SEARCH · PubMed Health

Results for “Internal validation”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 829 records · Page 46Linked to original sources

PubMedDate not supplied

The use of claims databases for outcomes research: rationale, challenges, and strategies.

Health care payers and policy makers need information about the cost and effectiveness of medical treatments. While randomized controlled trials historically are the primary source of medical information, they are expensive and labor-intensive, and often have limited utility for answering questions about "real-world" patient populations. These problems have led to an increasing reliance on claims database research in making policy decisions about treatment options. However, both researchers and decision makers should recognize the limitations and unique features of claims databases. Recommendations for avoiding or minimizing threats to internal validity, construct validity, and external validity are: (1) use of a study design that includes comparisons; (2) ensuring that the study design and conclusions are consistent with the database; (3) a priori conceptual modeling of the research question; (4) use of appropriate constructs; (5) explicit examination of alternative explanations for study findings; (6) sensitivity analyses of key assumptions; (7) awareness of the distinction between statistical and practical significance of findings; (8) generalization only when appropriate; and (9) reporting of relevant information. Given that any study design or data source has limitations, we hope that this paper will encourage a philosophy of methodological pluralism in outcomes research. Awareness and accurate reporting of validity issues will strengthen and extend the information resources currently available to decision makers.

Decision Making↗

PubMed2001

The quality of reporting of randomized clinical trials published in Ophthalmology.

PURPOSE: To evaluate the quality of reporting of all the new randomized clinical trials published during 1999 in OPHTHALMOLOGY: using the CONSORT statement parameters. DESIGN: Descriptive series of published studies. STUDIES INCLUDED: Randomized clinical trials. METHODS: Eligible studies were all randomized clinical trials published in Volume 106 (1999) of OPHTHALMOLOGY: that reported the results of prospectively conducted studies in humans comparing two or more therapeutic options with regard to their effect on one or various outcomes, in which the authors stated that a process of randomization or quasi-randomization was performed before the interventions. Each study was evaluated by two independent observers establishing the specific report in the published manuscript of 57 CONSORT statement descriptors, and consensus was obtained between evaluators. MAIN OUTCOME MEASURES: Overall presence of CONSORT statement descriptors in published reports. RESULTS: The mean number of positive CONSORT descriptors for the 24 eligible randomized clinical trials was 33.42 (standard error of the mean [SEM] 1.57) of 57 possible. This score was significantly different (P: < 0.001) from the score of 16.6 (standard error of the mean 0.6) reported for OPHTHALMOLOGY: in the 1991 to 1994 study by Scherer and Crawley. Of the nine descriptors measuring the quality of abstract reporting, a mean of 6.25 (SEM 0.3) was included in the 24 study abstracts evaluated, significantly different from the Scherer and Crawley score (5.2, SEM 0.2. P: < 0.001). Four and six descriptors increased and decreased, respectively, their reporting in more than 20%. Key descriptors such as hypothesis postulation, primary outcome determination, sample size calculations, and a discussion of the limitations of the study such as bias, imprecision, and internal validity are still reported in less than 42% of clinical trials. CONCLUSIONS: This study describes for the first time after the adoption of the CONSORT statement recommendations the status on the quality of reporting of recently published randomized clinical trials in OPHTHALMOLOGY: Although not a direct measure of the intrinsic quality of a study, reporting quality provides the reader with useful tools for the evaluation of its validity. The quality of reporting of randomized clinical trials shows an overall improvement when compared with the period between 1991 and 1994. However, there is still significant room for improvement, especially in descriptors essential for the validation of clinical trial results that are still widely underreported.

Guidelines as Topic↗

PubMed2001

The Berkeley Contact Lens Extended Wear Study. Part I : Study design and conduct.

OBJECTIVE: The primary aim of the Berkeley Contact Lens Extended Wear Study (CLEWS) was to test the hypotheses that extended wear of rigid gas-permeable (RGP) contact lenses with greater oxygen permeability (Dk) reduces the incidence of contact lens-associated keratopathy (CLAK) and increases the survival rate in RGP extended wear (EW). In this article we describe the clinical trial design in detail, present the results of subject recruitment and retention, and provide the baseline demographic and ocular characteristics of the CLEWS subjects, whose data will be analyzed to address the study aims in a companion article. DESIGN: A randomized, concurrently controlled clinical trial. INTERVENTION: Subjects were fitted with day wear (DW) high-Dk RGP lenses and then adapted to EW. Subjects who adapted to EW were then randomly assigned to either high- or medium-Dk RGP lenses for 12 months of 6-nights/week EW. MAIN OUTCOME MEASURES: Slit-lamp assessment and grading of 17 possible keratopathies, measurement of refractive error and corneal curvature, and symptoms. Follow-up data were collected every 3 months. RESULTS: From 545 subjects entering the DW adaptation phase, 201 adapted to EW and were randomly assigned to medium- or high-Dk lenses for 12 months of EW. The baseline characteristics of the two study groups were similar and did not differ from the 344 DW subjects who failed to adapt to EW. The distributions of oxygen transmissibility for the two study groups were disjoint, indicating that each group received distinctly different levels of hypoxia. CONCLUSIONS: We show that CLEWS was appropriately designed to address the study hypotheses, was conducted with regard for the safety of the subjects, and adhered to rigorous protocols designed to control for bias and ensure the integrity of study data. We establish the internal validity of between-group statistical comparisons and characterize our study population to permit informed evaluation of the applicability of our results to the contact lens-wearing population in general.

Adult↗

PubMed2000

Simultaneous assessment of ecto- and cytosolic-5'-nucleotidase activities in brain micropunches.

We propose a new methodology for simultaneous assessment of ecto- and cytosolic-5'-nucleotidase that can be utilized in brain to measure the activity of these enzymes in micropunches of tissues. It is based on the differential sensitivity of both enzymes to alpha,beta-methyleneadenosine 5'-diphosphate (AMP-CP) and the requirements for magnesium as a co-factor. The design of assay protocol contains an internal validation by allowing comparisons between total level of 5'-nucleotidase activity with that calculated from the sum of individual activities of the ecto- and cytosolic-5'-nucleotidases. We have applied this new approach to assess the activity of ecto- and cytosolic-5'-nucleotidase in the brain regions relevant to sleep regulation. The level of both enzymes was significantly lower in the cerebral cortex than other brain regions tested.

5'-Nucleotidase↗

PubMed2002

[Interpretation of results of clinical trials in benign prostatic hyperplasia].

The random clinical trial (RCT) is the most suitable study to evaluate the treatment effectiveness in the benign prostatic hyperplasia (BPH). Although most of the urologists will not collaborate in a RCT development, they will treat BPH patients, so it is very important to know if a CRT in BPH is well designed and their conclusions are correct. The aim of this article is to give the basic elements of analysis that urologists need in order to evaluate the quality and the level of evidence of a RCT in BPH. This article emphasizes the three main elements of a RCT: to check if the study has been correctly performed (internal validity), to evaluate if the treatment achieves an important clinical improvement (relevance of the results) and the applicability of the results in our patients (external validity). The article shows that to analyse these elements common sense and clinical judgment are needed rather than statistical knowledge.

Data Interpretation, Statistical↗

PubMedDate not supplied

[Cancer incidence estimation in Spain: period 1993-1996].

OBJECTIVE: To estimate the number of incident cases of cancer in Spain between 1993 and 1996. METHODS: We used data on the incidence of cancer from nine Spanish population-based cancer registries published in the monograph Cancer incidence in Five Continents, vols. VI and VII (period 1983-92). The National Institute of Statistics provided mortality data (period 1983-96). Generalized linear mixed models were used to estimate the number of incident cases. The incidence/mortality ratio was modeled. To account for heterogeneity, the providence of residence was considered as a random effect. Other factors analyzed were sex, age and period. Model parameters were estimated using a Bayesian approach with BUGS software. Estimates were valdated by comparing the observed number of cases with those predicted by the model in the regions with cancer registry data. RESULTS: The average number of incident cases per annum for all cancer sites except non-melanoma skin cancer was 78,440 for men and 55,480 for women. The most frequent neoplasm in men was lung with 15,480 cases followed by bladder with 9,445 cases and colorectal with 8,876 cases. In women the most frequent cancer was breast with 13,490 cases followed by colorectal with 8,274 cases. These absolute frequencies showed an increasing time trend for all cancers and for the most frequent sites, with the exception of stomach and uterine cervix. Internal validation of the estimates allowed calculation of a relative error smaller than 10%. IMPLICATIONS: This is the first time that the number of incident cases of cancer in Spain has been estimated with methods that account for heterogeneity. These figures show the importance of cancer as a public health problem in our community.

Adult↗

PubMed1998

Program integrity in primary and early secondary prevention: are implementation effects out of control?

We examined the extent to which program integrity (i.e., the degree to which programs were implemented as planned) was verified and promoted in evaluations of primary and early secondary prevention programs published between 1980 and 1994. Only 39 of 162 outcome studies featured specified procedures for the documentation of fidelity. Of these, only 13 considered variations in integrity in analyzing the effects of the program. Lowered adherence to protocol was often associated with poorer outcome. There was mixed evidence of dosage effects. The omission of integrity data, particularly measures of adherence, may compromise the internal validity of outcome studies in the prevention literature. We do not view procedures for integrity verification as inconsistent with the adaptation of interventions to the needs of receiving communities.

Adolescent↗

PubMed1999

Using conjoint analysis to take account of patient preferences and go beyond health outcomes: an application to in vitro fertilisation.

There has been an assumption in the health economics literature that health outcomes are all that need to be considered when attempting to measure the benefits from health care interventions. This is most evident in the development of the quality adjusted life year (QALY) approach to benefit assessment. This paper challenges this view and considers the technique of conjoint analysis (CA) as a methodology for both taking account of patient preferences and considering attributes beyond health outcomes. The technique is applied to in vitro fertilisation. CA is shown to be sensitive to considering health outcomes, nonhealth outcomes and process attributes. It is also shown to be internally consistent and internally valid. The paper demonstrates the application of CA to estimating willingness to pay indirectly. It is argued that benefit assessment within health economics should extend beyond health outcomes and future research should investigate more thoroughly the potential application of CA in this area. However, methodological issues need addressing before the instrument becomes an established evaluative instrument.

Choice Behavior↗

PubMed2003

17alpha-methyltestosterone: 28-day oral toxicity study in the rat based on the "Enhanced OECD Test Guideline 407" to detect endocrine effects.

A 28-day oral gavage toxicity study in the rat with 17alpha-methyltestosterone was conducted as part of the international validation exercise on the modified Enhanced OECD Test Guideline 407 (Organisation for Economic Co-operation and Development, Paris). Special emphasis was placed on the endocrine mediated effects exerted by 17alpha-methyltestosterone, a potent androgen agonist. The test compound was administered daily by oral gavage for at least 28 days to groups of 7-week-old-Wistar rats. Dose levels were 0, 10, 40 and 200 mg/kg body weight per day for males and 0, 10, 100 and 600 mg/kg body weight per day for females. In addition, and outside the remit of the enhanced protocol, testosterone levels in males, oestradiol levels in females and luteinizing hormone (LH) levels in both sexes were measured, to provide a broader profile on the hormonally mediated effects of 17alpha-methyltestosterone. Furthermore, stage-specific quantification of Terminal deoxynucleotidyl transferase-mediated dUTP Nick-End Labeling (TUNEL)-labeled germ cells (apoptotic germ cells) in the seminiferous tubules was also performed, in an effort to demonstrate the precise stages in the spermatogenic cycle 17alpha-methyltestosterone exerts its effect. In this study, the most critical additional parameters contained in the Enhanced OECD Test Guideline 407 for the detection of endocrine disruption were considered to be the histopathological assessment and organ weight data of endocrine-related tissues. Beyond the scope of this validation exercise, an increase in apoptosis in specific germ cell types was detected using the TUNEL assay in male rats treated at 200 and 40 mg/kg.

Administration, Oral↗

PubMed1997

[Registries of morbimortality in cardiology: methods].

The effectiveness of diagnostic, preventive and therapeutic procedures, whose efficacy has been assessed in clinical trials, should be tested in a real treatment scenario. The procedures used in acute myocardial infarction (AMI) management can be evaluated by means of cohort studies that include all consecutive patients admitted to one or several hospitals. Such studies are called hospital registries. They are simpler to organize and cheaper than clinical trials. On the other hand, the AMI population-based registries allow the establishment of the incidence and mortality rates, as well as case-fatality as they include those patients who die before reaching hospital facilities. In both types of registries a set of variables on co-morbidity, age, sex, severity, and the utilization of procedures along with the course of the disease are systematically recorded in each patient using standard definitions to warrant the internal validity. In hospital registries, the external validity of the results will depend on whether the sample of hospitals represents the population where it was obtained. A good registry should include patients with a wide age range, allow the analysis of specific subgroups of patients such as non-Q wave or first AMI to allow for comparison with other registries. In addition, it should also permit a mid-term follow-up, respect ethical issues, receive appropriate funding and keep a multidisciplinary team involved in its design and development.

Cardiology↗

PubMed2001

Clinical precision of myofascial trigger point location in the trapezius muscle.

Myofascial trigger points (TrPs) have been clinically described as discrete areas of muscle tenderness presenting in taut bands of skeletal muscle. Using well-defined clinical criteria, prior investigations have demonstrated interrater reliability in the diagnosis of TrPs within a given muscle. No reports exist, however, with respect to the precision with which experienced clinicians can determine the anatomic locations of TrPs within a muscle. This paper details a study wherein four trained clinicians achieved statistically significant reliability (see below) in estimating the precise locations of latent TrPs in the trapezius muscle of volunteer subjects (n=20). To do so, the clinicians trained extensively together prior to the study. The precise anatomic location of each subject's primary TrP was measured in a blinded fashion using a 3 dimensional (3-D) camera system. Use of this measurement system permitted the anatomic co-ordinates of each TrP to be located without providing feedback to subsequent clinicians. The clinicians each used a pressure algometer along with patient feedback to document the sensitivity of each suspected TrP site, however unlike routine clinical practice, the algometry was performed with a double-blinded approach hence the results were only examined post-hoc. At the time of data collection (algometry readings unknown), 16 of the 20 subjects were judged to present with a latent TrP. Subsequently, when subjected to a criterion pressure threshold value of <3.0 kg.cm(-2), 12 of these TrPs were classified as being clinically sensitive. To assess the 3-D measurement precision, and the reliability of the TrP estimates, statistical measures of the SEM and the Generalizability coefficient (G-coeff) were determined for all suspected TrP sites in the superior-inferior, medial-lateral and anterior-posterior directions. The best results were determined by pooling the measurements of all 4 clinicians, however, based upon exceeding a criterion reliability threshold of 80%, the use of just two testers was found to produce reliable results. The two-tester condition yielded a precision of 7.5, 7.6 and 6.5 mm (SEM) with reliability (G-coeff) of 0.92, 0.86 and 0.83, respectively. Given the double-blinded methodology, the use of pressure algometry was also found to demonstrate internal validity. The algometer responses associated with TrP estimates varied inversely with respect to the clinical group's reliability in identify the TrP locations. To summarize, for the trapezius muscle, this study demonstrates that two trained examiners can reliably localize latent TrPs with a precision that essentially approaches the physical dimensions of the clinician's own fingertips. Finally, it should be recognized that the ability to precisely document TrP location appears critical to the success of future studies that may be designed to investigate the etiology and pathogenesis of this commonly diagnosed clinical disorder.

Adult↗

PubMed2003

Single versus multiple drug focus in substance abuse clinical trials research.

Complex patterns of multiple substance use pose clinical and methodological challenges for substance abuse clinical trials research. To increase measurement precision and internal validity, the modal approach has been to target both treatment interventions and outcome assessment to a single class of abused substance. This strategy warrants reconsideration because it entails limitations in recruitment feasibility and generalization of study findings. This report reviews pros and cons of single versus multiple targeted drugs, suggests guidelines for choosing between these strategies and outlines methods for broadening the scope of substance abuse clinical trails to take abuse of multiple substances into account. We recommend that investigators consider moving away from a single drug focus in three ways. First, include systematic assessment of a wide range of psychoactive substance use throughout the trial and evaluate the impact of study treatments on use of all classes of drugs. Second, except where contraindicated, include patients who use and abuse multiple classes of substances even in trials evaluating treatment of a single targeted drug. Third, consider inclusion of polysubstance abusers or those who primarily abuse multiple classes of substances in the same clinical trial. Although many treatment efficacy questions can best be answered by single focus studies, we recommend that such designs be adopted only after less restrictive designs are first considered.

Clinical Trials as Topic↗

PubMed2001

Development of non-radio isotopic endpoint of murine local lymph node assay based on 5-bromo-2'-deoxyuridine (BrdU) incorporation.

Allergic contact dermatitis is a serious health problem. Over the last decade, the murine local lymph node assay (LLNA) has been developed to detect chemical allergens, and international validation studies have been conducted. We have tried to establish an alternative non-radioisotopic endpoint for the LLNA by using 5-bromo-2'-deoxyuridine (BrdU) incorporation in place of radioisotopes, such as [3H]thymidine, employed in the standard method. BrdU was given as a single administration at 5 mg/animal 2 days following three consecutive daily applications of a test chemical. BrdU incorporation into draining lymph node cells was measured using an enzyme immunosorbent assay technique. In this study, p-benzoquinone(PBQ), trimellitic anhydride (TMA), citral(CT) and dextran (DEX) were used as pilot chemicals. PBQ, TMA and CT, which are classified as moderate to strong sensitizers in the guinea pig maximization test and were positive in the original LLNA, were also found to elicit positive responses in the alternative LLNA using BrdU incorporation. In contrast, DEX tested negative in the modified assay consistent with previous guinea pig and LLNA data. Consequently, the modified LLNA endpoint using BrdU incorporation may represent a useful alternative to the standard assay in situations, where there is a need to avoid the use of radioisotopes.

Acyclic Monoterpenes↗

PubMed2001

From pain to self-awareness--a qualitative analysis of the significance of group participation for persons with chronic musculoskeletal pain.

The experiences of persons with chronic musculoskeletal pain who participated in a twelve-session process and experience-oriented learning programme were analysed with qualitative methods. The programme was based on a phenomenological frame of understanding where the individual's experience of her/his situation was essential. The educational approach was inspired by personal construct theory that calls attention to the human being's capacity to redefine and reconstruct the meanings of any situation and symptom. Certain qualities and values were embedded in the group programme: A context that emphasised an understanding of the body 'as a talking subject' rather than focusing on pain and diagnoses; the wholeness of participants' situation rather than viewing chronic muscular pain as either physical or psychological: activity, participation and operating within the participants' everyday language and ways of expressing themselves; respecting, seeing, listening and trusting the group participants; focusing on each participant's and the whole group's resources, potentials and possibilities; challenging the participants to evoke their inner authority and internal validation instead of surrendering authority on their pain to the health personnel. Self-reports shortly after, and a year after, participation indicated that participants in the groups had reconstructed some patterns in their lives, both in relation to self and others. They had an increased awareness of self, less pain and more constructive ways of handling pain and life situation.

Chronic Disease↗

PubMed1996

Can the NASCET technique for measuring carotid stenosis be reliably applied outside the trial?

PURPOSE: The North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the Asymptomatic Carotid Artery Study (ACAS) both confirmed the effectiveness of carotid endarterectomy for preventing stroke in patients who have significant carotid stenosis. A uniform technique for measuring carotid stenosis from an arteriogram (% stenosis = [1 - minimum residual lumen/normal distal cervical internal carotid artery diameter] x 100) was used in both trials, with reproducibility internally validated. The reliability of this measurement when used outside the trials for defining carotid stenosis has not been validated. Imprecise calculation of carotid stenosis can result in a 50% overestimation of significant carotid disease and potential overuse of carotid surgery. This is a prospective study of the reliability of carotid stenosis measurements performed by practicing physicians of different specialties and different levels of clinical experience. METHODS: Two vascular surgeons and two interventional radiologists (one resident and one staff member per specialty), blinded to results, calculated the percent stenosis from 219 consecutive arteriograms performed to evaluate extracranial carotid artery occlusive disease; 72 random films were reread by each individual. The interpretations were grouped as < 60% or > or = 60% stenosis (ACAS) and as < 30%, 30% to 69%, and > or = 70% stenosis (NASCET). Interobserver and intraobserver agreement were analyzed with the kappa statistic and Pearson correlation coefficients. RESULTS: Interobserver reliability in categorizing carotid stenosis revealed excellent agreement for both ACAS (kappa = 0.825 to 0.903) and NASCET groups (kappa = 0.729 to 0.793). Interobserver correlation coefficients ranged from 0.91 to 0.95. Intraobserver agreement was also highly reproducible for both the ACAS (kappa = 0.732 to 0.970) and NASCET categories (kappa = 0.634 to 0.805). Intraobserver correlation coefficients ranged from 0.89 to 0.95. CONCLUSION: The NASCET technique for quantification of carotid stenosis can be easily learned by physicians and reliably implemented for appropriate identification of candidates for carotid endarterectomy.

Angiography, Digital Subtraction↗

PubMed2001

Treatment of reflex sympathetic dystrophy (CRPS type 1): a research synthesis of 21 randomized clinical trials.

A blinded meta analysis was performed on randomized clinical trials (RCT) on the medicinal treatment of reflex sympathetic dystrophy (complex regional pain syndrome type I) to assess the methodological quality and quantify the analgesic effect of treatments by calculating individual and summary effect sizes. The internal validity of 21 RCTs was investigated and the quality weighted summary effect size was calculated using a fixed effect model (Glass Delta). The methodological quality ranged from moderate to good (average 46%). Differences were found between the trials in inclusion/exclusion criteria, treatment methods, duration of treatments and trials, and measurement instruments. Statistical analysis was possible for four subgroups; one evaluating the analgesic effects of sympathetic suppressors in general (n = 12), one subgroup concerning the analgesic effects of guanethidine (n = 6), one investigating the analgesic effect of intravenous regional sympathetic blocks (n = 9), and one subgroup (n = 5) evaluating the analgesic effect of calcitonin. Except for the calcitonin subgroup (P = 0.002), the quality-weighted summary effect size of these subgroups were not significant. No significant analgesic effect by sympathetic suppressing agents could be established. Calcitonin seems to provide effective pain relief in reflex sympathetic dystrophy patients. The results of the present study show that weighting methodological quality influences the magnitude of the effect sizes of specific treatment methods. Future studies should control for methodological quality.

Analgesics↗

PubMed1998

International comparisons of professional assessments in orthodontics: Part 1--Treatment need.

An international survey has been undertaken to assess variation in professional assessment of orthodontic treatment need. Ninety-seven orthodontists from nine countries examined a standard sample of 240 dental study casts to judge the need for orthodontic treatment in terms of dental health, dental esthetics, and deviation from normal. Participants also indicated their assessment of treatment complexity and whether they would recommend treatment. Practitioners' subjective assessments were found to be only moderately reliable overall. Of the cases examined, 76% [corrected] obtained a consensus of 80% or greater on the need for treatment. Logistic regression equations were derived to explain the observed variation in treatment decisions. It was found that occlusal traits from the dental casts were highly predictive of the treatment decision, and that the practitioners' country of origin and payment methods are important influences on prescribing behavior. The treatment decisions were predicted with an accuracy of 84% by using occlusal score values for the dental esthetics, the degree of upper arch crowding, the presence of crossbite, the anterior overbite, and the buccal segment sagittal relationship. It is suggested that these traits may form the basis for an internationally validated index of treatment need for use in clinical audit and orthodontic research.

Adult↗

PubMed2002

Patient education for preventing diabetic foot ulceration. A systematic review.

OBJECTIVE: Ulceration of the feet, which can result in loss of limbs and death, is a major health problem for people with diabetes mellitus. The objective of this review is to assess the effectiveness of patient education to prevent diabetic foot ulcers. RESEARCH DESIGN AND METHODS: We conducted a systematic review of randomized controlled trials (RCTs) that evaluated educational programmes for the prevention of foot ulcers in people with diabetes mellitus. We used standard search methods of the Cochrane "Wounds Groups". Two reviewers working independently extracted data and assessed study quality. RESULTS: The methodologic quality of the 8 included RCTs was poor. The internal validity score (range 0-10) of individual RCTs ranged from 2 to 4. Four trials compared the effect of intensive with brief educational interventions; 2 of these reported clinical endpoints. One study involving high-risk patients reported a reduction in ulcer incidence (OR 0.28, 95% confidence interval [CI] 0.13-0.59) and amputation rate (OR 0.32, 95% CI 0.14-0.71) after 1 year. The other RCT did not find an effect after 7 years of follow-up. Two trials showed that participants' foot care knowledge significantly improved with education. In one trial, foot care knowledge was significantly worse at 6 months, although foot care behavior improved significantly. One RCT, that compared patient foot care education as part of a general diabetes education program to usual care, showed no reduction in the risk of foot ulceration. In one RCT, patient education as part of a complex intervention targeted at both people with diabetes and doctors reduced the prevalence of serious foot lesions at 1 year (OR 0.41, 95% CI 0.16-1.00) and improved foot care behavior. Evidence from two RCTs comparing the effect of patient-tailored education in addition to usual care was conflicting. SUMMARY: Evidence, limited by poor methodologic quality and conflicting results, suggests that patient education may have positive but short-lived effects on foot care knowledge and behavior of patients and may reduce foot ulceration and amputations, especially in high-risk patients. High-quality randomized controlled trials are needed to establish the efficacy of patient education to prevent diabetic foot ulcerations.

Diabetic Foot↗