Introduction ORIGINAL PAPER. Stephanie Stiel 1 & Maria Heckel 1 & Britta Christensen 1 & Christoph Ostgathe 1 & Carsten Klein 1

Transcription

1 Support Care Cancer (2016) 24: DOI /s ORIGINAL PAPER In-service documentation tools and statements on palliative sedation in Germany do they meet the EAPC framework recommendations? A qualitative document analysis Stephanie Stiel 1 & Maria Heckel 1 & Britta Christensen 1 & Christoph Ostgathe 1 & Carsten Klein 1 Received: 21 May 2015 /Accepted: 2 August 2015 /Published online: 14 August 2015 # Springer-Verlag Berlin Heidelberg 2015 Abstract Background Numerous (inter-)national guidelines and frameworks have been developed to provide recommendations for the application of palliative sedation (PS). However, they are still not widely known, and large variations in PS clinical practice can be found. Aim This study aims to collect and describe contents from documents used in clinical practice and to compare to what extent they match the European Association for Palliative Care (EAPC) framework recommendations. Design and methods In a national survey on PS in Germany 2012, participants were asked to upload their in-service templates, assessment tools, specific protocols, and in-service statements for the application and documentation of PS. These documents are analyzed by using systematic structured content analysis. Results Three hundred seven content units of 52 provided documents were coded. The analyzed templates are very heterogeneous and also contain items not mentioned in the EAPC framework. Among 11 scales for the evaluation of sedation level, the Ramsey Sedation Score (n = 5) and the Richmond- Agitation-Sedation-Scale (n = 2) were found most often. For Both authors Stephanie Stiel and Maria Heckel contributed equally to this manuscript. * Carsten Klein carsten.klein@uk-erlangen.de; 1 Department of Palliative Medicine, Comprehensive Cancer Center CCC Erlangen-EMN, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany symptom assessment, three different scales were provided one time respectively. In all six PS statements, the common core elements were possible indications for PS, instructions on dose titration, patient monitoring, and care. Wide congruency exists for physical and psychological indications. Most documents coincide on midazolam as a preferred drug and basic monitoring in regular intervals. Aspects such as pre-emptive discussion of the potential role of sedation, informational needs of relatives, and care for the medical professionals are mentioned rarely. Conclusions The analyzed templates do neglect some points of the EAPC recommendations. However, they expand the ten-point scheme of the framework in some details. The findings may facilitate the development of standardized consensus documentation and monitoring draft as an operational statement. Keywords Palliative care. Sedation. Evaluation. Assessment. Documentation. Qualitative research Introduction Although palliative and hospice care can achieve sufficient symptom relief for the majority of terminally ill and dying patients, a minority of them is in need of palliative sedation (PS) as a last resort when common therapeutic measures do not succeed in symptom and problem alleviation (1). PS has been discussed controversially in the literature and received growing scientific attention during the past years. Misunderstandings concerning probable life-shortening effects of PS and differentiating PS from euthanasia (2 4) may have led to barriers and concerns in the application of PS in clinical practice. Rather inconsistent treatment regimens and research findings on the definition (1, 5 8), incidence (9, 10),

2 460 Support Care Cancer (2016) 24: indications (10 12), medication, and general professionals attitudes (13 18) toward PS were reported (9, 15). Due to these uncertainties, the necessity for standardized guidelines was expressed (19). According to this specific need, (inter-)national guidelines and frameworks were developed to provide recommendations for the application of PS in clinical practice (20 23). Although these guidelines have been available for several years now, they are still not widely known and not consistently applied in clinical practice. In publishing the framework on PS, the European Association for Palliative Care (EAPC) wanted to foster the development of national guidelines. The set of recommendations contains the consensus of an international board of experts in the field of PS. Shortly after the original publication, the EAPC framework on PS had been translated in German and published on a national level. Supported by the German Association of Palliative Medicine, this publication can be seen as a baseline fortheuseofpsingermany. Large variations in PS practice are found and, as a result, clinical performance still differs (24, 25). Additionally, a lack of documentation and standardized practice of PS was apparent in an audit of PS practice performed as a quality improvement program (25). In the meantime, these (inter-)national guidelines, position statements, and the related literature on PS recommendations have been investigated, in order to evaluate its content and methodological quality (26, 27). Gurschick et al. compared several published guidelines on PS from different medical societies and found variances considering definitions of the practice, indications for its use, continuation of life-prolonging therapies, medications used, and timing/prognosis throughout these guidelines (28). The authors concluded that these variances may impede consistency in clinical practice. Therefore, data on the provision of PS after implementation of guidelines have to be collected and disseminated for a better understanding of the current practice. Schildmann and Schildmann reported similar results from a systematic literature search and analysis of nine international guidelines on PS (29). In Germany, a systematic overview of the current clinical practice has been achieved by a questionnaire survey (30). As part of this study, representatives from participating palliative care institutions were requested to provide their in-service documentation and evaluation tools used for preparation, documentation, monitoring, and evaluation of PS for further analysis and synthesis. These tools are designed by each institution individually, so a comparison and consolidation of results between several institutions is impeded (31). It is not known whether these templates meet the recommended standards of the EAPC guideline framework on PS. Study aim This study aims to (1) collect contents from provided documents used in clinical practice of PS in Germany, (2) to describe common core elements and particularities of these inservice documents, and (3) to compare, on the one hand, to what extent the documents match the recommendations from the EAPC framework and, on the other hand, how these documents used in clinical practice expand contents from the EAPC framework. Methods and material Study design and participants In September and October 2012, palliative care units (PCU), inpatient hospices (H), specialized outpatient palliative care services (SAPV), and specialized outpatient pediatric palliative care services (SAPPV) listed in national address registers were invited via to participate, each with one representative, in a national survey on the clinical practice of PS (30). The participants were asked to answer a questionnaire about their common clinical use of PS. The questionnaire consisted of a total of 34 questions divided into 7 sections (number of patients, indications, monitoring, documentation, clinical practice, guidelines, and demographics). In addition to the questionnaire, the participants were asked to upload their in-service templates and tools for the evaluation of symptom burden and sedation depth, specific protocols for the documentation of PS, and inservice statements for the application of PS. These documents are analyzed here using a qualitative approach. Additional unpublished data from the original quantitative survey are added to this qualitative analyses presented here to connect and emphasize single findings. The final study plan was presented to the ethics committee of the medical faculty of Erlangen. A formal approval was not regarded as necessary. Data processing and analysis Data processing and analysis of the provided in-service documents was carried out with MAXQDA (32). For data analysis, systematic structured content analysis adapted from Mayring and Schreier (33, 34) was used.

3 Support Care Cancer (2016) 24: First, all provided document sets were inserted in MAXQDA. A theoretical derived set of categories had been previously assigned according to the EAPC framework (35): 1. Recommend pre-emptive discussion of the potential role of sedation in end-of-life care and contingency planning 2. Describe the indications in which sedation may or should be considered 3. Describe the necessary evaluation and consultation procedures 4. Specify consent requirements 5. Indicate the need to discuss the decision-making process with the patient s family 6. Present direction for selection of the sedation method 7. Present direction for dose titration, patient monitoring, and care 8. Guidance for decisions regarding hydration and nutrition and concomitant medications 9. The care and informational needs of the patient sfamily 10. Care for the medical professionals The ten main content categories, including subcategories of the EAPC framework, were specified in code memos, each citing the EAPC recommendations explications. All document content fragments were allocated deductively to the ten main categories and subcategories. Document contents which did not match the given categories were collected in text-related codes and allocated to new categories expanding the pre-defined tenpoint scheme of the EAPC framework afterwards. Subsequently, based on this data preparation, common core elements and particularities of the provided in-service documents are described within the four document sets (set 1: scales on level of sedation; set 2: scales on symptom assessment; set 3: PS statements; set 4: PS documentation templates; see Table 1). In a third step, contents within the document sets were compared to the EAPC framework recommendations. For quality assurance of the data processing, two researcher independently allocated documents to the four sets and document contents to the ten-point category system. Inconsistencies were checked by a third researcher and discussed until consensus was found. Table 1 Document provision by institutions (palliative care units (PCU), inpatient hospices (H), specialized outpatient (pediatric), palliative care services (SAP(P)V)) PCU H SAP(P)V Sum Set 1 Scales on level of sedation Set 2 Scales on symptom assessment Set 3 PS statements Set 4 PS documentation templates The methodological prodecure of data processing and analysis is shown in Fig. 1. Results The questionnaire was sent to 605 contact persons from PCU (261), H (197), SAPV (127), and SAPPV (20). During 6 weeks of study application in September and October 2012, 225 invited participants filled in and returned the questionnaire. An overall response rate of 37.2 % was achieved. Due to inconsistencies, we excluded four questionnaires, resulting in n = 221 data sets. In total, the participants uploaded 58 documents. After re-allocation of all documents to the four respective document sets, deduplication, and exclusion of non-specific contributions for PS, the following distribution was used for further analysis (see Table 1). Ultimately, 307 content units from 52 documents were coded. The majority of all content units (n =224,73%)couldbe allocated to one of the ten EAPC core items unambiguously. The remaining 83 (27 %) content units were coded to new categories expanding the pre-defined ten-point scheme of the EAPC framework (see Tables 2 and 3). Set1:scalesonsedationlevel Within the given 11 scales for the evaluation of sedation level, the Richmond-Agitation-Sedation-Scale (RASS) was found Data processing Analysis Set 1 (n = 11) in-house documents (N = 52) Set 2 (n = 3) Set 3 (n = 6) content units allocated to 10 main categories + subcategories according to EAPC framework Sets contents structured content analysis Sets core elements Sets rarities Set 4 (n = 32) new categories Sets matching to EAPC framework Fig. 1 Methodological prodecure of data processing and analysis

4 462 Support Care Cancer (2016) 24: Table 2 Specific information from provided PS statements (N = 6) according to ten-point EAPC framework EAPC framework/ps statements Recommend pre-emptive discussion of the potential role of sedation in end-of-life care and contingency planning 2. Describe the indications in which sedation may or should be considered 3. Describe the necessary evaluation and consultation procedures 4. Specify consent requirements 5. Indicate the need to discuss the decisionmaking process with the patient s family 6. Present direction for selection of the sedation method 7. Present direction for dose titration, patient monitoring, and care Timely patient information on PS in foreseeable trajectory Refractory physical and psychological symptoms, good night sleep, emergency reasons Team conference with patient and family Procedure discussed with patient, family; 24 h between information and beginning PS; written signed information; shared decision making Unbearable physical and psychological symptoms, emergency reasons, not pain Timely patient and family information on PS in foreseeable trajectory Refractory physical and psychological symptoms, precaution for existential issues Team conference Team conference (add. second palliative care physician) Physician patient information or evaluation of presumed patient will; shared decision making; no consulting of patient and family by nurses Information, discussion; evaluation of (presumed) patient will; patient/ family consent and team consent; exception: emergency Agitation, panic disorder, terminal agitation Refractory physical, psychological and existential symptoms Team conference, ethical case discussion, decision: physician Informed patient consent; exception: emergency Refractory physical, psychological and existential symptoms Indication: two independent palliative care physicians, team decision Procedure discussed with patient, family, proxy; 24 h between information and beginning PS; written signed information; exception: emergency Closest relatives, proxy Relatives Relatives Patient, relatives Patient, relatives Intermittent vs. continuous; conscious vs. deep sedation Measures in case of overdose; used medication: according to symptoms and physician s decision, preferably used drug: midazolam; application s.c. or i.v.; dose calculation: upward titration of drug until required sedation depth is achieved, half of necessary dose is used as dose/h; monitoring of vital signs before PS, every 15 min while titration and in regular times during PS Application s.c. or i.v. via pump; preferably used drugs: midazolam, promethazine; regular monitoring; no reduction of nursing and personal care; re-evaluation of decision on PS in regular intervals Intermittent vs. continuous; aim is symptom relief Individual adaptation of drug and dosage; preferably used drug: midazolam, lorazepam, diazepam; s.c., i.v.; oral, sublingual, or rectal application others: levomepromazine, promazine, haloperidol utilize secondary sedative effects of strong opioids; combination of drugs possible; documentation; and evaluation of symptoms, vigilance, dosage, vital signs, breathing, ability to communicate, and course of PS in continuously in regular intervals Intermittent vs. continuous; sedation depth according to symptom burden and patient wish Drugs: haloperidol, promethazine (20 gtt); diazepam (10 20 gtt); lorazepam (1 mg) agitation: drug application: i.m., i.v., s.c. Midazolam (5 mg i.v) infusion Continuation of nursing care; attention to patient environment; documentation; and evaluation of symptoms, level of PS, dosage, vital parameters, breathing, and course of PS in regular intervals; no upward titration of opioids for PS; benzodiazepines, neuroleptics, or combinations; application: sublingual, s.c., i.v. levomepromazine ( mg per day); haloperidol ( mg per day) (s.c., i.v.); midazolam ( mg per h, s.c., i.v.); lorazepam (1 2.5 mg every 6 h, sublingual) Intermittent vs. continuous; conscious vs. deep sedation Documentation of specific PS checklist; assessment of level of sedation, breathing, heart rate, and communication ability twice per shift

5 Support Care Cancer (2016) 24: Table 2 (continued) EAPC framework/ps statements Decision on restriction and withdrawal of life sustaining therapies independent from decision on PS; other measures for symptom control continued; route switched to s.c. No PS without pain therapy; patients without pain medication prior to PS should receive morphine (5 10 mg every 4 h, s.c.); oral drugs must be switched to s.c. route prior to PS Physician and nurse decision which concomitant drugs should be continued during PS; decision on continuation of nutrition and hydration independent from PS Individual decision on continuation of nutrition and hydration independent from PS; special attention to pain therapy because of inability to communicate pain Continuation and adaptation of pain and other symptom therapies according to burden; discussion on continuation of nutrition and hydration part of patient information 8. Guidance for decisions regarding hydration and nutrition and concomitant medications Sufficient time for relatives' adoption of patient; resuming talking about open questions, emotions, and course of treatment; additional post funeral offers 9. The care and informational needs of the patient s family Sufficient time for team discussions during PS and resuming discussion on open questions, emotions, and options for treatment improvement afterwards 10. Care for the medical professionals twice, the Ramsey Sedation Score five times, and once in an extended version including an item on breathing. Three nonspecified scores using verbal rating scales for (a) level of consciousness from 0 (awake, oriented) to 6 (coma, no reaction), for sedation level (b) from 0 (awake) to 3 (coma), or (c) by discrimination of either Beasily arousable^ or Bsleeping deeply^ were uploaded. The EAPC framework mentions RASS as an example. The proposal of measuring the patients level of consciousness was put into practice using the RASS or the Ramsey Sedation Score or individually defined verbal rating scales. In the quantitative questionnaire, each out of n = 221, 17 participants stated having used the RASS and 40 the Ramsey Sedation Score, 4 used the Agitation (Distress) Scale, and 32 stated having used internal or other scales. Set 2: scales on symptom assessment Three scales on symptom assessment were provided one time respectively: (1) an instrument for pain assessment in elderly patients with dementia validated originally in French (36)and then validated in German (37) (Beobachtungsinstrument für das Schmerzassessment bei alten Menschen mit Demenz (BISAD)); (2) a verbal rating scale from 0 (no) to 3 (severe) for nausea, vomiting, dyspnea, anxiety, sadness, agitation, and disorientation; and (3) a numerical rating scale from 1 to 10 for pain in rest or movement pain. The Critical-Care Pain Observation Tool which was given as an example in the EAPC framework was not mentioned as being used in PS practice. However, all practical scales match the recommendation to assess symptom intensities or the severity of suffering. In the quantitative questionnaire, of the 221 participants, 115 stated having used VAS, NRS, or VRS to document symptoms, 6 having used the Edmonton Symptoms Assessment System, 24 the Minimal Documentation System (MIDOS) for patients in palliative care, 50 the symptom and problem checklist of the German Hospice and Palliative Care Evaluation (HOPE), and 22 other internal scales (24). Set 3: general statements on PS The common core elements in all six statements were possible indications for PS and instructions on dose titration, patient monitoring, and care. In detail, wide congruency exists for physical (dyspnea, pain, nausea, delirium) and psychological (fear, depression) indications for PS. Only one statement specified that psychological suffering and existential distress should be considered cautiously, as described in the EAPC framework. Two statements mention restlessness as indication for PS; one explicitly states that pain should be treated by analgesics and not by sedation, and sedation during pain therapy has to be seen as a secondary effect (see Table 2).

6 464 Support Care Cancer (2016) 24: Table 3 Specific additional information from provided PS general statements (N = 6) expanding the ten-point EAPC framework Additional categories/ps Statements Potential adverse outcomes and risks of sedation in palliative care Inability for interaction, loss of legal capacity, family concerns, clinical risks such as paradoxical agitation, and hastened dying process Abuse of palliative sedation Refusal of euthanasia and intentional hastening of dying process Injudicious use of palliative sedation Discrimination of primary and secondary PS Other treatment option for symptom relief available; PS due to excessive demands on professionals; relatives wish for PS, not patient wish No pain treatment via PS, pain therapy might lead to secondary decrease of consciousness Refusal of euthanasia; unintentional hastening of dying process acceptable Discrimination of primary sedation using benzodiazepines and narcotics vs. secondary sedative effects caused by other drugs such as opioids PS aiming at symptom relief, refusal of euthanasia

7 Support Care Cancer (2016) 24: Regarding information on directives for medication, dose titration, patient monitoring, and care, the transmitted documents coincide in opinion in terms of midazolam as a preferred drug for PS and basic monitoring (of at least vital parameters and level of sedation in four statements) in regular intervals. One statement included Promazin as a possible drug for PS, but this drug is not approved in Germany. Information on measures in case of overdose, continuation of nursing care during PS, and special attention to the patient environment were each reported in one statement. Two contradictory statements concerning the use of strong opioids were found. One statement explicitly recommends the use of the secondary sedative effect of strong opioids for PS, while another statement argues against upward titration of strong opioids for PS purpose. Only two statements describe the monitoring of symptoms during PS. Comparing these contents to the EAPC framework, the description of midazolam as a first choice of medication and the monitoring of vital parameters in practice statements match the recommendation of EAPC. The interval set for patient monitoring during upward titration and during adequate sedation differ slightly from the EAPC recommendation, generally with a trend to more frequent up to hourly monitoring and documentation. The evaluation of adverse effects of PS reported in the EAPC framework was not described in practical statements (see Table 2). Five statements included information on necessary evaluation and consultation procedures, consent requirements, the need to discuss the decision-making process with the patients family, the direction for the selection of the sedation method, and decisions regarding hydration and nutrition and concomitant medications (see Table 2). Two practical statements require written informed consent from the patient or the proxy which is not specified in the EAPC framework. One practical statement states in the section on consent requirements that nurses are not entitled to give advice concerning PS to patients and families. Two statements mentioned pre-emptive discussion of the potential role of sedation if PS could become necessary to treat growing symptom burden. One statement explains the informational needs of the relatives in detail, and one mentions explicitly the care for the medical professionals (see Table 2). Expansion of the ten-point scheme of the EAPC Framework on PS: Some of the additional categories we found are included in the introduction section of the EAPC framework considering Bpotential adverse outcomes and risks of sedation in palliative care such as problem practices, abuse of palliative sedation, and injudicious use of palliative sedation.^ BAbuse of PS^ means that hastening the patient s death is aimed with PS, while Binjudicious use^ is given if the indication does not justify the intervention. Furthermore, other content units were ascribed to the Bdiscrimination of primary and secondary PS^ and were summarized accordingly in a new category (see Table 3). Set 4: PS documentation templates The EAPC framework recommends explicitly documenting pre-emptive discussion of the potential role of sedation in end-of-life care, evaluation and consultation procedures, the content and conclusion from the discussion about Baims, benefits and risks of proposed sedation^ with patient (EAPC framework, S. 585), and, during sedation, the reasons for a change of dose in prescribed medication and the effect of this change. Of the 32 templates provided in this set, 11 included documentation on evaluation and consultation procedures, 15 included documentation about conclusions of patients consent, and 23 included documentation pertaining to changes in medication. Patient monitoring was mainly documented in tables including written vital parameters or checklists confirming that a specific monitoring had taken place. Between 3.1 and 50.0 % of all 32 documents include specific information about the documentation of indications, the decision-making process with the patient s family,the direction for selection of the sedation method, the decisions regarding hydration and nutrition and concomitant medications, and care and informational needs of the patient s family.for instance, indications were documented by confirming symptoms within a given symptom checklist or via free text entries. Two templates offer a tick box to confirm that the reason for PS is the explicit patients wish. In comparison, the EAPC framework does not comment on patient wish as the only indication. Our quantitative survey provides the information that 117 (out of n = 221) PC providers document monitoring of PS in the routine patient documentation. Forty-four (out of n = 221) stated having used free entries for documentation of PS (24). Discussion To the best of our knowledge, this is the first analysis which has considered in-service documents used in clinical PS practice in Germany. Former studies have considered scientifically derived assessment tools or theoretical guidelines and recommendations, but no investigation has yet looked at those documents which were specifically developed and used in clinical every-day practice (27, 29, 38). In summary, the findings reported here show that rather wide accordance with the EAPC recommendations exists in the main areas. Many documentation templates contained the proposed Richmond-Agitation-Sedation-Scale or the Ramsey Sedation Score to assess the level of sedation. Basic monitoring shows lack of symptom assessment and documentation, but symptoms might be documented elsewhere in routine patient charts. None of the practical assessments contained the recommended Critical-Care Pain Observation Tool, since it is not available in the German language. Regarding statements

8 466 Support Care Cancer (2016) 24: for the application of PS, all statements reported on possible indications for PS, and gave directions for dose titration, patient monitoring, and care. Surprisingly, one statement named Promazin as a drug used for PS, although this is not approved in Germany. Pre-emptive discussion of the role of PS in cases where extreme distress is foreseen is only mentioned in two documents. Since patients in extreme distress are no longer capable of giving informed consent, the pre-emptive discussion is essential to give the patient the opportunity to express his wishes for end-of-life therapies. Professionals in palliative care should focus on the possible role of PS for end-of-life care wherever unbearable suffering may be expected. Likely, this will not increase the sedation rate at the end of life, but rather reduce the rate of sedation in emergency situations without the chance to discuss this treatment with the patient or inform the relatives. PS documentation templates varied considerably in their individual content, extent, and patterns of documentation. The EAPC framework explicitly recommends documenting the decision-making process, the indication for sedation, the planned depth and duration of sedation, as well as an overview of the discussions with the patient s family. During the course of sedation, changes in medication and effects of these should be documented. Other contents of documentation regarding medication can implicitly be marked as necessary due to medical or medico-legal reasons, e.g., medication and dosage. Most of the documentation templates cover the recommended subjects of decision making and indication. Differences can be seen in documentation during sedation, since medication and changes in dosage are not always contained in the specific PS documentation. As a result, reasons for changes and effects cannot be found in the templates. Similarly, it might be possible that, e.g., pre-emptive discussions about PS with patients are documented elsewhere in routine documentation and not within the specific PS documentation, as the results of the quantitative survey suggest. Nevertheless, documentation of vital parameters seems to be an important topic. Informational needs of caregivers are seldom explained in detail but mentioned implicitly in other sections of the statements, e. g., about potential adverse outcomes and risks of sedation in palliative care. These results are in line with former findings reported in the palliative care literature. Brinkkemper et al. published a systematic review on 30 retro- or prospective studies, former reviews and guidelines, and extracted relevant information on the method of monitoring of PS. The authors describe that most studies focus on the monitoring of refractory symptoms or on the level of awareness to control the depth of sedation, and therefore use Numeric Pain Rating Scales, Visual Analog Scales, the Memorial Delirium Assessment Scale, the Communication Capacity Scale, and Agitation Distress Scale (38). Nevertheless, these findings display contents of scientific approaches, but do not give a picture of instruments and tools used in clinical practice besides the research attempts. Overall, it is notable that many palliative and hospice care institutions develop their own PS material and templates, so that a very broad range of documents exists which differ considerably. This phenomenon is apparent, however, in many domains of assessment in palliative and hospice care (31). Nevertheless, if even official guidelines on PS from different medical societies vary in terms of definitions, indications, continuation of life-prolonging therapies, medications, and timing of PS in terms of prognosis, teams in clinical practice may feel the need to define their own philosophy and practice of PS and their own specific documents (28). As the EAPC framework is designed as a recommendation for procedural guidelines, it is meant to be adapted according to local cultural, legal, or setting considerations (35). The documents provided by the participants in this study show various checklists and free text possibilities which could be interpreted as the need for step-by-step guidance in clinical practices. Study limitations Although in this study a large number of different in-service documents were investigated, looking at the response rate, it can be supposed that not the full range of existing documentation contents is displayed and analyzed here. Because documents of different palliative and hospice care institutions are integrated in one analysis, the investigation does not distinguish between specific documentation needs for single settings. The study aims to give an overview which might lead to a flexible and best suitable documentation proposal to be used in all palliative and hospice care settings. Conclusions The recommendations of the EAPC framework are not fully met by the templates analyzed in this study. Nevertheless, the provided PS general statements add specific additional information expanding the ten-point EAPC scheme. Team members might still be uncertain as to (a) what contents must be considered in the preparation, discussion, and decisionmaking before PS; (b) what has to be observed and documented during PS; and (c) how the treatment outcome can be evaluated. As a result, there might be a professionals need for a standardized operational statement on PS for clinical practice. The findings reported from this analysis may facilitate the development of standardized national consensus documentation and a monitoring draft as an operational statement consented by palliative and hospice care institutions. This standardized operational statement could ultimately ease the clinical step-by-step application.

9 Support Care Cancer (2016) 24: Acknowledgments This study received an initial start-up funding from the BErlanger Leistungsbezogene Anschubfinanzierung und N- achwuchsförderung^ (ELAN) ( Klein), a local fund to support research and education at the Friedrich-Alexander-Universität Erlangen- Nürnberg. The authors graciously thank all participants for answering the questionnaire and especially all colleagues for providing us with insight into their in-service documents used in PS. Conflict of interest References The authors have no conflict of interest to declare. 1. Morita T, Tsuneto S, Shima Y (2002) Definition of sedation for symptom relief: a systematic literature review and a proposal of operational criteria. J Pain Symptom Manag 24(4): Omeri A (1997) 19th International Nursing Caring Conference. Human caring: The primacy of love and existential suffering. Helsinki, Finland, June Nurs Inq 4(4): Carr MF, Mohr GJ (2008) Palliative sedation as part of a continuum of palliative care. 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