Current level of shared decision-making in hepatobiliary surgical oncology (SAPACHA).

BACKGROUND: Shared decision-making (SDM) may improve patient autonomy and health outcomes. This study assessed the level of SDM at both ends of the spectrum of hepatobiliary surgery to identify needs and opportunities for improvement. METHODS: A mixed-methods study was performed. Consultations regarding surgery for perihilar cholangiocarcinoma (pCCA) or hepatocellular adenoma (HCA) were prospectively included between September 2020 and December 2022. The level of patient involvement in treatment decision-making was assessed objectively by analysis of audio-recorded consultations using the OPTION-5 instrument. The perceived level of SDM was appreciated by patients (SDM-Q-9) and surgeons (SDM-Q-doc) through questionnaires. Higher scores indicated higher levels of SDM. Outcomes were compared between patient groups and two focus groups were held. RESULTS: Ten pCCA- and nine HCA-patients were included in the quantitative part of the study. Median OPTION-5, SDM-Q-9 and SDM-Q-doc scores were 35% (IQR: 25-45%), 86% (IQR: 76-96%), and 73% (IQR: 71-78%), respectively. SDM-Q-9 scores among HCA-patients (79% [IQR: 71-82%]) were significantly lower than in pCCA-patients (96% [IQR: 93-100%], p < 0.001). In focus groups, patients reported a lack of information, support, and expressed positive attitudes towards decision support tools (DSTs). CONCLUSION: Patient involvement and information provision among HPB-surgical patients show room for improvement, particularly for HCA-patients. DSTs may be helpful for this purpose.

Healthcare professionals' views on shared decision-making in plastic surgery in the Netherlands.

BACKGROUND: In shared decision-making (SDM), patients and healthcare professionals (HCPs) reach a joint clinical decision based on the best available evidence and the patient's preferences. SDM seems particularly valuable in plastic surgery, as often multiple treatment options are available. This cross-sectional online survey study aimed to assess HCPs' views and knowledge about SDM, identify facilitators and barriers of SDM, and determine specific requirements for SDM within plastic surgery. METHODS: Participants were HCPs working in plastic surgery in the Netherlands. Participant characteristics, SDM knowledge, perceived facilitators and barriers, and requirements were assessed using a custom-made online survey. Two researchers thematically analyzed qualitative data. RESULTS: We received 124 responses (with a response rate of 23%). Most respondents were attending plastic surgeons (79%), and 60% had more than 10 years of experience. Almost all respondents considered SDM important (91%), and most (78%) indicated that they applied SDM during consultations. However, only 15% of the HCPs showed a comprehensive understanding of the principle of SDM. Sufficient time, available sources of information (on treatment options and SDM), and decision support tools were identified as important requirements for SDM. CONCLUSIONS: Despite the positive attitudes toward SDM, there is a clear need for SDM training of HCPs, uniform sources of information and guidelines, and improved awareness and availability of decision support tools. National plastic surgery societies can play a crucial role in improving SDM-related knowledge, the availability of information and decision support tools, and the implementation of SDM in the field of plastic surgery.

Patient-Reported Outcomes of Medical Tattooing for Capillary Malformations.

BACKGROUND: Patients with capillary malformations (CMs) may undergo medical tattooing (MT) as an alternative to laser therapy. But little is known about treatment results and impact from the patients' perspective. OBJECTIVES: In this cross-sectional digital survey study, we evaluated the patient-reported outcomes of MT for CMs. METHODS: MT practices were identified via the Dutch Association of Skin Therapists and Google. These practices invited all their CM patients who had undergone MT between January 2011 and September 2021 to participate. Baseline and treatment characteristics, tattooing effectiveness, patient satisfaction with treatment outcomes, and complications were evaluated using a custom-made online survey. Quality of life was assessed with the Dermatology Life Quality Index (DLQI) questionnaire. Factors associated with treatment effectiveness and patient satisfaction were identified via bivariate analysis and ordinal logistic regression analysis. RESULTS: Most of the 89 respondents were female (69%). Almost all CMs were located on the face (90%) and mainly (dark) red (74%). Nearly all patients had undergone laser therapy (91%). Median number of tattooing sessions was 5 (IQR: 4.0-8.0). Thirty-seven percent of the patients perceived >75% color reduction. Younger patients were more likely to obtain lower treatment effectiveness (OR 0.44, 95% CI: 0.20-0.97). Most patients (83%) were satisfied with treatment results. Patients with lighter (OR 0.30, 95% CI: 0.13-0.72), non-facial (OR 0.15, 95% CI: 0.03-0.89), and hypertrophic CMs (OR 0.30, 95% CI: 0.11-0.82) were less likely to be satisfied with treatment outcomes. Patients with lighter skin types were more satisfied (OR 2.89, 95% CI: 1.23-6.80). Complications included transient pain (23%), bleeding (3.4%), hypertrophic scarring (1.1%), hypopigmentation (1.1%), and a halo around the tattoo (1.1%). CONCLUSION: MT seems a valid alternative treatment in addition to laser therapy for CMs, with mild complications. Most patients are (very) satisfied with treatment results, while color reduction is incomplete. Hence, it seems appropriate to decide together with patients whether or not to use MT as primary treatment or secondary to laser therapy.

Evidence-Based Medicine Course in Combination With Journal Clubs to Promote Evidence-Based Surgery.

Introduction To provide high-quality surgical care, surgeons must critically appraise medical literature to adapt their clinical practice whenever convincing evidence emerges. This will promote evidence-based surgery (EBS). Over the last decade, we have organized monthly journal clubs (JCs) and more extensive quarterly EBS courses for surgical residents and PhD students, supervised by surgical staff. We evaluated the participation, satisfaction, and knowledge gained by this EBS program, to make the program future-proof and aid other educators. Materials and methods An anonymous digital survey was distributed via email among residents, PhD students, and surgeons of the Amsterdam University Medical Centers' (UMC) surgical department in April 2022. The survey included general questions on EBS education, specific course-oriented questions for the residents and PhD students, and questions about supervision for surgeons. Results The survey was completed by 47 respondents from the surgery department of the Amsterdam UMC University Hospital, of whom 63.8% (n=30) were residents or PhD students and 36.2% (n=17) were surgeons. During one year of the combined EBS course and JCs, the EBS course was attended by 40.0% (n=12) of PhD students and was rated with a mean score of 7.6/10. JCs were attended by 86.6% (n=26) of residents or PhD students and received a mean score of 7.4/10. Reported strengths of the JCs were their easy accessibility and the acquisition of critical appraisal skills and scientific knowledge. A reported point of improvement was to focus more deeply on specific epidemiological topics per meeting. Of the surgeons, 64.7% (n=11) had supervised at least one JC and gave a mean score of 8.5/10. The main reasons to supervise JCs were the distribution of knowledge (45.5%), scientific discussion (36.3%), and contact with PhD students (18.1%). Conclusion Our EBS educational program, including JCs and EBS courses, was well appreciated by residents, PhD students, and staff. This format is advocated for other centers aiming to better implement EBS in surgical practice.

What helps the successful implementation of digital decision aids supporting shared decision-making in cardiovascular diseases? A systematic review.

Aims: Although digital decision aids (DAs) have been developed to improve shared decision-making (SDM), also in the cardiovascular realm, its implementation seems challenging. This study aims to systematically review the predictors of successful implementation of digital DAs for cardiovascular diseases. Methods and results: Searches were conducted in MEDLINE, Embase, PsycInfo, CINAHL, and the Cochrane Library from inception to November 2021. Two reviewers independently assessed study eligibility and risk of bias. Data were extracted by using a predefined list of variables. Five good-quality studies were included, involving data of 215 patients and 235 clinicians. Studies focused on DAs for coronary artery disease, atrial fibrillation, and end-stage heart failure patients. Clinicians reported DA content, its effectivity, and a lack of knowledge on SDM and DA use as implementation barriers. Patients reported preference for another format, the way clinicians used the DA and anxiety for the upcoming intervention as barriers. In addition, barriers were related to the timing and Information and Communication Technology (ICT) integration of the DA, the limited duration of a consultation, a lack of communication among the team members, and maintaining the hospital's number of treatments. Clinicians' positive attitude towards preference elicitation and implementation of DAs in existing structures were reported as facilitators. Conclusion: To improve digital DA use in cardiovascular diseases, the optimum timing of the DA, training healthcare professionals in SDM and DA usage, and integrating DAs into existing ICT structures need special effort. Current evidence, albeit limited, already offers advice on how to improve DA implementation in cardiovascular medicine.

Stakeholders' Views on Information Needed in a Patient Decision Aid for Microtia Reconstruction.

OBJECTIVE: To assess which information about microtia and the possible reconstructive options health care providers (HCPs), patients and parents believe should be included in a patient decision aid (PtDA). DESIGN: A mixed-methods study comprised of an online survey of HCPs and focus group discussions with patients and parents. PARTICIPANTS: Survey respondents were members of the International Society for Auricular Reconstruction (ISAR). Focus group participants were patients with microtia and their parents, recruited through the microtia outpatient clinic at Amsterdam UMC, and through a Dutch patient organization for cleft and craniofacial conditions. METHODS: An online, investigator-made survey was sent to ISAR members in December 2021. Semi-structured focus group discussions were held in February 2022. Quantitative results were summarized, and qualitative results were thematically grouped. RESULTS: Thirty-two HCPs responded to the survey (response rate 41%). Most respondents (n = 24) were plastic surgeons, who had a median of 15 years of experience (IQR: 7-23 years). Two focus groups were held with a total of five patients and two parents. HCPs, patients and parents generally agreed on the information needed in a PtDA, emphasizing the importance of realistic expectation management. Patients and parents also considered psychosocial and functional outcomes, patient experiences, as well as patients' involvement in decision-making important. CONCLUSIONS: A PtDA for microtia reconstruction should target all patients with microtia, and include information on at least technique-related information, expected esthetic results, possible adverse effects, psychosocial and functional outcomes and patient experiences. Preference eliciting questions should be developed for both pediatric patients and their parents.

Shared decision-making and the duration of medical consultations: A systematic review and meta-analysis.

OBJECTIVE: 1) determine whether increased levels of Shared Decision-Making (SDM) affect consultation duration, 2) investigate the intervention characteristics involved. METHODS: MEDLINE, EMBASE, CINAHL and Cochrane library were systematically searched for experimental and cross-sectional studies up to December 2021. A best-evidence synthesis was performed, and interventions characteristics that increased at least one SDM-outcome, were pooled and descriptively analyzed. RESULTS: Sixty-three studies were selected: 28 randomized clinical trials, 8 quasi-experimental studies, and 27 cross-sectional studies. Overall, pooling of data was not possible due to substantial heterogeneity. No differences in consultation duration were found more often than increased or decreased durations. . Consultation times (minutes:seconds) were significantly increased only among interventions that: 1) targeted clinicians only (Mean Difference [MD] 1:30, 95% Confidence Interval [CI] 0:24-2:37); 2) were performed in primary care (MD 2:05, 95%CI 0:11-3:59; 3) used a group format (MD 2:25, 95%CI 0:45-4:05); 4) were not theory-based (MD 4:01, 95%CI 0:38-7:23). CONCLUSION: Applying SDM does not necessarily require longer consultation durations. Theory-based, multilevel implementation approaches possibly lower the risk of increasing consultation durations. PRACTICE IMPLICATIONS: The commonly heard concern that time hinders SDM implementation can be contradicted, but implementation demands multifaceted approaches and space for training and adapting work processes.

Shared decision-making in patients with multiple sclerosis.

Multiple sclerosis (MS) is a chronic and progressive neurological disorder impacting physical, cognitive, and psychosocial health. The disease course, severity, and presence of symptoms differ within and between persons over time and are unpredictable. Given the preference-sensitive nature of many key decisions to be made, and the increasing numbers of disease-modifying therapies, shared decision-making (SDM) with patients seems to be key in offering optimum care and outcomes for people suffering from MS. In this paper, we describe our perspective on how to achieve SDM in patients with MS, following key SDM-elements from established SDM-frameworks. As for deliberation in the clinical encounter, SDM communication training of professionals and feedback on their current performance are key aspects, as well as encouraging patients to participate. Concerning information for patients, it is important to provide balanced, evidence-based information about the benefits and the harms of different treatment options, including the option of surveillance only. At the same time, attention is needed for the optimal dosage of that information, given the symptoms of cognitive dysfunction and fatigue among MS-patients, and the uncertainties they have to cope with. Finally, for broader communication, a system is required that assures patient preferences are actually implemented by multidisciplinary MS-teams. As SDM is also being implemented in many countries within the context of value-based health care, we consider the systematic use of outcome information, such as patient-reported outcome measures (PROMs) and Patient Decision Aids, as an opportunity to achieve SDM.

Predictors of the Level of Shared Decision Making in Vascular Surgery: A Cross Sectional Study.

OBJECTIVE: Although patients with vascular diseases often face multiple treatment options with different risks and benefits, the application of shared decision making (SDM) remains low. In SDM, clinicians and their patients work together to decide upon the treatment option that best fits the patient's situation and preference. This study aimed to reveal predictors of the extent to which the SDM process occurs in vascular surgery. METHODS: This was a cross sectional cohort substudy of the OVIDIUS trial, a multicentre, randomised, stepped wedge trial on the effect of implementing SDM supporting tools. The data of outpatients visiting university and general hospitals and suffering from abdominal aortic aneurysms (AAAs), intermittent claudication (IC), or varicose veins (VV) were used. Consultations were audio recorded. SDM levels were scored independently by two evaluators, using the OPTION-5 instrument, on a scale from 0% (no SDM effort) to 100% (exemplary SDM effort). Possible associations between the OPTION-5 scores and patient, clinician, and consultation characteristics were investigated using multivariable linear regression analysis. RESULTS: Of the 342 patients included (AAA, n = 87; VV, n = 143; IC, n = 112), 60% were male and mean age was 64 years. Overall, the SDM score was relatively low; mean ± SD 33.8% ± 13.2%, mainly due to insufficient support for the patient in deliberating their options. Regression analysis showed that the mean SDM scores in consultation with patients with IC and patients with VV were -9.9 (95% confidence interval [CI] -13.2 - -6.5; p < .001) and -12.7 (95% CI -17.3 - -8.0; p < .001) points lower than in patients with AAA, respectively. Consultations by a resident in training or nurse practitioner resulted in a -8.6 (95% CI -13.1 - -4.0; p < .001) and -4.2 (95% CI -7.9 - -0.42; p = .029) point lower SDM score than by a surgeon, respectively. A consultation longer than 30 minutes resulted in a 5.8 (95% CI 1.3 - 10.3; p = .011) point higher SDM score than consultations lasting fewer than 10 minutes. CONCLUSION: In this study, it was found that SDM can still be improved, especially by helping patients understand and deliberate about their options. Spending time weighing up the options, notably with patients with IC and VV, will help improve the SDM process. Training in SDM consultations is important, particularly for junior clinicians.

Improving Shared Decision Making in Vascular Surgery: A Stepped Wedge Cluster Randomised Trial.

OBJECTIVE: Different treatment options are available and feasible for various vascular surgical disorders. Hence, vascular surgery seems an area par excellence for shared decision making (SDM), in which clinicians incorporate the patient's preferences into the final treatment decision. However, current SDM levels in vascular surgical outpatient clinics are below expectations. To improve this, different decision support tools (DSTs) have been developed: online patient decision aids, consultation cards, and decision cards. METHODS: This stepped wedge cluster randomised trial was conducted in 13 Dutch hospitals. Besides the developed DSTs, training on how to apply SDM during the clinician patient encounter was used in this study. Data were obtained via questionnaires and audio recordings. The primary outcome was the OPTION-5 score, an objective tool to assess the level of SDM, expressed as a percentage of exemplary performance. Main secondary outcomes were patients' disease specific knowledge, consultation duration, and treatment choice. Factors influencing OPTION-5 scores were studied using linear regression analysis. RESULTS: Included in the study were 342 patients with an abdominal aortic aneurysm (AAA; n = 87), intermittent claudication (IC; n = 143), or varicose veins (VV; n = 112). Audiotapes of 395 consultations were analysed. Overall the mean OPTION-5 score significantly improved from 28.7% to 37.8% (mean difference 9.1%, 95% CI 6.5% - 11.8%) after implementation of the DSTs. Also, patient knowledge increased significantly (median increase: 13%, effect size: 0.13, p = .025). The number of patients choosing non-surgical treatment choices increased, with 21.4% to 28.8% for patients with AAA and doubled (16.0% to 32.0%) among patients with IC. For surgeons, the SDM training and for patients the decision aid significantly and independently increased OPTION-5 scores (p < .001 and p = .047, respectively). CONCLUSION: Introducing DSTs improves the level of shared decision making in vascular surgery, improves patient knowledge, and shifts their preference towards more non-surgical treatments. The SDM training for clinicians and the decision aid for patients appeared the most effective means of improving SDM. TRIAL REGISTRATION: NTR6487.

Effectiveness of Individual Feedback and Coaching on Shared Decision-making Consultations in Oncology Care: Protocol for a Randomized Clinical Trial.

BACKGROUND: Shared decision-making (SDM) is particularly important in oncology as many treatments involve serious side effects, and treatment decisions involve a trade-off between benefits and risks. However, the implementation of SDM in oncology care is challenging, and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM but is considered time consuming. OBJECTIVE: This study aims to address the effectiveness of an individual SDM training program using the concept of deliberate practice. METHODS: This multicenter, single-blinded randomized clinical trial will be performed at 12 Dutch hospitals. Clinicians involved in decisions with oncology patients will be invited to participate in the study and allocated to the control or intervention group. All clinicians will record 3 decision-making processes with 3 different oncology patients. Clinicians in the intervention group will receive the following SDM intervention: completing e-learning, reflecting on feedback reports, performing a self-assessment and defining 1 to 3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group will not receive the SDM intervention until the end of the study. The primary outcome will be the extent to which clinicians involve their patients in the decision-making process, as scored using the Observing Patient Involvement-5 instrument. As secondary outcomes, patients will rate their perceived involvement in decision-making, and the duration of the consultations will be registered. All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand. RESULTS: This trial was retrospectively registered on August 03, 2021. Approval for the study was obtained from the ethical review board (medical research ethics committee Delft and Leiden, the Netherlands [N20.170]). Recruitment and data collection procedures are ongoing and are expected to be completed by July 2022; we plan to complete data analyses by December 2022. As of February 2022, a total of 12 hospitals have been recruited to participate in the study, and 30 clinicians have started the SDM training program. CONCLUSIONS: This theory-based and blended approach will increase our knowledge of effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target the knowledge, attitude, and skills of clinicians. The patients will also be involved in the design and implementation of the study. TRIAL REGISTRATION: Netherlands Trial Registry NL9647; https://www.trialregister.nl/trial/9647. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35543.

Comparison of the CollaboRATE and SDM-Q-9 questionnaires to appreciate the patient-reported level of shared decision-making.

OBJECTIVE: To compare CollaboRATE and SDM-Q-9 questionnaires when appreciating patient-perceived level of shared decision-making (SDM) in doctor-patient consultations. METHODS: Data were harvested from five separate studies on SDM, conducted in three university and one large community hospital in the Netherlands, using Dutch versions of both questionnaires. CollaboRATE and SDM-Q-9 scores were expressed as percentages. Correlation was assessed using Spearman's Rho coefficient. Bland&Altman analysis was used to assess the degree of agreement. Top scores were calculated to assess possible ceiling effects. RESULTS: The five studies included 442 patients. Median CollaboRATE scores (88.9%, IQR 81.5-100%) were significantly higher (p < 0.001) than SDM-Q-9 scores (80.0%, IQR 64.4-100%). Correlation was moderate (Rho=0.53, p < 0.001). A systematic, 12.5-point higher score was found across the range of scores when using CollaboRATE. Top scores for CollaboRATE and SDM-Q-9 were present in 37.5% and 17% of questionnaires, respectively. CONCLUSIONS: Overall, CollaboRATE and SDM-Q-9 questionnaires showed a high level of patient-perceived SDM. However, CollaboRATE only moderately correlated with SDM-Q-9 and had a stronger ceiling effect. PRACTICE IMPLICATIONS: When choosing a SDM-measurement tool, its benefits and limitations should be weighed. These metrics should be combined with objective scores of SDM, as these may differ from the patients' subjective interpretation.

Effects and Working Mechanisms of a Multilevel Implementation Program for Applying Shared Decision-Making while Discussing Systemic Treatment in Breast Cancer.

Background: Enhancing the application of shared decision-making (SDM) is critical for integrating patient preferences in breast cancer treatment choices. We investigated the effect of an adapted multilevel SDM implementation program in breast cancer care. Methods: Breast cancer patients qualifying for (neo)adjuvant systemic treatment were included in a multicenter before−after study. Consultations were audio recorded between June 2018 and July 2019 and analyzed using the five-item Observing Patient Involvement in Decision-Making (OPTION-5) instrument to score SDM application by clinicians. The Shared Decision-Making Questionnaire (SDM-Q-9) was used to rate patients' perceived SDM level. Consultation duration, decision types, number of options discussed and consultations per patient were monitored. Regression analysis was used to investigate the correlated variables and program components. Results: Mean OPTION-5 scores increased from 33.9 (n = 63) before implementation to 54.3 (n = 49) after implementation (p < 0.001). The SDM-Q-9 scores did not change: 91.1 (n = 51) at baseline versus 88.9 (n = 23) after implementation (p = 0.81). Without increasing consultation time, clinicians discussed more options after implementation. The regression analysis showed that exposure to the implementation program, redistribution of tasks and discussing feedback from consultations was associated with a higher level of SDM. Conclusion: The multilevel program helped clinicians achieve clinically relevant improvement in SDM, especially when it is tailored to (individuals in) teams and includes (e-)training, discussing feedback on consultations and redistribution of tasks.

Evaluation of a multilevel implementation program for timeout and shared decision making in breast cancer care: a mixed methods study among 11 hospital teams.

OBJECTIVE: Evaluation of a multilevel implementation program on shared decision making (SDM) for breast cancer clinicians. METHODS: The program was based on the 'Measurement Instrument for Determinants of Innovations-model' (MIDI). Key factors for effective implementation were included. Eleven breast cancer teams selected from two geographical areas participated; first six surgery teams and second five systemic therapy teams. A mixed method evaluation was carried out at the end of each period: Descriptive statistics were used for surveys and thematic content analysis for semi-structured interviews. RESULTS: Twenty-eight clinicians returned the questionnaire (42%). Clinicians (96%) endorse that SDM is relevant to breast cancer care. The program supported adoption of SDM in their practice. Limited financial means, time constraints and concurrent activities were frequently reported barriers. Interviews (n = 21) showed that using a 4-step SDM model - when reinforced by practical examples, handy cards, feedback and training - helped to internalize SDM theory. Clinicians experienced positive results for their patients and themselves. Task re-assignment and flexible outpatient planning reinforce sustainable change. Patient involvement was valued. CONCLUSION: Our program supported breast cancer clinicians to adopt SDM. PRACTICE IMPLICATIONS: To implement SDM, multilevel approaches are needed that reinforce intrinsic motivation by demonstrating benefits for patients and clinicians.

[Updated Dutch law demands shared decision-making]. / Meer 'samen beslissen' nodig door aangescherpte Wgbo.

In January 2020, the Dutch law on the medical treatment agreement was updated. In this update, shared decision-making is explicitly mentioned as a prerequisite during doctor-patient encounters. This entails explicit exploration of the patient's wishes, views and preferences and their integration in medical decision-making. There is growing interest in shared decision-making from patient advocacy and professional societies, the government, and healthcare insurers. However, both care professionals and patients are not yet used to applying this in their encounters. Creating awareness, training and organisational changes are essential aspects to foster shared decision-making. Various (umbrella) organisations in healthcare have developed (digital) tools for both care professionals and patients to support shared decision-making. This article addresses these tools to nudge all stakeholders towards shared decision-making.

Therapeutic Strategies for Untreated Capillary Malformations of the Head and Neck Region: A Systematic Review and Meta-Analyses.

BACKGROUND: Capillary malformations of the head and neck region often cause psychological and physical burden. As the effectiveness of modern laser and light therapies is still suboptimal, patients often seek different therapeutic strategies. Other recognized, but not routinely proposed therapies include cosmetic camouflage, surgery, and medical tattooing. Information on therapeutic outcomes is currently lacking for patients to adequately participate in the treatment decision-making process. OBJECTIVE: The objective of this systematic review was to review the effectiveness and safety of recognized therapies for untreated capillary malformations of the head and neck: laser and light treatment modalities, photodynamic therapy, cosmetic camouflage, medical tattooing, and surgery. METHODS: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched up to 16 December, 2020 for observational and experimental studies examining recognized therapies for untreated capillary malformations of the head and neck. Two reviewers independently evaluated the risk of bias of included studies. Predefined treatment and safety outcomes of pooled data were scored using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: We included 48 observational and three randomized studies (totaling 3068 patients), evaluating nine different therapies. No studies on surgery or cosmetic camouflage matched our inclusion criteria. The pooled proportion of patients reaching a ≥75% clearance was 43% (95% confidence interval 24-64%; I2 = 55%) for the pulsed dye laser after three to eight treatment sessions (GRADE score: very low). Other therapies were less effective. Hyperpigmentation was most frequently described after the pulsed dye laser (incidences up to 40%). Pain was most common after photodynamic therapy, yet the intensity was unreported. Substantial heterogeneity among studies as to patient characteristics and outcomes limited pooling and data comparisons. CONCLUSIONS: The pulsed dye laser seems preferable for treatment-naive capillary malformations of the head and neck region, yet demonstrates greater hyperpigmentation rates compared with other therapies. Our results are, however, based on low-quality evidence. Future studies using uniform outcome measures and validated metrics are warranted for study comparability. Based on this systematic review, clinicians and patients should be aware of the limited evidence about the available options when making (shared) treatment decisions for capillary malformations. TRIAL REGISTRATION: Review registration number PROSPERO database: CRD42020199445.

Fasting habits over a 10-year period: An observational study on adherence to preoperative fasting and postoperative restoration of oral intake in 2 Dutch hospitals.

BACKGROUND: Since 1999, international guidelines recommend fasting from solid foods up to 6 hours and clear liquids up to 2 hours before surgery. Early recovery after surgery programs recommend restoration of oral intake as soon as possible. This study determines adherence to these guidelines up to 20 years after its introduction. METHODS: A 2-center observational study with a 10-year interval was performed in the Netherlands. In period 1 (2009), preoperative fasting time was observed as primary outcome. In period 2 (2019), preoperative fasting and postoperative restoration of oral intake were observed. Fasting times were collected using an interview-assisted questionnaire. RESULTS: During both periods, 311 patients were included from vascular, trauma, orthopedic, urological, oncological, gastrointestinal, and ear-nose-throat and maxillary surgical units. Duration of preoperative fasting was prolonged in 290 (90.3%) patients for solid foods and in 208 (67.8%) patients for clear liquids. Median duration of preoperative fasting from solid foods and clear liquids was respectively 2.5 and 3 times the recommended 6 and 2 hours, with no improvements from one period to another. Postoperative food intake was resumed within 4 hours in 30.7% of the patients. Median duration of perioperative fasting was 23:46 hours (interquartile range 20:00-30:30 hours) for solid foods and 11:00 hours (interquartile range 7:53-16:00 hours) for clear liquids. CONCLUSION: Old habits die hard. Despite 20 years of fasting guidelines, surgical patients are still exposed erroneously to prolonged fasting in 2 hospitals. Patients should be encouraged to eat and drink until 6 and 2 hours, respectively, before surgery and to restart eating after surgery.

Outcomes of Conservative Treatment in Patients with Chronic Limb Threatening Ischaemia: A Systematic Review and Meta-Analysis.

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) is the most severe form of peripheral arterial disease. International guidelines recommend arterial revascularisation in patients with CLTI. However, these patients are often fragile elderly people with significant comorbidities, whose vascular anatomy is not always suitable for open or endovascular revascularisation. Recent studies have suggested acceptable outcomes of conservative treatment. A systematic review of the available literature was conducted to obtain best estimates of outcomes of conservative treatment in patients with CLTI. DATA SOURCES: MEDLINE, Embase, and Cochrane Central. REVIEW METHODS: A systematic review and meta-analysis was carried out following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. MEDLINE, Embase, and Cochrane Central were searched from inception until September 2019. All studies reporting on outcomes of conservative treatment for CLTI were considered. Study selection, data extraction, and risk of bias assessment were done by two investigators independently. Risk of bias was evaluated with a modified version of the Cochrane tool for observational studies. Outcomes of interest were all cause mortality, major amputation, and amputation free survival (AFS) after at least 12 months of follow up. A random effects model was used for meta-analyses. RESULTS: Twenty-seven publications were included, consisting of 12 observational studies and 15 placebo arms from randomised clinical trials, totalling 1 642 patients. Most studies included patients with non-reconstructable CLTI. Overall study quality was moderate. The pooled 12 month all cause mortality rate in 14 studies comprising 1 003 patients was 18% (95% confidence interval [CI] 13 - 25, I2 = 73%). The pooled major amputation rate from 14 studies comprising 755 patients was 27% (95% CI 20 - 36, I2 = 65%) after one year, and pooled AFS rate after 12 months in 11 studies with 970 patients was 60% (95% CI 52 - 67, I2 = 75%). CONCLUSION: Conservative treatment for patients with CLTI may be considered and does not always result in loss of limb or patient demise. The results of this review can be used to inform patients with CLTI about conservative treatment as part of a shared decision making process.

Development of three different decision support tools to support shared decision-making in vascular surgery.

BACKGROUND: Shared decision-making (SDM) is known to improve quality of care. Particularly in vascular surgery treatment options are often preference-sensitive. Unfortunately, vascular surgeons infrequently apply SDM. Decision support tools (DSTs) have been shown to be helpful in SDM. OBJECTIVE: This article describes the development process of three different DSTs to help vascular surgeons and patients apply SDM. PATIENT INVOLVEMENT: Patients' information needs were obtained via focus group meetings. Fifty-two patients and eighteen vascular surgeons not involved in the development process evaluated the comprehensibility and usability of the DST-prototypes. METHODS: A multidisciplinary steering group commissioned the development of the three DSTs according to international standards. RESULTS: Digital decision aids and paper-based consultation cards and decision cards were developed for patients with an abdominal aortic aneurysm, carotid artery disease, intermittent claudication or varicose veins. Patients preferred the use of the decision aids followed by consultation cards, whereas vascular surgeons preferred to use decision cards followed by decision aids. DISCUSSION: Decision aids, consultation cards and decision cards for four vascular diseases are now available to all vascular surgeons and patients in the Netherlands. The DSTs were well received by both surgeons and patients. English versions are also available.