Stool-based testing for post-polypectomy colorectal cancer surveillance safely reduces colonoscopies: The MOCCAS study.

BACKGROUND AND AIMS: Colonoscopy-based surveillance to prevent colorectal cancer (CRC) causes substantial burden for patients and healthcare. Stool tests may help to reduce surveillance colonoscopies, by limiting colonoscopies to individuals at increased risk of AN. METHODS: This cross-sectional observational study included individuals aged 50-75 with surveillance indication. Before bowel preparation, participants collected samples for a multitarget stool DNA (mt-sDNA) test and two fecal immunochemical tests (FITs). Test accuracies were calculated for all surveillance indications. Only for the post-polypectomy indication, most common and associated with a relatively low CRC risk, long-term impact of stool-based surveillance was evaluated with the ASCCA model. Stool-based strategies were simulated to tune each tests' positivity threshold to obtain strategies at least as effective as colonoscopy surveillance. RESULTS: 3453 individuals had results for all stool tests and colonoscopy. 2226 had previous polypectomy, 1003 previous CRC and 224 familial risk. Areas under the receiver operating characteristic curve for AN were 0.72 (95% CI; 0.69-0.75) for the mt-sDNA test, 0.61 (95% CI; 0.58-0.64) for the FIT OC-Sensor and 0.59 (95% CI; 0.56-0.61) for the FIT FOB-Gold. Stool-based post-polypectomy surveillance strategies at least as effective as colonoscopy surveillance, reduced the number of colonoscopies by 15-41% and required 5.6-9.5 stool tests over the lifetime of a person. Mt-sDNA-based surveillance was more costly than colonoscopy surveillance, whereas FIT-based surveillance saved costs. CONCLUSIONS: This study shows that stool-based post-polypectomy surveillance strategies can be safe and cost-effective, with potential to reduce the number of colonoscopies by up to 41%.

Patient Satisfaction Following Primary Closure or Second Intention Healing After Conventional Nasal Skin Cancer Excision: A Cross-sectional Cohort Study.

BACKGROUND: Nasal reconstruction after conventional surgical excision (CSE) of nonmelanoma skin cancer (NMSC) can be challenging. After excision and before the pathologic report, a simple reconstruction is favored. Yet, little is known about patient satisfaction after primary closure and second intention healing. OBJECTIVE: Patient satisfaction after nasal defect reconstruction with primary closure or second intention healing, using the FACE-Q Skin Cancer. METHODS: All patients who underwent CSE of nasal NMSC with immediate primary closure or second intention healing between March 2018 and March 2020 at Máxima Medisch Centrum Veldhoven were identified and asked to complete the FACE-Q Skin Cancer. RESULTS: Of 183 patients, 140 patients completed the questionnaire. Fifty-five defects were closed by primary closure (38.5%) and 88 by second intention healing (61.5%). Thirty-one complications were reported (16.7%), of which 87.1% ( n = 27) after second intention healing ( p = .004). Both groups experienced high facial and scar satisfaction, low appearance-related distress, and no to minimal adverse effects. Second intention healing had 2.7 higher odds of achieving the maximum scar satisfaction score ( p = .02). CONCLUSION: This study shows high satisfaction on facial and scar appraisal, low appearance-related distress, and no to minimal adverse effects for second intention healing and primary closure after CSE of nasal NMSC.

Local heating-induced cutaneous vasodilation in reinnervated and noninnervated deep inferior epigastric perforator flaps.

INTRODUCTION: Cutaneous vascular reactivity to local heating in free flaps has not been characterized. We aimed to assess local heating-induced cutaneous vasodilation in reinnervated and noninnervated deep inferior epigastric perforator (DIEP) flaps. METHODS: We conducted a cross-sectional study of 21 female patients with an uncomplicated unilateral delayed DIEP breast reconstruction at least 2 years after surgery. DIEP flaps and contralateral breasts were subjected to direct local heating, and skin blood flow was assessed using laser-Doppler flowmetry. To evaluate sensory-nerve-fiber function, touch perception thresholds were assessed using a 20-piece Touch-test™ Sensory Evaluator, and cutaneous warm detection and heat pain thresholds were measured using a TSA-II device. RESULTS: Of the participants, 10 had a reinnervated DIEP flap with a single coapted nerve (mean flap weight, 610 ± 296 g) and 11 had a noninnervated DIEP flap (mean flap weight, 613 ± 169 g). Mean age was 58 ± 11 years, mean follow-up time was 5 ± 1 years, and mean BMI was 24 ± 3 kg/m2 . DIEP flaps exhibited significantly weaker cutaneous vasodilation in response to local heating than contralateral breasts (median peak skin blood flow, 59 [25th-75th percentile, 36-71] a.u. for DIEP flaps versus 94 [74-141] a.u. for contralateral breasts; p < .001). The magnitude of the response was similar between reinnervated and noninnervated flaps (median peak skin blood flow, 55 [25th-75th percentile, 39-68] a.u. for reinnervated DIEP flaps versus 66 [36-77] a.u. for noninnervated DIEP flaps; p = .75). Of participants with reinnervated DIEP flaps, 90% perceived heat pain below the 50°C safety threshold, as compared to 36% of participants with noninnervated DIEP flaps (two-tailed p = .02). CONCLUSION: Our results suggest that free flap transfer causes longstanding impairment, yet not complete abolition, of both the sensory nerve-mediated and nitric oxide-dependent local heating-induced cutaneous vasodilatory systems. We found no statistical evidence that flap reinnervation improves the ability to raise skin blood flow in response to local heating.

Pressure Masks for Facial Scar Treatment after Oncological Reconstruction: Long-Term Patient Satisfaction and Quality of Life.

INTRODUCTION: With increasing incidence of facial skin cancer, more patients undergo facial reconstruction following Mohs micrographic surgery (MMS). Aesthetically unpleasing, thickened facial flaps, and disturbing scars can be treated with a pressure mask with inner silicone lining to help improve functional and aesthetic outcomes. However, data on long-term patient satisfaction and quality of life (QoL) following this treatment are lacking. METHODS: We aimed to assess long-term satisfaction and QoL of patients who underwent local flap reconstruction following MMS. Patients treated between January 2012 and October 2020 were invited to answer FACE-Q and SCAR-Q questionnaires. Demographic data, skin cancer type and location, type of reconstruction, postoperative complications, duration of pressure mask therapy, daily compliance, and additional scar treatment were collected to explore possible predictors. RESULTS: Of 92 eligible patients, 50 responded. Eighteen respondents were male (36%) and 32 were female (64%). Mean duration of pressure mask therapy was 10.20 ± 4.61 months. Patients were 61.14 ± 32.91 months after completion of pressure mask therapy upon participation. Patients whose reconstruction consisted of multiple flaps had significantly worse outcomes in social function (p = 0.012), scar appearance (p = 0.045), and scar symptoms (p = 0.008). A trend of increasing time since therapy completion predicting better outcomes was observed for all scales, and it was a significant predictor for better scar appearance (p = 0.001) and less scar symptoms (p = 0.001). CONCLUSION: Pressure mask treatment for facial flaps and scars following MMS results in good long-term patient satisfaction and QoL. Multiple local flaps, reflecting a larger skin defect postexcision, is a predictor for worse outcomes in social function, scar appearance, and symptoms. Increasing time is associated with increasing satisfaction, which reflects satisfactory and stable long-term effects of treatment, possibly combined with more acceptance of the result over time.

Medical Specialist Care Utilization Prior to the Explantation of Cosmetic Silicone Breast Implants: A Nationwide Retrospective Data Linkage Study.

BACKGROUND: Explantation is the proposed treatment for breast implant illness (BII). Little is known about which medical specialists are visited and what diagnoses are made before explantation is provided as the treatment. OBJECTIVES: This study investigated medical specialist care utilization in women with cosmetic breast implants who underwent explantation compared to women who chose breast implant replacement surgery and to women without breast implants. METHODS: Retrospective cohort study using data linkage with the Dutch Breast Implant Registry and the Dutch health insurance claims database. Visits to medical specialists were examined over the 3 years before explantation. A total of 832 explantation patients were matched and compared to 1463 breast implant replacement patients and 1664 women without breast implants. RESULTS: Explantation patients were more likely to have visited > 5 different medical specialties compared to both replacement patients (12.3% vs. 5.7%; p < 0.001) and women without breast implants (12.3% vs. 3.7%; p < 0.001). Among explantation patients, women who underwent explantation because of BII were more likely to have visited > 5 different medical specialties compared to women who underwent explantation because of other reasons (25.0% vs. 11.0%; p < 0.001). CONCLUSIONS: Women who underwent explantation of breast implants had higher utilization of medical specialist care in the years before explantation compared to women who underwent breast implant replacement surgery and women without breast implants. Medical specialist care use was especially high among women for whom BII was the registered reason for explantation. These findings suggest further research is needed into the link between BII and the use of medical specialist care. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Aesthetic Evaluation of Breast Reconstruction with Autologous Fat Transfer vs. Implants.

BACKGROUND: Autologous fat transfer (AFT) seems to be a new minimal invasive method for total breast reconstruction, yet how patients, surgeons, and laymen evaluate cosmesis is lacking. The aim of this study was to evaluate the aesthetic outcome of AFT (intervention group) for total breast reconstruction post-mastectomy, as compared to implant-based reconstruction (IBR) (control group). METHODS: A random and blinded 3D photographic aesthetic outcome study was performed on a selection of 50 patients, scored by three panels: plastic surgeons, breast cancer patients, and laymen. Secondary outcomes included agreement within groups and possible patient characteristics influencing scoring. RESULTS: Breast cancer patients and plastic surgeons did not differ in the aesthetic scores between the treatment groups. In contrast, the laymen group scored AFT patients lower than IBR patients (- 1.04, p < 0.001). Remarkably, mean given scores were low for all groups and overall agreement within groups was poor (ICC < 0.50). Higher scores were given when subjects underwent a bilateral reconstruction and if a mamilla was present. CONCLUSION: Evaluation of aesthetic outcomes varies greatly. Hence, aesthetic outcome remains a very personal measure and this emphasizes the importance of thorough patient counseling including information on achievable aesthetic results before starting a reconstructive procedure. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Influence of Personality on Health Complaints and Quality of Life in Women With Breast Implants.

BACKGROUND: A causal relation between systemic symptoms and breast implants has not been established. Psychological factors, such as personality and psychological distress, are strongly associated with the development of medically unexplained symptoms. It can be hypothesized that psychological factors may be related to the development of breast implant illness (BII). OBJECTIVES: This study was conducted to evaluate the correlation between self-reported health complaints, health- and breast-related quality of life (QoL), and personality, in women with cosmetic breast implants. METHODS: Women who attended the plastic surgery outpatient clinic of Maastricht University Medical Center between October 2020 and October 2021 for reasons related to their implants and women recruited for a BII study at the Center during this period were invited to participate in this study. Only women who underwent cosmetic breast augmentation were eligible. Participants completed a physical complaints score form and the BREAST-Q, SF-36, and EPQ-RSS questionnaires via an online survey. RESULTS: In total, 201 women completed the questionnaires. Extroversion and social desirability were predominant personality traits in women with breast implants, followed by neuroticism. Relatively high levels of neuroticism were found compared with normative data. Neuroticism correlated significantly with health status and breast-related QoL. Physical and mental health-related QoL had the strongest correlations with neuroticism (ß = -3.94, ß = -4.86, P < 0.001). CONCLUSIONS: Personality can play a role in the development of complaints. High levels of neuroticism are seen in cosmetic surgery patients and are negatively correlated with subjective health and patient-reported outcomes in women with breast implants. Therefore, neuroticism may be a factor in the development of BII.

Neuroimaging in Breast Implant Illness: An fMRI Pilot Study.

BACKGROUND: Some women with breast implants report systemic and cognitive symptoms known as breast implant illness (BII), which are very similar to those of fibromyalgia. Functional MRI (fMRI) has shown altered brain activity in fibromyalgia patients. OBJECTIVES: The aim of this pilot study was to investigate whether brain alterations could be observed in BII patients by fMRI. METHODS: Women aged 18 to 76 with silicone breast implants for cosmetic reasons were recruited through a Dutch online BII support organization (MKS) and through the Maastricht University Medical Center. Study participants comprised 12 women with BII and 12 women without symptoms. Participants completed questionnaires regarding demographic characteristics, medical history, psychosocial complaints (Four-Dimensional Symptom Questionnaire), cognitive failure (Mini-Mental State Examination), and pain intensity and pain-related disability (Chronic Pain Grade Scale). Subsequently, brain images of all participants were obtained by resting-state fMRI and diffusion tensor imaging in a 3-T MRI scanner (Siemens Medical System, Erlangen, Germany). RESULTS: Eleven BII patients and 12 healthy controls were included in the analysis. Baseline characteristics were similar in the 2 groups and the mean silicone exposure was 15 years. Patients scored significantly higher than controls on both pain intensity and disability. Patients scored worse on depression, somatization, distress, and anxiety compared with asymptomatic women. Mini-Mental State Examination scores were normal. However, the analyses of both functional connectivity and structural integrity showed no significant differences between the 2 groups. CONCLUSIONS: This pilot study showed no evidence of brain alterations in BII patients. However, patients scored significantly worse on psychosocial symptoms than controls. Psychological factors appear to play an important role in BII and should be further investigated.

Donor Site Satisfaction Following Autologous Fat Transfer for Total Breast Reconstruction.

BACKGROUND: With evolving breast cancer survival and patient preferences, it is essential that reconstructive surgeons worldwide continue searching for the best reconstruction technique for patients. Autologous fat transfer (AFT) is a relatively new technique for total breast reconstruction that has already proven to be effective and safe with all advantages of autologous tissue. However, little is known about the aesthetic results and satisfaction concerning donor sites. OBJECTIVES: The aim of this study was to measure donor site satisfaction following AFT for total breast reconstruction in breast cancer patients. METHODS: Between May and August of 2021, participants of the BREAST- trial who were at least 24 months after their final reconstruction surgery were invited to complete an additional survey concerning donor sites. The BODY-Q was utilized for data collection. Results of AFT patients were compared with a control group of implant-based reconstruction patients who did not have a donor site. RESULTS: A total of 51 patients (20 control, 31 intervention) completed the questionnaire. Satisfaction with body did not statistically differ between the groups. The most frequent complaint was contour irregularities (31 reports, 60.8%), with the least favorable donor site being thighs (23 reports, 53.5%) in the AFT group. CONCLUSIONS: Satisfaction with body did not differ between breast cancer patients receiving AFT or implant-based reconstruction, meaning that large-volume liposuction does not aesthetically affect the utilized donor sites. Nevertheless, reconstructive surgeons should be aware of possible donor site complications, especially contour irregularities at the thighs, and discuss this with their patients.

Chromosome 20 loss is characteristic of breast implant-associated anaplastic large cell lymphoma.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a very rare type of T-cell lymphoma that is uniquely caused by a single environmental stimulus. Here, we present a comprehensive genetic analysis of a relatively large series of BIA-ALCL (n = 29), for which genome-wide chromosomal copy number aberrations (CNAs) and mutational profiles for a subset (n = 7) were determined. For comparison, CNAs for anaplastic lymphoma kinase (ALK)- nodal anaplastic large cell lymphomas (ALCLs; n = 24) were obtained. CNAs were detected in 94% of BIA-ALCLs, with losses at chromosome 20q13.13 in 66% of the samples. Loss of 20q13.13 is characteristic of BIA-ALCL compared with other classes of ALCL, such as primary cutaneous ALCL and systemic type ALK+ and ALK- ALCL. Mutational patterns confirm that the interleukin-6-JAK1-STAT3 pathway is deregulated. Although this is commonly observed across various types of T-cell lymphomas, the extent of deregulation is significantly higher in BIA-ALCL, as indicated by phosphorylated STAT3 immunohistochemistry. The characteristic loss of chromosome 20 in BIA-ALCL provides further justification to recognize BIA-ALCL as a separate disease entity. Moreover, CNA analysis may serve as a parameter for future diagnostic assays for women with breast implants to distinguish seroma caused by BIA-ALCL from other causes of seroma accumulation, such as infection or trauma.

Cancer worry after facial nonmelanoma skin cancer resection and reconstruction: A 1-year prospective study.

OBJECTIVE: Nonmelanoma skin cancer (NMSC) is one of the most diagnosed cancers in the world, with the number of new occurrences rising every year. Most patients with facial skin cancer experience cancer-related worry. Yet, little is known about their worry during the period after cancer treatment. This study aimed to assess the long-term change of cancer worry after surgical treatment in patients with NMSC. METHODS: Patients undergoing surgery for facial NMSC between December 2017 and March 2020 were asked to complete the FACE-Q Skin Cancer-Cancer Worry scale before (baseline), 3-month, and 1-year post-surgery. RESULTS: A total of 151 patients completed the baseline and 3-month, and 99 (65.6%) the 1-year post-operative survey. A significant decrease in cancer worry score was seen between baseline and 3-month post-surgery (p < 0.001). No difference was found between the 3-month and 1-year post-surgery scores (p = 0.78). Less improvement in cancer worry was seen for patients who had one facial skin cancer in their medical history (p = 0.001) and patients who had a history of facial surgery (p < 0.001). CONCLUSION: Post-surgery patients still experience cancer worry. Therefore, targeted counseling might be of value when coping with cancer-related concerns. Patients with a history of facial NMSC and patients with a history of facial surgery might benefit from additional counseling.

Clinical Validation of a Multitarget Fecal Immunochemical Test for Colorectal Cancer Screening : A Diagnostic Test Accuracy Study.

BACKGROUND: The fecal immunochemical test (FIT) is used in colorectal cancer (CRC) screening, yet it leaves room for improvement. OBJECTIVE: To develop a multitarget FIT (mtFIT) with better diagnostic performance than FIT. DESIGN: Diagnostic test accuracy study. SETTING: Colonoscopy-controlled series. PARTICIPANTS: Persons (n = 1284) from a screening (n = 1038) and referral (n = 246) population were classified by their most advanced lesion (CRC [n = 47], advanced adenoma [n = 135], advanced serrated polyp [n = 30], nonadvanced adenoma [n = 250], and nonadvanced serrated polyp [n = 53]), along with control participants (n = 769). MEASUREMENTS: Antibody-based assays were developed and applied to leftover FIT material. Classification and regression tree (CART) analysis was applied to biomarker concentrations to identify the optimal combination for detecting advanced neoplasia. Performance of this combination, the mtFIT, was cross-validated using a leave-one-out approach and compared with FIT at equal specificity. RESULTS: The CART analysis showed a combination of hemoglobin, calprotectin, and serpin family F member 2-the mtFIT-to have a cross-validated sensitivity for advanced neoplasia of 42.9% (95% CI, 36.2% to 49.9%) versus 37.3% (CI, 30.7% to 44.2%) for FIT (P = 0.025), with equal specificity of 96.6%. In particular, cross-validated sensitivity for advanced adenomas increased from 28.1% (CI, 20.8% to 36.5%) to 37.8% (CI, 29.6% to 46.5%) (P = 0.006). On the basis of these results, early health technology assessment indicated that mtFIT-based screening could be cost-effective compared with FIT. LIMITATION: Study population is enriched with persons from a referral population. CONCLUSION: Compared with FIT, the mtFIT showed better diagnostic accuracy in detecting advanced neoplasia because of an increased detection of advanced adenomas. Moreover, early health technology assessment indicated that these results provide a sound basis to pursue further development of mtFIT as a future test for population-based CRC screening. A prospective screening trial is in preparation. PRIMARY FUNDING SOURCE: Stand Up to Cancer/Dutch Cancer Society, Dutch Digestive Foundation, and HealthHolland.

The Perception of Esthetic Importance of Craniofacial Elements.

ABSTRACT: The human face is an important human structure, often judged by its esthetics. It serves great purpose, as it is and always has been involved in both cultural matters, such as art, as well as biological matters, such as exhibition of emotion and mate selection. Throughout history, there have been multiple studies on what makes a face attractive. Despite the myriad ways in which the face has been explored academically, there has been a lack of reports on which craniofacial elements are deemed the most important for attractiveness subjectively. To fill up this gap on the perception of the esthetics of the human face, as well as to provide a contemporary view on the matter, this research was conducted. Participants were asked to fill out a questionnaire with a visual analogue scale for each craniofacial element and questions about appearance satisfaction. A total of 299 participants were enrolled in this study. Eyes, hair and teeth were deemed to be the most important craniofacial elements for attractiveness. Women scored teeth, hair, and eyebrows significantly higher than men, men scored higher in satisfaction with their own appearance than women. Older people, married people and people in a relationship care less about the opinion of others regarding their appearance. The results from this study can be used to identify a focus in the future development of esthetically related matters, such as plastic surgery or art and will add to the academic knowledge on the perception of craniofacial beauty.

Self-Reported Health Complaints in Women Undergoing Explantation of Breast Implants.

BACKGROUND: Concerns about the safety of silicone breast implants (SBIs) have existed for years, but a causal relation between systemic complaints and SBIs has not been proven. Nevertheless, some women are worried and even request explantation. OBJECTIVES: This study aimed to review the explantation procedures performed, focusing on patient-reported symptoms preoperatively, the effect of explantation, and the effect of breast reconstruction on these symptoms. METHODS: A retrospective chart review was performed for patients who had undergone explantation between 2010 and 2020 at Maastricht University Medical Center. Patients who had undergone tissue expander removal, tissue expander-implant exchange, or direct implant exchange were excluded. RESULTS: More than half of the patients undergoing explantation reported complaints, mostly pain. Some 15% reported systemic complaints they believed were implant related. Breast implant illness (BII) was found to be the fifth most common indication for explantation (11.2%). A history of either allergies or implant rupture resulted in higher odds ratios of having BII (odd ratios, 2.1 and 2.1, respectively). Subjective improvement of BII after explantation was reported by about 60% of patients. CONCLUSIONS: A relatively low prevalence of suggested BII exists among women undergoing explantation; 1 in 9 procedures were performed for this reason. Allergy and implant rupture may increase the likelihood of having BII. About 60% of BII patients experienced an improvement in their complaints after implant removal. Autologous breast reconstruction appears a good alternative. Prospective studies into health complaints and quality of life should be performed to confirm the effectiveness of explantation as a therapy for BII.

Using a Digital Implant Catalog Improves Data Quality and Reduces Administrative Burden in the Dutch Breast Implant Registry.

BACKGROUND: Correct registration of implant characteristics is essential to monitor implant safety within implant registries. Currently, in the nationwide Dutch Breast Implant Registry (DBIR), these characteristics are being registered manually by plastic surgeons, resulting in administrative burden and potentially incorrect data entry. OBJECTIVES: This study evaluated the accuracy of manually registered implant data, possible consequences of incorrect data, and the potential of a Digital Implant Catalog (DIC) on increasing data quality and reducing the administrative burden. METHODS: Manually entered implant characteristics (fill, shape, coating, texture) of newly inserted breast implants in the DBIR, from 2015 to 2019, were compared with the corresponding implant characteristics in the DIC. Reference numbers were employed to match characteristics between the 2 databases. The DIC was based on manufacturers' product catalogs and set as the gold standard. RESULTS: A total of 57,361 DBIR records could be matched with the DIC. Accuracy of implant characteristics varied from 70.6% to 98.0%, depending on the implant characteristic. The largest discrepancy was observed for "texture" and the smallest for "coating." All manually registered implant characteristics resulted in different conclusions about implant performance compared with the DIC (P < 0.01). Implementation of the DIC reduced the administrative burden from 14 to 7 variables (50%). CONCLUSIONS: Implementation of a DIC increases data quality in the DBIR and reduces the administrative burden. However, correct registration of reference numbers in the registry by plastic surgeons remains key for adequate matching. Furthermore, all implant manufacturers should be involved, and regular updates of the DIC are required.

Urgent endoscopic retrograde cholangiopancreatography with sphincterotomy versus conservative treatment in predicted severe acute gallstone pancreatitis (APEC): a multicentre randomised controlled trial.

BACKGROUND: It remains unclear whether urgent endoscopic retrograde cholangiopancreatography (ERCP) with biliary sphincterotomy improves the outcome of patients with gallstone pancreatitis without concomitant cholangitis. We did a randomised trial to compare urgent ERCP with sphincterotomy versus conservative treatment in patients with predicted severe acute gallstone pancreatitis. METHODS: In this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, patients with predicted severe (Acute Physiology and Chronic Health Evaluation II score ≥8, Imrie score ≥3, or C-reactive protein concentration >150 mg/L) gallstone pancreatitis without cholangitis were assessed for eligibility in 26 hospitals in the Netherlands. Patients were randomly assigned (1:1) by a web-based randomisation module with randomly varying block sizes to urgent ERCP with sphincterotomy (within 24 h after hospital presentation) or conservative treatment. The primary endpoint was a composite of mortality or major complications (new-onset persistent organ failure, cholangitis, bacteraemia, pneumonia, pancreatic necrosis, or pancreatic insufficiency) within 6 months of randomisation. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, ISRCTN97372133. FINDINGS: Between Feb 28, 2013, and March 1, 2017, 232 patients were randomly assigned to urgent ERCP with sphincterotomy (n=118) or conservative treatment (n=114). One patient from each group was excluded from the final analysis because of cholangitis (urgent ERCP group) and chronic pancreatitis (conservative treatment group) at admission. The primary endpoint occurred in 45 (38%) of 117 patients in the urgent ERCP group and in 50 (44%) of 113 patients in the conservative treatment group (risk ratio [RR] 0·87, 95% CI 0·64-1·18; p=0·37). No relevant differences in the individual components of the primary endpoint were recorded between groups, apart from the occurrence of cholangitis (two [2%] of 117 in the urgent ERCP group vs 11 [10%] of 113 in the conservative treatment group; RR 0·18, 95% CI 0·04-0·78; p=0·010). Adverse events were reported in 87 (74%) of 118 patients in the urgent ERCP group versus 91 (80%) of 114 patients in the conservative treatment group. INTERPRETATION: In patients with predicted severe gallstone pancreatitis but without cholangitis, urgent ERCP with sphincterotomy did not reduce the composite endpoint of major complications or mortality, compared with conservative treatment. Our findings support a conservative strategy in patients with predicted severe acute gallstone pancreatitis with an ERCP indicated only in patients with cholangitis or persistent cholestasis. FUNDING: The Netherlands Organization for Health Research and Development, Fonds NutsOhra, and the Dutch Patient Organization for Pancreatic Diseases.

Treatment Outcome Measurement Instruments for Port Wine Stains: A Systematic Review of Their Measurement Properties.

BACKGROUND: A plethora of outcome measurement instruments (OMIs) are being used in port wine stain (PWS) studies. It is currently unclear how valid, responsive, and reliable these are. OBJECTIVES: The aim of this systematic review was to appraise the content validity and other measurement properties of OMIs for PWS treatment to identify the most appropriate instruments and future research priorities. METHODS: This study was performed using the updated Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology and adhered to PRISMA guidelines. Comprehensive searches in Medline and Embase were performed. Studies in which an OMI for PWS patients was developed or its measurement properties were evaluated were included. Two investigators independently extracted data and assessed the quality of included studies and instruments to perform qualitative synthesis of the evidence. RESULTS: In total, 1,034 articles were screened, and 77 full-text articles were reviewed. A total of 8 studies were included that reported on 6 physician-reported OMIs of clinical improvement and 6 parent- or patient-reported OMIs of life impact, of which 3 for health-related quality of life and 1 for perceived stigmatization. Overall, the quality of OMI development was inadequate (63%) or doubtful (37%). Each instrument has undergone a very limited evaluation in PWS patients. No content validity studies were performed. The quality of evidence for content validity was very low (78%), low (15%), or moderate (7%), with sufficient comprehensibility, mostly sufficient comprehensiveness, and mixed relevance. No studies on responsiveness, minimal important change, and cross-cultural validity were retrieved. There was moderate- to very low-quality evidence for sufficient inter-rater reliability for some clinical PWS OMIs. Internal consistency and measurement error were indeterminate in all studies. CONCLUSIONS: There was insufficient evidence to properly guide outcome selection. Additional assessment of the measurement properties of OMIs is needed, preferentially guided by a core domain set tailored to PWS.

The Effect of Cranial Shape on Esthetic Self-Worth in Bald Men.

ABSTRACT: During the last 3 decades, the incidence of positional plagiocephaly and brachycephaly has increased. Treatment options are conservative and can include physiotherapy and molding helmet therapy. The decision to start therapy is based on patient history and subjective assessment of cranial shape by the physician and the parents. To determine the impact of these deformations on esthetic self-worth, as well as cranial shape, this study was conducted on a population of adult bald men.Participants were asked to fill in a questionnaire about the amount of comments received on cranial shape, as well as grade their general esthetic and grade craniofacial features using a visual analogue scale. The cranial proportions and symmetry were measured using plagiocephalometry.50 adult bald men were included in this study. The prevalence of nonsynostotic plagiocephaly was 12%; the prevalence of nonsynostotic brachycephaly was 0%. No significant correlation was found between plagiocephaly or brachycephaly, cranial circumference, width or length and amount of comments on cranial shape, cosmetic assessment of appearance or cosmetic assessment of cranial shape. On average, teeth and eyes were given the highest cosmetic value, eyebrows and chin were given the lowest scores.Cranial shape does not have a significant impact on the amount of comments received on cranial shape, nor the cosmetic assessment of either overall appearance or cranial shape in bald men. For bald men, eyes and teeth are more important craniofacial features in cosmetic assessment. There is no clear esthetic need to treat deviating cranial shape with helmet therapy in male patients.

Demographics of Positional Plagiocephaly and Brachycephaly; Risk Factors and Treatment.

ABSTRACT: In the last 3 decades, the incidence of positional cranial deformations in infants, such as positional plagiocephaly and positional brachycephaly, has increased. The deviating shape often causes parental concern for the later psychosocial wellbeing of the child. Treatment options are nonoperative, varying from positional change to helmet therapy, of which the effect has often been debated. Multiple risk factors have been associated with an increased risk on the development of these deformations. The goal of this study was to assess the impact of known risk factors on the type and severity of resulting positional cranial deformation.Parents were asked to fill out a questionnaire regarding the presence of risk factors, such as gender, age, pregnancy duration, method of delivery and reasons for atypical deliveries, breech position, birth weight, developmental status, positional preference, family history, number of siblings, and torticollis presence. Treatment methods were documented and plagiocephalometry was used to measure the cranial proportions. All children were invited to participate in short-term follow-up. The significance of the risk factors and the effect of different kinds of therapy are discussed. Although no significant correlation was found between severity and risk factors, some risk factors could be correlated with the kind of positional cranial deformation. Of the different therapies, helmet therapy had a significant impact on the reduction of positional plagiocephaly.

The Prevalence of Self-Reported Health Complaints and Health-Related Quality of Life in Women With Breast Implants.

BACKGROUND: Some of the millions of women with silicone breast implants (SBIs) report a pattern of systemic complaints, known as ASIA syndrome. However, the association between these complaints and breast implants remains uncertain. OBJECTIVES: This study aimed to evaluate the prevalence of complaints in women with breast implants and healthy controls, and to compare their health-related quality of life. METHODS: Four groups of subjects were requested to fill in a general and a diagnostic questionnaire, and the Short Form 36. Group 1 was recruited from the Dutch foundation for breast implant illness (BII). Two groups were recruited from Dutch hospitals, where they had been augmented or reconstructed with SBIs (group 2) or saline-filled and hydrogel implants (group 3). A control group without breast implants was recruited from friends of subjects from group 2. RESULTS: In total, 238 women completed the questionnaires. ASIA manifestations appeared in the majority of the respondents (72.3%-98.8%), with a latency period of 0 to 35 years. Adjusted for age, smoking, and comorbidities, typical symptoms only occurred significantly more frequently in group 1. The presence of a chronic disease was an independent predictor for ASIA syndrome. The health-related quality of life was lower in women with SBIs than in women without breast implants. CONCLUSIONS: The adjusted prevalence of BII manifestations is not significantly higher in women with SBIs than in women without implants. The findings of this study suggest that results on BII are subject to selection bias. Further studies are needed to prove an association between self-reported complaints and SBIs.