Enhancing Vascularized Composite Allograft Supercooling Preservation: A Multifaceted Approach with CPA Optimization, Thermal Tracking, and Stepwise Loading Techniques.

Vascularized composite allografts (VCAs) present unique challenges in transplant medicine, owing to their complex structure and vulnerability to ischemic injury. Innovative preservation techniques are crucial for extending the viability of these grafts, from procurement to transplantation. This study addresses these challenges by integrating cryoprotectant agent (CPA) optimization, advanced thermal tracking, and stepwise CPA loading strategies within an ex vivo rodent model. CPA optimization focused on various combinations, identifying those that effectively suppress ice nucleation while mitigating cytotoxicity. Thermal dynamics were monitored using invasive thermocouples and non-invasive FLIR imaging, yielding detailed temperature profiles crucial for managing warm ischemia time and optimizing cooling rates. The efficacy of stepwise CPA loading versus conventional flush protocols demonstrated that stepwise (un)loading significantly improved arterial resistance and weight change outcomes. In summary, this study presents comprehensive advancements in VCA preservation strategies, combining CPA optimization, precise thermal monitoring, and stepwise loading techniques. These findings hold potential implications for refining transplantation protocols and improving graft viability in VCA transplantation.

VCA supercooling in a swine partial hindlimb model.

Vascularized composite allotransplantations are complex procedures with substantial functional impact on patients. Extended preservation of VCAs is of major importance in advancing this field. It would result in improved donor-recipient matching as well as the potential for ex vivo manipulation with gene and cell therapies. Moreover, it would make logistically feasible immune tolerance induction protocols through mixed chimerism. Supercooling techniques have shown promising results in multi-day liver preservation. It consists of reaching sub-zero temperatures while preventing ice formation within the graft by using various cryoprotective agents. By drastically decreasing the cell metabolism and need for oxygen and nutrients, supercooling allows extended preservation and recovery with lower ischemia-reperfusion injuries. This study is the first to demonstrate the supercooling of a large animal model of VCA. Porcine hindlimbs underwent 48 h of preservation at - 5 °C followed by recovery and normothermic machine perfusion assessment, with no issues in ice formation and favorable levels of injury markers. Our findings provide valuable preliminary results, suggesting a promising future for extended VCA preservation.

Effect of Subnormothermic Machine Perfusion on the Preservation of Vascularized Composite Allografts After Prolonged Warm Ischemia.

BACKGROUND: Warm ischemia time (WIT) and ischemia-reperfusion injury are limiting factors for vascularized composite allograft (VCA) transplantation. Subnormothermic machine perfusion (SNMP) has demonstrated the potential to extend WIT in organ transplantation. This study evaluates the effect of SNMP on VCA viability after prolonged WIT. METHODS: Rat hindlimbs underwent WIT for 30, 45, 60, 120, 150, or 210 min, followed by 3-h SNMP. Monitoring of perfusion parameters and outflow determined the maximum WIT compatible with limb viability after SNMP. Thereafter, 2 groups were assessed: a control group with inbred transplantation (Txp) after 120 min of WIT and an experimental group that underwent WIT + SNMP + Txp. Graft appearance, blood gas, cytokine levels, and histology were assessed for 21 d. RESULTS: Based on potassium levels, the limit of WIT compatible with limb viability after SNMP is 120 min. Before this limit, SNMP reduces potassium and lactate levels of WIT grafts to the same level as fresh grafts. In vivo, the control group presented 80% graft necrosis, whereas the experimental group showed no necrosis, had better healing (P = 0.0004), and reduced histological muscle injury (P = 0.012). Results of blood analysis revealed lower lactate, potassium levels, and calcium levels (P = 0.048) in the experimental group. Both groups presented an increase in interleukin (IL)-10 and IL-1b/IL-1F2 with a return to baseline after 7 to 14 d. CONCLUSIONS: Our study establishes the limit of WIT compatible with VCA viability and demonstrates the effectiveness of SNMP in restoring a graft after WIT ex vivo and in vivo, locally and systemically.

The Development of a European Multidisciplinary Cleft Lip and Palate Registry by the European Reference Network CRANIO: Experiences, Barriers, And Facilitators.

The European Reference Network for Rare Craniofacial Aanomalies and Ear-Nose-Throat disorders aims to improve care for patients with such afflictions, including cleft lip and palate (CL/P) across Europe. Cleft treatment remains varied throughout European centers, inhibiting meaningful comparison of treatment outcomes. To overcome these issues, a European-wide common CL/P dataset and registry was developed, facilitating standardized treatment endpoints and outcome measures for international comparison and benchmarking of CL/P centers. Questionnaires and semi-structured interviews were used to determine the set-up of the registry. Previous CL/P initiatives were analyzed to create an initial dataset, refined through consensus meetings. In total, 87 cleft specialists working in specialized CL/P centers from 16 European nations participated. Consensus on a common dataset was reached. A "Level 1" dataset, with mandatory clinical and patient-reported outcome measures, and "Level 2" dataset with additional outcome measures. Finally, 2 dashboards were developed for data dissemination. The development of the European CL/P common dataset and registry tackled challenges with resource disparities, variations in specialists within CL/P teams, regulatory differences in patient data usage, patient-reported outcome measures availability in European languages, and use of assessment tools. This study described the successful development of the European Reference Network for Rare Craniofacial Aanomalies and Ear-Nose-Throat disorders CL/P common dataset and registry. This achievement will help improve patient care and outcomes for patients with CL/P in Europe. Furthermore, this study provides useful information for initiatives with similar aims.

Body Contouring Surgery After Bariatric Surgery Improves Long-Term Health-Related Quality of Life and Satisfaction With Appearance: An International Longitudinal Cohort Study Using the BODY-Q.

OBJECTIVE: To examine health-related quality of life (HRQL) and satisfaction with appearance in patients who have undergone bariatric surgery (BS) with or without subsequent body contouring surgery (BCS) in relation to the general population normative for the BODY-Q. BACKGROUND: The long-term impact of BS with or without BCS has not been established using rigorously developed and validated patient-reported outcome measures. The BODY-Q is a patient-reported outcome measure developed to measure changes in HRQL and satisfaction with appearance in patients with BS and BCS. METHODS: Prospective BODY-Q data were collected from 6 European countries (Denmark, the Netherlands, Finland, Germany, Italy, and Poland) from June 2015 to February 2022 in a cohort of patients who underwent BS. Mixed-effects regression models were used to analyze changes in HRQL and appearance over time between patients who did and did not receive BCS and to examine the impact of patient-level covariates on outcomes. RESULTS: This study included 24,604 assessments from 5620 patients. BS initially led to improved HRQL and appearance scores throughout the first postbariatric year, followed by a gradual decrease. Patients who underwent subsequent BCS after BS experienced a sustained improvement in HRQL and appearance or remained relatively stable for up to 10 years postoperatively. CONCLUSIONS: Patients who underwent BCS maintained an improvement in HRQL and satisfaction with appearance in contrast to patients who only underwent BS, who reported a decline in scores 1 to 2 years postoperatively. Our results emphasize the pivotal role that BCS plays in the completion of the weight loss trajectory.

What is the optimal assessment of speech? A multicentre, international evaluation of speech assessment in 2500 patients with a cleft.

OBJECTIVES: Speech problems in patients with a cleft palate are often complex and multifactorial. Finding the optimal way of monitoring these problems is challenging. The International Consortium of Health Outcomes Measurement (ICHOM) has developed a set of standardised outcome measures at specific ages for patients with a cleft lip and/or palate, including measures of speech assessment. This study evaluates the type and timing of speech outcome measures currently included in this ICHOM Standard Set. Additionally, speech assessments in other cleft protocols and initiatives are discussed. DESIGN, SETTING AND PARTICIPANTS: An international, multicentre study was set up including centres from the USA and the Netherlands. Outcomes of clinical measures and Patient Reported Outcome Measures (PROMs) were collected retrospectively according to the ICHOM set. PROM data from a field test of the CLEFT-Q, a questionnaire developed and validated for patients with a cleft, were collected, including participants from countries with all sorts of income statuses, to examine the value of additional moments of measurement that are used in other cleft initiatives.Data from 2500 patients were included. Measured outcomes contained univariate regression analyses, trend analyses, t-tests, correlations and floor and ceiling effects. RESULTS: PROMs correlated low to moderate with clinical outcome measures. Clinical outcome measures correlated low to moderate with each other too. In contrast, two CLEFT-Q Scales correlated strongly with each other. All PROMs and the Percent Consonants Correct (PCC) showed an effect of age. In patients with an isolated cleft palate, a ceiling effect was found in the Intelligibility in Context Scale. CONCLUSION: Recommendations for an optimal speech outcome assessment in cleft patients are made. Measurement moments of different cleft protocols and initiatives are considered in this proposition. Concerning the type of measures, adjustment of the current PCC score outcome seems appropriate. For centres with adequate resources and specific interest in research, translation and validation of an upcoming tool, the Cleft Audit Protocol for Speech Augmented, is recommended.

Diagnostic Gene Panel Testing in (Non)-Syndromic Patients with Cleft Lip, Alveolus and/or Palate in the Netherlands.

Objectives: Clefts of the lip, alveolus and/or palate (CLA/P) are the most common craniofacial congenital malformations in humans. These oral clefts can be divided into non-syndromic (isolated) and syndromic forms. Many cleft-related syndromes are clinically variable and genetically heterogeneous, making it challenging to distinguish syndromic from non-syndromic cases. Recognition of syndromic/genetic causes is important for personalized tailored care, identification of (unrecognized) comorbidities, and accurate genetic counseling. Therefore, next generation sequencing (NGS)-based targeted gene panel testing is increasingly implemented in diagnostics of CLA/P patients. In this retrospective study, we assess the yield of NGS gene panel testing in a cohort of CLA/P cases. Methods: Whole exome sequencing (WES) followed by variant detection and interpretation in an a priori selected set of genes associated with CLA/P phenotypes was performed in 212 unrelated CLA/P patients after genetic counseling between 2015 and 2020. Medical records including family history and results of additional genetic tests were evaluated. Results: In 24 CLA/P cases (11.3%), a pathogenic genetic variant was identified. Twenty out of these 24 had a genetic syndrome requiring specific monitoring and follow-up. Six of these 24 cases (25%) were presumed to be isolated CLA/P cases prior to testing, corresponding to 2.8% of the total cohort. In eight CLA/P cases (3.8%) without a diagnosis after NGS-based gene panel testing, a molecular diagnosis was established by additional genetic analyses (e.g., SNP array, single gene testing, trio WES). Conclusion: This study illustrates NGS-based gene panel testing is a powerful diagnostic tool in the diagnostic workup of CLA/P patients. Also, in apparently isolated cases and non-familial cases, a genetic diagnosis can be identified. Early diagnosis facilitates personalized care for patients and accurate genetic counseling of their families.

Core outcomes for orofacial clefts: reconciling traditional and ICHOM minimum datasets.

OBJECTIVE/DESIGN/SETTING: This retrospective study sought voluntary participation from leading cleft centres from Europe and Brazil regarding core outcome measures. The results of this study would inform the debate on core outcome consensus pertaining to the European Reference Network for rare diseases (ERN CRANIO) and achieve a core outcome set for cleft care providers worldwide. INTERVENTION/METHOD: Five orofacial cleft (OFC) disciplines were identified, within which all of the International Consortium of Health Outcomes Measurement (ICHOM) outcomes fall. One questionnaire was designed for each discipline and comprised 1. the relevant ICHOM's outcomes within that discipline, and 2. a series of questions targeted to clinicians. What core outcomes are currently measured and when, did these align with the ICHOM minimum, if not how did they differ, and would they recommend modified or additional outcomes?. RESULTS: For some disciplines participants agreed with the ICHOM minimums but urged for earlier and more frequent intervention. Some clinicians felt that some of the ICHOM standards were compatible but that different ages were preferred and for others the ICHOM standards were acceptable but developmental stages should be preferred to absolute time points. CONCLUSION/IMPLICATIONS: Core outcomes for OFC were supported in principle but there are differences between the ICHOM recommendations and the 2002 WHO global consensus. The latter are established in many centres with historical archives of OFC outcome data, and it was concluded that with some modifications ICHOM could be moulded into useful core outcomes data for inter-centre comparisons worldwide.

Body Image and Weight Loss Outcome After Bariatric Metabolic Surgery: a Mixed Model Analysis.

PURPOSE: As in nonsurgical weight loss populations, body image may partly explain differences in weight loss outcomes after surgery. The aim of this study was to determine the prospective association between body image and weight loss in a longitudinal cohort of patients up to 3 years after bariatric metabolic surgery. MATERIALS AND METHODS: The BODY-Q self-report questionnaire was used to assess body image. Linear mixed models evaluated associations of baseline body image with weight loss in the first year as well as associations of body image at 12 months and first-year change in body image with weight loss 12 to 36 months after surgery. RESULTS: Available body image data included 400 (100%), 371 (93%), 306 (77%), 289 (72%), and 218 (55%) patients at baseline and 4, 12, 24, and 36 months, respectively. Body image scores improved significantly until 12 months, followed by a gradual decline. Scores remained improved in comparison to baseline (ß = 31.49, 95% CI [27.8, 35.2], p < .001). Higher baseline body image was associated with less weight loss during the first year, and the effect size was trivial (ß = -0.05, 95% CI [-0.09, -0.01], p = .009). Body image and change in body image were not associated with weight loss 12 to 36 months after surgery. CONCLUSION: Body image improved after bariatric metabolic surgery. Although no clinically relevant associations of body image with weight loss were demonstrated, the gradual decline in body image scores underlines the importance of long-term follow-up with regular assessment of this aspect of quality of life.

Validation of the Dutch Version of the BODY-Q Measuring Appearance, Health-Related Quality of Life, and Experience of Healthcare in Patients Undergoing Bariatric and Body Contouring Surgery.

BACKGROUND: The BODY-Q is a patient-reported outcome measure developed for use in bariatric and body contouring surgery. OBJECTIVES: The objective of this study was to examine the validity and reliability of the Dutch version of the BODY-Q. METHODS: The BODY-Q consists of 163 items in 21 independently functioning scales that measure appearance, health-related quality of life, and experience of care. The data used to validate the Dutch BODY-Q were provided by 2 prospective multicenter cohort studies across 3 hospitals in the Netherlands. The BODY-Q was administered before and after surgery at 3 or 4 months and 12 months. Rasch measurement theory (RMT) analysis was used to evaluate the BODY-Q for targeting, category threshold order, Rasch model fit, Person Separation Index, and differential item functioning by language (original English data vs Dutch data). RESULTS: Data were collected between January 2016 and May 2019. The study included 876 participants, who provided 1614 assessments. Validity was supported by 3 RMT findings: most scales showed good targeting, 160 out of 163 items (98.2%) evidenced ordered thresholds, and 142 out of 163 items (87.1%) fitted the RMT model. Reliability was high with Person Separation Index values >0.70 for 19 out of 21 scales. There was negligible influence of differential item functioning by language on person item locations and the scale scoring. CONCLUSIONS: This study provides evidence for the reliability and validity of the Dutch BODY-Q for use in bariatric and body contouring patients in the Netherlands. The Dutch BODY-Q can be used in (inter)national research and clinical practice.

The relationship of body image and weight: A cross-sectional observational study of a Dutch female sample.

Body image concerns may play a role in weight changing behaviour. The objective of this study was to assess body image in different weight groups. Participants reported satisfaction with (AE) and investment in (AO) appearance, and the discrepancy between current and ideal body size (BS). These scores were compared between weight groups based on body-mass index (BMI) using analysis of variance. One-sample t-tests and Cohen's d effect sizes examined the magnitude of differences within each weight group relative to neutral midpoints of the scales; cluster analysis identified body image profiles. A total of 27 896 women were included in this study. AE scores were highest for people with underweight and normal weight, AO scores were highest for the underweight group and lowest in class III obesity, and BS scores were largest in the obese groups (all p < .001) Cluster analysis identified eight body image profiles. In people with obesity, the most prevalent profiles included a preference for a smaller body and low satisfaction with appearance, but differed in investment in appearance (low vs. high). Most people with underweight were allocated to profiles showing high investment in their appearance, preference of a larger body, but differences in satisfaction with appearance (neutral vs. high). While people with a higher BMI have on average more body image concerns, different body image profiles exist in all weight groups. Future research should examine whether and which individuals in terms of body image profile may benefit more from weight interventions.

Using the BODY-Q to develop a prospective cohort of patients undergoing bariatric and body contouring surgery: A study protocol.

The BODY-Q is a patient-reported outcome measure designed to measure health-related quality of life, satisfaction with appearance and experience with healthcare in patients with obesity who undergo bariatric surgery and/or body contouring surgery after massive weight loss. The aim of this study is to collect long term PRO-data from patients living with obesity undergoing bariatric surgery, comparing patient undergoing or not undergoing body contouring surgery. This study will be a multicentre, prospective longitudinal cohort study with participation of three bariatric medical centres in the Netherlands. The BODY-Q will be used to measure the satisfaction with appearance and HRQL. Patients undergoing bariatric surgery, age >18 years and <65 years and who are able to read and understand Dutch can be included. All bariatric procedures are eligible for inclusion. Administration of the questionnaires will be done preoperatively for bariatric and body contouring surgery as well as at 3, 12, 24, 36, 48 and 60 months post-operatively. Patient-reported outcomes measurements are becoming more important with the shift to patient-centred healthcare. The collected longitudinal data can be helpful in determining the effectiveness and value of bariatric and body contouring surgery from the patient's perspective, and can contribute to patient tailored postoperative care.

Supercooling: A Promising Technique for Prolonged Organ Preservation in Solid Organ Transplantation, and Early Perspectives in Vascularized Composite Allografts.

Ex-vivo preservation of transplanted organs is undergoing spectacular advances. Machine perfusion is now used in common practice for abdominal and thoracic organ transportation and preservation, and early results are in favor of substantially improved outcomes. It is based on decreasing ischemia-reperfusion phenomena by providing physiological or sub-physiological conditions until transplantation. Alternatively, supercooling techniques involving static preservation at negative temperatures while avoiding ice formation have shown encouraging results in solid organs. Here, the rationale is to decrease the organ's metabolism and need for oxygen and nutrients, allowing for extended preservation durations. The aim of this work is to review all advances of supercooling in transplantation, browsing the literature for each organ. A specific objective was also to study the initial evidence, the prospects, and potential applications of supercooling preservation in Vascularized Composite Allotransplantation (VCA). This complex entity needs a substantial effort to improve long-term outcomes, marked by chronic rejection. Improving preservation techniques is critical to ensure the favorable evolution of VCAs, and supercooling techniques could greatly participate in these advances.

Patient-Level Factors Associated with Health-Related Quality of Life and Satisfaction with Body After Bariatric Surgery: a Multicenter, Cross-Sectional Study.

BACKGROUND: Health-Related Quality of Life (HRQL) is a key outcome of success after bariatric surgery. Not all patients report improved HRQL scores postoperatively, which may be due to patient-level factors. It is unknown which factors influence HRQL after surgery. Our objective was to assess patient-level factors associated with HRQL after surgery. METHODS: This international cross-sectional study included 730 patients who had bariatric surgery. Participants completed BODY-Q scales pertaining to HRQL and satisfaction with body, and demographic characteristics were obtained. The sample was divided into three groups based on time since surgery: 0 - 1 year, 1 - 3 years and more than 3 years. Uni- and multivariable linear regression analyses were conducted to identify variables associated with the BODY-Q scales per group. RESULTS: The 0 - 1 year postoperative group included 377 patients (50.9%), the 1 - 3 years postoperative group 218 (29.4%) and the more than 3 years postoperative group 135 patients (18.2%). Lower current body-mass index (BMI), more weight loss (%TWL), being employed, having no comorbidities, higher age and shorter time since surgery were significantly associated with improved HRQL outcomes postoperatively. None of these factors influenced all BODY-Q scales. The effect of current BMI increased with longer time since surgery. CONCLUSION: Factors including current BMI, %TWL, employment status, presence of comorbidities, age and time since surgery were associated with HRQL postoperatively. This information may be used to optimize patient-tailored care, improve patient education and underline the importance of long-term follow-up with special attention to weight regain to ensure lasting improvement in HRQL.

Joint Distraction for Thumb Carpometacarpal Osteoarthritis: 2-Year Follow-up Results of 20 Patients.

Background Joint distraction is a fairly new treatment for patients with symptomatic thumb carpometacarpal osteoarthritis (CMC1 OA). A previous pilot study of five patients showed that CMC1 joint distraction is technically feasible. The current study presents the results of CMC1 joint distraction in 20 patients with a 2-year follow-up period. Purposes The primary study aim was to assess if patients with CMC1 OA have better physical function and less pain 2 years after CMC1 joint distraction. Second, we assessed the number of patients who achieved a minimal clinically important difference (MCID) in patient-reported outcome measures at each follow-up time point. Furthermore, this study sought differences on magnetic resonance imaging (MRI) of the CMC1 joint before and after distraction. Adverse events were noted and reported. Methods Twenty patients (median age of 54 years) with symptomatic CMC1 OA and an established indication for a trapeziectomy were enrolled. An external distractor device was placed over the CMC1 joint and left in situ for 8 weeks. Disabilities of the Arm, Shoulder, and Hand (DASH) score, Michigan Hand Outcome Questionnaire (MHQ), visual analogue scale (VAS), and grip strength were recorded preoperatively and at 3, 6, 12, and 24 months postoperatively. Results Two years after joint distraction, physical function and pain scores had improved significantly compared with baseline: DASH from 48 to 17, MHQ from 56 to 83, and VAS for pain from 50 to 18 mm. Fourteen of 19 patients (74%) reached an MCID in DASH and MHQ scores. One patient was not satisfied with treatment outcome and chose to proceed with a trapeziectomy 14 months after initial distraction therapy. Conclusions This study demonstrates that CMC1 joint distraction can postpone more invasive surgical interventions (e.g., trapeziectomy) for at least 2 years. Larger comparative studies are needed to assess the value of CMC1 joint distraction in the treatment of CMC1 OA. Level of Evidence This is a Level IV, prospective case series study.

Clinical Practice Guidelines on the Treatment of Patients with Cleft Lip, Alveolus, and Palate: An Executive Summary.

Significant treatment variation exists in the Netherlands between teams treating patients with cleft lip, alveolus, and/or palate, resulting in a confusing and undesirable situation for patients, parents, and practitioners. Therefore, to optimize cleft care, clinical practice guidelines (CPGs) were developed. The aim of this report is to describe CPG development, share the main recommendations, and indicate knowledge gaps regarding cleft care. Together with patients and parents, a multidisciplinary working group of representatives from all relevant disciplines assisted by two experienced epidemiologists identified the topics to be addressed in the CPGs. Searching the Medline, Embase, and Cochrane Library databases identified 5157 articles, 60 of which remained after applying inclusion and exclusion criteria. We rated the quality of the evidence from moderate to very low. The working group formulated 71 recommendations regarding genetic testing, feeding, lip and palate closure, hearing, hypernasality, bone grafting, orthodontics, psychosocial guidance, dentistry, osteotomy versus distraction, and rhinoplasty. The final CPGs were obtained after review by all stakeholders and allow cleft teams to base their treatment on current knowledge. With high-quality evidence lacking, the need for additional high-quality studies has become apparent.

Can we decrease the duration of basal thumb joint distraction for early osteoarthritis from 8 to 6 weeks? Study protocol for a non-inferiority randomized controlled trial.

BACKGROUND: To our knowledge, to date, 52 patients with thumb carpometacarpal osteoarthritis (CMC1 OA) were treated with joint distraction. So far, most patients experienced improved physical function and less pain. After 2 years, only 1 patient proceeded to trapeziectomy. This study assesses if we can safely lower the distraction duration from 8 to 6 weeks for CMC1 joint distraction, maintaining the improvement in physical function and pain. METHODS: This is a monocenter randomized controlled non-inferiority trial that includes patients younger than 65 years of age with ongoing symptoms of CMC1 OA and an established indication for surgery. All patients will be treated with CMC1 joint distraction. The primary outcome is to assess whether 6 weeks of joint distraction is not inferior to 8 weeks in terms of physical function at 1 year after surgery. Secondary outcomes will identify differences between groups at 1 year in pain intensity, patient satisfaction, hand health status, adverse event rates, treatment failure, differences in thumb strength and range of motion, and radiographic changes. DISCUSSION: If safe, the duration of basal thumb joint distraction can be reduced to 6 weeks, reducing patient burden. Because this is a relatively new treatment, this trial will provide greater knowledge of potential adverse events. This knowledge allows for more informed decision making for patients considering CMC1 distraction treatment. Future studies can directly compare joint distraction to other treatments of CMC1 joint arthritis like splinting and trapeziectomy. TRIAL REGISTRATION: Central Committee on Research Involving Human Subjects (CCMO), NL68225.100.18; registered on 9 August 2019. Medical Research Ethics Committees United (MEC-U), R19.003; registered on 9 August 2019. Netherlands Trial Register, NL8016 ; registered on 15 September 2019.

The PRS Rainbow Classification for Assessing Postbariatric Contour Deformities.

BACKGROUND: There is a need for a reliable classification system to grade contour deformities and to inform reimbursement of body contouring surgery after massive weight loss. We developed the PRS Rainbow Classification, which uses select photographs to provide standardized references for evaluating patient photographs, to classify contour deformities in postbariatric patients. To assess the reliability of the PRS Rainbow Classification to classify contour deformities in massive weight loss patients. METHODS: Ten independent experienced plastic surgeons, 7 experienced medical advisors of the healthcare insurance company, and 10 laypersons evaluated 50 photographs per anatomical region (arms, breast, abdomen, and medial thighs). Each participant rated the patient photographs on a scale of 1-3 in an online survey. The inter-observer and the intra-observer reliabilities were determined using intra-class correlation coefficients (ICCs). The ICC analyses were performed for each anatomical region. RESULTS: Inter-observer reliability was moderate to good in the body regions "arms," "abdomen," "medial thighs," with mean ICC values of 0.678 [95% confidence interval (CI), 0.591-0.768], 0.685 (95% CI, 0.599-0.773), and 0.658 (95% CI, 0.569-0.751), respectively. Inter-observer reliability was comparable within the 3 different professional groups. Intra-observer reliability (test-retest reliability) was moderate to good, with a mean overall ICC value of 0.723 (95% CI, 0.572-0.874) for all groups and all 4 body regions. CONCLUSIONS: The moderate to good reliability found in this study validates the use of the PRS Rainbow Classification as a reproducible and reliable classification system to assess contour deformities after massive weight loss. It holds promise as a key part of instruments to classify body contour deformities and to assess reimbursement of body contouring surgery.

Variation in Offer of Operative Treatment to Patients With Trapeziometacarpal Osteoarthritis.

PURPOSE: Operative treatment of trapeziometacarpal osteoarthritis (TMC OA) is discretionary. There is substantial surgeon-to-surgeon variation in offers of surgery. This study assessed factors associated with variation in recommendation of operative treatment to patients with TMC OA. Secondarily, we studied factors associated with preferred operative technique and surgeon demographic factors variability in recommendation for operative treatment. METHODS: We invited all hand surgeon members of the Science of Variation Group to review 16 scenarios of patients with TMC OA and asked the surgeons whether they would recommend surgical treatment for each patient and, if yes, which surgical technique they would offer (trapeziectomy, trapeziectomy with ligament reconstruction and/or tendon interposition, joint replacement, or arthrodesis). Scenarios varied in pain intensity, relief after injection, radiographic severity, and psychosocial symptoms. RESULTS: Patient characteristics associated with greater likelihood to recommend surgical treatment were substantial pain, a previous injection that did not relieve pain, radiograph with severe TMC OA, and few symptoms of depression. Practice region was the only factor associated with preferred surgical technique and trapeziectomy with ligament reconstruction and/or tendon interposition the most commonly recommended treatment. There was low agreement among surgeons regarding treatment recommendations. CONCLUSIONS: The notable variation in offers of operative treatment for TMC OA is largely associated with variable attention to subjective factors. Future studies might address the relative influence of surgeon incentives and beliefs, objective pathophysiology, and subjective patient factors on variation in surgeon recommendations. CLINICAL RELEVANCE: Surgeons' awareness of the potential influence of subjective factors on their recommendations might contribute to efforts to ensure that patient choices reflect what matters most to them and are not based on misconceptions.

Quality of Life and Patient Satisfaction in Adults Treated for a Cleft Lip and Palate: A Qualitative Analysis.

OBJECTIVE: Long-term outcomes of patients born with a cleft lip and palate (CLP) are scarcely investigated. Yet, this patient group is of particular interest, as they can provide a valuable retrospective view upon their treatment experiences and psychological adjustment. Qualitative accounts may be especially useful in understanding the patient journey. DESIGN: The present study set out to evaluate quality of life and satisfaction with treatment in adult patients previously treated for CLP at the Wilhelmina Children's Hospital. Semistructured interviews were performed. PATIENTS: A total of 22 patients aged 17 to 35 years (mean: 25 years) were interviewed about their experiences of growing up with CLP and of the treatment they received. Interviews were audio-recorded and factors thought to influence psychological adjustment were identified. RESULTS: Four main themes were identified: background factors, support systems, treatment factors, and coping/internal factors. Each theme was described with illustrative quotes. CONCLUSION: This study underlines that psychological adjustment can fluctuate over time and greatly differs between individuals, even during adulthood. Psychological support should therefore be available beyond the finalization of the treatment course. Furthermore, the majority of participants stated they had wanted more psychological support as a child to facilitate resilience and to help them cope with challenges.