Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial.

BACKGROUND: Knowledge about the efficacy of behavioural intervention technologies that can be used by cancer survivors independently from a health-care provider is scarce. We aimed to assess the efficacy, reach, and usage of Oncokompas, a web-based eHealth application that supports survivors in self-management by monitoring health-related quality of life (HRQOL) and cancer-generic and tumour-specific symptoms and obtaining tailored feedback with a personalised overview of supportive care options. METHODS: In this non-blinded, randomised, controlled trial, we recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma. Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient Reported Outcomes Following Initial Treatment and Long term Evaluation of Survivorship (PROFILES) registry. Participants were randomly assigned (1:1) by an independent researcher to the intervention group (access to Oncokompas) or control group (access to Oncokompas after 6 months), by use of block randomisation (block length of 68), stratified by tumour type. The primary outcome was patient activation (knowledge, skills, and confidence for self-management), assessed at baseline, post-intervention, and 3-month and 6-month follow-up. Linear mixed models (intention-to-treat) were used to assess group differences over time from baseline to 6-month follow-up. The trial is registered in the Netherlands Trial Register, NTR5774 and is completed. FINDINGS: Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility were recruited and randomly assigned to the intervention (320) or control group (305). Median follow-up was 6 months (IQR 6-6). Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7 [95% CI -0·8-4·1], p=0·41). INTERPRETATION: Oncokompas did not improve the amount of knowledge, skills, and confidence for self-management in cancer survivors. This study contributes to the evidence for the development of tailored strategies for development and implementation of behavioural intervention technologies among cancer survivors. FUNDING: Dutch Cancer Society (KWF Kankerbestrijding).

Measuring health-related quality of life in colorectal cancer patients: systematic review of measurement properties of the EORTC QLQ-CR29.

INTRODUCTION: The EORTC QLQ-CR29 is a patient-reported outcome measure to evaluate health-related quality of life among colorectal cancer patients in research and clinical practice. The aim of this systematic review was to investigate whether the initial positive results regarding the measurement properties of the QLQ-CR29 are confirmed in subsequent studies. METHODS: A systematic search of Embase, Medline, PsycINFO, and Web of Science was conducted to identify studies investigating the measurement properties of the QLQ-CR29 published up to January 2019. For the 11 included studies, data were extracted, methodological quality was assessed, results were synthesized, and evidence was graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on the measurement properties: structural validity, internal consistency, reliability, measurement error, construct validity (hypothesis testing, including known-group comparison, convergent and divergent validity), cross-cultural validity, and responsiveness. RESULTS: Internal consistency was rated as "sufficient," with low evidence. Reliability was rated as "insufficient," with moderate evidence. Construct validity (hypothesis testing; known-group comparison, convergent and divergent validity) was rated as "inconsistent," with moderate evidence. Structural validity, measurement error, and responsiveness were rated as "indeterminate" and could therefore not be graded. CONCLUSION: This review indicates that current evidence supporting the measurement properties of the QLQ-CR29 is limited. Additionally, better quality research is needed, taking into account the COSMIN methodology.

Translation of the eHealth Impact Questionnaire for a Population of Dutch Electronic Health Users: Validation Study.

BACKGROUND: The eHealth Impact Questionnaire (eHIQ) provides a standardized method to measure attitudes of electronic health (eHealth) users toward eHealth. It has previously been validated in a population of eHealth users in the United Kingdom and consists of 2 parts and 5 subscales. Part 1 measures attitudes toward eHealth in general and consists of the subscales attitudes towards online health information (5 items) and attitudes towards sharing health experiences online (6 items). Part 2 measures the attitude toward a particular eHealth application and consists of the subscales confidence and identification (9 items), information and presentation (8 items), and understand and motivation (9 items). OBJECTIVE: This study aimed to translate and validate the eHIQ in a Dutch population of eHealth users. METHODS: The eHIQ was translated and validated in accordance with the COnsensus-based Standards for the selection of health status Measurement INstruments criteria. The validation comprised 3 study samples, with a total of 1287 participants. Structural validity was assessed using confirmatory factor analyses and exploratory factor analyses (EFAs; all 3 samples). Internal consistency was assessed using hierarchical omega (all 3 samples). Test-retest reliability was assessed after 2 weeks, using 2-way intraclass correlation coefficients (sample 1). Measurement error was assessed by calculating the smallest detectable change (sample 1). Convergent and divergent validity were assessed using correlations with the remaining measures (all 3 samples). A graded response model was fit, and item information curves were plotted to describe the information provided by items across item trait levels (all 3 samples). RESULTS: The original factor structure showed a bad fit in all 3 study samples. EFAs showed a good fit for a modified factor structure in the first study sample. This factor structure was subsequently tested in samples 2 and 3 and showed acceptable to good fits. Internal consistency, test-retest reliability, convergent validity, and divergent validity were acceptable to good for both the original as the modified factor structure, except for test-retest reliability of one of the original subscales and the 2 derivative subscales in the modified factor structure. The graded response model showed that some items underperformed in both the original and modified factor structure. CONCLUSIONS: The Dutch version of the eHIQ (eHIQ-NL) shows a different factor structure compared with the original English version. Part 1 of the eHIQ-NL consists of 3 subscales: attitudes towards online health information (5 items), comfort with sharing health experiences online (3 items), and usefulness of sharing health experiences online (3 items). Part 2 of the eHIQ-NL consists of 3 subscales: motivation and confidence to act (10 items), information and presentation (13 items), and identification (3 items).

Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial.

BACKGROUND: Cancer survivors have to deal with a wide range of physical symptoms, psychological, social and existential concerns, and lifestyle issues related to cancer and its treatment. Therefore, it is essential that they have access to optimal supportive care services. The eHealth self-management application Oncokompas was developed to support cancer survivors with where they need to turn to for advice and guidance, as well as to increase their knowledge on the availability of optimal support. A randomised controlled trial will be conducted to assess the efficacy, cost-utility and reach of Oncokompas as an eHealth self-management application compared with care as usual among cancer survivors. METHODS/DESIGN: Adult cancer survivors diagnosed with breast, colorectal or head and neck cancer or lymphoma who are at 3 months to 5 years since curative treatment will be included. In total, 544 cancer survivors will be randomly assigned to the intervention group or a wait-list control group. The primary outcome measure is patient activation. Secondary outcome measures include self-efficacy, personal control, perceived patient-physician interaction, need for supportive care, mental adjustment to cancer and health-related quality of life. Furthermore, cost-utility outcomes will be assessed. Reach is defined as the percentage of cancer survivors who get access to Oncokompas within the context of this trial. Questionnaires will be administered at baseline, post-intervention and at 3- and 6-month follow-up. DISCUSSION: In this study, we will evaluate the efficacy and cost-utility of Oncokompas among cancer survivors, as well as the reach of Oncokompas. These are essential first steps in the translation of research into practice and contribute to sustainable adoption, implementation and maintenance of an evidence-based Oncokompas. TRIAL REGISTRATION: Netherlands Trial Register identifier: NTR5774 . Registered on 8 March 2016.

Hospital variation in allogeneic transfusion and extended length of stay in primary elective hip and knee arthroplasty: a cross-sectional study.

OBJECTIVES: Outcomes in total hip and knee arthroplasty (THA and TKA), such as allogeneic transfusions or extended length of stay (LoS), can be used to compare the performance of hospitals. However, there is much variation in these outcomes. This study aims to rank hospitals and to assess hospital differences of two outcomes in THA and TKA: allogeneic transfusions and extended LoS, and to additionally identify factors associated with these differences. DESIGN: Cross-sectional medical record review study. SETTING: Data were gathered in 23 Dutch hospitals. PARTICIPANTS: 1163 THA and 986 TKA patient admissions. OUTCOMES: Hospitals were ranked based on their observed/expected (O/E) ratios regarding allogeneic transfusion and extended LoS percentages (extended LoS was defined by postoperative stay >4 days). To assess the reliability of these rankings, we calculated which percentage of the existing variation was based on differences between hospitals as compared with random variation (after adjustment for variation in patient characteristics). Associations between hospital-specific factors and O/E ratios were used to explore potential sources of differences. RESULTS: The variation in O/E ratios between hospitals ranged from 0 to 4.4 for allogeneic transfusion, and from 0.08 to 2.7 for extended LoS. Variation in transfusion could in 21% be explained by hospital differences in THA and 34% in TKA. For extended LoS this was 71% in THA and 78% in TKA. Better performance (low O/E ratios) in transfusion was associated with more frequent tranexamic acid (TXA) use in TKA (R=-0.43, p=0.04). Better performance in extended LoS was associated with more frequent TXA use in THA (R=-0.45, p=0.03) and TKA (R=-0.65, p<0.001) and local infiltration analgesia (LIA) in TKA (R=-0.60, p=0.002). CONCLUSIONS: Ranking hospitals based on allogeneic transfusion is unreliable due to small percentages of variation explained by hospital differences. Ranking based on extended LoS is more reliable. Hospitals using TXA and LIA have relatively fewer patients with transfusions and extended LoS.

The effectiveness of a de-implementation strategy to reduce low-value blood management techniques in primary hip and knee arthroplasty: a pragmatic cluster-randomized controlled trial.

BACKGROUND: Perioperative autologous blood salvage and preoperative erythropoietin are not (cost) effective to reduce allogeneic transfusion in primary hip and knee arthroplasty, but are still used. This study aimed to evaluate the effectiveness of a theoretically informed multifaceted strategy to de-implement these low-value blood management techniques. METHODS: Twenty-one Dutch hospitals participated in this pragmatic cluster-randomized trial. At baseline, data were gathered for 924 patients from 10 intervention and 1040 patients from 11 control hospitals undergoing hip or knee arthroplasty. The intervention included a multifaceted de-implementation strategy which consisted of interactive education, feedback on blood management performance, and a comparison with benchmark hospitals, aimed at orthopedic surgeons and anesthesiologists. After the intervention, data were gathered for 997 patients from the intervention and 1096 patients from the control hospitals. The randomization outcome was revealed after the baseline measurement. Primary outcomes were use of blood salvage and erythropoietin. Secondary outcomes included postoperative hemoglobin, length of stay, allogeneic transfusions, and use of local infiltration analgesia (LIA) and tranexamic acid (TXA). RESULTS: The use of blood salvage (OR 0.08, 95% CI 0.02 to 0.30) and erythropoietin (OR 0.30, 95% CI 0.09 to 0.97) reduced significantly over time, but did not differ between intervention and control hospitals (blood salvage OR 1.74 95% CI 0.27 to 11.39, erythropoietin OR 1.33, 95% CI 0.26 to 6.84). Postoperative hemoglobin levels were significantly higher (ß 0.21, 95% CI 0.08 to 0.34) and length of stay shorter (ß -0.36, 95% CI -0.64 to -0.09) in hospitals receiving the multifaceted strategy, compared with control hospitals and after adjustment for baseline. Transfusions did not differ between the intervention and control hospitals (OR 1.06, 95% CI 0.63 to 1.78). Both LIA (OR 0.0, 95% CI 0.0 to 0.0) and TXA (OR 0.3, 95% CI 0.2 to 0.5) were significantly associated with the reduction in blood salvage over time. CONCLUSIONS: Blood salvage and erythropoietin use reduced over time, but not differently between intervention and control hospitals. The reduction in blood salvage was associated with increased use of local infiltration analgesia and tranexamic acid, suggesting that de-implementation is assisted by the substitution of techniques. The reduction in blood salvage and erythropoietin did not lead to a deterioration in patient-related secondary outcomes. TRIAL REGISTRATION: www.trialregister.nl, NTR4044.

Use of implicit persuasion in decision making about adjuvant cancer treatment: A potential barrier to shared decision making.

BACKGROUND: Shared decision making (SDM) is widely advocated, especially for preference-sensitive decisions like those on adjuvant treatment for early-stage cancer. Here, decision making involves a subjective trade-off between benefits and side-effects, and therefore, patients' informed preferences should be taken into account. If clinicians consciously or unconsciously steer patients towards the option they think is in their patients' best interest (i.e. implicit persuasion), they may be unwittingly subverting their own efforts to implement SDM. We assessed the frequency of use of implicit persuasion during consultations and whether the use of implicit persuasion was associated with expected treatment benefit and/or decision making. METHODS: Observational study design in which consecutive consultations about adjuvant systemic therapy with stage I-II breast cancer patients treated at oncology outpatient clinics of general teaching hospitals and university medical centres were audiotaped, transcribed and coded by two researchers independently. RESULTS: In total, 105 patients (median age = 59; range: 35-87 years) were included. A median of five (range: 2-10) implicitly persuasive behaviours were employed per consultation. The number of behaviours used did not differ by disease stage (P = 0.07), but did differ by treatment option presented (P = 0.002) and nodal status (P = 0.01). About 50% of patients with stage I or node-negative disease were steered towards undergoing chemotherapy, whereas 96% of patients were steered towards undergoing endocrine therapy, irrespective of expected treatment benefit. Decisions were less often postponed if more implicit persuasion was used (P = 0.03). INTERPRETATION: Oncologists frequently use implicit persuasion, steering patients towards the treatment option that they think is in their patients' best interest. Expected treatment benefit does not always seem to be the driving force behind implicit persuasion. Awareness of one's use of these steering behaviours during decision making is a first step to help overcome the performance gap between advocating and implementing SDM.

Systematic screening for undernutrition in hospitals: predictive factors for success.

BACKGROUND & AIMS: Since 2007, systematic screening for undernutrition has become a performance indicator (PI) for hospitals within the National Benchmarks on Quality of Care of the Dutch Health Care Inspectorate (HCI). Its introduction was guided by a national implementation program. The aim of this study was to evaluate the screening results from 2007 to 2010 and to identify predictive factors for achieved screening results. METHODS: All 97 Dutch hospitals were obliged to report screening results to the HCI. An additional questionnaire was developed to determine hospital characteristics, including hospital type, size, participation in implementation program, screening tool used, use of electronic records, presence of hospital-wide or ward task forces, and protocol-defined referral. Multivariate linear regression analysis was used to identify predictive factors for the obtained screening results in 2010. RESULTS: The mean screening percentage increased from 51 ± 28% in 2007 (n = 75 hospitals, n = 340,000 patients) to 72 ± 17% in 2010 (n = 97; n = 1,050,000) (p < 0.01). Eighty-one hospitals returned the questionnaire. A higher screening percentage was associated with more clinical admissions (highest vs. lowest tertile: ß = 14.0, 95% CI 3.9-20.5; p < 0.01; middle vs. lowest: ß = 7.3, -0.8 to 15.6; p = 0.05), presence of protocol-defined referral to a dietician (ß = 10.5, 2.9-18.0; p < 0.01), and use of the SNAQ screening tool (vs. MUST: ß = 9.1, 1.7-16.6; p = 0.02). CONCLUSION: Screening percentages have increased significantly since the introduction of the PI. Screening was more frequent in hospitals which have more patient admissions, protocol-defined referral to a dietician, and who use the SNAQ screening tool. This information may assist in improving Dutch screening rates and in implementation in other countries.

De-implementation of expensive blood saving measures in hip and knee arthroplasties: study protocol for the LISBOA-II cluster randomized trial.

BACKGROUND: Despite evidence that erythropoietin and intra- and postoperative blood salvage are expensive techniques considered to be non-cost-effective in primary elective total hip and knee arthroplasties in the Netherlands, Dutch medical professionals use them frequently to prevent the need for allogeneic transfusion. To actually change physicians' practice, a tailored strategy aimed at barriers that hinder physicians in abandoning the use of erythropoietin and perioperative blood salvage was systematically developed. The study aims to examine the effectiveness, feasibility and costs of this tailored de-implementation strategy compared to a control strategy. METHODS/DESIGN: A cluster randomized controlled trial including an effect, process and economic evaluation will be conducted in a minimum of 20 Dutch hospitals. Randomisation takes place at hospital level. The hospitals in the intervention group will receive a tailored de-implementation strategy that consists of four components: interactive education, feedback in educational outreach visits, electronically sent reports on hospital performance (all aimed at orthopedic surgeons and anesthesiologists), and information letters or emails aimed at other involved professionals within the intervention hospital (transfusion committee, OR-personnel, pharmacists). The hospitals in the control group will receive a control strategy (i.e., passive dissemination of available evidence). Outcomes will be measured at patient level, using retrospective medical record review. This will be done in all hospitals at baseline and after completion of the intervention period. The primary outcome of the effect evaluation is the percentage of patients undergoing primary elective total hip or knee arthroplasty in which erythropoietin or perioperative blood salvage is applied. The actual exposure to the tailored strategy and users' experiences will be assessed in the process evaluation. In the economic evaluation, the costs of the tailored strategy and the control strategy in relation to the difference in their effectiveness will be compared. DISCUSSION: This study will show whether a systematically developed tailored strategy is more effective for de-implementation of non-cost-effective blood saving measures than the control strategy. This knowledge can be used in national and international initiatives to make healthcare more efficient. It also provides more generalized knowledge regarding de-implementation strategies. TRIAL REGISTRATION: This trial is registered at the Dutch Trial Register NTR4044.