Original article Strahlenther Onkol 2014 · 190:138–148 DOI 10.1007/s00066-013-0555-3 Received: 3 September 2013 Accepted: 11 September 2013 Published online: 11 January 2014 © Springer-Verlag Berlin Heidelberg 2014

J. Dunst1 · N. Willich2 · H. Sack3 · R. Engenhart-Cabillic4 · V. Budach5 · W. Popp6 1 University of Lübeck 2 University of Münster 3 German Society of Radiation Oncology (DEGRO), Berlin 4 University of Marburg 5 Charité Berlin 6 Prime Networks AG, Basel

The QUIRO Study (assurance of quality and innovation in radiooncology): methodology, instruments and practices

QUIRO aims to establish a valid level of quality and innovation in radiation oncology. Over 6 years, 27 specific surveys were conducted at 24 radiooncological departments. In all, 36 renowned experts from the field of radiation oncology (mostly head physicians and full professors) supported the realization of the study. A total of 34,000 records with more than a million individual data were collected (e.g., the time required for physicians during first irradiation in the treatment of breast cancer)

Methodological orientation and terminological definitions Characterization of the approach In the late 1980s, process management respectively business process re-engineering (BPR) became the new formula of strategic orientation and revitalization of the industrial enterprise [3, 10]. The former dominating, structural issues such as the analysis of organizations in decentralized units (and their later re-reintegration into the corporate network) were pushed into the background. Processes began to reveal companies, divisions, departments and individual positions in a wider context [13, 21, 23]. The process became the focus of any analysis and conceptions [5, 13]. The integration of this idea into the

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area of health care, especially into the hospital management, was not long in coming and processes turned into workflows and “clinical” as well as “critical” pathways [4, 7, 15, 16, 19, 22, 25]. Thus, for QUIRO it was obvious to focus on the “process” as the methodological anchor point of change, renewal and optimization and means of systematizing diversified medical–technical procedures according to standardized criteria. “Process” means to bring order into complex chronological relationships and to systematically develop and use knowledge potential (improvement of quality, practical implementation of innovation, utilization efficiency of resources, raising value added). Processes are suitable as a translation mechanism to establish standards and to transform them into concrete as well as consistent clinical action. The possible uses of the process approach can be seen in two respects: a) the creative–analytical aspect: F systematic process design and modeling of procedures [4, 7, 22], F structured acquisition, processing and deposit or storage of information (inter alia from research reports, expert interviews, surveys) [22], and F systematic documentation and analysis of the processes and procedures in the form of knowledge databases [16, 25];

b) the application-related aspect: F assurance of process quality, proactive care management and controlling of treatment processes (IT-based pathways) [9, 14, 17, 20, 22], F structured communication between the physicians, the medical physics experts and the medical technical assistants for the purpose of labor division (inter alia in the form of interlocking with patient documentation) [8, 11, 20], and F targeted information (e.g., within the framework of patient education to improve compliance) [4, 14]. Moreover, the process approach is particularly suited to determine systematically, differentiated, and detailed the resource requirements in the complex context of performance and make them transparent.

“Process” as a methodological anchor point A salient feature of the chosen methodological approach is the “process” as a tool of systematizing diversified medical–technical procedures of the patient care and radiooncological chronologically according to standardized criteria. The core of the methodology is the “process” which chronologically orders

the range of tasks in patient care and in clinical operation of radiation ­oncology. With the process-based approach the ­ideals (evidence-based care; also in the form of clinical guidelines) are transformed into reality on the level of medi­ cine. This happens by systematizing the clinical care on a technological and working level, in other words the procedural arrangement of the single working steps. Using a process approach, structured treatment concepts can be developed with a high degree of operationalization, checked at regular intervals and enhanced corresponding to the medical technical progress and new scientific plus practical knowledge. New forms of treatment can be brought to a safe practical application on the basis of a known and maybe already clinically implemented approach. The central focus lies on the human resources and the expressible volume of work by time (and ultimately over time related cost rates in money) [12, 18] that is required to carry out quality- and innovation-assured processes, as well as the temporal use of the infrastructure. However, the economic fundamentals of this infrastructure, such as investment and operating costs, are not part of the QUIRO study.

Action fields and types of process In the actions field a distinction between patient care and radiooncological operation is carried out. Hence, processes can be either distinguished as “patient-related treatment processes” or “clinical processes”. Clinical processes conduce at the core to maintain operational activities and the ongoing optimization of radiooncological operations. Quality management is a special case and an important subset of this. In contrast to the actual productive service provision, the clinical processes are indirectly productive or “unproductive” overhead functions. In addition to the various forms of quality management, overhead functions can be also administrative and managerial tasks, research and teaching, institutionalized and personal training and the like. Physicians and staff, which mean in detail head, senior, assistant physicians, medical

physics experts (MPE), and medical technical assistants (MTRA), are affected differently by these overhead functions. The most complete picture of the spectrum of treatment processes and clinical features appears as a necessary condition to obtain a realistic overall result of needed human resources in the field of radiation oncology that is needed to meet the expectation of an assured high quality level of service provision as well as medical– technological supply. The overhead functions require making a meaningful distinction between the radiotherapy department in the narrow sense and its administrative environment in the wider structure of the department. As the boundaries are fluid, the results of the study concerning occupational human resources have no absolute and unlimited validity in individual cases. While the elicitation of the resource requirement of patient care has its origin in the “process” approach, it is concluded that the need of resources by physicians and staff in the operational processes can be measured exactly from these overhead tasks. In the case of patient care, the question arises of how high the demand for physicians and staff during a physical treatment planning, a routine irradiation and a patient interview is. On the other hand, in the case of overhead, the time a doctor deals with quality management, billing questions, research and staff interview is questioned. The first set of questions can be answered tumor- or indication-specific, while only general answers are possible for the second. The distinction between “care provision” and “clinical operations” as a separate and distinct action field has, thus, a leading character in research. In both cases, the data of resource requirements are collected; however, the survey design is different. In care provision, it is a matter of “process”, but in clinical operation of functions. The total resource requirements result from the process-oriented time recording plus the task-oriented overhead survey. The two parts together provide a complete picture of the spectrum of tasks and binding of resources. Principally, in the process types of care provision a distinction between primary, secondary, and auxiliary processes is

made. Primary processes are focused on immediate medical service provision and form the focal points of the expert work, the surveys and measurements. It is a question of F processes with personal medical patient contact (first, routine, and final counseling with patient), F processes of treatment planning and irradiation, and F processes to ensure the ­individual treatment approach (presentation of patients in tumor conferences and team meetings, planning, and organization of the treatment). In the flanking secondary and auxiliary processes, it comes to documentation tasks, the manufacturing of positioning aids and the like. In this project, those processes were considered as an integral part of the primary processes. Hence, when speaking of processes, these primary processes are meant (see also the section Exemplary results of the process structure). In the functional structuring of tasks in the overhead, a distinction must be made in F functions of the “genuine overhead” (administration, etc.), F functions of the “patient-related overhead” (patient records, etc.), and F functions of the “non-genuine overhead” (research and teaching, etc.). The second group of overhead functions entail points of contact, if not an overlap with the actual patient care. As a result, data cleansing is inevitable to avoid potential double counting. Consequently, these activities have been entirely added to the patient-related overhead. Thus, the QUIRO study can be divided into two parts: F Part I: measurement of time during the processes of actual patient care (process-based time evaluation) and F Part II: capture of the task range and the time demand in overhead (taskoriented overhead survey). This article is about the time evaluation, i.e., Part I of the study.

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Abstract · Zusammenfassung Strahlenther Onkol 2014 · 190:138–148  DOI 10.1007/s00066-013-0555-3 © Springer-Verlag Berlin Heidelberg 2014 J. Dunst · N. Willich · H. Sack · R. Engenhart-Cabillic · V. Budach · W. Popp

The QUIRO Study (assurance of quality and innovation in radiooncology): methodology, instruments and practices Abstract Purpose.  The QUIRO study aimed to establish a secure level of quality and innovation in radiation oncology. Over 6 years, 27 specific surveys were conducted at 24 radiooncological departments. In all, 36 renowned experts from the field of radiation oncology (mostly head physicians and full professors) supported the realization of the study. Methods.  A salient feature of the chosen methodological approach is the “process” as a means of systematizing diversified medical–technical procedures according to standardized criteria. On the one hand, “processes” as a tool of translation are adapted for creating and transforming standards into concrete clinical and medical actions; on the other hand, they provide the basis for standardized instruments and methods to determine

the required needs of physicians, staff, and equipment. In the foreground of the collection and measurement of resource requirements were the processes of direct service provision which were subdivided into modules for reasons of clarity and comprehensibility. Overhead tasks (i.e., participation in quality management) were excluded from the main study and examined in a separate survey with appropriate methods. Results.  After the exploration of guidelines, tumor- or indication-specific examination and treatment processes were developed in expert workshops. Moreover, those ­specific modules were defined which characterize these entities and indications in a special degree. Afterwards, these modules were compiled according to their time and resources

required in the “reference institution”, i.e., in specialized and as competent recognized departments (mostly from the university area), by various suitable survey methods. Conclusion.  The significance of the QUIRO study and the validity of the results were optimized in a process of constant improvements and comprehensive checks. As a consequence, the QUIRO study yields representative results concerning the resource requirement for specialized, qualitatively and technologically highly sophisticated radiooncologic treatment in Germany Keywords Quality assurance, health care · Radiotherapy · Surveys · Health resources · Radiation oncology

Die QUIRO-Studie (Qualitäts- und Innovationssicherung in der Radioonkologie): Methodik, Instrumente und Verfahren Zusammenfassung Ziel.  Die QUIRO-Studie verfolgte das Ziel der Sicherung von Qualität und Innovation in der Radioonkologie. In einem Zeitraum von 6 Jahren wurden 27 Einzelerhebungen an 24 Kliniken durchgeführt. Dabei unterstütz­ ten 36 namhafte Fachexperten aus der Radioonkologie (mehrheitlich Chefärzte und Lehrstuhlinhaber) die Umsetzung der Studie. Methoden.  Hervorstechendes Merkmal des gewählten methodischen Ansatzes ist der „Prozess“ als Mittel der Systematisierung verschiedener medizinisch-technischer Abläufe nach einheitlichen Kriterien. „Prozesse“ sind als Umsetzungswerkzeuge einerseits geeig­ net, Normen zu schaffen und in konkretes klinisches wie ärztliches Handeln zu überführen, anderseits liefern sie die Basis, um mit standardisierten Instrumenten und Verfahren den Ressourcenbedarf an Ärzten, Personal und Technik zu ermitteln. Im Vordergrund der Erhebung und Messung des Ressourcenbe-

Combined normative–deductive and empirical–inductive approach The process as a methodological core of the approach is subjected to a dual consideration: on the one hand, it comes to expert-based development of treatment processes based on the consensus princi-

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darfs standen die Prozesse der unmittelbaren Leistungserbringung, die zur Verbesserung der Übersichtlichkeit des komplexen Versorgungsgeschehens in Module untergliedert wurden. Aufgabenstellungen des Overheads (wie z. B. Beteiligung an Klinik- oder Quali­ tätsmanagement) wurden aus der Hauptstudie ausgeklammert und im Rahmen einer separaten Erhebung mit einem hierfür spezifisch geeigneten Design untersucht. Ergebnisse.  Nach Exploration und ­Analyse von Leitlinien wurden tumor- bzw. indikationsspezifische Untersuchungs- und Behandlungsprozesse in Expertenworkshops entwickelt sowie jene spezifischen ­Module definiert, die diese Entitäten und Indikationen in besonderem Maße charakterisieren. Anschließend wurden diese Module im Hinblick auf ihren erforderlichen Zeit- und Resourcenbedarf zusammengestellt, nachdem dieser in „Referenzeinrichtungen“, d. h. in da-

ple (as normative–deductive aspect); on the other hand, it comes to time “surveying” and analysis of work processes by empirical acquisition (as empirical–inductive aspect). Findings from the empirical research should consciously relativize normative positions in the context of multilevel and cross-over clinical expert work

rauf spezialisierten und als besonders kompetent ausgewiesenen Kliniken (mehrheitlich aus dem universitären Bereich) mit verschiedenen geeigneten Erhebungsmethoden ermittelt wurde. Schlußfolgerung.  Die Aussagekraft der QUIRO-Studie sowie die Validität der Ergebnisse wurden in einem Prozess steter Verfahrensverbesserungen und ­umfassender Plausibilitätsprüfungen optimiert. In der Summe gibt die QUIRO-Studie ein repräsentatives Bild des Ressourcenbedarfs bei spezialisierter qualitativer und technologisch hochstehender radioonkologischer Versorgung in Deutschland. Schlüsselwörter Qualitätssicherung, Gesundheitswesen · Strahlentherapie · Erhebungen · Gesundheitsressourcen · Radioonkologie

to counteract the absoluteness of individual expert view and to give the consensus a more sustainable basis.

Key terms Central terms in the main part of the QUIRO study are tumor entity, indica-

tion, treatment process, module, activity and functional unit. The definitions of those terms are following: F Tumor entity: Tumors can be described with the help of localization and histological classification. It is possible to combine tumors of interest according to their similar locations or histological classification to tumor entities. An example of a tumor entity is head and neck cancer. F Indication: Basically, an indication is the use of a specific medical or radiotherapeutic action if appropriate for a particular disease. In the QUIRO project, the term indication means special forms of radiation therapy, e.g. stereotactic irradiation. F Treatment process: All in all, the treatment process is the chronological order of the patient’s medical care in a radiotherapy department. The starting point can be the patient’s introduction in the tumor board after the takeover of the medical record by the radiation oncologist. Special followup appointments can form the end of the treatment process. F Module: To improve the clarity of complex treatment processes and subprocesses and their diverse individual steps, a summary of related subprocesses and steps for single modules is made. Tumor- or indication-specific treatment processes are divided into relevant modules and displayed on this aggregation level. First irradiation with field control is an example for one module (as part of the overall context of all process-related examination and treatment activities). F Activity: In order to achieve a sufficient degree of detail and concreteness, modules are divided into activi­ ties. An example of an activity is the production of verification images (as part of the module “First irradiation with field control”). This subdivision serves to clarify content and verifies if modules are complete. Because of the partial strong overlap and thus only partially reliable observation of individual activities, no measurements were performed at this level.

F Functional unit: The specific medical and technical environments in which services on the patients by the use of medical, human, and technical resources take place are referred to as functional units. Functional units can be one or more rooms (e.g., irradiation unit with control and technical rooms as well as the actual room with “table” for the radiation application) or can be part of a room (e.g., patientrelated chemotherapy application unit as part of examination and treatment room).

After conducting the survey: F validation of the survey results of the measured tumor types or indications and F verification and possibly modification of the survey results to transfer them into derived, analogue tumors and indications.

Expert-supported development of treatment processes as normative–deductive aspect

Parallel to the design of the treatment process, the interpretation and validation of the survey results was in foreground. The instruments of the processual structure and its representation were different software tools which were experimentally implemented (e.g., ARIS, known as an industry standard in the field of process management).

Selection and compound of the expert groups

Exemplary results of the process structure

The expert groups were composed tumor- and indication-specifically. The experts themselves are or were head or chief physicians of clinical radiotherapeutic institutions (in the majority of cases in university hospitals). At the same time, these departments were the locations of the empirical surveys. In particular, it had been carefully considered that experts (1) come from different radiooncological “schools” in Germany and (2) represent hospitals which are considered as reference institution of the examined tumor or indication spectrum.

The overall process of a tumor- or indication-specific radiooncologic treatment, which was structured during the expert workshops, was organized into modules. Those modules can be characterized all in all, as F counseling modules, F routine modules, F quality modules, F planning modules, and F irradiation modules.

Procedures and instruments of expert work The flow of work in the expert groups was as follows: Before conducting the survey: F evaluation of the guidelines of interested tumor entity or indication (exploration), F tentative structuring of modularbased, tumor-, or indication-specific treatment pathways (in relation to the main therapeutic process; based on the evaluation of guidelines), and F discussion and modification of the main processes, their modules, and their content of activities during expert workshops.

For the first three groups of modules, expert estimates and the results of questionnaires (i.e., these modules were generally and not tumor-specific surveyed) were balanced against each other in order to gain an empirically-based, safe expert judgment. In contrast, the planning and irradiation modules are based on strictly empirical data (see . Fig. 1). A modular treatment path can be generated from those modules and adapted to each tumor or any indication. The treatment path in . Fig. 2 represents the modules for head and neck cancer and their affiliation to the respective module groups which is graphically highlighted (module typology I). In . Fig. 3, the modules relate to the survey types (module typology II). Planning and irradiation modules are usually of specific nature, whereas counseling modules are more of generStrahlentherapie und Onkologie 2 · 2014 

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Original article Processes subdivided into:

Modules*

*homogenous work packages with related, dovetailed activities

subdivided into:

Counselling Modules

Planning and Irradiation Modules

Quality Modules

Routine Modules

general (non-tumor specific) time recording (by questionnaire)

tumor and indication specific time recording

expert survey in workshop

Survey of medical and human resource requirements along the expert-based treatment processes as empirical–inductive aspect Selection principle “reference department” The selected cancer department must have the status of reference institution. In this connection, the availability of medical expertise and corresponding medical technique, such as sufficient number of patients per year or during the survey period, was equally assumed.

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Furthermore, the need of human resources has been recorded during additional chemotherapy, as the circumstances require. These surveys were not distinguished by specific diseases because of the low expected significance.

Instruments and procedures for surveys

Fig. 1 8 Methodological approach

al nature. Deduced modules are an exception. As an example, data for the module “First irradiation with field control (virtual planning)” was not collected. Under the assumption that field control takes 1.2 times longer in the form of virtual planning, it was deduced from the module “First irradiation with field control (conventional planning)” which was surveyed. As a result, the opportunity was created to develop clinical pathways according to the state of medical research and technology and substitute missing data in a normative way or by specific and precisely accurate time measuring.

Besides, a distinction between an irradiation with or without an additional boost was made. In addition to the tumors and indications mentioned above, the radiooncological care was recorded based on the process approach to F degenerative diseases, F palliative radiotherapy, and F irradiation of tumors in children and adolescents.

Empirically collected “primary” tumor entities and indications The following tumor entities were directly empirically measured: F rectal cancer, F head and neck cancer, F breast cancer, and F prostate cancer. Plus the following specific indications: F stereotactic radiotherapy and radiosurgery, F hyperthermia, and F particularly innovative irradiation methods, such as IMRT (intensitymodulated radiotherapy), rotation or dynamic modulation, proton, and heavy ion irradiation. Those tumors or indications—at least in the context of the present study—can also be named “primary entity” or “primary indication”. Regarding the tumor entities—where indicated—various radiation types were distinguished: F external megavoltage radiotherapy and F brachytherapy 1 LDR method and 1 HDR method.

The following survey methods were used: F for tumor or indication specific planning and treatment modules: standardized survey of departments with reference status, F for non-tumor specific, general modules with routine nature (counseling with patients, medical report): standardized questionnaire at selected departments with high patient numbers, and F for special quality modules (e.g., external case discussion in tumor board, internal patient management in team meeting): non-standardized expert interview. Therefore, only those process modules were specifically surveyed when it was expected to find differentiated resource requirements for each entity or indication (e.g., the actual specific planning and radiation modules). Thus, two filters were used in the widely ramified radiooncological treatment to minimize the survey and data acquisition efforts: F significant (primary) tumors or indications were defined for radiation oncology and F representative modules for those (primary) tumors or indications were surveyed.

Key

Assignment (poss. first contact with patient)

Quality Module Treatment planning

Physical irradiation planning

Tumor board

Approval of radiotherapy plan

Routine Module Planning Module

Verification of dose distribution

Team meeting

Irradiation Module

Counselling Module

Counselling with patient

Optional

Simulation

First irradiation with field control Tumor localization (conventional)

Tumor localization (virtual)

Counselling with patient

Protocol of medical round

Final counselling with patient

Medical report

Team meeting Follow-up appointment Routine irradiation

CT planning with contrast agent

CT planning without contrast agent

Routine irradiation with field control

Definition of radiation volumes by physician

Fig. 2 8 Modular treatment path; example of head and neck cancer (module typology I)

Key

Assignment (poss. first contact with patient)

Quality Module Treatment planning

Physical irradiation planning

Tumor board

Approval of radiotherapy plan

Team meeting

Verification of dose distribution

Routine Module

Counselling with patient

Simulation

First irradiation with field control Tumor localization (virtual)

Tumor localization (conventional)

Counselling with patient

Protocol of medical round

Final counselling with patient

Medical report

Team meeting Follow-up appointment Routine irradiation

CT planning with contrast agent

CT planning without contrast agent

Routine irradiation with field control

Definition of radiation volumes by physician

Fig. 3 8 Modular treatment path; example of head and neck cancer (module typology II)

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Original article Source of information Empiricism

Expertise

Tools

Method (steps)

Tool for process modelling (supportive usage in expert workshops)

Process and time recording tool Questionnaires (deduced from recording tool) Evaluation tool

Research of guidelines Tentative structuring of modular-based treatment paths in the context of exploration (= main processes) Modification of main processes and its modules in expert workshops Validation of survey results Verification/modification of the survey results to transfer them into analogue tumors or indications

Refining of the process and time recording tool based on the results of the expert workshops Data acquisition by documentation staff (each particular clinic) Support from helpdesk Statistical evaluation Walkthrough and review of the survey results (with medical head and project coordinators) Validation with the help of special analysis (such as cross-comparisons)

Specific modules

Tumor specific survey

Fig. 4 9 Overview of methods and instruments

General modules

Indication specific survey

Non-tumor specific questionnaire

Tumor and indicator specific measured survey data

Expert workshops

Empirically grounded expert judgment

Room occupancy time and required medical and non-medical human resources of empirically collected tumors and indications

Transfer of data using modifications (expert workshops)

Room occupancy time and required medical and non-medical human resources of derived tumors

Fig. 5 8 Data collection and structure of the QUIRO study

To systematically substitute the resulting gaps, these methods where used: F general surveys, F expert interviews, and F transfer of the result of primary to analogue/secondary tumors or indications.

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Systematically, the surveys were carried out as follows: F refining or specific adapting of the process and time recording tools based on the results of the expert workshops,

F local kick-off meeting with medical head and employees who are involved in the data acquisition of the particular department, F designation of a coordinator (as a permanent point of contact within the hospital, especially for scheduling,

monitoring the ongoing survey activities, linking patient-related time recording with patient records, etc.), F data acquisition by documentation staff (with an amount of work per institution of approximately 80 h within the survey period, an average of 12 weeks; supported by a central helpdesk), F walkthrough and review of the survey results together with the medical head and the project coordinator at the individual locations, and F validation of the survey results with the help of special analysis (including cross-comparisons). For the actual data collection and the subsequent analysis the following tools were used: F process and time recording tool (programmed by using Excel or Access), F questionnaires (deduced from the recording tool), and F process and time evaluation tool (based on Excel or Access). When the presence of the documentation staff did not disturb the doctor–patient contact and a continuous, non-fractional activity took place, electronic tools were used for documentation (mainly in the irradiation unit and the CT room). For counseling and planning activities, however, survey questionnaires, which were completed by the doctors and physicists themselves, were used. An overview of tools and methods is shown in . Fig. 4. The subjects of the evaluation are described in the following sections.

Patient or case characteristics The following patient characteristics were considered to be relevant: F patient ID, F day of admission/discharge, F age and sex of the patient, F type of treatment (outpatient/inpatient), F reason for irradiation (adjuvant irradiation, i.e. after operation; neoadjuvant radiation, i.e. before surgery; or short-term irradiation, i.e. shortened or onetime therapy),

F beginning of recording, F principal diagnosis/secondary diagnosis, F tumor classification (using the TNM staging) and location of the tumor, and F condition (specification based on the ECOG scale). Correlation and regression analyses, inter alia to detect the dependence of the resource requirements on the patient’s general condition and age, were conducted, but the results have not been published yet.

Subjects of the evaluation The observations and measurements were made during the actual operations at the module level within the defined functional units. The following functional units were defined: F external meeting room, F doctor’s office, F examination and treatment room, combined with consulting room, F planning unit with possible special planning CT or planning MRI, with potential special tumor localization, with simulator and planning workplace, and F irradiation unit with control room, technical room, and irradiation room. During an activity in a certain function unit, following subjects were measured: a) with reference to the functional unit: F room occupancy time (in minutes; period of the patient’s presence in functional unit which means that the functional unit is occupied by/for the patient; setup and changeover time are included) and F performance time (in minutes; duration of actual performance (service provision in the narrow sense) which takes place in an irradiation room as well as in the planning unit (CT, MRI or conventional simulator); also referred to as “couch time”; in other functional units without “couch”, i.e., without the immediate presence of the patient, the room occupancy time equals the performance time),

b) with regard to the categories of medical and non-medical personnel: F number of persons (in the service provision involved physicians and staff), F ratio of attendance (percentage of time involvement during the service provision, as measured by the room occupancy time; associated with the recorded time of physicians and staff in minutes), and F activities within the modules (performed by physicians and/or staff). The following categories of physicians and staff were distinguished: F physicians: 1 chief physician/medical head of department, 1 radiooncologist, and 1 assistant physician/physician in training; F staff: 1 medical physics expert (MPE), 1 technicians (medical-technical radiology assistants), and 1 nurse.

Transfer from “measured” to “analogue” tumor types/indications Analogue “secondary” tumor entities Not all tumor types and indications could be surveyed due to the enormous effort. Therefore, the goal was to project the measured tumors onto tumor entities which were not empirically recorded, but only considered at expert level. This required that the collected data had the characteristic of a tracer or indicator. The spectrum of analogue treated or transferred tumors and indications ranged from anus, endometrial, bladder, and skin to vagina, vulva, and cervix. A total of 22 tumor entities were measured by a relational process on the basis of the observed data. In the case of the QUIRO study, these tumors are also called “secondary entities”.

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Original article

Method of the derivation and data transfer

Plausibility check of the survey results

The transfer from the empirical results to the analogue treated tumors and indications was conducted in an expert workshop which consisted of the following steps: F Step 1: Analysis of relationships and analogies between “primary entity data” and the derived tumors and indications, F Step 2: Transfer of the data in the first round (with general modification of the basic parameters), F Step 3: Adjustment of data in a second round (refined modification), and F Step 4: Checking the transfer of the basic parameters (based on relational considerations).

Department-related cross-comparison of measured tumor entities

Initially, the treatment process of the analogue tumors was compared to the processes of the underlying primary entities, checked for correspondence, and adjusted if necessary to ensure the validity of the outcome. Subsequently, on the level of modules it was necessary to estimate the need of resources (physicians, non-medical staff) in patient care. This estimation was based on the “primary entity”. The validation and derivation of the resource requirement occurred on three levels: F first, on the level of tumor entities (review of analogies, identification of “reference entity” to the derived tumor), F after, on the level of the processes concerning the type, content, and arrangement of the process modules (identification of “reference process”; modification of this process, experiential specification of the frequency of each module per sequence and the number of sequence per patient), and F last, on the level within the modules with respect to the required time and number of persons or presence of physicians and staff (identification of the “reference module”, specification of the more, less or about the same effort as in primary entity).

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The same tumor entities were compared between the hospitals participating in the survey (plausibility test I for collected data of tumor entities). The point of this crosscomparison was to consider the human resource requirements within the different modules and to make an analysis of an outlier at the level of individual data (i.e., the level of one single module of an individual patient). Outliers with respect to the required time could occur for operational reasons (i.e., installation of a new or failure of an already older linear accelerator or testing of new planning software). According to the cross-comparison, however, inhomogeneities showed up that appeared justified. In one case, a highly qualified technician of a department was involved in the treatment planning by precontouring organs at risk. That was unusual at the other participating department; therefore this case appeared as an outlier. In other cases, the availability of certain technical features determined the coordination plus clinical planning and irradiation procedure. For example, the limited CT capacity of one department had to be taken into account and, as a result, the virtual simulation with conventional simulators had to be used to a greater extent. Another peculiar feature was the use of assistant physicians who had been involved at all stages of the treatment process in service provision because of training. Hence, the human resource requirement varied according to the intensity of training in the different departments, especially university departments. An increase of time requirement was not only observed for assistant physicians, but at the same time also a higher ratio of presence of a medical specialist because of the required supervision.

Module-related cross-comparison of measured and derived tumor entities The cross-comparison of the same modules compared between all tumor entities followed a different logic and happened later in the stage of validation of the results instead (plausibility test II for measured and derived tumor entities). In contrary to the plausibility test I, it was not a consideration of outliers at the level of individual records and observations, but the assessment and interpretation of relations. The questions were why the medical definition of target volumes of tumor X was associated with a significantly higher time requirement than of tumor Y and which determinants of a disease pattern cause differences in resource binding. The starting point for this type of plausibility was not a concrete, individual tumor entity considered with different department specific standards and context which could explain differences, but the spectrum of all collected data and derived tumors with the same types of modules as relevant interconnections and points of comparison.

Conclusion In the QUIRO study, the selected method of data collection and data structure was and is due to the complexity of the subject and its dynamic development. The results of different tumor entities were and will be published in this journal. To show a representative cross-section of tumor entities, indications, procedures, etc., compromises had to be deliberately and consciously sought and implemented systematically, because not everything could be measured or collected because of limited time and financial budgets. Some parts could only be ­estimated on a high quality level or derived from measurements and surveys. The body of data had to be composed modularly in a “multi-story” manner. A variety of surveys at different departments were initially synchronized, and then the results were aligned and merged. From the expert’s point of view, each tumor entity, every indication, every method had one typical

pathway as an ideal model of a diagnostic and therapeutic treatment. A number of modules, such as the “tumor board” or the “final counseling” had a general characteristic, whereas especially planning and irradiation modules had specific characteristics that had to be measured tumor-, indication-, and process-specifically. Literally, the project schedule was like a “learning organization”, which—lived deliberately—is most likely to help overcome problems of this category of complexity. The result shown in Fig. 5 retrospectively illustrates the methods and data structure.  A valuation of the results obtained leads to the following conclusions: F Assessment of representativeness, validity and reliability: A generally positive assessment can be made in particular on those modules that have been collected in large numbers at several hospitals (e.g., routine irradiation, but also first irradiation with and without field control and individual planning modules). The results were always scrutinized. The so-called “medical schools”, department-specific standards, different available planning and radiation technology, and also the different qualifications of documentation forces and the different organizational conditions at the locations of the survey can be seen as “disturbance variables”. The perfect coherence of the data set across all individual surveys (different tumor types, various planning and irradiation method, various locations, different survey methods) in a project of several years appeared as an unrealizable goal. It was important to always question the results of the empirical research to identify and interpret differences and to balance results with moderation, if necessary, after a thorough analysis of outliers and imbalances. In this case, the expertise needed to support the empiricism. F Assessment of the possibilities and limits of empiricism: The benefits of empiricism remain undoubted despite the occasional survey problems in the details. Empirical evidence made it clear that there is not the one standard of

service in radiation oncology and there never will be. However, the results also made it clear that empirical reference values are essential in order to obtain individual orientation, e.g., for planning the need of human resources. In addition, it provides the base for the subject as a whole, in order to justify funding requirements to secure the future radiooncological care supply. In summary, the significance of the QUIRO study and the validity of the results were optimized by the following measures in a process of constant procedure improvements: F priority for empiricism, wherever possible, F highest level of standardization with the help of structured instruments and procedures, F systematic identification and interpretation of differences between hospitals and of outliers of individual clinics, and F expert-based adjustment in justified individual cases as a result of the plausibility checks. The different results that the QUIRO study showed in recent years have been, are and will be subject of publications in Strahlentherapie und Onkologie. Moreover, they were the basis of the methodological guidelines of DEGRO and are an important part of the so-called “online service” of DEGRO which will be available in January 2014 [1, 2, 6, 24]. In association with DEGRO, the professional association of German radiooncologists (“Berufsverband Deutscher Strahlentherapeuten”, BVDST) that is responsible for the economic interests of the whole subject was able to refer on the data material to analyze the need of resources and establish an appropriate remuneration of radiooncological services. This ensures the sustainability of radiation oncology. In this case, representativeness, plausibility, and relevance are arguments to gain attention. The complex survey and data structure of QUIRO already lead to diverse benefits and potential were created which may be used in the future as well.

Original article Corresponding address Dr. W. Popp Burgunderstr. 14, 4051 Basel Switzerland [email protected]

Compliance with ethical guidelines Conflict of interest.  J. Dunst, N. Willich, H. Sack, R. Engenhart-Cabillic, V. Budach, and W. Popp state that there are no conflicts of interest. The accompanying manuscript does not include studies on humans or animals.

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