Percutaneous Image-Guided Treatment of Pediatric Deep-Vein Occlusions.

Pediatric venous occlusions are a growing cause of morbidity and mortality, especially in hospitalized patients. Catheter-directed recanalization is a safe and effective treatment option in appropriately selected patients. Benefits of catheter directed therapies (CDTs) include the prevention of pulmonary embolism and end organ failure acutely as well as superior vena cava syndrome and post-thrombotic syndrome chronically. Timely diagnosis, recognition of underlying factors for thrombosis, and familiarity with the spectrum of tools and techniques for CDT are essential to optimizing outcomes in the acute setting. Recanalization of chronic venous occlusions can similarly provide symptomatic relief and achieve long term vessel patency. This review will detail the scope, techniques, and outcomes for CDT in the treatment of acquired systemic deep vein occlusions.

Time-Driven Activity-Based Cost Comparison of Osteoid Osteoma Ablation Techniques.

OBJECTIVE: Compare the cost of performing an osteoid osteoma ablation using cone beam CT (CBCT) with overlay fluoroscopic guidance to ablation using conventional CT (CCT) guidance and microwave ablation (MWA) to radiofrequency ablation (RFA). METHODS: An 11-year retrospective study was performed of all patients undergoing osteoid osteoma ablation. Ablation equipment included a Cool tip RFA probe (Covidien, Minneapolis, Minnesota) or a Neuwave PR MWA probe (Ethicon, Rariton, New Jersey). The room times as well as immediate recovery time were recorded for each case. Cost analysis was then performed using time-driven activity-based costing for rate-dependent variables including salaries, equipment depreciation, room time, and certain supplies. Time-independent costs included the disposable interventional radiology supplies and ablation systems. Costs were reported for each service providing care and using conventional cost accounting methods with variable and fixed expenditures. RESULTS: A total of 91 patients underwent 96 ablation procedures in either CBCT (n = 66) or CCT (n = 30) using either MWA (n = 51) or RFA (n = 45). The anesthesia induction (22.7 ± 8.7 min versus 15.9 ± 7.2 min, P < .001), procedure (64.7 ± 27.5 min versus 47.3 ± 15.3 min; P = .001), and room times (137.7 ± 33.7 min versus 103.9 ± 22.6. min; P < .001) were significantly longer for CBCT procedures. The procedure time did not differ significantly between MWA and RFA (62.1 ± 27.4 min versus 56.1 ± 23.3 min; P = .27). Multiple regression analysis demonstrated lower age (P = .046), CBCT use (P = .001), RFA use (P = .02), and nonsupine patient position (P = .01) significantly increased the total procedural cost. After controlling for these variables, the total cost of CBCT ($5,981.32 ± $523.93 versus $5,378.93 ± $453.12; P = .001) remained higher than CCT and the total cost of RFA ($5,981.32 ± $523.93 versus $5,674.43 ± $549.14; P = .05) approached a higher cost than MWA. CONCLUSION: The use of CBCT with overlay fluoroscopic guidance for osteoid osteoma ablation resulted in longer in-room times and greater cost when compared with CCT. These cost considerations should be weighed against potential radiation dose advantage of CBCT when choosing an image guidance modality. Younger age, RFA use, and nonsupine patient position additionally contributed to higher costs.

Delaying Invasive Treatment in Unilateral Head and Neck Lymphatic Malformation Improves Outcomes.

OBJECTIVES: Large (De Serres stage [IV-V]) head and neck lymphatic malformations (HNLMs) often have multiple, high-risk, invasive treatments (ITs) to address functional compromise. Logically reducing HNLM ITs should reduce treatment risk. We tested whether delaying HNLM ITs reduces total IT number. MATERIALS: Consecutive HNLM patients (n = 199) between 2010 and 2017, aged 0-18 years. METHODS: ITs (surgery or sclerotherapy) were offered for persistent or dysfunction causing HNLMs. Treatment effectiveness categorized by IT number: optimal (0-1), acceptable (2-5), or suboptimal (>5). Clinical data were summarized, and outcome associations tested (χ2 ). Relative risk (RR) with a Poisson working model tested whether HNLM observation or IT delay (>6 months post-diagnosis) predicts treatment success (i.e., ≤1 IT). RESULTS: Median age at HNLM diagnosis was 1.3 months (interquartile range [IQR] 0-45 m) with 107/199(54%) male. HNLM were stage I-III (174 [88%]), IV-V (25 [13%]). Initial treatment was observation (70 [35%]), invasive (129 [65%]). Treatment outcomes were optimal (137 [69%]), acceptable (36 [18%]), and suboptimal (26 [13%]). Suboptimal outcome associations: EXIT procedure, stage IV-V, oral location, and tracheotomy (p < 0.001). Stage I-III HNLMs were initially observed compared with stage I-III having ITs within 6 months of HNLM diagnosis, had a 82% lower relative treatment failure risk ([i.e., >1 IT], RR = 0.09, 95% CI 0.02-0.36, p < 0.001). Stage I-III HNLMs with non-delayed ITs had reduced treatment failure risk compared with IV-V (RR = 0.47, 95% CI 0.33-0.66, p < 0.001). CONCLUSION: Observation and delayed IT in stage I-III HNLM ("Grade 1") is safe and reduces IT (i.e., ≤1 IT). Stage IV-V HNLMs ("Grade 2") with early IT have a greater risk of multiple ITs. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:956-962, 2023.

Safety of Periprocedural Antithrombotics during Pediatric Transplant Liver Biopsies.

The purpose of this study was to compare the adverse event (AE) rates of percutaneous pediatric transplant liver biopsies in patients receiving periprocedural antithrombotic agents with those in patients not receiving them. A 19-year retrospective single-center study of ultrasound-guided transplant liver biopsies was conducted. Patients who received aspirin for <5 days (n = 51) or heparin <4 hours (n = 15) before biopsy were separately grouped. AEs were reported using the Society of Interventional Radiology classification. In 276 biopsy samples from patients with a mean age of 6.75 years ± 5.80, the overall AE (P = .72) and moderate AE (P = .78) rates for control and antithrombotic groups were not significantly different. No severe AEs or deaths occurred. In conclusion, aspirin continuation during percutaneous pediatric transplant liver biopsies may be safe, but more studies are necessary to confirm the safety of periprocedural heparin.

Alpelisib for the treatment of PIK3CA-related head and neck lymphatic malformations and overgrowth.

PURPOSE: PIK3CA-related overgrowth spectrum (PROS) conditions of the head and neck are treatment challenges. Traditionally, these conditions require multiple invasive interventions, with incomplete malformation removal, disfigurement, and possible dysfunction. Use of the PI3K inhibitor alpelisib, previously shown to be effective in PROS, has not been reported in PIK3CA-associated head and neck lymphatic malformations (HNLMs) or facial infiltrating lipomatosis (FIL). We describe prospective treatment of 5 children with PIK3CA-associated HNLMs or head and neck FIL with alpelisib monotherapy. METHODS: A total of 5 children with PIK3CA-associated HNLMs (n = 4) or FIL (n = 1) received alpelisib monotherapy (aged 2-12 years). Treatment response was determined by parental report, clinical evaluation, diary/questionnaire, and standardized clinical photography, measuring facial volume through 3-dimensional photos and magnetic resonance imaging. RESULTS: All participants had reduction in the size of lesion, and all had improvement or resolution of malformation inflammation/pain/bleeding. Common invasive therapy was avoided (ie, tracheotomy). After 6 or more months of alpelisib therapy, facial volume was reduced (range 1%-20%) and magnetic resonance imaging anomaly volume (range 0%-23%) were reduced, and there was improvement in swallowing, upper airway patency, and speech clarity. CONCLUSION: Individuals with head and neck PROS treated with alpelisib had decreased malformation size and locoregional overgrowth, improved function and symptoms, and fewer invasive procedures.

Time-Driven Cost Analysis of Noncuffed Venous Catheter Placement in Infants: Bedside versus IR Suite.

PURPOSE: To compare the direct bundled costs of interventional radiology (IR) suite versus bedside placement of noncuffed central venous catheters in infants. METHODS: A single-center retrospective review was performed of all noncuffed upper extremity (peripherally inserted central venous catheter [PICC]) and tunneled femoral (tunneled femoral central venous catheter [TCVC]) catheters placed in infants between January 1, 2018, and December 31, 2018. Propensity score matching was performed adjusting for age, birth weight, procedure weight, and catheter days. Process maps for each procedure were created based on location and sedation type. Technical success and complications were recorded for each placement. The total direct bundled cost for each catheter placement was calculated by summing the procedure and complication costs. RESULTS: A total of 142 procedures were performed on 126 matched patients with a technical success of 96% at the bedside and 100% in the IR suite (P = .08). The complication rates did not significantly differ between the 2 groups (P = .51). The total direct bundled costs for catheter placement were $1421.3 ± 2213.2 at the bedside and $2256.8 ± 3264.7 in the IR suite (P = .001). CONCLUSIONS: The bundled cost of bedside femoral catheter placement is significantly less than that of fluoroscopic TCVC and PICC placement performed in the IR suite, mainly related to differences in sedation costs.

Emergent stent-graft repair of a massive aortic pseudoaneurysm secondary to Behçet's disease in a child.

An 11-year-old male with vasculitis was found to have a large abdominal aortic pseudoaneurysm on diagnostic angiography. This report describes endovascular repair of the pseudoaneurysm by stent-graft exclusion. The existing literature surrounding this rare and potentially fatal condition is also reviewed.

Transforaminal intrathecal delivery of nusinersen using cone-beam computed tomography for children with spinal muscular atrophy and extensive surgical instrumentation: early results of technical success and safety.

BACKGROUND: Nusinersen, the only treatment approved by the United States Food and Drug Administration for spinal muscular atrophy (SMA), is delivered intrathecally. Many children with SMA have extensive spinal instrumentation and deformities, often precluding the use of standard approaches for gaining intrathecal access. Furthermore the anatomical distortion that often occurs with rotoscoliosis can complicate the use of fluoroscopic guidance. Compared to fluoroscopy, CT affords superior guidance for complex needle placements. This opens up alternatives to the posterior (interlaminar) technique, including transforaminal and caudal approaches. OBJECTIVE: This study describes the early results of technical success, complications and radiation dose of intrathecal delivery of nusinersen using cone-beam CT guidance with two-axis fluoroscopic navigational overlay. MATERIALS AND METHODS: We conducted a retrospective review of 15 consecutive nusinersen injections performed in four children with SMA and extensive spinal hardware precluding standard posterior lumbar puncture techniques. These children were treated using transforaminal thecal access employing cone-beam CT with navigational overlay. We analyzed results including technical success, complications and total fluoroscopy time. RESULTS: All procedures were technically successful. No major complications and one minor complication were reported; the minor complication was a post-procedural neuropathic headache that was attributed to procedural positioning and was treated successfully with gabapentin. The average procedural fluoroscopy time and air kerma were 1.9 min and 55.8 mGy, respectively. CONCLUSION: Cone-beam CT guidance with two-axis navigational overlay is a safe, effective method for gaining transforaminal intrathecal access in children with spinal abnormalities and hardware precluding the use of standard techniques.

C-reactive Protein in Periodontitis and its Comparison with Body Mass Index and Smoking Behaviour.

INTRODUCTION: Chronic periodontitis is an infectious disease resulting in inflammation within the supporting tissues of the teeth, progressive attachment loss, and bone loss. In addition to declining oral health, there is always low grade infection present in periodontitis. Studies show increased levels of systemic biomarkers in periodontal disease such as CRP, which is considered a key-marker of CVD. Research has also shown positive association between BMI and smoking with periodontitis and CRP. The objective of the study was to assess the levels of CRP in patients with and without periodontitis and their relation with BMI and smoking behaviour. METHODS: Patients visiting the Dental department of Bir Hospital were invited to participate in the study. Total 31 subjects in each group: Case (periodontitis) and Control (without periodontitis) were selected using convenience sampling technique. All subjects underwent periodontal examination by a single examiner. Serum CRP samples were taken before periodontal treatment. Data analysis was done by SPSS 17 software program. RESULTS: Increase in mean CRP levels in periodontitis (5.8595mg/L) with high statistical significance (P=0.000) in comparison to subjects without periodontitis (1.1214mg/L) was observed. BMI showed positive association with periodontitis (P=0.046) but not with CRP (0.213). Smoking behaviour showed no significant relation with either CRP (P=0.344) or periodontitis (P=0.541). CONCLUSIONS: We found highly significant association between periodontitis and CRP levels but not always with BMI and smoking. CRP, which is an established marker for CVD was significantly increased in periodontal infections. Hence, a close interaction among Physician, Periodontist and Patient to prevent adverse health situations is recommended.

Proximal myopathy with focal depletion of mitochondria and megaconial congenital muscular dystrophy are allelic conditions caused by mutations in CHKB.

We recently evaluated two of the original three patients (siblings) diagnosed with Proximal Myopathy with Focal Depletion of Mitochondria. The condition was named for the distinctive pattern of enlarged mitochondria around the periphery of muscle fibres with a complete absence in the middle. These siblings, aged 37 and 40, are cognitively normal with mild non-progressive muscle weakness and a susceptibility to rhabdomyolysis. Both were shown to be compound heterozygotes for novel mutations (c.263C>T + c.950T>A) in CHKB, the gene currently associated with Megaconial Congenital Muscular Dystrophy. Individuals with this condition have early-onset muscle weakness and profound intellectual disability but share the same unique pattern on muscle biopsy as was noted in Proximal Myopathy with Focal Depletion of Mitochondria; focal depletion of mitochondria was surrounded by abnormally large "megaconial" mitochondria. Thus the phenotypic spectrum of CHKB mutations ranges from a congenital muscular dystrophy with intellectual disability to a later-onset non-progressive muscular weakness with normal cognition.

Alpha-sarcoglycanopathy presenting as exercise intolerance and rhabdomyolysis in two adults.

Two patients with exercise-induced myalgias and rhabdomyolysis with myoglobinuria were evaluated with muscle biopsy and comprehensive myopathy next generation sequencing (NGS) gene panels. Genetic analysis revealed homozygosity for two known pathogenic SGCA mutations (R284C in Patient 1 and V247M in Patient 2). Muscle biopsy showed minimal changes with normal immunohistochemistry for α-sarcoglycan. Western blotting showed 27% and 35% of normal α-sarcoglycan immunoreactivity when compared to age matched controls, confirming the diagnosis of α-sarcoglycanopathy in both patients. The sarcoglycan genes should be added to the differential diagnosis for cases that present with rhabdomyolysis, exercise intolerance, and hyperCKemia, even in the absence of muscle weakness or normal α-sarcoglycan immunohistochemistry. Work-up of patients with these types of non-specific presentation may be best facilitated through the use of non-specific NGS myopathy panels.

An Adaptive Thresholding Method for BTV Estimation Incorporating PET Reconstruction Parameters: A Multicenter Study of the Robustness and the Reliability.

OBJECTIVE: The aim of this work was to assess robustness and reliability of an adaptive thresholding algorithm for the biological target volume estimation incorporating reconstruction parameters. METHOD: In a multicenter study, a phantom with spheres of different diameters (6.5-57.4 mm) was filled with (18)F-FDG at different target-to-background ratios (TBR: 2.5-70) and scanned for different acquisition periods (2-5 min). Image reconstruction algorithms were used varying number of iterations and postreconstruction transaxial smoothing. Optimal thresholds (TS) for volume estimation were determined as percentage of the maximum intensity in the cross section area of the spheres. Multiple regression techniques were used to identify relevant predictors of TS. RESULTS: The goodness of the model fit was high (R(2): 0.74-0.92). TBR was the most significant predictor of TS. For all scanners, except the Gemini scanners, FWHM was an independent predictor of TS. Significant differences were observed between scanners of different models, but not between different scanners of the same model. The shrinkage on cross validation was small and indicative of excellent reliability of model estimation. CONCLUSIONS: Incorporation of postreconstruction filtering FWHM in an adaptive thresholding algorithm for the BTV estimation allows obtaining a robust and reliable method to be applied to a variety of different scanners, without scanner-specific individual calibration.

Rhabdomyolysis Due to Severe Hypophosphatemia in Diabetic Ketoacidosis.

Rhabdomyolysis is a syndrome characterized by injury to skeletal muscle fibers with disruption and release of toxic metabolites into circulation. It is characterized by triad of muscle weakness, myalgia and dark urine and is associated with increased creatine kinase and lactate dehydrogenase. A severely malnourished 10 year old girl with severe diabetic ketoacidosis as hemr initial presentation of type 1 diabetes mellitus developed rhabdomyolysis (CK- 12,000 U/L) with non-oliguric renal failure during her initial course of hospital stay. The possible cause of her RM was attributed to severe hypophosphatemia (minimum serum phosphate, 0.8 mg/dL). Management of diabetic ketoacidosis phosphate supplementation and urinary alkalinization with diuresis improved her clinical course. She was discharged on Day 9 with Insulin. We recommend frequent monitoring of serum phosphate during early period of DKA, particularly in malnourished children, and its normalization in case of severe hypophosphatemia.

A case of invasive papillary breast carcinoma: Fierce façade with favorable prognosis.

Invasive papillary carcinoma of the breast is a rare, distinct variant comprising approximately less than 1-2% of all newly diagnosed cases of breast carcinoma and is usually found in postmenopausal women with a more favorable prognosis. We report an unusual case in a 45-year-old perimenopausal female who came with a complaint of lump in right breast for duration of 1 year. A simple mastectomy was undertaken for histopathological study and immunohistochemistry (IHC) which showed characteristic features of an invasive papillary breast carcinoma. We present this case in view of its rarity and to highlight this clinicopathological subtype for its good prognosis and to avoid overtreatment.

Ultrasound-guided musculoskeletal interventions in American football: 18 years of experience.

OBJECTIVE: Myotendinous strains, contusions, and hematomas are common injuries in American football. Along with ligament sprains and inflammatory disorders, musculoskeletal injuries often result in lost participation time. This article summarizes 18 years of experience with 128 ultrasound-guided drainages and injections in 69 football players with 88 injuries. CONCLUSION: When performed by an operator with sufficient expertise in diagnostic and procedural skills, ultrasound-guided musculoskeletal interventions are minimally invasive, are safe, and can play an integral role in injury management.

IMRT or 3D-CRT in glioblastoma? A dosimetric criterion for patient selection.

Intensity modulated radiation therapy (IMRT) is increasingly employed in glioblastoma (GBM) treatment. The present work aimed to assess which clinical-dosimetric scenario could benefit the most from IMRT application, with respect to three-dimensional conformal radiation therapy (3D-CRT). The number of organs at risk (OARs) overlapping the planning target volume (PTV) was the parameter describing the clinical-dosimetric pattern. Based on the results, a dosimetric decision criterion to select the most appropriate treatment technique is provided. Seventeen previously irradiated patients were retrieved and re-planned with both 3D-CRT and IMRT. The prescribed dose was 60 Gy/30fx. The cases were divided into 4 groups (4 patients in each group). Each group represents the scenario where 0, 1, 2 or 3 OARs overlapped the target volume, respectively. Furthermore, in one case, 4 OARs overlapped the PTV. The techniques were compared also in terms of irradiated healthy brain tissue. The results were evaluated by paired t-test. IMRT always provided better target coverage (V95%) than 3D-CRT, regardless the clinical-dosimetric scenario: difference ranged from 0.82% (p = 0.4) for scenario 0 to 7.8% (p = 0.02) for scenario 3, passing through 2.54% (p = 0.18) and 5.93% (p = 0.08) for scenario 1 and 2, respectively. IMRT and 3D-CRT achieved comparable results in terms of dose homogeneity and conformity. Concerning the irradiation of serial-kind OARs, both techniques provided nearly identical results. A statistically significant dose reduction to the healthy brain in favor of IMRT was scored. IMRT seems a superior technique compared to 3D-CRT when there are multiple overlaps between OAR and PTV. In this scenario, IMRT allows for a better target coverage while maintaining equivalent OARs sparing and reducing healthy brain irradiation. The results from our patients dataset suggests that the overlap of three OARs can be used as a dosimetric criterion to select which patients should receive IMRT treatment.

SU-E-J-168: 4D-PET for Target Volume Delineation in Respiratory-Gated Radiation Therapy.

PURPOSE: To find an optimized workflow for the use of respiratory-gated PET (4D-PET) in target volume delineation of tumors subject to respiratory-gated radiation therapy. METHODS: 15 patients with lung (11) and pancreas (4) tumors who had FDG-PET-CT for target delineation prior to EBRT were studied. Patients were selected among the group that showed respiratory-induced tumor motion 〉5mm. 4D-PET was performed by means of a Philips Gemini BigBore scanner, using the Varian RPM gating system. An identical system was available at the linac for treatment. The breathing cycle was equally divided in 4 phases, according to a previous study. Since planning was made on a single CT-phase, no ITV was explicitly built from the set of phases. The BTV was identified with SUV=2.2 threshold and the PTV was obtained expanding the BTV by 8mm(S-I), 5mm(A-P) and 3mm(L-R) to account for residual motion and setup errors. The most advantageous CT-phase for treatment planning was then identified by simulating plans on each phase and analyzing the resulting DVHs of OARs (lung, trachea, oesophagus, spinal cord, left ventricle). RESULTS: The observed maximum range of motion was 5.5mm(L-R), 12.3mm(A-P) and 19.2mm(S-I). The standard deviation of the BTV volume in the 4 phases ranged from 6% to 13.7%. V20 (lung) ranged 7.1%-15.2% in inspiration and 7.8%-18.6% in expiration. The mean dose to the oesophagus ranged 0.1-2.2Gy in inspiration and 1.4-2.0Gy in expiration. In general, the dose to OARs was smaller when planning on a single phase than on the overall, respiratory-uncontrolled volume (p-value〈0.05). CONCLUSIONS: The BTV volume was almost constant between phases, confirming that the motion might be described by 4 phases. There was no obvious choice of the optimal phase for treatment planning, suggesting patient-by-patient studies. However, planning and delivery on one phase consistently allowed dose sparing to be obtained compared to non-gated techniques.

Clinical target volume delineation in glioblastomas: pre-operative versus post-operative/pre-radiotherapy MRI.

OBJECTIVES: Delineation of clinical target volume (CTV) is still controversial in glioblastomas. In order to assess the differences in volume and shape of the radiotherapy target, the use of pre-operative vs post-operative/pre-radiotherapy T(1) and T(2) weighted MRI was compared. METHODS: 4 CTVs were delineated in 24 patients pre-operatively and post-operatively using T(1) contrast-enhanced (T1(PRE)CTV and T1(POST)CTV) and T(2) weighted images (T2(PRE)CTV and T2(POST)CTV). Pre-operative MRI examinations were performed the day before surgery, whereas post-operative examinations were acquired 1 month after surgery and before chemoradiation. A concordance index (CI) was defined as the ratio between the overlapping and composite volumes. RESULTS: The volumes of T1(PRE)CTV and T1(POST)CTV were not statistically different (248 ± 88 vs 254 ± 101), although volume differences >100 cm(3) were observed in 6 out of 24 patients. A marked increase due to tumour progression was shown in three patients. Three patients showed a decrease because of a reduced mass effect. A significant reduction occurred between pre-operative and post-operative T(2) volumes (139 ± 68 vs 78 ± 59). Lack of concordance was observed between T1(PRE)CTV and T1(POST)CTV (CI = 0.67 ± 0.09), T2(PRE)CTV and T2(POST)CTV (CI = 0.39 ± 0.20) and comparing the portion of the T1(PRE)CTV and T1(POST)CTV not covered by that defined on T2(PRE)CTV images (CI = 0.45 ± 0.16 and 0.44 ± 0.17, respectively). CONCLUSION: Using T(2) MRI, huge variations can be observed in peritumoural oedema, which are probably due to steroid treatment. Using T(1) MRI, brain shifts after surgery and possible progressive enhancing lesions produce substantial differences in CTVs. Our data support the use of post-operative/pre-radiotherapy T(1) weighted MRI for planning purposes.

Effectiveness of a community pharmacist intervention in diabetes care: a randomized controlled trial.

WHAT IS KNOWN AND OBJECTIVE: There is little evidence from well-designed randomized controlled trials of the impact of community pharmacist intervention on the clinical management of patients with type 2 diabetes. It is also not known how sustainable any observed effects on glycaemic control are, over time. This study was initiated to address both these issues. METHODS: A 6-month, randomized, controlled parallel-group trial in 66 community pharmacies was conducted in Belgium. Patients were randomly assigned to receive usual pharmacist care (n = 135) or a predefined pharmacist intervention (n = 153). The intervention mainly focused on correct medication use, medication adherence and healthy lifestyle promotion. Primary outcome was glycaemic control, as measured by fasting plasma glucose and HbA1c. Sustainability of changes in glycaemic control was assessed by additional glucose measurements 18 months after the end of the study. RESULTS AND DISCUSSION: The intervention significantly reduced HbA1c (between-group difference: 0·5%, P = 0.009). The largest impact on HbA1c was observed when pharmacotherapy changes (i.e., type and/or dose of hypoglycaemic agents) initiated by the physician were sustained with pharmaceutical care: HbA1c was reduced by 1·05% in the intervention group, whose medication was changed, compared with a reduction of 0·02% in the therapy-modification only, group. It was also found that the diabetes education program resulted in improved self-management and better knowledge of diabetes. Eighteen months after the end of the formal study period, the mean HbA1c of the intervention group did not differ significantly from the control group (7·4% vs. 7·2%). WHAT IS NEW AND CONCLUSION: This study provides new evidence, from a randomized controlled trial, of the beneficial effect of community pharmacist intervention in the clinical management of type 2 diabetic patients. However, questions remain about the sustainability of the observed improvements.