Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation: A RCT-study protocol of the PIANISSIMO study.

BACKGROUND: Spinal Cord Stimulation (SCS) may provide pain relief in patients with therapy-refractory Persistent Spinal Pain Syndrome Type II (PSPS-T2). Despite the evidence that SCS can reduce disability and reduce pain medication usage, only 25% of the patients is able to completely omit pain medication usage after 12 months of SCS. To tackle the high burden of patients who consume a lot of pain medication, tapering programs could be initiated before starting a trajectory with SCS. The current objective is to examine whether a pain medication tapering program before SCS alters disability in PSPS-T2 patients compared to no tapering program. METHODS AND DESIGN: A three-arm, parallel-group multicenter randomized controlled trial will be conducted including 195 patients who will be randomized (1:1:1) to either (a) a standardized pain medication tapering program, (b) a personalized pain medication tapering program, or (c) no tapering program before SCS implantation, all with a follow-up period until 12 months after implantation. The primary outcome is disability. The secondary outcomes are pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication usage, psychological constructs, sleep, symptoms of central sensitization, and healthcare expenditure. DISCUSSION: Within the PIANISSIMO project we propose a way to reduce the risks of adverse events, medication-induced hyperalgesia, tolerance, and dependence by providing pain medication tapering before SCS. Due to the lack of a commonly accepted in-hospital tapering approach, two different tapering programs will be evaluated in this study. If pain medication tapering programs are deemed to be more effective than no tapering on disability, this would add to the evidence towards an improved patient-centered care model in this patient group and set a clear path to advocate for pain medication tapering before SCS as the new standard treatment guideline for these patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05861609. Registered on May 17, 2023.

Quantifying societal burden of radiation-induced small bowel toxicity in patients with rectal cancer.

Introduction: Advancements in rectal cancer (RC) treatment not only led to an increase in lives saved but also improved quality of life (QoL). Notwithstanding these benefits, RC treatment comes at the price of gastrointestinal morbidity in many patients. Health economic modelling poses an opportunity to explore the societal burden of such side-effects. This study aims to quantify radiation-induced late small bowel (SB) toxicity in survivors of RC for Three-Dimensional Conformal Radiation Therapy (3D-CRT), Intensity Modulated Radiation Therapy (IMRT) and Intensity Modulated Radiation Therapy - Image Guided Radiation Therapy (IMRT/IGRT). Materials and methods: Materials and A model-based health economic evaluation was performed. The theoretical cohort consists of a case-mix of survivors of RC aged 25-99 years according to Belgian age-specific incidence rates. A societal perspective was adopted. The base case analysis was complemented with one-way deterministic analyses, deterministic scenario analyses and probabilistic sensitivity analysis (1,000 iterations). Results were presented as mean lifetime incremental cost (€) and utility (QALYs) per patient. Results: The analyses showed that the use of innovative radiotherapy (RT) improves lifetime QoL in survivors of RC by 0.11 QALYs and 0.05 QALYs by preferring IMRT/IGRT and IMRT over 3D-CRT, respectively. The use of IMRT/IGRT and IMRT results in an incremental cost-saving of €3,820 and €1,863 per patient, solely by radiation-induced SB toxicity, compared to 3D-CRT. Discussion and conclusion: It is important to consider late toxicity effects in decisions regarding investments and reimbursement as our analysis highlighted the potential long-term cost-savings and improved QoL of novel RT techniques in patients with rectal cancer.

The Mediating Role of Pain Cognitions and Pain Sensitivity in the Treatment Effect of Perioperative Pain Neuroscience Education in People Undergoing Surgery for Lumbar Radiculopathy.

Though perioperative pain neuroscience education (PPNE) positively influences patients' surgical outcomes, little is known about the mechanisms behind this treatment's success. Therefore, this study aims to evaluate the potential mediating role of pain cognitions and pain sensitivity in the treatment effect of PPNE on postoperative quality of life in people undergoing surgery for lumbar radiculopathy. This secondary analysis uses data from 120 participants of a randomized controlled trial who were randomized to receive either PPNE or perioperative biomedical education before undergoing surgery for lumbar radiculopathy. Quality of life was assessed 1-year postsurgery using the short form 36-item health survey (SF36) physical and mental component scores. Potential mediators included pain cognitions (ie, kinesiophobia, pain catastrophizing, and hypervigilance) and pain sensitivity (ie, endogenous nociceptive modulation), assessed 6 weeks postsurgery. Mediation models were constructed using structural equation modeling, and 95% confidence intervals (CIs) were calculated using 10,000 bootstrap samples. Analyses show a significant total effect for PPNE (estimate = .464, 95% CI [.105, .825]) and a significant indirect effect via pain catastrophizing on the SF36 physical component (estimate = .124, 95% CI [.001, .293]). No mediating effect was found through the remaining pain cognitions or pain sensitivity measures. Also, no potential mediators were identified for the treatment effect of PPNE on the SF36 mental component. Our findings suggest that pain catastrophizing mediates the treatment effect of PPNE on physical health-related quality of life in people undergoing surgery for lumbar radiculopathy. PERSPECTIVE: This secondary analysis identified pain catastrophizing as a mediator for PPNE in people undergoing surgery for lumbar radiculopathy. More so, its findings indicate that this educational intervention can enhance the postoperative physical health-related quality of life of these patients by addressing their catastrophizing thoughts. TRIAL REGISTRATION: Clinicaltrials.gov (NCT02630732).

Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS II) statement: a validated Dutch translation.

OBJECTIVES: This study primarily aimed to develop a validated Dutch translation of the 28 items of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) II. A secondary aim was to provide a worked example of a scientifically valid translation process. METHODS: A four-step process was applied: (1) forward translation, (2) backward translation, (3) quantitative validation (two back-translated English versions vs. original English version), and (4) qualitative validation (one Dutch version vs. original English version), resulting in the final Dutch CHEERS II checklist. RESULTS: During quantitative validation, the average scores indicated high language comparability (1.88 (SD 0.70); 1.70 (SD 0.73)) and interpretation similarity (1.77 (SD 0.81); 1.54 (SD 0.74)). Four items required formal revision. In the qualitative validation step, feedback primarily focused on specific terms 'outcomes,' 'benefits and harms,' '(year of) conversion,' 'any,' and 'characterizing.' CONCLUSION: Despite English being the common language of science, translating research instruments remains relevant to enhance clarity, accessibility, and inclusivity. The Dutch translation can be used by students, regulators, researchers, or others to report and evaluate reporting of economic evaluations. Our detailed description of the applied methodology can facilitate future translations of research instruments.

Biopsychosocial rehabilitation in the working population with chronic low back pain: a concept analysis.

OBJECTIVE: To identify the essential attributes of biopsychosocial rehabilitation for chronic low back pain in the working population. DESIGN: A concept analysis was conducted according to the 8-step method of Walker and Avant. This framework provides a clear concept and theoretical and operational definitions. METHODS: Five databases were searched, followed by a systematic screening. Subsequently, attributes, illustrative cases, antecedents, consequences and empirical referents were formulated. RESULTS: Of the 3793 studies identified, 42 unique references were included. Eleven attributes were identified: therapeutic exercise, psychological support, education, personalization, self-management, participation, follow-up, practice standard, goal-setting, social support, and dietary advice. Subsequently, illustrative cases were described. Antecedents, such as motivation, preparedness and a multidisciplinary team, were found, together with consequences such as decreased pain, less sick-leave and increased function and work status. Finally, examples of empirical referents were given. CONCLUSION: This study identified the attributes that are necessary to develop biopsychosocial rehabilitation intervention programmes for chronic low back pain. The defined concept of biopsychosocial rehabilitation for chronic low back pain may serve as a solid base to further develop and apply interventions. Future research should focus on the objectification of biopsychosocial rehabilitation and conceptualization regarding how personalization is done.

Influence of Preoperative Pain, Cognitions, and Quantitative Sensory Testing Measures on the Effects of Perioperative Pain Neuroscience Education for People Receiving Surgery for Lumbar Radiculopathy: Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVE: To explore whether preoperative pain intensity, pain cognitions, and quantitative sensory measures influence the established effectiveness of perioperative pain neuroscience education (PPNE) on health-related quality of life at 1 year after surgery for lumbar radiculopathy. DESIGN: Secondary analysis of a triple-blinded randomized controlled trial. METHODS: Participants (n = 90) were Dutch-speaking adults (18-65 years) who were scheduled for surgery for lumbar radiculopathy in 3 Belgian hospitals. They were randomized (1:1) to receive PPNE (n = 41) or perioperative biomedical education (n = 49). Linear mixed models were built for health-related quality of life (ie, SF-6D utility values, Physical and Mental Component of the 36-item Short Form Health Survey) using the following independent variables: therapy, time, and preoperative scores for back and leg pain intensity, pain catastrophizing, kinesiophobia, hypervigilance, and quantitative sensory measures. RESULTS: The impact of PPNE on SF-6D utility values over time was influenced by kinesiophobia (F = 3.30, P = .02) and leg pain intensity (F = 3.48, P = .02). Regardless of the intervention, back pain intensity negatively influenced SF-6D values over time (F = 3.99, P = .009). The Physical Component scores were negatively impacted by back pain intensity (F = 9.08, P = .003) and were influenced over time by leg pain intensity (F = 2.87, P = .04). The Mental Component scores were negatively impacted by back pain intensity (F = 6.64, P = .01) and pain catastrophizing (F = 5.42, P = .02), as well as hypervigilance (F = 3.16, P = .03) and leg pain intensity (F = 3.12, P = .03) over time. CONCLUSION: PPNE may be more effective than perioperative biomedical education in improving postoperative health utility values in patients who reported higher kinesiophobia and leg pain intensity before surgery for lumbar radiculopathy. J Orthop Sports Phys Ther 2024;54(4):1-10. Epub 8 January 2024. doi:10.2519/jospt.2024.12051.

Cost-Utility of an Exercise Referral Scheme Versus Doing Nothing in Flemish Adults: Exploring the Impact of Key Assumptions.

BACKGROUND: This health-economic evaluation assessed the cost-effectiveness of an exercise referral scheme (ERS) versus doing nothing in the Flemish region (Belgium), with a particular focus on the impact of several scenarios. METHODS: A 14-state Markov model was applied to compare the expected costs and quality-adjusted life years (QALYs) of 2 alternatives: the Flemish ERS (2019 data, mean age 52 y, 69.1% women) and doing nothing. A health care payer perspective was adopted and a lifetime time horizon was applied. A set of 18 scenario analyses is presented. In addition, univariate and probabilistic sensitivity analyses were performed. RESULTS: Under the assumptions selected for the base-case analysis, the Flemish ERS is moderately cost-effective compared with doing nothing, with an incremental cost-utility ratio of €28,609/QALY. Based on the scenario analyses, the results largely depend on the assumptions regarding the continuation of the intervention effect and the frequency with which the intervention is repeated. The greatest health gains can be made when a sustainable behavioral change is achieved among participants. The probabilistic sensitivity analysis confirmed that the cost-effectiveness results were not robust. CONCLUSIONS: If it is possible to induce a sustainable behavioral change with an intervention delivered at 2- or 5-year intervals, then the Flemish ERS is potentially cost-effective compared with doing nothing (given a €40,000/QALY threshold). These results suggest the importance of repeated implementation of the program together with careful monitoring of the adherence and the sustainability of the observed effects in a real-world setting.

FFRct use for acute chest pain triage in the emergency department: a cost-effectiveness analysis.

AIMS: To model and assess the cost-effectiveness of CT-based fractional flow reserve (FFRct) for a population of low to intermediate risk patients for coronary artery disease (CAD) presenting to the emergency department (ED) with acute chest pain. METHODS AND RESULTS: Using a decision tree model with a 1 year time horizon and from a health care perspective, two diagnostic pathways using FFRct are compared to current clinical routine combining coronary computed tomography angiography (CCTA) with an exercise test. Model data are drawn from the literature and nationally reported data. Outcomes are assessed as the number of avoided invasive coronary angiographies (ICAs) showing no obstructive CAD and quality of life (QoL) in a theoretical cohort of 1000 patients. Sensitivity analyses are performed to test the robustness of the results. Determining FFRct when CCTA is inconclusive is a cost-effective and dominant strategy with a potential saving of 198€/patient, 154 avoided unnecessary ICA showing no obstructive CAD (uICA)/1000 patients and an average improvement in QoL of 0.008 QALY/patient. With an additional 574€/patient, 8 avoided uICA/1000 patients and an improvement in QoL of 0.001 QALY/patient, a strategy where FFRct is always performed is cost-effective only when considering high cost-effectiveness thresholds. CONCLUSIONS: For patients presenting to the ED with acute chest pain and a low to intermediate pre-test probability of CAD, a diagnostic strategy where FFRct is determined after an inconclusive CCTA is cost-effective. Clinical trials investigating both sensitivity and specificity of FFRct, as well as QoL associated with the use of this technology in this setting are warranted.

Introduction of ultra-hypofractionation in breast cancer: Implications for costs and resource use.

PURPOSE: A shift towards (ultra-)hypofractionated breast irradiation can have important implications for the practice of contemporary radiation oncology. This paper presents a systematic analysis of the impact of different fractionation schedules on multiple key performance indicators, namely resource use, costs, work times, throughput and waiting times. MATERIALS AND METHODS: Time-driven activity-based costing (TD-ABC) is applied to calculate the costs and resources consumed where the perspective of the radiotherapy department in adopted. Three fractionation regimens are considered: ultra-hypofractionation (5 x 5.2 Gy, UHF), moderate hypofractionation (15 x 2.67 Gy, HF) and conventional fractionation (25 x 2 Gy, CF). Subsequently, a discrete event simulation (DES) model of the radiotherapy care pathway is developed and scenarios are compared in which the following factors are varied: distribution of fractionation regimens, patient volume and operating hours. RESULTS: The application of (U)HF can permit radiotherapy departments to reduce the use of scarce resources, realise work time and cost savings, increase throughput and reduce waiting times. The financial advantages of (U)HF are, however, reduced in cases of excess capacity and cost savings may therefore be limited in the short-term. Moreover, although an extension of operating hours has favourable effects on throughput and waiting times, it may also reduce cost differences between fractionation schedules by increasing the capacity of resources. CONCLUSION: By providing an in-depth analysis of the consequences associated with a shift towards (U)HF in breast cancer, the present study demonstrates how a DES model based on TD-ABC costing can assist radiotherapy professionals in making data-driven decisions.

Functional performance recovery after individualized nutrition therapy combined with a patient-tailored physical rehabilitation program versus standard physiotherapy in patients with long COVID: a pilot study.

BACKGROUND: Long COVID is suggested to be present in 14 to 43% of COVID 19-survivors. Literature on this new condition states a need for a multidisciplinary approach including physical exercise and nutrition. The aim of the current pilot study is to investigate the feasibility of the proposed protocol to prepare for a randomized controlled study that addresses the effectiveness of a personalized multimodal treatment compared to standard physiotherapy. METHODS: This is a protocol of the UNLOCK (Nutrition and LOComotoric rehabilitation in long COVID) study, a pragmatic, single center, randomized controlled pilot trial with two groups. Patients with persisting symptoms related to a SARS-CoV-2 infection will receive either standard physiotherapy or a personalized multimodal treatment for a period of 12 weeks, consisting of individualized physical exercise program combined with individualized nutritional therapy. They will be followed-up at 6, 12, and 18 weeks after randomization. DISCUSSION: A multidisciplinary approach for dealing with long COVID is needed. Because of the lack of clear data and the fact that this is a very heterogenic group, we aim to prepare and optimize a randomized controlled study that addresses the effectiveness of a personalized multimodal treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05254301 (since February 24, 2022).

Predicting return to work after traumatic brain injury using machine learning and administrative data.

BACKGROUND: Accurate patient-specific predictions on return-to-work after traumatic brain injury (TBI) can support both clinical practice and policymaking. The use of machine learning on large administrative data provides interesting opportunities to create such prognostic models. AIM: The current study assesses whether return-to-work one year after TBI can be predicted accurately from administrative data. Additionally, this study explores how model performance and feature importance change depending on whether a distinction is made between mild and moderate-to-severe TBI. METHODS: This study used a population-based dataset that combined discharge, claims and social security data of patients hospitalized with a TBI in Belgium during the year 2016. The prediction of TBI was attempted with three algorithms, elastic net logistic regression, random forest and gradient boosting and compared in their performance by their accuracy, sensitivity, specificity and area under the receiver operator curve (ROC AUC). RESULTS: The distinct modelling algorithms resulted in similar results, with 83% accuracy (ROC AUC 85%) for a binary classification of employed vs. not employed and up to 76% (ROC AUC 82%) for a multiclass operationalization of employment outcome. Modelling mild and moderate-to-severe TBI separately did not result in considerable differences in model performance and feature importance. The features of main importance for return-to-work prediction were related to pre-injury employment. DISCUSSION: While clearly offering some information beneficial for predicting return-to-work, administrative data needs to be supplemented with additional information to allow further improvement of patient-specific prognose.

Effect of perioperative pain neuroscience education in people undergoing surgery for lumbar radiculopathy: a multicentre randomised controlled trial.

BACKGROUND: Perioperative education should be improved to decrease unfavourable outcomes after lumbar surgery. This trial aimed to compare effectiveness in terms of pain, quality of life, pain cognition, surgical experience, healthcare use, work resumption, and cost-effectiveness of perioperative pain neuroscience education (PPNE) vs traditional biomedical education (perioperative biomedical education [PBE]) in people undergoing surgery for lumbar radiculopathy. METHODS: In this multicentre RCT (ClinicalTrials.gov: NCT02630732), patients undergoing surgery for lumbar radiculopathy in three Belgian hospitals were randomised to receive PPNE or PBE. Both groups received one preoperative and one postoperative one-to-one education session and a booklet (balanced interventions), with an essentially different content (PPNE: biopsychosocial; PBE: biomedical). Pain was the primary outcome (Visual Analogue Scales+quantitative sensory testing). Assessments were at 3 days, 6 weeks, and 6 and 12 months after surgery. RESULTS: Between March 2016 and April 2020, participants were randomly assigned to PPNE (n=58) or PBE (n=62). At 12 months, PPNE did not lead to significantly better pain outcomes, but it did result in more favourable 36-item Short Form Health Survey physical component (additional increase: 46.94; 95% confidence interval [CI]: 14.16-79.73; medium effect), Tampa Scale of Kinesiophobia (additional decrease: 3.15; 95% CI: 0.25-6.04; small effect), and Pain Catastrophising Scale (additional decrease: 6.18; 95% CI: 1.97-10.39; medium effect) scores. Females of the PPNE group showed higher probability for work resumption (95% vs 60% in the PBE group). PPNE was cost-effective compared with PBE (incremental costs: €-2732; incremental quality-adjusted life years: 0.012). CONCLUSIONS: Perioperative pain neuroscience education showed superior clinical and cost-effectiveness than perioperative biomedical education in people undergoing surgery for lumbar radiculopathy. CLINICAL TRIAL REGISTRATION: NCT02630732.

Proportion of clinical holistic responders in patients with persistent spinal pain syndrome type II treated by subthreshold spinal cord stimulation compared to best medical treatment: a study protocol for a multicentric randomised controlled trial (TRADITION).

BACKGROUND: Integrating information on bodily functions, pain intensity and quality of life into one composite measure of a holistic responder has recently been proposed as a useful method to evaluate treatment efficacy of spinal cord stimulation (SCS) in patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2). Previous studies already demonstrated the efficacy of standard SCS over best medical treatment (BMT) and the superiority of new subthreshold (i.e. paresthesia free) SCS paradigms compared to standard SCS. Nevertheless, the efficacy of subthreshold SCS compared to BMT has not yet been investigated in patients with PSPS-T2, neither with unidimensional outcomes nor with a composite measure. The current objective is to examine whether subthreshold SCS, compared to BMT, provided to patients with PSPS-T2 results in a different proportion of clinical holistic responders (as composite measure) at 6 months. METHODS: A two-arm multicentre randomised controlled trial will be conducted whereby 114 patients will be randomised (1:1) to (a) BMT or (b) paresthesia-free SCS. After a follow-up period of 6 months (primary time endpoint), patients receive the opportunity to cross over towards the other treatment group. The primary outcome is the proportion of clinical holistic responders at 6 months (i.e. a composite measure of pain intensity, medication, disability, health-related quality of life and patient satisfaction). The secondary outcomes are work status, self-management, anxiety, depression and healthcare expenditure. DISCUSSION: Within the TRADITION project, we propose to shift the focus from a unidimensional outcome measure towards a composite measure as primary outcome measure to evaluate the efficacy of currently used subthreshold SCS paradigms. The lack of methodologically rigorous trials exploring the clinical efficacy and socio-economic consequences of subthreshold SCS paradigms is pressing, especially in light of the growing burden of PSPS-T2 on the society. TRIAL REGISTRATION: ClinicalTrials.gov NCT05169047. Registered on December 23, 2021.

Exploring Associations between Healthcare Use and Demographics, Pain and Pain Cognitions in People Scheduled for Surgery for Lumbar Radiculopathy: A Cross-Sectional Study.

This cross-sectional study explored associations between demographics, pain intensity and cognitions on the one hand and healthcare use (HCU) on the other hand in people undergoing surgery for lumbar radiculopathy. HCU during the 2 months preceding surgery was evaluated using a retrospective questionnaire. Demographics included sex, age and level of education and equivalent income. Back and leg pain intensity were evaluated using a visual analogue scale. Pain cognitions were assessed with the Tampa scale of kinesiophobia, the pain catastrophizing scale and the pain vigilance and awareness questionnaire. The sample comprised 120 participants (52% males; 49 years (Quartile (Q)1-Q3: 37.3-57.43)). The number of visits to the general practitioner was associated with sex (incidence rate ratio (IRR) for males = 0.811; p = 0.050), pain catastrophizing (IRR = 1.010; p = 0.041), pain magnification (IRR = 1.058; p = 0.004) and leg pain intensity (IRR = 1.004; p = 0.038). The number of neurosurgeon visits was associated with level of education (IRR moderate education = 1.518; p = 0.016 (reference: low education)). Receiving zero physiotherapy visits was associated with higher back pain intensity (Beta = 0.018; p = 0.028). Highest level of analgesics used was associated with sex (IRR for males = 0.502; p = 0.047) and leg pain (IRR = 1.014; p = 0.034). Only the association between general practitioner visits and pain magnification remained significant in multivariable analyses (IRR = 1.061; p = 0.033). The results suggest a rather indirect relationship between HCU and demographics, pain intensity and cognitions, involving a potential interplay between several patient- and healthcare system-related factors.

Experimental Pain Measurements Do Not Relate to Pain Intensity and Pain Cognitions in People Scheduled for Surgery for Lumbar Radiculopathy.

OBJECTIVE: The present cross-sectional study aims to unravel associations of pain intensity and cognitions with quantitative sensory testing in people scheduled for surgery for lumbar radiculopathy. Additionally, insight will be provided into the presence of dysfunctional nociceptive processing and maladaptive pain cognitions in this population. DESIGN: Cross-sectional study. SETTING: Data from three hospitals in Belgium. SUBJECTS: The final sample comprised 120 participants with lumbar radiculopathy scheduled for surgery, included between March 2016 and April 2019. METHODS: Self-reported pain intensity was assessed on a visual analog scale, and pain cognitions were assessed with self-reported questionnaires (Pain Catastrophizing Scale, Tampa Scale for Kinesiophobia, and Pain Vigilance and Awareness Questionnaire). Quantitative sensory testing (detection thresholds, pain thresholds, temporal summation, and conditioned pain modulation) was evaluated, as well. RESULTS: Evidence was found for the presence of an impaired inhibitory response to nociceptive stimuli and maladaptive pain cognitions in this population. Kinesiophobia was found to be present to a maladaptive degree in the majority of the patients (n = 106 [88%]). Significant, but weak, associations between electrical pain thresholds at the sural nerves and leg pain intensity (sural nerve symptomatic side: r = -0.23; P = 0.01; non-symptomatic side: r = -0.22; P = 0.02) and kinesiophobia levels (sural nerve non-symptomatic side: r = -0.26; P = 0.006) were identified. CONCLUSIONS: Electrical detection thresholds and correlates for endogenous nociceptive facilitation and inhibition were not found to be related to any of the pain cognitions or to pain intensity in people scheduled to undergo surgery for lumbar radiculopathy.

Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study.

BACKGROUND: For patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2), spinal cord stimulation (SCS) may serve as an effective minimally invasive treatment. Despite the evidence that SCS can improve return to work (RTW), only 9.5 to 14% of patients implanted with SCS are effectively capable of returning to work. Thus, it seems that current post-operative interventions are not effective for achieving RTW after SCS implantation in clinical practice. The current objective is to examine whether a personalised biopsychosocial rehabilitation programme specifically targeting RTW alters the work ability in PSPS-T2 patients after SCS implantation compared to usual care. METHODS: A two-arm, parallel-group multicentre randomised controlled trial will be conducted including 112 patients who will be randomised (1:1) to either (a) a personalised biopsychosocial RTW rehabilitation programme of 14 weeks or (b) a usual care arm, both with a follow-up period until 12 months after the intervention. The primary outcome is work ability. The secondary outcomes are work status and participation, pain intensity, health-related quality of life, physical activity and functional disability, functional capacities, sleep quality, kinesiophobia, self-management, anxiety, depression and healthcare expenditure. DISCUSSION: Within the OPERA project, we propose a multidisciplinary personalised biopsychosocial rehabilitation programme specifically targeting RTW for patients implanted with SCS, to tackle the high socio-economic burden of patients that are not re-entering the labour market. The awareness is growing that the burden of PSPS-T2 on our society is expected to increase over time due to the annual increase of spinal surgeries. However, innovative and methodologically rigorous trials exploring the potential to decrease the socio-economic burden when patients initiate a trajectory with SCS are essentially lacking. TRIAL REGISTRATION: ClinicalTrials.gov NCT05269212. Registered on 7 March 2022.

Health-related quality of life in persons post-COVID-19 infection in comparison to normative controls and chronic pain patients.

The Coronavirus disease 2019 (COVID-19) pandemic exerted a tremendous pressure on the healthcare system, people's social life, mental health and financial status with profound implications for the general population. The exact impact of the pandemic on the overall physical, mental and social wellbeing of COVID-19 infection survivors on the long term has not yet been explored in a thorough way. Based on the reporting of persistent pain, fatigue and dyspnea symptoms by these survivors, it is our hypothesis that their quality of life will be extremely impacted, as is observed in patients with chronic pain. Therefore, the first aim of this study was to perform an in-depth evaluation of the quality of life of post-COVID-19 infected persons. The second aim was to compare the quality of life of these persons with a normative population and with patients with chronic pain. Health-related quality of life, as a measure for a person's overall physical, mental, and social wellbeing, was measured with the 3-level EQ5D in 547 post-COVID-19 infected persons. These data were compared to reference data from normal population records for Belgium and to data from patients with chronic pain after spinal surgery with two-way analyses of variance. In total, 89.58% of the post-COVID-19 infected persons reported pain/discomfort and 82.45% indicated limitations when performing usual activities, when evaluated 287 days (SD: 150) after the infection. Self-care was preserved in most post-COVID-19 persons, whereby only 13.16% indicated problems. The mean EQ5D-3L index score was 0.57 (SD: 0.23) and EQ5D VAS mean score was 56.6 (SD: 18.2). The mean index score for the normative population was significantly higher than for COVID-19 infected persons [mean difference of 0.31 (95% from 0.29 to 0.33), p < 0.01] while the mean score of chronic pain patients was significantly lower than the score of COVID-19 infected persons [mean difference of -0.31 (95% from -0.29 to -0.33), p < 0.01]. Compared to age-and sex adjusted reference data, health-related quality of life of persons with long COVID is severely impacted. In relation to patients with chronic pain after spinal surgery, the quality of life of post-COVID-19 infected persons seemed to be better. Clinical trial registration: https://www.clinicaltrials.gov/, identifier: NCT04912778.

Traumatic brain injury hospitalizations in Belgium: A brief overview of incidence, population characteristics, and outcomes.

Background: There is a need for complete and accurate epidemiological studies for traumatic brain injury (TBI). Secondary use of administrative data can provide country-specific population data across the full spectrum of disease. Aim: This study aims to provide a population-based overview of Belgian TBI hospital admissions as well as their health-related and employment outcomes. Methods: A combined administrative dataset with deterministic linkage at individual level was used to assess all TBI hospitalizations in Belgium during the year 2016. Discharge data were used for patient selection and description of injuries. Claims data represented the health services used by the patient and health-related follow-up beyond hospitalization. Finally, social security data gave insight in changes to employment situation. Results: A total of 17,086 patients with TBI were identified, with falls as the predominant cause of injury. Diffuse intracranial injury was the most common type of TBI and 53% had injuries to other body regions as well. In-hospital mortality was 6%. The median length of hospital stay was 2 days, with 20% being admitted to intensive care and 28% undergoing surgery. After hospitalization, 23% had inpatient rehabilitation. Among adults in the labor force pre-injury, 72% of patients with mild TBI and 59% with moderate-to-severe TBI returned to work within 1 year post-injury. Discussion: Administrative data are a valuable resource for population research. Some limitations need to be considered, however, which can in part be overcome by enrichment of administrative datasets with other data sources such as from trauma registries.

Quantifying Societal Burden of Radiation-Induced Cardiovascular Events in Breast Cancer Survivors.

Background and Purpose: Radiation-induced cardiotoxicity is an important health concern for clinicians during treatment of breast cancer (BC) patients. Underlying mechanisms are well-documented, whereas little is known about the societal impact of this long-term effect. This study aimed to quantify the additional burden of radiation-induced cardiovascular (CV) diseases in BC survivors. Materials and Methods: Conventional health economic modelling techniques were applied to estimate attributed CV-related costs and disutility in a hypothetical cohort of BC survivors. A situation in which radiotherapy caused an additional CV risk was compared with a situation in which this risk was not taken into account. Uncertainty was assessed via deterministic and probabilistic sensitivity analyses. Analyses were performed from a broad societal perspective up until 20 years after BC treatment. Results: Radiation-induced cardiotoxicity evokes a mean incremental cost of €275.10 per woman over a time horizon of 20 years after BC treatment. An additional decrement of 0.017 QALYs (per woman) might be expected when taking the radiation-induced cardiotoxic risk into account in BC survivors. Incremental costs and disutility increased with age. A scenario analysis showed that these results were more profound in women with more advanced staging. Conclusion: Our analyses suggest that with current radiation techniques, rather minor costs and disutility are to be expected from radiation-induced cardiotoxicity in BC survivors. The cost of past investments in order to achieve current mean heart dose (MHD) seems justified when considering the gains from cost and disutility reduction resulting from radiation-induced cardiovascular events. The question we might consider is whether future opportunity costs associated with investments on further technological advancements offset the expected marginal benefit from further reducing the MHD.

Cost-effectiveness of exercise referral schemes: a systematic review of health economic studies.

BACKGROUND: This systematic review aimed to provide an overview of the existing literature on cost-effectiveness of exercise referral schemes (ERSs). METHODS: A systematic search was performed in MEDLINE, EMBASE, EconLit, Web of Science and PsycINFO. Main inclusion criteria were: (1) insufficiently active people; (2) ERSs and (3) full health economic evaluations. No publication year limits were applied. The methodological quality was assessed independently by two reviewers using the Consensus Health Economic Criteria (CHEC) checklist. RESULTS: Fifteen eligible publications were retrieved, presenting results of 12 different studies. Compared with usual care, ERSs were found to be cost-effective in a majority of the analyses, but with modest health gains and costs per individual. These cost-effectiveness results were also sensitive to small changes in input parameters. Two studies found that ERSs combined with a pedometer/accelerometer are cost-effective, compared with usual ERS practice. Two other studies found that an ERS with phone support and an ERS with face-to-face support might be equally effective, with similar costs. CONCLUSION: Although the literature demonstrated that ERSs could be cost-effective compared with usual care, these results were not robust. Based on a small number of studies, ERSs could be optimized by using tracking devices, or by providing a choice to the participants about the delivery mode. There is need for clarity on the effectiveness of and attendance to ERS, as more certainty about these key input parameters will strengthen health-economic evidence, and thus will allow to provide a clearer message to health policy-makers.