Comparison of Approaches to Select a Propensity Score Matched Control Group in the Absence of an Obvious Start of Follow Up for this Group: An Example Study on the Economic Impact of the DMP Bronchial Asthma.

BACKGROUND: Claims data are a valuable data source to investigate the economic impact of new health care services. While the date of enrollment into the new service is an obvious start of follow-up for participants, the strategy to select potential controls is not straightforward due to a missing start of follow-up to ascertain possible confounders. The aim of this study was to compare different approaches to select controls via Propensity Score Matching (PSM) using the disease management program (DMP) bronchial asthma (BA) as an example. METHODS: We conducted a retrospective cohort study of BA patients between 2013 and 2016 to examine total one-year health care costs and all-cause mortality. We implemented different scenarios regarding the selection of potential controls: I) allotment of a random index date with subsequent PSM, II) calendar year-based PSM (landmark analysis) and III) calendar quarter-based PSM. In scenario I, we applied 2 approaches to assign a random index date: a) assign random index date among all quarters with a BA diagnosis and b) assign random index date and thereafter examine if a BA diagnosis was documented in that quarter. RESULTS: No significant differences in total one-year health care costs between DMP BA participants and non-participants were observed in any of the scenarios. This could to some extent be explained by the higher mortality in the control groups in all scenarios. CONCLUSION: If the loss of potential controls can be compensated, scenario Ib is a pragmatic option to select a control group. If that is not the case, scenario III is the more sophisticated approach, with the limitation that baseline characteristics prior PSM cannot be depicted and computational time or memory size needed to conduct the analysis need to be sufficient.

Prescribing practice of pregabalin/gabapentin in pain therapy: an evaluation of German claim data.

OBJECTIVES: To analyse the prevalence and incidence of pregabalin and gabapentin (P/G) prescriptions, typical therapeutic uses of P/G with special attention to pain-related diagnoses and discontinuation rates. DESIGN: Secondary data analysis. SETTING: Primary and secondary care in Germany. PARTICIPANTS: Four million patients in the years 2009-2015 (anonymous health insurance data). INTERVENTION: None. PRIMARY AND SECONDARY OUTCOME MEASURES: P/G prescribing rates, P/G prescribing rates associated with pain therapy, analysis of pain-related diagnoses leading to new P/G prescriptions and the discontinuation rate of P/G. RESULTS: In 2015, 1.6% of insured persons received P/G prescriptions. Among the patients with pain first treated with P/G, as few as 25.7% were diagnosed with a typical neuropathic pain disorder. The remaining 74.3% had either not received a diagnosis of neuropathic pain or showed a neuropathic component that was pathophysiologically conceivable but did not support the prescription of P/G. High discontinuation rates were observed (85%). Among the patients who had discontinued the drug, 61.1% did not receive follow-up prescriptions within 2 years. CONCLUSION: The results show that P/G is widely prescribed in cases of chronic pain irrespective of neuropathic pain diagnoses. The high discontinuation rate indicates a lack of therapeutic benefits and/or the occurrence of adverse effects.

Cost associated with hematopoietic stem cell transplantation: a retrospective claims data analysis in Germany.

AIM: Quantify hematopoietic stem cell transplantation (HSCT) costs in German patients with acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). METHODS: The primary outcome was direct and indirect costs in patients with ALL/DLBCL/FL who received HSCT between 2010 and 2014. Costs were evaluated two to four quarters before to eight quarters after HSCT. RESULTS: Among 258 patients with HSCT, direct costs were €290,125/patient (pediatric ALL), €246,266/patient (adult ALL), €230,399/patient (DLBCL/FL allogeneic) and €107,457/patient (DLBCL/FL autologous). Indirect costs with HSCT were €52,939/patient (adult ALL), €20,285/patient (DLBCL/FL allogeneic) and €29,881/patient (DLBCL/FL autologous). CONCLUSION: Direct and indirect costs associated with HSCT are substantial for patients with ALL, DLBCL and FL. Novel therapies that reduce HSCT use could reduce medical costs.

Do We Need to Rethink the Epidemiology and Healthcare Utilization of Parkinson's Disease in Germany?

Epidemiological aspects of Parkinson's disease (PD), co-occurring diseases and medical healthcare utilization of PD patients are still largely elusive. Based on claims data of 3.7 million statutory insurance members in Germany in 2015 the prevalence and incidence of PD was determined. PD cases had at least one main hospital discharge diagnosis of PD, or one physician diagnosis confirmed by a subsequent or independent diagnosis or by PD medication in 2015. Prevalence of (co-)occurring diseases, mortality, and healthcare measures in PD cases and matched controls were compared. In 2015, 21,714 prevalent PD cases (standardized prevalence: 511.4/100,000 persons) and 3,541 incident PD cases (standardized incidence: 84.1/100,000 persons) were identified. Prevalence of several (co-)occurring diseases/complications, e.g., dementia (PD/controls: 39/13%), depression (45/22%), bladder dysfunction (46/22%), and diabetes (35/31%), as well as mortality (10.7/5.8%) differed between PD cases and controls. The annual healthcare utilization was increased in PD cases compared to controls, e.g., regarding mean ± SD physician contacts (15.2 ± 7.6/12.2 ± 7.3), hospitalizations (1.3 ± 1.8/0.7 ± 1.4), drug prescriptions (overall: 37.7 ± 24.2/21.7 ± 19.6; anti-PD medication: 7.4 ± 7.4/0.1 ± 0.7), assistive/therapeutic devices (47/30%), and therapeutic remedies (57/16%). The standardized prevalence and incidence of PD in Germany as well as mortality in PD may be substantially higher than reported previously. While frequently diagnosed with co-occurring diseases/complications, such as dementia, depression, bladder dysfunction and diabetes, the degree of healthcare utilization shows large variability between PD patients. These findings encourage a rethinking of the epidemiology and healthcare utilization in PD, at least in Germany. Longitudinal studies of insurance claims data should further investigate the individual and epidemiological progression and healthcare demands in PD.

German claims data analysis to assess impact of different intraocular lenses on posterior capsule opacification and related healthcare costs.

AIM: Cataract extraction is one of the most frequent surgeries in Germany. In most cases, the clouded natural lens is replaced by a hydrophobic or hydrophilic acrylic intraocular lens (IOL) implant. The most common long-term complication after cataract surgery is the development of a posterior capsule opacification (PCO). Although no precise real world data are available, published evidence suggests a lower risk for PCO development for hydrophobic acrylic IOLs compared to hydrophilic acrylic IOLs. Therefore, in the present study we assessed real world data on the impact of different IOL material types on the incidence of post-operative PCO treatment. SUBJECT AND METHODS: In this retrospective study, we included 3,025 patients who underwent cataract extraction and implantation of either an acrylic hydrophobic or hydrophilic IOL in 2010. We assessed clinical outcomes and direct costs in a 4-year follow-up period after cataract surgery from a statutory health insurance (SHI) perspective in Germany. RESULTS: PCO that required capsulotomies occurred significantly (p < 0.0001) less frequent in patients who had received a hydrophobic IOL (31.57% of 2,078 patients) compared to the group with hydrophilic IOL implants (56.6% of 947 patients) and costs per patient for postoperative treatment in a 4-year follow-up were 50.03 € vs. 87.81 € (i.e. 75% higher in the latter group, p < 0.0001). CONCLUSION: Considering the high prevalence of cataract, the economic burden associated with adverse effects of cataract extraction is of great relevance for the German SHI. Hydrophobic lenses seem to be superior regarding both medical and economic results.

Timely Referral to Outpatient Nephrology Care Slows Progression and Reduces Treatment Costs of Chronic Kidney Diseases.

INTRODUCTION: We present a new approach to evaluate the importance of ambulatory nephrology care in patients with chronic kidney disease (CKD). METHODS: An anonymized health claims database of German insurance companies was searched in a retrospective analysis for patients with CKD using the codes of the International Classification of Diseases, 10th German modification. A total of 105,219 patients with CKD were identified. Patients were assigned to the group "timely referral," when nephrology care was present in the starting year 2009, or initiated during the following 3 years in CKD1-4. Using frequency matching for age and gender, 21,024 of the late referral group were matched with the equal number of patients in the timely referral group. Hospital admission rates, total treatment costs, and kidney function (change in CKD stages, start of dialysis, mortality) were documented each year during the 4-year follow-up. RESULTS: Hospital admission rates (110%-186%) and total treatment costs (119%-160%) were significantly higher (P < 0.03) in late referral compared with timely referral. In the timely referral group, significantly more patients did not change their CKD stage (65%-72.9% vs. 52%-64.6%, P < 0.05) compared with late referral. Starting in CKD3 more patients tended to start dialysis in 1 year in timely referral (1.9 ± 0.6 vs. 1.0 ± 0.4, P = 0.1). In contrast, death rates were significantly higher in the late referral group (18.8 ± 1.8% vs. 6.7 ± 0.4%, P = 0.0001). DISCUSSION: Timely referral to outpatient nephrology care is associated with slowed disease progression, less hospital admissions, reduced total treatment costs, and improved survival in patients with CKD.

Prevalence of Nontuberculous Mycobacterial Pulmonary Disease, Germany, 2009-2014.

We analyzed routine statutory health insurance claim data to determine prevalence of nontuberculous mycobacterial pulmonary disease in Germany. Documented prevalence rates of this nonnotifiable disease increased from 2.3 to 3.3 cases/100,000 population from 2009 to 2014. Prevalence showed a strong association with advanced age and chronic obstructive pulmonary disease.

Influence of thyroid hormone therapy on the fracture rate - A claims data cohort study.

INTRODUCTION: It has been debated for years whether long-term thyroid hormone intake causes fractures. Not only have previous studies suffered from design limitations, they also reached contradictory conclusions. We investigated thyroid hormones (thyroxine) as a possible risk factor for fractures in a cohort of 6.7 million persons based on administrative data. METHODS: The database consists of anonymized settlement data of approximately 70 German statutory health insurances covering a time period of six years. All subjects aged 60 and above were included in the study; subjects with repeated thyroxine prescriptions were assigned to the exposure group; members without thyroxine prescriptions to the control group. Outcome was any incident fracture during a declared time period. In order to calculate fracture risk, we performed multivariate cox regression analyses to adjust for confounders. RESULTS: Of 798 770 subjects fulfilling the inclusion criteria, 11.7% took thyroxine regularly and belong to the exposure group. The final cox regression showed that subjects taking thyroxine have a 6.3% higher risk (HR 1.063; CI 1.046-1.080, p=<.0001) than members of the control group. DISCUSSION: The study supports the assumption that long term thyroxine intake leads to an increase in fracture risk among patients older than 60years. The findings have implications for long term thyroxine treatment.

The epidemiology of food allergy in Europe: protocol for a systematic review.

BACKGROUND: The European Academy of Allergy and Clinical Immunology is in the process of developing its Guideline for Food Allergy and Anaphylaxis, and this protocol of a systematic review is one of seven inter-linked evidence syntheses that are being undertaken in order to provide a state-of-the-art synopsis of the current evidence base in relation to epidemiology, prevention, diagnosis and clinical management and impact on quality of life, which will be used to inform the formulation of clinical recommendations.The aims of the systematic review will be to understand and describe the epidemiology of food allergy, i.e. frequency, risk factors and outcomes of patients suffering from food allergy, and to describe how these characteristics vary by person, place and time. METHODS: A highly sensitive search strategy has been developed to retrieve articles that have investigated the various aspects of the epidemiology of food allergy. The search will be implemented by combining the concepts of food allergy and its epidemiology from electronic bibliographic databases. DISCUSSION: This systematic review will provide the most up to date estimates of the frequency of food allergy in Europe. We will attempt to break these down by age and geographical region in Europe. Our analysis will take into account the suitability of the study design and the respective study biases that could affect exposure and outcome. We will examine the different methods to diagnose food allergy and the associated measures of occurrence.

The epidemiology of anaphylaxis in Europe: protocol for a systematic review.

BACKGROUND: The European Academy of Allergy and Clinical Immunology is in the process of developing its Guideline for Food Allergy and Anaphylaxis, and this systematic review is one of seven inter-linked evidence syntheses that are being undertaken in order to provide a state-of-the-art synopsis of the current evidence base in relation to epidemiology, prevention, diagnosis and clinical management and impact on quality of life, which will be used to inform clinical recommendations.The aims of this systematic review will be to understand and describe the epidemiology of anaphylaxis, i.e. frequency, risk factors and outcomes of anaphylaxis, and describe how these characteristics vary by person, place and time. METHODS: A highly sensitive search strategy has been designed to retrieve all articles combining the concepts of anaphylaxis and epidemiology from electronic bibliographic databases. DISCUSSION: This review will aim to provide some estimates of the incidence and prevalence of anaphylaxis in Europe. The occurrence of anaphylaxis can have a profound effect on the quality of life of the sufferer and their family. Estimates of disease frequency will help us to ascertain the burden of anaphylaxis and provide useful comparators for management strategies.