A core outcome domain set for clinical research on capillary malformations (the COSCAM project): an e-Delphi process and consensus meeting.

BACKGROUND: There is limited evidence on the best available treatment options for capillary malformations (CMs), mainly due to the absence of uniform outcome measures in trials on therapies. A core outcome set (COS) enables standard reporting of trial outcomes, which facilitates comparison of treatment results. OBJECTIVES: To develop a core outcome domain set (CDS), as part of a core outcome set (COS), for clinical research on CMs. METHODS: Sixty-seven potentially relevant outcome subdomains were recognized based on the literature, focus group sessions, and input from the COSCAM working group. These outcome subdomains were presented in an online Delphi study to CM experts (medical specialists and authors of relevant literature) and (parents of) patients with CM (international patient associations). During three e-Delphi study rounds, the participants repeatedly scored the importance of these outcome subdomains on a seven-point Likert scale. Participants could also propose other relevant outcome subdomains. Consensus was defined as ≥ 80% agreement as to the importance of an outcome subdomain among both stakeholder groups. The CDS was finalized during an online consensus meeting. RESULTS: In total 269 participants from 45 countries participated in the first e-Delphi study round. Of these, 106 were CM experts from 32 countries, made up predominantly of dermatologists (59%) and plastic surgeons (18%). Moreover, 163 (parents of) patients with CM from 28 countries participated, of whom 58% had Sturge-Weber syndrome. During the two subsequent e-Delphi study rounds, 189 and 148 participants participated, respectively. After the entire consensus process, consensus was reached on 11 outcome subdomains: colour/redness, thickness, noticeability, distortion of anatomical structures, glaucoma, overall health-related quality of life, emotional functioning, social functioning, tolerability of intervention, patient satisfaction with treatment results, and recurrence. CONCLUSIONS: We recommend the CDS to be used as a minimum reporting standard in all future trials of CM therapy. Our next step will be to select suitable outcome measurement instruments to score the core outcome subdomains. What is already known about this topic? Besides physical and functional sequelae, capillary malformations (CMs) often cause emotional and social burden. The lack of uniform outcome measures obstructs proper evaluation and comparison of treatment strategies. As a result, there is limited evidence on the best available treatment options. The development of a core outcome set (COS) may improve standardized reporting of trial outcomes. What does this study add? A core outcome domain set (CDS), as part of a COS, was developed for clinical research on CMs. International consensus was reached on the recommended core outcome subdomains to be measured in CM trials: colour/redness, thickness, noticeability, distortion of anatomical structures, glaucoma, overall health-related quality of life, emotional functioning, social functioning, tolerability of intervention, patient satisfaction with treatment results, and recurrence. This CDS enables the next step in the development of a COS, namely to reach consensus on the core outcome measurement instruments to score the core outcome subdomains. What are the clinical implications of this work? The obtained CDS will facilitate standardized reporting of treatment outcomes, thereby enabling proper comparison of treatment results. This comparison is likely to provide more reliable information for patients about the best available treatment options.

Patient-Reported Outcomes of Yearly Imaging Surveillance in Patients Following Endovascular Aortic Aneurysm Repair.

Little is known about the impact of standardized imaging surveillance on anxiety levels and well-being of patients after endovascular aortic aneurysm repair (EVAR). We hypothesize that patient anxiety levels increase just before receiving the imaging results compared with standard anxiety levels. METHODS: Prospective cohort study from November 2018 to May 2020 including post-EVAR patients visiting the outpatient clinics of 4 Dutch hospitals for imaging follow-up. The Patient-Reported Outcomes Measurement Information System (PROMIS) was used. Patients completed the PROMIS Anxiety v1.0 Short Form (SF) 4a, PROMIS-Global Health Scale v1.2, and PROMIS-Physical Function v1.2 SF8b at 2 time points: prior to the result of the imaging study (T1: pre-visit) and 6-8 months later (T2: reference measurement). Mean T-scores at T1 were compared to T2, and T2 to the general 65+ Dutch population. RESULTS: Altogether 342 invited patients were eligible, 214 completed the first questionnaire, 189 returned 2 completed questionnaires and 128 patients did not participate. Out of 214 respondents, 195 were male (91.1%) and the mean (standard deviation) age was 75.2 (7.0) years. There were no significant differences between T1 and T2 in anxiety levels (0.48; 95% confidence interval[CI] -0.42-1.38), global mental health (0.27; 95% CI -0.79-0.84), global physical health (0.10; 95% CI -0.38-1.18) and physical function (0.53; 95% CI -0.26-1.32). Compared with the 65+ Dutch population, at T2 patients experienced more anxiety (3.8; 95% CI 2.96-5.54), had worse global physical health (-3.2; 95% CI -4.38 - -2.02) and physical function (-2.4; 95% CI -4.00 - -0.80). Global mental health was similar (-1.0; 95% CI -2.21 - 0.21). CONCLUSIONS: Post-EVAR patients do not experience more anxiety just before receiving surveillance imaging results than outside this period, but do suffer from more anxiety and worse physical outcomes than the 65+ Dutch population.

Chronically ill children's participation and health outcomes in shared decision-making: a scoping review.

Based on the United Nations Conventions on the Rights of the Child (CRC), it is a child's right to participate in all matters concerning its wellbeing. Little is known about chronically and/or critically ill children's participation in pediatric shared decision-making (SDM). We explored medical literature to see if and how these children participate in pediatric SDM. We searched relevant medical databases published between January 2008 and January 2020 for studies targeting children aged 4-18 years old, suffering from a chronic and/or critical disease. We found 9 relevant studies. SDM interventions mostly used were decision aids (n=8), questionnaires for caretakers/parents and children (n=4), and a SDM toolkit (n=2). Perceived involvement in SDM and knowledge increased amongst children, adolescents, and caretakers following these interventions. Decisional conflict measured using the 0-100 point DCS scale (higher scores indicate more decisional conflict) was reduced by 15.9 points in one study (p<0.01) and 17.8 points in another (95%CI: 13.3-22.9). Lower scores were associated with higher satisfaction with the decision aid by children, caretakers, and clinicians.Conclusion: Stakeholders should advocate initiatives to facilitate a child's participation preferences regarding pediatric SDM since decision support tools help chronically ill children to be more involved in SDM as they increase the children's knowledge and satisfaction and reduce decisional conflicts. What is Known: • Decision aids can help improve participation, knowledge, satisfaction, and health outcomes. • Quality and consistency of the information exchange impact quality and outcome of SDM. What is New: • Depending on a child's age, evolving capacities, and communication and participation preferences, more evidence is needed on which tools are suitable for chronically ill children to ensure their preferred participation in pediatric SDM. • Pediatricians adopt healthcare SDM tools and techniques that do not always take into account that a child's right to participate in pediatric SDM including the tendency to use interventions that are not specifically designed for pediatrics.

Development of a core outcome domain set for clinical research on capillary malformations (the COSCAM project).

BACKGROUND: Due to a large variety in treatment outcomes reported in therapeutic trials and lacking patient-relevant outcomes, it is hard to adequately compare and improve current therapies for patients with capillary malformations (CMs). The Core Outcome Set for Capillary Malformations (COSCAM) project aims to develop a core outcome set (COS) for use in future CM trials, in which we will first develop a core outcome (sub)domain set (CDS). Here, we describe the methods for the development of a CDS and present the results of the first development stage. METHODS: The COSCAM project is carried out according to the recommendations of the Cochrane Skin Core OUtcomes Set INitiative (CS-COUSIN) and the Core Outcome Measures in Effectiveness Trials (COMET) initiative. During the first stage, we identified all potentially relevant outcome subdomains based on a systematic review, two focus group sessions and input from patient representatives of Dutch patient organizations and the COSCAM-founding group. In stage two, we will present the subdomains in a three-round e-Delphi study and online consensus meeting, in which CM patients, parents/caregivers and CM experts worldwide rate the importance of the proposed subdomains, hereby finalizing the core outcome (sub)domains of the CDS. RESULTS: A total of 67 potential outcome subdomains were included; sixteen were previously used in the literature, 20 were proposed by Dutch patients and their parents/caregivers (n = 13) in focus group sessions and 38 were suggested by the experts of the COSCAM-founding group. Seven were excluded because of overlap. CONCLUSION: The final CDS may serve as a minimum standard in future CM trials, thereby facilitating adequate comparison of treatment outcomes. After this CDS development, we will select appropriate outcome measurement instruments to measure the core outcome subdomains.

Improving shared decision-making in vascular surgery by implementing decision support tools: study protocol for the stepped-wedge cluster-randomised OVIDIUS trial.

BACKGROUND: Shared decision-making improves the quality of patient care. Unfortunately, shared decision-making is not yet common practice among vascular surgeons. Thus, decision support tools were developed to assist vascular surgeons and their patients in using shared decision-making. This trial aims to evaluate the effectiveness and implementation of decision support tools to improve shared decision-making during vascular surgical consultations in which a treatment decision is to be made. METHODS: The study design is a multicentre stepped-wedge cluster-randomised trial. Eligible patients are adult patients, visiting the outpatient clinic of a participating medical centre for whom several treatment options are feasible and who face a primary treatment decision for their abdominal aortic aneurysm, carotid artery disease, intermittent claudication, or varicose veins. Patients and vascular surgeons in the intervention group receive decision support tools that may help them adopt shared decision-making when making the final treatment decision. These decision support tools are decision aids, consultation cards, decision cards, and a practical training. Decision aids are informative websites that help patients become more aware of the pros and cons of the treatment options and their preferences regarding the treatment choice. Consultation cards with text or decision cards with images are used by vascular surgeons during consultation to determine which aspect of a treatment is most important to their patient. In the training vascular surgeons can practice shared decision-making with a patient actor, guided by a medical psychologist. This trial aims to include 502 vascular surgical patients to achieve a clinically relevant improvement in shared decision-making of 10 out of 100 points, using the 5-item OPTION instrument to score the audio-recordings of consultations. DISCUSSION: In the OVIDIUS trial the available decision support tools for vascular surgical patients are implemented in clinical practice. We will evaluate whether these tools actually improve shared decision-making in the consultation room. The stepped-wedge cluster-randomised study design will ensure that at the end of the study all participating centres have implemented at least some of the decision support tools and thereby a certain level of shared decision-making. TRIAL REGISTRATION: Netherlands Trial Registry, NTR6487 . Registered 7 June 2017. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487.

Delphi Study to Reach International Consensus Among Vascular Surgeons on Major Arterial Vascular Surgical Complications.

BACKGROUND: The complications discussed with patients by surgeons prior to surgery vary, because no consensus on major complications exists. Such consensus may improve informed consent and shared decision-making. This study aimed to achieve consensus among vascular surgeons on which complications are considered 'major' and which 'minor,' following surgery for abdominal aortic aneurysm (AAA), carotid artery disease (CAD) and peripheral artery disease (PAD). METHODS: Complications following vascular surgery were extracted from Cochrane reviews, national guidelines, and reporting standards. Vascular surgeons from Europe and North America rated complications as major or minor on five-point Likert scales via an electronic Delphi method. Consensus was reached if ≥ 80% of participants scored 1 or 2 (minor) or 4 or 5 (major). RESULTS: Participants reached consensus on 9-12 major and 6-10 minor complications per disease. Myocardial infarction, stroke, renal failure and allergic reactions were considered to be major complications of all three diseases. All other major complications were treatment specific or dependent on disease severity, e.g., spinal cord ischemia, rupture following AAA repair, stroke for CAD or deep wound infection for PAD. CONCLUSION: Vascular surgeons reached international consensus on major and minor complications following AAA, CAD and PAD treatment. This consensus may be helpful in harmonizing the information patients receive and improving standardization of the informed consent procedure. Since major complications differed between diseases, consensus on disease-specific complications to be discussed with patients is necessary.

Systematic review of shared decision-making in surgery.

BACKGROUND: Multiple treatment options are generally available for most diseases. Shared decision-making (SDM) helps patients and physicians choose the treatment option that best fits a patient's preferences. This review aimed to assess the extent to which SDM is applied during surgical consultations, and the metrics used to measure SDM and SDM-related outcomes. METHODS: This was a systematic review of observational studies and clinical trials that measured SDM during consultations in which surgery was a treatment option. Embase, MEDLINE and CENTRAL were searched. Study selection, quality assessment and data extraction were conducted by two investigators independently. RESULTS: Thirty-two articles were included. SDM was measured using nine different metrics. Thirty-six per cent of 13 176 patients and surgeons perceived their consultation as SDM, as opposed to patient- or surgeon-driven. Surgeons more often perceived the decision-making process as SDM than patients (43·6 versus 29·3 per cent respectively). SDM levels scored objectively using the OPTION and Decision Analysis System for Oncology instruments ranged from 7 to 39 per cent. Subjective SDM levels as perceived by surgeons and patients ranged from 54 to 93 per cent. Patients experienced a higher level of SDM during consultations than surgeons (93 versus 84 per cent). Twenty-five different SDM-related outcomes were reported. CONCLUSION: At present, SDM in surgery is still in its infancy, although surgeons and patients both think of it favourably. Future studies should evaluate the effect of new interventions to improve SDM during surgical consultations, and its assessment using available standardized and validated metrics.

Randomized clinical trial of intracutaneously versus transcutaneously sutured ileostomy to prevent stoma-related complications (ISI trial).

BACKGROUND: Ileostomy construction is a common procedure but can be associated with morbidity. The stoma is commonly secured to the skin using transcutaneous sutures. It is hypothesized that intracutaneous sutures result in a tighter adherence of the peristomal skin to the stoma plate to prevent faecal leakage. The study aimed to compare the effect of intracutaneous versus transcutaneous suturing of ileostomies on faecal leakage and quality of life. METHODS: This randomized trial was undertaken in 11 hospitals in the Netherlands. Patients scheduled to receive an ileostomy for any reason were randomized to intracutaneous or transcutaneous suturing (IC and TC groups respectively). The primary outcome was faecal leakage. Secondary outcomes were stoma-related quality of life and costs of stoma-related materials and reinterventions. RESULTS: Between April 2011 and February 2016, 339 patients were randomized to the IC (170) or TC (169) group. Leakage rates were higher in the IC than in the TC group (52·4 versus 41·4 per cent respectively; risk difference 11·0 (95 per cent c.i. 0·3 to 21·2) per cent). Skin irritation rates were high (78·2 versus 72·2 per cent), but did not differ significantly between the groups (risk difference 6·1 (95 per cent c.i. -3·2 to 15·10) per cent). There were no significant differences in quality of life or costs between the groups. CONCLUSION: Intracutaneous suturing of an ileostomy is associated with more peristomal leakage than transcutaneous suturing. Overall stoma-related complications did not differ between the two techniques. Registration number: NTR2369 ( http://www.trialregister.nl).

Not All Patients with Critical Limb Ischaemia Require Revascularisation.

OBJECTIVES: International guidelines recommend revascularisation as the preferred treatment for patients with critical limb ischaemia (CLI). Most contemporary research focuses on the outcome of invasive procedures for CLI, but little is known about the outcome of conservative management. Amputation free survival (AFS) and overall survival (OS) was investigated in patients with CLI who did or did not receive revascularisation, and characteristics associated with clinical outcomes were explored. METHODS: This was a retrospective cohort study of consecutive patients with chronic CLI between 2010 and 2014 in a Dutch university hospital. CLI was defined as the presence of ischaemic rest pain or tissue loss in conjunction with an absolute systolic ankle pressure < 50 mmHg or a toe pressure < 30 mmHg. Patients were divided into invasive (revascularisation within 6 weeks), deferred invasive (revascularisation after 6 weeks), or permanently conservative treatment groups. Univariable and multivariable survival analyses were used to identify factors associated with AFS and OS. RESULTS: The majority (66.7%; N = 96) of the identified 144 patients with CLI (mean age 71.2 years; median follow-up 99 weeks) underwent revascularisation within 6 weeks of diagnosis. Deferred invasive treatment was provided in 18.1% (N = 26) patients and 22 patients (15.3%) were treated permanently conservatively. AFS and OS did not differ significantly between the three groups (Breslow-Wilcoxon p = .16 for AFS and p = .09 for OS). Age, chronic obstructive pulmonary disease (COPD), and heart disease were significant independent predictors of AFS. Age, COPD, and hypertension were significant independent predictors of OS. Treatment was not a significant predictor of either AFS or OS. CONCLUSIONS: Not all patients with CLI require revascularisation to achieve an AFS that is similar to patients undergoing revascularisation, although the efficacy of conservative versus invasive treatment in CLI patients is still unclear. Further prospective studies should determine subgroups of patients in whom revascularisation may be omitted.

Home visits as part of a new care pathway (iAID) to improve quality of care and quality of life in ostomy patients: a cluster-randomized stepped-wedge trial.

AIM: Morbidity in patients with an ostomy is high. A new care pathway, including perioperative home visits by enterostomal therapists, was studied to assess whether more elaborate education and closer guidance could reduce stoma-related complications and improve quality of life (QoL), at acceptable cost. METHOD: Patients requiring an ileostomy or colostomy, for any inflammatory or malignant bowel disease, were included in a 15-centre cluster-randomized 'stepped-wedge' study. Primary outcomes were stoma-related complications and QoL, measured using the Stoma-QOL, 3 months after surgery. Secondary outcomes included costs of care. RESULTS: The standard pathway (SP) was followed by 113 patients and the new pathway (NP) by 105 patients. Although the overall number of stoma-related complications was similar in both groups (SP 156, NP 150), the proportion of patients experiencing one or more stoma-related complications was significantly higher in the NP (72% vs 84%, risk difference 12%; 95% CI: 0.3-23.3%). Although in the NP more patients had stoma-related complications, QoL scores were significantly better (P < 0.001). In the SP more patients required extra care at home for their ostomy than in the NP (60.6% vs 33.7%, respectively; risk difference 26.9%, 95% CI: 13.5-40.4%). Stoma revision was done more often in the SP (n = 11) than in the NP (n = 2). Total costs in the SP did not differ significantly from the NP. CONCLUSION: The NP did not reduce the number of stoma-related complications but did lead to improved quality of care and life, against similar costs. Based on these results the NP, including perioperative home visits by an enterostomal therapist, can be recommended.

The current level of shared decision-making in anesthesiology: an exploratory study.

BACKGROUND: Shared decision-making (SDM) seeks to involve both patients and clinicians in decision-making about possible health management strategies, using patients' preferences and best available evidence. SDM seems readily applicable in anesthesiology. We aimed to determine the current level of SDM among preoperative patients and anesthesiology clinicians. METHODS: We invited 115 consecutive preoperative patients, visiting the pre-assessment outpatient clinic of the department of Anesthesiology at the Academic Medical Center of Amsterdam. Inclusion criteria were patients who needed surgery in the arms, lower abdomen or legs, and in whom three anesthesia techniques were feasible. The SDM-level of the consultation was scored objectively by independent observers who judged audio-recordings of the consultation using the OPTION5-scale, ranging from 0% (no SDM) to 100% (optimum SDM), as well as subjectively by patients (using the SDM-Q-9 and CollaboRATE questionnaires) and clinicians (SDM-Q-Doc questionnaire). Objective and subjective SDM-levels were assessed on five-point and six-point Likert scales, respectively. Both scores were expressed as percentages. RESULTS: Data of 80 patients could be analysed. Objective SDM-scores were low (30.5%). Subjective scores of the SDM-Q-9 and CollaboRATE were high among patients (91.7% and 96.3%, respectively) and among clinicians (SDM-Q-Doc; 84.3%). Apparently, they appreciated satisfaction rather than SDM, being poorly aware of what SDM entails. CONCLUSION: The level of SDM in an outpatient anesthesiology clinic where preoperative patients receive information about various possible anesthesia options, was found to be low. Thus, there is room for improving the level of SDM. Some suggestions are given how this can be achieved.

Systematic CT evaluation of reduction and hardware positioning of surgically treated calcaneal fractures: a reliability analysis.

INTRODUCTION: Up to date, there is a lack of reliable protocols that systematically evaluate the quality of reduction and hardware positioning of surgically treated calcaneal fractures. Based on international consensus, we previously introduced a 23-item scoring protocol evaluating the reduction and hardware positioning in these fractures based on postoperative computed tomography. The current study is a reliability analysis of the described scoring protocol. METHODS: Three raters independently and systematically evaluated anonymized postoperative CT scans of 102 surgically treated calcaneal fractures. A selection of 25 patients was scored twice by all individual raters to calculate intra-rater reliability. The scoring protocol consisted of 23 items addressing quality of reduction and hardware positioning. Each of these four-option questions was answered as: 'optimal', 'suboptimal (but not needing revision)', 'not acceptable (needing revision)' or 'not judgeable'. We used intraclass correlation coefficients (ICC's) to calculate inter- and intra-rater reliability. RESULTS: Inter-rater reliability of the overall 23-item protocol was good (ICC 0.66, 95% CI 0.64-0.69). Individual items that scored an inter-rater ICC ≥0.60 included evaluation of the calcaneocuboid joint, the posterior talocalcaneal joint, the anterior talocalcaneal joint, the position of the plate and sustentaculum screws and screws protruding the tuber and medial wall. The intra-rater reliability for the overall protocol was good for all three individual raters with ICC's between 0.60 and 0.70. CONCLUSION: Our scoring protocol for the radiological evaluation of operatively treated calcaneal fractures is reliable in terms of inter- and intra-rater reliability.

Effects of intra-operative fluoroscopic 3D-imaging on peri-operative imaging strategy in calcaneal fracture surgery.

INTRODUCTION: Previous studies demonstrated that intra-operative fluoroscopic 3D-imaging (3D-imaging) in calcaneal fracture surgery is promising to prevent revision surgery and save costs. However, these studies limited their focus to corrections performed after 3D-imaging, thereby neglecting corrections after intra-operative fluoroscopic 2D-imaging (2D-imaging). The aim of this study was to assess the effects of additional 3D-imaging on intra-operative corrections, peri-operative imaging used, and patient-relevant outcomes compared to 2D-imaging alone. PATIENTS AND METHODS: In this before-after study, data of adult patients who underwent open reduction and internal fixation (ORIF) of a calcaneal fracture between 2000 and 2014 in our level-I Trauma center were collected. 3D-imaging (BV Pulsera with 3D-RX, Philips Healthcare, Best, The Netherlands) was available as of 2007 at the surgeons' discretion. Patient and fracture characteristics, peri-operative imaging, intra-operative corrections and patient-relevant outcomes were collected from the hospital databases. Patients in whom additional 3D-imaging was applied were compared to those undergoing 2D-imaging alone. RESULTS: A total of 231 patients were included of whom 107 (46%) were operated with the use of 3D-imaging. No significant differences were found in baseline characteristics. The median duration of surgery was significantly longer when using 3D-imaging (2:08 vs. 1:54 h; p = 0.002). Corrections after additional 3D-imaging were performed in 53% of the patients. However, significantly fewer corrections were made after 2D-imaging when 3D-imaging was available (Risk difference (RD) -15%; 95% Confidence interval (CI) -29 to -2). Peri-operative imaging, besides intra-operative 3D-imaging, and patient-relevant outcomes were similar between groups. CONCLUSION: Intra-operative 3D-imaging provides additional information resulting in additional corrections. Moreover, 3D-imaging probably changed the surgeons' attitude to rely more on 3D-imaging, hence a 15%-decrease of corrections performed after 2D-imaging when 3D imaging was available. No substantiation for cost reduction was found through reduction in peri-operative imaging or in terms of improved patient-relevant outcomes.

Shared Decision Making in Vascular Surgery: An Exploratory Study.

OBJECTIVES: Shared decision making (SDM) is a process in which patients and their doctors collaborate in choosing a suitable treatment option by incorporating patient values and preferences, as well as the best available evidence. Particularly in vascular surgery, several conditions seem suitable for SDM because there are multiple treatment options. The objective of this study was to assess the degree of SDM behaviour in vascular surgery. METHODS: Vascular surgeons of four Dutch hospitals selected consultations with patients who were facing a treatment decision. Immediately after the consultation, patients and surgeons completed the (subjective) SDM Q-9 and SDM Q-doc questionnaires respectively, to appreciate the perceived level of SDM behaviour. Two evaluators independently and objectively rated SDM behaviour in the audiotaped consultations, using the Observing Patient Involvement (OPTION-12) scale. RESULTS: Nine vascular surgeons and three vascular surgeons in training conducted 54 consultations. The patients' median SDM Q-9 score was high, 93% (IQR 79-100%), and 16/54 (29.6%) of them gave the maximum score. The surgeons' median score was also high, 84% (IQR 73-92%), while 4/54 (7.4%) gave the maximum score. In contrast, mean OPTION score was 31% (SD 11%). Surgeons hardly ever asked the patients for their preferred approach to receive information, whether they had understood the provided information, and how they would like to be involved in SDM. CONCLUSIONS: Currently, objective SDM behaviour among vascular surgeons is limited, even though the presented disorders allow for SDM. Hence, SDM in vascular surgical consultations could be improved by increasing the patients' and surgeons' awareness and knowledge about the concept of SDM.

Hide and seek: does the toe-brachial index allow for earlier recognition of peripheral arterial disease in diabetic patients?

OBJECTIVE/BACKGROUND: Arterial calcification may render the ankle-brachial index (ABI) unreliable in diabetic patients. Although guidelines recommend the toe-brachial index (TBI) for patients with falsely elevated ABI arbitrarily defined as an ABI > 1.4, arterial calcification is also common among diabetic patients with an ABI ≤ 1.4. This could result in a "falsely normalized" ABI and under-diagnosis of peripheral arterial disease (PAD). We investigated whether diabetes invalidates the ABI as opposed to the TBI, and if the TBI may therefore be more suitable for detecting PAD in diabetic patients. METHODS: The difference between ABI and TBI was compared between diabetic and non-diabetic patients with an ABI ≤ 1.4 referred to the vascular laboratory. A Bland-Altman plot was constructed to assess whether ABI-TBI differences were dependent on the magnitude of the measurements. Subgroup analyses were performed for patients with a normal ABI, and for patients with critical ischemia. RESULTS: The population comprised 161 diabetic (252 limbs) and 160 non-diabetic (253 limbs) patients (mean age 67). Median ABIs (0.79 vs. 0.80) were similar, while median TBI was 0.07 higher in diabetics (p = 0.024). The ABI-TBI difference in diabetics and non-diabetics was similar (0.32 vs. 0.35; p = .084), and was also similar for patients with a normal ABI. Moreover, ABI-TBI differences in diabetic- and non-diabetic patients overlapped, irrespective of the magnitude of the measurements. Diabetes was not associated with larger differences between ankle and toe pressures (mean difference -0.9 mmHg, 95% confidence interval -15 to 13 mmHg) among patients with critical ischemia. CONCLUSION: No evidence was found that the TBI may overcome the potentially invalidated ABI in diabetic patients with an ABI ≤ 1.4. ABI and TBI are strongly associated, and this relationship is not influenced by diabetes. Therefore, the TBI does not allow for earlier detection of ischemia in diabetes.

Factors affecting timing of closure and non-reversal of temporary ileostomies.

BACKGROUND: Although stoma closure is considered a simple surgical intervention, the interval between construction and reversal is often prolonged, and some ileostomies may never be reversed. We evaluated possible predictors for non-reversal and prolonged interval between construction and reversal. MATERIAL AND METHODS: In a cohort study of ileostomy patients treated in a large teaching hospital, we collected data from the surgical complication and enterostomal therapists' registries between January 2001 and December 2011. Parameters responsible for morbidity, mortality, length of stay and time interval between construction and reversal were analysed. RESULTS: Of 485 intentionally temporary ileostomies, 359 were reversed after a median of 5.6 months (IQR 3.8-8.9 months), while 126 (26%) remained permanent. End ileostomy and intra-abdominal abscess independently delayed reversal. Age, end ileostomy, higher body mass index and preoperative radiotherapy were independent factors for non-reversal. Median duration of hospitalisation for reversal was 7.0 days (5-13 days). Morbidity and mortality were 31 and 0.9%, respectively. In 20 patients (5.5%), re-ileostomy was necessary. CONCLUSIONS: A substantial number of ileostomies that are intended to be temporary will never be reversed. If reversed, the interval between construction and reversal is longer than anticipated, while morbidity after reversal and duration of hospitalisation are considerable. Besides a temporary ileostomy, there are two other options: no diversion or a permanent colostomy. Shared decision-making is to be preferred in these situations.

Trigger tool versus verbal inventory to detect surgical complications.

PURPOSE: Traditionally, registering complications after surgery is based on voluntary reporting or incident reports. These methods may fail to detect the total number of complications. A trigger tool was developed to detect complications in hospitalized surgical patients. In this diagnostic study, we compared its sensitivity and specificity with the verbal inventory by surgical staff and residents. METHODS: A set of 31 potential triggers was chosen based on a systematic review and availability in hospital databases. The trigger tool was developed using multivariable regression and Receiver Operating Characteristic (ROC) analyses. A reference standard consisted of 300 patients, 150 with and 150 without complications. Sensitivity and specificity of the trigger tool and verbal inventory were determined. RESULTS: The final trigger tool consisted of nine triggers. Sensitivities of the trigger tool and verbal inventory were 70.7 vs. 78.7%, respectively, while specificities were 70.0 vs. 100.0%, respectively. Sensitivity values to detect major complications were 97.2 vs. 80.6%, respectively. CONCLUSIONS: The proposed customized trigger tool for a university hospital to detect surgical patients with complications appeared as accurate as a verbal inventory and even more accurate to detect major complications.