Societal costs before and up to 1 year after the first fracture liaison service visit in patients requiring anti-osteoporosis treatments.

This study aimed to estimate societal and healthcare costs incurred before and 1 year after the first fracture liaison services (FLS) visit and to explore differences in fracture type. All costs after 1 year significantly decreased compared to costs preceding the first visit. Fracture type did not significantly affect costs. INTRODUCTION: Limited literature is available on resource utilization and costs of patients visiting fracture liaison services (FLS). This study aimed to estimate the societal and healthcare costs incurred by patients with a recent fracture requiring anti-osteoporosis medication before and 1 year after the first FLS visit and to explore differences according to fracture type. METHODS: Resource utilization was collected through a self-reported questionnaire with a 4-month recall on health resource utilization and productivity losses immediately following the first FLS visit, and 4 and 12 months later. Unit costs derived from the national Dutch guideline for economic evaluations were used to compute societal and healthcare costs. Linear mixed-effect models, adjusted for confounders, were used to analyze societal and healthcare costs over time as well as the effect of fracture type on societal and healthcare costs. RESULTS: A total of 126 patients from two Dutch FLS centers were included, of whom 72 sustained a major fracture (hip, vertebral, humerus, or radius). Societal costs in the 4 months prior to the first visit (€2911) were significantly higher compared to societal costs 4 months (€711, p-value = 0.009) and 12 months later (€581, p-value = 0.001). Fracture type did not have a significant effect on total societal or healthcare costs. All costs 12 months after the initial visit were numerically lower for major fractures compared to others. CONCLUSION: Societal and healthcare costs in the year following the first FLS visit significantly decreased compared to those costs preceding the first visit.

The Assessment of Burden of ColoRectal Cancer (ABCRC)-tool; a validity and reliability study.

INTRODUCTION: Follow-up care after treatment for colorectal cancer (CRC) is increasingly focused on health-related quality of life (HRQoL) and functional outcomes. The Assessment of Burden of ColoRectal Cancer (ABCRC)-tool is developed to measure these outcomes and support patient-oriented care. The tool comprises items assessing burden of disease and lifestyle parameters. It consists of a generic module combined with one of the three CRC specific modules. The objective of this study is to assess the construct validity and reliability of the items of the ABCRC-tool. METHODS: Patients who were receiving follow-up care after surgical CRC treatment were invited to complete the ABCRC-tool together with other validated patient-reported outcome measures (PROMs). Construct validity was assessed by testing expected correlations between items of the ABCRC-tool and domains of other PROMs and by examining predefined hypotheses regarding differences in subgroups of patients. Patients completed the ABCRC-tool twice, with 8 days apart, to evaluate its reliability. RESULTS: In total, 177 patients participated (64% male) with a mean age of 67 years (range 33-88). The colon, rectum and stoma module were completed by subsequently 89, 53 and 35 patients. Most items correlated as expected with anticipated domains of the EORTC QLQ-C30 or EORTC QLQ-CR29 (all p-values <0.05). Furthermore, the ABCRC-tool could discriminate between subgroups of patients. The intraclass correlation coefficient (ICC) was good (>0.70) for most items, indicating good reliability. CONCLUSION: The ABCRC-tool is a valid and reliable instrument that is ready for use in a clinical setting to support personalized follow-up care after CRC treatment.

Cerebral Autoregulation Assessment Using the Near Infrared Spectroscopy 'NIRS-Only' High Frequency Methodology in Critically Ill Patients: A Prospective Cross-Sectional Study.

Impairments in cerebral autoregulation (CA) are related to poor clinical outcome. Near infrared spectroscopy (NIRS) is a non-invasive technique applied to estimate CA. Our general purpose was to study the clinical feasibility of a previously published 'NIRS-only' CA methodology in a critically ill intensive care unit (ICU) population and determine its relationship with clinical outcome. Bilateral NIRS measurements were performed for 1-2 h. Data segments of ten-minutes were used to calculate transfer function analyses (TFA) CA estimates between high frequency oxyhemoglobin (oxyHb) and deoxyhemoglobin (deoxyHb) signals. The phase shift was corrected for serial time shifts. Criteria were defined to select TFA phase plot segments (segments) with 'high-pass filter' characteristics. In 54 patients, 490 out of 729 segments were automatically selected (67%). In 34 primary neurology patients the median (q1-q3) low frequency (LF) phase shift was higher in 19 survivors compared to 15 non-survivors (13° (6.3-35) versus 0.83° (-2.8-13), p = 0.0167). CA estimation using the NIRS-only methodology seems feasible in an ICU population using segment selection for more robust and consistent CA estimations. The 'NIRS-only' methodology needs further validation, but has the advantage of being non-invasive without the need for arterial blood pressure monitoring.

Inducing oscillations in positive end-expiratory pressure improves assessment of cerebrovascular pressure reactivity in patients with traumatic brain injury.

The cerebral pressure reactivity index (PRx), through intracranial pressure (ICP) measurements, informs clinicians about the cerebral autoregulation (CA) status in adult-sedated patients with traumatic brain injury (TBI). Using PRx in clinical practice is currently limited by variability over shorter monitoring periods. We applied an innovative method to reduce the PRx variability by ventilator-induced slow (1/min) positive end-expiratory pressure (PEEP) oscillations. We hypothesized that, as seen in a previous animal model, the PRx variability would be reduced by inducing slow arterial blood pressure (ABP) and ICP oscillations without other clinically relevant physiological changes. Patients with TBI were ventilated with a static PEEP for 30 min (PRx period) followed by a 30-min period of slow [1/min (0.0167 Hz)] +5 cmH2O PEEP oscillations (induced (iPRx period). Ten patients with TBI were included. No clinical monitoring was discontinued and no additional interventions were required during the iPRx period. The PRx variability [measured as the standard deviation (SD) of PRx] decreased significantly during the iPRx period from 0.25 (0.22-0.30) to 0.14 (0.09-0.17) (P = 0.006). There was a power increase around the induced frequency (1/min) for both ABP and ICP (P = 0.002). In conclusion, 1/min PEEP-induced oscillations reduced the PRx variability in patients with TBI with ICP levels <22 mmHg. No other clinically relevant physiological changes were observed. Reduced PRx variability might improve CA-guided perfusion management by reducing the time to find "optimal" perfusion pressure targets. Larger studies with prolonged periods of PEEP-induced oscillations are required to take it to routine use.NEW & NOTEWORTHY Cerebral autoregulation assessment requires sufficient slow arterial blood pressure (ABP) waves. However, spontaneous ABP waves may be insufficient for reliable cerebral autoregulation estimations. Therefore, we applied a ventilator "sigh-function" to generate positive end-expiratory pressure oscillations that induce slow ABP waves. This method demonstrated a reduced variability of the pressure reactivity index, commonly used as continuous cerebral autoregulation measure in a traumatic brain injury population.

A head-to-head comparison of EQ-5D-5L and SF-6D in Dutch patients with fractures visiting a Fracture Liaison Service.

AIMS: This study compared the psychometric properties of EQ-5D-5L and SF-6D to assess the interchangeability of both instruments in patients with a recent fracture presenting at a Fracture Liaison Service (FLS). MATERIALS AND METHODS: Data from a prospective observational study in a Dutch FLS clinic were used. Over 3 years, subjects were interviewed at several time points using EQ-5D-5L and SF-36. Floor and ceiling effects were evaluated. Agreement was evaluated by intra-class correlation coefficients and visualized in Bland-Altman plots. Spearman's rank correlation coefficients were applied to assess convergent validity. Mann-Whitney U test or Kruskal-Wallis H test as well as effect size (ES) were used to explore known-groups validity. Responsiveness was explored using standardized response mean (SRM) and ES. For each measurement property, hypotheses on direction and magnitude of effects were formulated. RESULTS: A total of 499 patients were included. EQ-5D-5L had a considerable ceiling effect in comparison to SF-6D (21 vs. 1.2%). Moderate agreement between the (UK and Dutch) EQ-5D-5L and SF-6D was identified with intra-class correlation coefficients of 0.625 and 0.654, respectively. Bland-Altman plots revealed proportional bias as the differences in utilities between two instruments were highly dependent on the health states. High correlation between instruments was found (UK: rho = 0.758; Dutch: rho = 0.763). EQ-5D-5L and SF-6D utilities showed high correlation with physical component score but low correlation with mental component score of SF-36. Both instruments showed moderate discrimination (ES > 0.5) for subgroup by baseline fracture type, and moderate responsiveness (SRM > 0.5) in patients that sustained a subsequent fracture. CONCLUSION: Both EQ-5D-5L and SF-6D appeared to be valid utility instruments in patients with fractures attending the FLS. However, they cannot be used interchangeably given only moderate agreement was identified, and differences in utilities and ceiling effect were revealed. Comparable construct validity and responsiveness were indicated, and neither instrument was found to be clearly superior.

The EQ-5D and SF-36 as generic multi-domain questionnaires are widely used to measure the health-related quality-of-life (HRQoL) in a sample of the persons who suffer from the diseases or the general population. Their responses could be converted to patients or societal Health State Utility Values (HSUVs) with the range of 0 ("death") to 1 ("full health"). A specific application of HSUV is to calculate quality-adjusted life years as the indicator of effectiveness to evaluate whether the cost of a new intervention is justified in terms of health gains through cost-utility analysis in health economics, the evidence can be further used to inform decision-making. However, different instruments differ in construct and valuation, potentially leading to different estimates for the person's same "health state", and healthcare decisions could be compromised when researchers or decision-makers are not aware of potential differences in HSUV. Therefore, it is important to gain insight into the specific psychometric properties of these instruments, and to understand whether instruments are interchangeable. Our study is based on data from a Dutch Fracture Liaison Service (FLS is a program for secondary fracture prevention), compared the psychometric properties and interchangeability of two instruments (EQ-5D-5L and SF-6D) in patients with a recent fracture presenting at the FLS, and suggested both instruments are valid in utility elicitation in our target population. However, they cannot be used interchangeably given only moderate agreement and differences in utilities. Neither instrument was found to be clearly superior given comparable construct and longitudinal validity, but different instruments values in different aspects of HRQoL assessment.

Effectiveness and cost-effectiveness of dynamic bracing versus standard care alone in patients suffering from osteoporotic vertebral compression fractures: protocol for a multicentre, two-armed, parallel-group randomised controlled trial with 12 months of follow-up.

INTRODUCTION: Patients with osteoporosis may suffer from a fracture after minimal trauma. Osteoporotic vertebral compression fractures (OVCFs) are among the most common fractures, often leading to substantial pain. There is a need for evidence-based conservative treatment to aid in the management of OVCFs. The objective of this randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of dynamic bracing in addition to standard care for improving quality of life (QoL) in patients suffering from an OVCF. METHODS AND ANALYSIS: Ninety-eight postmenopausal women from two academic and four community hospitals with a recent symptomatic thoracolumbar OVCF will be randomised into either the standard care or dynamic bracing group. In the dynamic bracing group, the Spinova Osteo orthosis will be used in addition to standard care. Standard care comprises pain control with analgesics, physical therapy and osteoporosis medication. The primary outcome parameter is QoL 1 year after inclusion, as measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life. A trial-based economic evaluation consisting of both cost-effectiveness analysis and cost-utility analysis will be performed based on empirical data obtained in the RCT. A process evaluation will assess the feasibility of dynamic bracing. All outcomes will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Medical Ethics Committee, University Hospital Maastricht and Maastricht University (METC azM/UM) (NL74552.068.20/METC 20-055). Patients will be included only after verification of eligibility and obtaining written informed consent. Results will be disseminated via the Dutch National Osteoporosis Patient Society and via publications and conferences. TRIAL REGISTRATION NUMBER: NL8746.

Serial Assessment of Myocardial Injury Markers in Mechanically Ventilated Patients With SARS-CoV-2 (from the Prospective MaastrICCht Cohort).

Myocardial injury in COVID-19 is associated with in-hospital mortality. However, the development of myocardial injury over time and whether myocardial injury in patients with COVID-19 at the intensive care unit is associated with outcome is unclear. This study prospectively investigates myocardial injury with serial measurements over the full course of intensive care unit admission in mechanically ventilated patients with COVID-19. As part of the prospective Maastricht Intensive Care COVID cohort, predefined myocardial injury markers, including high-sensitivity cardiac troponin T (hs-cTnT), N-terminal pro-B-type natriuretic peptide (NT-proBNP), and electrocardiographic characteristics were serially collected in mechanically ventilated patients with COVID-19. Linear mixed-effects regression was used to compare survivors with nonsurvivors, adjusting for gender, age, APACHE-II score, daily creatinine concentration, hypertension, diabetes mellitus, and obesity. In 90 patients, 57 (63%) were survivors and 33 (37%) nonsurvivors, and a total of 628 serial electrocardiograms, 1,565 hs-cTnT, and 1,559 NT-proBNP concentrations were assessed. Log-hs-cTnT was lower in survivors compared with nonsurvivors at day 1 (ß -0.93 [-1.37; -0.49], p <0.001) and did not change over time. Log-NT-proBNP did not differ at day 1 between both groups but decreased over time in the survivor group (ß -0.08 [-0.11; -0.04] p <0.001) compared with nonsurvivors. Many electrocardiographic abnormalities were present in the whole population, without significant differences between both groups. In conclusion, baseline hs-cTnT and change in NT-proBNP were strongly associated with mortality. Two-thirds of patients with COVID-19 showed electrocardiographic abnormalities. Our serial assessment suggests that myocardial injury is common in mechanically ventilated patients with COVID-19 and is associated with outcome.

Nationwide implementation of a decision aid on vaginal birth after cesarean: a before and after cohort study.

OBJECTIVES: Woman with a history of a previous cesarean section (CS) can choose between an elective repeat CS (ERCS) and a trial of labor (TOL), which can end in a vaginal birth after cesarean (VBAC) or an unplanned CS. Guidelines describe women's rights to make an informed decision between an ERCS or a TOL. However, the rates of TOL and vaginal birth after CS varies greatly between and within countries. The objective of this study is to asses nation-wide implementation of counselling with a decision aid (DA) including a prediction model, on intended delivery compared to care as usual. We hypothesize that this may result in a reduction in practice variation without an increase in cesarean rates or complications. METHODS: In a multicenter controlled before and after cohort study we evaluate the effect of nation-wide implementation of a DA. Practice variation was defined as the standard deviation (SD) of TOL percentages. RESULTS: A total of 27 hospitals and 1,364 women were included. A significant decrease was found in practice variation (SD TOL rates: 0.17 control group vs. 0.10 intervention group following decision aid implementation, p=0.011). There was no significant difference in the ERCS rate or overall CS rates. A 21% reduction in the combined maternal and perinatal adverse outcomes was seen. CONCLUSIONS: Nationwide implementation of the DA showed a significant reduction in practice variation without an increase in the rate of cesarean section or complications, suggesting an improvement in equality of care.

Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial.

BACKGROUND: Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. METHODS: This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. DISCUSSION: The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04101773.

Long-term sickness absence in a working population: development and validation of a risk prediction model in a large Dutch prospective cohort.

BACKGROUND: Societal expenditures on work-disability benefits is high in most Western countries. As a precursor of long-term work restrictions, long-term sickness absence (LTSA) is under continuous attention of policy makers. Different healthcare professionals can play a role in identification of persons at risk of LTSA but are not well trained. A risk prediction model can support risk stratification to initiate preventative interventions. Unfortunately, current models lack generalizability or do not include a comprehensive set of potential predictors for LTSA. This study is set out to develop and validate a multivariable risk prediction model for LTSA in the coming year in a working population aged 45-64 years. METHODS: Data from 11,221 working persons included in the prospective Study on Transitions in Employment, Ability and Motivation (STREAM) conducted in the Netherlands were used to develop a multivariable risk prediction model for LTSA lasting ≥28 accumulated working days in the coming year. Missing data were imputed using multiple imputation. A full statistical model including 27 pre-selected predictors was reduced to a practical model using backward stepwise elimination in a logistic regression analysis across all imputed datasets. Predictive performance of the final model was evaluated using the Area Under the Curve (AUC), calibration plots and the Hosmer-Lemeshow (H&L) test. External validation was performed in a second cohort of 5604 newly recruited working persons. RESULTS: Eleven variables in the final model predicted LTSA: older age, female gender, lower level of education, poor self-rated physical health, low weekly physical activity, high self-rated physical job load, knowledge and skills not matching the job, high number of major life events in the previous year, poor self-rated work ability, high number of sickness absence days in the previous year and being self-employed. The model showed good discrimination (AUC 0.76 (interquartile range 0.75-0.76)) and good calibration in the external validation cohort (H&L test: p = 0.41). CONCLUSIONS: This multivariable risk prediction model distinguishes well between older workers with high- and low-risk for LTSA in the coming year. Being easy to administer, it can support healthcare professionals in determining which persons should be targeted for tailored preventative interventions.

Physical, Psychological, and Social Factors Associated with Exacerbation-Related Hospitalization in Patients with COPD.

BACKGROUND AND OBJECTIVE: Exacerbation(s) of chronic obstructive pulmonary disease (eCOPD) entail important events describing an acute deterioration of respiratory symptoms. Changes in medication and/or hospitalization are needed to gain control over the event. However, an exacerbation leading to hospitalization is associated with a worse prognosis for the patient. The objective of this study is to explore factors that could predict the probability of an eCOPD-related hospitalization. METHODS: Data from 128 patients with COPD included in a prospective, longitudinal study were used. At baseline, physical, emotional, and social status of the patients were assessed. Moreover, hospital admission during a one year follow-up was captured. Different models were made based on univariate analysis, literature, and practice. These models were combined to come to one final overall prediction model. RESULTS: During follow-up, 31 (24.2%) participants were admitted for eCOPD. The overall model contained six significant variables: currently smoking (OR = 3.93), forced vital capacity (FVC; OR = 0.97), timed-up-and-go time (TUG-time) (OR = 14.16), knowledge (COPD knowledge questionnaire, percentage correctly answered questions (CIROPD%correct)) (<60% (OR = 1.00); 60%-75%: (OR = 0.30); >75%: (OR = 1.94), eCOPD history (OR = 9.98), and care dependency scale (CDS) total score (OR = 1.12). This model was well calibrated (goodness-of-fit test: p = 0.91) and correctly classified 79.7% of the patients. CONCLUSION: A combination of TUG-time, eCOPD-related admission(s) prior to baseline, currently smoking, FVC, CDS total score, and CIROPD%correct allows clinicians to predict the probability of an eCOPD-related hospitalization.

Impact on perinatal health and cost-effectiveness of risk-based care in obstetrics: a before-after study.

BACKGROUND: Obstetric health care relies on an adequate antepartum risk selection. Most guidelines used for risk stratification, however, do not assess absolute risks. In 2017, a prediction tool was implemented in a Dutch region. This tool combines first trimester prediction models with obstetric care paths tailored to the individual risk profile, enabling risk-based care. OBJECTIVE: To assess impact and cost-effectiveness of risk-based care compared to care-as-usual in a general population. METHODS: A before-after study was conducted using 2 multicenter prospective cohorts. The first cohort (2013-2015) received care-as-usual; the second cohort (2017-2018) received risk-based care. Health outcomes were (1) a composite of adverse perinatal outcomes and (2) maternal quality-adjusted life-years. Costs were estimated using a health care perspective from conception to 6 weeks after the due date. Mean costs per woman, cost differences between the 2 groups, and incremental cost effectiveness ratios were calculated. Sensitivity analyses were performed to evaluate the robustness of the findings. RESULTS: In total 3425 women were included. In nulliparous women there was a significant reduction of perinatal adverse outcomes among the risk-based care group (adjusted odds ratio, 0.56; 95% confidence interval, 0.32-0.94), but not in multiparous women. Mean costs per pregnant woman were significantly lower for risk-based care (mean difference, -€2766; 95% confidence interval, -€3700 to -€1825). No differences in maternal quality of life, adjusted for baseline health, were observed. CONCLUSION: In the Netherlands, risk-based care in nulliparous women was associated with improved perinatal outcomes as compared to care-as-usual. Furthermore, risk-based care was cost-effective compared to care-as-usual and resulted in lower health care costs.

Hypertensive organ damage predicts future cognitive performance: A 9-year follow-up study in patients with hypertension.

Hypertension is associated with cognitive deficits, probably caused by cerebral small vessel disease. The authors examined whether additional presence of cardiac and renal organ damages, and their combined presence, are associated with future cognitive performance. In 78 patients with essential hypertension (mean age 51.2 ± 12.0 years), brain damage was determined by MRI features, cardiac damage by left ventricular mass index (LVMI), and renal damage by estimated glomerular filtration rate (eGFR) and albuminuria. At 9-year follow-up, neuropsychological assessment was performed. LVMI was associated with future lower cognition (P = 0.032), independent of age, sex, premorbid cognition, and brain damage, but eGFR and albuminuria were not. The presence of 2 or 3 types of organ damage compared to none was associated with future lower cognition. Increasing number of hypertensive organ damages, and cardiac damage independently of brain damage, might indicate a more severe hypertensive disease burden and could help to identify patients at risk of cognitive problems.

The Maastricht Frailty Screening Tool for Hospitalised Patients (MFST-HP) to Identify Non-Frail Patients.

BACKGROUND: The Maastricht frailty screening tool for hospitalised patients (MFST-HP) is a frailty screening tool that is fully integrated in the nursing assessment at admission. This study aims to determine the predictive value of the MFST-HP for the health outcomes length of hospital stay, discharge destination, readmission and mortality. METHODS: Data of 2691 hospitalised patients (70+), admitted between 01-01-2013 and 31-12-2013, were included in the study. The predictive value of the MFST-HP was analysed by means of receiver operating characteristics curves. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for different MFST-HP cut-off scores were examined. RESULTS: Mean age of the population was 78.9 years (SD 6.4) and their average length of stay was 10.2 days (SD 9.7). Nearly 75.0% of the patients were discharged to their home and around. Approximately 25% of the patients were readmitted within 120 days. Mortality rates were 4.3% and 9.5% (within 30 or 120 days postdischarge, respectively). The area under the curve was moderate and varied from 0.50 to 0.69 for the different outcomes. As a result of high values on negative predictive value (between 73.5% and 96.7%) the MFST-HP is able to rule out a large proportion of non-frail patients. In this study 84% of the patients had a MFST-HP score of ≥ 6, suggested as most favourable cut off. CONCLUSIONS: The MFST-HP seems to operate more strongly as a non-frailty indicator than as a frailty indicator and may in this respect help professionals to decide upon subsequent care. The MFST-HP is able to rule out 84% of the non-frail population in this study. The remaining 16% need to be assessed by means of a comprehensive geriatric assessment or rapid geriatric assessment, to gain more insight in the level of vulnerability in the frail-group.

Diagnostic Accuracy and Clinical Implications of Translabial Ultrasound for the Assessment of Levator Ani Defects and Levator Ani Biometry in Women With Pelvic Organ Prolapse: A Systematic Review.

OBJECTIVE: The aim of this study was to assess the diagnostic accuracy and clinical implications of translabial 3-dimensional (3D) ultrasound for the assessment of levator ani defects and biometry in women with pelvic organ prolapse (POP). METHODS: We performed a systematic literature search through computerized databases including MEDLINE (via PubMed), EMBASE (via OvidSP), and the Cochrane Library using both medical subject headings and text terms from January 1, 2003, to December 25, 2015.We included articles that reported on POP status and diagnostic accuracy measurements with translabial 3D ultrasound or transperineal ultrasound for the detection of levator ani defects or for measuring pelvic floor biometry, that is, levator ani hiatus, or reported on the clinical relevance of using translabial 3D ultrasound for levator ani defects or measuring pelvic floor biometry in women with POP. RESULTS: Thirty-one articles were selected in accordance with parts of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines that can be applied to studies of diagnostic accuracy. Twenty-two articles (71%) are coauthored by 1 expert in this field. Detecting levator ani defects with translabial 3D ultrasound compared with magnetic resonance imaging showed a moderate to good agreement, whereas measuring hiatal biometry on translabial 3D ultrasound compared with magnetic resonance imaging showed a moderate to very good agreement.The interobserver agreement for diagnosing levator ani defects and measuring the levator hiatal area showed a moderate to very good agreement. Furthermore, levator ani defects increase the risk of cystocele and uterine prolapse, and levator ani defects are associated with recurrent POP.Finally, a larger hiatus was associated with POP and recurrent POP. CONCLUSIONS: Translabial 3D ultrasound is reproducible for diagnosing levator ani defects and ballooning hiatus. Both levator ani defects and a larger hiatal area are, in a selected population of patients with pelvic floor dysfunction, associated with POP and recurrent POP. More research is needed concerning external validation because most data in this article are coauthored by 1 expert in this field.

A protocol of a randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis: the Lumbar Interbody Fusion Trial (LIFT).

BACKGROUND: With a steep increase in the number of instrumented spinal fusion procedures, there is a need for comparative data to develop evidence based treatment recommendations. Currently, the available data on cost and clinical effectiveness of the two most frequently performed surgeries for lumbar spondylolisthesis, transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF), are not sufficient. Therefore, current guidelines do not advise which is the most appropriate surgical treatment strategy for these patients. Non-randomized studies comparing TLIF and PLIF moreover suggest that TLIF is associated with fewer complications, less blood loss, shorter surgical time and hospital duration. TLIF may therefore be more cost-effective. The results of this study will provide knowledge on short- and long-term clinical and economical effects of TLIF and PLIF procedures, which will lead to recommendations for treating patients with lumbar spondylolisthesis. METHODS: Multicenter blinded Randomized Controlled Trial (RCT; blinding for the patient and statistician, not for the clinician and researcher). A total of 144 patients over 18 years old with symptomatic single level lumbar degenerative, isthmic or iatrogenic spondylolisthesis whom are candidates for LIF (lumbar interbody fusion) surgery through a posterior approach will be randomly allocated to TLIF or PLIF. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) a process evaluation. The primary clinical outcome measures are: change in disability measured with Oswestry Disability Index (ODI) and change in quality adjusted life years (QALY) measured with EQ-5D-5L. Secondary clinical outcome measures are: Short Form (36) Health Survey (SF-36), VAS back pain, VAS leg pain, Hospital Anxiety Depression Scale (HADS), complications, productivity related costs (iPCQ) and medical costs (iMCQ). Measurements will be carried out at five fixed time points (pre-operatively and at 3, 6, 12 and 24 months). DISCUSSION: It is hypothesized that TLIF, compared to PLIF, has similar clinical outcome or is possibly better in reducing disability. Moreover, direct medical costs are expected to be lower due to less surgical morbidity, shorter hospital stay and shorter surgical time. Indirect costs are assumed to be lower for TLIF as well, because we suspect less working days are lost. Currently, prospective data comparing clinical and cost-effectiveness of both techniques are not available. Therefore, in clinical practice both techniques are used and the choice for technique is greatly based on surgeon's preference. The demand for spinal fusion surgery has risen steeply over the last 10 years and is expected to increase even further in the near future. As a result, the burden on society (and the working population) will increase. In case our hypothesis is confirmed, treatment guidelines will be adapted, and TLIF will be recommended as first choice surgical treatment of lumbar spondylolisthesis. Ultimately this will lead to reduction of (direct and indirect) costs and better clinical outcome for spondylolisthesis patients eligible for instrumented spinal surgery. TRIAL REGISTRATION NUMBER: Netherlands Trial Registry, number 5722 (registration date March 30, 2016).

Care-as-usual provided to formerly preeclamptic women in the Netherlands in the next pregnancy: health care consumption, costs and maternal and child outcome.

OBJECTIVE: To explore hospital costs by pregnant women with a history of early-onset preeclampsia or HELLP syndrome, managed according to customary, but non-standardized prenatal care, by relating maternal and child outcome to maternal health care expenditure. STUDY DESIGN: This was a cohort study, in women of 18 years or older who suffered from early-onset preeclampsia or HELLP syndrome in their previous pregnancy (n=104). We retrieved data retrospectively from hospital information systems and medical records of patients who had received customary, non-standardized prenatal care between 1996 and 2012. Our analyses focused on the costs generated between the first antenatal visit at the outpatient clinic and postpartum hospital discharge. Outcome measures were hospital resource use, costs, maternal and child outcome (recurrence of preeclampsia or HELLP syndrome, incidence of eclampsia, gestational age at delivery, intrauterine fetal demise, small-for-gestational-age birth and low 5min Apgar score). We used linear regression analyses to evaluate whether maternal and child outcome and baseline characteristics correlated with hospital costs. RESULTS: Maternal hospital costs per patient averaged € 8047. The main cost drivers were maternal admissions and outpatient visits, together accounting for 80% of total costs. Primary cost drivers were preterm birth and recurrent preeclampsia or HELLP syndrome. CONCLUSION: Hospital costs in the next pregnancy of formerly preeclamptic women varied widely with over 70% being medically unexplainable. The results of this study support the view that care standardization in these women can be expected to improve costs and efficacy of care without compromising outcome.

Cost-effectiveness of recurrence risk guided care versus care as usual in women who suffered from early-onset preeclampsia including HELLP syndrome in their previous pregnancy (the PreCare study).

BACKGROUND: Preeclampsia and HELLP syndrome may have serious consequences for both mother and fetus. Women who have suffered from preeclampsia or the HELLP syndrome, have an increased risk of developing preeclampsia in a subsequent pregnancy. However, most women will develop no or only minor complications. In this study, we intend to determine cost-effectiveness of recurrence risk guided care versus care as usual in pregnant women with a history of early-onset preeclampsia. METHODS/DESIGN: We developed a prediction model to estimate the individual risk of recurrence of early-onset preeclampsia and the HELLP syndrome. In a before-after study, pregnant women with preeclampsia or HELLP syndrome in their previous pregnancy receiving care as usual (before introduction of the prediction model) will be compared with women receiving recurrence risk guided care (after introduction of the prediction model). Eligible and pregnant women will be recruited at six university hospitals and seven large non-university tertiary referral hospitals in the Netherlands. The primary outcome measure is the recurrence of early-onset preeclampsia or HELLP syndrome in women allocated to the regular monitoring group. For the economic evaluation, a modelling approach will be used. Costs and effects of recurrence risk guided care with those of care as usual will be compared by means of a decision model. Two incremental cost-effectiveness ratios will be calculated: 1) cost per Quality Adjusted Life Year (mother unit of analysis) and 2) cost per live born child (child unit of analysis). DISCUSSION: This is, to our knowledge, the first study that evaluates prospectively the efficacy of a multivariable prediction rule for recurrent hypertensive disease in pregnancy. Results of this study could either be integrated into the current guideline on Hypertensive Disorders in Pregnancy, or be used to develop a new guideline.