EORTC QLQ-C30 general population normative data for the United States.

OBJECTIVE: The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a frequently used cancer-specific health-related quality of life (HRQoL) questionnaire. To aid interpretation of data obtained via EORTC QLQ-C30, general population norm data have been published for many countries. However, despite its frequent use in the United States, no normative data by sex and age exist to date. Therefore, this study aimed to generate sex- and age-specific EORTC QLQ-C30 normative data for the United States. METHODS: Recruitment and data collection were carried out via online panels as part of a larger cross-sectional study. For the recruitment, the sample was stratified by sex and age (18-39, 40-49, 50-59, 60-69, ≥ 70 years) to achieve a balanced distribution, with n = 100 per subgroup. Descriptive statistics are presented by age and age/sex. RESULTS: A total of N = 1009 respondents completed the survey (n = 508 females, n = 501 males). More than two thirds of participants (72.5%) reported at least one health condition, e.g., arthritis (26%). Across EORTC QLQ-C30 scales, women and men 60 years and older reported generally better/higher functioning and better/lower symptom scores compared to the younger age groups. CONCLUSION: To date, no specific EORTC QLQ-C30 general population normative data have been published for the United States. This paper provides these important normative data, which will greatly support the interpretation of EORTC QLQ-C30 scale scores obtained from US cancer patients, and also enable comparison with European norms.

Effects of blended learning training for oncology physicians to advise their patients about complementary and integrative therapies: results from the multicenter cluster-randomized KOKON-KTO trial.

BACKGROUND: Many oncology physicians are confronted with the topic of complementary and integrative medicine (CIM) by cancer patients. This study examined whether a blended learning (e-learning and a workshop) to train oncology physicians in providing advice on CIM therapies to their cancer patients, in addition to distributing an information leaflet about reputable CIM websites, had different effects on physician-reported outcomes in regard to consultations compared with only distributing the leaflet. METHODS: In a multicenter, cluster-randomized trial, 48 oncology physicians were randomly allocated to an intervention group (CIM consultation and an information leaflet) or a control group (information leaflet only). After the training, the oncology physicians conducted 297 consultations with their cancer patients. Measurements were assessed at oncology physician, physician-patient-interaction (measured by external reviewers), and patient levels. This analysis focused on the physician outcomes of stress reaction and perceived consultation skill competency. In addition, qualitative interviews were conducted with a subsample of oncology physicians who experienced both, the intervention and control condition. RESULTS: The oncology physicians in the intervention group showed a lower stress reaction in all measured dimensions after CIM consultations than those in the control group. There was no significant difference between oncology physicians in the intervention and control groups regarding the perceived consultation skill competency (overburden: intervention 1.4 [95% CI: 0.7;2.1]; control 2.1 [95% CI: 1.4;2.7], tension: 1.3 [95% CI: 0.7;2.0] vs. 1.9 [95% CI: 1.3;2.5], and discomfort with consultation situations: 1.0 [95% CI: 0.4;1.7]; vs. 1.7 [95% CI: 1.2;2.3]). The qualitative data showed that only providing the leaflet seemed impersonal to oncology physicians, while the training made them feel well prepared to conduct a full conversation about CIM and provide the information leaflet. CONCLUSIONS: In our exploratory study providing structured CIM consultations showed positive effects on the perceived stress of oncology physicians, and the training was subjectively experienced as an approach that improved physician preparation for advising cancer patients about CIM, however no effects regarding perceived consultation skill competency were found. TRIAL REGISTRATION: The trial registration number of the KOKON-KTO study is DRKS00012704 in the German Clinical Trials Register (Date of registration: 28.08.2017).

Patient-reported outcomes for people with diabetes: what and how to measure? A narrative review.

Patient-reported outcomes (PROs) are valuable for shared decision making and research. Patient-reported outcome measures (PROMs) are questionnaires used to measure PROs, such as health-related quality of life (HRQL). Although core outcome sets for trials and clinical practice have been developed separately, they, as well as other initiatives, recommend different PROs and PROMs. In research and clinical practice, different PROMs are used (some generic, some disease-specific), which measure many different things. This is a threat to the validity of research and clinical findings in the field of diabetes. In this narrative review, we aim to provide recommendations for the selection of relevant PROs and psychometrically sound PROMs for people with diabetes for use in clinical practice and research. Based on a general conceptual framework of PROs, we suggest that relevant PROs to measure in people with diabetes are: disease-specific symptoms (e.g. worries about hypoglycaemia and diabetes distress), general symptoms (e.g. fatigue and depression), functional status, general health perceptions and overall quality of life. Generic PROMs such as the 36-Item Short Form Health Survey (SF-36), WHO Disability Assessment Schedule (WHODAS 2.0), or Patient-Reported Outcomes Measurement Information System (PROMIS) measures could be considered to measure commonly relevant PROs, supplemented with disease-specific PROMs where needed. However, none of the existing diabetes-specific PROM scales has been sufficiently validated, although the Diabetes Symptom Self-Care Inventory (DSSCI) for measuring diabetes-specific symptoms and the Diabetes Distress Scale (DDS) and Problem Areas in Diabetes (PAID) for measuring distress showed sufficient content validity. Standardisation and use of relevant PROs and psychometrically sound PROMs can help inform people with diabetes about the expected course of disease and treatment, for shared decision making, to monitor outcomes and to improve healthcare. We recommend further validation studies of diabetes-specific PROMs that have sufficient content validity for measuring disease-specific symptoms and consider generic item banks developed based on item response theory for measuring commonly relevant PROs.

Development, Implementation, and Evaluation of an e-Learning in Integrative Oncology for Physicians and Students Involving Experts and Learners: Experiences and Recommendations.

In this project, an e-Learning program for complementary and integrative medicine in oncology was systematically developed, implemented, and evaluated in a stepwise procedure. Learning objectives and content were defined within the KOKON project network, considering the educational competencies for integrative oncology. To design a valuable e-Learning, experts were involved in all relevant steps of the process, as well as stakeholders from various target groups (undergraduates: medicine students, postgraduates: oncology physicians). We used mixed methods including quantitative surveys, progress tests, and qualitative focus groups. The developed e-Learning program led to a significant measurable knowledge gain about complementary and integrative medicine. In parallel, physicians and students were subjectively satisfied with the training. For the majority of e-Learning elements, the needs of both target groups are comparable. Furthermore, both groups emphasized the value of formative assessment tools for gaining knowledge. From the various surveys and experiences collected in this project, we derive recommendations for others developing e-Learning programs.

Education Competencies for Integrative Oncology in Germany: Results of a Stakeholder Engagement Survey Study.

BACKGROUND: Integrative Medicine (IM) training programs in oncology lacked standardized education core competencies to ensure the practical relevance of its learning content and objectives. In a previous international and interprofessional consensus procedure, core competencies were developed for health professionals working in Integrative Oncology (IO). However, the transferability of the developed core competencies to IO physicians working in Germany has not yet been verified. The overall aim of this survey study as part of the KOKON Project (Kompetenznetzwerk Komplementärmedizin in der Onkologie; Competence Network Complementary Medicine in Oncology) was to investigate if the international core competencies developed for IO for a broader group of health professionals are suitable for physicians in Germany. MATERIAL AND METHODS: Paper-pencil and digital questionnaires were distributed amongst various stakeholder groups (cancer patients and representatives; IO physicians; members of IM organization and IM researchers; multipliers of cancer support groups). The stakeholders were asked to rate the 37 core competencies developed according to their importance for the respective stakeholder group (not important, moderately, very important). Analyses were conducted using a 60% agreement threshold for medium to highly important competencies and 50% agreement threshold for highly important competencies. RESULTS: We contacted different persons from various stakeholder groups (n > 370) with a survey response rate of 55.5-68.4% (n = 271) depending on the respective stakeholder group. Using the 50% agreement threshold, all competencies were accepted by the stakeholder groups. 27 competencies were considered very important by 60% of the survey participants. In particular, cancer patients and cancer support groups showed similar results. CONCLUSION: The list of developed international core competencies for IM health professionals seems to be suitable for physicians providing IO in Germany according to different stakeholder groups. The implementation of competencies can support the development of evidence-based, patient-centered training programs for physicians.

[Assessment of Patient-reported Outcomes in Routine Medical Care: Patient-reported Outcome Measures (PROMs) and Patient-reported Experience Measures (PREMs)]. / Empirische Erfassung patient*innenberichteter Merkmale: PROMs und PREMs.

Information from patients about their own quality of life, experiences in care, and individual assessments of treatment processes and outcomes are becoming increasingly important. Patient-reported characteristics can refer to subjective information about their own health (Patient-Reported Outcome Measures [PROMs]) or to objective information about their experience during the treatment process (Patient-Reported Experience Measures [PREMs]). This article provides an overview of the similarities and differences between PROMs and PREMs. Subsequently, ways to collect PROMs and PREMs are presented and in doing so, an insight into probabilistic testing theory (item response theory) and computer adaptive testing is given. Using national and international initiatives as examples, the implementation of PROMs and PREMs in health care systems is presented and future implementation strategies are discussed within an outlook.

App-Based Relaxation Exercises for Patients With Chronic Neck Pain: Pragmatic Randomized Trial.

BACKGROUND: Chronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear. OBJECTIVE: The aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone. METHODS: Smartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week's average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain-related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used. RESULTS: We screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI -0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app. CONCLUSIONS: The study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques. TRIAL REGISTRATION: ClinicalTrials.gov NCT02019134; https://clinicaltrials.gov/ct2/show/NCT02019134. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/1745-6215-15-490.

Education Competencies for Integrative Oncology-Results of a Systematic Review and an International and Interprofessional Consensus Procedure.

Integrative oncology is a burgeoning field and typically provided by a multiprofessional team. To ensure cancer patients receive effective, appropriate, and safe care, health professionals providing integrative cancer care should have a certain set of competencies. The aim of this project was to define core competencies for different health professions involved in integrative oncology. The project consisted of two phases. A systematic literature review on published competencies was performed, and the results informed an international and interprofessional consensus procedure. The second phase consisted of three rounds of consensus procedure and included 28 experts representing 7 different professions (medical doctors, psychologists, nurses, naturopathic doctors, traditional Chinese medicine practitioners, yoga practitioners, patient navigators) as well as patient advocates, public health experts, and members of the Society for Integrative Oncology. A total of 40 integrative medicine competencies were identified in the literature review. These were further complemented by 18 core oncology competencies. The final round of the consensus procedure yielded 37 core competencies in the following categories: knowledge (n = 11), skills (n = 17), and abilities (n = 9). There was an agreement that these competencies are relevant for all participating professions. The integrative oncology core competencies combine both fundamental oncology knowledge and integrative medicine competencies that are necessary to provide effective and safe integrative oncology care for cancer patients. They can be used as a starting point for developing profession-specific learning objectives and to establish integrative oncology education and training programs to meet the needs of cancer patients and health professionals.

Development and Implementation of Situational Judgment Tests as an Evaluation Method for Training Oncology Physicians: Application in the KOKON-KTO Training.

Situational judgment tests (SJTs) are often used in aptitude testing and present practice-specific challenges. Their implementation into online training programs provides the opportunity to assess learning progress and improve training quality. In this study, text-based SJTs for oncology physicians were developed, validated, and implemented into the KOKON-KTO training which uses a blended learning training format to teach oncology physicians how to consult cancer patients on complementary and integrative medicine (CIM). The SJT was implemented to measure the e-learning results. In the development and validation phase, a total of 15 SJTs (each SJT including 1 best choice answer based on training content and 4 distractors; 9 SJTs for oncologists and 6 SJTs for oncology gynecologists only) were developed by an interprofessional team (n=5) using real-case vignettes and applying an in-depth review process. Best answers were validated by experts (oncologists and oncology gynecologists) with experience in advising cancer patients on CIM. In the implementation and evaluation phase, SJTs were answered by KOKON-KTO training participants (n=19) pre- and post e-learning. Results were analyzed using descriptive measurements, item difficulties, and Cohen's d for effect size pre- and post-training. The experts (n=12, 49.8% gynecologists) agreed with best choice answers (69.4% for oncology gynecology; 81.5% for oncology) in 12 out of 15 SJTs. Comparing pre- and post-training scores, KOKON-KTO training participants were able to improve knowledge substantially (effect sizes for oncologists d=1.7; oncology gynecologists d= .71). Future studies need to increase the number of experts and SJTs in order to apply further psychometric measurements. As part of the KOKON-KTO study, this project is registered as DRKS00012704 on the "German Clinical Trials Register" (Date of registration: 28.08.2017).

Effects of training oncology physicians advising patients on complementary and integrative therapies on patient-reported outcomes: A multicenter, cluster-randomized trial.

BACKGROUND: Many patients with cancer do not disclose complementary medicine use but want their physician's advice on this matter. This study evaluated whether using blended learning (e-learning plus a workshop) to train oncology physicians in providing advice on complementary and integrative medicine (CIM) therapies to their patients with cancer, in addition to distributing an information leaflet on reputable CIM websites, had different effects on patient-reported outcomes for the consultation than only distributing the leaflet. METHODS: In this multicenter, cluster-randomized trial, patients from private practices/hospital departments, recruited by 48 oncology physicians randomly allocated to an intervention group (CIM consultation plus information leaflet) or a control group (information leaflet), received CIM information. Patient-reported outcomes included satisfaction (Patient Satisfaction With Information on Cancer Treatment), readiness to make a decision (Preparation for Decision Making), and physician-patient communication (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire and Communication 26 [EORTC QLQ-COMU26]) for the consultation. Qualitative interviews were conducted with a physician subsample. RESULTS: A total of 291 patients (128 in the intervention group and 169 in the control group) advised by 41 physicians participated. Patients in the intervention group rated physician-patient communication higher on all EORTC QLQ-COMU26 scales (mean total score, 84.3 [95% CI, 79.5-89.2] vs 73.6 [95% CI, 69.3-78.0]; P = .002), were more satisfied with the advice (mean, 4.2 [95% CI, 4.0-4.4] vs 3.7 [95% CI, 3.5-3.8]; P < .001), and were readier to make a decision (mean, 63.5 [95% CI, 57.4-69.6] vs 53.2 [95% CI, 47.8-58.7]; P = .016) than the control group. Physicians who reported patients in both settings seemed satisfied with the advice given. CONCLUSIONS: This study evaluated a novel education intervention for training oncology physicians in providing CIM advice in routine care. Providing structured CIM consultations had positive effects on patient satisfaction, readiness to make decisions, and physician-patient communication.

Five Lessons Learned From Randomized Controlled Trials on Mobile Health Interventions: Consensus Procedure on Practical Recommendations for Sustainable Research.

BACKGROUND: Clinical research on mobile health (mHealth) interventions is too slow in comparison to the rapid speed of technological advances, thereby impeding sustainable research and evidence-based implementation of mHealth interventions. OBJECTIVE: We aimed to establish practical lessons from the experience of our working group, which might accelerate the development of future mHealth interventions and their evaluation by randomized controlled trials (RCTs). METHODS: This paper is based on group and expert discussions, and focuses on the researchers' perspectives after four RCTs on mHealth interventions for chronic pain. RESULTS: The following five lessons are presented, which are based on practical application, increase of speed, and sustainability: (1) explore stakeholder opinions, (2) develop the mHealth app and trial simultaneously, (3) minimize complexity, (4) manage necessary resources, and (5) apply behavior change techniques. CONCLUSIONS: The five lessons developed may lead toward an agile research environment. Agility might be the key factor in the development and research process of a potentially sustainable and evidence-based mHealth intervention.

Defining Criteria for Guiding Cancer Patients to Find a Reputable Complementary Medicine Provider: Results of a Literature Review and a Consensus Procedure.

PURPOSE: Even in cases of positive evidence for complementary medicine (CM) therapies, it is still difficult for cancer patients to identify reputable providers. The aim of this study was to develop and evaluate a criteria list to provide guidance to cancer patients seeking a reputable CM provider. METHODS: The design combined a literature review, an expert consensus procedure (n=15) and an assessment from three stakeholder perspectives (patients (n=18), CM providers (n=26) and oncology physicians (n=20)). RESULTS: A total of 30 existing CM criteria were extracted from the literature, and 12 more were added by the experts. The main challenge was to define criteria that could easily be applied by the patients. A final comprehensive list of 8 criteria guiding cancer patients to find a reputable CM provider was developed. CONCLUSION: Health professionals and cancer information services might find the criteria list helpful when aiming to strengthen patients' awareness of quality-related factors associated with CM providers. The criteria developed might be helpful when standards are established for quality assurance in CM in oncology.

Training oncology physicians to advise their patients on complementary and integrative medicine: An implementation study for a manual-guided consultation.

BACKGROUND: The unmonitored use of complementary medicine in patients with cancer can be associated with an increased risk of safety-related issues, such as lower adherence to conventional cancer therapies. Training oncology physicians to advise their patients about the effectiveness and safety of these therapies could improve this situation. METHODS: The objective of this study was to develop and pretest a consultation framework that has high potential to be widely implemented. The framework comprises: 1) a systematically developed and tested, manualized, guided consultation; and 2) blended learning training (e-learning and communication skills training workshop) to upskill oncology physicians in advising their patients on complementary and integrative medicine (CIM). For this implementation study, mixed methods were used to develop the manual (literature review, consensus procedure, pilot testing) and the training (questionnaires and interviews with oncology physicians and patients with cancer and an examination of the skills in a setting with standardized patients). RESULTS: The training was tested with 47 oncology physicians from across Germany. The manual-guided consultation (context: general information on the setting and communication techniques; inform: consultation duration and content; capture: previous CIM use; prioritize: focus on consultation; advise: evidence-based CIM recommendations; discuss, advise, accept, or advise against other CIM; concretize advice: summary and implementation; and monitor: documentation) was considered suitable. The structure and time frame (maximum, 20 minutes) of the consultation as well as the training were feasible and well accepted. CONCLUSIONS: The current study demonstrates that the KOKON-KTO framework (a German acronym for Competence Network for Complementary Medicine - Consultation Training for Oncology Physicians) is suitable for training oncology physicians. Its implementation can lead to better physician-patient communication about CIM in cancer.

International ResearchKit App for Women with Menstrual Pain: Development, Access, and Engagement.

BACKGROUND: Primary dysmenorrhea is a common condition in women of reproductive age. A previous app-based study undertaken by our group demonstrated that a smartphone app supporting self-acupressure introduced by a health care professional can reduce menstrual pain. OBJECTIVE: This study aims to evaluate whether a specific smartphone app is effective in reducing menstrual pain in 18- to 34-year-old women with primary dysmenorrhea in a self-care setting. One group of women has access to the full-featured study app and will be compared with 2 control groups who have access to fewer app features. Here, we report the trial design, app development, user access, and engagement. METHODS: On the basis of the practical implications of the previous app-based study, we revised and reengineered the study app and included the ResearchKit (Apple Inc) framework. Behavior change techniques (BCTs) were implemented in the app and validated by expert ratings. User access was estimated by assessing recruitment progress over time. User evolution and baseline survey respondent rate were assessed to evaluate user engagement. RESULTS: The development of the study app for a 3-armed randomized controlled trial required a multidisciplinary team. The app is accessible for the target population free of charge via the Apple App Store. In Germany, within 9 months, the app was downloaded 1458 times and 328 study participants were recruited using it without external advertising. A total of 98.27% (5157/5248) of the app-based baseline questions were answered. The correct classification of BCTs used in the app required psychological expertise. CONCLUSIONS: Conducting an innovative app study requires multidisciplinary effort. Easy access and engagement with such an app can be achieved by recruitment via the App Store. Future research is needed to investigate the determinants of user engagement, optimal BCT application, and potential clinical and self-care scenarios for app use. TRIAL REGISTRATION: ClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ).

Evaluation of a blended-learning training concept to train oncology physicians to advise their patients about complementary and integrative medicine (KOKON-KTO): study protocol for a prospective, multi-center, cluster-randomized trial.

BACKGROUND: Many cancer patients are interested in complementary and integrative medicine during and after regular cancer treatment. Given the high number of users it is important that physicians and patients engage in a dialog about useful complementary and integrative medicine therapies during cancer treatment. In a prospective, multi-center, cluster-randomized evaluation study we will develop, implement and evaluate a training program for oncology physicians advising their patients on complementary and integrative medicine. The main objective of the study is to evaluate whether training physicians in a blended-learning approach (e-learning + skills-training workshop) in providing advice to their cancer patients on complementary and integrative medicine, in addition to handing out an information leaflet about reputable websites, has different effects on the outcomes of patients, physicians, and their interaction level, compared to only giving out the information leaflet. METHODS/DESIGN: Forty-eight oncology physicians will be included into a cluster-randomized trial to either participate or not in the blended-learning training. Physicians will then advise 10 cancer patients each, resulting in 480 patients participating in the trial. The blended learning consists of nine units of up to 45 min of e-learning and 18 units of up to 45 min of on-site skills-training workshop focusing. Outcomes will be measured on the physician, patient, and physician-patient-interaction level. DISCUSSION: A blended-learning program for oncology physicians to advise their cancer patients in a systematic way and a reasonable time frame on complementary and integrative medicine will be evaluated in depth in a large cluster-randomized trial. TRIAL REGISTRATION: German Clinical Trials Register, ID: DRKS00012704 . Registered on 28 August 2017.