Efficacy and potential determinants of exercise therapy in knee and hip osteoarthritis: A systematic review and meta-analysis

BackgroundExercise is an effective treatment for osteoarthritis. However, the effect may vary from one patient (or study) to another.ObjectiveTo evaluate the efficacy of exercise and its potential determinants for pain, function, performance, and quality of life (QoL) in knee and hip osteoarthritis (OA).MethodsWe searched 9 electronic databases (AMED, CENTRAL, CINAHL, EMBASE, MEDLINE Ovid, PEDro, PubMed, SPORTDiscus and Google Scholar) for reports of randomised controlled trials (RCTs) comparing exercise-only interventions with usual care. The search was performed from inception up to December 2017 with no language restriction. The effect size (ES), with its 95% confidence interval (CI), was calculated on the basis of between-group standardised mean differences. The primary endpoint was at or nearest to 8 weeks. Other outcome time points were grouped into intervals, from < 1 month to ≥ 18 months, for time-dependent effects analysis. Potential determinants were explored by subgroup analyses. Level of significance was set at P ≤ 0.10.ResultsData from 77 RCTs (6472 participants) confirmed statistically significant exercise benefits for pain (ES 0.56, 95% CI 0.44–0.68), function (0.50, 0.38–0.63), performance (0.46, 0.35–0.57), and QoL (0.21, 0.11–0.31) at or nearest to 8 weeks. Across all outcomes, the effects appeared to peak around 2 months and then gradually decreased and became no better than usual care after 9 months. Better pain relief was reported by trials investigating participants who were younger (mean age < 60 years), had knee OA, and were not awaiting joint replacement surgery.ConclusionsExercise significantly reduces pain and improves function, performance and QoL in people with knee and hip OA as compared with usual care at 8 weeks. The effects are maximal around 2 months and thereafter slowly diminish, being no better than usual care at 9 to 18 months. Participants with younger age, knee OA and not awaiting joint replacement may benefit more from exercise therapy. These potential determinants, identified by study-level analyses, may have implied ecological bias and need to be confirmed with individual patient data.     

Cost-Effectiveness of a Cardiac Rehabilitation Program Specifically Designed for Patients With Obesity Within the OPTICARE XL Randomized Controlled Trial

ObjectiveTo assess the cost-effectiveness of a cardiac rehabilitation (CR) program specifically designed for cardiac patients with obesity vs standard CR.DesignCost-effectiveness analysis based on observations in a randomized controlled trial.SettingThree regional CR centers in the Netherlands.ParticipantsCardiac patients (N=201) with obesity (BMI≥30 kg/m²) referred to CR.InterventionsParticipants were randomized to a CR program specifically designed for patients with obesity (OPTICARE XL; N=102) or standard CR. OPTICARE XL included aerobic and strength exercise and behavioral coaching on diet and physical activity during 12 weeks, followed by a 9-month after-care program with “booster” educational sessions. Standard CR consisted of a 6- to 12-week aerobic exercise program, supplemented with cardiovascular lifestyle education.Main Outcome MeasuresAn economic evaluation, with an 18-month time horizon, in terms of quality-adjusted life years (QALYs) and costs from the societal perspective was performed. Costs were reported in 2020 Euros, discounted at a 4% annual rate, and health effects were discounted at a 1.5% annual rate.ResultsOPTICARE XL CR and standard CR resulted in comparable health gain per patient (0.958 vs 0.965 QALYs, respectively; P=.96). Overall, OPTICARE XL CR saved costs (-€4542) compared with the standard CR group. The direct costs for OPTICARE XL CR were higher than for standard CR (€10,712 vs €9951), whereas indirect costs were lower (€51,789 vs €57,092), but these differences were not significant.ConclusionsThis economic evaluation showed no differences between OPTICARE XL CR and standard CR in health effects and costs in cardiac patients with obesity.     

Variability in effect sizes of exercise therapy for knee osteoarthritis depending on comparator interventions

BackgroundSystematic reviews of exercise therapy for knee osteoarthritis (OA) have largely ignored the variability in comparator interventions.ObjectiveTo assess how effect estimates of exercise therapy for knee OA as reported in randomized controlled trials vary depending on the comparator interventions.MethodsWe followed the Cochrane Handbook and PRISMA guidance to conduct and report this meta-epidemiological study. Randomised controlled trials (RCTs) were identified from systematic reviews published in 2015 or later and reference lists of included studies. Exercise therapy RCTs testing interventions that adhered to the American College of Sports Medicine (ACSM) guidelines compared to any comparator intervention in people with knee OA and reporting outcomes of knee pain, physical function and/or quadriceps strength at the end of intervention were included.ResultsThirty-five RCTs with 2412 participants were included. Comparator interventions included no intervention, non-ACSM compliant exercise therapy, education/self-management, and passive modalities. For pain, standardized mean difference (SMD) for ACSM compliant exercise therapy compared to passive modalities was 1.76 (95% CI 0.49, 3.04), no intervention 0.93 (95% CI 0.50; 1.36), education/self-management 0.27 (95% CI 0.07, 0.47), and non-ACSM compliant exercise therapy 0.09 (95% CI -0.06, 0.23). For physical function, SMD for ACSM compliant exercise therapy compared to passive modalities was 1.29 (95% CI 0.41, 2.17), no intervention 0.76 (95% CI 0.15, 1.36), non-ACSM compliant exercise therapy 0.25 (95% CI -0.00, 0.51) and education/self-management 0.21 (95% CI -0.14, 0.55). For quadriceps strength, SMD for ACSM compliant exercise therapy compared to no intervention was 0.69 (95% CI 0.42, 0.96), non-ACSM compliant exercise therapy 0.23 (95% CI -0.01, 0.46), education/self-management -0.02 (95% CI -0.45, 0.42) and passive modalities 0.80 (95% CI -0.10, 1.71).ConclusionThe effect of exercise therapy for knee OA varies significantly depending on the comparator intervention. This variability should be assessed routinely in systematic reviews.     

Cost–benefit Analysis in Health Care: The Case of Bariatric Surgery Compared With Diet

PurposeThe aim of the present study was to assess, by using a cost–benefit analysis, the net monetary benefit (NMB) of bariatric surgery compared with diet (including physical exercise) for obese patients, from both an Italian payer perspective and the broader societal perspective.MethodsThe study considered the following groups of patients: (1) patients with a body mass index (BMI) ≥40 kg/m² without complications + patients with BMI ≥35 kg/m² with complications; (2) patients with BMI ≥35 kg/m² and diabetes; and (3) patients with BMI ranging from 30 to 35 kg/m² and diabetes. A Markov model was developed to project the lifetime health outcomes (life years and quality-adjusted life years [QALYs]) and costs associated with bariatric surgery and diet for the considered groups of patients. The clinical effectiveness of each strategy was based on the likelihood of experiencing cardiovascular events or events related to the presence of diabetes. Data on clinical effectiveness, quality of life, productivity losses, and out-of-pocket costs were mainly derived from the literature; direct costs were obtained from official tariffs or the literature. Different scenarios were considered for the analyses in addition to the base case. According to both perspectives considered, the NMB was calculated by first assuming a willingness-to-pay threshold (30,000€ per QALY), then converting health benefits (QALYs) into the common monetary metric (ie, the euro). NMB was calculated as follows: (incremental benefit × willingness-to-pay – incremental cost).FindingsFor all the scenarios and groups of patients considered, the NMB of bariatric surgery versus diet, on a lifetime horizon, from the payer perspective was positive and ranged from 54,647€ to 122,960€; it varied between 141,192€ and 380,286€ from the societal perspective. In the former case, the NMB turns positive after 3–4 years, indicating that bariatric surgery may be a worthy investment also in the short run for the National Health Service; in the latter case, for a time horizon longer than 2–3 years, the surgical option begins to show advantages for the whole society.ImplicationsDespite its defined cost-effectiveness, bariatric surgery is under-diffused because the initial investment for the technology is often considered a barrier. The cost–benefit analysis showed that bariatric surgery, compared with diet, may be a worthwhile technology for obese patients in Italy from both a payer perspective and the broader societal perspective.     

Full kinetic chain manual and manipulative therapy plus exercise compared with targeted manual and manipulative therapy plus exercise for symptomatic osteoarthritis of the hip: a randomized controlled trial

Brantingham JW, Parkin-Smith G, Cassa TK, Globe GA, Globe D, Pollard H, deLuca K, Jensen M, Mayer S, Korporaal C. Full kinetic chain manual and manipulative therapy plus exercise compared with targeted manual and manipulative therapy plus exercise for symptomatic osteoarthritis of the hip: a randomized controlled trial.ObjectiveTo determine the short-term effectiveness of full kinematic chain manual and manipulative therapy (MMT) plus exercise compared with targeted hip MMT plus exercise for symptomatic mild to moderate hip osteoarthritis (OA).DesignParallel-group randomized trial with 3-month follow-up.SettingTwo chiropractic outpatient teaching clinics.ParticipantsConvenience sample of eligible participants (N=111) with symptomatic hip OA were consented and randomly allocated to receive either the experimental or comparison treatment, respectively.InterventionsParticipants in the experimental group received full kinematic chain MMT plus exercise while those in the comparison group received targeted hip MMT plus exercise. Participants in both groups received 9 treatments over a 5-week period.Main Outcome MeasuresWestern Ontario and McMasters Osteoarthritis Index (WOMAC), Harris hip score (HHS), and Overall Therapy Effectiveness, alongside estimation of clinically meaningful outcomes.ResultsTotal dropout was 9% (n=10) with 7% of total data missing, replaced using a multiple imputation method. No statistically significant differences were found between the 2 groups for any of the outcome measures (analysis of covariance, P=.45 and P=.79 for the WOMAC and HHS, respectively).ConclusionsThere were no statistically significant differences in the primary or secondary outcome scores when comparing full kinematic chain MMT plus exercise with targeted hip MMT plus exercise for mild to moderate symptomatic hip OA. Consequently, the nonsignificant findings suggest that there would also be no clinically meaningful difference between the 2 groups. The results of this study provides guidance to musculoskeletal practitioners who regularly use MMT that the full kinematic chain approach does not appear to have any benefit over targeted treatment.     

Cost-effectiveness and Net Monetary Benefit of Durvalumab Consolidation Therapy Versus No Consolidation Therapy After Chemoradiotherapy in Stage III Non–small Cell Lung Cancer in the Italian National Health Service

PurposeThe aim of this study was to evaluate the cost-effectiveness and net monetary benefit of durvalumab consolidation therapy compared with no consolidation therapy after chemoradiotherapy in patients with stage III non–small cell lung cancer with programmed cell death 1 ligand 1 expression ≥1% from the Italian National Health Service perspective.MethodsWe developed a 12-month decision tree combined with a lifetime cohort Markov model in which patients were assigned to receive durvalumab consolidation therapy or active follow-up (Italian standard of care) after chemoradiotherapy to compare cost-effectiveness and net monetary benefit of the two strategies during a 40-year period. Clinical outcomes data were obtained from the respective clinical trials and extrapolated using survival analysis; cost data were derived from Italian official sources and relevant real-world studies. The incremental cost-effectiveness ratio, incremental cost-utility ratio, and incremental net monetary benefit were computed and compared against a 16,372 € per quality-adjusted life-year (QALY) willingness-to-pay threshold. We performed deterministic sensitivity analysis and probabilistic sensitivity analysis to assess how uncertainty affected results; we also performed scenario analyses to compare results under different pricing settings.FindingsIn the base-case scenario, during a 40-year period, the total costs for patients treated with durvalumab consolidation therapy and active follow-up were €59,860 and €49,840 respectively; life-years gained were 3.47 and 3.31, respectively; and QALYs gained were 2.73 and 2.50, respectively, with an incremental cost-effectiveness ratio of €62,131 per life-year, an incremental cost-utility ratio of €42,322 per QALY, and an incremental net monetary benefit of €−6,144. We found that durvalumab was cost-effective (incremental net monetary benefit = 0) when a discount of 13% and 30% on its official price was applied, considering all other drugs priced according to official or maximum selling prices, respectively. Results were most sensitive to the progression-free survival rate for durvalumab and active follow-up, health utility in progression-free state, and price of subsequent treatments.ImplicationsOur analysis indicates that durvalumab consolidation is cost-effective when a discount is applied on its official price. These results suggest that durvalumab may deliver an incremental health benefit with a contained upfront cost during a 40-year period, from the Italian National Health Service perspective, providing added value in a potentially curative care setting.     

Cost-Effectiveness and Net Monetary Benefit of Olaparib Maintenance Therapy Versus No Maintenance Therapy After First-line Platinum-based Chemotherapy in Newly Diagnosed Advanced BRCA1/2-mutated Ovarian Cancer in the Italian National Health Service

PurposeThe aim of this study was to evaluate the cost-effectiveness and net monetary benefit of olaparib maintenance therapy compared with no maintenance therapy after first-line platinum-based chemotherapy in newly diagnosed advanced BRCA1/2-mutated ovarian cancer from the Italian National Health Service (NHS) perspective.MethodsWe developed a lifetime Markov model in which a cohort of patients with newly diagnosed advanced BRCA1/2-mutated ovarian cancer was assigned to receive either olaparib maintenance therapy or active surveillance (Italian standard of care) after first-line platinum-based chemotherapy to compare cost-effectiveness and net monetary benefit of the 2 strategies. Data on clinical outcomes were obtained from related clinical trial literature and extrapolated using parametric survival analyses. Data on costs were derived from Italian official sources and relevant real-world studies. The incremental cost-effectiveness ratio (ICER), incremental cost-utility ratio (ICUR), and incremental net monetary benefit (INMB) were computed and compared against an incremental cost per quality-adjusted life-year (QALY) gained of €16,372 willingness-to-pay (WTP) threshold. We used deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) to assess how uncertainty affects results; we also performed scenario analyses to compare results under different pricing settings.FindingsIn the base-case scenario, during a 50-year time horizon, the total costs for patients treated with olaparib therapy and active surveillance were €124,359 and €97,043, respectively, and QALYs gained were 7.29 and 4.88, respectively, with an ICER of €9,515 per life-year gained, an ICUR of €11,345 per QALY gained, and an INMB of €12,104. In scenario analyses, considering maximum selling prices for all other drugs, ICUR decreased to €11,311 per QALY and €7,498 per QALY when a 10% and 20% discount, respectively, was applied to the olaparib official price, and the INMB increased to €12,186 and €21,366, respectively. DSA found that the model results were most sensitive to the proportion of patients with relapsing disease in response to platinum-based chemotherapy, time receiving olaparib first-line maintenance treatment, and subsequent treatments price. According to PSAresults, olaparib was associated with a probability of being cost-effective at a €16,372 per QALY WTP threshold ranging from 70% to 100% in the scenarios examined.ImplicationsOur analysis indicates that olaparib maintenance therapy may deliver a significant health benefit with a contained upfront cost during a 50-year time horizon, from the Italian NHS perspective, providing value in a setting with curative intent.     

Limited effect of a self-management exercise program added to spa therapy for increasing physical activity in patients with knee osteoarthritis: A quasi-randomized controlled trial

BackgroundThe efficacy of spa therapy in osteoarthritis (OA) has ever been demonstrated, with a good level of evidence for pain and disability. The effect of a self-management program with spa therapy on physical activity (PA) level has never been demonstrated.ObjectiveThis study aimed to assess, at 3 months, the effectiveness of 5 sessions of a self-management exercise program in patients with knee OA (KOA) who benefit from 18 days of spa therapy and received an information booklet (on proposed physical exercises) on improvement in at least one PA level.MethodsThis was an interventional, multicentre, quasi-randomized controlled trial with a cluster randomized design (1-month period). People 50 to 75 years old with symptomatic knee OA were included in 3 spa therapy centres in France (Bourbon Lancy, Le Mont Dore, Royat). Both groups received conventional spa therapy sessions during 18 days and an information booklet on the benefits of PA practice for KOA. The intervention group additionally received 5 self-management exercise sessions. The main outcome was improvement in at least one PA level according to the International Physical Activity Questionnaire (IPAQ) short-form categorical score (low to moderate or high, or moderate to high) at 3 months. Secondary outcomes were the evolution of PA (MET-min/week), disability, pain, anxiety, depression, self-efficacy, fears and beliefs concerning KOA, barriers to and facilitators of regular PA practice, consumption of painkillers and adherence to physical exercise program at 3 months. Assessors but not participants or caregivers were blinded.ResultsIn total, 123 patients were randomized, 54 to the intervention group and 69 to the control group. Considering the main outcome, at 3 months, 37% of patients in the intervention group showed improvement in at least one PA level according to the IPAQ categorical score versus 30.4% in the control group (P = 0.44). In the intervention group, 13 (24.1%) patients showed improvement from low to moderate PA level (vs. 8 [11.6%] in the control group), 2 (3.7%) from low to high (vs. 2 [2.9%]) and 5 (9.3%) from moderate to highvs. 11 [15.9%]). Both intervention and control groups showed increased IPAQ continuous scores (MET-min/week) at 3 months, although not significantly. HAD anxiety and depression scores were significantly reduced in the intervention group (P = 0.001 and P = 0.049, respectively) and the perception of PA was better in the intervention than control group for motivation and barriers scores (P = 0.019 and P = 0.002, respectively).ConclusionsThis study showed the lack of impact of a short self-management program on PA level in addition to 18-day spa therapy for KOA, but both intervention and control groups showed improved PA level.     

Five-year cost-utility analysis of acute renal replacement therapy: a societal perspective

Purpose

Assessment of the cost utility (CU) of acute renal replacement therapy (RRT) from a societal perspective during a 5-year follow-up.

Methods

This was a cross-sectional cohort study in a medical-surgical intensive care unit and an acute RRT unit of 410 consecutive patients treated with acute RRT in Helsinki University Hospital in 2000–2002. Five-year survival and health-related quality of life (HRQoL) were assessed and used to calculate quality-adjusted life years (QALYs) in two ways. They were first calculated for the 5-year follow-up period and, second, estimated for the expected lifetime. HRQoL was assessed by the EuroQol (EQ-5D) in 2003. The cost analysis included hospital costs during index hospitalization along with hospital and societal costs for the following 5 years. The CU ratio was determined as total costs divided by gained QALYs.

Results

Median survival time for all patients was 0.20 years and the EQ-5D index score was 0.68, 0.18 lower than that of the age- and gender-matched general population. All RRT-treated patients gained 0.10 QALYs/patient and hospital survivors 2.54 QALYs in 5 years. Overall the CU ratio was poor [5 year median 271,116 (29,782–2,177,581) €/QALY]. However, it was acceptable (less than 50,000 €/QALY) in patients who survived for more than a year and did not need chronic RRT. Cost utility decreased with increasing age exceeding 1.0 million €/QALY in the older groups.

Conclusions

In general, the CU ratio of acute RRT is poor. However, it is acceptable in patients with renal recovery who survive for more than 1 year.     

What are the unsupervised exercise adherence rates in clinical trials for knee osteoarthritis? A systematic review

BackgroundExercise is an effective intervention for knee osteoarthritis (OA), and unsupervised exercise programs should be a common adjunct to most treatments. However, it is unknown if current clinical trials are capturing information regarding adherence.ObjectiveTo summarize the extent and quality of reporting of unsupervised exercise adherence in clinical trials for knee OA.MethodsReviewers searched five databases (PubMed, CINAHL, Medline (OVID), EMBASE and Cochrane). Randomized controlled trials where participants with knee OA engaged in an unsupervised exercise program were included. The extent to which exercise adherence was monitored and reported was assessed and findings were subgrouped according to method for tracking adherence. The types of adherence measurement categories were synthesized. A quality assessment was completed using the Physiotherapy Evidence Database (PEDro) scores.ResultsOf 3622 abstracts screened, 176 studies met criteria for inclusion. PEDro scores for study quality ranged from two to ten (mean=6.3). Exercise adherence data was reported in 72 (40.9%) studies. Twenty-six (14.8%) studies only mentioned collection of adherence. Adherence rates ranged from 3.7 to 100% in trials that reported adherence. For 18 studies (10.2%) that tracked acceptable adherence, there was no clear superiority in treatment effect based on adherence rates.ConclusionsClinical trials for knee OA do not consistently collect or report adherence with unsupervised exercise programs. Slightly more than half of the studies reported collecting adherence data while only 40.9% reported findings with substantial heterogeneity in tracking methodology. The clinical relevance of these programs cannot be properly contextualized without this information.     

Cost-utility of collaborative nurse-led self-management support for primary care patients with anxiety,depressive or somatic symptoms: A cluster-randomized controlled trial (the SMADS trial)

BackgroundAnxiety, depressive and somatoform disorders are highly prevalent and cause a huge economic burden. A nurse-led collaborative care intervention has been set up in order to improve self-management of patients with these mental disorders in primary care in Hamburg, Germany. The aim of this study was to determine the cost-utility of this nurse-led intervention from the health care payer perspective.MethodsThis analysis was part of a 12-month cluster-randomized controlled trial aiming to increase perceived self-efficacy of primary care patients with anxiety, depressive or somatic symptoms by collaborative nurse-led self-management support compared with routine care. A cost-effectiveness analysis using quality-adjusted life years was performed. Net-monetary benefit regressions adjusted for baseline differences for different willingness-to-pay thresholds were conducted and cost-effectiveness acceptability curves were constructed.ResultsIn total, n = 325 patients (intervention group: n = 134; control group: n = 191) with a mean age of 40 from 20 primary care practices were included in the analysis. The adjusted differences in quality-adjusted life years and mean total costs between intervention group and control group were +0.02 and +€1145, respectively. Neither of the two differences was statistically significant. The probability for cost-effectiveness of the complex nurse-led intervention was 49% for a willingness-to-pay of €50,000 per additional quality-adjusted life year. The probability for cost-effectiveness did not exceed 65%, independent of the willingness-to-pay.ConclusionThe complex nurse-led intervention promoting self-management for primary care patients with anxiety, depressive or somatic symptoms did not prove to be cost-effective relative to routine care from a health care payer perspective.     

Knee osteoarthritis: key treatments and implications for physical therapy

BackgroundKnee osteoarthritis (OA) is a chronic progressive disease that imparts a substantial socioeconomic burden to society and healthcare systems. The prevalence of knee OA has dramatically risen in recent decades due to consistent increases in life expectancy and obesity worldwide. Patient education, physical exercise, and weight loss (for overweight or obese individuals) constitute the first-line knee OA treatment approach. However, less than 40% of patients with knee OA receive this kind of intervention. There is an unmet need for healthcare professionals treating individuals with knee OA to understand the current recommended treatment strategies to provide effective rehabilitation.ObjectiveTo guide physical therapists in their clinical decision making by summarizing the safest and most efficacious treatment options currently available, and by delineating the most traditional outcome measures used in clinical research for knee OA.ConclusionThere is a need for healthcare providers to abandon low-quality and ineffective treatments and educate themselves and their patients about the current best evidence-based practices for knee OA.     

A comparison of two manual physical therapy approaches and electrotherapy modalities for patients with knee osteoarthritis: A randomized three arm clinical trial

A broad spectrum of physical therapy exercise programs provides symptom relief and functional benefit for patients with knee OA. Manual physical therapy, including tailored exercise programs provide relatively higher level benefit that persists to one year. It is currently unknown if there are important differences in the effects of different manual physical therapy techniques for patients with knee OA and there are virtually no studies comparing manual physical therapy and electrotherapy modalities. The aim of the study was to compare long-term results between three treatment groups (mobilization with movements [MWMs], passive joint mobilization [PJM], and electrotherapy) to determine which treatment is most effective in patients with knee OA. A single-blind randomized clinical trial with parallel design was conducted in patients with knee OA. Seventy-two consecutive patients (mean age 56.11 ± 6.80 years) with bilateral knee OA were randomly assigned to one of three treatment groups: MWMs, PJM, and electrotherapy. All groups performed an exercise program and received 12 sessions. The primary outcome measures of the functional assessment were the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) and Aggregated Locomotor Function (ALF) test scores. The secondary outcome measures were pain level, measured using a pressure algometer and a visual analogue scale (VAS), range of motion (ROM), measured using a digital goniometer, and muscle strength, evaluated with a handheld dynamometer. Patients were assessed before treatment, after treatment and after 1 year of follow-up. Patients receiving the manual physical therapy interventions consisting of either MWM or PJM demonstrated a greater decrease in VAS scores at rest, during functional activities, and during the night compared to those in the electrotherapy group from baseline to after the treatment (p < 0.05). This improvement continued at the 1-year follow-up (p < 0.05). The MWMs and PJM groups also showed significantly improved WOMAC and ALF scores, knee ROM and quadriceps muscle strength compared to those in the electrotherapy group from baseline to 1-year follow-up (p < 0.05). In the treatment of patients with knee OA, manual physical therapy consisting of either MWM or PJM provided superior benefit over electrotherapy in terms of pain level, knee ROM, quadriceps muscle strength, and functional level.     

Effect of gender on strength gains after isometric exercise coupled with electromyographic biofeedback in knee osteoarthritis: A preliminary study

ObjectiveThe objective of this trial was to evaluate the effect of gender on strength gains after five week training programme that consisted of isometric exercise coupled with electromyographic biofeedback to the quadriceps muscle.Materials and methodsForty-three (20 men and 23 women) patients with knee osteoarthritis (OA), were placed into two groups based on their gender. Both groups performed isometric exercise coupled with electromyographic biofeedback for five days a week for five weeks.ResultsBoth groups reported gains in muscle strength after five week training. However, the difference was found to be statistically insignificant between the two groups (P = 0.224).ConclusionThe results suggest that gender did not affect gains in muscle strength by isometric exercise coupled with electromyographic biofeedback in patients with knee OA.     

Cost-effectiveness of varenicline versus bupropion, nicotine-replacement therapy, and unaided cessation in Greece

BackgroundVarenicline was designed to relieve symptoms of nicotine withdrawal, including cigarette craving, and to block the reinforcing effects of continued nicotine use. The cost-effectiveness of varenicline in some countries has not been studied.ObjectiveThe aim of this study was to compare the cost-effectiveness of varenicline to that of bupropion, nicotine-replacement therapy (NRT), and unaided cessation in the Greek health care setting. The analysis takes into account a societal security (third-party payer) perspective.MethodsTo perform the analyses of the benefits of smoking cessation in terms of smoking-related morbidity, mortality, and associated medical costs, a Markov model was used that simulated the progress of a hypothetical cohort of current smokers making a single attempt to quit smoking at the beginning of the timeframe of the analysis. The robustness of the results was assessed using a series of 1-way sensitivity analyses.ResultsVarenicline was associated with the potential prevention of 14.1, 14.2, and 35.1 additional cases of the 4 smoking-related diseases incorporated into the model, per 1000 smokers willing to quit, versus bupropion, NRT, and unaided cessation, respectively. Potentially avoided smoking-related deaths with varenicline were estimated at 3.24, 3.26, and 7.5 per 1000 quitters versus the 3 comparators. Varenicline led to a potential gain of 33.78, 33.91, and 83.97 QALYs per 1000 persons willing to make a quit attempt versus the 3 comparators. Varenicline was associated with cost-savings against both active comparators for the lifetime horizon. Overall, the cost per additional quitter with varenicline, considering only the costs of the smoking-cessation strategy, was €2659 (€1015) for a lifetime horizon compared with bupropion (NRT); however, when all direct costs were incorporated into the analysis, varenicline was cost-saving.ConclusionThe findings from the present study suggest that, compared with the widely used treatment options bupropion and NRT, as well as unaided cessation, varenicline may enhance smoking-cessation treatment outcomes while substantially reducing the overall costs of smoking to the health care system.     

Physical exercise and depression

Abstract

Objectives: The objective was to review studies which used physical exercise as an intervention to treat major depression, focusing on methodology, mechanisms of action, types of physical exercise and treatment outcomes.

Methods: Perform a search of the literature in the databases PsycINFO and PubMed 2000–2010 with ‘major depression’, ‘exercise’, ‘outcome’, ‘physical activity’ and ‘aerobic training’ as search terms. The inclusion criteria were: RCT treating depression with physical exercise with no limitations concerning age, gender or medication status.

Results: Eight studies fulfilled the inclusion criteria and were included. Seven of the eight studies showed significantly improved mood and reduced depression. Physiological and psychological mechanisms may be more relevant to mechanisms of action than social factors. Physical exercise had the same positive effect as sertraline in two studies. Also physical exercise and sertraline given together in one of two studies had a positive effect. Three studies measured an increase in aerobic capacity, two with correlated mood improvements. One showed a correlation between increased muscle strength and reduced feelings of depression.

Conclusion: Physical exercise can be an effective treatment against depression. A mood enhancing effect of exercise was identified in the interventions regardless of the mechanism of action. There is a need for more highly controlled clinical intervention studies treating depression with physical exercise, focusing on increasing the knowledge about mechanisms of action, type of exercise, intensity and frequency of exercise.     

Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program

BACKGROUND AND PURPOSE: Manual therapy and exercise have not previously been compared with a home exercise program for patients with osteoarthritis (OA) of the knee. The purpose of this study was to compare outcomes between a home-based physical therapy program and a clinically based physical therapy program. SUBJECTS: One hundred thirty-four subjects with OA of the knee were randomly assigned to a clinic treatment group (n=66; 61% female, 39% male; mean age [+/-SD]=64+/-10 years) or a home exercise group (n=68, 71% female, 29% male; mean age [+/-SD]=62+/-9 years). METHODS: Subjects in the clinic treatment group received supervised exercise, individualized manual therapy, and a home exercise program over a 4-week period. Subjects in the home exercise group received the same home exercise program initially, reinforced at a clinic visit 2 weeks later. Measured outcomes were the distance walked in 6 minutes and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). RESULTS: Both groups showed clinically and statistically significant improvements in 6-minute walk distances and WOMAC scores at 4 weeks; improvements were still evident in both groups at 8 weeks. By 4 weeks, WOMAC scores had improved by 52% in the clinic treatment group and by 26% in the home exercise group. Average 6-minute walk distances had improved about 10% in both groups. At 1 year, both groups were substantially and about equally improved over baseline measurements. Subjects in the clinic treatment group were less likely to be taking medications for their arthritis and were more satisfied with the overall outcome of their rehabilitative treatment compared with subjects in the home exercise group. DISCUSSION AND CONCLUSION: Although both groups improved by 1 month, subjects in the clinic treatment group achieved about twice as much improvement in WOMAC scores than subjects who performed similar unsupervised exercises at home. Equivalent maintenance of improvements at 1 year was presumably due to both groups continuing the identical home exercise program. The results indicate that a home exercise program for patients with OA of the knee provides important benefit. Adding a small number of additional clinical visits for the application of manual therapy and supervised exercise adds greater symptomatic relief.     

Cost-effectiveness Comparison of Ceftazidime/Avibactam Versus Meropenem in the Empirical Treatment of Hospital-acquired Pneumonia,Including Ventilator-associated Pneumonia,in Italy

PurposeCeftazidime/avibactam (CAZ-AVI) is a fixed-dose combination antibiotic approved in Europe and the United States for patients with hospital-acquired pneumonia, including ventilator-associated pneumonia (HAP/VAP). The economic benefits of a new drug such as CAZ-AVI are required to be assessed against those of available comparators, from the perspective of health care providers and payers, through cost-effectiveness and cost-utility analyses. The objective of this analysis was to compare the cost-effectiveness of CAZ-AVI versus meropenem in the empirical treatment of appropriate hospitalized patients with HAP/VAP caused by gram-negative pathogens, from the perspective of publicly funded health care in Italy (third-party perspective, based on the data from the REPROVE (Ceftazidime-Avibactam Versus Meropenem In Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia) clinical study; ClinicalTrials.gov NCT01808092).MethodsA patient-level, sequential simulation model of the HAP/VAP clinical course was developed using spreadsheet software. The analysis focused on direct medical costs. The time horizon of the model selected was 5 years, with an annual discount rate of 3% on costs and quality-adjusted life-years (QALYs). Clinical inputs for treatment comparisons were mainly obtained from the REPROVE clinical study data. In addition to clinical outcomes observed in the trial, the model incorporated impact of resistance pathogens, based on data from published studies and expert opinion. Certain assumptions were made for some model parameters due to a lack of data.FindingsThe analysis demonstrated that the intervention sequence (CAZ-AVI followed by colistin + high-dose meropenem) versus the comparator sequence (meropenem followed by colistin + high-dose meropenem) provided a better clinical cure rate (+13.52%), which led to a shorter hospital stay (−0.40 days per patient), and gains in the number of life-years (+0.195) and QALYs (+0.350) per patient. The intervention sequence had an estimated net incremental total cost of €1254 ($1401) per patient, and the estimated incremental cost-effectiveness ratio was €3581 ($4000) per QALY gained, well below the willingness-to-pay threshold of €30,000 ($33,507) per QALY in Italy.ImplicationsThe model results showed that CAZ-AVI is expected to provide clinical benefits in hospitalized patients with HAP/VAP in Italy at an acceptable cost compared to meropenem.