ≥18 years with advanced STS treated at eight centres (three in the UK, five in the Netherlands). Patients will be recruited prior to starting first-line or third-line chemotherapy and invited to complete questionnaires using the Patient-Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship registry (PROFILES); an established international registry for collection of cancer patient-reported outcomes. Online (or paper) questionnaires will be completed at baseline, each cycle of chemotherapy and 2-3 monthly during follow-up. The questionnaire package includes the Decisional Conflict Scale, Control Preferences Scale, Quality-Quantity Questionnaire, treatment expectations, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30), EORTC financial toxicity items, Work Ability Index, Functional Assessment of Cancer Therapy-General (FACT-G) items and Decisional Regret Scale. Clinical data will be extracted from patient records and linked with questionnaire responses. The primary outcome measure is the change in global HRQoL from baseline to after cycle 4 of first-line chemotherapy (based on published data showing that patients with advanced STS complete a median number of four cycles of first-line chemotherapy)., Ethics and Dissemination: Heath Research Authority and Research Ethics Committee (REC 17/NI/0197). Results from the Health-related quality Of Life In patients with advanced Soft TIssue sarcomas treated with Chemotherapy (HOLISTIC) study will be published in peer-reviewed journals and disseminated at local, national and international conferences. We will also present our findings at any appropriate patient meetings and involve patients in study-related publications., Trial Registration Number: NCT03621332., Competing Interests: Competing interests: RLJ is a consultant for: Adaptimmune, Blueprint, Clinigen, Eisai, Epizyme, Daichii, Deciphera, Immunedesign, Lilly, Merck, Pharmamar. WTAvDG has received research grants from Novartis and has been on advisory board from Bayer. The other authors declare that they have no competing interests., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Exposure to poor environmental conditions has been associated with deterioration of physical and mental health, and with reduction of cognitive performance. Environmental conditions may also influence cognitive development of children, but epidemiological evidence is scant. In developed countries, children spend 930 hours per year in a classroom, second only to time spent in their bedroom. Using continuous sensing technology, we investigate the relationship between indoor environmental quality (IEQ) and cognitive performance of school-aged children. The proposed study will result in a better understanding of the effects of environmental characteristics on cognitive performance, thereby paving the way for experimental studies., Methods and Analysis: A study protocol is presented to reliably measure IEQ in schools. We will monitor the IEQ of 280 classrooms for 5 years, covering approximately 10 000 children. Each classroom in the sample is permanently equipped with a sensor measuring air quality (carbon dioxide and coarse particles), temperature, relative humidity, light intensity and noise levels, all at 1 min intervals. The location of sensing equipment within and across rooms has been validated by a pilot study. Academic performance of school-aged children is measured through standardised cognitive tests. In addition, a series of health indicators is collected (eg, school absence and demand for healthcare), together with an extensive set of sociodemographic characteristics (eg, parental income, education, occupational status)., Ethics and Dissemination: Medical Ethical Approval for the current study was waived by the Medical Ethical Committee azM/UM (METC 2018-0681). In addition, data on student performance and health stems from an already existing data infrastructure that are granted with ethical approval by the Ethical Review Committee Inner City faculties (ERCIC_092_12_07_2018). Health data are obtained from the 'The Healthy Primary School of the Future' (HPSF) project. Medical Ethical Approval for HPSF was waived by the Medical Ethical Committee of Zuyderland, Heerlen (METC 14 N-142). The HPSF study protocol was registered in the database ClinicalTrials.gov on 14-06-2016 with reference number NCT02800616, this study is currently in the Results stage. Data collection from Gemeentelijke Gezondheidsdienst Zuid-Limburg (GGD-ZL) is executed by researchers of HPSF, this procedure has been fully approved by the Medical Ethical Committee of Zuyderland. The questionnaires on level of comfort will be filled in anonymously by students and teachers. The study will follow the EU General Data Protection Regulation (EU GDPR) and Dutch data protection law to ensure protection of personal data, as well as maintain proper data management and anonymisation.The protocol discussed in this paper includes significant efforts focused on integrating results and making them available to both the scientific community and the wider public, including policy makers. The results will lead to multiple scientific articles that will be disseminated through peer-reviewed international journals, as well as through conference presentations. In addition, we will exploit ongoing collaboration with project stakeholders and project partners to disseminate information to the target audience. For example, the results will be presented to school boards in the Netherlands, through engagement with the Coalition for Green Schools, as well as to school boards in USA, through engagement with the Center for Green Schools., Trial Registration Number: NCT02800616; Results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Because of the lack of prehospital protocols to rule out a non-ST-segment elevation acute coronary syndrome (NSTE-ACS), patients with chest pain are often transferred to the emergency department (ED) for thorough evaluation. However, in low-risk patients, an ACS is rarely found, resulting in unnecessary healthcare consumption. Using the HEART (History, ECG, Age, Risk factors and Troponin) score, low-risk patients are easily identified. When a point-of-care (POC) troponin measurement is included in the HEART score, an ACS can adequately be ruled out in low-risk patients in the prehospital setting. However, it remains unclear whether a prehospital rule-out strategy using the HEART score and a POC troponin measurement in patients with suspected NSTE-ACS is cost-effective., Methods and Analysis: The ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) presentation at the ED (control group) or (2) POC troponin T measurement (intervention group) and transfer of the care to the general practitioner in case of a low troponin T value. In total, 866 patients will be included. Follow-up will be performed after 30 days, 6 months and 12 months., Ethics and Dissemination: This trial has been accepted by the Medical Research Ethics Committee region Arnhem-Nijmegen. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses., Trial Registration Number: Netherlands Trial Register (NL7148)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Patients with non-muscle-invasive bladder cancer (NMIBC) have a good survival but are at high risk for tumour recurrence and disease progression. It is important to identify lifestyle habits that may reduce the risk of recurrence and progression and improve health-related quality of life (HRQOL). This paper describes the rationale and design of the UroLife study. The main aim of this study is to evaluate whether lifestyle habits are related to prognosis and HRQOL in patients with NMIBC., Methods and Analysis: The UroLife study is a multicentre prospective cohort study among more than 1100 newly diagnosed patients with NMIBC recruited from 22 hospitals in the Netherlands. At 6 weeks and 3, 15 and 51 months after diagnosis, participants fill out a general questionnaire, and questionnaires about their lifestyle habits and HRQOL. At 3, 15 and 51 months after diagnosis, information about fluid intake and micturition is collected with a 4-day diary. At 3 and 15 months after diagnosis, patients donate blood samples for DNA extraction and (dietary) biomarker analysis. Tumour samples are collected from all patients with T1 disease to assess molecular subtypes. Information about disease characteristics and therapy for the primary tumour and subsequent recurrences is collected from the medical records by the Netherlands Cancer Registry. Statistical analyses will be adjusted for age, gender, tumour characteristics and other known confounders., Ethics and Dissemination: The study protocol has been approved by the Committee for Human Research region Arnhem-Nijmegen (CMO 2013-494). Patients who agree to participate in the study provide written informed consent. The findings from our study will be disseminated through peer-reviewed scientific journals and presentations at (inter)national scientific meetings. Patients will be informed about the progress and results of this study through biannual newsletters and through the website of the study and of the bladder cancer patient association., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Environmental exposures are intertwined with mental health outcomes. People are exposed to the environments in which they currently live, and to a multitude of environments along their daily movements and through their residential relocations. However, most research assumes that people are immobile, disregarding that such dynamic exposures also serve as stressors or buffers potentially associated with depression and suicide risk. The aim of the Dynamic Urban Environmental Exposures on Depression and Suicide (NEEDS) study is to examine how dynamic environmental exposures along people's daily movements and over their residential histories affect depression and suicide mortality in the Netherlands., Methods and Analysis: The research design comprises two studies emphasising the temporality of exposures. First, a cross-sectional study is assessing how daily exposures correlate with depression. A nationally representative survey was administered to participants recruited through stratified random sampling of the population aged 18-65 years. Survey data were enriched with smartphone-based data (eg, Global Positioning System tracking, Bluetooth sensing, social media usage, communication patterns) and environmental exposures (eg, green and blue spaces, noise, air pollution). Second, a longitudinal population register study is addressing the extent to which past environmental exposures over people's residential history affect suicide risk later in life. Statistical and machine learning-based models are being developed to quantify environment-health relations., Ethics and Dissemination: Ethical approval (FETC17-060) was granted by the Ethics Review Board of Utrecht University, The Netherlands. Project-related findings will be disseminated at conferences and in peer-reviewed journal papers. Other project outcomes will be made available through the project's web page, http://www.needs.sites.uu.nl., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The aim of this paper is to construct a theoretical framework for information and communication technology (ICT)-enabled partnership towards diabetes management., Design: We conducted an inductive case study and held interviews on the development and use of an artificial pancreas (AP) system for diabetes management., Setting: The study was carried out in the Netherlands with users of an AP system., Participants: We interviewed six patients with type 1 diabetes, five healthcare professionals (two medical specialists and three diabetes nurses), and one policy advisor from the Ministry of Health, Welfare and Sport., Results: We built a new theoretical framework for ICT-enabled person-centred diabetes management, covering the central themes of self-managing the disease, shared analysing of (medical) data and experiencing the partnership. We found that ICT yielded new activities of data sharing and a new role for data professionals in the provision of care as well as contributed to carefree living thanks to the semiautomated management enabled by the device. Our data suggested that to enable the partnership through ICT, organisational adjustments need to be made such as the development of new ICT services and a viable financial model to support these services., Conclusion: The management of diabetes through ICT requires an adjustment of the partnership between persons with the chronic condition and the healthcare professional(s) in such a way that the potential for self-managing the condition by analysing the newly available (medical) data (from the AP system) together leads to an experience of partnership between patients and healthcare professionals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Urinary tract infections (UTIs) are an important reason to consult a general practitioner (GP). Here, we describe antimicrobial drug prescribing patterns for UTIs by GPs in relation to the Dutch primary care guidelines., Methods: We conducted a population-based cohort study in the Dutch Integrated Primary Care Information (IPCI)database, which encompasses approximately 2.5 million patients. All patients aged ≥12 years with at least 1 year of follow-up from 1996 to 2014 were extracted from the database. The number of prescriptions and choice of drug type were investigated over time and in different age categories. The choice of antimicrobial drug classes for UTIs and the duration of nitrofurantoin use in women were compared with the Dutch primary care guidelines of 1989, 1999, 2005 and 2013., Results: The source population comprised 1 755 085 patients who received 2 019 335 antimicrobial drug prescriptions; 401 655 (35.1%) prescriptions were for UTIs (45.2% in women and 12.6% in men). The proportion of prescriptions for UTIs within all prescriptions with an indication code increased from 5.2% in 1996 to 14% in 2014 in men and from 28% in 1996 to 50% in 2014 in women. In men, UTIs were most frequently treated with fluoroquinolones during the entire study period, whereas fluoroquinolones were only advised as first choice in the latest guideline of 2013. In women, UTIs were increasingly (p<0.05) treated with nitrofuran derivatives with a statistically significant difference after implementation of the guideline of 2005. Compliance to the advised duration of nitrofurantoin prescriptions in women has increased since the guideline of 2005., Conclusions: Antimicrobial drug prescribing for UTIs seemed to have increased over time. Prescribing in line with the UTI guidelines increased with regard to choice and duration of antimicrobial drugs. We showed that databases like IPCI, in which prescription and indication are monitored, can be valuable antibiotic stewardship tools., Competing Interests: Competing interests: KV works for a department that in the past received unconditional grants from Pfizer/BI, Yamanouchi, GSK and Novartis, none of which are related to the content of this paper. The other authors have nothing to declare., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Explore the occurrence and nature of questionable research practices (QRPs) in the reporting of messages and conclusions in international scientific Health Services Research (HSR) publications authored by researchers from HSR institutions in the Netherlands., Design: In a joint effort to assure the overall quality of HSR publications in the Netherlands, 13 HSR institutions in the Netherlands participated in this study. Together with these institutions, we constructed and validated an assessment instrument covering 35 possible QRPs in the reporting of messages and conclusions. Two reviewers independently assessed a random sample of 116 HSR articles authored by researchers from these institutions published in international peer-reviewed scientific journals in 2016., Setting: Netherlands, 2016., Sample: 116 international peer-reviewed HSR publications., Main Outcome Measures: Median number of QRPs per publication, the percentage of publications with observed QRP frequencies, occurrence of specific QRPs and difference in total number of QRPs by methodological approach, type of research and study design., Results: We identified a median of six QRPs per publication out of 35 possible QRPs. QRPs occurred most frequently in the reporting of implications for practice, recommendations for practice, contradictory evidence, study limitations and conclusions based on the results and in the context of the literature. We identified no differences in total number of QRPs in papers based on different methodological approach, type of research or study design., Conclusions: Given the applied nature of HSR, both the severity of the identified QRPs, and the recommendations for policy and practice in HSR publications warrant discussion. We recommend that the HSR field further define and establish its own scientific norms in publication practices to improve scientific reporting and strengthen the impact of HSR. The results of our study can serve as an empirical basis for continuous critical reflection on the reporting of messages and conclusions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.)

Objectives: This paper aims to describe the degree to which general practitioners (GPs) explore suicidal behaviour among depressed patients in the Netherlands., Design: An observational study of consultations between GPs and depressed patients., Setting: 39 sentinel GP practices within the Netherlands in 2017., Participants: Patients with a registration of depression., Primary and Secondary Outcome Measures: Primary outcome measure is suicide exploration by the GP. Secondary outcome measures at patient level, assessed by surveying GPs, include prevalence and severity of suicidal thoughts. Secondary outcome measures at GP level include follow-up actions of GP and reasons not to explore suicidality., Results: A total of 1034 questionnaires were included in the analyses. GPs assessed and explored suicidality in 44% of patients with depression (66% in patients with a new episode of depression). GPs explored suicidal feelings more often in patients with a new episode of depression (OR 4.027, p<0.001, 95% CI 2.924 to 5.588), male patients (OR 1.709, p<0.001, 95% CI 1.256 to 2.330) or younger patients (OR 1.017, p<0.001, 95% CI 1.009 to 1.026). Multilevel analysis showed that 22% of the variation in suicide exploration is due to differences in GP practice. Thirty-eight per cent of the patients who were asked by their GP, reported (severe) suicidal ideation. Most GPs (68%) did not explore suicidal feelings because they thought the patient would not be suicidal., Conclusion: GPs explored suicidal thoughts in less than half of all depressed patients and in two-thirds of patients with a new episode of depression. Suicide prevention training is recommended to enhance suicide exploration., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The European population is rapidly ageing. In order to handle substantial future challenges in the healthcare system, we need to shift focus from treatment towards health promotion. The PreventIT project has adapted the Lifestyle-integrated Exercise (LiFE) programme and developed an intervention for healthy young older adults at risk of accelerated functional decline. The intervention targets balance, muscle strength and physical activity, and is delivered either via a smartphone application (enhanced LiFE, eLiFE) or by use of paper manuals (adapted LiFE, aLiFE)., Methods and Analysis: The PreventIT study is a multicentre, three-armed feasibility randomised controlled trial, comparing eLiFE and aLiFE against a control group that receives international guidelines of physical activity. It is performed in three European cities in Norway, Germany, and The Netherlands. The primary objective is to assess the feasibility and usability of the interventions, and to assess changes in daily life function as measured by the Late-Life Function and Disability Instrument scale and a physical behaviour complexity metric. Participants are assessed at baseline, after the 6 months intervention period and at 1 year after randomisation. Men and women between 61 and 70 years of age are randomly drawn from regional registries and respondents screened for risk of functional decline to recruit and randomise 180 participants (60 participants per study arm)., Ethics and Dissemination: Ethical approval was received at all three trial sites. Baseline results are intended to be published by late 2018, with final study findings expected in early 2019. Subgroup and further in-depth analyses will subsequently be published., Trial Registration Number: NCT03065088; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: In long-term care (LTC), it is unclear which qualitative instruments are most effective and useful for monitoring the quality of the care relationship from the client's perspective. In this paper, we describe the research design for a study aimed at finding and optimising the most suitable and useful qualitative instruments for monitoring the care relationship in LTC., Methods and Analysis: The study will be performed in three organisations providing care to the following client groups: physically or mentally frail elderly, people with mental health problems and people with intellectual disabilities. Using a participatory research method, we will determine which determinants influence the quality of a care relationship and we will evaluate up to six instruments in cooperation with client-researchers. We will also determine whether the instruments (or parts thereof) can be applied across different LTC settings., Ethics and Dissemination: This study protocol describes a participatory research design for evaluating the quality of the care relationship in LTC. The Medical Ethics Committee of the Radboud University Nijmegen Medical Centre decided that formal approval was not needed under the Dutch Medical Research Involving Human Subjects Act. This research project will result in a toolbox and implementation plan, which can be used by clients and care professionals to measure and improve the care relationship from the client's perspective. The results will also be published in international peer-reviewed journals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Screening for symptoms of postintensive care syndrome is based on a long list of questionnaires, filled out by the intensive care unit (ICU) survivor and manually reviewed by the health professional. This is an inefficient and time-consuming process. The aim of this study was to evaluate the feasibility of a web-based triage tool and to compare the outcomes from web-based questionnaires to those from paper-based questionnaires., Design: A mixed-methods study., Setting: Nine Dutch ICU follow-up clinics., Participants: 221 ICU survivors and 14 health professionals., Interventions: A web-based triage tool was implemented by nine ICU follow-up clinics. End users, that is, health professionals were interviewed in order to evaluate the feasibility of the triage tool. ICU survivors were invited to fill out web-based questionnaires 3 months after hospital discharge., Primary Outcomes: Outcomes of the questionnaires were merged with clinical data from a national quality registry to assess the differences in outcomes between paper-based and web-based questionnaires., Results: 221 ICU survivors received an invitation to fill out questionnaires, 93 (42.1%) survivors did not respond to the invitation. Respondents to the web-based questionnaires (n=54) were significantly younger and had a significantly longer ICU stay than those who preferred the paper-based questionnaires (n=74). The prevalence of mental, physical and nutritional problems was high, although comparable between the groups. Health professionals' interviews revealed that the software was complex to use (n=8) and although emailing survivors is very convenient, not all survivors have an email address (n=7)., Conclusions: Web-based screening software has major benefits compared with paper-based screening. However, implementation has shown to be rather difficult and there are important barriers to consider. Although different in age, the health status is comparable between the users of the web-based questionnaire and paper-based questionnaire., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: There is a critical need for population-based prospective cohort studies because they follow individuals before the onset of disease, allowing for studies that can identify biomarkers and disease-modifying effects, and thereby contributing to systems epidemiology., Participants: This paper describes the design and baseline characteristics of an intensively examined subpopulation of the LifeLines cohort in the Netherlands. In this unique subcohort, LifeLines DEEP, we included 1539 participants aged 18 years and older., Findings to Date: We collected additional blood (n = 1387), exhaled air (n = 1425) and faecal samples (n = 1248), and elicited responses to gastrointestinal health questionnaires (n = 1176) for analysis of the genome, epigenome, transcriptome, microbiome, metabolome and other biological levels. Here, we provide an overview of the different data layers in LifeLines DEEP and present baseline characteristics of the study population including food intake and quality of life. We also describe how the LifeLines DEEP cohort allows for the detailed investigation of genetic, genomic and metabolic variation for a wide range of phenotypic outcomes. Finally, we examine the determinants of gastrointestinal health, an area of particular interest to us that can be addressed by LifeLines DEEP., Future Plans: We have established a cohort of which multiple data levels allow for the integrative analysis of populations for translation of this information into biomarkers for disease, and which will offer new insights into disease mechanisms and prevention., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Introduction: This paper presents an international cross-sectional study on person-centred communication with older people receiving healthcare (COMHOME). Person-centred care relies on effective communication, but few studies have explored this with a specific focus on older people. The main aim of the COMHOME study is to generate knowledge on person-centred communication with older people (>65 years) in home healthcare services, radiographic and optometric practice., Methods and Analysis: This study will explore the communication between care providers and older persons in home care services. Home healthcare visits will be audiorecorded (n=500) in Norway, the Netherlands and Sweden. Analyses will be performed with the Verona Coding Definitions for Emotional Sequences (VR-CoDES), the Roter Interaction Analysis System (RIAS) and qualitative methods. The content of the communication, communicative challenging situations as well as empathy, power distance, decision-making, preservation of dignity and respect will be explored. In Norway, an additional 100 encounters, 50 in optometric practice (video recorded) and 50 in radiographic practice (audiorecorded), will be analysed. Furthermore, healthcare providers' self-reported communication skills, empathy, mindfulness and emotional intelligence in relation to observed person-centred communication skills will be assessed using well-established standardised instruments., Ethics and Dissemination: Depending on national legislation, approval of either the central ethical committees (eg, nation or university), the national data protection officials or the local ethical committees (eg, units of home healthcare) was obtained. Study findings will be disseminated widely through peer-reviewed publications and conference presentations. The research findings will add knowledge to improve services provided to this vulnerable group of patients. Additionally, the findings will underpin a training programme for healthcare students and care providers focusing on communication with older people., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Introduction: Obesity and type 2 diabetes (T2D) are highly prevalent among African migrants compared with European descent populations. The underlying reasons still remain a puzzle. Gene-environmental interaction is now seen as a potential plausible factor contributing to the high prevalence of obesity and T2D, but has not yet been investigated. The overall aim of the Research on Obesity and Diabetes among African Migrants (RODAM) project is to understand the reasons for the high prevalence of obesity and T2D among sub-Saharan Africans in diaspora by (1) studying the complex interplay between environment (eg, lifestyle), healthcare, biochemical and (epi)genetic factors, and their relative contributions to the high prevalence of obesity and T2D; (2) to identify specific risk factors within these broad categories to guide intervention programmes and (3) to provide a basic knowledge for improving diagnosis and treatment., Methods and Analysis: RODAM is a multicentre cross-sectional study among homogenous sub-Saharan African participants (ie, Ghanaians) aged >25 years living in rural and urban Ghana, the Netherlands, Germany and the UK (http://rod-am.eu/). Standardised data on the main outcomes, genetic and non-genetic factors are collected in all locations. The aim is to recruit 6250 individuals comprising five subgroups of 1250 individuals from each site. In Ghana, Kumasi and Obuasi (urban stratum) and villages in the Ashanti region (rural stratum) are served as recruitment sites. In Europe, Ghanaian migrants are selected through the municipality or Ghanaian organisations registers., Ethics and Dissemination: Ethical approval has been obtained in all sites. This paper gives an overview of the rationale, conceptual framework and methods of the study. The differences across locations will allow us to gain insight into genetic and non-genetic factors contributing to the occurrence of obesity and T2D and will inform targeted intervention and prevention programmes, and provide the basis for improving diagnosis and treatment in these populations and beyond.