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Protocol for evaluating the effects of the Reducing Cardiometabolic Diseases Risk dietary pattern in the Chinese population with dyslipidaemia: a single-centre, open-label, dietary intervention study
  1. Qi Wu1,
  2. Liyang Zhang1,
  3. Cheng Cheng1,
  4. Xukun Chen1,
  5. Shanshan Bian2,
  6. Li Huang1,
  7. Tongtong Li1,
  8. Zhenshu Li1,3,
  9. Huan Liu1,3,4,
  10. Jing Yan3,4,5,
  11. Yue Du3,4,5,
  12. Yongjie Chen3,4,6,
  13. Meilin Zhang1,3,4,
  14. Lichun Cao7,
  15. Wen Li1,3,4,
  16. Fei Ma3,4,6,
  17. Guowei Huang1,3,4,8
  1. 1Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin, China
  2. 2Department of Nutrition, The Second Hospital of Tianjin Medical University, Tianjin, China
  3. 3Tianjin Key Laboratory of Environment, Nutrition and Public Health, Tianjin, China
  4. 4Key Laboratory of Prevention and Control of Major Diseases in the Population, Ministry of Education, Tianjin Medical University, Tianjin, China
  5. 5Department of Social Medicine and Health Management, School of Public Health, Tianjin Medical University, Tianjin, China
  6. 6Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China
  7. 7Department of General Practice, Dazhangzhuang Community Medical Service Center, Beichen District, Tianjin, China
  8. 8The Province and Ministry Co-Sponsored Collaborative Innovation Center for Medical Epigenetics, Tianjin, China
  1. Correspondence to Professor Guowei Huang; huangguowei{at}tmu.edu.cn; Professor Fei Ma; mafei{at}tmu.edu.cn

Abstract

Introduction Cardiometabolic disease (CMD) is the leading cause of mortality in China. A healthy diet plays an essential role in the occurrence and development of CMD. Although the Chinese heart-healthy diet is the first diet with cardiovascular benefits, a healthy dietary pattern that fits Chinese food culture that can effectively reduce the risk of CMD has not been found.

Methods/design The study is a single-centre, open-label, randomised controlled trial aimed at evaluating the effect of the Reducing Cardiometabolic Diseases Risk (RCMDR) dietary pattern in reducing the risk of CMDs in people with dyslipidaemia and providing a reference basis for constructing a dietary pattern suitable for the prevention of CMDs in the Chinese population. Participants are men and women aged 35–45 years with dyslipidaemia in Tianjin. The target sample size is 100. After the run-in period, the participants will be randomised to the RCMDR dietary pattern intervention group or the general health education control group with a 1:1 ratio. The intervention phases will last 12 weeks, with a dietary intervention of 5 working days per week for participants in the intervention group. The primary outcome variable is the cardiometabolic risk score. The secondary outcome variables are blood lipid, blood pressure, blood glucose, body composition indices, insulin resistance and 10-year risk of cardiovascular diseases.

Ethics and dissemination The study complies with the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings and the Declaration of Helsinki. Signed informed consent will be obtained from all participants. The study has been approved by the Medical Ethics Committee of the Second Hospital of Tianjin Medical University (approval number: KY2023020). The results from the study will be disseminated through publications in a peer-reviewed journal.

Trial registration number Chinese Clinical Trial Registry (ChiCTR2300072472).

  • Randomized Controlled Trial
  • Cardiovascular Disease
  • NUTRITION & DIETETICS
  • DIABETES & ENDOCRINOLOGY
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2023-082957

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    STRENGTHS AND LIMITATIONS OF THIS STUDY

    • The Reducing Cardiometabolic Diseases Risk dietary pattern is designed based on the dietary habits of Chinese people, and following it can help reduce the risk of cardiometabolic diseases.

    • The pattern considers dietary feeding and guidance, which can help participants learn and maintain healthy eating habits even after the study ends.

    • The blinding of data analysis and indicator detection techniques used during the study helped minimise any bias that could have affected the results of the open trial.

    Introduction

    Cardiometabolic disease (CMD) is a kind of syndrome with cardiovascular damage and abnormal metabolism, including a series of diseases, such as cardiovascular disease (CVD), diabetes, dyslipidaemia and metabolic syndrome,1 which is the leading cause of mortality in China2 and worldwide.3 Dyslipidaemia is not only a type of CMD, but also a significant risk factor for other CMDs. In China, the prevalence of dyslipidaemia in adults has reached 35%, and has remained at a high level in recent years.4 Several studies have found a potential association between lipid metabolism and the risk of CMDs.5–7 It was plausible that dietary interventions might affect the risk of CMDs by regulating some lipid molecules.8 9

    Diet is one of the ordinary and modifiable factors of CMDs. According to the Global Burden of Diseases Study 2017, nearly one-fifth of total death globally was attributed to diseases such as CVDs, metabolic diseases and cancers caused by unhealthy diet.10 In 2019, China ranked first globally in terms of the absolute number of diet-related CVD death and disability-adjusted life-year burden.11 In the past few decades, the dietary structure of the Chinese has undergone notable changes. In China, from 1982 to 2012, consumption of cereals, tubers and vegetables decreased; consumption of fruits, milk, eggs and nuts remained low; animal food consumption, primarily pork, increased rapidly, from 52.6 g/day to 137.7 g/day; cooking oil and salt consumption remained high; and the percentage of energy from fat increased from 18.4% to 32.9%.12 High sodium, low fruit and low marine n-3 fatty acids were leading dietary risk factors for CMD mortality in China.13 Therefore, in the prevention and treatment of CMD, it is of great value to study the association between dietary factors and CMD, and to develop dietary patterns appropriate for the Chinese.

    Dietary pattern analysis is essential for exploring the relationship between the intake of various food groups or multiple nutrients and health outcomes from a holistic perspective, which is closer to daily diets.14 15 Some Hesperian healthy dietary patterns have been demonstrated to be cardiometabolic protective, such as the Dietary Approaches to Stop Hypertension (DASH) and the Mediterranean diet.16–18 However, because Chinese food culture differs from Hesperian food culture, healthy dietary patterns cannot simply be copied. The Chinese heart-healthy (CHH) diet is the first diet with a cardiovascular protective effect that fits Chinese food culture, but its effect on metabolic diseases is unclear.19 To date, a healthy dietary pattern has not been found that can comprehensively prevent CMDs in line with the dietary characteristics of the Chinese.

    Consequently, a dietary pattern that might improve CMD health based on Chinese food culture was developed—the Reducing Cardiometabolic Diseases Risk (RCMDR) dietary pattern. This single-centre, randomised, open-label, parallel-controlled dietary intervention study was designed to assess the effect of the RCMDR dietary pattern on reducing CMD risk in people with dyslipidaemia. Moreover, the secondary aim of this study is to assess the effect of the RCMDR dietary pattern on improving blood lipids, blood pressure, blood glucose, insulin resistance, body composition indices and 10-year CVD risk.

    Methods

    Study design

    A single-centre, open-label, randomised controlled dietary intervention study was designed. In Tianjin, 100 eligible participants aged 35–45 years with dyslipidaemia will be recruited. Enhanced management of dyslipidaemia in this age group may better reduce the risk of incident CVD and diabetes and contribute to the primary prevention of CMDs.20–22 Participants will be randomised and allocated into the RCMDR dietary pattern intervention group or the general health education control group, with 50 participants in each group. After a 1-week run-in period, participants in the intervention group will receive free standard breakfasts and lunches and dietary guidance based on the RCMDR dietary pattern. Standard breakfasts and lunches will be prepared and cooked by cooks based on menus and recipes developed by a nutritionist, using the ingredients available in local markets. According to the 2023 Chinese guideline for lipid management, the lipid level should be reviewed in the first 3–6 months for those receiving non-pharmacological treatment such as diet control.4 Consistent with previous studies,23 24 the interventions will last 12 weeks. During intervention phases, standard breakfasts and lunches will be provided 5 working days per week, and dietary advice will be provided 2 rest days per week. Participants in the control group will receive dietary guidance based on the ‘Dietary Guidelines for Chinese Residents (2022)’ for 12 weeks. The schedule of follow-up, physical examinations and indices measurements will be the same for both groups. Figure 1 shows the flow chart of the study.

    Figure 1
    Figure 1

    The flow chart of the study. CVD, cardiovascular disease; RCMDR, Reducing Cardiometabolic Diseases Risk.

    Participant recruitment

    Participants will be recruited by researchers using posters. After an initial understanding of the study, potential participants will enrol voluntarily. Men and women aged 35–45 years with dyslipidaemia are eligible for the study according to the results of their latest physical examination. Subsequently, participants will be randomised into intervention and control groups. The details of inclusion and exclusion criteria are listed.

    Inclusion criteria

    1. Aged 35–45 years, permanent residents in Tianjin.

    2. With borderline elevation of blood lipids and low or moderate risk of atherosclerotic CVD (ASCVD), meeting one of the following conditions:

      • 5.2 mmol/L≤total cholesterol (TC)<7.2 mmol/L.

      • 3.4 mmol/L≤low-density lipoprotein cholesterol (LDL-C)<4.9 mmol/L.

      • 1.7 mmol/L≤triglyceride (TG)<2.3 mmol/L.

      • High-density lipoprotein cholesterol (HDL-C) <1.0 mmol/L.

    3. Without lipid-lowering therapy (the above dyslipidaemic population).

    4. Agree to participate in the study and sign an informed consent form.

    Exclusion criteria

    1. With high-risk or extremely high-risk ASCVD,4 meeting one of the following conditions:

      • Patients with ASCVD.

      • Patients with diabetes ≥40 years old.

      • Chronic kidney disease stages 3–4.

      • Patients with grade 2 or above hypertension, or those with grade 1 hypertension who have two or more risk factors (risk factors include smoking, HDL-C <1.0 mmol/L, men aged ≥45 years old).

    2. With a tumour or mental health diseases (such as depression, mania, anxiety, schizophrenia).

    3. With abnormal thyroid, liver or kidney function.

    4. With cardiovascular or cerebrovascular diseases.

    5. With active epilepsy or severe auditory perception disorders, which make it difficult for participants to cooperate with the investigation.

    6. The researchers consider the person unfit to complete the study.

    Run-in period and randomisation

    After signing informed consent forms, participants will enter a 1-week run-in period. The purpose of setting a run-in period is to help participants familiarise themselves with the intervention scheme and to allow the researchers to ascertain participants’ intake of daily food and estimated energy requirement (EER), as well as to identify and exclude participants who are failing to adhere to the study protocol. During the run-in, participants in both groups will be requested to keep dietary records of the variety and intake of all foods consumed during the day. At the end of the run-in period, participants will be reassessed for eligibility and adherence to the study protocol. Any participant who fails to complete dietary records for 2 or more days a week for any reason will be excluded from further participation in the study.

    Participants will be formally enrolled in the study if they pass the run-in period and complete the baseline data collection. Participants will be randomised into intervention and control groups with a 1:1 ratio by a statistical analyst unaware of the study, using a random sequence generated by SPSS V.24.0. The randomised allocation concealment will be ensured using opaque sealed envelopes. The researchers responsible for recruitment would not know the allocation sequence in advance.

    Blinding

    In the study, we will only provide the feeding intervention to participants in the intervention group, so it is not possible to implement blinding to the participants. Meanwhile, it is also infeasible to blind the cooks, nutritionists and researchers in charge of preparing and measuring the standard meals. In addition, the researchers responsible for outcome assessment and data analysis will be blinded to the group allocation, and the data will be input into the computer by people outside the research team. On the other side, it might be easier to recruit participants in an open-label study than in a blinded study.

    Intervention

    Depending on the EER of the participants in the intervention group, the standard meals will be divided into three energy classes: 1400–1700 kcal, 1700–2000 kcal and over 2000 kcal. Standard breakfasts and lunches will be prepared in the kitchen, then delivered to the fixed canteen and distributed to each participant in the intervention group. Participants will be required to take photos of the leftovers from each standard meal and record the intake of all food consumed on weekdays (excluding standard meals) and rest days. Researchers will calculate the intake of daily nutrients based on these data and provide personalised dietary guidance to the participants. The frequency of dietary guidance will be once a week in the first month, once every 2 weeks in the second month and once in the third month.

    The participants in the control group will not be provided with standard meals, but will only receive dietary guidance based on the ‘Dietary Guidelines for Chinese Residents (2022)’. Participants in the control group will be required to choose any 1 working day and rest day every week for dietary records. The frequency of dietary guidance will be the same as the intervention group.

    Recipes of standard meals will be developed by researchers, nutritionists and cooks based on the nutritional composition of the RCMDR dietary pattern. The nutrient composition of the RCMDR dietary pattern and the methods to reach it are shown in table 1. Compared with other dietary patterns with cardiometabolic benefits, such as the DASH diet and the Mediterranean diet,25 26 the nutrient composition of the RCMDR dietary pattern was more similar to that of the CHH diet, including energy proportions of macronutrients and the amount of sodium, potassium and fibre. Besides, considering the participants have dyslipidaemia, we added a restriction on the intake of cholesterol.

    View this table:
    Table 1

    The nutrient composition of the RCMDR dietary pattern and methods to reach the goals of nutrients

    The RCMDR dietary pattern was preliminarily developed based on previous studies’ evidence, including food types, intake ranges and explanations. Then, the Delphi method was used to optimise and modify the dietary pattern. In the end, a total of 23 experts completed two rounds of consultation, and the results showed that the active coefficients of the two rounds of expert consultation were 92.00% and 100%; the expert authority indices of the two rounds of expert consultation were 0.751 and 0757; and the Kendall’s W coefficients of the two rounds of expert consultation were 0.302 and 0.504; thus, a consensus was obtained (online supplemental file 1). The final RCMDR dietary pattern was established, including 9 domains, 20 subdomains and 5 elements. The detailed content of the RCMDR dietary pattern is shown in table 2.

    View this table:
    Table 2

    The RCMDR dietary pattern

    Compared with the CHH diet and ‘Dietary Guidelines for Chinese Residents (2022)’, the RCMDR dietary pattern has some characteristics concerning the intake of food groups. First, the intake of whole grains, vegetables, soy and its products, and nuts increased. Because of the cardiometabolic protective effects of these foods,27–30 we increased the intake of whole grains to 90–150 g/day, approximately accounting for one-half of cereals; increased the intake of vegetables to 350–550 g/day; increased the intake of soybeans to 30–40 g/day; and increased the intake of nuts to 10–20 g/day. Second, we reduced the intake of animal-based foods and divided meat intake into fish, poultry and livestock. In particular, the intake of red meat was reduced to 100–125 g/week and processed meat was banned. Meanwhile, considering the high content of lipids such as cholesterol, TGs and phospholipids in egg yolk,31 the intake of eggs was adjusted to three to five per week. However, the frequency of fish consumption was increased to three to four times per week, emphasising the importance of consuming fish rich in n-3 polyunsaturated fatty acids (PUFAs). Third, the RCMDR dietary pattern emphasised alternating consumption of various vegetable oils rich in unsaturated fatty acids and avoiding animal oils. In order to achieve this target, our standard breakfast and lunch will be cooked with olive oil, and participants will be encouraged to use vegetable oils rich in n-3 PUFAs for low-temperature cooking at home, such as flaxseed oil.32

    Specifically, the RCMDR dietary pattern includes a set of recipes of 2-week non-repeating and interchangeable standard breakfasts and lunches, as well as suggestions for dinners. These recipes were developed based on the nutrient composition and the food group intake of the RCMDR dietary pattern. Considering the generalisability and affordability of the RCMDR dietary pattern, the daily cost was approximately 50–60 renminbi per person per day, using common local food ingredients and cooking methods. In addition, the study will adopt a combination of feeding intervention and dietary guidance, making it easier for the participants and their families to learn and master the dietary pattern according to these recipes. Even after the experiment, the RCMDR dietary pattern is easy to grasp and stick to. A sample 1-day recipe is shown in table 3.

    View this table:
    Table 3

    An example of a 1-day recipe for a diet

    Measurements and data collection

    Formal baseline data collection will be conducted on the last 2 days of the run-in period, including a questionnaire interview on demography (age, gender, education, marital status), lifestyle (smoking, drinking, physical activity and sleep status), dietary habit (frequency questionnaire and 24-hour food record), history of diseases (hypertension and diabetes), family history of disease (hypertension, diabetes, hyperlipidaemia, coronary heart disease, stroke and cancer), medication use (antihypertensive drugs and antidiabetic drugs), dietary supplement use (fish oil, vitamin C, vitamin B, calcium tablets, folic acid, multivitamins, iron, others), physical examinations (height, weight, blood pressure, waist–hip ratio, body composition indices), fasting blood test (fasting blood glucose (FBG), fasting insulin (FINS), glycated haemoglobin (HbA1c), fasting C peptide, TC, TGs, LDL-C, HDL-C, folic acid, homocysteine (Hcy), liver function (alanine aminotransferase (ALT), aspartate transaminase (AST)), kidney function (serum uric acid, urea, creatinine), apolipoprotein E (ApoE) and methylenetetrahydrofolate reductase (MTHFR) genotype polymorphism.

    Methods of physical measurements

    Blood pressure measurement: the Omron J710 upper arm electronic blood pressure monitor measures systolic blood pressure (SBP) and diastolic blood pressure (DBP). The third measurement will be required if the difference between SBP and DBP exceeds 10 mm Hg.

    Body composition indices measurement: the body composition analyser and bioelectrical impedance method were used to measure body composition indices, such as height, weight, waist-to-hip ratio, body fat mass, body muscle mass and visceral fat mass, subcutaneous fat mass, basal energy expenditure, EER, etc.

    Blood sample collection and tests

    Blood samples will be collected at baseline and the end of the study. Before collecting blood samples, participants will be required to fast for at least 10 hours overnight. Fasting venous blood from participants will be collected by qualified nurses. The blood samples will be refrigerated and transported to the central laboratory of the School of Public Health, Tianjin Medical University. Analysis of FBG (using the glucose oxidase method), HbA1c (using the immunosuppressive turbidimetry), TG and TC (using the enzyme endpoint method), HDL-C and LDL-C (using the polyethylene sulfate precipitation method), and ALT, AST, serum uric acid, urea and creatinine (using the enzymatic method) will be carried out on a Roche Cobas 8000 automatic biochemistry analyser. Fasting C peptide and FINS were measured using ELISA kit. Serum folic acid was measured using a chemiluminescence immunoassay analyser. Serum Hcy (using the enzyme cycling method) was measured using an automated chemical analyser. ApoE and MTHFR genotype polymorphism testing will be commissioned by a gene sequencing company.

    Dietary intake of foods and nutrients

    First, all raw materials will be weighed before cooking, including the amount of oil and salt used. After cooking, each dish will be weighed according to the energy level of the standard meal. Researchers will calculate the average daily energy and dietary nutrients each participant takes using the China Food Composition (sixth edition) based on the photos of leftovers and dietary records submitted by the participants.33

    Follow-up schedules

    At the mid-term of the study, the uninformed researchers will carry out the same questionnaire interview. At the end of the study, the uninformed researchers will conduct the same questionnaire interview and physical examination of the participants using the same method as the baseline. The frequency of dietary guidance for participants in both groups will be the same: once a week in the first month, once every 2 weeks in the second month and once in the third month. Dietary data of participants in the intervention group will be collected daily, and in the control group will be collected twice a week. The schedule of measurements and visits of the study has been summarised in table 4.

    View this table:
    Table 4

    The schedule of measurements and visits of the study

    Outcomes

    The primary outcome is the change in cardiometabolic risk (CM-risk) score from baseline to the end of the study. The secondary outcomes include a change in blood lipid (LDL-C, TC, TG, HDL-C), blood pressure, FBG, insulin resistance measured by Homeostasis Model Assessment, body composition indices and 10-year risk of CVD from the Prediction for Atherosclerotic Cardiovascular Disease Risk in China.34

    Sample size

    Although the CM-risk score is the primary outcome, the methods of calculating the cardiometabolic score in different studies are inconsistent. Participants in the study have dyslipidaemia, and according to the 2023 Chinese guideline for lipid management, LDL-C is the primary target for lipid intervention.4 Therefore, the sample size in the study was calculated using the change of LDL-C from baseline to the end of the study. According to the previous study that the calorie-restricted Mediterranean-style diet successfully reduced LDL-C by 0.23 mmol/L for patients with hypercholesterolaemia in 4 weeks, we conservatively assumed that the RCMDR dietary pattern will reduce LDL-C by 0.3 mmol/L in 12 weeks, and the SD of LDL-C change is 0.5 mmol/L in the control group.35 To have 80% power with a type I error rate of 5% to detect the assumed effect size, we would need 44 participants in each group. Assuming that 10% of study participants will be lost by the end of the study, 100 participants will be recruited.

    Data management

    Data will be collected in an electronic database. Participants will only be identified by a unique ID. Hard copies of data sheets containing participants’ files and other data (including questionnaires, test results, records of informed consent and other documents related to the conduct of the study) will be kept securely in a locked filing cabinet in a locked office, accessible only to key research team members. Blood samples will be kept in a locked freezer. All data and blood samples will be stored in Tianjin Medical University.

    Statistical analysis

    Statistical analyses will be performed using SPSS V.24.0 software. The analyses of outcomes will follow the intention-to-treat principle. Continuous variables conforming to normal distribution will be expressed as mean±SD, and non-normally distributed continuous variables will be expressed as median with limits of the IQR (25th and 75th percentiles). Categorical variables will be shown as frequencies and proportions (percentages). The differences in baseline variables between groups will be evaluated by using a t-test, Wilcoxon rank test or χ2 test. Linear regression will be used to estimate the absolute differences between the two groups regarding primary and secondary outcomes and reported as the least squares mean after adjusting the centre. Sensitivity analyses will be conducted to repeat the primary analyses with imputed missing values. We will use multiple imputations to impute missing values of outcomes. A two-sided p value of <0.05 will be considered statistically significant.

    Quality control

    The reliability and validity of the questionnaire are high. According to the purpose of this study, based on previous studies, multiple collective discussions were conducted to unify the evaluation standards of the questionnaire, ensuring scientificity, consistency and comparability. All researchers participating in this study must receive uniform training and be tested after training, including standard operating procedures for participant data collection and methods for collecting and preserving biological samples to ensure accurate and complete information and to avoid measurement bias. All biological samples will be tested in the central laboratory of Tianjin Medical University. The researchers responsible for detecting relevant indicators will be blinded to the randomisation grouping of participants.

    Patient and public involvement

    This research study did not involve patients or the general public in its design, conduct, reporting or dissemination.

    Ethics and dissemination

    The study complies with the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings and the Declaration of Helsinki. Signed informed consent will be obtained from all participants (online supplemental file 2). The study has been approved by the Medical Ethics Committee of the Second Hospital of Tianjin Medical University (approval number: KY2023020) and registered in the Chinese Clinical Trial Registry (ChiCTR2300072472). The results from the study will be disseminated through publications in a peer-reviewed journal.

    Current status

    The first participant was enrolled on 14 June 2023.

    In summary, the study is a randomised controlled dietary intervention trial to evaluate the effect of the RCMDR dietary pattern on cardiometabolic health in people with dyslipidaemia. The study not only comprehensively considered the effect of diet on CMDs, but also considered the generalisability and affordability of the RCMDR dietary pattern among the population. The study’s findings will significantly prevent CMDs in China and improve Chinese residents’ nutritional status and health levels.

    Ethics statements

    Patient consent for publication

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    Footnotes

    • Contributors GH, WL and FM conceived and designed the study. QW, LZ, CC, XC, LH and TL will perform the study, collect and analyse all experimental data. QW provided the first version of the manuscript. SB, ZL, HL, JY, YD, YC, MZ, LC, WL, FM and GH provided critical comments on the original manuscript. WL and GH revised and finalised the manuscript. All authors read and approved the final version of the manuscript.

    • Funding This research was supported by the National Nutrition Science Research Grant of Chinese Nutrition Society (grant number: CNS-NNSRG2022-149).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.