A patient decision aid for breast cancer patients deciding on their radiation treatment, no change in decisional conflict but better informed choices.

BACKGROUND AND PURPOSE: In selected breast cancer patients, radiation treatment (RT) lowers the recurrence risk, with minor or no improvement of survival. In these patients, the choice to undergo RT is considered a preference-sensitive decision. To facilitate shared decision-making (SDM) for this choice, a patient decision aid was made. We aimed to evaluate the effect of the PtDA on decisional conflict. MATERIAL AND METHODS: We performed a multi-center pre- and post-intervention study (BRASA-trial). The first 214 patients made a choice without support of the PtDA; the subsequent 189 patients received a link to the PtDA. The primary endpoint was decisional conflict; secondary endpoints were perceived SDM and knowledge on treatment options. Patients filled out questionnaires immediately after, and three months after their decision. Data were analyzed with multi-level regression analysis. RESULTS: After correcting for the difference in age and educational level, the mean (±SD) decisional conflict for the intervention group (27.3 ± 11.4) was similar to the control group (26.8 ± 11.4; difference = 0.86, 95 %CI 1.67,3.36) three months after their decision. This also applied to perceived SDM. Patients exposed to the PtDA pursued additional treatment less often (45% vs 56%, odds ratio 0.59, 95 %CI 0.37,0.95) and scored significantly higher on the knowledge test (7.4 ± 2.5 vs 6.1 ± 2.7, corrected difference = 1.0, 95 %CI 0.50,1.49). There was no significant increase in consultation time. CONCLUSIONS: Handing out the PtDA was not associated with improved scores in decisional conflict or perceived SDM, but it was associated with a choice for less additional treatment and better knowledge about the treatment options.

Implementing a patient decision aid, a process evaluation of a large-scale pre- and post-implementation trial.

PURPOSE: Patient decision aids (PtDAs) have been reported to have a positive influence on patients making a health care decision in trials. Nevertheless, post-trial implementation is poor. The aim of this study is to explore patient, clinician, and organizational success factors for implementing a PtDA designed for breast cancer patients, facing a decision on their radiation treatment. METHODS: We performed a process evaluation within a multi-center pre- and post-implementation trial. The PtDA was incorporated as much as possible in the logistics of 13 participating centers. Tracking data were collected on PtDA use. Process characteristics were recorded by both clinicians and patients. A logistic regression method was applied to investigate which process characteristics were significantly related to the probability that patients logged in to the PtDA. RESULTS: 189 patients received the PtDA of whom140 (77%) used the PtDA. If patients received the link via the surgery department they were more likely to use the PtDA (OR 9.77 (1.28-74.51)), compared to patients that received the link via the radiation oncology department. If the report of the multidisciplinary team stated that radiation treatment "had to be discussed with the patient", patients were more likely to use the PtDA (OR 2.29 (1.12-4.71)). Educational level was not related to the probability of PtDA use. CONCLUSIONS: We accomplished a high level of PtDA use. Patients were more likely to use the PtDA if they received the link via the surgery department and if "to be discussed with the patient" was written in the multidisciplinary team report.

Elicitation of preferences in the second half of the shared decision making process needs attention; a qualitative study.

BACKGROUND: It is known that the use of a Patient Decision Aid (PtDA), combined with advice for professionals on how and when to use it, can enhance the involvement of patients in the treatment decision. However, we need more knowledge with respect to the intention-behaviour gap. This study aims to analyse patients' experiences with the Shared Decision Making (SDM) process to find clues to close this gap. METHODS: This qualitative study was part of a pilot study aiming to implement SDM in early adopter breast cancer teams. Patients were given access to a personalised PtDA. Breast cancer teams were instructed on how and when to deliver the PtDA. We interviewed 20 patients about their experience with the PtDA and SDM in general. RESULTS: Most patients experienced SDM, though to a certain extent. Choice talk and option talk were commonly experienced, however the elicitation of preferences and decision talk was rare. The PtDA was used by the majority of patients (N = 13), all indicating that it was useful, especially to recall all the information given. Patients appreciated the contribution of breast cancer nurses in the SDM process. They considered them as true case managers, easy to approach and supportive. CONCLUSION: Although patients felt well-informed and satisfied about risk-communication, the elicitation of preferences appeared very limited to non-existent. We recommend that breast cancer teams divide tasks in the SDM process and reallocate the elicitation of preferences to the nurses in a well-defined clinical pathway.

Risk communication in a patient decision aid for radiotherapy in breast cancer: How to deal with uncertainty?

BACKGROUND AND AIM: Patient decision aids for oncological treatment options, provide information on the effect on recurrence rates and/or survival benefit, and on side-effects and/or burden of different treatment options. However, often uncertainty exists around the probability estimates for recurrence/survival and side-effects which is too relevant to be ignored. Evidence is lacking on the best way to communicate these uncertainties. The aim of this study is to develop a method to incorporate uncertainties in a patient decision aid for breast cancer patients to support their decision on radiotherapy. METHODS: Firstly, qualitative interviews were held with patients and health care professionals. Secondly, in the development phase, thinking aloud sessions were organized with four patients and 12 health care professionals, individual and group-wise. RESULTS: Consensus was reached on a pictograph illustrating the whole range of uncertainty for local recurrence risks, in combination with textual explanation that a more exact personalized risk would be given by their own physician. The pictograph consisted of 100 female icons in a 10 x 10 array. Icons with a stepwise gradient color indicated the uncertainty margin. The prevalence and severity of possible side-effects were explained using verbal labels. CONCLUSIONS: We developed a novel way of visualizing uncertainties in recurrence rates in a patient decision aid. The effect of this way of communicating risk uncertainty is currently being tested in the BRASA study (NCT03375801).

What do patients and health care professionals view as important attributes in radiotherapy decisions? Input for a breast cancer patient decision aid.

BACKGROUND AND AIM: There is increased attention for shared decision making (SDM) when deciding on radiotherapy for selected patients with Stage 0-2 breast cancer. This study aimed to explore patients' and health care professionals' experiences, decisional attributes and needs as input for the development of a patient decision aid to facilitate SDM. METHODS: Qualitative semi-structured interviews were held with fifteen breast cancer patients, being confronted with a radiotherapy decision one month to eight years earlier. Another fifteen interviews were held with professionals specialized in breast cancer care. Interviews were transcribed verbatim and independently coded by two researchers, who agreed upon relevant issues. RESULTS: Most patients made their decision by weighing the advantages of radiotherapy, i.e. comparing the decrease in recurrence risk with and without radiotherapy, and disadvantages, i.e. possible side effects. Patients and professionals agreed that recurrence risks should be communicated, but not on how to deal with uncertainty. There was wide variation in which, and how, side effects were explained by professionals. The most common side effects mentioned by both patients and professionals were skin toxicity, fatigue and breast deformity. CONCLUSION: Patients and professionals appeared to agree on what type of attributes should be communicated during SDM on radiotherapy, but how this should be done is up for discussion. To ensure the patient's voice these attributes and needs need to be incorporated in the risk communication and value elicitation part of the patient decision aid. The format in which the attributes are communicated should be critically evaluated.

Does lack of deeper understanding of shared decision making explains the suboptimal performance on crucial parts of it? An example from breast cancer care.

PURPOSE: Although most of the clinicians in breast cancer care seem to approve of shared decision making (SDM), actual implementation is limited. The aim of this study was to explore the experiences, issues and concerns of early-adopter professionals with regards to shared decision making. METHODS: This qualitative descriptive study was part of a pilot study aimed at implementing SDM in breast cancer teams. We interviewed 27 clinicians; 9 breast cancer surgeons, 11 nurse practitioners and 7 nurses. The teams were exposed to a multifaceted implementation programme, among others: a patient decision aid (PtDA), a procedure to disseminate the PtDA and advice on redesigning the clinical pathway. RESULTS: Participants considered SDM, including the delivery of the PtDA, to be a team effort, in which every professional should take responsibility. Most clinicians primarily focused on the first steps of SDM ignoring preference and decision talk. The remaining steps, like the uptake of the PtDA in the clinical pathway, were regarded as challenging, with surgeons, intentionally or unconsciously, delegating this responsibility to nurses. One barrier to successfully implementing SDM seems to lie in the fact that clinicians were unaware of their lack of competency regarding SDM. CONCLUSIONS: A deeper understanding is needed among clinicians of what SDM actually is and how a PtDA contributes to this process. Nurses play an important role in the delivery of the PtDA, but their role is not clearly defined. Teams should consider a clear realignment of tasks between surgeons and nurses, which implies redesign of the pathway.

Interprofessional Pulmocheck care pathway: An innovative approach to managing pediatric asthma care in the Netherlands.

OBJECTIVES: Under-diagnosis and suboptimal asthma control in children persists. An innovative care pathway was developed by a hospital department of pediatrics with the aim to detect pulmonary problems in children and provide appropriate treatment possibilities through systematic feedback towards the referring primary care physician. Primary care physicians can use this pathway to refer children with asthma-like symptoms for a one-day assessment. Goals are to measure the usage of the pathway by primary care general practitioners (GPs), the outcomes in terms of new diagnoses of asthma, the reduction in regular referrals, generated recommendations/therapy and the adequacy of asthma follow-up. METHODS: We collected all feedback letters sent to the GP concerning children who underwent the Pulmocheck in 2010, 2011 and 2012. Furthermore, all GPs, who had referred a child to the Pulmocheck in this period and that subsequently was diagnosed with asthma and was further managed in primary care, were sent a follow-up questionnaire in 2014. RESULTS: There were 121 referrals from 51 GPs in 3 years to this pathway. In 59.5% of these referrals a new diagnosis of asthma was established. In 90.9% one or more changes in clinical management were advised. The response rate to the follow-up questionnaires was 65.7% of which 4.8% of the children with new established asthma were reviewed four times or more in the follow-up period, 17.4% two times, 65.2% once, and in 8.7% were not followed. CONCLUSIONS: The specialty pediatric asthma care pathway revealed a high number of children with newly diagnosed asthma, but was also helpful to exclude this diagnosis. However, the referral rate of GPs to this pathway was low, but in the children, that were referred several changes in the clinical management were advised and the frequency of monitoring of the children with diagnosed asthma was not in accordance with the asthma guidelines.

Developing a patient decision aid for the treatment of women with early stage breast cancer: the struggle between simplicity and complexity.

BACKGROUND: A patient decision aid (PtDA) can support shared decision making (SDM) in preference-sensitive care, with more than one clinically applicable treatment option. The development of a PtDA is a complex process, involving several steps, such as designing, developing and testing the draft with all the stakeholders, known as alpha testing. This is followed by testing in 'real life' situations, known as beta testing, and then finalising the definite version. Our aim was developing and alpha testing a PtDA for primary treatment of early stage breast cancer, ensuring that the tool is considered relevant, valid and feasible by patients and professionals. METHODS: Our qualitative descriptive study applied various methods including face-to-face think-aloud interviews, a focus group and semi-structured telephone interviews. The study population consisted of breast cancer patients facing the choice between breast-conserving therapy with or without preceding neo-adjuvant chemotherapy and mastectomy, and professionals involved in breast cancer care in dedicated multidisciplinary breast cancer teams. RESULTS: A PtDA was developed in four iterative test rounds, taking nearly 2 years, involving 26 patients and 26 professionals. While the research group initially opted for simplicity for the sake of implementation, the clinicians objected that the complexity of the decision could not be ignored. Other topics of concern were the conflicting views of professionals and patients regarding side effects, the amount of information and how to present it. CONCLUSION: The development was an extensive process, because the professionals rejected the simplifications proposed by the research group. This resulted in the development of a completely new draft PtDA, which took double the expected time and resources. The final version of the PtDA appeared to be well-appreciated by professionals and patients, although its acceptability will only be proven in actual practice (beta testing). TRIAL REGISTRATION: NTR TC 5721 .

Effect of audit and feedback with peer review on general practitioners' prescribing and test ordering performance: a cluster-randomized controlled trial.

BACKGROUND: Much research worldwide is focussed on cost containment and better adherence to guidelines in healthcare. The research focussing on professional behaviour is often performed in a well-controlled research setting. In this study a large-scale implementation of a peer review strategy was tested on both test ordering and prescribing behaviour in primary care in the normal quality improvement setting. METHODS: We planned a cluster-RCT in existing local quality improvement collaboratives (LQICs) in primary care. The study ran from January 2008 to January 2011. LQICs were randomly assigned to one of two trial arms, with each arm receiving the same intervention of audit and feedback combined with peer review. Both arms were offered five different clinical topics and acted as blind controls for the other arm. The differences in test ordering rates and prescribing rates between both arms were analysed in an intention-to-treat pre-post analysis and a per-protocol analysis. RESULTS: Twenty-one LQIC groups, including 197 GPs working in 88 practices, entered the trial. The intention-to-treat analysis did not show a difference in the changes in test ordering or prescribing performance between intervention and control groups. The per-protocol analysis showed positive results for half of the clinical topics. The increase in total tests ordered was 3% in the intervention arm and 15% in the control arm. For prescribing the increase in prescriptions was 20% in the intervention arm and 66% in the control group. It was observed that the groups with the highest baseline test ordering and prescription volumes showed the largest improvements. CONCLUSIONS: Our study shows that the results from earlier work could not be confirmed by our attempt to implement the strategy in the field. We did not see a decrease in the volumes of tests ordered or of the drugs prescribed but were able to show a lesser increase instead. Implementing the peer review with audit and feedback proved to be not feasible in primary care in the Netherlands. TRIAL REGISTRATION: This trial was registered at the Dutch trial register under number ISRCTN40008171 on August 7th 2007.

The development of a personalized patient education tool for decision making for postmenopausal women with osteoporosis.

UNLABELLED: A personalized patient education tool for decision making (PET) for postmenopausal women with osteoporosis was developed by means of a systematic development approach. A prototype was constructed and refined by involving various professionals and patients. Professionals and patients expressed a positive attitude towards the use of the PET. INTRODUCTION: The purpose was to systematically develop a paper-based personalized PET to assist postmenopausal women with osteoporosis in selecting a treatment in line with their personal values and preferences. METHODS: The development of the PET was based on a systematic process including scope, design, development of a prototype, and alpha testing among professionals and patients by semi-structured interviews. RESULTS: The design and development resulted in a four-page PET prototype together with a one-page fact sheet of the different drug options. The prototype PET provided the personal risk factors, the estimated individualized risk for a future major osteoporotic fracture and potential reduction with drugs, and a summary of advantages and disadvantages whether or not to start drugs. The drug fact sheet presents five attributes of seven drugs in a tabular format. The alpha testing with professionals resulted in some adaptations, e.g., inclusion of the possibility to calculate fracture risk based on various individual risk scoring methods. Important results from the alpha testing with patients were differences in the fracture risk percentage which was seen as worthwhile to start drugs, the importance of an overview of side effects, and of the timing of the PET into the patient pathway. All women indicated that the PET could be helpful for their decision to select a treatment. CONCLUSION: Physicians and patients expressed a positive attitude towards the use of the proposed PET. Further research would be needed to test the effects of the PET on feasibility in clinical workflow and on patient outcomes.

Effects of a web-based decision aid regarding diagnostic self-testing. A single-blind randomized controlled trial.

UNLABELLED: Currently, there are many diagnostic self-tests on body materials available to consumers. The aim of this study was to assess the effect of an online decision aid on diagnostic self-testing for cholesterol and diabetes on knowledge among consumers with an intention to take these tests. A randomized controlled trial was designed. A total of 1259 consumers with an intention to use a diagnostic cholesterol or diabetes self-test were selected from an existing Dutch Internet panel. The intervention group was invited to view an online decision aid offering general information on self-testing and test-specific information on cholesterol and diabetes self-testing, including indications for testing, how to perform the test and interpreting the result. The placebo condition consisted of a limited information sheet. Multiple regression analysis showed that the knowledge level in the diabetes arm was higher in the intervention group than in the control group (B = 0.657; 95% CI, 0.011-1.303), as was the number of participants with an informed choice (OR, 1.672; 95% CI, 1.134-2.465). No differences were found in the cholesterol arm. Consumers who are considering doing a self-test should have access to independent information on self-testing and be encouraged to read this information. TRIAL REGISTRATION: Dutch Trial Register: NTR 3149.

Process evaluation of physical activity counselling with and without the use of mobile technology: A mixed methods study.

BACKGROUND: A monitoring-and-feedback tool was developed to stimulate physical activity by giving feedback on physical activity performance to patients and practice nurses. The tool consists of an activity monitor (accelerometer), wirelessly connected to a Smartphone and a web application. Use of this tool is combined with a behaviour change counselling protocol (the Self-management Support Programme) based on the Five A's model (Assess-Advise-Agree-Assist-Arrange). OBJECTIVES: To examine the reach, implementation and satisfaction with the counselling protocol and the tool. DESIGN: A process evaluation was conducted in two intervention groups of a three-armed cluster randomised controlled trial, in which the counselling protocol was evaluated with (group 1, n=65) and without (group 2, n=66) the use of the tool using a mixed methods design. SETTINGS: Sixteen family practices in the South of the Netherlands. PARTICIPANTS: Practice nurses (n=20) and their associated physically inactive patients (n=131), diagnosed with Chronic Obstructive Pulmonary Disease or Type 2 Diabetes, aged between 40 and 70 years old, and having access to a computer with an Internet connection. METHODS: Semi structured interviews about the receipt of the intervention were conducted with the nurses and log files were kept regarding the consultations. After the intervention, questionnaires were presented to patients and nurses regarding compliance to and satisfaction with the interventions. Functioning and use of the tool were also evaluated by system and helpdesk logging. RESULTS: Eighty-six percent of patients (group 1: n=57 and group 2: n=56) and 90% of nurses (group 1: n=10 and group 2: n=9) responded to the questionnaires. The execution of the Self-management Support Programme was adequate; in 83% (group 1: n=52, group 2: n=57) of the patients, the number and planning of the consultations were carried out as intended. Eighty-eight percent (n=50) of the patients in group 1 used the tool until the end of the intervention period. Technical problems occurred in 58% (n=33). Participants from group 1 were significantly more positive: patients: χ(2)(2, N=113)=11.17, p=0.004, and nurses: χ(2)(2, N=19)=6.37, p=0.040. Use of the tool led to greater awareness of the importance of physical activity, more discipline in carrying it out and more enjoyment. CONCLUSIONS: The interventions were adequately executed and received as planned. Patients from both groups appreciated the focus on physical activity and personal attention given by the nurse. The most appreciated aspect of the combined intervention was the tool, although technical problems frequently occurred. Patients with the tool estimated more improvement of physical activity than patients without the tool.

Sustainability of an enhanced recovery after surgery program (ERAS) in colonic surgery.

BACKGROUND: Between 2006 and 2008 the enhanced recovery after surgery (ERAS) program was implemented in colonic surgery in one-third of all hospitals in the Netherlands (n = 33). This resulted in enhanced recovery and a decrease in hospital length of stay (LOS) from a median of 9 days at baseline to 6 days at one-year follow-up. The present study assessed the sustainability of the ERAS program 3-5 years after its implementation. MATERIALS AND METHODS: From the 33 ERAS hospitals, 10 initially successful hospitals were selected, with success defined as a median LOS of 6 days or lower and protocol adherence rates above 70 %. In 2012 a retrospective audit of 30 consecutive patients was performed in each of these hospitals. Sustainability of the ERAS program was assessed on hospital level, using median hospital LOS, protocol adherence rates and time to functional recovery. Data were compared with the implementation phase data. RESULTS: Overall median LOS in the selected hospitals increased from 5.25 days (interquartile range [IQR] 4.75-6.00; min, 4.00-max, 6.00) to 6 days (IQR 5.00-7.00; min, 5.00-max, 8.00), but this change was not significant (p = 0.052). Time to functional recovery was equal in both phases: median 3.00 days (p = 0.26). Protocol adherence decreased from 75 to 67 % (p = 0.32). Especially adherence to postoperative care elements dropped considerably. CONCLUSIONS: Despite a slight decrease in protocol adherence, the ERAS program was sustained reasonably well in the 10 selected hospitals, although there was quite some variation between the hospitals.

How do gut feelings feature in tutorial dialogues on diagnostic reasoning in GP traineeship?

Diagnostic reasoning is considered to be based on the interaction between analytical and non-analytical cognitive processes. Gut feelings, a specific form of non-analytical reasoning, play a substantial role in diagnostic reasoning by general practitioners (GPs) and may activate analytical reasoning. In GP traineeships in the Netherlands, trainees mostly see patients alone but regularly consult with their supervisors to discuss patients and problems, receive feedback, and improve their competencies. In the present study, we examined the discussions of supervisors and their trainees about diagnostic reasoning in these so-called tutorial dialogues and how gut feelings feature in these discussions. 17 tutorial dialogues focussing on diagnostic reasoning were video-recorded and transcribed and the protocols were analysed using a detailed bottom-up and iterative content analysis and coding procedure. The dialogues were segmented into quotes. Each quote received a content code and a participant code. The number of words per code was used as a unit of analysis to quantitatively compare the contributions to the dialogues made by supervisors and trainees, and the attention given to different topics. The dialogues were usually analytical reflections on a trainee's diagnostic reasoning. A hypothetico-deductive strategy was often used, by listing differential diagnoses and discussing what information guided the reasoning process and might confirm or exclude provisional hypotheses. Gut feelings were discussed in seven dialogues. They were used as a tool in diagnostic reasoning, inducing analytical reflection, sometimes on the entire diagnostic reasoning process. The emphasis in these tutorial dialogues was on analytical components of diagnostic reasoning. Discussing gut feelings in tutorial dialogues seems to be a good educational method to familiarize trainees with non-analytical reasoning. Supervisors need specialised knowledge about these aspects of diagnostic reasoning and how to deal with them in medical education.

Technology combined with a counseling protocol to stimulate physical activity of chronically ill patients in primary care.

An iterative user-centered design method was used to develop and test mobile technology (the It's LiFe! tool/monitor) embedded in primary care, followed by a three months feasibility study with 20 patients and three nurses. The tool consists of an accelerometer that transfers data to an app on a Smartphone, which is subsequently connected to a server. Physical activity levels are measured in minutes per day compared to pre-set activity goals, which are set by patients in dialogue with nurses. Nurses can monitor patients' physical activity via a secured website. The counseling protocol is based on the Five A's model and consists of a limited number of behavior change consultations intertwined with interaction with and responses from the tool. The technology supports nurses when performing physical activity counseling. Provided that no connectivity problems occur, the It's LiFe! intervention is feasible, and its longitudinal effects will be tested in a cluster RCT.

Sustainability of short stay after breast cancer surgery in early adopter hospitals.

Between 2005 and 2007 a short stay programme for breast cancer surgery was successfully implemented in early adopter hospitals. The current study evaluates the sustainability of this success five years following implementation. A retrospective audit of 160 consecutive patients undergoing breast cancer surgery was performed five years following implementation of short stay. The total proportion of patients treated in short stay was 82% (hospital 1 83%, hospital 2 78%, hospital 3 87%, hospital 4 80%) after five years follow-up, which was comparable to the proportion in short stay directly after implementation (p = 0.938). Overall compliance to the key recommendations to facilitate short stay after breast cancer surgery increased from 65% directly after implementation to 78% five years after implementation. This study shows that short stay after breast cancer surgery was successfully sustained in early adopter hospitals five years following implementation.

[Securing the financing of care for the frail elderly: problems and solutions]. / Borging van de financiering van zorg voor kwetsbare ouderen in het Nationaal Programma Ouderenzorg: knelpunten en oplossingsrichtingen.

Projects within the Dutch National Program for Elderly Care (NPO) have been experimenting since 2008 to increase coherence in care for the frail elderly. Invest-NPO explored the problems and solutions to secure the financing of these innovative projects. Problems were expected with coordination because there was not yet a structural reimbursement for such an activity for the frail elderly. There where doubts about the adequacy of reimbursement for multidisciplinary consultation and certain structural conditions. The existing fragmentation across multiple domains and reimbursement rules made it difficult to achieve an integrated approach and creativeness in care. The principles of bundled payment can be helpful in problems concerning multidisciplinary consultation, structural conditions and coordination because joint agreements are needed. According to many, capitation is even a better solution if properly applied, because there are fewer boundaries in deciding how care is organized. Initiatives from entrepreneurs may represent first steps in the right direction. The findings of Invest-NPO may contribute to the development of further steps.