Methodological issues for the economic evaluation of health interventions: a concise state of the art

This paper presents a preliminary report of the Italian Society of Medical Statistics and Clinical Epidemiology (SISMEC) working group called SiPrEMAS (Evidence Synthesis and Decision Modelling in Health) collating some topics addressed throughout the first two years of collaboration. It contains a rapid overview of the principal methods used for the economic evaluation of health interventions. Special focus is given to the process of assembling and pooling the available evidence, modeling methods, the analysis of uncertainty (structural and on parameters), cost analysis and cost consequences analysis. This paper intends to stimulate the discussion among different professionals involved in the decision making process at national level, trying to (re)bridge the gap between decision makers and researchers

The ability of lumbar spine DXA and phalanx QUS to detect previous fractures in young thalassemic patients with hypogonadism, hypothyroidism, diabetes, and hepatitis-B: A 2-year subgroup analysis from the Taranto Area of Apulia Region.

BACKGROUND: Osteoporosis is a leading cause of morbidity in patients affected by β-thalassemia major or intermediate; we aimed to assess the association between demineralization observed in young thalassemic patients. METHODS: A total of 88 patients with β-thalassemia were recruited at Microcitemia Center of Taranto Hospital under the Prevention Osteoporosis and Fractures research project from 2008 to 2010. All the patients were screened with both dual energy x-ray absorptiometry (DXA) and quantitative ultrasound (QUS). T score and Z score values were obtained for each subject. RESULTS: The overall prevalence of demineralization was 84% with DXA and 70% with QUS, whereas normality was found in 16% of patients screened with DXA and in 30% of cases with QUS. Hypogonadism, hypothyroidism, diabetes mellitus, hepatitis-B, and the presence of previous fragility fractures were significantly associated with the demineralization status (lower T scores values) both with DXA and QUS. CONCLUSION: Our data confirm that DXA and QUS examinations are both useful for detecting bone demineralization in thalassemic patients

Nulliparity enhances the risk of second primary malignancy of the breast in a cohort of women treated for thyroid cancer

<p>Abstract</p> <p>Background</p> <p>Many studies have reported an increased risk of developing a second primary malignancy (SPM) of the breast in women treated for thyroid cancer. In this study, we investigated several potential risk factors for this association. The aim of this retrospective cohort study was to identify a subgroup of women surgically treated for papillary thyroid cancer that may benefit from more careful breast cancer screening.</p> <p>Methods</p> <p>A total of 101 women surgically treated for papillary thyroid cancer from 1996 to 2009 with subsequent follow-up were interviewed by phone regarding personal risk factors and lifestyle habits. Only 75 questionnaires could be evaluated due to a 25.7% rate of patients not retrieved or refusing the interview. Data analysis was performed using a multivariate logistic model.</p> <p>Results</p> <p>The standardised incidence ratio (SIR) for breast cancer was 3.58 (95% IC 1.14 - 8.37). Our data suggest a protective effect of multiparity on the development of a SPM of the breast (O.R. 0.15; 95% IC 0.25 - 0.86). Significant associations were not found with other known risk factors including Body Mass Index (BMI), age at first tumour, concurrent metabolic diseases, smoking, physical activity and familiarity.</p> <p>Conclusions</p> <p>This study confirms that a higher incidence of SPM of the breast is observed in women treated for papillary thyroid cancer. Additionally, this risk is increased by nulliparity, thus a strict breast screening program for nulliparous women treated for thyroid cancer may be advisable.</p

Increasing delta-9-tetrahydrocannabinol (Δ-9-THC) content in herbal cannabis over time: systematic review and meta-analysis.

AIM: The objective of this meta-analysis is to assess the data regarding changes in herbal cannabis potency over time (from 1970 to 2009). METHODS: Systematic searches of 17 electronic scientific databases identified studies on this topic, within which 21 case series studies satisfied our inclusion criteria of reporting the mean tetrahydrocannabinol (THC) value per number of samples per year. No language, publication date, publication type or status restrictions were imposed. The study selection and data extraction processes were performed independently but uniformly by two authors, included screening, determination of eligibility and inclusion of the eligible studies in the systematic review, and a meta-analysis of the results on THC content in herbal cannabis samples. We considered papers and not monographic scientific publications, rejecting all studies that were not focused on the subject of this review. RESULTS: Meta-analysis by year was performed on 21 studies containing 75 total mean THC observations from 1979 to 2009 using the random effects model. The results revealed much variability between studies. Further, there was a significant correlation between year and mean THC in herbal cannabis. The combined data indicated the correlation between year and mean THC in herbal cannabis, revealing a temporal trend of increasing potency (5% above the mean THC value in the Poisson regression analysis). CONCLUSIONS: The results of the analysis suggest that there has been a recent and consistent increase in cannabis potency worldwide

Adjunctive efficacy of probiotics in the treatment of experimental peri-implant mucositis with mechanical and photodynamic therapy: a randomized, cross-over clinical trial

Aim: To evaluate the adjunctive clinical efficacy of probiotics in the treatment of peri-implant mucositis (p-iM) with professionally administered plaque removal (PAPR) and photodynamic therapy (PDT). Materials and methods: Following p-iM induction, patients underwent PAPR + PDT and were randomly assigned to receive the professional and home-based administration of probiotics (Lactobacillus plantarum and Lactobacillus brevis) (test treatment) or placebo preparation (control treatment) according to a cross-over design. Clinical parameters were assessed at six sites for each implant before as well as at 2 and 6 weeks after professional treatment administration. Results: Twenty patients contributing one dental implant each were included. Immediately before treatment and at 6 weeks, the median number of sites with bleeding on probing (BoP+) sites per implant unit was 4 (3–6) and 2 (0–2) (p < 0.001), respectively, for test treatment, and 3.5 (2–4) and 2 (0–3) (p = 0.03), respectively, for control treatment. No significant difference in clinical outcomes was observed between treatment groups. Conclusion: The combination of PAPR and PDT either alone or associated with probiotics determined a significant reduction in the number of BoP+ sites at 2 and 6 weeks around implants with p-iM. The adjunctive use of probiotics did not significantly enhance the clinical outcomes of PAPR + PDT

Improving adherence in osteoporosis: A new management algorithm for the patient with osteoporosis

Introduction: Bisphosphonates are the first-choice treatment for osteoporosis. They effectively increase bone mineral density, reduce markers of bone resorption, and lower the incidence of new fractures in patients with osteoporosis-related fracture. However, the efficacy observed in clinical trials may not be realized in a real-life setting, partly due to poor adherence to therapy, with a significant worsening of clinical outcomes. Several issues contribute to poor adherence to osteoporosis medication, including inconvenient dosing regimens and concerns about possible adverse events. Although strategies to improve adherence have been investigated, new approaches are required. Areas covered: We review available data and propose a new approach to improve adherence to osteoporosis therapy in clinical practice. We present the current evidence and personal experience from a group of Italian osteoporosis experts. Expert opinion: To improve adherence, we propose a multifaceted approach, which includes the Triad Model suggested by the World Health Organization, direct observed therapy and the use of drugs with longer administration intervals, e.g., zoledronic acid. The integration of these strategies may provide the basis for a marked increase in adherence to osteoporosis therapy, and improved clinical outcomes in a real-life scenario. © 2011 Informa UK, Ltd

Clinical improvement and resorption of calcifications in calcific tendinitis of the shoulder after shock wave therapy at 6 months' follow-up: a systematic review and meta-analysis.

OBJECTIVES: To evaluate the effectiveness of shock wave therapy (SWT) for functional improvement and the reduction of pain in patients with calcific tendinitis of the shoulder, and to determine the rate of disappearance of calcifications after therapy at 6 months' follow-up. DATA SOURCES: Articles were searched from the Cochrane Library, MEDLINE, Embase, CINAHL, and Ovid database. STUDY SELECTION: We included randomized controlled trials from 1992 to 2011, and their quality was assessed using the Physiotherapy Evidence Database (PEDro) scale. DATA EXTRACTION: Studies were evaluated by 2 independent reviewers for their methodologic quality. Disagreements were settled by a third reviewer. Data were then extracted and cross-checked for accuracy. The reviewers were not blinded to the authors of the articles. DATA SYNTHESIS: In 4 of the 6 studies included for review, the resorption of calcifications was evaluated using meta-analysis because the studies had 2 treatment groups, while the other 2 studies were analyzed descriptively because they had 3 treatment groups. Fixed- and random-effects models were used to meta-analyze total and partial resorption ratios, and I(2) statistics were calculated to assess heterogeneity. CONCLUSIONS: We found a clinical improvement with a pooled total resorption ratio of 27.19 (95% confidence interval [CI], 7.20-102.67) and a pooled partial resorption ratio of 16.22 (95% CI, 3.33-79.01). SWT increases shoulder function, reduces pain, and is effective in dissolving calcifications. These results were maintained over the following 6 months

Clinical improvement and resorption of calcifications in calcific tendinitis of the shoulder after shock wave therapy at 6 months' follow-up: a systematic review and meta-analysis.

OBJECTIVES: To evaluate the effectiveness of shock wave therapy (SWT) for functional improvement and the reduction of pain in patients with calcific tendinitis of the shoulder, and to determine the rate of disappearance of calcifications after therapy at 6 months' follow-up. DATA SOURCES: Articles were searched from the Cochrane Library, MEDLINE, Embase, CINAHL, and Ovid database. STUDY SELECTION: We included randomized controlled trials from 1992 to 2011, and their quality was assessed using the Physiotherapy Evidence Database (PEDro) scale. DATA EXTRACTION: Studies were evaluated by 2 independent reviewers for their methodologic quality. Disagreements were settled by a third reviewer. Data were then extracted and cross-checked for accuracy. The reviewers were not blinded to the authors of the articles. DATA SYNTHESIS: In 4 of the 6 studies included for review, the resorption of calcifications was evaluated using meta-analysis because the studies had 2 treatment groups, while the other 2 studies were analyzed descriptively because they had 3 treatment groups. Fixed- and random-effects models were used to meta-analyze total and partial resorption ratios, and I(2) statistics were calculated to assess heterogeneity. CONCLUSIONS: We found a clinical improvement with a pooled total resorption ratio of 27.19 (95% confidence interval [CI], 7.20-102.67) and a pooled partial resorption ratio of 16.22 (95% CI, 3.33-79.01). SWT increases shoulder function, reduces pain, and is effective in dissolving calcifications. These results were maintained over the following 6 months

Long-term clinical outcomes and cost-effectiveness analysis in multivessel percutaneous coronary interventions: Comparison of drug-eluting stents, bare-metal stents and a mixed approach in patients at high and low risk of repeat revascularisation

Aims: To evaluate the long-term effectiveness and cost-efficacy of drug-eluting stents (DES) in a real world setting of multivessel percutaneous coronary intervention (PCI). Methods and results: We evaluated the 2-year outcome of all multivessel PCI in de novo lesions enrolled in a prospective web-based multicentre registry from July 2003 to December 2006. Among the 2,898 eligible patients, 1,315 were treated with bare-metal stent (BMS) alone, 657 with DES alone, and 926 with both. At 2-years, use of DES was associated with a lower propensity score adjusted incidence of major adverse cardiac events (MACE), death and myocardial infarction, and target vessel revascularisation (TVR) compared with BMS but only in patients at high risk of TVR. No difference was apparent between "pure" DES and the mixed approach. The matched cost-effectiveness analysis revealed DES to be more costly and more effective with a reasonable incremental cost-efficacy ratio for any MACE avoided only in patients with a high risk of TVR and only in comparison with "pure" BMS patients. Conclusions: In this real-world multivessel PCI registry, the use of DES and a mixed approach were associated with a 2-year reduction of adverse clinical outcomes in comparison with BMS especially in patients with a high risk of TVR. DES were cost-effective only in patients at high risk of TVR. © Europa Edition 2010. All rights reserved