-
1.
Regional Variations in Alirocumab Dosing Patterns in Patients with Heterozygous Familial Hypercholesterolemia During an Open-Label Extension Study.
Langslet, G, Hovingh, GK, Guyton, JR, Baccara-Dinet, MT, Letierce, A, Manvelian, G, Farnier, M
Cardiovascular drugs and therapy. 2020;(4):515-523
-
-
Free full text
-
Abstract
PURPOSE During the alirocumab open-label extension study ODYSSEY OLE (open-label extension; NCT01954394), physicians could adjust alirocumab dosing for enrolled patients, who were diagnosed with heterozygous familial hypercholesterolemia (HeFH) and who had completed previous phase III clinical trials with alirocumab. This post hoc analysis evaluated the differences in physician-patient dosing decisions between the regions of Western Europe, Eastern Europe, North America, and the rest of the world (ROW). METHODS Patients (n = 909) who received starting dose alirocumab 75 mg every 2 weeks (Q2W) during ODYSSEY OLE (patients from FH I, FH II, and LONG TERM parent studies) were included. Low-density lipoprotein cholesterol (LDL-C) levels were blinded until week 8; subsequently, LDL-C values were communicated to physicians. From week 12, dose adjustment from 75 to 150 mg Q2W, or vice versa, was possible. RESULTS Mean LDL-C values used for the decision to increase dose from 75 to 150 mg Q2W were higher in Eastern Europe (3.7 mmol/L; 144.0 mg/dL) and ROW (3.8 mmol/L; 145.2 mg/dL) compared with Western Europe (3.1 mmol/L; 118.6 mg/dL) and North America (3.3 mmol/L; 126.6 mg/dL). Irrespective of region, the mean LDL-C at the time of decision to maintain at 75 mg Q2W was approximately 1.8 mmol/L (70 mg/dL). During ODYSSEY OLE (median treatment duration of 131.7 weeks), alirocumab was shown to have no unexpected long-term safety concerns. CONCLUSIONS In this OLE study, the observed variations in clinical treatment decisions suggest that physicians may perceive the severity of HeFH and/or the treatment of HeFH differently depending on their region.
-
2.
Evaluation of ranibizumab and aflibercept for the treatment of diabetic macular edema in daily clinical practice.
Plaza-Ramos, P, Borque, E, García-Layana, A
PloS one. 2019;(10):e0223793
Abstract
PURPOSE To evaluate the efficacy and safety of ranibizumab and aflibercept in the treatment of diabetic macular edema in a real world study, and to compare the two treatments with each other. METHODS Retrospective observational study of 213 eyes from 141 patients with diabetic macular edema was completed between June 2014 and June 2016. 122 were treated with ranibizumab intravitreal injection and 91 with aflibercept intravitreal injection, with a loading phase of 3 injections and a Pro Re Nata protocol. The drug was selected by the physician and fluorescein angiography was performed by physician`s criteria. Re-treatment was performed when a decline in BCVA, an increase of central macular thickness or an increase or persistence of intraretinal fluid in OCT was observed. The primary outcome was the mean change in best corrected visual acuity at 1 year, while central macular thickness, central macular volume, the number of injections and visits were evaluated as secondary outcomes. The correlation between BCVA at 4th month visit and BCVA at 12th month visit was also evaluated. RESULTS The mean baseline best corrected visual acuity for the eyes treated with ranibizumab was 0.55 (+/- 0.35) logMAR, and with aflibercept it was 0.48 (+/- 0.29) (P = 0.109). Best corrected visual acuity improved in both groups, and at the end of the follow-up was 0.40 (+/- 0.35) in the ranibizumab group and 0.40 (+/- 0.29) in the aflibercept group (P = 0.864). Best corrected visual acuity at 4th month visit is correlated at a high value (R = 0.789) with the one at the end of the study. No differences were found in central macular thickness, central macular volume and glycosylated hemoglobin when adjusting with baseline values. The overall number of injections was 5.77 (+/- 2.01), being 5.56 (+/- 2.0) in the ranibizumab group and 6.07 (+/- 1.99) in the aflibercept group (P = 0.069). The main outcome determining final best corrected visual acuity was the baseline best corrected visual acuity (P<0.001). CONCLUSION There are no differences in efficacy between ranibizumab and aflibercept in diabetic macular edema treatment in this real world study.
-
3.
The effect of third-party reporting on adoption of evidence-based mesalazine regimens in ulcerative colitis: an observational study.
Kruis, W, Leifeld, L, Morgenstern, J, Pfützer, R, Reimers, B, Ceplis-Kastner, S, ,
Journal of Crohn's & colitis. 2013;(4):e125-32
Abstract
BACKGROUND AND AIMS The optimal mesalazine dosing strategy for ulcerative colitis (UC) continues to evolve. The current study aimed to explore whether documenting drug use could prompt changes in prescribing habits. METHODS In a multicenter, prospective, observational study, outpatients with active or quiescent UC were enrolled if they were receiving, or were planned to receive, sustained release mesalazine microgranules (Pentasa). Clinical and prescribing data were collected at study entry, after 2 and 8 weeks. Physician-reported influences on prescribing decisions were recorded at study entry. RESULTS 360 patients were analyzed (203 active UC, 157 remission). Prior to study entry, the range of oral mesalazine doses was 0.50-6.00 g/day in active UC patients, and 0.50-4.00 g/day for patients in remission. These changed to 1.50-5.00 g/day and 1.00-4.00 g/day, respectively, at study entry with little change thereafter. Use of a single daily mesalazine dose increased from 16.7% to 58.0% of active cases during the study, and from 5.9% to 46.8% in remission cases. Gastroenterologists reported that their basis for prescription decision-making was most frequently medical experience (80.8%), followed by guidelines (67.2%), further education or colleagues' recommendations (50.0%) and current study results (20.0%). CONCLUSION In this analysis of mesalazine dosing in routine clinical practice, there was an improvement in adherence to European Crohn's and Colitis Organisation (ECCO) guidelines and in use of once-daily dosing, consistent with recent trial results, following documentation of dosing regimens. Written reporting of drug dosing schedules should be considered fundamental for chronic, complex diseases such as UC.
-
4.
Effect of an intervention to improve the management of patients with diabetes in primary care practice.
Alfadda, AA, Bin-Abdulrahman, KA, Saad, HA, Mendoza, CD, Angkaya-Bagayawa, FF, Yale, JF
Saudi medical journal. 2011;(1):36-40
Abstract
OBJECTIVE To assess the effect of an intervention targeted at primary care physicians (PCPs) in order to improve their management of diabetic patients. METHODS Diabetic patients seen by PCPs in King Khalid University Hospital, Riyadh, Kingdom of Saudi Arabia from January 2008 to July 2009 were included in this prospective cohort study. The PCPs were divided into intervention and control groups. The intervention group with the help of an assistant, utilized a customized designed computer program generating a checklist for the PCPs. The list included clinical and biochemical screening tests needed for the patients current visit, according to evidence-based diabetes guidelines. For the control group, no assistant was used. At the end of one year, an independent reviewer evaluated the patients' files in both groups to assess the adherence to diabetes guidelines. RESULTS We enrolled 162 patients in the control group and 517 patients in the intervention group. The intervention significantly improved the percentage of patients being screened for diabetic complications; retinopathy from 24.7-98.5%, neuropathy from 25.9-92%, and nephropathy from 37.8-73.7%. There was no improvement in glycemic control in both groups and glycosylated hemoglobin level (HbA1c) values were still above the 7% target. CONCLUSION Management of diabetic patients in the primary care clinics is below standard. The intervention applied was effective in promoting better adherence to evidence-based diabetes guidelines.
-
5.
Low failure rate of fixed administered activity of 400 MBq 131I with pre-treatment with carbimazole for thyrotoxicosis: the Gateshead Protocol.
Razvi, S, Basu, A, McIntyre, EA, Wahid, ST, Bartholomew, PH, Weaver, JU, ,
Nuclear medicine communications. 2004;(7):675-82
Abstract
BACKGROUND Thyrotoxicosis is associated with significant morbidity, therefore adequate control of the disease is paramount. The outcome of treatment of thyrotoxicosis using radioiodine shows variable failure rates depending, amongst other things, on the administered activity of radioiodine and the use of anti-thyroid drugs. Thus, management should follow an evidence based protocol, which has a low failure rate. METHOD We prospectively analysed the outcome of treatment using our Gateshead protocol of a fixed administered activity of radioiodine therapy (400 MBq) given to 201 patients (including 140 with Graves' disease, 48 with toxic multinodular goitre (TMNG) and 13 with toxic nodule) followed up for a median period of 12 months (range, 6-77 months). Carbimazole was discontinued in patients rendered euthyroid 16 days prior to radioiodine. No routine anti-thyroid drugs or thyroxine were given following radioiodine unless hypothyroidism or thyrotoxicosis occurred. RESULTS Following the Gateshead protocol led to a failure rate of 6.5% (eight females with Graves' disease, four females with TMNG and one female with toxic nodule), 29% euthyroidism and 64% hypothyroidism. The rates of hypothyroidism for women and for men were: in Graves' disease 77% and 79%, in TMNG 29% and 75%, in toxic nodule 42% and 0%, respectively. CONCLUSIONS Our observations show that withholding an antithyroid drug in excess of just over 2 weeks prior to administering a fixed administered activity of radioiodine in patients with thyrotoxicosis leads to the lowest reported failure rate, irrespective of the underlying cause. One possible mechanism for this could be the avoidance of drug induced radio-resistance.
-
6.
Nonresponse bias: does it affect measurement of clinician behavior?
Solberg, LI, Beth Plane, M, Brown, RL, Underbakke, G, McBride, PE
Medical care. 2002;(4):347-52
Abstract
BACKGROUND Previous studies of nonresponders have not assessed the effects of nonresponse on the accuracy of clinician behavior measurements. Knowledge of these effects is critical to both research and quality improvement. OBJECTIVE To evaluate the hypothesis that nonresponders to a survey would not adversely affect the ability to measure rates of preventive services. RESEARCH DESIGN Four primary-care medical practices participating in a randomized clinical trial provided an unusual opportunity to compare the medical record-documented care of both responders and nonresponders to a survey of their patients. SUBJECTS Three hundred forty-five nonresponders and 321 responders to a questionnaire requesting participation in the study. MEASURES Differences in patient characteristics and diseases and documentation of screening and management of tobacco use, hypertension, and hypercholesterolemia. RESULTS Although the survey process resulted in a response rate of only 52.5% and some statistically significant differences in responder and nonresponder characteristics, there were no differences in management behavior regarding cardiovascular risk factors. Responders were more likely to have adjusted documentation of tobacco use (OR = 1.4), blood pressure measurement (OR = 9.8), and cholesterol testing (OR = 2.0), but not family history of cardiovascular disease. The most striking difference in subject characteristics was that 22.0% of nonresponders and only 12.1% of responders were tobacco users (P = 0.002). CONCLUSIONS This study confirms that survey nonresponders may have some different characteristics and risk factor screening rates than responders. However, if confirmed by others, nonresponders who have risk factors identified may not be managed differently than responders.
-
7.
Improving quality improvement using achievable benchmarks for physician feedback: a randomized controlled trial.
Kiefe, CI, Allison, JJ, Williams, OD, Person, SD, Weaver, MT, Weissman, NW
JAMA. 2001;(22):2871-9
Abstract
CONTEXT Performance feedback and benchmarking, common tools for health care improvement, are rarely studied in randomized trials. Achievable Benchmarks of Care (ABCs) are standards of excellence attained by top performers in a peer group and are easily and reproducibly calculated from existing performance data. OBJECTIVE To evaluate the effectiveness of using achievable benchmarks to enhance typical physician performance feedback and improve care. DESIGN Group-randomized controlled trial conducted in December 1996, with follow-up through 1998. SETTING AND PARTICIPANTS Seventy community physicians and 2978 fee-for-service Medicare patients with diabetes mellitus who were part of the Ambulatory Care Quality Improvement Project in Alabama. INTERVENTION Physicians were randomly assigned to receive a multimodal improvement intervention, including chart review and physician-specific feedback (comparison group; n = 35) or an identical intervention plus achievable benchmark feedback (experimental group; n = 35). MAIN OUTCOME MEASURE Preintervention (1994-1995) to postintervention (1997-1998) changes in the proportion of patients receiving influenza vaccination; foot examination; and each of 3 blood tests measuring glucose control, cholesterol level, and triglyceride level, compared between the 2 groups. RESULTS The proportion of patients who received influenza vaccine improved from 40% to 58% in the experimental group (P<.001) vs from 40% to 46% in the comparison group (P =.02). Odds ratios (ORs) for patients of achievable benchmark physicians vs comparison physicians who received appropriate care after the intervention, adjusted for preintervention care and nesting of patients within physicians, were 1.57 (95% confidence interval [CI], 1.26-1.96) for influenza vaccination, 1.33 (95% CI, 1.05-1.69) for foot examination, and 1.33 (95% CI, 1.04-1.69) for long-term glucose control measurement. For serum cholesterol and triglycerides, the achievable benchmark effect was statistically significant only after additional adjustment for physician characteristics (OR, 1.40 [95% CI, 1.08-1.82] and OR, 1.40 [95% CI, 1.09-1.79], respectively). CONCLUSION Use of achievable benchmarks significantly enhances the effectiveness of physician performance feedback in the setting of a multimodal quality improvement intervention.
-
8.
Does a fixed physician reminder system improve the care of patients with coronary artery disease? A randomized controlled trial.
Frances, CD, Alperin, P, Adler, JS, Grady, D
The Western journal of medicine. 2001;(3):165-6
-
9.
The impact of Put Prevention into Practice on selected clinical preventive services in five Texas sites.
Gottlieb, NH, Huang, PP, Blozis, SA, Guo, JL, Murphy Smith, M
American journal of preventive medicine. 2001;(1):35-40
Abstract
OBJECTIVE To determine whether the implementation of the Put Prevention Into Practice (PPIP) office-based system would increase the delivery rates of specific clinical preventive services among demonstration clinics. METHODS Chart review was conducted before (n=372) and 33 to 39 months after (n=376) the implementation of the PPIP office-based system in two community health centers and three family practice residency programs in Texas. The population included all adult patients aged > or = 19 years who had presented to the clinic during the study periods. RESULTS Documentation of timely cholesterol screening increased from 70% to 84%; smoking assessment, from 56% to 80%; for women, up-to-date Papanicolaou smear, from 70% to 81%; annual mammograms (women aged > or =51), from 30% to 48%; and up-to-date tetanus-diphtheria immunizations, from 19% to 59%. For adults aged > or =66 years, documentation of pneumococcal immunization increased from 22% to 48%, while influenza immunizations improved, although not significantly (45% to 49%). Blood pressure screening was almost universal (99%) at baseline and at 33- to 39-month follow-up. CONCLUSION PPIP system changes were associated with an observed increase in delivery of selected clinical preventive services.
-
10.
A controlled time-series trial of clinical reminders: using computerized firm systems to make quality improvement research a routine part of mainstream practice.
Goldberg, HI, Neighbor, WE, Cheadle, AD, Ramsey, SD, Diehr, P, Gore, E
Health services research. 2000;(7):1519-34
Abstract
OBJECTIVE To explore the feasibility of conducting unobtrusive interventional research in community practice settings by integrating firm-system techniques with time-series analysis of relational-repository data. STUDY SETTING A satellite teaching clinic divided into two similar, but geographically separated, primary care group practices called firms. One firm was selected by chance to receive the study intervention. Forty-two providers and 2,655 patients participated. STUDY DESIGN A nonrandomized controlled trial of computer-generated preventive reminders. Net effects were determined by quantitatively combining population-level data from parallel experimental and control interrupted time series extending over two-month baseline and intervention periods. DATA COLLECTION Mean rates at which mammography, colorectal cancer screening, and cholesterol testing were performed on patients due to receive each maneuver at clinic visits were the trial's outcome measures. PRINCIPAL FINDINGS Mammography performance increased on the experimental firm by 154 percent (0.24 versus 0.61, p = .03). No effect on fecal occult blood testing was observed. Cholesterol ordering decreased on both the experimental (0.18 versus 0.1 1, p = .02) and control firms (0.13 versus 0.07, p = .03) coincident with national guidelines retreating from recommending screening for young adults. A traditional uncontrolled interrupted time-series design would have incorrectly attributed the experimental-firm decrease to the introduction of reminders. The combined analysis properly indicated that no net prompting effect had occurred, as the difference between firms in cholesterol testing remained stochastically stable over time (0.05 versus 0.04, p = .75). A logistic-regression analysis applied to individual-level data produced equivalent findings. The trial incurred no supplementary data collection costs. CONCLUSIONS The apparent validity and practicability of our reminder implementation study should encourage others to develop computerized firm systems capable of conducting controlled time-series trials.