Treatment of chronic lower back pain (CLBP) should be stratified for best medical and economic outcome. To improve the targeting of potential participants for exclusive therapy offers from payers, ...Freytag et al. developed a tool to classify back pain chronicity classes (CC) based on claim data. The aim of this study was to evaluate the criterion validity of the model. Administrative claim data and self-reported patient information from 3,506 participants (2014-2021) in a private health insurance health management programme in Germany were used to validate the tool. Sensitivity, specificity, and Matthews' correlation coefficient (MCC) were calculated comparing the prediction with actual grades based on von Korff's graded chronic pain scale (GCPS). The secondary outcome was an updated view on direct health care costs (€) of patients with back pain (BP) grouped by GCPS. Results showed a fair correlation between predicted CC and actual GCPS grades. A total of 69.7% of all cases were correctly classified. Sensitivity and specificity rates of 54.6 and 76.4% underlined precision. Correlation between CC and GCPS with an MCC of 0.304 also indicated a fair relationship between prediction and observation. Cost data could be clearly grouped by GCPS: the higher the grade, the higher the costs and the use of health care. This was the first study to compare the predicted severity of BP using claim data with the actual severity of BP by GCPS. Based on the results, the usage of CC as a single tool to determine who receives CLBP treatment cannot be recommended. CC is a good tool to segment candidates for specific types of intervention in BP. However, it cannot replace a medical screening at the beginning of an intervention, as the rate of false negatives is too high. Trial registration The study was conducted using routinely collected data from an intervention, which was previously evaluated and registered retrospectively in the German Registry of Clinical Trials under DRKS00015463 (04/09/2018). Informed consent and the self-reported questionnaire have remained unchanged since the study and, therefore, are still valid according to the ethics proposal.
Abstract
Background
Nonspecific chronic low back pain (CLBP) is a complex symptom with numerous possible causes and influencing factors. Understanding how modifiable factors affect the course of CLBP ...is important for preventing progression. As the COVID-19 pandemic has changed the lifestyle of many people, this study paper assessed whether it also changed the influence of modifiable lifestyle factors (regular exercise and sedentary behaviour) and mental health factors (anxiety and depression) on CLBP pain intensity and disability by comparing the strength of these associations before and during the pandemic. We hypothesised that the importance of regular physical activity and good mental health for CLBP patients would increase during the pandemic.
Methods
These questions were investigated in a cross-sectional study of insurance claims data and self-reported data from various questionnaires from 3,478 participants in a German CLBP health intervention (2014–2021) by calculating pre- and intra-pandemic odds ratios (OR) and 95% confidence intervals (CI) for each variable of interest and outcome. Potential confounders were also considered. Pandemic status was treated as an effect modifier. Based on the date of enrolment, participants were classified as “pre-pandemic” or “pandemic”.
Results
Regularly exercising ≥ 4 h/week significantly reduced the odds of high disability for men (OR 0.49, 95% CI 0.31 – 0.79,
p
= 0.003) and women (OR 0.30, 95% CI 0.14 – 0.563,
p
= 0.002) and reduced the probability of severe pain in women (OR 0.37, 95% CI 0.21 – 0.65,
p
< 0.001). Each one-point increase in PHQ-4 score for anxiety and depression increased the OR of high pain intensity by 1.25 points (95% CI 1.18 – 1.34,
p
< 0.001). A clear impact of COVID-19 lockdowns was observed. In individuals who exercised ≥ 4 h/week the OR of high disability was 0.57 (95% CI 0.36 – 0.92,
p
= 0.021) in the pre-pandemic group compared to 0.29 (95% CI 0.12 – 0.56,
p
= 0.002) in the pandemic group. The probability of high disability increased from an OR of 1.42 (95% CI 1.33 – 1.52,
p
< 0.001) per marginal increase in the PHQ-4 scale before the pandemic, to an OR of 1.73 (95% CI 1.58 – 1.89,
p
< 0.001) during the pandemic.
Conclusions
The magnitude of association of the factors that influenced high pain intensity and disability increased during the pandemic. On the one hand, the protective effect of regular exercising was greater in participants surveyed during lockdown. On the other hand, a higher risk through anxiety or depression during the lockdown was identified. An additional study with objective measures of sedentary behaviour and physical activity is needed to validate these results. More in-depth investigation of lockdown-induced associations between reduced daily physical activity, increased levels of anxiety and depression, and their effects on CLPB could also be worthwhile.
Trial registration
This study used routinely collected data from a CLBP intervention that was previously evaluated and registered in the German Registry of Clinical Trials under DRKS00015463 (04/09/2018). The original ethics approval, informed consent and self-reported questionnaire have remained unchanged and are still valid.
Multidisciplinary biopsychosocial rehabilitation (MBR) is highly recommended for chronic lower back pain (CLBP) treatment, but its economic benefit remains to be clearly demonstrated. The purpose of ...this study is to analyse the effect of a 12-month MBR programme of behavioural change coaching and device-supported exercise on direct medical costs, sick leave and health-related quality of life (HRQOL) at 24 months.
An incremental cost-effectiveness analysis was conducted in Germany from a private health insurance perspective using data from a multi-centre, two-arm randomised controlled trial with parallel-group Zelen's randomisation and 24-month follow-up. After removing dissimilarities in characteristics between MBR and usual care (control) via propensity score matching, treatment effects were calculated using a difference-in-difference approach.
Base-case analysis of the MBR (n=112) and usual care group (n=111) showed an incremental cost-effectiveness ratio (ICER) of €8,296 per quality-adjusted life year (QALY) gained, indicating that the intervention was cost-effective. Compared to the controls, MBR reduced economically unaccounted sick leave due to back pain in the last six months by 17.5 days (p = 0.001) and had a positive effect on health-related quality of life (HRQOL) (0.046, p=0.026). Subgroup analysis of participants with major impairment demonstrated that a dominant intervention was possible, as reflected by an ICER of - €7,302 per QALY. Savings were driven by a - €1,824 reduction in back pain-specific costs. Moreover, sick leave was 27 days (p = 0.006) less in the MBR group.
This first cost-effectiveness study with combined data from a private health insurer and a controlled trial in Germany demonstrated that long term MBR for the treatment of CLBP is cost-effective. Subgroups with major impairment from back pain benefitted more from the intervention than those with minor impairment. MBR significantly reduced sick leave in all participants. Hence, it is a profitable intervention from a societal point of view.
The trial of the evaluation study was retrospectively registered in the German Clinical Trials Register under trial number DRKS00015463 retrospectively (dated 4 Sept 2018).
To facilitate access to evidence-based care for back pain, a German private medical insurance offered a health program proactively to their members. Feasibility and long-term efficacy of this ...approach were evaluated.
Using Zelen's design, adult members of the health insurance with chronic back pain according to billing data were randomized to the intervention (IG) or the control group (CG). Participants allocated to the IG were invited to participate in the comprehensive health program comprising medical exercise therapy and life style coaching, and those allocated to the CG to a longitudinal back pain survey. Primary outcomes were back pain severity (Korff's Chronic Pain Grade Questionnaire) as well as health-related quality of life (SF-12) assessed by identical online questionnaires at baseline and 2-year follow-up in both study arms. In addition to analyses of covariance, a subgroup analysis explored the heterogeneity of treatment effects among different risks of back pain chronification (STarT Back Tool).
Out of 3462 persons selected, randomized and thereafter contacted, 552 agreed to participate. At the 24-month follow-up, data on 189 of 258 (73.3%) of the IG were available, in the CG on 255 of 294 (86.7%). Significant, small beneficial effects were seen in primary outcomes: Compared to the CG, the IG reported less disability (1.6 vs 2.0; p = 0.025; d = 0.24) and scored better at the SF-12 physical health scale (43.3 vs 41.0; p < 0.007; d = 0.26). No effect was seen in back pain intensity and in the SF-12 mental health scale. Persons with medium or high risk of back pain chronification at baseline responded better to the health program in all primary outcomes than the subgroup with low risk at baseline.
After 2 years, the proactive health program resulted in small positive long-term improvements. Using risk screening prior to inclusion in the health program might increase the percentage of participants deriving benefits from it.
The trial was registered at the German Clinical Trials Register under DRKS00015463 retrospectively (dated 4 Sept 2018).
Purpose
Diabetes is considered one of the fastest growing diseases worldwide. Especially in the treatment of type 2 diabetes, lifestyle interventions have proven to be effective. However, long-term ...studies in real-world contexts are rare, which is why further research is needed. The aim of the present study is to investigate whether effects achieved in the context of a long-term lifestyle intervention can be sustained by patients in the long term.
Methods
In a two-arm randomized trial we compared diabetes care as usual to a lifestyle intervention combining telemedically support and individual needs-based telephone coaching. The study included 151 patients with type 2 diabetes randomized to either the intervention or control group. Intervention Group (IG; N = 86, 80.2% male, mean age: 59.7) received telemedical devices and telephone coaching over a period of 12 months, Control Group (CG; N = 65, 83.1% male, mean age: 58,8) received care as usual. The primary outcome was chance in Hb
A1c
. A follow-up survey was conducted after 24 months.
Results
The intervention group showed significantly better HbA1c- values compared to the control group at both 12 and 24 months (12 M: − 0.52 (-0.73; − 0.32), p < .000; 24 M: − 0.38 (-0.61; − 0.15), p = .001). The strongest change was seen in the first three months, with the best value obtained at 6 months and stable thereafter.
Conclusion
Combined telephone coaching with telemedicine support could lead to better long-term glycemic control in people with type 2 diabetes. In the future, more long-term studies should be conducted in real-world settings and lifestyle interventions should be offered more widely.
We report on surface pretreatment for ohmic contacts to p-doped In0.53Ga0.47 As with improved thermal stability. It is found that the cleaning of In0.53Ga0.47 As surface by ammonium sulfide or ...sulfuric acid offers the optimum surface treatment prior to metal deposition. Contacts using an iridium contact layer and palladium diffusion barrier were fabricated and compared to a conventional platinum-based contact Pt/Ti/Pt/Au. Pt-based metal stack suffered from void formation and high reactivity with the semiconductor when annealed at 240 °C for a few hours, as examined by transmission electron microscopy. As a result, the Pt-based stack exhibited strong deterioration of the resistivity. On the other hand, the Ir contact maintained its integrity during thermal stress. The improved contact exhibited a void and reaction-free microstructure and offered stable resistivity values with annealing.
Display omitted
•The pretreatment of In0.53Ga047As with H2SO4 and (NH4)2S were found to be optimal.•Pt diffuses inside the InGaAs, creating voids and intermetallics reactions.•No diffusion was detected for Ir and a sharp interface is confirmed by FIB data.•Measurements confirmed the deterioration of the resistivity of the Pt contact•In contrast, Ir-contact offered stable results.
Zein, a corn‐derived protein, has a variety of applications ranging from drug delivery to tissue engineering and wound healing. This work aims to develop a biocompatible scaffold for dermal ...applications based on thermally annealed electrospun propolis‐loaded zein nanofibers. Pristine fibers' biocompatibility is determined in vitro. Next, propolis from Melipona quadrifasciata is added to the fibers at different concentrations (5% to 25%), and the scaffolds are studied. The physicochemical properties of zein/propolis precursor dispersions are evaluated and the results are correlated to the fibers' properties. Due to zein's and propolis' very favorable interactions, which are responsible for the increase in the dispersions surface tension, nanometric size ribbon‐like fibers ranging from 420 to 575 nm are obtained. The fiber's hydrophobicity is not dependent on propolis concentration and increases with the annealing procedure. Propolis inhibitory concentration (IC50) is determined as 61.78 µg mL−1. When loaded into fibers, propolis is gradually delivered to cells as Balb/3T3 fibroblasts and are able to adhere, grow, and interact with pristine and propolis‐loaded fibers, and cytotoxicity is not observed. Therefore, the zein–propolis nanofibers are considered biocompatible and safe. The results are promising and provide prospects for the development of wound‐healing nanofiber patches—one of propolis' main applications.
Nanofibers are a promising material that can facilitate the wound‐healing process. Propolis‐loaded nanofibers are developed using a totally green method. A complete physical–chemical investigation is carried out and a mechanism of interaction between fibers and skin‐derived cells is proposed. This new material can prospect the development of wound‐healing nanofiber patches.
In this paper we describe sea ice change and variability during the Canadian International Polar Year (IPY) program and examine several regional and hemispheric causes of this change. In a companion ...paper (Barber et al.,
Climate Change
2012
) we present an overview of the consequences of this observed change and variability on ecosystem function, climatically relevant gas exchange, habitats of primary and apex predators, and impacts on northern peoples. Sea ice-themed research projects within the fourth IPY were designed to be among the most diverse international science programs. They greatly enhanced the exchange of Inuit knowledge and scientific ideas across nations and disciplines. This interdisciplinary and cultural exchange helped to explain and communicate the impacts of a transition of the Arctic Ocean and ecosystem to a seasonally ice-free state, the commensurate replacement of perennial with annual sea ice types and the causes and consequences of this globally significant metamorphosis. This paper presents a synthesis of scientific sea ice research and traditional knowledge results from Canadian-led IPY projects between 2007 and 2009. In particular, a summary of sea ice trends, basin-wide and regional, is presented in conjunction with Inuit knowledge of sea ice, gathered from communities in northern Canada. We focus on the recent observed changes in sea ice and discuss some of the causes of this change including atmospheric and oceanic forcing of both dynamic and thermodynamic forcing on the ice. Pertinent results include: 1) In the Amundsen Gulf, at the western end of the Northwest Passage, open water persists longer than normal and winter sea ice is thinner and more mobile. 2) Large areas of summer sea ice are becoming heavily decayed during summer and can be broken up by long-period waves being generated in the now extensive open water areas of the Chukchi Sea. 3) Cyclones play an important role in flaw leads—regions of open water between pack ice and land-fast ice. They delay the formation of new ice and the growth of multi-year ice. 4) Feedbacks involving the increased period of open water, long-period wave generation, increased open-ocean roughness, and the precipitation of autumn snow are all partially responsible for the observed reduction in multiyear sea ice. 5) The atmosphere is observed as remaining generally stable throughout the winter, preventing vertical entrainment of moisture above the surface.
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