Redefining diagnosis-related groups (DRGs) for palliative care - a cross-sectional study in two German centres.

BACKGROUND: Hospital costs and cost drivers in palliative care are poorly analysed. It remains unknown whether current German Diagnosis-Related Groups, mainly relying on main diagnosis or procedure, reproduce costs adequately. The aim of this study was therefore to analyse costs and reimbursement for inpatient palliative care and to identify relevant cost drivers. METHODS: Two-center, standardised micro-costing approach with patient-level cost calculations and analysis of the reimbursement situation for patients receiving palliative care at two German hospitals (7/2012-12/2013). Data were analysed for the total group receiving hospital care covering, but not exclusively, palliative care (group A) and the subgroup receiving palliative care only (group B). Patient and care characteristics predictive of inpatient costs of palliative care were derived by generalised linear models and investigated by classification and regression tree analysis. RESULTS: Between 7/2012 and 12/2013, 2151 patients received care in the two hospitals including, but not exclusively, on the PCUs (group A). In 2013, 784 patients received care on the two PCUs only (group B). Mean total costs per case were € 7392 (SD 7897) (group A) and € 5763 (SD 3664) (group B), mean total reimbursement per case € 5155 (SD 6347) (group A) and € 4278 (SD 2194) (group B). For group A/B on the ward, 58%/67% of the overall costs and 48%/53%, 65%/82% and 64%/72% of costs for nursing, physicians and infrastructure were reimbursed, respectively. Main diagnosis did not significantly influence costs. However, duration of palliative care and total length of stay were (related to the cost calculation method) identified as significant cost drivers. CONCLUSIONS: Related to the cost calculation method, total length of stay and duration of palliative care were identified as significant cost drivers. In contrast, main diagnosis did not reflect costs. In addition, results show that reimbursement within the German Diagnosis-Related Groups system does not reproduce the costs adequately, but causes a financing gap for inpatient palliative care.

'Palliative sedation'? A retrospective cohort study on the use and labelling of continuously administered sedatives on a palliative care unit.

BACKGROUND: Sedatives are frequently used towards the end of life. However, there is scarce information when their use is labelled as 'palliative sedation'. AIM: To assess the use and labelling of 'continuous administration of sedatives within the last 7 days of life', based on objective operational criteria, on a palliative care unit. DESIGN: Retrospective cohort study, using medical records. Explorative statistical analysis (SPSS 23). SETTING/PARTICIPANTS: Patients who died on a palliative care unit from August 2014 to July 2015. Sedatives recorded were benzodiazepines, levomepromazine, haloperidol ⩾5 mg/day and propofol. RESULTS: Of the 192 patients, 149 (78%) patients received continuous sedatives within the last week of life. The prevalence of delirium/agitation was significantly higher in patients with continuous sedatives compared to those without continuous sedatives at admission to the unit (35% vs 16%, p = 0.02) and on the day before death (58% vs 40%, p = 0.04). The term '(palliative) sedation' was used in the records for 22 of 149 (15%) patients with continuous sedatives. These patients had significantly higher total daily midazolam doses 2 days before death (median (range), 15.0 (6.0-185.0) mg vs 11.5 (1.0-70.0) mg, p = 0.04) and on the day of death (median (range), 19.5 (7.5-240.0) mg vs 12.5 (2.0-65.0) mg, p = 0.01). The dose range was large in both groups. CONCLUSION: The prevalence of delirium/agitation was associated with the administration of continuous sedatives. There was no consistent pattern regarding labelling the use of continuous sedatives as '(palliative) sedation'. Multicentre mixed-methods research is needed for a better characterization of sedation practices in palliative care.

Barriers for the implementation of guidelines in palliative care-results from a national survey of professionals.

BACKGROUND: In 2015, an evidence- and consensus-based palliative care guideline in adults with incurable cancer was published by the German Guideline Program. Barriers and enablers for the guideline implementation of members of the German Association for Palliative Medicine (DGP) were unknown. Therefore, the aims of this study were (1) to evaluate professionals' knowledge, motivation, and outcome expectancy towards already existing recommendations for palliative care and (2) to evaluate the self-experienced competence in five medical key topics presented in the new guideline. METHODS: A web-based online survey with all DGP members in 2014 using a specifically designed questionnaire including 62 questions was used. Independent predictors for identified barriers were analysed using multivariable logistic regression analyses. RESULTS: All 4786 members with known email address were invited, 1181 followed the link, 1138 began to answer, and 1031 completed the questionnaire. Fifty-four percent know already existing recommendations concerning palliative care, 8.4% know and use these recommendations; of the latter group, 44.2% do not notice any improvement of their treatment when applying them. Of key symptoms addressed in the guideline, depression was the symptom with lowest perceived competence (63.7 vs. > 90% for other symptoms). Non-physicians and those working in settings with little contact to seriously ill or dying patients feel less competent in almost all symptoms. CONCLUSION: Emphasis on the high-quality and evidence- and consensus-based character of the guideline should be underlined in future implementation processes. Implementation strategies should focus on depression and non-physicians and those professionals working in settings with little contact to seriously ill patients.

Care of cancer patients at the end of life in a German university hospital: A retrospective observational study from 2014.

BACKGROUND: Cancer care including aggressive treatment procedures during the last phase of life in patients with incurable cancer has increasingly come under scrutiny, while integrating specialist palliative care at an early stage is regarded as indication for high quality end-of-life patient care. AIM: To describe the demographic and clinical characteristics and the medical care provided at the end of life of cancer patients who died in a German university hospital. METHODS: Retrospective cross-sectional study on the basis of anonymized hospital data for cancer patients who died in the Munich University Hospital in 2014. Descriptive analysis and multivariate logistic regression analyses for factors influencing the administration of aggressive treatment procedures at the end of life. RESULTS: Overall, 532 cancer patients died. Mean age was 66.8 years, 58.5% were men. 110/532 (20.7%) decedents had hematologic malignancies and 422/532 (79.3%) a solid tumor. Patients underwent the following medical interventions in the last 7/30 days: chemotherapy (7.7%/38.3%), radiotherapy (2.6%/6.4%), resuscitation (8.5%/10.5%), surgery (15.2%/31.0%), renal replacement therapy (12.0%/16.9%), blood transfusions (21.2%/39.5%), CT scan (33.8%/60.9%). In comparison to patients with solid tumors, patients with hematologic malignancies were more likely to die in intensive care (25.4% vs. 49.1%; p = 0.001), and were also more likely to receive blood transfusions (OR 2.21; 95% CI, 1.36 to 3.58; p = 0.001) and renal replacement therapy (OR 2.65; 95% CI, 1.49 to 4.70; p = 0.001) in the last 7 days of life. Contact with the hospital palliative care team had been initiated in 161/532 patients (30.3%). In 87/161 cases (54.0%), the contact was initiated within the last week of the patient's life. CONCLUSIONS: Overambitious treatments are still reality at the end of life in cancer patients in hospital but patients with solid tumors and hematologic malignancies have to be differentiated. More efforts are necessary for the timely inclusion of specialist palliative care.

Critical attitudes and beliefs towards guidelines amongst palliative care professionals - results from a national survey.

BACKGROUND: Little is known about palliative care professionals' attitudes towards guidelines. In 2015, the German Association for Palliative Medicine (DGP) published an evidence based guideline for palliative care in adults with incurable cancer. Before publication we conducted a national survey among members of the DGP to detect possible barriers and facilitators for its implementation. The aim of the present publication was to evaluate critical attitudes and beliefs which could hinder the effective implementation of the new guideline and to evaluate differences within professional groups and medical specialisations. METHODS: This web-based online survey was addressed to all members of the DGP in summer 2014. Twenty-one questions concerning attitudes and beliefs towards guidelines were a priori developed to represent the following topics: scepticism regarding the quality of guidelines, doubts about the implementation of guidelines, restrictions in treatment options through guidelines, discrepancy between palliative care values and guidelines. Differences within professions and specialisations were tested using Kruskal-Wallis tests. RESULTS: All 4.786 members with known email address were invited, 1.181 followed the link, 1.138 began to answer the questionnaire and 1.031 completed the questionnaire. More than half of participating members were physicians and one third nurses. Scepticism regarding the quality of existing guidelines was high (range 12.8-73.2%). Doubts regarding practical aspects of guidelines were less prevalent but still high (range 21.8-57.6%). About one third (range 5.4-31.4%) think that guidelines restrict their treatment options. In addition, 38.8% believed that guidelines are a kind of cookbook and restrict the flexibility of individual patient care. The majority saw no or little discrepancy between palliative care values and guidelines (range 68.4-82.6%). There were relatively small but significant differences between professions and specialisations. CONCLUSION: The person-centred and individual approach of palliative care does not seem to contradict the acceptance of guidelines. Main barriers were related to scepticism regarding the quality of guidelines and the implementation of guidelines in general.

Invasive Haemophilus influenzae infections in Germany: impact of non-type b serotypes in the post-vaccine era.

BACKGROUND: Haemophilus influenzae type b (Hib) vaccination led to a significant decrease in invasive bacterial infections in children. The aim of this study was to assess a potential shift to more non-type b invasive infections in a population with high Hib vaccination coverage and to compare the burden of suffering between children with Hib, capsulated non-b and non-capsulated Hi infections. METHODS: Cases with confirmed invasive Hi infections were ascertained through two independent nationwide active surveillance systems in 1998-2005. Information on possible predisposing conditions and clinical information was available from 2001 onwards. RESULTS: The total number of reported non-type b Hi cases varied between 10 cases in 1998, 27 in 2000 and 14 in 2005. In each year, non-capsulated serotypes outnumbered capsulated non-type b ones. 192 cases were detected in 2001-2005, more than one half was non-type b and 88% of the non-type b cases were non-capsulated. For cases with Hib/capsulated non-type b infections the most common clinical presentation was meningitis (67% each); 89%/78% had no potential predisposing condition, 75%/72% completely recovered from disease and 6% (each) died. In contrast, meningitis was diagnosed in 34% of the non-capsulated Hi infections, septicaemia in 28% and pneumonia 21%; 62% had no potential predisposing condition, 83% completely recovered and 3% died. CONCLUSION: There was no increase in non-type b Hi invasive infections during 8 years of active surveillance in Germany. Invasive disease due to non-type b Hi is not confined to children with risk factors. In patients with capsulated non-type b Hi infections the proportion of meningitis cases is similar to Hib, but double as high as in non-capsulated Hi.

Effectiveness of hexavalent vaccines against invasive Haemophilus influenzae type b disease: Germany's experience after 5 years of licensure.

Vaccine effectiveness (VE) was determined with a case-cohort approach using Cox regression. Cases with confirmed systemic Hib infections in children born from 1 August 2000 to 31 December 2004 were ascertained through two independent nationwide active surveillance systems. A representative cohort of 1303 children born in the same time frame was randomly sampled in a nationwide immunisation survey. Thirty cases were eligible for VE calculation; 19 were unvaccinated and 11 vaccinated with hexavalent vaccines. VE was 68.4% (95% CI: 19.0-87.6) for incomplete primary series and 90.4% (95% CI: 70.6-96.8) for the full primary series. For full immunisation VE was 100.0% (95% CI: 52.7-100.0). Hexavalent vaccines show a high effectiveness against invasive Hib disease in Germany.

Surveillance for rare infectious diseases: is one passive data source enough for Haemophilus influenzae?

BACKGROUND: The completeness of a compulsory reporting system of systemic Haemophilus influenzae infections in children in Germany is studied by means of cross-linking registry data from three sources and applying capture-recapture methods. METHODS: Cases were collected for the years 2001-05 by three national data sources: a passive administration registry (SurvNet@RKI), an active hospital surveillance system and an active laboratory surveillance system. The case definition required cultural detection of H. influenzae in blood or cerebrospinal fluid. Linkage was carried out by month and year of birth, sex, geographical region and date of disease onset. Capture-recapture models were used to estimate the incidence of invasive H. influenzae infections. RESULTS: SurvNet@RKI reported 113 H. influenzae and 38 H. influenzae type b (Hib) cases, compared to a total of 231 and 68 cases, respectively, reported by all three sources combined. Best-fitting 3-source capture-recapture estimations amounts to 258 (95% confidence interval: 247-276) H. influenzae and 71 (69-74) Hib cases. SurvNet@RKI data depicted a similar decrease in annual H. influenzae cases as the capture-recapture estimates but failed to detect the underlying decrease in Hib cases which was observed in the capture-recapture estimates due to a considerable annual variability of ascertainment of serotyped cases in SurvNet@RKI ranging from 14% to 69%. CONCLUSIONS: Because of small variability of ascertainment, the compulsory passive reporting system depicted trends in H. influenzae incidence, although less than half of the cases were ascertained. However, time trend in Hib cases could not be depicted, because of highly variable serotyping proportions.

Vaccination coverage in children can be estimated from health insurance data.

BACKGROUND: The introduction of new vaccines for young children requires instruments for a rapid and timely assessment of the progressively increasing vaccination coverage. We assessed whether routine data generated by statutory health insurances (SHI) might be used to monitor vaccination coverage in young children. METHODS: For 90% of the population Germany's healthcare system is premium-funded through SHI. Specific medical codes on childhood vaccination are used for billing. These were used to analyse vaccine uptake up to 24 months in children born in Bavaria between 2001-10-01 and 2002-12-31. For children insured in the biggest SHI, vaccination coverage estimates based on billing data were compared to estimates considering only continuously insured children since birth, based on additional data provided by this SHI. RESULTS: Definition of an appropriate denominator from the billing data was a major challenge: defining the denominator by any consultation by children with different ID numbers yielded 196,732 children, exceeding the number of births in Bavaria by a factor of 1.4. The main causes for this inflated denominator were migration and change of health insurance number. A reduced dataset based on at least one physician's visit in the first six months and 2nd year of life yielded 111,977 children. Vaccination coverage estimates for children in the biggest SHI were at maximum 1.7% higher than in the data set based on continuously insured children. CONCLUSION: With appropriate adjustments to define the denominator physician's billing data provide a promising tool to estimate immunisation coverage. A slight overestimation based on these data was explained by children never seeing a physician.

The use of combination vaccines has improved timeliness of vaccination in children.

BACKGROUND: In Germany, Haemophilus influenzae type b (Hib), polio and hepatitis B (HBV) vaccines have been combined with diphtheria, tetanus and acellular pertussis vaccines. We examined whether the use of combination vaccines has improved the timing of these vaccinations. METHODS: Vaccination information was obtained from representative nationwide telephone interviews about 2701 children born from 1996 through 2003 in Germany. We assessed up-to-date vaccination as the percentage of children vaccinated by 3, 5 and 15 months for the first dose, full primary series and full immunization, respectively. We compared results over periods when different combination vaccines were used. We also compared median age at first dose, full priming and full immunization for children receiving different types of combination vaccines. RESULTS: During the study period, monovalent vaccines were replaced by higher-valent combination vaccines. With the change from mono- to 4-, 5- and 6-valent vaccines, up-to-date vaccination increased for Hib, polio and HBV. Median age at immunization improved by 0.5 month for Hib, 0.4 month for polio and 0.9 month for HBV at the first dose and 2.2 months for Hib, 3.2 months for polio and 1.4 months for HBV at full immunization when comparing hexavalent with monovalent vaccines. Median age for 4-5-valent vaccines was intermediate. The difference between monovalent and 6-valent vaccines remained significant after stratifying/adjusting for the effect of birth cohorts. CONCLUSION: Combination vaccines are usually advocated for reducing the number of injections. In Germany, however, the use of combination vaccines has also significantly improved timeliness of immunizations.

Excessive crying beyond 3 months may herald other features of multiple regulatory problems.

OBJECTIVE: To assess duration of excessive crying and its relation to sleep and eating disturbances in a population sample of infants. DESIGN: Cross-sectional study. SETTING: Random digit-dialing survey, enrolling birth cohorts between 1999 and 2003, in Germany. PARTICIPANTS: Children aged 4 years and younger. MAIN EXPOSURES: Excessive crying, retrospectively ascertained according to modified Wessel's criteria, and duration of excessive crying. MAIN OUTCOME MEASURES: Severe eating or sleeping problems at interview. RESULTS: The participation rate in the random digit-dialing survey was 62%. The analysis was confined to 1865 children with complete data. The observed prevalence for excessive crying ever was 16.3% (95% confidence interval [CI], 14.7-18.1), beyond 3 months 5.8% (95% CI, 4.8-6.9), and beyond 6 months 2.5% (95% CI, 1.9-3.3). Excessive crying only in the first 3 months did not increase the prevalence of sleep or eating disturbances whereas crying beyond 6 months did; prevalence of eating disorders was 19.1% (95% CI, 9.1-33.3) and prevalence of sleeping disorders was 12.8% (95% CI, 4.8-25.7) compared with 2.7% (95% CI, 1.9-3.6) and 3.6% (95% CI, 2.7-4.6), respectively, in children without excessive crying. CONCLUSIONS: Persistence of crying beyond the first 6 months heralded a higher prevalence of eating or sleeping difficulties in children with excessive crying than in children without excessive crying. These parents should be offered support and counseling over a broader spectrum of features related to multiple regulatory problems.

Immunisation status of children in Germany: temporal trends and regional differences.

UNLABELLED: In Germany, a low coverage with hepatitis B and measles vaccines and a considerable delay in administration of all recommended vaccines were previously apparent. Whether there have been improvements and whether there are regional differences within Germany is not known. Using representative nationwide telephone interviews on 2,701 children born 1996-2003, we assessed vaccination coverage for the first dose or full primary series (2/3 doses, depending on vaccine used) at 24 months of age. The proportions vaccinated with the first dose, full priming and full immunisation (2/3 doses plus booster in the 2nd year of life) until the end of the recommended age (3, 5 and 15 months, respectively, for diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b (Hib) and hepatitis B vaccines (DTPPolioHibHep), and 15 for the first measles, mumps and rubella dose (MMR) were used as indicators of compliance with national guidelines. Coverage for polio, Hib and hepatitis B vaccines increased, while coverage for the first MMR dose remained constantly low at about 70%. Vaccination coverage differed substantially among the German states and was highest for the new states. Compliance with national guidelines increased from 2.5% to 15% for the full primary DTPPolioHibHep series, from 16.2% to 44.7% for the first MMR dose and from 1.0% to 19.3% for the full immunisation with all recommended vaccines (DTPPolioHibHepMMR). CONCLUSION: Vaccination coverage at 24 months and compliance with national guidelines has improved for most vaccines in Germany. However, improving coverage for measles, mumps, rubella and eliminating the regional disparities remain a major challenge for the public health sector.

Sudden and unexpected deaths after the administration of hexavalent vaccines (diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilius influenzae type b): is there a signal?

UNLABELLED: Deaths in temporal association with vaccination of hexavalent vaccines have been recently reported. The objective of this paper is to assess whether these temporal associations can be attributed to chance. Standardised mortality ratios (SMR) for deaths within 1 to 28 days after administration of either of the two hexavalent vaccines in the 1st and 2nd year of life were determined using the respective annual rates for sudden unexpected deaths (SUDs) from the national vital statistics. The distribution of SUD cases and the vaccination uptake by month were estimated from surveys and sales figures for the individual vaccines. Sensitivity analyses were performed to account for limitations in the data sources. For one of the vaccines, Vaccine B, all SMRs were well below one. For the other, Vaccine A, SMRs exceeded one insignificantly on the 1st day after vaccination in the 1st year of life. In the 2nd year of life, however, the SMRs for SUD cases within 1 day of vaccination with vaccine A were 31.3 (95% CI 3.8-113.1; two cases observed; 0.06 cases expected) and 23.5 (95% CI 4.8-68,6) for within 2 days after vaccination (three cases observed; 0.13 cases expected). Extensive sensitivity analyses could not attribute these findings to limitations of the data sources. CONCLUSION: These findings based on spontaneous reporting do not prove a causal relationship between vaccination and sudden unexpected deaths. However, they constitute a signal for one of the two hexavalent vaccines which should prompt intensified surveillance for unexpected deaths after vaccination.

Four and one-half-year follow-up of the effectiveness of diphtheria-tetanus toxoids-acellular pertussis/Haemophilus influenzae type b and diphtheria-tetanus toxoids-acellular pertussis-inactivated poliovirus/H. influenzae type b combination vaccines in Germany.

BACKGROUND: Recently an increase in the number of invasive Haemophilus influenzae type b (Hib) cases was observed in the United Kingdom, which coincided with a temporary change from diphtheria-tetanus toxoids-wild-type pertussis to diphtheria-tetanus toxoids-acellular pertussis (DTaP) Hib vaccines. A study in Germany based on approximately 2 years of follow-up, estimated vaccine effectiveness (VE) of DTaP/Hib and DTaP-inactivated poliovirus/Hib combination vaccines against invasive Hib disease to be high. OBJECTIVES: To assess VE of DTaP-containing Hib vaccines against Hib in Germany with the use of extended follow-up of case surveillance and vaccine uptake. SUBJECTS AND METHODS: Cases with confirmed systemic Hib infections in children born between June 1, 1996 and December 31, 1998 were ascertained by a nationwide active surveillance system from January 1998 through June 2002. A representative subcohort of 667 children born in the same time frame was randomly sampled in a nationwide vaccine coverage survey. VE was determined with a case-cohort approach of Cox regression with time-dependent covariates. RESULTS: Thirty-six cases of Hib disease were reported. Of these, 10 were vaccinated with DTaP-containing Hib vaccines only and 20 were not vaccinated. Of the 10 vaccinated cases, 4 had received an incomplete primary series (1-2 doses), and 6 had received the full primary series (3 doses), 3 of whom also received the booster dose. VE of combination vaccines against invasive Hib infection was 89.6% [95% confidence interval (CI), 67.0-96.7] for an incomplete primary series, 96.7% (95% CI 87.7-99.1) for a full primary series and 98.5% (95% CI 94.5-99.6) for a booster dose (irrespective of priming). CONCLUSION: Hib combination vaccines containing acellular pertussis antigens continue to be highly effective in Germany.