A Randomized Controlled Trial Using Epidural Analgesia for Pain Relief After Lumbar Interlaminar Decompressive Spine Surgery: The RAPID trial.

STUDY DESIGN: Prospective, double-blind randomized controlled trial. OBJECTIVE: If an intraoperative single bolus of epidural bupivacaine can result in less postoperative pain following lumbar spinal decompression surgery. SUMMARY OF BACKGROUND DATA: Adequate postoperative pain management following lumbar spinal decompression surgery is important, as it will lead to early mobilization, less complications, and a shorter hospital stay. Opioid consumption should be limited due to their frequently accompanied side effects and their addictive nature. During the final phase of lumbar decompression surgery, the epidural space becomes easily accessible. This might be an ideal moment for surgeons to administer an epidural bolus of analgesia as a safe and effective method for postoperative pain relief. MATERIALS AND METHODS: In this trial, we compared a single intraoperative bolus of epidural analgesia using bupivacaine 0.25% to placebo (NaCl 0.9%) and its effect on postoperative pain following lumbar spinal decompression surgery. The primary outcome was the difference in Numeric (Pain) Rating Scale between the intervention and placebo groups during the first 48 hours after surgery. RESULTS: Both the intervention group and the placebo group consisted of 20 randomized patients (N=40). Statistically significant lower mean Numeric (Pain) Rating Scale pain scores were observed in the intervention group in comparison with the control group (main effect group: -2.35±0.77, P =0.004). The average pain score was lower in the intervention group at all postoperative time points. No study-related complications occurred. CONCLUSION: This randomized controlled trial shows that administrating a bolus of intraoperative epidural bupivacaine is a safe and effective method for reducing early postoperative pain following lumbar decompression surgery.

Advocating uniformity in spine surgery: a practical disease-specific guideline for trial-based economic evaluations.

OBJECTIVES: Despite the availability of general and national guidelines for the conduct and reporting of economic evaluations, there is heterogeneity in economic evolutions concerning spine surgery. This is partly the result of differing levels of adherence to the existing guidelines and the lack of disease-specific recommendations for economic evaluations. The extensive heterogeneity in study design, follow-up duration and outcome measurements limit the comparability of economic evaluations in spine surgery. This study has three objectives: (1) to create disease-specific recommendations for the design and conduct of trial-based economic evaluations in spine surgery, (2) to define recommendations for reporting economic evaluations in spine surgery as a complement to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 checklist and (3) to discuss methodological challenges and defining the need for future research. DESIGN: A modified Delphi method according to the RAND/UCLA Appropriateness Method. SETTING: A four-step process was followed to create and validate disease-specific statements and recommendations for the conduct and reporting of trial-based economic evaluations in spine surgery. Consensus was defined as >75% agreement. PARTICIPANTS: A total of 20 experts were included in the expert group. Validation of the final recommendations was obtained in a Delphi panel, which consisted of 40 researchers in the field who were not included in the expert group. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measure is a set of recommendations for the conduct and reporting, as a complement to the CHEERS 2022 checklist, of economic evaluations in spine surgery. RESULTS: A total of 31 recommendations are made. The Delphi panel confirmed consensus on all of the recommendations in the proposed guideline. CONCLUSION: This study provides an accessible and practical guideline for the conduct of trial-based economic evaluations in spine surgery. This disease-specific guideline is a complement to existing guidelines, and should aid in reaching uniformity and comparability.

Referrals, Symptoms and Treatment of Patients Referred to a Secondary Spine Centre-How Can We Help?

INTRODUCTION: Spinal disorders are amongst the conditions with the highest burden of disease. To limit the increase of healthcare-related costs in the ageing population, the selection of different types of care for patients with spinal disorders should be optimized. The first step is to investigate the characteristics of these patients and the relationship with treatment. RESEARCH QUESTION: The primary aim of this study was to provide insights in the characteristics, symptoms, diagnosis and treatment of patients referred to a specialized spinal health care centre. The secondary aim was to perform an in-depth analysis of resource utilization for a representative subgroup of patients. METHODS: This study describes the characteristics of 4855 patients referred to a secondary spine centre. Moreover, an extensive analysis of a representative subgroup of patients (~20%) is performed. RESULTS: The mean age was 58.1, 56% of patients were female, and the mean BMI was 28. In addition, 28% of patients used opioids. Mean self-reported health status was 53.3 (EuroQol 5D Visual Analogue Scale), and pain ranged from 5.8 to 6.7 (Visual Analogue Scale neck/back/arm/leg). Additional imaging was received by 67.7% of patients. Surgical treatment was indicated for 4.9% of patients. The majority (83%) of non-surgically treated patients received out-of-hospital treatment; 25% of patients received no additional imaging or in-hospital treatment. CONCLUSION: The vast majority of patients received non-surgical treatments. We observed that ~10% of patients did not receive in-hospital imaging or treatment and had acceptable or good questionnaire scores at the time of referral. These findings suggest that there is potential for improvement in efficacy of referral, diagnosis, and treatment. Future studies should aim to develop an evidence base for improved patient selection for clinical pathways. The efficacy of chosen treatments requires investigation of large cohorts.

A systematic review comparing the cost-effectiveness of the direct anterior, posterior, and straight lateral approach in total hip arthroplasty.

Background: Total hip arthroplasty is a reliable option to treat osteoarthritis. It reduces pain, increases quality of life, and restores function. The direct anterior approach (DAA), posterior approach (PA), and straight lateral approach (SLA) are mostly used. This systematic review evaluates current literature about costs and cost-effectiveness of DAA, PA, and SLA. Methods: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) systematic search, registered in the PROSPERO database (registration number: CRD42021237427), was conducted of databases PubMed, CINAHL, EMBASE, Cochrane, Clinical Trials, Current Controlled Trials, ClinicalTrials.gov, NHS Centre for Review and Dissemination, Econlit, and Web of Science. Eligible studies were randomized controlled trials (RCTs) or comparative cohort studies reporting or comparing costs or cost-effectiveness of either approach as the primary outcome. The risk of bias (RoB) was assessed. For comparison, all costs were converted to American Dollars (reference year 2016). Results: Six systematic review studies were included. RoB ranged from low to high, the level of evidence ranged from 2 to 4, and methodological quality was moderate. Costs ranged from $5313.85 to $15 859.00 (direct) and $1921.00 to $6364.30 (indirect) in DAA. From $5158.46 to $12 344.47 (direct) to $2265.70 to $5566.01 (indirect) for PA and from $3265.62 to $8501.81 (direct) and $2280.16 (indirect) for SLA. Due to heterogeneity of included costs, they were not directly comparable. Solid data about cost-effectiveness cannot be presented. Conclusions: Due to limited and heterogenous evidence about costs and cost-effectiveness, the effect of these in surgical approach is unknown. Further well-powered research to make undisputed conclusions is needed.

Methodology of economic evaluations in spine surgery: a systematic review and qualitative assessment.

OBJECTIVES: The present study is a systematic review conducted as part of a methodological approach to develop evidence-based recommendations for economic evaluations in spine surgery. The aim of this systematic review is to evaluate the methodology and quality of currently available clinical cost-effectiveness studies in spine surgery. STUDY DESIGN: Systematic literature review. DATA SOURCES: PubMed, Web of Science, Embase, Cochrane, Cumulative Index to Nursing and Allied Health Literature, EconLit and The National Institute for Health Research Economic Evaluation Database were searched through 8 December 2022. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Studies were included if they met all of the following eligibility criteria: (1) spine surgery, (2) the study cost-effectiveness and (3) clinical study. Model-based studies were excluded. DATA EXTRACTION AND SYNTHESIS: The following data items were extracted and evaluated: pathology, number of participants, intervention(s), year, country, study design, time horizon, comparator(s), utility measurement, effectivity measurement, costs measured, perspective, main result and study quality. RESULTS: 130 economic evaluations were included. Seventy-four of these studies were retrospective studies. The majority of the studies had a time horizon shorter than 2 years. Utility measures varied between the EuroQol 5 dimensions and variations of the Short-Form Health Survey. Effect measures varied widely between Visual Analogue Scale for pain, Neck Disability Index, Oswestry Disability Index, reoperation rates and adverse events. All studies included direct costs from a healthcare perspective. Indirect costs were included in 47 studies. Total Consensus Health Economic Criteria scores ranged from 2 to 18, with a mean score of 12.0 over all 130 studies. CONCLUSIONS: The comparability of economic evaluations in spine surgery is extremely low due to different study designs, follow-up duration and outcome measurements such as utility, effectiveness and costs. This illustrates the need for uniformity in conducting and reporting economic evaluations in spine surgery.

Minimally Invasive Sacroiliac Joint Fusion vs Conservative Management in Patients With Sacroiliac Joint Dysfunction: A Systematic Review and Meta-Analysis.

BACKGROUND: The sacroiliac joint (SIJ) is affected in 14% to 22% in individuals presenting with chronic low back or buttock pain. This percentage is even higher in patients who underwent lumbar fusion surgery: 32% to 42%. Currently, there is no standard treatment or surgical indication for SIJ dysfunction. When patients do not respond well to nonsurgical treatment, minimally invasive sacroiliac joint fusion (MISJF) seems to be a reasonable option. This systematic review and meta-analysis evaluates the current literature on the effectiveness of MISJF compared to conservative management in patients with SIJ dysfunction. METHODS: A systematic search of health-care databases was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Inclusion criteria were randomized controlled trials (RCTs) or prospective and retrospective comparative cohort studies that compared MISJF with conservative management. Primary outcome measures were pain, disability, and patient satisfaction measured by patient-reported outcome measures. Secondary outcomes were adverse events (AEs), serious AEs, financial benefits, and costs. RESULTS: Two RCTs and one retrospective cohort study were included comparing MISJF and conservative management with regard to pain and disability outcome, encompassing 388 patients (207 conservative and 181 surgical). In a pooled mean difference analysis, MISJF demonstrated greater reduction in visual analog scale-pain score compared to conservative management: -37.03 points (95%CI [-43.91, -30.15], P < 0.001). Moreover, MISJF was associated with a greater reduction in Oswestry Disability Index outcome: -21.14 points (95% CI [-24.93, -17.35], P < 0.001). AEs were low among the study groups and comparable across the included studies. One cost-effectiveness analysis was also included and reported that MISJF is more cost-effective than conservative management.001). AEs were low among the study groups and comparable across the included studies. One cost-effectiveness analysis was also included and reported that MISJF is more cost-effective than conservative management. CONCLUSIONS: This systematic review and meta-analysis suggest that MISJF, using cannulated triangular, titanium implants, is more effective and cost-effective than conservative management in reducing pain and disability in patients with SIJ dysfunction. Further well-powered, independent research is needed to improve the overall evidence.

Process Evaluation of Lumbar Interbody Fusion Surgeries in Five Dutch Hospitals: A Qualitative Analysis.

Background and Objectives: Only limited qualitative research concerning instrumented spine surgeries has been published, despite the increasing number of these surgeries and the evident importance of qualitative analysis of the processes surrounding these complex interventions. Current qualitative research is mainly limited to the experiences, emotions and expectations of patients. Insight into the full process, including experiences from the perspective of informal caregivers and healthcare professionals, remains scarce. Materials and Methods: Data were gathered by means of semi-structured face-to-face interviews. In total, there were 27 participants, including 11 patients, 7 informal caregivers and 9 healthcare professionals. The interview process was audiotaped, and each interview was transcribed verbatim. To systematically analyse the gathered data, software for qualitative analysis (NVivo) was used. After immersion in the raw data of transcripts and field notes, a list of broad categories for organising the data into meaningful clusters for analysis was developed. All interviews were coded by the first author, and 25% was independently assessed by the second author. Results: The results of our study describe several promoting and limiting factors concerning the process of lumbar fusion surgery from the perspective of patients, informal caregivers and healthcare providers. The most frequently mentioned promoting factors were: information and opportunities to ask questions during consultations; multidisciplinary consultations; good communication and guidance during hospitalization; and follow-up appointments. The most frequently mentioned limiting factors were: lack of educational material; lack of guidance and communication prior to, during and after hospitalisation. Conclusion: Overall, participants were satisfied with the current healthcare-process in lumbar fusion surgery. However, we found that lack of educational material and guidance during the process led to insecurity about complaints, surgery and recovery. To improve the process of lumbar interbody fusion and to increase patient satisfaction, healthcare providers should focus on guiding and educating patients and informal caregivers about the pre-operative trajectory, the surgery and the recovery. From the healthcare providers' perspective, the process could be improved by multidisciplinary consultations and a dedicated spine team in the operation room. Although this study focusses on lumbar fusion surgery, results could be translated to other fields of spine surgery and surgery in general.

Evidence-based recommendations for economic evaluations in spine surgery: study protocol for a Delphi consensus.

INTRODUCTION: Considering the rising global healthcare expenses, economic evaluations are more important than ever. Even though the number of studies regarding costs and cost-effectiveness is increasing, the quality of these studies remains relatively low. This is mainly caused by abundant heterogeneity in methods used for determining, calculating and reporting cost data, despite current general guidelines for the conduct of economic evaluations. Disease-specific recommendations for the conduct of economic evaluations in the field of spine surgery, as complement to existing general guidelines, will ameliorate overall research quality, comparability and interpretability and thus, the overall quality. We aim to provide expert-based recommendations for the design, conduct, and reporting of economic evaluations in spine surgery. METHODS AND ANALYSIS: A modified Delphi study will be conducted to formulate expert-based recommendations. The following steps will be taken:(1) The conduct of a systematic review to identify relevant publications and identify relevant authors. Formation of an expert group and a Delphi-panel. (2) Drafting of statements based on articles included in the systematic literature review. Validation of drafted statements by the expert group. Step 2 can be repeated up to three times, statements can be discarded and adjusted in these rounds. Statements with more than 75% agreement will be accepted as consensus statements. (3) Validation of statements by the Delphi-panel. (4) Final recommendations. ETHICS AND DISSEMINATION: The underlying work is based on existing literature and published data and does not include participation of patients, and thus does not require ethical review approval. The final recommendations are intended for (clinical) researchers in the field of cost-effectiveness in spine surgery. The Delphi method ensures that the final output reflects the opinions of international participants and gives insight in the adherence level to the recommendations. The aim is to reach uniformity in design, conduct and reporting of these studies, as is currently lacking. This will provide a solid basis to determine cost-effectiveness of spine surgeries and consequently aid to limit the rising healthcare costs. The findings of this study and the final recommendations will be disseminated in conferences and seminars and will be published in an international peer-reviewed journal.

Cost-effectiveness of open transforaminal lumbar interbody fusion (OTLIF) versus minimally invasive transforaminal lumbar interbody fusion (MITLIF): a systematic review and meta-analysis.

BACKGROUND CONTEXT: The number of performed instrumented lumbar spine surgeries and associated health-care-related costs has increased over the last decades, and will increase further in the future. With the consistent growth of health-care-related costs, cost-effectiveness of surgical techniques is of major relevance. Common indications for instrumented lumbar spine surgery are spondylolisthesis and degenerative disease. A commonly used technique is the open transforaminal lumbar interbody fusion (OTLIF). Nowadays, there is an increasing interest in the minimally invasive variation of this technique (minimally invasive transforaminal lumbar interbody fusion [MITLIF]). Currently available literature describes that MITLIF has comparable or even better clinical results compared to OTLIF. Cost-effectiveness of MITLIF and OTLIF is important considering the growing health-care related costs, although no consensus has been reached regarding the most cost-effective technique. In this systematic review, previous literature concerning costs and cost-effectiveness of OTLIF was compared with MITLIF in patients with lumbar spondylolisthesis or degenerative disease. Furthermore, methodological quality of included studies was assessed. PURPOSE: This study aims to evaluate the current literature on cost-effectiveness of OTLIF compared MITLIF to in patients with lumbar spondylolisthesis or degenerative disease. STUDY DESIGN: This study is a systematic literature review and meta-analysis. STUDY SAMPLE: Clinical studies reporting costs or cost-effectiveness for either OTLIF or MITLIF in patients with spondylolisthesis, lumbar instability, or degenerative disease were included. OUTCOME MEASURES: The following data items were evaluated: study design, study population, utility measurement tool, gained quality adjusted life years (QALYs), cost sources, health care and societal perspective costs, total costs, costs per QALY (cost-effectiveness) and incremental cost-effectiveness ratio (ICER). METHODS: A systematic search was conducted using databases PubMed, CINAHL, EMBASE, Cochrane, Clinical Trials, Current Controlled Trials, ClinicalTrials.gov, NHS Centre for Review and Dissemination, Econlit and Web of Science on studies reporting OTLIF or MITLIF, spondylolisthesis or lumbar instability or degenerative disease, and costs. Relevant studies were selected and reviewed independently by two authors. For comparison, all costs were converted to American dollars with the reference year 2018. RESULTS: After duplicate removal, a total of 892 studies were identified. Eventually, 32 studies were included. Nine studies compared OTLIF and MITLIF directly. All studies mentioned health care perspective costs. Seven studies mentioned societal perspective costs. Cost-effectiveness of OTLIF was mentioned in five studies, ranging from $47,303/QALY to $218,766/QALY. Cost-effectiveness of MITLIF was mentioned in one study, $121,105/QALY. Meta-analysis of hospital perspective costs showed a significant overall effect in favor of MITLIF, with a mean difference of $2,650. There was great heterogeneity in health care and societal perspective costs due to different in-, and exclusion factors, baseline characteristics, and calculation methods. Overall quality of studies was low. CONCLUSIONS: OTLIF and MITLIF appear to be expensive interventions when using a threshold of $50,000/QALY. Results of this study and previous literature suggest that MITLIF is more cost-effective compared to OTLIF. Considering the increase in health care costs of instrumented spine surgery, cost-effectiveness could be one of the factors in surgical decision-making. Prospective randomized studies directly comparing cost-effectiveness of OTLIF and MITLIF from both hospital and societal perspectives are needed to obtain higher level of evidence.