Real-world evidence on clinical outcomes in immune thrombocytopenia treated with thrombopoietin receptor agonists.

Aim: Eltrombopag and romiplostim are US FDA approved for treatment of immune thrombocytopenia in patients with insufficient response to other treatments. Clinical or real-world data comparing outcomes of the two drugs are limited. Methods: This retrospective cross-sectional study sought information on bleeding-related episodes (BREs), adverse events (AEs) and other outcomes of eltrombopag or romiplostim treatment in immune thrombocytopenia. Results: Patients receiving eltrombopag experienced significantly reduced BREs, severe BREs, rescue medication use and platelet transfusions. Diarrhea and headache were significantly less frequent in patients receiving eltrombopag; other AEs occurred equally in both groups. Conclusion: There may be a potential advantage for the use of eltrombopag versus romiplostim in the practice settings studied, based on rates of BREs and AEs and rescue medication utilization.

Impact of an intervention on the prescription of aliskiren after new evidence on safety reported.

PURPOSE: The purpose of the study is to analyze the impact of an intervention to disseminate safety alerts on the utilization of Aliskiren added to angiotensin converting enzyme inhibitor (ACEI) or an angiotensin-receptor blocker (ARB). METHODS: Quasi-experimental design (non-randomized intervention) comparing the utilization of Aliskiren + ACEI or ARB in a primary care area-intervention (PCA-I) with a primary care area-control (PCA-C) following a safety alert. All physicians were provided with a list of diabetic patients (DM) on Aliskiren + ACEI or ARB. Physicians in the PCA-I received also a non-DM patients list, a report with recommendations and information on the utilization of Aliskiren + ACEI or ARB in their area. Information was obtained from electronic medical records, period from May 2010 to December 2012. Interrupted time series analysis were used to assess the effect of the intervention on the number of patients on Aliskiren + ACEI or ARB. RESULTS: The number of DM receiving Aliskiren + ACEI or ARB at the time of the alert (23 December 2011) was 106 in the PCA-I (91 non-DM) and 45 in the PCA-C (25 non-DM). After the alert, a decreased in the number of patients on Aliskiren + ACEI or ARB was noted at both PCAs, although the average of daily treatments ended was significantly higher in the PCA-I, both in the DM group (slope after alert: -0.81, 95%CI -0.91 to -0.71 vs. -0.30, 95%CI -0.37 to -0.22) as well as in the non-DM group (-0.56, 95%CI -0.67 to -0.45 vs. -0.10 95%CI -0.17 to -0.04). CONCLUSIONS: The prescription of Aliskiren + ACEI or ARB decreased at both PCAs, albeit such decreased was more significant at the PCA-I. The intervention led to a more expeditious implementation of the safety alert recommendations. Copyright © 2016 John Wiley & Sons, Ltd.

Predicting the Burden of Revision Knee Arthroplasty: Simulation of a 20-Year Horizon.

OBJECTIVES: To estimate future utilization scenarios for knee arthroplasty (KA) revision in the Spanish National Health System in the short- and long-term and their impact on primary KA utilization. METHODS: A discrete-event simulation model was built to represent KA utilization for 20 years (2012-2031) in the Spanish National Health System. Data on KA utilization from 1997 to 2011 were obtained from the minimum data set. Three scenarios of future utilization of primary KA (1, fixed number since 2011; 2, fixed age- and sex-adjusted rates since 2011; and 3, projection using a linear regression model) were combined with two prosthesis survival functions (W [worse survival], from a study including primary KA from 1995 to 2000; and B [better survival], from the Catalan Registry of Arthroplasty, including primary KA from 2005 to 2013). The simulation results were analyzed in the short-term (2015) and the long-term (2030). RESULTS: Variations in the number of revisions depended on both the primary utilization rate and the survival function applied, ranging from increases of 8.3% to 31.6% in the short- term and from 38.3% to 176.9% in the long-term, corresponding to scenarios 1-B and 3-W, respectively. The prediction of increases in overall surgeries ranged from 0.1% to 22.3% in the short-term and from 3.7% to 98.2% in the long-term. CONCLUSIONS: Projections of the burden of KA provide a quantitative basis for future policy decisions on the concentration of high-complexity procedures, the number of orthopedic surgeons required to perform these procedures, and the resources needed.

Impact of a priority system on patients in waiting lists for knee arthroplasty.

RATIONALE, AIMS AND OBJECTIVES: The Agency for Health Quality and Assessment of Catalonia (AQuAS) developed a system for the prioritization of patients on non-urgent waiting lists for cataract as well as knee and hip arthroplasty. The aim was to evaluate the impact of the priority system's application for primary knee arthroplasty (PKA). METHODS: A retrospective evaluative study with data from the Data Tracking and Management Registry of the CatSalut Waiting Lists for PKA of hospitals in the public hospital network in the period 2003-2009. A description of the characteristics of patients on waiting lists was made and the association between priority scoring and waiting time and the order of operation analysed. Finally, waiting times were simulated that patients would have experienced if being operated on strictly according to a first in first out system or one of priority scoring, to compare them with real waiting times. RESULTS: The number of people included on waiting lists for PKA was 67403. 67% had a priority score. The distribution of the priority score was negatively skewed with an average score of 70 points. The association with the priority score for the waiting time as well as the order of the operations performed was practically null. CONCLUSIONS: The study concludes that, globally, the prioritization system for PKA has been implemented but had no effect on the prioritization of patients based on their severity. Nevertheless, in some centres, a moderate correlation between the order of operations performed and the priority score was identified.

Joint registries as continuous surveillance systems: the experience of the Catalan Arthroplasty Register (RACat).

The aim was to present results on prosthesis performance in Catalonia for the period 2005-2010. All publicly funded hospitals submit in an electronic format data on hip and knee arthroplasties: patients' insurance identification number, hospital, joint (hip/knee), type of arthroplasty (primary/revision), side (right/left), date of surgery and prosthesis (manufacturer name and catalogue number). A standard survival analysis based on Kaplan-Meier estimation was carried out. Fifty-two hospitals have sent information to the RACat which has data on 36,951 knee and 26,477 hip arthroplasties. Cumulative prostheses revision risks at 3 years were 3.3% (95% CI: 3.1-3.6) for knee, 2.9% (95% CI: 2.5-3.3) for total hip and 2.5% (95% CI: 2.0-3.1) for partial hip. When compared to other registries a higher risk of revision was observed.

[The efficiency of drug prescription: impact of a therapeutic exchange program]. / Eficiencia en la prescripción de medicamentos: impacto de un programa de intercambio terapéutico.

OBJECTIVE: To assess the impact of substituting proton pump inhibitors (PPI) for omeprazole. METHOD: We performed a community trial of the impact of a therapeutic exchange program in the primary care teams of a region compared with non-implementation in a control region. The study included patients prescribed a PPI between May 2008 and June 2009. The intervention consisted of providing educational sessions to physicians (n=68), as well as a list of patients receiving a PPI who were suitable for therapeutic exchange. Information was gathered from medical records (PPI prescribed, primary care team) and the pharmacy database (cost of defined daily doses of the PPI). The percentage of therapeutic exchange in each region before and after the intervention was compared through relative risk (RR). The percentage of omeprazole at the end of each study period and changes in PPI costs were also calculated. RESULTS: Therapeutic exchange was higher in the intervention group (RR: 4.2; 95%CI: 3.1-5.8) than in the control group (RR: 1.8; 95%CI: 1.2-2.6). The percentage of patients prescribed omeprazole increased from 86.2% to 89.3% in the intervention region and from 84.3% to 84.7% in the control region. The total cost of the PPI group decreased by 7.6% in the intervention region and increased by 2.0% in the control group. CONCLUSIONS: This study demonstrates the effectiveness of the therapeutic exchange program. This is a simple intervention that is able to modify prescription and reduce its costs.

Relationship between total hip replacement appropriateness and surgical priority instruments.

RATIONALE: Variability in indications for total hip replacement (THR) and unequal waiting times may limit health care access. OBJECTIVE: To analyse the relationship between appropriateness and previously developed surgical priority instruments. METHOD: Multicentre cross-validation study of patients placed on the waiting list for THR. Information on surgical priority, surgeons' evaluation of priority through a visual analogue scale (VAS) and health-related quality of life (HRQOL) (Health Utilities Index mark 3, EQ-5D, Western Ontario McMaster Osteoarthritic Index) was collected. THR indications were considered appropriate, uncertain or inappropriate according to appropriateness criteria. Statistical differences and clinically important differences in surgical priority, VAS and HRQOL between appropriateness categories were analysed with the Mann-Whitney U-test and effect size (ES), respectively. Surgical priority score's ability to discriminate appropriate and inappropriate indications was evaluated through the area under the receiver-operating characteristic curve (AUC) and its 95% confidence interval (95% CI). RESULTS: 49.4% (87) of the THR indications were deemed appropriate, 39.8% (70) uncertain and 10.8% (19) inappropriate. Differences in surgical priority score, VAS and HRQOL between appropriateness categories were statistically significant. Clinically important differences were generally small (ES, 0.2-0.5) between inappropriate and uncertain, moderate (ES, 0.5-0.8) between uncertain and appropriate, and large (ES > 0.8) between inappropriate and appropriate categories. The AUC to discriminate appropriate and inappropriate indications was 0.97 (95% CI: 0.96-0.99) and 0.90 (95% CI: 0.83-0.97), respectively. CONCLUSIONS: The relationship between the surgical priority and appropriateness instruments reinforces their validity and could improve waiting list management by establishing maximum waiting periods based on patients' characteristics.

Different hip and knee priority score systems: are they good for the same thing?

OBJECTIVE: The aim of the present study was to compare two priority tools used for joint replacement for patients on waiting lists, which use two different methods. METHODS: Two prioritization tools developed and validated by different methodologies were used on the same cohort of patients. The first, an IRYSS hip and knee priority score (IHKPS) developed by RAND method, was applied while patients were on the waiting list. The other, a Catalonia hip-knee priority score (CHKPS) developed by conjoint analysis, was adapted and applied retrospectively. In addition, all patients fulfilled pre-intervention the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Correlation between them was studied by Pearson correlation coefficient (r). Agreement was analysed by means of intra-class correlation coefficient (ICC), Kendall coefficient and Cohern kappa. The relationship between IHKPS, CHKPS and baseline WOMAC scores by r coefficient was studied. RESULTS: The sample consisted of 774 consecutive patients. Pearson correlation coefficient between IHKPS and CHKPS was 0.79. The agreement study showed that ICC was 0.74, Kendall coefficient 0.86 and kappa 0.66. Finally, correlation between CHKPS and baseline WOMAC ranged from 0.43 to 0.64. The results according to the relationship between IHKPS and WOMAC ranged from 0.50 to 0.74. CONCLUSIONS: Results support the hypothesis that if the final objective of the prioritization tools is to organize and sort patients on the waiting list, although they use different methodologies, the results are similar.

Comparison of 3 systems for assigning priority to patients on waiting lists for cataract extraction.

OBJECTIVE: As the demand for cataract surgery grows, patients in some health care systems are assigned to a waiting list. Several explicit priority tools have been developed. We compared 3 of these: the IRYSS-Cataract Priority Score (ICPS), Catalan Agency for Health Technology Assessment and Research cataract priority system (CCPS), and Western Canada Waiting List project for cataract surgery (WCWL). DESIGN: Prospective cohort study. PARTICIPANTS: A total of 1723 consecutive patients awaiting cataract surgery at 5 hospitals. METHODS: The ICPS, CCPS, and WCWL were applied to these patients after the collection of data. The 3 prioritization systems were compared using correlation methods, 95% limits of agreement, and the kappa coefficient. RESULTS: Means and standard deviations for the different prioritization systems were 60.9 (22.2) for the ICPS, 35.7 (20.4) for the CCPS, and 25.7 (21.5) for the WCWL. Pearson's correlation coefficients were 0.56 between the ICPS and the CCPS, 0.62 between the WCWL and CCPS, and 0.71 between the ICPS and WCWL. The kappa value among them ranged from 0.13 to 0.40, and the intraclass correlation coefficients ranged from 0.31 to 0.55. CONCLUSIONS: These 3 prioritization tools showed acceptable correlations but assigned significantly different point scores to similar scenarios. This may have consequences when using these tools for managing a waiting list for cataract extraction.

Potential for 2 priority systems to be used as appropriateness of indication tools for cataract surgery.

OBJECTIVE: To test 2 systems developed to prioritize patients on waiting lists for cataract surgery, the Western Canadian Waiting List (WCWL), and the Catalan Agency for Health Technology Assessment and Research Cataract Priority System (CCPS), as tools for judging the appropriateness of the intervention. DESIGN: Cross-sectional study with follow-up. PARTICIPANTS: A total of 1723 prospective patients awaiting cataract extraction in 5 hospitals were included in the study. METHODS: Priority scores using the WCWL and the CCPS systems were calculated and compared with visual acuity (VA) and visual function, measured by the Visual Function-14 index, before and after surgery. The sensitivity of each priority system to different groups was evaluated using a validated appropriateness of indications tool for cataract extraction. One-way analysis of variance and the Jonckheere-Terpstra test were used to detect differences in group scores. Spearman correlation coefficients were also examined. RESULTS: The WCWL and CCPS systems produced different mean values according to the preoperative levels of VA and visual function (p < 0.0001). Neither system showed a significant difference in mean scores based on gains in VA and visual function. Both systems produced different mean scores according to the different groups of appropriateness set by the appropriateness of indications tool for cataract (p < 0.0001). CONCLUSIONS: Given that appropriateness tools should correlate with outcomes, we recommend using neither the WCWL nor the CCPS for appropriateness purposes. Incorporating new criteria into these systems may improve the correlation with important outcomes and their adequacy for use as appropriateness tools.

Arthroplasty registers: a review of international experiences.

OBJECTIVES: Registers have proven to be a valuable instrument in the evaluation of arthroplasty procedures and the performance of implants. The aim of this study was to describe the structure, functioning, and content of arthroplasty registers in Europe and other parts of the world. METHODS: A search of technical reports was carried out through the Internet and in Medline/PubMed. The exhaustiveness of the information was confirmed using the links to Web pages of other registers and contacts with key people. Aims, methods in data collection and evaluation, internal structure and organization, participants, validity of the data, and other variables were assessed for each arthroplasty register using a qualitative content analysis of the texts. RESULTS: Fifteen arthroplasty registers were identified which published sufficient information to conduct a comparative analysis. Eight additional registers were identified but no information was available on the Internet or in English. Most registers were initiatives of an orthopaedic society receiving governmental funding. Data were collected using standardized clinical forms and additional information from clinical-administrative datasets or other registers (mortality, implant costs, hip fractures). The main outcome measure of these registers is survival of the prostheses. Registers use the Internet and their annual reports as the main strategy for the dissemination and feed-back of their results. CONCLUSIONS: Scientific or professional societies and the public health administration should collaborate in the development of arthroplasty registers. To adequately assess the results of observational data information on the structure, the process of arthroplasty interventions and patients characteristics should be collected.

[Hip and knee arthroplasties in Catalonia [Spain] from 1994 to 2005]. / Artroplastias de cadera y rodilla en Cataluña desde 1994 a 2005.

OBJECTIVE: Hip and knee arthroplasties are the most frequent surgical procedures in Catalonia. The aim of this study was to describe changes in the rates of these procedures and in their characteristics between 1994 and 2005. METHODS: We performed a cross-sectional study of total hip (THR) and knee (TKR) primary and revision joint replacement discharges using the Minimum Data Set (ICD-9-CM codes 81.51, 81.53, 81.54 and 81.55). Standardized THR and TKR rates by age and sex and revision burden were calculated and changing trends were analyzed through joinpoint regression. Four time periods were defined and patient and hospital stay characteristics were analyzed by comparing period 4 with period 1 through logistic regression models. RESULTS: In THR, the rates per 10,000 inhabitants increased from 4.1 to 6.6 between 1994 and 2000. In TKR, rates increased from 2.6 to 15.5 between 1994 and 2005. Hip revision burden increased until 2001, whereas knee revision burden increased for the entire period. The main reason for surgery was osteoarthritis. In both THR and TKR, the number of patients aged 75 or older and comorbidity increased. CONCLUSIONS: The increase in the rates and the change in patients' profile may reflect broadening of the indication criteria for these procedures. The impact of the foreseeable increase in revision surgery could be reduced by developing systems to evaluate prosthesis survival and clinical practice guidelines.

Prioritisation of patients on waiting lists for hip and knee arthroplasties and cataract surgery: Instruments validation.

BACKGROUND: Prioritisation instruments were developed for patients on waiting list for hip and knee arthroplasties (AI) and cataract surgery (CI). The aim of the study was to assess their convergent and discriminant validity and inter-observer reliability. METHODS: Multicentre validation study which included orthopaedic surgeons and ophthalmologists from 10 hospitals. Participating doctors were asked to include all eligible patients placed in the waiting list for the procedures under study during the medical visit. Doctors assessed patients' priority through a visual analogue scale (VAS) and administered the prioritisation instrument. Information on socio-demographic data and health-related quality of life (HRQOL) (HUI3, EQ-5D, WOMAC and VF-14) was obtained through a telephone interview with patients. The correlation coefficients between the prioritisation instrument score and VAS and HRQOL were calculated. For the reliability study a self-administered questionnaire, which included hypothetic patients' scenarios, was sent via postal mail to the doctors. The priority of these scenarios was assessed through the prioritisation instrument. The intraclass correlation coefficient (ICC) between doctors was calculated. RESULTS: Correlations with VAS were strong for the AI (0.64, CI95%: 0.59-0.68) and for the CI (0.65, CI95%: 0.62-0.69), and moderate between the WOMAC and the AI (0.39, CI95%: 0.33-0.45) and the VF-14 and the CI (0.38, IC95%: 0.33-0.43). The results of the discriminant analysis were in general as expected. Inter-observer reliability was 0.79 (CI95%: 0.64-0.94) for the AI, and 0.79 (CI95%: 0.63-0.95) for the CI. CONCLUSION: The results show acceptable validity and reliability of the prioritisation instruments in establishing priority for surgery.

[Non-occupational post-exposure HIV prophylaxis. Knowledge and practices among physicians and groups with risk behavior]. / Profilaxis postexposición al virus de la inmunodeficiencia humana no ocupacional. Conocimientos y prácticas de profesionales y grupos con conductas de riesgo.

BACKGROUND AND OBJECTIVE: Although occupational post-exposure HIV prophylaxis is widely admitted and used, the non-occupational post-exposure prophylaxis (NONOPEP) is controversial. Prevention of mother-to-child HIV transmission, experimental studies in animal models and retrospective studies in health workers, along with biological plausibility, would justify the use of NONOPEP in certain circumstances. Our objectives were: 1) To review the existence of recommendations; 2) To describe the attitudes, knowledge and practices of the professionals involved in the attention of non-occupational exposures to HIV; 3) To describe the attitudes and knowledge on such a prophylaxis by people with risk behaviours (homosexual men and intravenous drug users (IDU)); and 4) To describe the NONOPEP-related responses of telephone services of public attention on AIDS. SUBJECTS AND METHOD: Descriptive study by means of a survey of each defined target population between September 1999 and July 2000, using self-administered questionnaires and personal interviews. Structured and simulated interviews were used to survey the telephone services. RESULTS: To date, no official recommendations exist. 84% (97/116) of consulted doctors have taken care of some of non-occupational accidental exposure to HIV over the last six months. 77% (75/97) have prescribed NONOPEP, and 76% of doctors prescribing NONOPEP (57/75) have used the 1998 CDC recommendations for occupational exposures. Most frequent observed cases were related to needle sticks in the street and preservative breakage. The assessment of certain risk factors and therapeutic performance in cases of intermediate risk showed discrepancies among doctors. 41% (103/252) among homosexuals and 2% (3/160) among IDU on treatment know the NONOPEP. 15% (15/98) and 98% (70/118) respectively would take less prevention to avoid HIV infection if they took the NONOPEP. It was mentioned the possibility of NONOPEP in 20% (12/59) of calls to the information telephone services on AIDS. CONCLUSIONS: HIV risk accidents susceptible of NONOPEP are relatively frequent. Without forgetting the greater importance of primary prevention, it is advisable to reach and agreement on homogeneous recommendations. It is also advisable to draw up a surveillance system to evaluate the application and eventually the effectiveness of these recommendations.

[Recommendations for non-occupational postexposure HIV prophylaxis. Spanish Working Group on Non-Occupational Postexposure HIV Prophylaxis of the Catalonian Center for Epidemiological Studies on AIDS and the AIDS Study Group]. / Recomendaciones para la profilaxis postexposición no ocupacional al VIH. Grupo de Consenso Español sobre Profilaxis Postexposición No Ocupacional al VIH de CEESCAT (Centre de Estudis Espidemiològics sobre la Sida a Catalunya) y GESIDA (Grupo de Estudio de SIDA).

Evidence is lacking on the possible efficacy and effectiveness of non-occupational postexposure prophylaxis (PEP). However, because of its biological plausibility, the use of antiretroviral (ARV) drugs to prevent the development of infection in certain cases of accidental or sporadic exposure has begun to be considered as common clinical practice. Previous studies performed in Spain have demonstrated both the demand and the prescription of ARV as PEP and especially the diversity and inconsistency in the criteria used. In this context, in April of 2000 the Centre for Epidemiological Studies on AIDS of Catalonia (CEESCAT) (Department of Health and Social Security of the Autonomous Government of Catalonia), in collaboration with the National AIDS Plan and the AIDS Study Group (GESIDA), promoted the creation of a working group for the drafting of recommendations for PEP against HIV outside the occupational health context. The recommendations have been made bearing in mind the exceptional character of the exposure, the time elapsed since exposure, as well as evaluation of the risk of infection according to the type of exposure and the information available on the source of infection. In addition, the recommendations include the immediate measures necessary, as well as the preventive measures and clinical follow-up required both for HIV and for other infectious agents. All PEP regimens should be started within 72 hours of exposure and appropriate daily doses of two nucleoside reverse transcriptase inhibitors (NRTIs) and a protease inhibitor (PI), or two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTIs), should be administered for four weeks, bearing in mind the pharmacological and clinical situation of the source person. These recommendations should be updated periodically.