Background: The majority of patients diagnosed with early-stage breast cancer are in a position to choose between having a mastectomy or lumpectomy with radiation therapy (breast-conserving therapy). Since the long-term survival rates for mastectomy and for lumpectomy with radiation therapy are comparable, patients’ informed preferences are important for decision-making. Although most clinicians believe that they do include patients in the decision-making process, the information that women with breast cancer receive regarding the surgical options is often rather subjective, and does not invite patients to express their preferences. Shared decision-making (SDM) is meant to help patients clarify their preferences, resulting in greater satisfaction with their final choice. Patient decision aids can be very supportive in SDM. We present the protocol of a study to β test a patient decision aid and optimise strategies for the implementation of SDM regarding the treatment of early-stage breast cancer in the actual clinical setting. Methods/design: This paper concerns a preimplementation and post-implementation study, lasting from October 2014 to June 2015. The intervention consists of implementing SDM using a patient decision aid. The intervention will be evaluated using qualitative and quantitative measures, acquired prior to, during and after the implementation of SDM. Outcome measures are knowledge about treatment, perceived SDM and decisional conflict. We will also conduct face-to-face interviews with a sample of these patients and their care providers, to assess their experiences with the implementation of SDM and the patient decision aid.
DOCUMENT
Breast cancer is the most prevalent form of cancer that affects women worldwide, posing a significant burden on public health. While advancements in early detection and improved treatments have led to a remarkable 90% five-year survival rate and an 83% ten-year survival rate, this has also resulted in more prophylactic mastectomies being performed. Despite advancements in breast-conserving techniques, immunotherapy, and hormone therapy, many women still undergo mastectomies as part of their cancer treatment. In all cases, this results in scarring, and additional side effects from treatment modalities may arise. The loss of a breast can profoundly impact health-related quality of life (HRQoL). Although HRQoL has improved greatly during the recent years, systematic and local therapy having side effects is not uncommon, and this needs more attention.
DOCUMENT
Purpose: This research aimed to explore factors associated with patient-reported breast and abdominal scar quality after deep inferior epigastric perforator (DIEP) flap breast reconstruction (BR). Material and Methods: This study was designed as a descriptive cross-sectional survey in which women after DIEP flap BR were invited to complete an online survey on breast and abdominal scarring. The online survey was distributed in the Netherlands in several ways in order to reach a diverse population of women. Outcomes were assessed with the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS). Additional items were assessed with a numeric rating scale (NRS). Results: A total of 248 women completed the survey. There was a statistically significant worse POSAS scar appraisal for the abdominal scar compared with the breast scar. The vast majority of women reported high scores on at least one scar characteristic of their breast scar or ab- dominal scar. Overall, color, stiffness, thickness, and irregularity scored higher than pain and itching. Women were only moderately positive about the size, noticeability, location, and the information provided regarding scarring. Conclusion: It is crucial to address the inevitability of scars in patient education before a DIEP flap BR, with a particular focus on the abdominal scar, as women experience abdominal scars significantly worse than their breast scars. Providing more information on the experience of other women and the expected appearance will contribute to having realistic expectations while allowing them to make well-informed decisions.
DOCUMENT
BACKGROUND: The face is a frequent site of burn, but prevalence rates vary and reports are often limited to one healthcare setting. We examined the incidence of facial burns in the Netherlands in Emergency Departments (ED), hospitals and burn centres. Additionally, we identified which patient, injury and burn-related characteristics were predictors of facial burns, facial surgery and facial reconstruction in burn centres.METHODS: A retrospective, observational study was conducted including data from the Dutch Injury Surveillance System, the National Hospital Discharge Register and burn centres in a 5-year period (2003-2007).RESULTS: Facial burn incidences per 100,000 were 15.1 for ED visits, 1.3 for hospital admissions and 1.4 for burn centre admissions. A total of 2691 patients were admitted to Dutch burn centres; 47.5% (n=1277) had facial burns of which 20.5% received primary facial surgery and 5.3% received facial reconstruction in follow-up. Predictors of facial burns and facial surgery were identified. Predictors of facial reconstructive surgery were burns to the neck (ventral), fire/flame burns and number of facial surgeries in the acute phase of the burn.CONCLUSIONS: One in five patients with facial burns admitted to a Dutch burn centre received primary facial surgery and 1 in 20 received facial reconstructive surgery within a follow-up of minimum 2 years.
DOCUMENT
For deep partial-thickness burns no consensus on the optimal treatment has been reached due to conflicting study outcomes with low quality evidence. Treatment options in high- and middle-income countries include conservative treatment with delayed excision and grafting if needed; and early excision and grafting. The majority of timing of surgery studies focus on survival rather than on quality of life. This study protocol describes a study that aims to compare long-term scar quality, clinical outcomes, and patient-reported outcomes between the treatment options. A multicentre prospective study will be conducted in the three Dutch burn centres (Rotterdam, Beverwijk, and Groningen). All adult patients with acute deep-partial thickness burns, based on healing potential with Laser Doppler Imaging, are eligible for inclusion. During a nine-month baseline period, standard practice will be monitored. This includes conservative treatment with dressings and topical agents, and excision and grafting of residual defects if needed 14–21 days post-burn. The subsequent nine months, early surgery is advocated, involving excision and grafting in the first week to ten days post-burn. The primary outcome compared between the two groups is long-term scar quality assessed by the Patient and Observer Scar Assessment Scale 3.0 twelve months after discharge. Secondary outcomes include clinical outcomes and patient-reported outcomes like quality of life and return to work. The aim of the study is to assess long-term scar quality in deep partial-thickness burns after conservative treatment with delayed excision and grafting if needed, compared to early excision and grafting. Adding to the ongoing debate on the optimal treatment of these burns. The broad range of studied outcomes will be used for the development of a decision aid for deep partial-thickness burns, to fully inform patients at the point of consent to surgery and support optimal person-centred care.
DOCUMENT
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)
DOCUMENT
Background: The use of patient-reported outcomes to improve burn care increases. Little is known on burn patients’ views on what outcomes are most important, and about preferences regarding online Patient Reported Outcome Measures (PROMs). Therefore, this study assessed what outcomes matter most to patients, and gained insights into patient preferences towards the use of online PROMs. Methods: Adult patients (≥18 years old), 3–36 months after injury completed a survey measuring importance of outcomes, separately for three time periods: during admission, short-term (< 6 months) and long-term (6–24 months) after burn injury. Both open and closed-ended questions were used. Furthermore, preferences regarding the use of patient-reported outcome measures in burn care were queried. Results: A total of 140 patients were included (response rate: 27%). ‘Not having pain’ and ‘good wound healing’ were identified as very important outcomes. Also, ‘physical functioning at pre-injury level’, ‘being independent’ and ‘taking care of yourself’ were considered very important outcomes. The top-ten of most important outcomes largely overlapped in all three time periods. Most patients (84%) had no problems with online questionnaires, and many (67%) indicated that it should take up to 15 minutes. Patients’ opinions differed widely on the preferred frequency of follow-up. Conclusions: Not having pain and good wound healing were considered very important during the whole recovery of burns; in addition, physical functioning at pre-injury level, being independent, and taking care of yourself were deemed very important in the short and long-term. These outcomes are recommended to be used in burn care and research, although careful selection of outcomes remains crucial as patients prefer online questionnaires up to 15 minutes.
DOCUMENT
In case of a major cyber incident, organizations usually rely on external providers of Cyber Incident Response (CIR) services. CIR consultants operate in a dynamic and constantly changing environment in which they must actively engage in information management and problem solving while adapting to complex circumstances. In this challenging environment CIR consultants need to make critical decisions about what to advise clients that are impacted by a major cyber incident. Despite its relevance, CIR decision making is an understudied topic. The objective of this preliminary investigation is therefore to understand what decision-making strategies experienced CIR consultants use during challenging incidents and to offer suggestions for training and decision-aiding. A general understanding of operational decision making under pressure, uncertainty, and high stakes was established by reviewing the body of knowledge known as Naturalistic Decision Making (NDM). The general conclusion of NDM research is that experts usually make adequate decisions based on (fast) recognition of the situation and applying the most obvious (default) response pattern that has worked in similar situations in the past. In exceptional situations, however, this way of recognition-primed decision-making results in suboptimal decisions as experts are likely to miss conflicting cues once the situation is quickly recognized under pressure. Understanding the default response pattern and the rare occasions in which this response pattern could be ineffective is therefore key for improving and aiding cyber incident response decision making. Therefore, we interviewed six experienced CIR consultants and used the critical decision method (CDM) to learn how they made decisions under challenging conditions. The main conclusion is that the default response pattern for CIR consultants during cyber breaches is to reduce uncertainty as much as possible by gathering and investigating data and thus delay decision making about eradication until the investigation is completed. According to the respondents, this strategy usually works well and provides the most assurance that the threat actor can be completely removed from the network. However, the majority of respondents could recall at least one case in which this strategy (in hindsight) resulted in unnecessary theft of data or damage. Interestingly, this finding is strikingly different from other operational decision-making domains such as the military, police and fire service in which there is a general tendency to act rapidly instead of searching for more information. The main advice is that training and decision aiding of (novice) cyber incident responders should be aimed at the following: (a) make cyber incident responders aware of how recognition-primed decision making works; (b) discuss the default response strategy that typically works well in several scenarios; (c) explain the exception and how the exception can be recognized; (d) provide alternative response strategies that work better in exceptional situations.
DOCUMENT
BACKGROUND: Burn survivors are frequently faced with disfiguring scars. Various techniques exist to improve scar appearance, such as laser treatment and dermabrasion. Next to that, surgical reconstruction, such as scar excision is an option. This randomized controlled trial investigates whether a larger burn scar can be excised using a skin-stretching device for wound closure, thereby optimizing use of adjacent healthy skin. This technique may allow scar excision in a one-step procedure instead of two or more steps, which is necessary for serial excision and tissue expansion.METHODS: Two arms were compared: scar excision and closure by skin stretch and scar excision without additional techniques. The primary outcome measure was scar surface area reduction. In addition, complications were registered.RESULTS: Fifteen patients were randomized for skin stretch and 15 patients were randomized for scar excision only. In the skin stretch group, 10 of 15 scars were completely excised compared with three of 15 in the scar excision-only group (p = 0.025). In the skin stretch group, a significantly larger reduction in scar area was achieved: 95 ± 11 percent of the scar was excised versus 78 ± 17 percent in the scar excision-only group (p = 0.003). One patient in the skin stretch group and three patients in the scar excision-only group experienced partial wound dehiscence (p = 0.598).CONCLUSIONS: In burn scar reconstructions, a significantly larger reduction in scar area can be achieved using a skin-stretching device compared with scar excision with no additional techniques, without an increased risk of complications. It was shown that skin stretching is of added value for scars that cannot be excised in a one-step procedure.
DOCUMENT
Study goal: This study was carried out to answer the following research question: which motivation do healthy volunteers have to participate in phase I clinical trials? - Methods: A literature search was done through Google Scholar and Academic Search Premier, followed by three interviews with volunteers who had recently concluded their participation in a (non-commercial) phase I trial. - Results: Our literature search revealed mainly commercial motives for volunteers to participate in phase I clinical trials. The interviews (with volunteers in a non-commercial trial) showed that other factors may also play a decisive role, such as: (1) wish to support the investigator (2) wish to contribute to science, (3) access to more/better health care (4) sociability: possibility to relax and to communicate with other participants (5) general curiosity. Precondition is that risks and burden are deemed acceptable. - Conclusions: financial remuneration appears to be the predominant motive to participate voluntarily in a clinical trial. Other reasons were also mentioned however, such as general curiosity, the drive to contribute to science and the willingness to help the investigator. In addition, social reasons were given such as possibility to relax and to meet other people. Potential subjects state that they adequately assess the (safety) risks of participating in a trial as part of their decision process.
DOCUMENT
