Percutaneous Transforaminal Endoscopic Discectomy Versus Open Microdiscectomy for Lumbar Disc Herniation: A Systematic Review and Meta-analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: To give a systematic overview of effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy (OM) in the treatment of lumbar disk herniation (LDH). SUMMARY OF BACKGROUND DATA: The current standard procedure for the treatment of sciatica caused by LDH, is OM. PTED is an alternative surgical technique which is thought to be less invasive. It is unclear if PTED has comparable outcomes compared with OM. METHODS: Multiple online databases were systematically searched up to April 2020 for randomized controlled trials and prospective studies comparing PTED with OM for LDH. Primary outcomes were leg pain and functional status. Pooled effect estimates were calculated for the primary outcomes only and presented as standard mean differences (SMD) with their 95% confidence intervals (CI) at short (1-day postoperative), intermediate (3-6 months), and long-term (12 months). RESULTS: We identified 2276 citations, of which eventually 14 studies were included. There was substantial heterogeneity in effects on leg pain at short term. There is moderate quality evidence suggesting no difference in leg pain at intermediate (SMD 0.05, 95% CI -0.10-0.21) and long-term follow-up (SMD 0.11, 95% CI -0.30-0.53). Only one study measured functional status at short-term and reported no differences. There is moderate quality evidence suggesting no difference in functional status at intermediate (SMD -0.09, 95% CI -0.24-0.07) and long-term (SMD -0.11, 95% CI -0.45-0.24). CONCLUSION: There is moderate quality evidence suggesting no difference in leg pain or functional status at intermediate and long-term follow-up between PTED and OM in the treatment of LDH. High quality, robust studies reporting on clinical outcomes and cost-effectiveness on the long term are lacking.Level of Evidence: 2.

Critical NIH Resources to Advance Therapies for Pain: Preclinical Screening Program and Phase II Human Clinical Trial Network.

Opioid-related death and overdose have now reached epidemic proportions. In response to this public health crisis, the National Institutes of Health (NIH) launched the Helping to End Addiction Long-term InitiativeSM, or NIH HEAL InitiativeSM, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. Herein, we describe two NIH HEAL Initiative programs to accelerate development of non-opioid, non-addictive pain treatments: The Preclinical Screening Platform for Pain (PSPP) and Early Phase Pain Investigation Clinical Network (EPPIC-Net). These resources are provided at no cost to investigators, whether in academia or industry and whether within the USA or internationally. Both programs consider small molecules, biologics, devices, and natural products for acute and chronic pain, including repurposed and combination drugs. Importantly, confidentiality and intellectual property are protected. The PSPP provides a rigorous platform to identify and profile non-opioid, non-addictive therapeutics for pain. Accepted assets are evaluated in in vitro functional assays to rule out opioid receptor activity and to assess abuse liability. In vivo pharmacokinetic studies measure plasma and brain exposure to guide the dose range and pretreatment times for the side effect profile, efficacy, and abuse liability. Studies are conducted in accordance with published rigor criteria. EPPIC-Net provides academic and industry investigators with expert infrastructure for phase II testing of pain therapeutics across populations and the lifespan. For assets accepted after a rigorous, objective scientific review process, EPPIC-Net provides clinical trial design, management, implementation, and analysis.

Stratified exercise therapy compared with usual care by physical therapists in patients with knee osteoarthritis: A randomized controlled trial protocol (OCTOPuS study).

OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy. METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed. CONCLUSION: This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.

Evaluating non-medical prescription opioid demand using commodity purchase tasks: test-retest reliability and incremental validity.

RATIONALE: Non-medical prescription opioid use and opioid use disorder (OUD) present a significant public health concern. Identifying behavioral mechanisms underlying OUD will assist in developing improved prevention and intervention approaches. Behavioral economic demand has been extensively evaluated as a measure of reinforcer valuation for alcohol and cigarettes, whereas prescription opioids have received comparatively little attention. OBJECTIVES: Utilize a purchase task procedure to measure the incremental validity and test-retest reliability of opioid demand. METHODS: Individuals reporting past year non-medical prescription opioid use were recruited using the crowdsourcing platform Amazon Mechanical Turk (mTurk). Participants completed an opioid purchase task as well as measures of cannabis demand, delay discounting, and self-reported pain. A 1-month follow-up was used to evaluate test-retest reliability. RESULTS: More intense and inelastic opioid demand was associated with OUD and more intense cannabis demand was associated with cannabis use disorder. Multivariable models indicated that higher opioid intensity and steeper opioid delay discounting rates each significantly and uniquely predicted OUD. Increased opioid demand intensity, but not elasticity, was associated with higher self-reported pain, and no relationship was observed with perceived pain relief from opioids. Opioid demand showed acceptable-to-good test-retest reliability (e.g., intensity rxx = .75; elasticity rxx = .63). Temporal reliability was lower for cannabis demand (e.g., intensity rxx = .53; elasticity rxx = .58) and discounting rates (rxx = .42-.61). CONCLUSIONS: Opioid demand was incrementally valid and test-retest reliable as measured by purchase tasks. These findings support behavioral economic demand as a clinically useful measure of drug valuation that is sensitive to individual difference variables.

A randomised controlled trial of the clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injections: the hip injection trial (HIT) protocol.

BACKGROUND: Evidence on the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis is limited and conflicting. The primary objective of the Hip Injection Trial (HIT) is to compare pain intensity over 6 months, in people with hip OA between those receiving an ultrasound-guided intra-articular hip injection of corticosteroid with 1% lidocaine hydrochloride plus best current treatment with those receiving best current treatment alone. Secondary objectives are to determine specified comparative clinical and cost-effectiveness outcomes, and to explore, in a linked qualitative study, the lived experiences of patients with hip OA and experiences and impact of, ultrasound-guided intra-articular hip injection. METHODS: The HIT trial is a pragmatic, three-parallel group, single-blind, superiority, randomised controlled trial in patients with painful hip OA with a linked qualitative study. The current protocol is described, in addition to details and rationale for amendments since trial registration. 204 patients with moderate-to-severe hip OA will be recruited. Participants are randomised on an equal basis (1:1:1 ratio) to one of three interventions: (1) best current treatment, (2) best current treatment plus ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40 mg) with 1% lidocaine hydrochloride, or (3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride alone. The primary endpoint is patient-reported hip pain intensity across 2 weeks, 2 months, 4 months and 6 months post-randomisation. Recruitment is over 29 months with a 6-month follow-up period. To address the primary objective, the analysis will compare participants' 'average' follow-up pain NRS scores, based on a random effects linear repeated-measures model. Data on adverse events are collected and reported in accordance with national guidance and reviewed by external monitoring committees. Individual semi-structured interviews are being conducted with up to 30 trial participants across all three arms of the trial. DISCUSSION: To ensure healthcare services improve outcomes for patients, we need to ensure there is a robust and appropriate evidence-base to support clinical decision making. The HIT trial will answer important questions regarding the clinical and cost-effectiveness of intra-articular corticosteroid injections. TRIAL REGISTRATION: ISRCTN: 50550256 , 28th July 2015.

Iliac Crest Bone Graft for Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Prospective Analysis of Inpatient Pain, Narcotics Consumption, and Costs.

STUDY DESIGN: Retrospective Analysis OBJECTIVE.: The aim of this study was to determine whether an association between increased acute pain, postoperative time, and direct hospital costs exists between the use of iliac crest bone grafting (ICBG) and bone morphogenic protein (BMP)-2 following a primary, single-level minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). SUMMARY OF BACKGROUND DATA: ICBG has been associated with enhanced fusion rates. Concerns have been raised in regards to increased operative time and postoperative pain. The advantages of ICBG compared to other spinal fusion adjuncts have been debated. METHODS: Prospective, consecutive analysis of patients undergoing primary, single-level MIS TLIF with ICBG was compared to a historical cohort of consecutive patients that received BMP-2. Operative characteristics were compared between groups using χ analysis or independent t test for categorical and continuous variables, respectively. Postoperative inpatient pain was measured using the Visual Analog Scale, and inpatient narcotics consumption was quantified as oral morphine equivalents. Outcomes were compared between groups using multivariate regression controlling for preoperative characteristics. RESULTS: A total of 98 patients were included in this analysis, 49 in each cohort. No significant differences were noted between cohorts with exception to sex (Females: ICBG, 53.06% vs. BMP-2, 32.65%, P = 0.041). There was a significant increase in operative time (14.53 minutes, P = 0.006) and estimated blood loss (16.64 mL, P = 0.014) in the ICBG cohort. Narcotics consumption was similar between groups on postoperative days 0 and 1. ICBG was associated with decreased total direct costs ($19,315 vs. $21,645, P < 0.001) as compared to BMP-2. CONCLUSION: Patients undergoing MIS TLIF with ICBG experienced increases in operative time and estimated blood loss that were not clinically significant. Furthermore, iliac crest harvesting did not result in an increase in acute pain or narcotics consumption. Further follow-up is necessary to determine the associated arthrodesis rates and long-term outcomes between each cohort. LEVEL OF EVIDENCE: 3.

Cost Utility Analysis of Cervical Therapeutic Medial Branch Blocks in Managing Chronic Neck Pain.

Background: Controlled diagnostic studies have established the prevalence of cervical facet joint pain to range from 36% to 67% based on the criterion standard of ≥ 80% pain relief. Treatment of cervical facet joint pain has been described with Level II evidence of effectiveness for therapeutic facet joint nerve blocks and radiofrequency neurotomy and with no significant evidence for intraarticular injections. However, there have not been any cost effectiveness or cost utility analysis studies performed in managing chronic neck pain with or without headaches with cervical facet joint interventions. Study Design: Cost utility analysis based on the results of a double-blind, randomized, controlled trial of cervical therapeutic medial branch blocks in managing chronic neck pain. Objectives: To assess cost utility of therapeutic cervical medial branch blocks in managing chronic neck pain. Methods: A randomized trial was conducted in a specialty referral private practice interventional pain management center in the United States. This trial assessed the clinical effectiveness of therapeutic cervical medial branch blocks with or without steroids for an established diagnosis of cervical facet joint pain by means of controlled diagnostic blocks. Cost utility analysis was performed with direct payment data for the procedures for a total of 120 patients over a period of 2 years from this trial based on reimbursement rates of 2016. The payment data provided direct procedural costs without inclusion of drug treatments. An additional 40% was added to procedural costs with multiplication of a factor of 1.67 to provide estimated total costs including direct and indirect costs, based on highly regarded surgical literature. Outcome measures included significant improvement defined as at least a 50% improvement with reduction in pain and disability status with a combined 50% or more reduction in pain in Neck Disability Index (NDI) scores. Results: The results showed direct procedural costs per one-year improvement in quality adjusted life year (QALY) of United States Dollar (USD) of $2,552, and overall costs of USD $4,261. Overall, each patient on average received 5.7 ± 2.2 procedures over a period of 2 years. Average significant improvement per procedure was 15.6 ± 12.3 weeks and average significant improvement in 2 years per patient was 86.0 ± 24.6 weeks. Limitations: The limitations of this cost utility analysis are that data are based on a single center evaluation. Only costs of therapeutic interventional procedures and physician visits were included, with extrapolation of indirect costs. Conclusion: The cost utility analysis of therapeutic cervical medial branch blocks in the treatment of chronic neck pain non-responsive to conservative management demonstrated clinical effectiveness and cost utility at USD $4,261 per one year of QALY.

The cost-effectiveness of patient-controlled analgesia vs. standard care in patients presenting to the Emergency Department in pain, who are subsequently admitted to hospital.

The clinical effectiveness of patient-controlled analgesia has been demonstrated in a variety of settings. However, patient-controlled analgesia is rarely utilised in the Emergency Department. The aim of this study was to compare the cost-effectiveness of patient-controlled analgesia vs. standard care in participants admitted to hospital from the Emergency Department with pain due to traumatic injury or non-traumatic abdominal pain. Pain scores were measured hourly for 12 h using a visual analogue scale. Cost-effectiveness was measured as the additional cost per hour in moderate to severe pain avoided by using patient-controlled analgesia rather than standard care (the incremental cost-effectiveness ratio). Sampling variation was estimated using bootstrap methods and the effects of parameter uncertainty explored in a sensitivity analysis. The cost per hour in moderate or severe pain averted was estimated as £24.77 (€29.05, US$30.80) (bootstrap estimated 95%CI £8.72 to £89.17) for participants suffering pain from traumatic injuries and £15.17 (€17.79, US$18.86) (bootstrap estimate 95%CI £9.03 to £46.00) for participants with non-traumatic abdominal pain. Overall costs were higher with patient-controlled analgesia than standard care in both groups: pain from traumatic injuries incurred an additional £18.58 (€21.79 US$23.10) (95%CI £15.81 to £21.35) per 12 h; and non-traumatic abdominal pain an additional £20.18 (€23.67 US$25.09) (95%CI £19.45 to £20.84) per 12 h.

Use of analgesics in young adults as a predictor of health care utilization and pain prevalence: Israel defense forces experience.

Pain evaluation in large community studies is difficult. Analgesics can be a useful tool in estimating pain-related conditions in which analgesic use is highly regulated. In this study, we evaluated analgesics consumption patterns of regular Israel Defense Force soldiers. We have performed a historical cohort study of 665,137 young adults during active duty in 2002 to 2012. Analgesics were prescribed to 518,242 (78%) soldiers, mostly for musculoskeletal pain (69.3%), abdominal pain (12.7%), and headache (12.1%). Acute (1-14 days), subacute (15-90), and chronic (>90 days) analgesic use episodes were experienced by 396,987 (59.7%), 74,591 (11.2%), and 46,664 (7%) of the population. In a multivariate model, predictors for chronic analgesics use were as follows: low intelligence, service in a combat supporting unit, previous pain diagnosis, male sex, Israeli nativity, low socioeconomic status, and high body mass index. Low intelligence had the highest odds ratio for chronic analgesic consumption (2.1) compared with other predictors. Chronic analgesic use was associated with a significant increase in health care utilization cost per year (911$ per soldier vs 199$ for nonusers), increased sick leave days per year (7.09 vs 0.67 for nonusers), and higher dropout rate from combat units (25% vs 9.2% for nonusers). Chronic use of analgesics is common among young adults, and it is an important predictor for unsuccessful military service and high health care utilization costs. Further studies in other setups are indicated.

Development, Validation, and Field-Testing of an Instrument for Clinical Assessment of HIV-Associated Neuropathy and Neuropathic Pain in Resource-Restricted and Large Population Study Settings.

HIV-associated sensory peripheral neuropathy (HIV-SN) afflicts approximately 50% of patients on antiretroviral therapy, and is associated with significant neuropathic pain. Simple accurate diagnostic instruments are required for clinical research and daily practice in both high- and low-resource setting. A 4-item clinical tool (CHANT: Clinical HIV-associated Neuropathy Tool) assessing symptoms (pain and numbness) and signs (ankle reflexes and vibration sense) was developed by selecting and combining the most accurate measurands from a deep phenotyping study of HIV positive people (Pain In Neuropathy Study-HIV-PINS). CHANT was alpha-tested in silico against the HIV-PINS dataset and then clinically validated and field-tested in HIV-positive cohorts in London, UK and Johannesburg, South Africa. The Utah Early Neuropathy Score (UENS) was used as the reference standard in both settings. In a second step, neuropathic pain in the presence of HIV-SN was assessed using the Douleur Neuropathique en 4 Questions (DN4)-interview and a body map. CHANT achieved high accuracy on alpha-testing with sensitivity and specificity of 82% and 90%, respectively. In 30 patients in London, CHANT diagnosed 43.3% (13/30) HIV-SN (66.7% with neuropathic pain); sensitivity = 100%, specificity = 85%, and likelihood ratio = 6.7 versus UENS, internal consistency = 0.88 (Cronbach alpha), average item-total correlation = 0.73 (Spearman's Rho), and inter-tester concordance > 0.93 (Spearman's Rho). In 50 patients in Johannesburg, CHANT diagnosed 66% (33/50) HIV-SN (78.8% neuropathic pain); sensitivity = 74.4%, specificity = 85.7%, and likelihood ratio = 5.29 versus UENS. A positive CHANT score markedly increased of pre- to post-test clinical certainty of HIV-SN from 43% to 83% in London, and from 66% to 92% in Johannesburg. In conclusion, a combination of four easily and quickly assessed clinical items can be used to accurately diagnose HIV-SN. DN4-interview used in the context of bilateral feet pain can be used to identify those with neuropathic pain.

Cost effectiveness of a novel 10 kHz high-frequency spinal cord stimulation system in patients with failed back surgery syndrome (FBSS).

OBJECTIVES: Spinal cord stimulation (SCS) is an effective method of relieving chronic intractable pain, and one of its key indications is failed back surgery syndrome (FBSS). The objective of the current study was to evaluate the cost effectiveness of 10 kHz high-frequency SCS (HF10 SCS) compared to conventional medical management (CMM), reoperation, and traditional nonrechargeable (TNR-SCS) and rechargeable SCS (TR-SCS). METHODS: A health economic model of SCS in the United Kingdom was reproduced in the perspective of the health care system to simulate costs and quality adjusted life years (QALYs) over 15 years. In the model, both a decision tree and the Markov model were used to describe the health outcomes of the evaluated therapies. RESULTS: HF10 SCS therapy showed a favorable incremental cost-effectiveness ratio (ICER) of £3,153 per QALY gained as compared to CMM and established dominance (less costly, more QALYs) compared to TNR-SCS (£8,802 per QALY vs. CMM) and TR-SCS (£5,101 per QALY vs. CMM). CONCLUSION: This first analysis of the cost effectiveness of HF10 SCS suggests that it is more cost effective and provides a greater number of QALYs than both TNR-SCS and TR-SCS.

Determination of the minimum improvement in pain, disability, and health state associated with cost-effectiveness: introduction of the concept of minimum cost-effective difference.

BACKGROUND: Minimum clinical important difference (MCID) has been adopted as the smallest improvement in patient-reported outcome needed to achieve a level of improvement thought to be meaningful to patients. OBJECTIVE: To use a common MCID calculation method with a cost-utility threshold anchor to introduce the concept of minimum cost-effective difference (MCED). METHODS: Forty-five patients undergoing transforaminal lumbar interbody fusion for degenerative spondylolisthesis were included. Outcome questionnaires were administered before and 2 years after surgery. Total cost per quality-adjusted life-year (QALY) gained was calculated for each patient. MCED was determined from receiver-operating characteristic curve analysis with a cost-effective anchor of < $50,000/QALY and < $75,000/QALY. MCID was determined with the health transition item as the anchor. RESULTS: Significant improvement was observed 2 years after transforaminal lumbar interbody fusion for all outcome measures. Mean total cost per QALY gained at 2 years was $42,854. MCED was greater than MCID for each outcome measure, meaning that a greater improvement was required to represent cost-effectiveness than a clinically meaningful improvement to patients. The area under the receiver-operating characteristic curve was consistently ≥ 0.70 with both cost-effective anchors, suggesting that outcome change scores were accurate predictors of cost-effectiveness. Mean cost per QALY gained was significantly lower for patients achieving compared with those not achieving an MCED in visual analog scale for leg pain ($43,560 vs. $112,087), visual analog scale for back pain ($41,280 vs. $129,440), Oswestry disability index ($30,954 vs. $121,750), and EuroQol 5D ($35,800 vs. $189,412). CONCLUSION: MCED serves as the smallest improvement in an outcome instrument that is associated with a cost-effective response to surgery. With the use of cost-effective anchor of < $50,000/QALY, MCED after transforaminal lumbar interbody fusion was 4 points for visual analog scale for low back pain, 3 points for visual analog scale for leg pain, 22 points for Oswestry disability index, and 0.31 QALYs for EuroQol 5D.

Spinal manipulation epidemiology: systematic review of cost effectiveness studies.

BACKGROUND: Spinal manipulative therapy (SMT) is frequently used by health professionals to manage spinal pain. With many treatments having comparable outcomes to SMT, determining the cost-effectiveness of these treatments has been identified as a high research priority. OBJECTIVE: To investigate the cost-effectiveness of SMT compared to other treatment options for people with spinal pain of any duration. METHODS: We searched eight clinical and economic databases and the reference lists of relevant systematic reviews. Full economic evaluations conducted alongside randomised controlled trials with at least one SMT arm were eligible for inclusion. Two authors independently screened search results, extracted data and assessed risk of bias using the CHEC-list. RESULTS: Six cost-effectiveness and cost-utility analysis were included. All included studies had a low risk of bias scoring ≥16/19 on the CHEC-List. SMT was found to be a cost-effective treatment to manage neck and back pain when used alone or in combination with other techniques compared to GP care, exercise and physiotherapy. CONCLUSIONS: This review supports the use of SMT in clinical practice as a cost-effective treatment when used alone or in combination with other treatment approaches. However, as this conclusion is primarily based on single studies more high quality research is needed to identify whether these findings are applicable in other settings.

Whiplash and the compensation hypothesis.

STUDY DESIGN: Review article. OBJECTIVE: To explain why the evidence that compensation-related factors lead to worse health outcomes is not compelling, either in general, or in the specific case of whiplash. SUMMARY OF BACKGROUND DATA: There is a common view that compensation-related factors lead to worse health outcomes ("the compensation hypothesis"), despite the presence of important, and unresolved sources of bias. The empirical evidence on this question has ramifications for the design of compensation schemes. METHODS: Using studies on whiplash, this article outlines the methodological problems that impede attempts to confirm or refute the compensation hypothesis. RESULTS: Compensation studies are prone to measurement bias, reverse causation bias, and selection bias. Errors in measurement are largely due to the latent nature of whiplash injuries and health itself, a lack of clarity over the unit of measurement (specific factors, or "compensation"), and a lack of appreciation for the heterogeneous qualities of compensation-related factors and schemes. There has been a failure to acknowledge and empirically address reverse causation bias, or the likelihood that poor health influences the decision to pursue compensation: it is unclear if compensation is a cause or a consequence of poor health, or both. Finally, unresolved selection bias (and hence, confounding) is evident in longitudinal studies and natural experiments. In both cases, between-group differences have not been addressed convincingly. CONCLUSION: The nature of the relationship between compensation-related factors and health is unclear. Current approaches to testing the compensation hypothesis are prone to several important sources of bias, which compromise the validity of their results. Methods that explicitly test the hypothesis and establish whether or not a causal relationship exists between compensation factors and prolonged whiplash symptoms are needed in future studies.

The fragmented story of pain: a saga of economic discourse, confusion and lack of holistic assessment in the residential care of older people.

The long-standing problem of overlooked and/or undertreated pain experienced by so many older people living in Australian residential care facilities condemns these people to a life robbed of quality. Such a degree of suffering experienced by older people calls into question the pain assessment skills of staff who work in residential care. However, the problem of undetected and unresolved pain experienced by older people is not simply a skill or knowledge issue. It is much broader than that. In this paper we portray pain as likened to a story; a narrative that only the older person, as the author, can impart and one in which only they can communicate their experience of pain. Nevertheless, as opposed to seeking the older person's pain narrative, nurses attempt to measure the immeasurable. In part, their actions relate to the confusing terminology which envelops pain assessment. However, political policy and economic discourse also influences nurses' pain assessment practises to the detriment of older people and the profession of gerontological nursing. Discussion in this paper includes the experience of pain for the older person, an overview of the specific role of pain-screening tools compared with the requirements of a person-centred pain assessment, and person-centred pathways to help nurses and others interpret and heed the older person's pain story. Analysis also incorporates the argument that current and previous Federal Government funding tools for residential care subtly impact on holistic pain assessment causing confusion for caregivers and fragmentation of the older person's pain story.

Identifying episodes of back pain using medical expenditures panel survey data: patient experience, use of services, and chronicity.

OBJECTIVE: To explore the correspondence between "Episodes-of-Pain" and "episodes of care" for individuals with back pain. METHODS: This study was a secondary analysis of Medical Expenditures Panel Survey (MEPS) 2-year longitudinal data. Individual use and utilization of back pain services were examined across ambulatory settings and providers, and linked to MEPS medical condition data to identify individuals with back pain who do not use or who delay or discontinue utilization of health services for back pain. "Episodes-of-Care" and Episodes-of-Pain were approximated through round-by-round temporal mapping of MEPS back pain utilization events data and medical conditions data. RESULTS: Of 10,193 individuals with back pain, approximately one fifth did not actively seek care for their back pain. Utilization of services for back pain (Episodes-of-Care) does not always correspond with an individual's full experience of back pain (Episodes-of-Pain). Upwards of 20% of MEPS respondents who use services for some back pain episodes, reported additional episodes for which they do not use services. CONCLUSIONS: These findings suggest that other longitudinal studies based only on data that reflect service use, for example, claims data, may incorrectly infer the nature of back pain and back pain episodes. Many individuals report ongoing back pain that continues beyond their Episodes-of-Care, and many individuals with persistent back pain may use prescription drugs, medical services, and other health services only intermittently.

PACE--the first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial.

BACKGROUND: Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP) should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses) results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN) for recovery from acute LBP. METHODS/DESIGN: The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol), PRN paracetamol (plus placebo time-contingent paracetamol) or a double placebo study arm. The primary outcome will be time (days) to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function, global perceived effect and sleep quality, captured at baseline and at weeks 1, 2, 4 and 12 by an assessor blind to treatment allocation. An economic analysis will be conducted to determine the cost-effectiveness of treatment from the health sector and societal perspectives. DISCUSSION: The successful completion of the trial will provide the first high quality evidence on the effectiveness of the use of paracetamol, a guideline endorsed treatment for acute LBP.

A cost-consequences analysis of the effect of pregabalin in the treatment of painful radiculopathy under medical practice conditions in primary care settings.

PURPOSE: To analyze the effect of pregabalin (PGB) on pain relief, longitudinal utilization of health and nonhealth resources and derived costs in patients with refractory painful radiculopathy under routine medical practice in primary care settings (PCS). METHODS: Subjects over 18 years of age with painful radiculopathy (cervical/lumbar) refractory to at least one previous analgesic therapy were included in a prospective, naturalistic, 12-week study. Consumption of resources included both health-care and nonhealth-care resources. Pain severity was measured using the Short Form of the McGill Pain Questionnaire. RESULTS: One thousand three hundred and four PGB-naive patients (55.8% women, 56.7 [12.9] years) were analyzed: 473 (36%) switched to monotherapy with PGB (PGBm), 676 (52%) received add-on therapy with PGB (PGBadd-on), and in 155 patients (12%) the previous treatment was replaced by a schedule not including PGB (non-PGB). As compared with the non-PGB, both PGBm and PGBadd-on schedules showed a significantly greater reduction of pain severity (36.1%, 56.1%, and 49.6% reductions, respectively, P < 0.001 between groups) and consumption of resources. Additional costs of drugs, particularly in the PGB subgroups (euro15.4, euro148.6 and euro145.3, respectively, P < 0.001) were offset by significantly greater reductions of all other components of health-care and nonhealth-care cost, thus resulting in a substantial reduction of total cost: euro1,203.3, euro1,423.2, and euro1,429.2, respectively (P < 0.001). CONCLUSION: In PCS, either PGBadd-on or PGBm under routine medical practice was associated with pain alleviation leading to significant longitudinal reductions in resource use and total costs compared with non-PGB-therapy in subjects with painful refractory cervical or lumbar radiculopathy.