Objective
Social functioning is an important factor in the evaluation of postoperative health‐related quality of life (HRQoL) for pituitary adenoma patients. In a prospective cohort study ...multidimensional HRQoL of non‐functioning (NFA) and functioning (FA) pituitary adenoma patients were evaluated following endoscopic endonasal surgery using the endoscopic endonasal sinus and skull base surgery questionnaire (EES‐Q).
Methods
Prospectively, 101 patients were included. The EES‐Q was completed preoperatively and postoperatively (2 weeks, 3 months, 1 year). Sinonasal complaints were completed daily during the first week postoperatively. Preoperative and postoperative scores were compared. A generalized estimating equation (uni‐ and multivariate) analysis was performed to identify significant HRQoL changes related to selected covariates.
Results
Two weeks postoperatively, physical (p < .05) and social (p < .05) HRQoL are worse and psychological (p < .05) HRQoL improved compared with preoperatively. Three months postoperatively, psychological HRQoL (p = .01) trended back to baseline and no differences in physical or social HRQoL were reported. One year postoperatively, psychological (p = .02) and social (p = .04) HRQoL improved while physical HRQoL remained stable. FA patients report a worse HRQoL preoperatively (social, p < .05) and 3 months postoperatively (social, p < .02 and psychological, p < .02). Sinonasal complaints peak in the first days postoperatively and gradually return to presurgical levels 3 months postoperatively.
Conclusions
The EES‐Q provides meaningful information on multidimensional HRQoL to improve patient‐centred health care. Social functioning remains the most difficult area in which to achieve improvements. Despite the relatively modest sample size, there is some indication that the FA group continues to show a downward trend (and thus improvement) even after 3 months, when most other parameters reach stability.
Level of evidence
Level II—B.
The EES‐Q provides meaningful information on multidimensional HRQoL in one single instrument to improve patient‐centred health care. Social HRQoL warrants extra attention as patients with pituitary adenoma experience the most inconveniences in social HRQoL preoperatively and during follow‐up.
Abstract
Background
Lipofilling has become popular as a treatment to improve aging-related skin characteristics (eg, wrinkles, pigmentation spots, pores, or rosacea). Different additives such as ...platelet-rich plasma (PRP) or stromal vascular fraction (SVF) have been combined with lipofilling to increase the therapeutic effect of adipose-derived stromal cells (ASCs).
Objectives
The aim of this study was to examine the hypothesis that mechanically isolated SVF augments the therapeutic effect of PRP-supplemented lipofilling to improve facial skin quality.
Methods
This prospective, double-blind, placebo-controlled, randomized trial was conducted between 2016 and 2019. In total, 28 female subjects were enrolled; 25 completed the follow-up. All patients received PRP-supplemented lipofilling with either mechanically isolated SVF or saline. SVF was isolated by fractionation of adipose tissue (tSVF). Results were evaluated by changes in skin elasticity and transepidermal water loss, changes in skin-aging-related features, ie, superficial spots, wrinkles, skin texture, pores, vascularity, and pigmentation, as well as patient satisfaction (FACE-Q), recovery, and number of complications up to 1 year postoperative.
Results
The addition of tSVF to PRP-supplemented lipofilling did not improve skin elasticity, transepidermal water loss, or skin-aging-related features. No improvement in patient satisfaction with overall facial appearance or facial skin quality was seen when tSVF was added to PRP-supplemented lipofilling.
Conclusions
In comparison to PRP-supplemented lipofilling, PRP-supplemented lipofilling combined with tSVF does not improve facial skin quality or patient satisfaction in a healthy population. PRP-supplemented lipofilling combined with tSVF can be considered a safe procedure.
Level of Evidence: 2
Efforts to evaluate HRQoL and calculate quality-adjusted life years (QALYs) for infants less than 12 months of age are hampered by the lack of preference-based HRQoL instruments for this group. To ...fill this gap, we developed the Infant Quality of life Instrument (IQI), which is administered through a mobile application. This article explains how weights were derived for the 4 levels of each health item.
The IQI includes 7 health items: sleeping, feeding, breathing, stooling/poo, mood, skin, and interaction. In an online survey, respondents from the general population (n = 1409) and primary caregivers (n = 1229) from China, the United Kingdom, and the United States were presented with 10 discrete choice scenarios. Coefficients for the item levels were obtained with a conditional logit model.
The highest coefficients were found for sleeping, feeding, and breathing. All coefficients for these items were negative and logically ordered, meaning that more extreme levels were less preferred. Stooling, mood, skin, and interaction showed some irregularities in the ordering of coefficients. Results for caregivers and the general population were about the same.
The IQI is the first generic instrument to assess overall HRQoL in infants up to 1 year of age. It is short and easy to administer through a mobile application. We demonstrated how to derive values for infant health states with a discrete choice methodology. Our next step will be to normalize these values into utilities ranging from 0 (dead) to 1 (best health state) and to collect IQI values in a clinical population.
Abstract
Background
Autologous lipofilling is an emerging procedure to treat and possibly reverse dermal scars and to reduce scar-related pain, but its efficacy and mechanisms are poorly understood.
...Objectives
The aim of this study was to test the hypothesis that repeated lipografts reverse dermal scars by reinitiation of wound healing.
Methods
In a prospective, non-placebo-controlled clinical study, 27 adult patients with symptomatic scars were given 2 lipofilling treatments at 3-month intervals. As primary outcome, clinical effects were measured with the Patient and Observer Scar Assessment Scale (POSAS). Scar biopsies were taken before and after treatments to assess scar remodeling at a cellular level.
Results
Twenty patients completed the study. Patients’ scars improved after lipofilling. The total POSAS scores (combined patient and observer scores) decreased from 73.2 14.7 points (mean standard deviation) pretreatment to 46.1 14.0 and 32.3 13.2 points after the first and second lipofilling treatment, respectively. Patient POSAS scores decreased from 37.3 8.8 points to 27.2 11.3 and 21.1 11.4 points, whereas observer POSAS scores decreased from 35.9 9.5 points to 18.9 6.0 and 11.3 4.5 points after the first and second treatment, respectively. After each lipofilling treatment, T lymphocytes, mast cells, and M2 macrophages had invaded scar tissue and were associated with increased vascularization. In addition, the scar-associated epidermis showed an increase in epidermal cell proliferation to levels similar to that normal in skin. Moreover, lipofilling treatment caused normalization of the extracellular matrix organization towards that of normal skin.
Conclusions
Autologous lipofilling improves the clinical outcome of dermal scars through the induction of a pro-regenerative immune response, increased vascularization, and epidermal proliferation and remodeling of scar tissue extracellular matrix.
Level of Evidence: 4
To decrease the burden of breast cancer (BC), the Chinese government recently introduced biennial mammography screening for women aged 45-70 years. In this study, we assess the effectiveness and ...cost-effectiveness of implementing this programme in urban China using a micro-simulation model.
The 'Simulation Model on radiation Risk and breast cancer Screening' (SiMRiSc) was applied, with parameters updated based on available data for the Chinese population. The base scenario was biennial mammography screening for women aged 45-70 years, and this was compared to a reference population with no screening. Seven alternative scenarios were then simulated by varying the screening intervals and participant ages. This analysis was conducted from a societal perspective. The discounted incremental cost-effectiveness ratio (ICER) was compared to a threshold of triple the gross domestic product (GDP) per life years gained (LYG), which was 30 785 USD/LYG. Univariate sensitivity analyses were conducted to evaluate model robustness. In addition, a budget impact analysis was performed by comparing biennial screening with no screening at a time horizon of 10 years.
Compared with no screening, the base scenario was cost-effective in urban China, giving a discounted average cost-effectiveness ratio (ACER) of 17 309 USD/LYG. The model was most sensitive to the cost of mammography per screen, followed by mean size of self-detected tumours, mammographic breast density and the cumulative lifetime risk of BC. The efficient frontier showed that at a threshold of 30 785 USD/LYG, the base scenario was the optimal scenario with a discounted ICER of 25 261 USD/LYG. Over 10 years, screening would incur a net cost of almost 38.1 million USD for a city with 1 million citizens.
Compared to no screening, biennial mammography screening for women aged from 45-70 is cost-effective in urban China.
Cardiac tachyarrhythmias are the leading cause of morbidity and mortality in patients with repaired tetralogy of Fallot (TOF). We evaluated risk factors for sustained ventricular tachyarrhythmia (VT) ...and atrial tachyarrhythmia (ATA) in these patients. Patients (n = 319) who underwent cardiac magnetic resonance (CMR) imaging at two tertiary centers between 2007 and 2016 were assessed. Potential risk markers, based on history, cardiac magnetic resonance imaging (CMR), electrocardiography (ECG) and echocardiography, were analyzed for prediction of the primary endpoint of VT, and the secondary endpoint of ATA. During a follow-up of 3.5 (0.9–6.1) years, 20 (6.3%) patients reached the primary endpoint, and 30 (9.4%) the secondary endpoint. Multivariable cox hazards regression identified right ventricular (RV) end-diastolic volume (Hazard ratio HR 2.03, per 10 ml/m
2
increase; p = 0.02), RV end-systolic volume (HR 3.04, per 10 ml/m
2
increase; p = 0.04), RV mass (HR 1.88, per 10 g/m
2
increase; p = 0.02), and RV ejection fraction (HR 6.06, per 10% decrease; p = 0.02) derived from CMR to be independent risk factors of VT. In addition, QRS-duration (HR 1.70, per 10 ms increase; p = 0.001) and body mass index (BMI: HR 1.8, per 5 kg/m
2
increase; p = 0.02) were independent markers of VT. Older age at TOF repair (HR 1.33, per 2 months increase; p = 0.03) and BMI (HR 1.76, per 5 kg/m
2
increase; p < 0.001) independently predicted ATA. RV systolic dysfunction, hypertrophy and dilatation on CMR, together with QRS prolongation, and obesity are predictive of VT in TOF patients. Older age at TOF repair and obesity were associated with the occurrence of ATA.
Adherence to medication is a favourable with regard to survival after kidney, heart and liver transplantation. Little is known about adherence to medication in lung transplant recipients. To ...determine the prevalence of adherence and identify risk factors of non-adherence (NA) we evaluated adherence to tacrolimus in adult lung transplant recipients who were at least 1 year after transplantation.
Tacrolimus intake was prospectively monitored using the Medication Event Monitoring System (MEMS). Recipients qualified as adherent if a timing-adherence score of ≥ 80% was reached. Patients' characteristics and possible risk factors for NA were collected using the Karnofsky Performance Index, Self-Care Agency ASA Scale, State-Trait Anxiety Inventory, Zung Self-Rating Depression Scale, and the Long-Term Medication Behavior Self-Efficacy Scale.
Ninety-one recipients used MEMS for a median of 95 days (range 50 to 124 days) and were included. They showed a median timing-adherence score of 98.1% (range 31.2% to 100%). A timing-adherence score of ≥ 80% was seen in 92.3% of the recipients. Multiple logistic regression showed an association of lower timing-adherence scores with younger age and lower ability of self-care.
Adherence to immunosuppressive therapy was very high in lung transplant recipients. Only 7.7% of the recipients were non-adherent. Younger recipients and recipients with lower ability of self-care appeared to be at risk for NA. Follow-up of clinical data is needed to determine whether NA is associated with poorer outcome, specifically bronchiolitis obliterans syndrome.
To develop patient-centered health content for a novel generic instrument (Château Santé Base CS-Base) that is suitable to generate values for health status.
Candidate items were drawn from existing ...health frameworks of generic health status instruments and placed in a diagram (HealthFANTM, Zeist, the Netherlands). Through an online survey, patients with a wide range of diseases were asked to select the 9 items that were most important to them. The importance of the items for the whole study group was determined by means of frequency distributions.
After handling duplicates and overlap, the remaining set of 47 items was placed in the HealthFAN. Among the 2256 Dutch patients who started the survey, the most common diagnoses were neck and back pain, diabetes, and asthma/chronic obstructive pulmonary disease. The 5 health items mentioned most frequently as most important were pain, personal relationships, fatigue, memory, and vision. Hearing and vision, anxiety and depression, and independence and self-esteem seemed highly intertwined, so we chose to pair these items.
A total of 12 health items were included in CS-Base. Its content is largely based on patient input and enables classification of patients' health status. CS-Base can be administered by means of an app on a mobile phone, which makes it a convenient and attractive tool for patients and researchers.
Background
To improve participation in the Dutch cervical cancer screening, a self-sampling device (SSD) was introduced in 2017 into the Dutch population-based screening programme (PBS) for the early ...detection of cervical cancer. The aim of this study was to gather potential preferences and experiences that might influence a woman’s decision to use the SSD in the Dutch PBS.
Methods
A scoping review was performed in the PubMed database. Studies that assessed preferences and experiences of women regarding the SSD were included, and preferences and experiences were extracted. In addition, in a qualitative study, the list of potential preferences and experiences specific for the Dutch PBS was extended based on semi-structured interviews with SSD users as well as non-SSD users who recently participated in the PBS, analysed in a structured manner by translating full sentences to key words.
Results
Ninety-eight studies were included in the scoping review and 16 interviews were performed. Frequently mentioned reasons for using the SSD, in both the interviews and the literature, were practicality and comfort. Frequently mentioned reasons for not using the SSD were fear of not performing the SSD procedure correctly and doubts on whether the results of the high-risk human papillomavirus (hrHPV) test will be reliable. A new positive experience elicited in the interviews was accessibility. Negative preferences and experiences were not being aware the SSD was an option, and the inconvenience that after an hrHPV-positive test result of the SSD, an additional smear test at the GP is necessary.
Conclusion
Several preferences and experiences play a role in the choice whether or not to use the SSD. Based on the currently found preferences and experiences, an app will be developed in order to assess which of these are the most important for women participating in the Dutch population-based cervical screening programme.
Background
Costs associated with extracorporeal membrane oxygenation (ECMO) are an important factor in establishing cost effectiveness. In this systematic review, we aimed to determine the total ...hospital costs of ECMO for adults.
Methods
The literature was retrieved from the PubMed/MEDLINE, EMBASE, and Web of Science databases from inception to 4 March 2020 using the search terms ‘extracorporeal membrane oxygenation’ combined with ‘costs’; similar terms or phrases were then added to the search, i.e. ‘Extracorporeal Life Support’ or ‘ECMO’ or ‘ECLS’ combined with ‘costs’. We included any type of study (e.g. randomized trial or observational cohort) evaluating hospital costs of ECMO in adults (age ≥18 years).
Results
A total of 1768 unique articles were retrieved during our search. We assessed 74 full-text articles for eligibility, of which 14 articles were selected for inclusion in this review; six papers were from the US, five were from Europe, and one each from Japan, Australia, and Taiwan. The sample sizes ranged from 16 to 18,684 patients. One paper exclusively used prospective cost data collection, while all other papers used retrospective data collection. Five papers reported charges instead of costs. There was large variation in hospital costs, ranging from US$22,305 to US$334,608 (2019 values), largely depending on the indication for ECMO support and location. The highest reported costs were for lung transplant recipients who were receiving ECMO support in the US, and the lowest reported costs were for extracorporeal cardiopulmonary resuscitation patients presenting with non-shockable rhythm in Japan. The additional costs of ECMO patients compared with non-ECMO patients varied between US$2518 and US$200,658. Personnel costs varied between 11 and 52% of the total amount.
Conclusions
ECMO therapy is an advanced and expensive technology, although reported costs differ considerably depending on ECMO indication and whether charges or costs are measured. Combined with the ongoing gathering of outcome data, cost effectiveness per ECMO indication could be determined in the future.