Primary Care Disease Management for Venous Leg Ulceration in German Healthcare: Results of the Ulcus Cruris Care Pilot Study.

Despite proven effectiveness, compression therapy is applied in only 20-40% of patients with venous leg ulceration, leading to avoidable chronification and morbidity. The Ulcus Cruris Care project was established to develop a new disease-management concept comparable to existing programs for chronic diseases to support evidence-based treatment of venous leg ulceration. This prospective controlled study assessed its first implementation. Interventional elements comprised online training for general practitioner practices, software support for case management, and educational materials for patients. A total of 20 practices and 40 patients were enrolled in a 1:1 ratio to the intervention and control group. Guideline-conform compression therapy was applied more frequently in the intervention group (19/20 [95%] vs. 11/19 [58%]; p = 0.006). For patients with ulcers existing ≤ 6 months, the healing rate at 12 weeks was 8/11 [73%] (intervention) compared to 4/11 [36%] (control; p = 0.087). Patients after intervention had higher scores for self-help and education in the PACIC-5A questionnaire (42.9 ± 41.6 vs. 11.4 ± 28.8; p = 0.044). Treatment costs were EUR 1.380 ± 1.347 (intervention) and EUR 2.049 ± 2.748 (control; p = 0.342). The results of this study indicate that the Ulcus Cruris Care intervention may lead to a significant improvement in care. Consequently, a broader rollout in German healthcare seems warranted.

Primary care disease management for venous leg ulceration-study protocol for the Ulcus Cruris Care [UCC] randomized controlled trial (DRKS00026126).

BACKGROUND: Venous leg ulcers (VLU) have a prevalence of 1-2% in developed countries, and affected patients are severely and long-term impaired in daily activities, work, and social participation. Evidence-based outpatient treatment based on compression therapy is frequently not implemented. The "Ulcus Cruris Care" project was established to develop a disease management concept to improve outpatient treatment for patients with VLU in German primary care. For this purpose, a multifaceted intervention was conceived consisting of an online training for general practitioners and medical assistants, standardized treatment recommendations, e-learning and print-based information for patients, and a software support for case management. The main aims of the Ulcus Cruris Care intervention are to promote standardized treatment according to current scientific knowledge, to facilitate case management for VLU patients exerted by medical assistants, and to support patient education and participation in the treatment process. The UCC trial was designed to evaluate the effectiveness of the Ulcus Cruris Care intervention. METHODS: The UCC trial is a prospective cluster-randomized controlled multicenter trial. Fifty GP practices are intended to be recruited and randomized 1:1 to intervention or control arm. Patients with venous leg ulcers will be recruited by participating GP practices, to include a total of 63 patients in each arm. The primary outcome is time to ulcer healing. Secondary outcomes comprise number and sizes of ulcers, recurrence, pain intensity according to the visual analog scale, health-related quality of life according to EQ-5D-5L, depressiveness according to Patient Health Questionnaire (PHQ-9), patient satisfaction according to the Patient Assessment of Chronic Illness Care (PACIC-5A) query, and adherence to VLU treatment. The outcome analysis of the UCC trial is accompanied by a health economic analysis and a process evaluation. DISCUSSION: The UCC trial will evaluate whether the Ulcus Cruris Care intervention may lead to faster wound healing, higher health-related quality of life, and lower use of medical resources. If the intervention turns out to have a positive impact on assessed outcomes, comprehensive implementation in primary care may be considered. TRIAL REGISTRATION: The trial protocol (version 1 as of July 19, 2021) has been registered in the German Clinical Trials Register on August 30, 2021 ( DRKS00026126 ).

Three year results of endovascular therapy with a new generation nitinol stent for femoro-popliteal artery lesions - a single-center outcome analysis of a subcohort of MISAGO 2 study.

BACKGROUND: Advances in stent technology have widened the field of indications for stent treatment of femoro-popliteal artery lesions, however the use of stents in bending arterial segments is restricted because some first- and second-generation nitinol stent designs did not respond well to the mechanical forces of femoro-popliteal segments in motion which pose a substantial risk of stent fracture inducing in-stent-stenosis. New generation nitinol stents are supposed to overcome these limitations but long-term results are rare. PATIENTS AND METHODS: In forty-five patients (mean age 68 y, range 50 - 85) with peripheral arterial disease (TASC II A-C, Rutherford category 2 - 5) forty-six lesions of the superficial femoral artery (37) or popliteal artery (9) were treated [25 high-grade stenoses, mean length 53 mm (range 30 - 145 mm); 21 chronic total occlusions, mean length 74 mm (range 30 - 180 mm)]. 74 % of lesions were located in the mobile bending arterial segments in the distal femoral or the popliteal segment. Clinical reevaluation performed at discharge, at 6, 12, 24, and 36 months included at least the measurement of ankle-brachial index (ABI) and duplex sonography. RESULTS: Procedural success rate was 100 %. At 6, 12, 24, and 36 months, cumulative primary patency rate was 93.5 %, 84.8 %, 80.5 %, and 74.3 % (SE<10); freedom from target lesion revascularization rate was 95.7 %, 89.2 %, 84.9 %, and 79.3 % (SE<10); Rutherford category and ABI improved in all patients and clinical success was maintained in more than 85 % of patients. CONCLUSIONS: Sustained technical and clinical success and good clinical long-term results were achieved with Misago™ nitinol stent implantation in femoro-popliteal lesions with moderate risk for in-stent-stenosis, and in the distal femoral and popliteal mobile segment.

Expenditure of chronic venous leg ulcer management in German primary care: results from a population-based study.

The aim of the study was to determine the demand on health service utilisation and to estimate the therapeutical costs caused by patients with chronic leg ulcer (CLU) in German primary care. A population-based case-control study was conducted using electronic medical records of 116 059 patients extracted from the CONTENT primary care database of Heidelberg, Germany, between April 2007 and March 2010. The drug and non drug prescription rates among patients with CLU were analysed by means of a unified German identification key and compared with those of patients with chronic venous insufficiency (CVI) without CLU. In the 3-year-contact group, CLU patients had significantly more patient-doctor encounters (55·9 versus 40·3; p < 0·0001), more referrals to home-care services (6·12 versus 3·08; p < 0·0001), and more admissions to hospitals (0·9 versus 0·4; p < 0·0001) than CVI patients, but no difference in referrals to specialists. The annual treatment costs for drugs and non drugs in CLU patients were substantially higher than in CVI patients (1645·75 € versus 1188·17 €; p < 0·0001). Wound dressings were identified as the most cost-enlarging factor. Summarising, CLU patients in primary care settings place a higher demand on health service utilisation and need nearly one-third higher therapeutical costs compared to venous patients without ulceration.

A German version of the Intermittent Claudication Questionnaire (ICQ): cultural adaptation and validation.

BACKGROUND: The Intermittent Claudication Questionnaire (ICQ) is a short questionnaire for the assessment of health-related quality of life (HRQOL) in patients with intermittent claudication (IC). The objective of this study was to translate the ICQ into German and to investigate the psychometric properties of the German ICQ version in patients with IC. PATIENTS AND METHODS: The original English version was translated using a forward-backward method. The resulting German version was reviewed by the author of the original version and an experienced clinician. Finally, it was tested for clarity with 5 German patients with IC. A sample of 81 patients were administered the German ICQ. The sample consisted of 58.0 % male patients with a median age of 71 years and a median IC duration of 36 months. Test of feasibility included completeness of questionnaires, completion time, and ratings of clarity, length and relevance. Reliability was assessed through a retest in 13 patients at 14 days, and analysis of Cronbach's alpha for internal consistency. Construct validity was investigated using principal component analysis. Concurrent validity was assessed by correlating the ICQ scores with the Short Form 36 Health Survey (SF-36) as well as clinical measures. RESULTS: The ICQ was completely filled in by 73 subjects (90.1 %) with an average completion time of 6.3 minutes. Cronbach's alpha coefficient reached 0.75. Intra-class correlation for test-retest reliability was r = 0.88. Principal component analysis resulted in a 3 factor solution. The first factor explained 51.5 of the total variation and all items had loadings of at least 0.65 on it. The ICQ was significantly associated with the SF-36 and treadmill-walking distances whereas no association was found for resting ABPI. CONCLUSIONS: The German version of the ICQ demonstrated good feasibility, satisfactory reliability and good validity. Responsiveness should be investigated in further validation studies.

Varicose veins are a risk factor for deep venous thrombosis in general practice patients.

BACKGROUND: The role of varicose veins (VV) as a risk factor for development of deep venous thrombosis (DVT) is still controversial. The aim of this study in primary care was to determine the impact of varicosity as a potential risk factor for developing DVT. PATIENTS AND METHODS: During the observation period between 01-Jan-2008 and 01-Jan-2011, all cases with VV (ICD code I83.9) and DVT (ICD codes I80.1 - I80.9) were identified out of the CONTENT primary care register (Heidelberg, Germany). The exposure of VV and DVT was based solely on ICD coding without regarding the accuracy of the diagnosis. The covariates age, gender, surgery, hospitalization, congestive heart failure, malignancy, pregnancy, hormonal therapy, and respiratory infection were extracted for each patient. Multivariate binary logistic regression was performed in order to assess potential risk factors for DVT. The SAS procedure "PROC GENMOD" (SAS version 9.2, 64-bit) was parameterised accordingly. A potential cluster effect (patients within practices) was regarded in the regression model. RESULTS: There were 132 out of 2,357 (5.6 %) DVT episodes among patients with VV compared to 728 out of 80,588 (0.9 %) in the patient cohort without VV (p < 0.0001). An increased risk of DVT was associated with previous DVT (adjusted odds ratio (OR): 9.07, 95 % confidence interval (CI): 7.78 - 10.91), VV (OR 7.33 [CI 6.14 - 8.74]), hospitalization during the last 6 months (OR 1.69 [CI 1.29 - 2.22]), malignancy (OR 1.55 [CI 1.19 - 2.02]), and age (OR 1.02 [CI 1.01 - 1.03]). CONCLUSIONS: There are strong associations between VV and DVT in a general practice population with documented VV. Special medical attention is required for patients with VV, a history of previous venous thromboembolism, comorbid malignancy, and recent hospital discharge, particularly those with a combination of these factors.

Secondary Pharmacotherapeutic Prevention among German Primary Care Patients with Peripheral Arterial Disease.

Background. The aim of the study was to determine the secondary preventive medical supply of patients with peripheral arterial disease (PAD) in German primary care. Methods and Results. A population-based case control study was conducted using electronic medical records of patients extracted from the CONTENT primary care database of Heidelberg, Germany, between April 2007 and March 2010. The prescription rates of cardiovascular medication among symptomatic PAD patients were analysed by means of the ATC classification and compared with those of patients with cardiovascular disease (CVD). 479 cases with PAD and 958 sex- and age-matched control CVD patients were identified. PAD patients showed significantly lower prescription rates for cardiac agents (21.7% versus 37%), ß-blockers (50.1% versus. 66.2%), and lipid-lowering agents (50.3% versus 55.9%) compared to CVD patients. In contrast, significantly more prescriptions of antidiabetic agents (28.2% versus 20.3%), particularly insulin and analogues (12.5% versus 8%), and calcium channel blockers (29.2% versus 24.3%) were found in PAD patients. Low-dose aspirin use among both PAD and CVD patients was underestimated, as it is available without a prescription. Conclusions. Optimal pharmacotherapeutical care of patients with PAD requires more intensive cardioprotective medication in primary care settings.

Lowering missing item values in quality-of-life questionnaires: an interventional study.

OBJECTIVE: Missing item values (MIV) often occur in quality-of-life (QoL) questionnaires. This study aimed to examine whether the use of introductory exemplary questions reduces the number of MIV and what patient-related factors influence effectiveness of such a QoL form training. METHODS: In a randomized controlled study in ten primary care practice settings, a total of 215 consecutively recruited patients with at least one chronic disease were requested to complete the Medical Outcomes Study 36 Items Short Form (SF-36) questionnaire, German version 1.0. Prior to filling out the QoL form, a sample of randomly selected patients answered three simple written questions similar in wording and appearance to the original SF-36 questionnaire. RESULTS: In total, 126 (58.6%) patients completed the SF-36 questionnaire without MIV. Despite MIV the forms of 46 (21.4%) patients were still computable, i.e., scoring of scales was possible after use of the standardized SF-36 imputation algorithm. After the imputation procedure, MIV significantly hampered generating computable sum scales in 29 (26.6%) of the control group and 14 (13.2%) of the interventional group (P < 0.05). A univariate analysis suggested no evidence that the number of MIV was reduced by the intervention. However, intervention led to a significant decrease of MIV in males but not in females. The education status affected the number of missing data independent of intervention. CONCLUSION: This cross-sectional study showed that the prior use of three self-created questions similar in wording and appearance to the SF-36 questionnaire significantly reduces MIV in male patients. School qualification of QoL respondents inversely correlated with the number of questionnaire MIV, but independent of education status all subjects did benefit from the QoL form training.

Quality of life and objective disease criteria in patients with intermittent claudication in general practice.

BACKGROUND: The quality of life (QoL) of patients with chronic diseases is an important decision criterion for medical treatment, especially in primary care settings. It is known that subjective sickness feelings often cannot be correlated with objective disease criteria. OBJECTIVE: The aim of the study was to determine the QoL of patients with intermittent claudication with the arterial morphology, haemodynamic parameters and functional disability of peripheral arterial occlusive disease (PAOD). METHODS: In 150 patients with stable intermittent claudication, the health-related QoL was compared with the angiogram score, the resting Doppler pressure values, and the initial claudication distance (ICD) and absolute claudication distance (ACD) with treadmill exercise. RESULTS: The QoL did not correlate significantly with either the angiogram score or the ankle systolic blood pressure and ankle brachial index. ICD and ACD correlated significantly with the QoL activity subscales of pain, complaints and functional status (P < 0.001). In a multiple regression analysis, ACD and body mass index were the most predictive variables for the QoL. CONCLUSION: The QoL of PAOD patients is independent of the peripheral Doppler pressure and the angiographic severity of the disease. The most important criterion for the QoL is the patient's functional disability.