Acceptability, values, and preferences of older people for chronic low back pain management; a qualitative evidence synthesis.

BACKGROUND: Chronic primary low back pain (CPLBP) and other musculoskeletal conditions represent a sizable attribution to the global burden of disability, with rates greatest in older age. There are multiple and varied interventions for CPLBP, delivered by a wide range of health and care workers. However, it is not known if these are acceptable to or align with the values and preferences of care recipients. The objective of this synthesis was to understand the key factors influencing the acceptability of, and values and preferences for, interventions/care for CPLBP from the perspective of people over 60 and their caregivers. METHODS: We searched MEDLINE, CINAHL and OpenAlex, for eligible studies from inception until April 2022. We included studies that used qualitative methods for data collection and analysis; explored the perceptions and experiences of older people and their caregivers about interventions to treat CPLBP; from any setting globally. We conducted a best fit framework synthesis using a framework developed specifically for this review. We assessed our certainty in the findings using GRADE-CERQual. RESULTS: All 22 included studies represented older people's experiences and had representation across a range of geographies and economic contexts. No studies were identified on caregivers. Older people living with CPLBP express values and preferences for their care that relate to therapeutic encounters and the importance of therapeutic alliance, irrespective of the type of treatment, choice of intervention, and intervention delivery modalities. Older people with CPLBP value therapeutic encounters that validate, legitimise, and respect their pain experience, consider their context holistically, prioritise their needs and preferences, adopt a person-centred and tailored approach to care, and are supported by interprofessional communication. Older people valued care that provided benefit to them, included interventions beyond analgesic medicines alone and was financially and geographically accessible. CONCLUSIONS: These findings provide critical context to the implementation of clinical guidelines into practice, particularly related to how care providers interact with older people and how components of care are delivered, their location and their cost. Further research is needed focusing on low- and middle-income settings, vulnerable populations, and caregivers.

Fracture liaison service utilising an emergency department information system to identify patients effectively reduce re-fracture rate is cost-effective and cost saving in Western Australia.

OBJECTIVES: To assess the benefits of the Emergency Department Information System (EDIS)-linked fracture liaison service (FLS). METHODS: Patients identified through EDIS were invited to attend an FLS at the intervention hospital, the Sir Charles Gairdner Hospital (SCGS-FLS). The intervention group was compared to usual care. Retrospective control (RC) at this hospital determined historical fracture risk (SCGH-RC). Prospective control (PC) was from a comparator, Fremantle Hospital (FH-PC). The main outcome measures were cost-effectiveness from a health system perspective and quality of life by EuroQOL (EQ-5D). Bottom-up cost of medical care, against the cost of managing recurrent fracture (weighted basket), was determined from the literature and 2013/14 Australian Refined Diagnosis Related Groups (AR-DRG) prices. Mean incremental cost-effectiveness ratios were simulated from 5000 bootstrap iterations. Cost-effectiveness acceptability curves were generated. RESULTS: The SCGH-FLS program reduced absolute re-fracture rates versus control cohorts (9.2-10.2%), producing an estimated cost saving of AUD$750,168-AUD$810,400 per 1000 patient-years in the first year. Between-groups QALYs differed with worse outcomes in both control groups (p < 0.001). The SCGH-FLS compared with SCGH-RC and FH-PC had a mean incremental cost of $8721 (95% CI -$1218, $35,044) and $8974 (95% CI -$26,701, $69,929), respectively, per 1% reduction in 12-month recurrent fracture risk. The SCGH-FLS compared with SCGH-RC and FH-PC had a mean incremental cost of $292 (95% CI -$3588, $3380) and -$261 (95% CI -$1521, $471) per EQ-5D QALY gained at 12 months respectively. With societal willingness to pay of $16,000, recurrent fracture is reduced by 1% in >80% of patients. CONCLUSIONS: This simple and easy model of identification and intervention demonstrated efficacy in reducing rates of recurrent fracture and was cost-effective and potentially cost saving.

Comparison of Alternative Methods to Assess the Cost-Effectiveness of Tumor-Agnostic Therapies: A Triangulation Approach Using Larotrectinib as a Case Study.

OBJECTIVES: The study objective was to investigate the economic value of tumor-agnostic therapies when only single-arm effectiveness data are available at launch by applying multiple methodologies to establish comparative effectiveness. METHODS: In the absence of direct comparative data, 3 methods were used to estimate the counterfactual: (1) a historical control based on a systematic literature review for each tumor site from the larotrectinib trials, (2) an intracohort comparison using the previous line of therapy time to progression from larotrectinib trials, and (3) a nonresponder control that applied outcomes for larotrectinib nonresponders. Cost-effectiveness was modeled using the partitioned survival approach. Stochastic parameter uncertainty was assessed in a probabilistic sensitivity analysis (PSA). A triangulated estimate of the mean cost-effectiveness result was generated combining all 3 counterfactual estimates. RESULTS: Incremental cost-effectiveness ratios were similar across the 3 methodologies in the deterministic analysis ranging from £83 868 (95% uncertainty interval [UI] £65 698-£107 668) to £104 922 per quality-adjusted life-year (95% UI £80 132-£139 658). PSA results for each method substantially overlapped when plotted on the cost-effectiveness plane. Weighting PSA results for each method equally in the triangulation method produced an incremental cost-effectiveness ratios of £95 587 per quality-adjusted life-year gained (95% UI £70 449-£137 431). CONCLUSIONS: In the absence of direct comparative data, different methods of estimating a counterfactual are possible, each with strengths and limitations. Triangulating results across the methods provides a composite view of the total uncertainty and a more consistent estimation of the cost-effectiveness of the tumor-agnostic intervention compared with choosing a single method.

"Listen to me, learn from me": a priority setting partnership for shaping interdisciplinary pain training to strengthen chronic pain care.

ABSTRACT: What are the care-seeking priorities of people living with chronic pain and carers and how can these shape interdisciplinary workforce training to improve high-value pain care? Phase 1: Australian people living with chronic pain (n = 206; 90% female) and carers (n = 10; 40% female) described their pain care priorities (eDelphi, round 1). A coding framework was inductively derived from 842 pain care priorities (9 categories, 52 priorities), including validation; communication; multidisciplinary approaches; holistic care; partnerships; practitioner knowledge; self-management; medicines; and diagnosis. Phase 2: In eDelphi round 2, panellists (n = 170; valid responses) rated the importance (1 = less important; 9 = more important) of the represented framework. In parallel, cross-discipline health professionals (n = 267; 75% female) rated the importance of these same priorities. Applying the RAND-UCLA method (panel medians: 1-3: "not important," 4-6: "equivocal," or 7-9: "important"), "important" items were retained where the panel median score was >7 with panel agreement ≥70%, with 44 items (84.6%) retained. Specific workforce training targets included the following: empathic validation; effective, respectful, safe communication; and ensuring genuine partnerships in coplanning personalised care. Panellists and health professionals agreed or strongly agreed (95.7% and 95.2%, respectively) that this framework meaningfully reflected the importance in care seeking for pain. More than 74% of health professionals were fairly or extremely confident in their ability to support care priorities for 6 of 9 categories (66.7%). Phase 3: An interdisciplinary panel (n = 5) mapped an existing foundation-level workforce training program against the framework, identifying gaps and training targets. Recommendations were determined for framework adoption to genuinely shape, from a partnership perspective, Australian interdisciplinary pain training.

A systematic review of the effects of probiotic administration in inflammatory arthritis.

OBJECTIVE: To systematically identify and appraise evidence of the formulation specific effects and population specific responses of probiotics in inflammatory arthritis. METHODS: MEDLINE (PubMed), CINAHL, EMBASE, and SCOPUS databases were searched for studies utilising probiotics in populations with inflammatory arthritis. The Joanna Briggs Institute (JBI) method was used to conduct the systematic review. A single reviewer undertook screening and data extraction. Two independent reviewers assessed the quality of evidence using JBI tools. RESULTS: The search identified 5876 unique articles, with 154 potentially relevant full text articles retrieved. Twelve studies met the inclusion criteria and were included in the review, of which ten (83%) were randomised control trials (RCT) and two (17%) were quasi-experimental studies. Four studies included a variety of spondyloarthopathies (SpAs) and eight studies focused on rheumatoid arthritis (RA). Probiotics were supplied for a median of 60 days and mode of 56 days across all included studies (range 7-365 days). Overall, 17 different probiotics were supplied in colony forming units (CFU) per 24 hrs ranging from 1 × 108 to 2.25 × 1011. The order of probiotics supplied to the most participants and across the most studies was Lactobacillales. There was no statistical difference in the relative risk (RR) of minor adverse events between probiotic and control groups (RR 1.02, 95% CI 0.69 to 1.51) when including nil event studies. Meta-analysis identified a statistically significant benefit of probiotics on quality of life with a standard mean difference (SMD) of -0.37 (95% CI -0.59,-0.15) with subgroup analysis favouring Lactobacillales-only formulations. Small but statistically significant reductions in pain were identified, with a mean difference (MD) of -8.97 (95% CI-15.38, -2.56) on a 100mm visual analogue scale, independent of formulation. Meta-analysis confirmed the known statistically significant benefit of probiotics on the inflammatory marker C-reactive protein (CRP) concentration MD (mg/L) -2.33 (95% CI -4.26, -0.41), with subgroup analysis demonstrating a greater effect in RA and from combined Bifidobacteriales and Lactobacillales formulations. CONCLUSION: This review indicates there may be differential benefits to combined formulations of Bifidobacteriales and Lactobacillales compared to purely Lactobacillales formulations, with respect to reducing pain, lowering CRP and improving quality of life. It also suggests variable benefits associated with the type of inflammatory arthritis. Relatively less benefit for lowering CRP was attributed to individuals with SpA compared to individuals with RA. Generalisability of results to clinical practice is limited by the dominant demographic of older individuals with established disease beyond the 'therapeutic window of intervention'. Small but statistically significant benefits require confirmation in clinical studies with greater consideration to potentially confounding factors of age, gender, diet and individual microbial signature.

Covariate-adjusted analysis of the Phase 3 REFLECT study of lenvatinib versus sorafenib in the treatment of unresectable hepatocellular carcinoma.

BACKGROUND: In the Phase 3 REFLECT trial in patients with unresectable hepatocellular carcinoma (uHCC), the multitargeted tyrosine kinase inhibitor, lenvatinib, was noninferior to sorafenib in the primary outcome of overall survival. Post-hoc review revealed imbalances in prognostic variables between treatment arms. Here, we re-analyse overall survival data from REFLECT to adjust for the imbalance in covariates. METHODS: Univariable and multivariable adjustments were undertaken for a candidate set of covariate values that a physician panel indicated could be prognostically associated with overall survival in uHCC. The values included baseline variables observed pre- and post-randomisation. Univariable analyses were based on a stratified Cox model. The multivariable analysis used a "forwards stepwise" Cox model. RESULTS: Univariable analysis identified alpha-fetoprotein (AFP) as the most influential variable. The chosen multivariable Cox model analysis resulted in an estimated adjusted hazard ratio for lenvatinib of 0.814 (95% CI: 0.699-0.948) when only baseline variables were included. Adjusting for post-randomisation treatment variables further increased the estimated superiority of lenvatinib. CONCLUSIONS: Covariate adjustment of REFLECT suggests that the original noninferiority trial likely underestimated the true effect of lenvatinib on overall survival due to an imbalance in baseline prognostic covariates and the greater use of post-treatment therapies in the sorafenib arm. TRIAL REGISTRATION: Trial number: NCT01761266 (Submitted January 2, 2013).

The cost-effectiveness of recommended adjunctive interventions for knee osteoarthritis: Results from a computer simulation model.

Objective: To estimate the potential lifetime health gains, healthcare costs, and cost-effectiveness of recommended adjunctive treatments for knee osteoarthritis delivered in addition to established core treatments, relative to core treatment only, from the perspective of the New Zealand (NZ) healthcare sector. Design: Recommended adjunctive knee osteoarthritis treatments were identified in clinical practice guidelines. Evidence of effectiveness was sourced from existing systematic reviews and meta-analyses. Treatment costs were calculated by applying local reference prices to estimated resource use. We used a validated computer simulation model of the impacts of knee osteoarthritis to estimate the cost-effectiveness of each adjunctive treatment at willingness-to-pay thresholds of one (primary), two, and three times per-capita GDP ($NZ52 300). Results: Data were collected on nine recommended adjunctive treatments: aquatic-based exercise, heat therapy, massage therapy, walking cane, cognitive behavioural therapy (CBT), topical non-steroidal anti-inflammatory drugs (NSAIDs), oral NSAIDs, intra-articular corticosteroids, and duloxetine. Relative to core treatments only, walking cane and heat therapy were cost-saving and provided greater QALYs; aquatic exercise and intra-articular corticosteroids were also cost-effective at all WTP thresholds. Topical NSAIDs and CBT were cost-effective only at higher WTP thresholds, while duloxetine, massage therapy, and oral NSAIDs were not cost-effective at any relevant threshold. Results were generally robust to varying modelling assumptions, although topical and oral NSAIDs and CBT became cost-effective in some scenarios. Conclusions: Delivering high-value, low-cost adjunctive interventions for knee osteoarthritis, alongside recommended core treatment, could deliver substantial health gains at low cost to the health system.

A quality-of-life mapping function developed from a grass pollen sublingual immunotherapy trial to a tree pollen sublingual immunotherapy trial.

Aims: Allergic rhinitis is caused by sensitivity to environmental allergens that can significantly impact quality-of-life. The objective of this analysis was to estimate health state utilities and quality-adjusted life days (QALDs) for a tree allergy immunotherapy trial, TT-04 (EudraCT No.2015-004821-15). Health-state utilities are a measure of patient preference for health states and are necessary to derive QALDs for cost-utility analysis. Preference-based utilities were not collected in the TT-04 trial, so a mapping algorithm was developed based on a similar grass allergy immunotherapy trial, GT-08 (EudraCT No. 2004-000083-27), to estimate utilities.Methods: A two-part model was developed to predict utilities for the GT-08 trial and applied to the TT-04 trial to estimate the difference in mean utility and QALDs between SQ tree sublingual immunotherapy (SLIT)-tablet and placebo.Results: Mean utility difference between SQ tree SLIT-tablet and placebo was 0.030 [95% CI = 0.015-0.046] during the birch pollen season (BPS), 0.019 [95% CI = 0.007-0.030] during the tree pollen season (TPS) and 0.018 [95% CI = 0.007-0.030] during the full trial. The treatment showed a QALD benefit of 1.26 [95% CI = 0.619-1.917] during the BPS, 1.90 [95% CI = 0.692-3.047] during the TPS, and 2.47 [95% CI = 0.930-4.101] during the full trial.Limitations: The generalizability of this algorithm is limited to allergy trials containing the same covariates as those present in the model. The analysis also assumes that grass and tree pollen allergy have the same relationship with EQ5D utilities, which is supported by the fact that both grass and tree pollen induce similar symptoms.Conclusions: Application of the mapping function enabled the calculation of QALDs associated with the treatment, with the caveat that data were extrapolated from grass seasonal allergy to tree seasonal allergy. The results showed a significant QALD benefit of the treatment over placebo in treatment of tree pollen-induced rhinoconjunctivitis.

3-month versus 6-month adjuvant chemotherapy for patients with high-risk stage II and III colorectal cancer: 3-year follow-up of the SCOT non-inferiority RCT.

BACKGROUND: Oxaliplatin and fluoropyrimidine chemotherapy administered over 6 months is the standard adjuvant regimen for patients with high-risk stage II or III colorectal cancer. However, the regimen is associated with cumulative toxicity, characterised by chronic and often irreversible neuropathy. OBJECTIVES: To assess the efficacy of 3-month versus 6-month adjuvant chemotherapy for colorectal cancer and to compare the toxicity, health-related quality of life and cost-effectiveness of the durations. DESIGN: An international, randomised, open-label, non-inferiority, Phase III, parallel-group trial. SETTING: A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand. PARTICIPANTS: Adults aged ≥ 18 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum. INTERVENTIONS: The adjuvant treatment regimen was either oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine, randomised to be administered over 3 or 6 months. MAIN OUTCOME MEASURES: The primary outcome was disease-free survival. Overall survival, adverse events, neuropathy and health-related quality of life were also assessed. The main cost categories were chemotherapy treatment and hospitalisation. Cost-effectiveness was assessed through incremental cost comparisons and quality-adjusted life-year gains between the options and was reported as net monetary benefit using a willingness-to-pay threshold of £30,000 per quality-adjusted life-year per patient. RESULTS: Recruitment is closed. In total, 6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis, n = 3035; 6-month analysis, n = 3030). Follow-up for the primary analysis is complete. The 3-year disease-free survival rate in the 3-month treatment group was 76.7% (standard error 0.8%) and in the 6-month treatment group was 77.1% (standard error 0.8%), equating to a hazard ratio of 1.006 (95% confidence interval 0.909 to 1.114; p-value for non-inferiority = 0.012), confirming non-inferiority for 3-month adjuvant chemotherapy. Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand-foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye) showed a significant increase in grade with 6-month duration; the greatest difference was for sensory neuropathy (grade ≥ 3 was 4% for 3-month vs.16% for 6-month duration), for which a higher rate of neuropathy was seen for the 6-month treatment group from month 4 to ≥ 5 years (p < 0.001). Quality-of-life scores were better in the 3-month treatment group over months 4-6. A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient. CONCLUSIONS: The study achieved its primary end point, showing that 3-month oxaliplatin-containing adjuvant chemotherapy is non-inferior to 6 months of the same regimen; 3-month treatment showed a better safety profile and cost less. For future work, further follow-up will refine long-term estimates of the duration effect on disease-free survival and overall survival. The health economic analysis will be updated to include long-term extrapolation for subgroups. We expect these analyses to be available in 2019-20. The Short Course Oncology Therapy (SCOT) study translational samples may allow the identification of patients who would benefit from longer treatment based on the molecular characteristics of their disease. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59757862 and EudraCT 2007-003957-10. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 64. See the NIHR Journals Library website for further project information. This research was supported by the Medical Research Council (transferred to NIHR Evaluation, Trials and Studies Coordinating Centre - Efficacy and Mechanism Evaluation; grant reference G0601705), the Swedish Cancer Society and Cancer Research UK Core Clinical Trials Unit Funding (funding reference C6716/A9894).

Patients diagnosed with bowel cancer are likely to have surgery to remove the tumour. Patients diagnosed with a more advanced stage of the disease are then likely to be offered what is known as adjuvant chemotherapy ­ chemotherapy to kill any cancer cells that have already spread but cannot be seen. Adjuvant chemotherapy is usually given over 6 months using two medicines known as oxaliplatin and fluoropyrimidine. This chemotherapy has side effects of diarrhoea, nausea and vomiting, and it reduces the numbers of cells in the blood. It can also damage nerves, which causes discomfort, numbness and tingling; in some cases, this can go on for years. These side effects are more likely to develop with longer treatment. This study looked at whether or not shortening the time over which patients were given oxaliplatin and fluoropyrimidine chemotherapy reduced its effectiveness. In this large study of over 6000 patients, half of the patients were allocated by chance to be treated for 3 months and the other half to be treated for 6 months. Reducing the time that patients had chemotherapy from 6 months to 3 months did not make the treatment less effective. When patients treated with chemotherapy over 3 months were compared with those treated over 6 months, 77% of patients in both groups were well with no detectable disease 3 years after surgery. Patients were less likely to get side effects with 3-month chemotherapy. In particular, the chance of persistent long-term nerve damage was lower, resulting in patients with 3-month chemotherapy having better health-related quality of life. Overall, the study showed that 3-month adjuvant chemotherapy for patients with bowel cancer is as effective as 6-month adjuvant chemotherapy and causes fewer side effects.

Cost-effectiveness of umeclidinium as add-on to ICS/LABA therapy in COPD: A UK perspective.

INTRODUCTION: The cost-effectiveness of long-acting muscarinic antagonist (LAMA) umeclidinium bromide (UMEC) 62.5 µg as add-on therapy to other maintenance COPD treatments is unknown. METHODS: This analysis assessed the cost-effectiveness of the following in COPD: UMEC + fluticasone furoate/vilanterol 100/25 µg (FF/VI); UMEC + fluticasone propionate/salmeterol 250/50 µg (FP/SAL); and UMEC + several alternative choices of inhaled corticosteroid/long-acting ß2-agonist (ICS/LABA). The model was informed with direct and indirect data from previously published studies, with a UK perspective and a lifetime horizon. Sensitivity analyses were also performed. RESULTS: For the lifetime horizon, compared with FF/VI, FP/SAL and ICS/LABAs, addition of UMEC was associated with incremental costs per quality-adjusted life-years (QALY) of £4050, £7210 and £5780, respectively, and incremental costs per life year gain of £3380, £6020 and £4940. All UMEC-containing regimens resulted in numerically lower exacerbation rates versus comparator regimens over a lifetime horizon. CONCLUSIONS: Addition of UMEC to various ICS/LABA treatments was associated with higher cost than ICS/LABA alone, but was cost-effective in most scenarios.

Actions required to implement integrated care for older people in the community using the World Health Organization's ICOPE approach: A global Delphi consensus study.

BACKGROUND: Integrated care is recognised as an important enabler to healthy ageing, yet few countries have managed to sustainably deliver integrated care for older people. We aimed to gather global consensus on the key actions required to realign health and long-term systems and integrate services to implement the World Health Organization (WHO) Integrated Care for Older People (ICOPE) approach. METHODS: A two-round eDelphi study, including a global consultation meeting, was undertaken to identify, refine and generate consensus on the actions required across high-, middle- and low-income countries to implement the WHO ICOPE approach. In round 1, a framework of 31 actions, empirically derived from previous WHO evidence reviews was presented to panellists to judge the relative importance of each action (numeric rating scale; range:1-9) and provide free-text comments concerning the scope of the actions. These outcomes were discussed and debated at the global consultation meeting. In round 2, a revised framework of 19 actions was presented to panellists to measure their extent of agreement and identify 'essential' actions (five-point Likert scale; range: strongly agree to strongly disagree). A threshold of ≥80% for agree/strongly agree was set a priori for consensus. RESULTS: After round 1 (n = 80 panellists), median scores across 31 actions ranged from 6 to 9. Based on pre-defined category thresholds for median scores, panellists considered 28 actions (90·3%) as 'important' and three (9·7%) as 'uncertain'. Fifteen additional actions were suggested for inclusion based on free-text comments, creating 46 for consideration at the global consultation meeting. In round 2 (n = 84 panellists), agreement (agree or strongly agree) ranged from 84·6-97·6%, suggesting consensus. Fourteen (73·7%) actions were rated as essential. CONCLUSION: Fourteen essential actions and five important actions are necessary at system (macro; n = 10) and service (meso; n = 9) levels to implement community-based integrated care for older people.

Patients' perceived needs for allied health, and complementary and alternative medicines for low back pain: A systematic scoping review.

OBJECTIVES: Allied health and complementary and alternative medicines (CAM) are therapeutic therapies commonly accessed by consumers to manage low back pain (LBP). We aimed to identify the literature regarding patients' perceived needs for physiotherapy, chiropractic therapy and CAM for the management of LBP. METHODS: A systematic scoping review of MEDLINE, EMBASE, CINAHL and PsycINFO (1990-2016) was conducted to identify studies examining patients' perceived needs for allied health and CAM for LBP. Data regarding study design and methodology were extracted. Areas of patients' perceived need for allied health and CAM were aggregated. RESULTS: Forty-four studies from 2202 were included: 25 qualitative, 18 quantitative and 1 mixed-methods study. Three areas of need emerged: (i) physiotherapy was viewed as important, particularly when individually tailored. However, patients had concerns about adherence, adverse outcomes and correct exercise technique. (ii) Chiropractic therapy was perceived to be effective and needed by some patients, but others were concerned about adverse outcomes. (iii) An inconsistent need for CAM was identified with some patients perceiving a need, while others questioning the legitimacy and short-term duration of these therapies. CONCLUSIONS: Our findings regarding patients' perceived needs for allied health and CAM for LBP may assist in informing development of more patient-centred guidelines and service models for LBP. Understanding patients' concerns regarding active-based physiotherapy, which is recommended in most guidelines, and issues surrounding chiropractic and CAM, which are generally not, may help inform management that better aligns patient's perceived needs with effective treatments, to improve outcomes for both patients and the health-care system.

Elements of integrated care approaches for older people: a review of reviews.

OBJECTIVE: The World Health Organization (WHO) recently proposed an Integrated Care for Older People approach to guide health systems and services in better supporting functional ability of older people. A knowledge gap remains in the key elements of integrated care approaches used in health and social care delivery systems for older populations. The objective of this review was to identify and describe the key elements of integrated care models for elderly people reported in the literature. DESIGN: Review of reviews using a systematic search method. METHODS: A systematic search was performed in MEDLINE and the Cochrane database in June 2017. Reviews of interventions aimed at care integration at the clinical (micro), organisational/service (meso) or health system (macro) levels for people aged ≥60 years were included. Non-Cochrane reviews published before 2015 were excluded. Reviews were assessed for quality using the Assessment of Multiple Systematic Reviews (AMSTAR) 1 tool. RESULTS: Fifteen reviews (11 systematic reviews, of which six were Cochrane reviews) were included, representing 219 primary studies. Three reviews (20%) included only randomised controlled trials (RCT), while 10 reviews (65%) included both RCTs and non-RCTs. The region where the largest number of primary studies originated was North America (n=89, 47.6%), followed by Europe (n=60, 32.1%) and Oceania (n=31, 16.6%). Eleven (73%) reviews focused on clinical 'micro' and organisational 'meso' care integration strategies. The most commonly reported elements of integrated care models were multidisciplinary teams, comprehensive assessment and case management. Nurses, physiotherapists, general practitioners and social workers were the most commonly reported service providers. Methodological quality was variable (AMSTAR scores: 1-11). Seven (47%) reviews were scored as high quality (AMSTAR score ≥8). CONCLUSION: Evidence of elements of integrated care for older people focuses particularly on micro clinical care integration processes, while there is a relative lack of information regarding the meso organisational and macro system-level care integration strategies.

3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial.

BACKGROUND: 6 months of oxaliplatin-containing chemotherapy is usually given as adjuvant treatment for stage 3 colorectal cancer. We investigated whether 3 months of oxaliplatin-containing chemotherapy would be non-inferior to the usual 6 months of treatment. METHODS: The SCOT study was an international, randomised, phase 3, non-inferiority trial done at 244 centres. Patients aged 18 years or older with high-risk stage II and stage III colorectal cancer underwent central randomisation with minimisation for centre, choice of regimen, sex, disease site, N stage, T stage, and the starting dose of capecitabine. Patients were assigned (1:1) to receive 3 months or 6 months of adjuvant oxaliplatin-containing chemotherapy. The chemotherapy regimens could consist of CAPOX (capecitabine and oxaliplatin) or FOLFOX (bolus and infused fluorouracil with oxaliplatin). The regimen was selected before randomisation in accordance with choices of the patient and treating physician. The primary study endpoint was disease-free survival and the non-inferiority margin was a hazard ratio of 1·13. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who started study treatment. This trial is registered with ISRCTN, number ISRCTN59757862, and follow-up is continuing. FINDINGS: 6088 patients underwent randomisation between March 27, 2008, and Nov 29, 2013. The intended treatment was FOLFOX in 1981 patients and CAPOX in 4107 patients. 3044 patients were assigned to 3 month group and 3044 were assigned to 6 month group. Nine patients in the 3 month group and 14 patients in the 6 month group did not consent for their data to be used, leaving 3035 patients in the 3 month group and 3030 patients in the 6 month group for the intention-to-treat analyses. At the cutoff date for analysis, there had been 1482 disease-free survival events, with 740 in the 3 month group and 742 in the 6 month group. 3 year disease-free survival was 76·7% (95% CI 75·1-78·2) for the 3 month group and 77·1% (75·6-78·6) for the 6 month group, giving a hazard ratio of 1·006 (0·909-1·114, test for non-inferiority p=0·012), significantly below the non-inferiority margin. Peripheral neuropathy of grade 2 or worse was more common in the 6 month group (237 [58%] of 409 patients for the subset with safety data) than in the 3 month group (103 [25%] of 420) and was long-lasting and associated with worse quality of life. 1098 serious adverse events were reported (492 reports in the 3 month group and 606 reports in the 6 month group) and 32 treatment-related deaths occurred (16 in each group). INTERPRETATION: In the whole study population, 3 months of oxaliplatin-containing adjuvant chemotherapy was non-inferior to 6 months of the same therapy for patients with high-risk stage II and stage III colorectal cancer and was associated with reduced toxicity and improved quality of life. Despite the fact the study was underpowered, these data suggest that a shorter duration leads to similar survival outcomes with better quality of life and thus might represent a new standard of care. FUNDING: Medical Research Council, Swedish Cancer Society, NETSCC, and Cancer Research UK.

Patients' perceived needs of health care providers for low back pain management: a systematic scoping review.

BACKGROUND CONTEXT: Optimal management of low back pain (LBP) involves patients' active participation in care, facilitated by positive interactions with their health care provider(s) (HCP). An understanding of patients' perceived needs regarding their HCP is, therefore, necessary to achieve such outcomes. Therefore, the aim of the present study is to review the existing literature regarding patients' perceived needs of HCP managing LBP. METHODS: A systematic scoping review of publications in MEDLINE, EMBASE, CINAHL, and PsycINFO (1990-2016) was performed. Descriptive data regarding study design and methodology were extracted, and risk of bias was assessed. Aggregates of patients' perceived needs of HCP for LBP were categorized. RESULTS: Forty-three studies (30 qualitative, 12 quantitative, and 1 mixed methods) from 1,829 were relevant. Four areas of perceived need emerged: (1) there are several characteristics of HCP that patients desire, such as good communication and shared decision-making; (2) patients wanted HCP to provide information, including a cause of their LBP and legitimization of their symptoms; (3) patients' valued holistic, individualized care, and continuity of care; and (4) patients perceived long waiting times, difficulties with access to treatment, cost, and personal effort to be obstacles to care. CONCLUSIONS: Patients with LBP want patient-centered care, to be actively involved, and they have identified characteristics of HCP that foster a good provider-patient relationship. They noted areas of dissatisfaction with HCP and perceived obstacles to care. Given limited health care resources, HCP and policy makers need to implement novel methods of health care delivery that address these issues to facilitate improved patient satisfaction and achieve better patient and health system outcomes.

An osteoarthritis model of care should be a national priority for New Zealand.

Osteoarthritis is highly prevalent, disabling and costly to the person and the community. The burden of this chronic condition is predicted to increase dramatically over the coming decades. Healthcare spending on osteoarthritis is unsustainable and action is needed to improve care delivery. At present, there is an over-emphasis on surgical and pharmacological interventions, despite evidence supporting conservative treatments such as exercise, weight loss and education. While clinical guidelines provide recommendations regarding best practice (ie, what to do), they fail to address how to operationalise these recommendations into clinical practice. Models of care (MoCs) can help bridge the evidence-practice gap by outlining evidence-informed interventions as well as how to implement them within a local system. However, New Zealand has no osteoarthritis MoC. The Mobility Action Programme, funded by the Ministry of Health, is delivering evidence-informed, multi-disciplinary care for osteoarthritis through local initiatives. Although the programme remains under evaluation it presents an opportunity to inform development of a national osteoarthritis MoC for New Zealand. A policy framework, such as a MoC, is needed to scale up successful programs and deliver best practice care nationwide. Ultimately, addressing the burden of osteoarthritis will require system-wide approaches involving public policy responses to target primary prevention.

Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial.

INTRODUCTION: Emergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial. METHODS AND ANALYSIS: The economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients' characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country's national health services, where costs will be expressed in euros adjusted for purchasing power parity. ETHICS AND DISSEMINATION: Ethical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of the concerned literature and communicated through the profiles of the authors at www.twitter.com and www.researchgate.net. TRIAL REGISTRATION NUMBER: NCT01927549; Pre-results.

Supporting the Evaluation and Implementation of Musculoskeletal Models of Care: A Globally Informed Framework for Judging Readiness and Success.

OBJECTIVE: To develop a globally informed framework to evaluate readiness for implementation and success after implementation of musculoskeletal models of care (MOCs). METHODS: Three phases were undertaken: 1) a qualitative study with 27 Australian subject matter experts (SMEs) to develop a draft framework; 2) an eDelphi study with an international panel of 93 SMEs across 30 nations to evaluate face validity, and refine and establish consensus on the framework components; and 3) translation of the framework into a user-focused resource and evaluation of its acceptability with the eDelphi panel. RESULTS: A comprehensive evaluation framework was developed for judging the readiness and success of musculoskeletal MOCs. The framework consists of 9 domains, with each domain containing a number of themes underpinned by detailed elements. In the first Delphi round, scores of "partly agree" or "completely agree" with the draft framework ranged 96.7%-100%. In the second round, "essential" scores ranged 58.6%-98.9%, resulting in 14 of 34 themes being classified as essential. SMEs strongly agreed or agreed that the final framework was useful (98.8%), usable (95.1%), credible (100%) and appealing (93.9%). Overall, 96.3% strongly supported or supported the final structure of the framework as it was presented, while 100%, 96.3%, and 100% strongly supported or supported the content within the readiness, initiating implementation, and success streams, respectively. CONCLUSION: An empirically derived framework to evaluate the readiness and success of musculoskeletal MOCs was strongly supported by an international panel of SMEs. The framework provides an important internationally applicable benchmark for the development, implementation, and evaluation of musculoskeletal MOCs.

Young people's experiences of persistent musculoskeletal pain, needs, gaps and perceptions about the role of digital technologies to support their co-care: a qualitative study.

OBJECTIVE: To investigate young people's experiences of persistent musculoskeletal pain, including care needs and current service gaps as well as perceptions about the role of digital technologies to support their co-care. METHODS: A qualitative study employing two independent data collection modes: in-depth individual semistructured interviews and focus groups. SETTING: Community settings throughout Australia. PARTICIPANTS: Participants were included if they had experienced persistent musculoskeletal pain of >3-month duration with an average of ≥3 on the visual analogue scale over the preceding 3 months, including non-specific conditions (eg, low back pain) and specific conditions (eg, juvenile idiopathic arthritis and other systemic arthritides), with/without pre-existing or current diagnosed mental health conditions. 23 young people (87.0% women; mean (SD) age: 20.8 (2.4) years) from across 6 Australian jurisdictions participated. Almost two-thirds of participants with persistent musculoskeletal pain reported comorbid mental health conditions. MAIN OUTCOME MEASURES: Inductive and deductive approaches to analyse and derive key themes from verbatim transcripts. RESULTS: Participants described their daily experiences of living with persistent musculoskeletal pain, their fears and the challenges imposed by the invisibility of pain, and the two-way relationship between their pain and mental well-being. A lack of relevant and accessible information and resources tailored to young people's unique needs, integrated and youth-relevant healthcare services and adequately skilled healthcare practitioners were identified as key care gaps. Participants strongly advocated for the use of digital technologies to improve access to age-appropriate resources and support for co-care. CONCLUSIONS: Young people living with persistent musculoskeletal pain described the absence of age-appropriate pain services and clearly articulated their perceptions on the role of, and opportunities provided by, digital technologies to connect with and support improved pain healthcare. Innovative and digitally-enabled models of pain care are likely to be helpful for this group.

The "e" in cost-effectiveness analyses. A case study of omalizumab efficacy and effectiveness for cost-effectiveness analysis evidence.

This article is a call for increased use of real-world evidence in health technology assessment and related policy and decision making. There is currently a disconnect between evidence used to guide regulatory approval of therapies and evidence used to inform therapeutic coverage and reimbursement decisions. Public and private payers need to understand not only whether an intervention works but also whether it offers good value compared with licensed alternatives (not placebo) as they are used in the real-world practice and population (not in a controlled trial environment). Addressing such concerns requires evidence to be drawn from a wide range of study designs, but with consideration and weighting given to their relative strengths and weaknesses, as well as their position on the pragmatic-explanatory (i.e., effectiveness-efficacy) continuum. The potential impact of using different types of evidence to inform cost-effectiveness analysis (CEA) is discussed for omalizumab, comparing and contrasting a CEA model informed by an omalizumab efficacy trial to a CEA model drawing primarily on evidence from effectiveness observational studies of omalizumab. There was reasonable agreement between the two omalizumab CEA models, although the incremental cost-effectiveness ratio generated by the effectiveness observational study-driven model was more favorable for omalizumab. Health technology assessment bodies and payers must use their judgment to determine which components of efficacy-based and effectiveness-based CEA evidence are most closely aligned with their goals. For each CEA evidence component, perhaps the two E's form bounds of the truth as well as a fuller picture of the uncertainty surrounding the truth.