Quality of knee osteoarthritis care in the Netherlands: a survey on the perspective of people with osteoarthritis.

BACKGROUND: Quality indicators (QIs) are used to monitor quality of care and adherence to osteoarthritis (OA) standards of care. Patient reported QIs can identify the most important gaps in quality of care and the most vulnerable patient groups. The aim of this study was to capture the perspective of people with knee OA (KOA) in the Netherlands on the quality of care received, and explore determinants related to lower achievement rates. METHODS: We sent an online survey to all members of The Dutch Knee Panel (n = 622) of the Sint Maartenskliniek Nijmegen, the Netherlands between September and October 2019. The survey consisted of a slightly adapted version of the "OsteoArthritis Quality Indicator" (OA-QI) questionnaire (18 items; yes, no, N/A); a rating of quality of KOA care on a 10-point scale; a question on whether or not one wanted to see change in the care for KOA; and an open-ended question asking recommendations for improvement of OA care. Furthermore, sociodemographic and disease related characteristics were collected. Pass rates for separate QIs and pass rates on patient level were calculated by dividing the number of times the indicator was achieved by the number of eligible persons for that particular indicator. RESULTS: A total of 434 participants (70%) completed the survey. The mean (SD) pass rate (those answering "Yes") for separate QIs was 49% (20%); ranging from 15% for receiving referral for weight reduction to 75% for patient education on how to manage knee OA. The mean (SD) pass rate on patient level was 52% (23%). Presence of OA in other joints, comorbidities, and having a knee replacement were associated with higher pass rates. On average, a score of 6.5 (1.6) was given for the quality of care received, and the majority of respondents (59%) wanted change in the care for KOA. Of 231 recommendations made, most often mentioned were the need for tailoring of care (14%), more education (13%), and more empathy and support from healthcare providers (12%). CONCLUSION: This study found patients are only moderately satisfied with the OA care received, and showed substantial gaps between perceived quality of care for OA and internationally accepted standards. Future research should focus on the underlying reasons and provide strategies to bridge these gaps.

Substitution scenario in follow-up of chronic cancer patients in primary care: prevalence, disease duration and estimated extra consultation time.

BACKGROUND: The incidence of cancer as well as survival rates for it are increasing. It is debated whether care in the chronic phase of cancer can be positioned in primary care due to doubts about capacity and workload. OBJECTIVE: To estimate GPs' extra consultation time if they assume responsibility for the care in the chronic phase of cancer. METHOD: Retrospective cohort study. Estimation of extra consultation time by quantifying prevalence, incidence, survival, number of chronic cancer patients, current practice contacts and registration of risk factors in patients with all types of cancers. RESULTS: The most prevalent types of cancer (with 5-year survival rates) are as follows: breast cancer (91.5%), colorectal cancer (63.8%), prostate cancer (78.3%), melanoma (91.9%) and bladder and urinary tract cancer (77.3%). Primary care practices include ~32 chronic cancer patients, with a potential extra consultation time of ~19 hours per year per 1000 patients. One-third (35%) are already in a chronic disease management programme and 57% were diagnosed >5 years ago. Registration of risk factors for cancer is incomplete, but of better quality when comorbidity is present. CONCLUSION: Numbers of chronic cancer patients and possible time investment by primary care professionals in the case of a substitution scenario should not be a limiting factor for transition of follow-up from secondary to primary care, as most of the patients were diagnosed >5 years ago and a large proportion of these patients are already monitored in an existing chronic care programme.

Preventive treatment for migraine in primary care, a population-based study in the Netherlands.

BACKGROUND: Preventive treatment of migraine contributes to reducing the impact of migraine but its extent of use in routine care is unknown. OBJECTIVE: The objective of this article is to assess current use, previous use, duration and course of preventive treatment of migraine in Dutch general practice. METHODS: We conducted a retrospective cohort study, for the period between 1997 and 2007, in the Interdisciplinary Processing of Clinical Information (IPCI) database, a GP research database in the Netherlands (source population of more than half a million subjects). All prevalent and incident migraine patients ( N = 7367) were included. RESULTS: About 13% of all migraine patients currently use preventive therapy and almost half of migraine patients have prior use. Of those starting with preventive treatment, 56% (95% CI: 54.3-64.7) still used it after nine months. There was a long delay between migraine diagnosis and preventive treatment start. Forty-four percent (95% CI 43.0-45.7) started preventive therapy in the study period. CONCLUSION: This large primary-care database study shows that a limited number of patients are current users of preventive treatment, but many patients have prior use. After diagnosis there is often an extended time before preventive treatment is applied. Also there is often only one attempt. The continuation in time seems appropriate. Preventive therapy in migraine still deserves focus.

Feasibility of pharmacy-initiated pharmacogenetic screening for CYP2D6 and CYP2C19.

PURPOSE: Our purpose was to investigate the feasibility of pharmacy-initiated pharmacogenetic (PGt) screening in primary care with respect to patient willingness to participate, quality of DNA collection with saliva kits, genotyping, and dispensing data retrieved from the pharmacy. METHODS: Polypharmacy patients aged >60 years who used at least one drug with Anatomical Therapeutic Chemical (ATC) code N06AA01-N06AX19 (antidepressants), A02BC01-A02BC05 (proton-pump inhibitors), N05AA01-N05AH04 (antipsychotics), or C07AB02 (metoprolol) in the preceding 2 years were randomly selected. DNA was collected with saliva kits and genotyped for CYP2D6 and CYP2C19 with the AmpliChip. Pharmacy dispensing records were retrieved and screened for drugs interacting with the patient's CYP2D6 and CYP2C19 genotype by using the evidence-based PGt guidelines from the Dutch Pharmacogenetics Working Group. RESULTS: Out of the 93 invited patients, 54 (58.1%) provided informed consent. Nine saliva samples (16.7%) contained too little DNA. Call rates for CYP2D6 and CYP2C19 were 93.3% and 100%, respectively. Frequencies of genotype-predicted phenotype were 2.4%, 38.1%, 54.8%, and 4.8% for CYP2D6 poor metabolizers (PM), intermediate metabolizers (IM), extensive metabolizers (EM), and ultrarapid metabolizers (UM) respectively. For CYP2C19 genotype-predicted phenotype, frequencies were 2.2%, 15.6%, and 82.2% for PM, IM, and EM, respectively. CONCLUSIONS: This study shows that pharmacy-initiated PGt screening is feasible for a primary care setting.

[Medication or lifestyle for obesity? New medication is a wake-up call for the general practitioner]. / Medicijnen of leefstijlinterventie bij obesitas?

The recent reimbursement of semaglutide and the recent RCT on tirzepatide for obesity sparks the discussion on the role of the Dutch general practitioner (GP) in lifestyle counselling. This discussion is also stimulated by recent reports and position papers of various influential institutions. Given a recent systematic review that shows the effectiveness of lifestyle counselling in primary care this should be considered and also more developed in the Netherlands. GPs need to formulate their needs regarding the facilities that they require to perform and refer for lifestyle counselling. In addition, policy makers need to work on a healthy lifestyle-stimulating environment. More research is needed to better tailor lifestyle interventions. Also more knowledge is needed on long-term side-effects and hard endpoints for medication. GP need to go for lifestyle and reserve medication for a small selected group of patients with severe obesity.

Triptan overuse in the Dutch general population: a nationwide pharmaco-epidemiology database analysis in 6.7 million people.

INTRODUCTION: A population-based observational study was used to assess the prevalence, demographics, risk factors, and costs of triptan overuse, defined as more than 30 (International Headache Society criteria) or 54 (stringent criteria) defined daily doses per 3 months. METHODS: Analysis of the Dutch Health Care Insurance Board Database for 2005, which included prescriptions for 6.7 million people (46% of the total Dutch population). RESULTS: Triptans were used by 85,172 (1.3%) people; of these, 8,844 (10.4%; 95% CI 10.2-10.6) were overusers by International Headache Society and 2,787 (3.3%; 95% CI 3.2-3.4) were overusers by stringent criteria. The triptan-specific odds ratios for the rate of International Headache Society overuse compared with sumatriptan were: 0.26 (95% CI 0.19-0.36) for frovatriptan; 0.34 (95% CI 0.32-0.37) for rizatriptan; 0.76 95% CI 0.68-0.85) for naratriptan; 0.86 (95% CI 0.72-1.02) for eletriptan; 0.97 (95% CI 0.88-1.06) for zolmitriptan; and 1.49 (95% CI 1.31-1.72) for almotriptan. Costs for overuse were 29.7 million euros; for the International Headache Society criteria this was 46% of total costs and for stringent criteria it was 23%. DISCUSSION: In the Dutch general population, 1.3% used a triptan in 2005, of which 10.3% were overusers and accounted for half of the total costs of triptans. Users of frovatriptan, rizatriptan and naratriptan had a lower level of overuse.

A single dose of doxycycline after an ixodes ricinus tick bite to prevent Lyme borreliosis: An open-label randomized controlled trial.

OBJECTIVES: A single dose of doxycycline after a tick bite can prevent the development of Lyme borreliosis in North America, but extrapolation to Europe is hampered by differences in Borrelia burgdorferi sensu lato genospecies and tick species. We assessed the efficacy of prophylaxis after a tick bite in Europe. METHODS: We conducted an open-label randomized controlled trial, administering a single dose of 200 mg doxycycline within 72 h after removing an attached tick from the skin, compared to no treatment. Potential participants ≥ 8 years of age who reported a recent tick bite online were invited for the study. After informed consent, they were randomly assigned to either the prophylaxis or the no-treatment group. Participants in the prophylaxis group were asked to visit their general practitioner to administer the antibiotics. All participants were followed up by online questionnaires. Our primary outcome was the development of physician-confirmed Lyme borreliosis in a modified-intention-to-treat analysis. This study is registered in the Netherlands Trial Register (NTR3953) and is closed. RESULTS: Between April 11, 2013, and June 10, 2015, 3538 potential participants were randomized, of whom 1689 were included in the modified-intention-to-treat analysis. 10 cases of Lyme borreliosis were reported out of 1041 participants (0.96%) in the prophylaxis group, and 19 cases out of 648 no-treatment participants (2.9%), resulting in a relative risk reduction of 67% (95% CI 31 - 84%), and a number-needed-to-treat of 51 (95% CI 29 - 180). No serious adverse events were reported. CONCLUSIONS: This primary care-based trial provides evidence that a single dose of doxycycline can prevent the development of Lyme borreliosis after an Ixodes ricinus tick bite.

Warts in primary schoolchildren: prevalence and relation with environmental factors.

BACKGROUND: Warts are very common in primary schoolchildren. However, knowledge on wart epidemiology and causes of wart transmission is scarce. OBJECTIVES: To determine the prevalence of warts in primary schoolchildren and to examine the relation with environmental factors in order to provide direction for well-founded recommendations on wart prevention. METHODS: In this cross-sectional study, the hands and feet of 1465 children aged 4-12 years from four Dutch primary schools were examined for the presence of warts. In addition, the children's parents completed a questionnaire about possible environmental risk factors for warts. RESULTS: Thirty-three per cent of primary schoolchildren had warts (participation rate 96%). Nine per cent had hand warts, 20% had plantar warts and 4% had both hand and plantar warts. Parental questionnaires (response rate 76%) showed that environmental factors connected to barefoot activities, public showers or swimming pool visits were not related to the presence of warts. An increased risk of the presence of warts was found in children with a family member with warts [odds ratio (OR) 1.9, 95% confidence interval (CI) 1.3-2.6] and in children where there was a high prevalence of warts in the school class (OR per 10% increase in wart prevalence in school class 1.6, 95% CI 1.5-1.8). CONCLUSIONS: One-third of primary schoolchildren have warts. This study does not find support for generally accepted wart prevention recommendations, such as wearing protective footwear in communal showers and swimming pool changing areas. Rather, recommendations should focus on ways to limit the transmission of wart viruses within families and school classes.

Women's motives for not participating in preconception counseling: qualitative study.

AIMS: Information about risk factors and preventive measures given before conception is estimated to prevent 15-35% of adverse pregnancy outcomes. We aimed to identify women's motives for not responding to an invitation for preconception counseling (PCC) from their general practitioner. METHODS: A purposive sample of 11 women who did not respond to an invitation for PCC and who became pregnant within 1 year was interviewed. RESULTS: Three key themes influencing nonresponse emerged from the data: perceived knowledge, perceived lack of risk and a misunderstanding of the aim of PCC. CONCLUSION: For successful future implementation of PCC, a more tailored approach may be necessary for certain (groups of) women, addressing the reasons why women do not consider themselves part of the target group for PCC.

[Health checks in the Netherlands difficult to control]. / Dreigende ontsporing van 'health checks'.

The Dutch Health Inspectorate has reviewed 22 health-check providing organisations, which according to the Dutch 'Wet op het Bevolkingsonderzoek' (Population Screening Act) might need a license. 20 organisations did require a license, mainly because they used cancer tests or radiation. The providers offered a considerable variety of tests, many of which were not clearly evidence-based. Patients were insufficiently educated about the content and risks of the tests. Gaps in the legislation make it difficult to control proper compliance with the law. The Dutch Health Inspectorate recommends the following improvements: better communication with professional organisations, better patient education, writing a guideline on health checks and updating legislation to reflect the latest practices concerning health checks.

[Telephone triage by the general practitioner: not a smart move]. / Telefonische triage door de huisarts: geen goed idee.

In the Telephone First approach that has been introduced in the UK, within a few hours of patients contacting their GP practice a general practitioner will call back all patients who want to make an appointment within a few hours. We think that it is not wise to introduce this system in the Netherlands. Research has not shown sufficient advantages and the system hampers rethinking the traditional way of handling patient requests and the growing workload in general practice. Instead, focus should be paid to more diverse and innovative ways of dealing with patient demands.

The development of an ICF-based questionnaire for patients with chronic conditions in primary care.

OBJECTIVES: We developed a self-reported questionnaire for patients in primary care with chronic conditions aged 50 years or older. The questionnaire supports a more person-centered approach by adopting a biopsychosocial focus on functional status instead of a focus on disease. STUDY DESIGN AND SETTING: Based on the International Classification of Functioning, Disability and Health (ICF), an ICF Primary Care set for patients with chronic conditions was constructed in three phases. In the first phase, we identified relevant ICF categories for the ICF Primary Care set by using existing ICF sets for chronic health conditions. The ICF Primary Care set was completed by a multidisciplinary expert panel and consisted of 52 ICF categories covering ICF's body functions, activities, participation, environmental factors, and personal factors. In the last phase, we constructed a draft version of the questionnaire by converting the ICF categories from the ICF Primary Care set into questions and corresponding scales. To improve the draft version of the questionnaire, we conducted cognitive interviews with patients with chronic conditions in an iterative process, focusing on the problems patients experienced in answering the items of the questionnaire. Interview analysis was used for assessing the content and construct validity of the questionnaire. RESULTS: Thirty cognitive interviews with patients were conducted in five different interview rounds. In these interviews, we identified 124 problems in the responding process of answering the questionnaire, mostly concerning difficulties with the comprehension of the constructs of the questions. The number of problems reduced from an average of 11 problems per interview in the first round to an average of two problems in the last round. CONCLUSION: Conclusion: The final version of the questionnaire demonstrated high content and construct validity (i.e., patients are well capable of describing their functional status in terms of ICF) and is applicable in primary care in the Netherlands.

Feasibility and validity of a tool for identification of people with intellectual disabilities in need of palliative care (PALLI).

BACKGROUND: There is a need for a specific tool that supports healthcare professionals in timely identifying people with intellectual disabilities (ID) in need of palliative care. Therefore, we developed PALLI: a tool for screening deteriorating health, indicative of a limited life expectancy. AIMS: We evaluated feasibility, construct validity and predictive validity of PALLI. METHODS: 190 people with ID likely to be in need of palliative care were included. Physicians and daily care professionals (DCPs) completed PALLI and provided information on health outcomes at baseline, after 5-6 months and after 10-12 months. Linear Mixed Models and Generalized Linear Mixed Models were used to test validity. RESULTS: Feasibility was adequate: physicians and DCPs were able to answer most items with 'yes' or 'no' and within a short amount of time. Construct validity was promising: a higher PALLI score at baseline was related to a higher level of decline in health, a higher symptom burden, a lower quality of life and more ADL-dependency at baseline. Predictive validity: only a higher physician-reported PALLI score at baseline significantly increased risk of death within 12 months. CONCLUSIONS: PALLI shows promising feasibility and validity and has potential as a tool for timely identifying people with ID who may benefit from palliative care.

WITHDRAWN: Drugs for treating giardiasis.

BACKGROUND: There can be a high rate of recurrence of disease after initial drug treatment for giardiasis. These drugs also have a range of adverse effects. OBJECTIVES: The objective of this review was to assess the effects of drug treatments for giardiasis. SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL, MEDLINE, EMBASE, Current Contents, and reference lists of articles. SELECTION CRITERIA: Randomised and quasi-randomised trials of drug therapy for giardiasis compared with placebo or another drug. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Thirty-four trials were included. Only one trial was without serious methodological flaws. Compared with placebo, drug treatment was associated with an improved cure rate (odds ratio 11.51, 95% confidence interval 2.29 to 57.98). Metronidazole treatment longer than three days had a better parasitological cure rate than other long treatment courses (odds ratio 2.41, 95% confidence interval 1.31 to 4.44), but there was significant heterogeneity between the trials. Available evidence has not detected a difference in cure between single dose therapy and longer treatment courses (odds ratio 0.33, 95% confidence interval 0.08 to 1.34). Within the single dose regimens, the available evidence did not demonstrate a difference in parasitological cure rate between tinidazole and other short therapies (odds ratio 3.39, 95% confidence interval 0.95 to 12.04), but had a higher clinical cure rate (odds ratio 5.33, 95% 2.66 to 10.67). AUTHORS' CONCLUSIONS: A single dose of tinidazole appears to give the highest clinical cure rate for giardiasis with relatively few adverse effects.

[The physician and prevention: by all means deliberate extensively, but do make a decision]. / Arts en preventie: je mag wikken en wegen, maar neem een besluit.

The role of prevention in medical care has recently been described and discussed in various strategy reports by Dutch medical professional organisations. However, there are still doubts concerning the effectiveness and feasibility of practising preventive medicine. Both inconclusive evidence on its effectiveness, including on long-term outcomes of preventive medicine interventions, and studies showing positive results have been published. In general, more intensive approaches towards lifestyle change are more effective. Regarding disease-related prevention intervention, various authors stress that this is undoubtedly a task reserved for physicians. Their degree of responsibility and input is less clear when it comes to indicated and selective prevention. Nonetheless, for these latter types of prevention there seems to be a role reserved for the physician, given the increase in lifestyle-related chronic diseases and the prevalence of social class related health inequity. Here, the author argues that physicians are ideally positioned as advisor and motivator, especially towards more vulnerable patients. Aftercare can be organised in partnership with other providers. To take an active role in prevention still needs 'guts', and physicians are challenged to take a position in this.

Health assessment instruments for people with intellectual disabilities-A systematic review.

BACKGROUND: People with intellectual disabilities (ID) experience health disparities and are less likely to undergo recommended age- and gender-specific screening and health promotion. New diagnoses are frequently missed. Assessments with the aid of health assessment instruments are a way to address these problems. AIM: The aim of this review is to find the available health assessment instruments for people with ID used in primary care and evaluate their quality. METHODS: We conducted an electronic literature search of papers published between January 2000 and May 2016. After a two-phase selection process (kappa: 0.81 and 0.77) we collected data from the 29 included peer-reviewed articles on the following four domains; development, clinimetric properties (i.e. validity, reliability, feasibility, acceptability), content (i.e. ID-related health problems, prevention and health promotion topics) and effectiveness of the instruments. RESULTS/CONCLUSIONS: We distinguished 20 different health assessment instruments. Limited information was found on the development of the instruments as well as on their clinimetric properties. The content of the instruments was rather diverse. The included papers agreed that health assessment instruments are effective. However, only three instruments evaluated effectiveness in a randomised controlled trial. Patients with ID, carers and general practitioners (GPs) generally appreciated the health assessment instruments. IMPLICATION: Two instruments, "Stay well and healthy -Health risk appraisal (SWH-HRA)"and the "Comprehensive Health Assessment Programme (CHAP)", appeared to have the highest quality. These instruments can be used to construct a health assessment instrument for people with ID that meets scientific standards.

GP-initiated preconception counselling in a randomised controlled trial does not induce anxiety.

BACKGROUND: Preconception counselling (PCC) can reduce adverse pregnancy outcome by addressing risk factors prior to pregnancy. This study explores whether anxiety is induced in women either by the offer of PCC or by participation with GP-initiated PCC. METHODS: Randomised trial of usual care versus GP-initiated PCC for women aged 18-40, in 54 GP practices in the Netherlands. Women completed the six-item Spielberger State Trait Anxiety Inventory (STAI) before PCC (STAI-1) and after (STAI-2). After pregnancy women completed a STAI focusing on the first trimester of pregnancy (STAI-3). RESULTS: The mean STAI-1-score (n = 466) was 36.4 (95% CI 35.4-37.3). Following PCC there was an average decrease of 3.6 points in anxiety-levels (95% CI, 2.4-4.8). Mean scores of the STAI-3 were 38.5 (95% CI 37.7-39.3) in the control group (n = 1090) and 38.7 (95% CI 37.9-39.5) in the intervention group (n = 1186). CONCLUSION: PCC from one's own GP reduced anxiety after participation, without leading to an increase in anxiety among the intervention group during pregnancy. We therefore conclude that GPs can offer PCC to the general population without fear of causing anxiety.

Cost effectiveness of brace, physiotherapy, or both for treatment of tennis elbow.

BACKGROUND: The annual incidence of tennis elbow in the general population is high (1-3%). Tennis elbow often leads to limitation of activities of daily living and work absenteeism. Physiotherapy and braces are the most common treatments. OBJECTIVES: The hypothesis of the trial was that no difference exists in the cost effectiveness of physiotherapy, braces, and a combination of the two for treatment of tennis elbow. METHODS: The trial was designed as a randomised controlled trial with intention to treat analysis. A total of 180 patients with tennis elbow were randomised to brace only (n = 68), physiotherapy (n = 56), or a combination of the two (n = 56). Outcome measures were success rate, severity of complaints, pain, functional disability, and quality of life. Follow up was at six, 26, and 52 weeks. Direct healthcare and non-healthcare costs and indirect costs were measured. Mean cost differences over 12 months were evaluated by applying non-parametric bootstrap techniques. RESULTS: No clinically relevant or statistically significant differences were found between the groups. Success rate at 12 months was 89% in the physiotherapy group, 86% in the brace group, and 87% in the combination group. Mean total costs per patient were 2069 euros in the brace only group, 978 euros in the physiotherapy group, and 1256 euros in the combination group. The mean difference in total costs between the physiotherapy and brace group was substantial (1005 euros), although not significant. Cost effectiveness ratios and cost utility ratios showed physiotherapy to be the most cost effective, although this also was not statistically significant. CONCLUSION: No clinically relevant or statistically significant differences in costs were identified between the three strategies.

Determinants of participation in a cardiometabolic health check among underserved groups.

Cardiometabolic diseases affect underserved groups disparately. Participation in health checks is also lower, widening health inequalities in society. Two-stage screening (non-invasive health risk assessment (HRA) and GP consultations for high-risk individuals) seems cost-effective, provided that drop-out rates are low in both steps. We aimed to explore the process of decision-making regarding HRA participation among underserved groups (45-70 y): native Dutch with a lower socioeconomic status (SES), Turkish, Moroccan, and Surinamese participants. We conducted a cross-sectional questionnaire study. The questionnaire comprised the following determinants: a self-formulated first reaction, a structured set of predefined determinants, and the most important barrier(s) and facilitator(s) for HRA completion. We used univariable and (stepwise) multivariate logistic regression analyses to assess which determinants were associated with HRA completion. Of the 892 participants in the questionnaire, 78% (n = 696) also completed the HRA. Moroccans and patients from GP practices with a predominantly non-Western population less often completed the HRA. A lower SES score, wanting to know one's risk, not remembering receiving the invitation (thus requiring a phone call), fear of the test result and/or adjusting lifestyle, perceived control of staying healthy, wanting to participate, and perceiving no barriers were associated with completing the HRA. We conclude that our 'hard-to-reach' population may not be unwilling to participate in the HRA. A more comprehensive approach, involving key figures within a community informing people about and providing help completing the HRA, would possibly be more suitable. Efforts should be particularly targeted at the less acculturated immigrants with an external locus of control.

Patient education for preventing diabetic foot ulceration.

BACKGROUND: Ulceration of the feet, which can result in loss of limbs and even death, is one of the major health problems for people with diabetes mellitus. OBJECTIVES: To assess the effectiveness of patient education on the prevention of foot ulcers in patients with diabetes mellitus. SEARCH STRATEGY: Eligible studies were identified by searching the Cochrane Wounds Group Specialised Register, (September 2004) and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2004). SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) which evaluated educational programmes for the prevention of foot ulcers in people with diabetes mellitus. There was no restriction on language of the publications. DATA COLLECTION AND ANALYSIS: Two reviewers undertook data extraction and assessment of study quality independently. MAIN RESULTS: Nine RCTs were included. Four trials compared the effect of intensive with brief educational interventions; two of these reported clinical endpoints. One study involving high-risk patients reported a reduction in ulcer incidence (Peto OR: 0.28 (95% CI 0.13 - 0.59)) and amputation rate (Peto OR: 0.32 (95% CI 0.14 - 0.71)) after one year. The other RCT did not find an effect at seven years follow-up. Participants' foot care knowledge significantly improved with education in two trials. In one trial foot care knowledge improved significantly in the control group, in contrast to the intervention group. Non-calcaneal callus was significantly reduced by education in one trial. One RCT did not find that patient foot care education, as part of a general diabetes education program, reduced foot ulceration compared with usual care. Patient education as part of a complex intervention, targeted at both people with diabetes and doctors, reduced the number of serious foot lesions at one year in one RCT (OR: 0.41(95% CI 0.16 -1.00)) and improved foot care behaviour. Evidence from three RCTs comparing the effect of patient-tailored education in addition to usual care was conflicting.The methodological quality of the nine included RCTs was poor. The internal validity score (range 0 - 10) of individual RCTs ranged from 2 to 5. AUTHORS' CONCLUSIONS: RCTs evaluating education for people with diabetes, aimed at preventing diabetic foot ulceration, are mostly of poor methodological quality. Weak evidence suggests that patient education may reduce foot ulceration and amputations, especially in high-risk patients. Foot care knowledge and behaviour of patients seem positively influenced by patient education in the short term. Because of conflicting results and the methodological shortcomings more RCTs are needed.