Validation of a 3D-printed model of cryptoglandular perianal fistulas.

INTRODUCTION: Visualising the course of a complex perianal fistula on imaging can be difficult. It has been postulated that three-dimensional (3D) models of perianal fistulas improve understanding of the perianal pathology, contribute to surgical decision-making and might even improve future outcomes of surgical treatment. The aim of the current study is to investigate the accuracy of 3D-printed models of perianal fistulas compared with magnetic resonance imaging (MRI). METHODS: MRI scans of 15 patients with transsphincteric and intersphincteric fistulas were selected and then assessed by an experienced abdominal and colorectal radiologist. A standardised method of creating a 3D-printed anatomical model of cryptoglandular perianal fistula was developed by a technical medical physicist and a surgeon in training with special interest in 3D printing. Manual segmentation of the fistula and external sphincter was performed by a trained technical medical physicist. The anatomical models were 3D printed in a 1:1 ratio and assessed by two colorectal surgeons. The 3D-printed models were then scanned with a 3D scanner. Volume of the 3D-printed model was compared with manual segmentation. Inter-rater reliability statistics were calculated for consistency between the radiologist who assessed the MRI scans and the surgeons who assessed the 3D-printed models. The assessment of the MRI was considered the 'gold standard'. Agreement between the two surgeons who assessed the 3D printed models was also determined. RESULTS: Consistency between the radiologist and the surgeons was almost perfect for classification (κ = 0.87, κ = 0.87), substantial for complexity (κ = 0.73, κ = 0.74) and location of the internal orifice (κ = 0.73, κ = 0.73) and moderate for the percentage of involved external anal sphincter in transsphincteric fistulas (ICC 0.63, ICC 0.52). Agreement between the two surgeons was substantial for classification (κ = 0.73), complexity (κ = 0.74), location of the internal orifice (κ = 0.75) and percentage of involved external anal sphincter in transsphincteric fistulas (ICC 0.77). CONCLUSIONS: Our 3D-printed anatomical models of perianal fistulas are an accurate reflection of the MRI. Further research is needed to determine the added value of 3D-printed anatomical models in preoperative planning and education.

Quality of life of patients with 3D-printed arm prostheses in a rural area of Sierra Leone.

INTRODUCTION: In Sierra Leone, access to prostheses is limited due to absence of practical knowledge, materials, trained staff, and high cost. This paper investigates the impact of a 3D printed prosthesis on the health-related quality of life (HRQoL) in prosthesis recipients. METHODS: Patients with upper extremity amputations were included in this case study from December 2018 until July 2019. Data on the HRQoL was gathered until April 2020 in Masanga Hospital, central rural Sierra Leone. At two follow-up moments the HRQoL was assessed by applying the standard EQ-5D-5L questionnaire. These two follow-up moments varied between one week and just over a year after receiving the prosthesis. A second patient questionnaire was used to assess prosthesis satisfaction. RESULTS: Seven patients were included. The results of the EQ-5D-5L questionnaire show no deterioration of the HRQoL in any patient and the overall HRQoL increased by almost 20% compared to the null measurement. One patient was lost to follow up after the first re-visit. The responses to the second questionnaire indicated that patients are satisfied with the prosthesis and use it in various situations. Patients often mentioned they feel more included in society when wearing the prosthesis. One patient says wearing the prosthesis helped in accepting the amputation. As a result, enough self-confidence was experienced without the prosthesis and the patients stopped wearing the prosthesis. DISCUSSION: The overall HRQoL in patients wearing a 3D-printed prosthesis increases compared to not wearing one. Assessing the HRQoL at regular intervals is important for the long-term follow-up and to safeguard sustainability and long-term success of this project. Nevertheless, defining the HRQoL is challenging due to cultural differences and misunderstandings. Therefore, the use of alternative questionnaires to define the HRQoL should be investigated. To improve and warrant long-term success, identifying long-term problems is important, and the second questionnaire accounts for this need.

Prognostic factors and quality of life after pelvic fractures. The Brabant Injury Outcome Surveillance (BIOS) study.

INTRODUCTION: Pelvic fractures can have long-term consequences for health-related quality of life (HRQoL). The main purpose of this study is to provide insight into short-term HRQoL in the first year after pelvic injury and to identify short-term prognostic factors of decreased outcome. METHODS: This is a prospective, observational, multicenter, follow-up cohort study in which HRQoL and functional outcomes were assessed during 12-month follow-up of injured adult patients admitted to 1 of 10 hospitals in the county of Noord-Brabant, the Netherlands. The data were collected by self-reported questionnaires at 1 week (including preinjury assessment) and 1, 3, 6 and 12 months after injury. The EuroQoL-5D (EQ-5D), visual analog scale (VAS), Merle d'Aubigné Hip Score (MAHS) and Majeed Pelvic Score (MPS) were used. Multivariable mixed models were used to examine the course of the HRQoL and the prognostic factors for decreased HRQoL and functional outcomes over time. RESULTS: A total of 184 patients with pelvic fractures were identified between September 2015-September 2016; the fractures included 71 Tile A, 44 Tile B and 10 Tile C fractures and 59 acetabular fractures. At the pre-injury, 1 week, and 1, 3, 6 and 12 months after injury time points, the mean EQ-5D Index values were 0.90, 0.26, 0.45, 0.66, 0.77 and 0.80, respectively, and the mean EQ-VAS values were 83, 45, 57, 69, 75 and 75, respectively. At 6 and 12 months after injury, 22 and 25% of the MPS < 65 year group, 38 and 47% of the MPS ≥ 65 year group and 34 and 51% of the MAHS group, respectively, reached the maximum score. Pre-injury score, female gender and high Injury Severity Score (ISS) were important prognostic factors for a decreased HRQoL, and the EQ-5D VAS ß = 0.43 (95% CI: 0.31 - 0.57), -6.66 (95% CI: -10.90 - -0.43) and -7.09 (95% CI: -6.11 - -5.67), respectively. DISCUSSION: Patients with pelvic fractures experience a reduction in their HRQoL. Most patients do not achieve the HRQoL of their pre-injury state within 1 year after trauma. Prognostic factors for decreased HRQoL are a low pre-injury score, high ISS and female gender. We do not recommend using the MAHS and MPS in mid- or long-term follow-up of pelvic fractures because of ceiling effects. Trial registration number NCT02508675.

Impact of preventive screening and lifestyle interventions in women with a history of preeclampsia: A micro-simulation study.

BACKGROUND: Preeclampsia is a female-specific risk factor for the development of future cardiovascular disease. Whether early preventive cardiovascular disease risk screenings combined with risk-based lifestyle interventions in women with previous preeclampsia are beneficial and cost-effective is unknown. METHODS: A micro-simulation model was developed to assess the life-long impact of preventive cardiovascular screening strategies initiated after women experienced preeclampsia during pregnancy. Screening was started at the age of 30 or 40 years and repeated every five years. Data (initial and follow-up) from women with a history of preeclampsia was used to calculate 10-year cardiovascular disease risk estimates according to Framingham Risk Score. An absolute risk threshold of 2% was evaluated for treatment selection, i.e. lifestyle interventions (e.g. increasing physical activity). Screening benefits were assessed in terms of costs and quality-adjusted-life-years, and incremental cost-effectiveness ratios compared with no screening. RESULTS: Expected health outcomes for no screening are 27.35 quality-adjusted-life-years and increase to 27.43 quality-adjusted-life-years (screening at 30 years with 2% threshold). The expected costs for no screening are €9426 and around €13,881 for screening at 30 years (for a 2% threshold). Preventive screening at 40 years with a 2% threshold has the most favourable incremental cost-effectiveness ratio, i.e. €34,996/quality-adjusted-life-year, compared with other screening scenarios and no screening. CONCLUSIONS: Early cardiovascular disease risk screening followed by risk-based lifestyle interventions may lead to small long-term health benefits in women with a history of preeclampsia. However, the cost-effectiveness of a lifelong cardiovascular prevention programme starting early after preeclampsia with risk-based lifestyle advice alone is relatively unfavourable. A combination of risk-based lifestyle advice plus medical therapy may be more beneficial.

Quality of life after pelvic ring fractures: Long-term outcomes. A multicentre study.

AIMS: This study was conducted to determine long-term (5-10 years) health-related quality of life (HRQOL) and ceiling effects in patients with a pelvic ring fracture. PATIENTS AND METHODS: We identified all patients with pelvic ring fractures after high-energy trauma admitted at two level 1 trauma centres in the Netherlands from 2006 to 2011. Patients were asked to complete the Majeed Pelvic Score (MPS), EuroQol-5D (EQ-5D) and Short Musculoskeletal Function Assessment (SMFA) questionnaires. HRQOL analysis used a multiple linear regression model. RESULTS: In total, 136 patients returned the questionnaires. The median follow-up period was 8.7 years. The mean MPS and EQ-5D-VAS scores were 85.1 and 74, respectively. The mean EQ-5D index scores were 0.87, 0.81 and 0.82 in Tile B, A and C patients, respectively. The mean SMFA index was 24. A ceiling effect was observed for 1/3 of the patients. After multiple linear regression analysis, no differences were identified among the various fracture types for each questionnaire, with the exception of 2 subscales of the MPS. CONCLUSION: Patients who suffer pelvic ring fractures generally have good HRQOL outcomes after 5-10 years. No significant differences were found among different fracture types. Long-term follow-up of patients with Tile C fractures is warranted.

Recurrence of pre-eclampsia and the risk of future hypertension and cardiovascular disease: a systematic review and meta-analysis.

BACKGROUND: Women with a history of hypertensive disorders, including pre-eclampsia, during pregnancy have a two- to-five-fold increased risk of cardiovascular disease (CVD). In 15% of women, pre-eclampsia recurs in the following pregnancy. OBJECTIVES: To evaluate all evidence on the future risk of developing hypertension and CVD after multiple pregnancies complicated by pre-eclampsia compared with pre-eclampsia in a single pregnancy followed by normal subsequent pregnancy. SEARCH STRATEGY: Embase and Medline were searched until June 2017. SELECTION CRITERIA: All relevant studies on the risk of developing hypertension, atherosclerosis, ischaemic heart disease, cerebrovascular accident (CVA), thromboembolism, heart failure or overall hospitalisation and mortality due to CVD after having had recurrent pre-eclampsia. DATA COLLECTION AND ANALYSIS: Twenty-two studies were included in the review. When possible, we calculated pooled risk ratios (RR) with 95% CI through random-effect analysis. MAIN RESULTS: Recurrent pre-eclampsia was consistently associated with an increased pooled risk ratio of hypertension (RR 2.3; 95% CI 1.9-2.9), ischaemic heart disease (RR 2.4; 95% CI 2.2-2.7), heart failure (RR 2.9; 95% CI 2.3-3.7), CVA (RR 1.7; 95% CI 1.2-2.6) and hospitalisation due to CVD (RR 1.6; 95% CI 1.3-1.9) when compared with women with subsequent uncomplicated pregnancies. Other studies on thromboembolism, atherosclerosis and cardiovascular mortality found a positive effect, but data could not be pooled. CONCLUSIONS: This systematic review and meta-analysis support consistent higher risk for future development of hypertension and CVD in women with recurring pre-eclampsia as opposed to women with a single episode of pre-eclampsia. TWEETABLE ABSTRACT: The risk of future cardiovascular disease increases when women have recurrence of pre-eclampsia compared with a single episode.

Quality of life after pelvic ring fractures: A cross-sectional study.

BACKGROUND: Pelvic ring fractures might have consequences for health-related quality of life (HrQoL). The main purpose of this study was to evaluate patients' HrQoL after a pelvic ring fracture, considering the patients' characteristics. A cross-sectional study was conducted using the EuroQoL-5D (EQ-5D) and the Majeed pelvic score (MPS). METHODS: One hundred ninety-five patients (86%) with pelvic ring fractures who were conservatively or surgically treated in a level 1 trauma centre between 2011 and 2015 were included in this study (mean follow up: 29 months, range 6-61). A telephone survey of all patients was conducted. Multiple logistic and linear regression analyses were used for statistical assessment with the EQ-5D and the MPS. The MPS results were split into two age groups with a cut-off point of 65 years. RESULTS: EQ-5D: The mean EQ-5D Visual Analogue Scale (VAS) for Tiles A-C was, respectively, 74 (SD 18), 74 (SD 19) and 67 (SD 21), and the mean EQ-5D index score was, respectively, 0.81 (SD 0.23), 0.77 (SD 0.30) and 0.71 (SD 0.26). Compared with Tile A, patients in Tile C experienced significantly more pain (odds ratio 6.28 (1.73-22.82 95% CI), P < 0.01). Clinically relevant differences in EQ-5D scores between Tile A and Tile C were seen in the domains of usual activities and anxiety and in the index score. MPS: The mean MPS of Tiles A-C patients in the <65 group was, respectively, 86 (SD 15), 81 (SD 17), and 74 (SD 16), and in the ≥65 group, it was, respectively, 69 (SD 15), 68 (SD 15) and 66 (SD 9). In the <65 group, significant differences in MPS results between the Tile groups regarding pain (P < 0.01) and the total MPS score (P = 0.04) were seen. Neither significant regression coefficients nor clinically relevant differences were found in the ≥65 group. CONCLUSIONS: In conclusion, our study showed that pain was increased in patients with Tile C fractures, compared with Tiles A and B. Furthermore, Tile C patients had significantly lower EQ-5D index and total MPS scores. However, these problems were not seen in the ≥65 group.

Prevalence, recovery patterns and predictors of quality of life and costs after non-fatal injury: the Brabant Injury Outcome Surveillance (BIOS) study.

INTRODUCTION: Trauma is a major public health problem worldwide that leads to high medical and societal costs. Overall, improved understanding of the full spectrum of the societal impact and burden of injury is needed. The main purpose of the Brabant Injury Outcome Surveillance (BIOS) study is to provide insight into prevalence, predictors and recovery patterns of short-term and long-term health-related quality of life (HRQoL) and costs after injury. MATERIALS AND METHODS: This is a prospective, observational, follow-up cohort study in which HRQoL, psychological, social and functional outcome, and costs after trauma will be assessed during 24 months follow-up within injured patients admitted in 1 of 10 hospitals in the county Noord-Brabant, the Netherlands. Data will be collected by self-reported questionnaires at 1 week (including preinjury assessment), and 1, 3, 6, 12 and 24 months after injury. If patients are not capable of filling out the questionnaires, proxies will be asked to participate. Also, information about mechanism and severity of injury, comorbidity and indirect and direct costs will be collected. Mixed models will be used to examine the course of HRQoL, functional and psychological outcome, costs over time and between different groups, and to identify predictors for poor or good outcome. RELEVANCE: This study should make a substantial contribution to the international collaborative effort to assess the societal impact and burden of injuries more accurately. The BIOS results will also be used to develop an outcome prediction model for outcome evaluation including, besides the classic fatal, non-fatal outcome. TRIAL REGISTRATION NUMBER: NCT02508675.

[Management of blunt renal trauma in paediatric patients]. / Behandeling van stomp nierletsel bij kinderen.

- In 90% of children, blunt abdominal trauma is the cause of renal, splenic or hepatic injury or an injury affecting a combination of these organs.- Because children's kidneys are anatomically less protected than those of adults, potential renal injury following direct trauma affecting the child's flank, for example by a handlebar or knee should be considered.- Symptoms of renal trauma include excoriations or haematoma on the flank, a 'seatbelt-sign', macroscopic haematuria and fractures of the ribs and vertebra.- As haematuria does not correlate with the severity of renal injury, all children with persistent haematuria should undergo renal imaging.- Children without abnormalities on Doppler ultrasound examination and without macroscopic haematuria can be discharged from the emergency room.- Conservative management of blunt renal trauma is indicated for all haemodynamically stable children. However, haemodynamically unstable children need to undergo an urgent laparotomy. The routine use of bed rest is only indicated for grade V renal injuries.- A DMSA scan is recommended 6-12 weeks after trauma for grade IV-V renal injury.

Determining scaphoid waist fracture union by conventional radiographic examination: an analysis of reliability and validity.

INTRODUCTION: Conventional radiographic imaging is the first imaging tool of choice in scaphoid fractures. The majority of undisplaced scaphoid waist fractures unite after 6 weeks of cast immobilization. We hypothesized that conventional radiographic imaging at 6 weeks after injury can both accurately and reliably predict union in undisplaced scaphoid waist fractures. MATERIALS AND METHODS: Fleiss' kappa statistics were used concerning the opinions of four observers reviewing 47 sets of good-quality scaphoid radiographs of undisplaced scaphoid waist fractures. As reference standard for union, radiographs were taken at a minimum of 6 months after injury to determine validity. RESULTS: Overall agreement was defined as moderate. (κ = 0.583) "No consolidation" (κ = 0.816), "full consolidation" (κ = 0.517) and "partial consolidation" (κ = 0.390) were defined as good, moderate and fair agreement, respectively. The average sensitivity and specificity of diagnosing scaphoid waist fracture union on standard scaphoid radiographs were 0.65 and 0.67, respectively. The positive predictive value for diagnosing union was 0.93 and the negative predictive value was 0.22. CONCLUSIONS: Conventional radiographic imaging is accurate and moderately reliable in diagnosing union, and reliable but inaccurate in diagnosing nonunion of scaphoid waist fractures at 6 weeks follow-up.

Multiplanar reconstruction computed tomography for diagnosis of scaphoid waist fracture union: a prospective cohort analysis of accuracy and precision.

OBJECTIVE: To examine reliability and validity concerning union of scaphoid fractures determined by multiplanar reconstruction computed tomography randomized at 6, 12, and 24 weeks after injury. MATERIALS AND METHODS: We used Fleiss' kappa to measure the opinions of three observers reviewing 44 sets of computed tomographic scans of 44 conservatively treated scaphoid waist fractures. We calculated kappa for the extent of consolidation (0-24 %, 25-49 %, 50-74 %, or 75-100 %) on the transverse, sagittal and coronal views. We also calculated kappa for no union, partial union, and union, and grouped the results for 6, 12, and 24 weeks after injury. As the reference standard for union, CT scans were performed at a minimum of 6 months after injury to determine validity. RESULTS: Overall inter-observer agreement was found to be moderate (κ = 0.576). No union (κ = 0.791), partial union (κ = 0.502), and union (κ = 0.683) showed substantial, moderate, and substantial agreement, respectively. The average sensitivity of multiplanar reconstruction CT for diagnosing union of scaphoid waist fractures was 73 %. The average specificity was 80 %. CONCLUSIONS: Our results suggest that multiplanar reconstruction computed tomography is a reliable and accurate method for diagnosing union or nonunion of scaphoid fractures. However, inter-observer agreement was lower with respect to partial union.

Micro-simulation of a smallpox outbreak using official register data.

To explore the efficacy of four vaccine-based policy strategies (ring vaccination, targeted vaccination, mass vaccination, and pre-vaccination of healthcare personnel combined with ring vaccination) for controlling smallpox outbreaks in Sweden, disease transmission on a spatially explicit social network was simulated. The mixing network was formed from high-coverage official register data of the entire Swedish population, building on the Swedish Total Population Register, the Swedish Employment Register, and the Geographic Database of Sweden. The largest reduction measured in the number of infections was achieved when combining ring vaccination with a pre-vaccination of healthcare personnel. In terms of per dose effectiveness, ring vaccination was by far the most effective strategy. The results can to some extent be adapted to other diseases and environments, including other countries, and the methods used can be analysed in their own right.

Economic consequences to society of pandemic H1N1 influenza 2009 - preliminary results for Sweden.

Experiments using a microsimulation platform show that vaccination against pandemic H1N1 influenza is highly cost-effective. Swedish society may reduce the costs of pandemic by about SEK 2.5 billion (approximately EUR 250 million) if at least 60 per cent of the population is vaccinated, even if costs related to death cases are excluded. The cost reduction primarily results from reduced absenteeism. These results are preliminary and based on comprehensive assumptions about the infectiousness and morbidity of the pandemic, which are uncertain in the current situation.

Production of human recombinant proapolipoprotein A-I in Escherichia coli: purification and biochemical characterization.

A human liver cDNA library was used to isolate a clone coding for apolipoprotein A-I (Apo A-I). The clone carries the sequence for the prepeptide (18 amino acids), the propeptide (6 amino acids), and the mature protein (243 amino acids). A coding cassette for the proapo A-I molecule was reconstructed by fusing synthetic sequences, chosen to optimize expression and specifying the amino-terminal methionine and amino acids -6 to +14, to a large fragment of the cDNA coding for amino acids 15-243. The module was expressed in pOTS-Nco, an Escherichia coli expression vector carrying the regulatable lambda PL promoter, leading to the production of proapolipoprotein A-I at up to 10% of total soluble proteins. The recombinant polypeptide was purified and characterized in terms of apparent molecular mass, isoelectric point, and by both chemical and enzymatic peptide mapping. In addition, it was assayed in vitro for the stimulation of the enzyme lecithin: cholesterol acyltransferase. The data show for the first time that proapo A-I can be produced efficiently in E. coli as a stable and undegraded protein having physical and functional properties indistinguishable from those of the natural product.