Effectiveness of a classification-based approach to low back pain in primary care - a benchmarking controlled trial.

OBJECTIVE: The aim of this study was to assess the effectiveness of classification-based approach for low back pain care in Finnish primary care. DESIGN: A benchmarking controlled trial design was used. SUBJECTS/PATIENTS: Three primary healthcare areas and 654 low back pain patients with or without sciatica. METHODS: Classification-based care (using the STarT Back Tool) was implemented using organizational-, healthcare professional-, and patient-level interventions. The primary outcome was change in Patient-Reported Outcomes Measurement Information System, Physical Function (PROMIS PF-20) from baseline to 12 months. RESULTS: No difference was found between the intervention and control in change in PROMIS PF-20 over the 12-month follow-up (mean difference 0.33 confidence interval -2.27 to 2.9, p = 0.473). Low back pain-related healthcare use, imaging, and sick leave days were significantly lower in the intervention group. Reduction in intensity of low back pain appeared to be already achieved at the 3-month follow-up (mean difference -1.3, confidence interval -2.1 to -0.5) in the intervention group, while in the control group the same level of reduction was observed at 12 months (mean difference 0.7, confidence interval -0.2 to 1.5, treatment*time p = 0.003).  Conclusion: Although classification-based care did not appear to influence physical functioning, more rapid reductions in pain intensity and reductions in healthcare use and sick leave days were observed in the intervention group.

Patient education booklet to support evidence-based low back pain care in primary care - a cluster randomized controlled trial.

BACKGROUND: Inappropriate imaging and low-value care for low back pain (LBP) are common. A new patient-education booklet was created to overcome identified barriers to the delivery of recommended care, including the use of inappropriate imaging. Our aim was to assess the effectiveness of this booklet as part of primary care for LBP patients in comparison to usual care. METHODS: A cluster-randomized trial was performed. The intervention involved providing practitioners with the new patient-education booklet and a 30-min training session on its use. The booklet was provided during the clinical consult to all consenting LBP patients in the intervention group. Primary outcomes were the proportion of patients presenting with LBP who underwent imaging examinations during the first three months of follow-up and PROMIS PF-20 (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form) change between baseline and three-month follow-up. Secondary outcomes, including sick leave and imaging examinations at 12 months, were investigated. Logistic regression using GEE-estimation was used for dichotomous outcomes, Poisson regression using GEE-estimation for count outcomes, and linear mixed models for continuous outcomes. RESULTS: Using the patient education booklet appeared to substantially reduce the proportion of LBP patients who underwent an imaging examination at three months, but the result was not statistically significant (OR 0.57, 95% confidence interval (Cl) 0.27 to 1.22). At 12 months, the effect was slightly larger and statistically significant (OR 0.50, 95%Cl 0.30 to 0.83, p = 0.008). No difference was observed in the PROMIS PF-20 T-score change between baseline and 3 months or 12 months (p = 0.365 and p = 0.923, respectively). The number of sick leave days in the intervention group was less than that in the control group at 3 months (RR 0.47, 95%Cl 0.26 to 0.83, p = 0.010) and at 12 months (RR 0.36, 95%Cl 0.18 to 0.72, p = 0.004). CONCLUSIONS: The booklet appeared to be effective in reducing the proportion of LBP patients who underwent imaging examinations over 12 months. The intervention had no discernible effect on the PROMIS PF20 T-score change. The number of sick leave days was substantially lower in the intervention group. TRIAL REGISTRATION: ISRCTN, ISRCTN14389368 , Registered 4 April 2019-Retrospectively registered.

Effectiveness of training in guideline-oriented biopsychosocial management of low-back pain in occupational health services - a cluster randomized controlled trial.

OBJECTIVE: This study aimed to investigate the effectiveness of brief training in the guideline-oriented biopsychosocial management of low-back pain (LBP) in occupational health services using a cluster-randomized design. A small sample of physiotherapists and physicians from the intervention units (N=12) were given three- to seven-day training focusing on the biopsychosocial management of LBP, while professionals in the control units (N=15) received no such training. METHODS: Eligible patients with LBP, with or without radicular pain, aged 18-65, were invited to participate. A web-based questionnaire was sent to all recruited patients at baseline, three months and one year. The primary outcome measure was disability (Oswestry Disability Index, ODI) over one year. Between-group differences were analyzed using linear and generalized linear mixed models adjusted for baseline-response delay as well as variables showing between-group imbalance at baseline. RESULTS: The final study sample comprised 234 and 81 patients in the intervention and control groups, respectively at baseline, and 137 and 47 patients, respectively, at one year. At baseline, the mean duration of pain was longer in the intervention group (P=0.017), and pain-related fear concerning physical activity was lower (P=0.012). We observed no significant difference between the groups' primary outcome measure (adjusted one-year mean difference in the ODI: 2.3; 95% confidence interval -1.0-5.7; P=0.175) or most secondary outcomes. CONCLUSIONS: Brief training in guideline-oriented biopsychosocial management of LBP for occupational health professionals did not appear to be effective in reducing patients' symptom over one-year follow-up compared to treatment as usual.

Evaluation of training in guideline-oriented biopsychosocial management of low back pain in occupational health services: Protocol of a cluster randomized trial.

BACKGROUND: To prevent low back pain (LBP) from developing into a prolonged disabling condition, clinical guidelines advocate early stage assessment, risk-screening, and tailored interventions. Occupational health services recommend guideline-oriented biopsychosocial screening and individualized assessment and management. However, it is not known whether training a limited number of health care professionals improves the management process. The primary objective of this study is to investigate whether training in the biopsychosocial practice model is effective in reducing disability. Furthermore, we aim to evaluate health-economic impacts of the training intervention in comparison to usual medical care. METHODS: The occupational health service units will be allocated into a training or control arm in a two-arm cluster randomized controlled design. The training of occupational physiotherapists and physicians will include the assessment of pain-related psychosocial factors using the STarT Back Tool and the short version of the Örebro Musculoskeletal Pain Screening Questionnaire, the use of an evidence-based patient education booklet as part of the management of LBP, and tailored individualized management of LBP according to risk stratification. The control units will receive no training. The study population will include patients aged 18-65 with nonspecific LBP. The primary outcome is a patient-reported Oswestry Disability Index from baseline to 12 months. By estimating group differences over time, we aim to evaluate the effectiveness of the training intervention in comparison to usual medical care, and to undertake an economic evaluation using individual patients' health care records (participant-level data) and the participating units' registries (cluster-level data). In addition, through interviews and questionnaires, we will explore the health care professionals' conceptions of the adoption of, the barriers to, and the facilitators of the implementation of the practice model. DISCUSSION: The evaluation of training in the guideline-oriented biopsychosocial management of LBP in occupational health services is justified because LBP represents an enormous burden in terms of work disability.

Cost-effectiveness analysis of PSA-based mass screening: Evidence from a randomised controlled trial combined with register data.

In contrast to earlier studies which have used modelling to perform cost-effectiveness analysis, this study links data from a randomised controlled trial with register data from nationwide registries to reveal new evidence on costs, effectiveness, and cost-effectiveness of organised mass prostate-cancer screening based on prostate-specific antigen (PSA) testing. Cost-effectiveness analyses were conducted with individual-level data on health-care costs from comprehensive registers and register data on real-world effectiveness from the two arms of the Finnish Randomised Study of Screening for Prostate Cancer (FinRSPC), following 80,149 men from 1996 through 2015. The study examines cost-effectiveness in terms of overall mortality and, in addition, in terms of diagnosed men's mortality from prostate cancer and mortality with but not from prostate cancer. Neither arm of the FinRSPC was clearly more cost-effective in analysis in terms of overall mortality. Organised screening in the FinRSPC could be considered cost-effective in terms of deaths from prostate cancer: averting just over one death per 1000 men screened. However, even with an estimated incremental cost-effectiveness ratio of below 20,000€ per death avoided, this result should not be considered in isolation. This is because mass screening in this trial also resulted in increases in death with, but not from, prostate cancer: with over five additional deaths per 1000 men screened. Analysis of real-world data from the FinRSPC reveals new evidence of the comparative effectiveness of PSA-based screening after 20 years of follow-up, suggesting the possibility of higher mortality, as well as higher healthcare costs, for screening-arm men who have been diagnosed with prostate cancer but who do not die from it. These findings should be corroborated or contradicted by similar analyses using data from other trials, in order to reveal if more diagnosed men have also died in the screening arms of other trials of mass screening for prostate cancer.

On value frameworks and opportunity costs in health technology assessment.

OBJECTIVES: Proceeding from a basic concept underpinning economic evaluation, opportunity cost, this study aims to explain how different approaches to economics diverge quite dramatically in their ideas of what constitutes appropriate valuation, both in principle and practice. Because the concept of opportunity cost does not inherently specify how valuation should be undertaken or specify how appropriate any economic value framework (EVF) might be, the three main economics-based approaches to providing evidence about value for health technology assessment are described. METHODS: This paper describes how the three main EVFs-namely, the extra-welfarist, welfarist, and classical-are most typically understood, applied, and promoted. It then provides clarification and assessment of related concepts and terminology. RESULTS: Although EVFs differ, certain underlying characteristics of valuation were identified as fundamental to all approaches to economic evaluation in practice. The study also suggests that some of the rhetoric and terms employed in relation to the extra-welfarist approach are not wholly justified and, further, that only the welfarist approach ensures adherence to welfare-economic principles. Finally, deliberative analysis, especially when connected with a classical economic approach, can serve as a useful supplement to other analytical approaches. CONCLUSIONS: All three approaches to economic evaluation have something to offer assessment processes, but they all display limitations too. Therefore, the author concludes that the language of economic evaluation should be used with sufficient humility to prevent overselling of EVFs, especially with regard to the qualities of evidence they provide for priority setting processes.

Costs of screening for prostate cancer: Evidence from the Finnish Randomised Study of Screening for Prostate Cancer after 20-year follow-up using register data.

OBJECTIVES: Few empirical analyses of the impact of organised prostate cancer (PCa) screening on healthcare costs exist, despite cost-related information often being considered as a prerequisite to informed screening decisions. Therefore, we estimate the differences in register-based costs of publicly funded healthcare in the two arms of the Finnish Randomised Study of Screening for Prostate Cancer (FinRSPC) after 20 years. METHODS: We obtained individual-level register data on prescription medications, as well as inpatient and outpatient care, to estimate healthcare costs for 80,149 men during the first 20 years of the FinRSPC. We compared healthcare costs for the men in each trial arm and performed statistical analysis. RESULTS: For all men diagnosed with PCa during the 20-year observation period, mean PCa-related costs appeared to be around 10% lower in the screening arm (SA). Mean all-cause healthcare costs for these men were also lower in the SA, but differences were smaller than for PCa-related costs alone, and no longer statistically significant. For men dying from PCa, although the difference was not statistically significant, mean all-cause healthcare costs were around 10% higher. When analysis included all observations, cumulative costs were slightly higher in the CA; however, after excluding extreme values, cumulative costs were slightly higher in the SA. CONCLUSIONS: No major cost impacts due to screening were apparent, but the FinRSPC's 20-year follow-up period is too short to provide definitive evidence at this stage. Longer term follow-up will be required to be better informed about the costs of, or savings from, introducing mass PCa screening.

Health-related quality of life in the Finnish trial of screening for prostate cancer.

BACKGROUND: Evidence of the potential impact of systematic screening for prostate cancer (PCa) on health-related quality of life (HRQoL) at a population-based level is currently scarce. OBJECTIVE: This study aims to quantify the long-term HRQoL impact associated with screening for PCa. DESIGN, SETTING, AND PARTICIPANTS: Postal questionnaire surveys were conducted in 1998, 2000, 2004, and 2011 among men in the Finnish PCa screening trial diagnosed with PCa (total n=7011) and among a random subsample of the trial population (n=2200). In 2011, for example, 1587 responses were received from men with PCa in the screening arm and 1706 from men in the control arm. In addition, from the trial subsample, 549 men in the screening arm and 539 in the control arm provided responses. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Health-state-value scores were compared between the intervention and control arms using three distinct HRQoL measures (15D, EQ-5D, and SF-6D), and statistical significance was assessed using t tests. In addition, differences over repeated assessments of HRQoL between groups were evaluated using generalised estimating equations. RESULTS AND LIMITATIONS: In the 2011 survey, a small but statistically significant difference emerged between the trial arms among men diagnosed with PCa (mean scores, screening vs control arm: 15D: 0.872 vs 0.866, p=0.14; EQ-5D: 0.852 vs 0.831, p=0.03; and SF-6D: 0.763 vs 0.756, p=0.06). Such differences in favour of the screening arm were not found among the sample of men from the trial (15D: 0.889 vs 0.892, p=0.62; EQ-5D: 0.831 vs 0.852, p=0.08; and SF-6D: 0.775 vs 0.777, p=0.88). The slight advantage with screening among men with PCa was reasonably consistent across time in the longitudinal analysis and was strongest among men with early-stage disease. CONCLUSIONS: These results show some long-term HRQoL benefit from screening for men with PCa but suggest little impact overall in the trial population.

Cost-effectiveness analysis of guidelines for antihypertensive care in Finland.

BACKGROUND: Hypertension is one of the major causes of disease burden affecting the Finnish population. Over the last decade, evidence-based care has emerged to complement other approaches to antihypertensive care, often without health economic assessment of its costs and effects. This study looks at the extent to which changes proposed by the 2002 Finnish evidence-based Current Care Guidelines concerning the prevention, diagnosis, and treatment of hypertension (the ACCG scenario) can be considered cost-effective when compared to modelled prior clinical practice (the PCP scenario). METHODS: A decision analytic model compares the ACCG and PCP scenarios using information synthesised from a set of national registers covering prescription drug reimbursements, morbidity, and mortality with data from two national surveys concerning health and functional capacity. Statistical methods are used to estimate model parameters from Finnish data. We model the potential impact of the different treatment strategies under the ACCG and PCP scenarios, such as lifestyle counselling and drug therapy, for subgroups stratified by age, gender, and blood pressure. The model provides estimates of the differences in major health-related outcomes in the form of life-years and costs as calculated from a 'public health care system' perspective. Cost-effectiveness analysis results are presented for subgroups and for the target population as a whole. RESULTS: The impact of the use of the ACCG scenario in subgroups (aged 40-80) without concomitant cardiovascular and related diseases is mainly positive. Generally, costs and life-years decrease in unison in the lowest blood pressure group, while in the highest blood pressure group costs and life-years increase together and in the other groups the ACCG scenario is less expensive and produces more life-years. When the costs and effects for subgroups are combined using standard decision analytic aggregation methods, the ACCG scenario is cost-saving and more effective. CONCLUSION: The ACCG scenario is likely to reduce costs and increase life-years compared to the PCP scenario in many subgroups. If the estimated trade-offs between the subgroups in terms of outcomes and costs are acceptable to decision-makers, then widespread implementation of the ACCG scenario is expected to reduce overall costs and be accompanied by positive outcomes overall.