Validating malignant melanoma ICD-9-CM codes in Umbria, ASL Napoli 3 Sud and Friuli Venezia Giulia administrative healthcare databases: a diagnostic accuracy study.

OBJECTIVES: To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying subjects with melanoma. DESIGN: A diagnostic accuracy study comparing melanoma ICD-9-CM codes (index test) with medical chart (reference standard). Case ascertainment was based on neoplastic lesion of the skin and a histological diagnosis from a primary or metastatic site positive for melanoma. SETTING: Administrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli Venezia Giulia (FVG) Region. PARTICIPANTS: 112, 130 and 130 cases (subjects with melanoma) were randomly selected from Umbria, NA and FVG, respectively; 94 non-cases (subjects without melanoma) were randomly selected from each unit. OUTCOME MEASURES: Sensitivity and specificity for ICD-9-CM code 172.x located in primary position. RESULTS: The most common melanoma subtype was malignant melanoma of skin of trunk, except scrotum (ICD-9-CM code: 172.5), followed by malignant melanoma of skin of lower limb, including hip (ICD-9-CM code: 172.7). The mean age of the patients ranged from 60 to 61 years. Most of the diagnoses were performed in surgical departments.The sensitivities were 100% (95% CI 96% to 100%) for Umbria, 99% (95% CI 94% to 100%) for NA and 98% (95% CI 93% to 100%) for FVG. The specificities were 88% (95% CI 80% to 93%) for Umbria, 77% (95% CI 69% to 85%) for NA and 79% (95% CI 71% to 86%) for FVG. CONCLUSIONS: The case definition for melanoma based on clinical or instrumental diagnosis, confirmed by histological examination, showed excellent sensitivities and good specificities in the three operative units. Administrative databases from the three operative units can be used for epidemiological and outcome research of melanoma.

HEALTH TECHNOLOGY DISINVESTMENT WORLDWIDE: OVERVIEW OF PROGRAMS AND POSSIBLE DETERMINANTS.

OBJECTIVES: In the past decade, there has been a growing interest in health technology disinvestment. A disinvestment process should involve all relevant stakeholders to identify and deliver the most effective, safe, and cost-effective healthcare interventions. The aim of the present study was to describe the state of the art of health technology disinvestment around the world and to identify parameters that could be associated with the implementation of disinvestment programs. METHODS: A systematic review of the literature was performed from database inception to November 2014, together with the collection of original data on socio-economic indicators from forty countries. RESULTS: Overall, 1,456 records (1,199 from electronic databases and 257 from other sources) were initially retrieved. After analyzing 172 full text articles, 38 papers describing fifteen disinvestment programs/experiences in eight countries were included. The majority (12/15) of disinvestment programs began after 2006. As expected, these programs were more common in developed countries, 63 percent of which had a Beveridge model healthcare system. The univariate analysis showed that countries with disinvestment programs had a significantly higher level of Human Development Index, Gross Domestic Product per capita, public expenditure on health and social services, life expectancy at birth and a lower level of infant mortality rate, and of perceived corruption. The existence of HTA agencies in the country was a strong predictor (p = .034) for the development of disinvestment programs. CONCLUSIONS: The most significant variables in the univariate analysis were connected by a common factor, potentially related to the overall development stage of the country.

Protocol for validating cardiovascular and cerebrovascular ICD-9-CM codes in healthcare administrative databases: the Umbria Data Value Project.

INTRODUCTION: Administrative healthcare databases can provide a comprehensive assessment of the burden of diseases in terms of major outcomes, such as mortality, hospital readmissions and use of healthcare resources, thus providing answers to a wide spectrum of research questions. However, a crucial issue is the reliability of information gathered. Aim of this protocol is to validate International Classification of Diseases, 9th Revision-Clinical Modification (ICD-9-CM) codes for major cardiovascular diseases, including acute myocardial infarction (AMI), heart failure (HF), atrial fibrillation (AF) and stroke. METHODS AND ANALYSIS: Data from the centralised administrative database of the entire Umbria Region (910 000 residents, located in Central Italy) will be considered. Patients with a first hospital discharge for AMI, HF, AF or stroke, between 2012 and 2014, will be identified in the administrative database using the following groups of ICD-9-CM codes located in primary position: (1) 410.x for AMI; (2) 427.31 for AF; (3) 428 for HF; (4) 433.x1, 434 (excluding 434.x0), 436 for ischaemic stroke, 430 and 431 for haemorrhagic stroke (subarachnoid haemorrhage and intracerebral haemorrhage). A random sample of cases, and of non-cases, will be selected, and the corresponding medical charts retrieved and reviewed for validation by pairs of trained, independent reviewers. For each condition considered, case adjudication of disease will be based on symptoms, laboratory and diagnostic tests, as available in medical charts. Divergences will be resolved by consensus. Sensitivity and specificity with 95% CIs will be calculated. ETHICS AND DISSEMINATION: Research protocol has been granted approval by the Regional Ethics Committee. Study results will be disseminated widely through peer-reviewed publications and presentations at national and international conferences.

Implantable devices for the closure of patent foramen ovale in adults: an Italian rapid health technology assessment.

Percutaneous closure of patent foramen ovale (PFO) is offered to patients suffering from cryptogenic stroke, transient ischemic attack or persistent migraine. Several PFO closure devices are CE marked but none have yet been approved by the FDA. On the Italian market 11 different PFO closure devices are available and more than 2500 PFO procedures were reported in 2012. We report findings of a systematic review and meta-analysis of studies in which patients with PFO and transient ischemic attacks, cryptogenic stroke or persistent migraine who underwent PFO closure were compared to patients treated by usual care. We included five controlled clinical trials and one randomized controlled trial. Included studies had poor methodological quality and heterogeneity. In the included randomized controlled trial, 4.7% of procedure-related serious adverse events were observed. Large multicenter, sufficiently powered, and properly randomized trials need to be conducted in Europe with particular attention to patient selection.

Modified versus standard intention-to-treat reporting: are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study.

BACKGROUND: Randomized controlled trials (RCTs) that use the modified intention-to-treat (mITT) approach are increasingly being published. Such trials have a preponderance of post-randomization exclusions, industry sponsorship, and favourable findings, and little is known whether in terms of these items mITT trials are different with respect to trials that report a standard intention-to-treat. METHODS: To determine differences in the methodological quality, sponsorship, authors' conflicts of interest, and findings among trials with different "types" of intention-to-treat, we undertook a cross-sectional study of RCTs published in 2006 in three general medical journals (the Journal of the American Medical Association, the New England Journal of Medicine and the Lancet) and three specialty journals (Antimicrobial Agents and Chemotherapy, the American Heart Journal and the Journal of Clinical Oncology). Trials were categorized based on the "type" of intention-to-treat reporting as follows: ITT, trials reporting the use of standard ITT approach; mITT, trials reporting the use of a "modified intention-to-treat" approach; and "no ITT", trials not reporting the use of any intention-to-treat approach. Two pairs of reviewers independently extracted the data in duplicate. The strength of the associations between the "type" of intention-to-treat reporting and the quality of reporting (sample size calculation, flow-chart, lost to follow-up), the methodological quality of the trials (sequence generation, allocation concealment, and blinding), the funding source, and the findings was determined. Odds ratios (OR) were calculated with 95% confidence intervals (CI). RESULTS: Of the 367 RCTs included, 197 were classified as ITT, 56 as mITT, and 114 as "no ITT" trials. The quality of reporting and the methodological quality of the mITT trials were similar to those of the ITT trials; however, the mITT trials were more likely to report post-randomization exclusions (adjusted OR 3.43 [95%CI, 1.70 to 6.95]; P < 0.001). We found a strong association between trials classified as mITT and for-profit agency sponsorship (adjusted OR 7.41 [95%CI, 3.14 to 17.48]; P < .001) as well as the presence of authors' conflicts of interest (adjusted OR 5.14 [95%CI, 2.12 to 12.48]; P < .001). There was no association between mITT reporting and favourable results; in general, however, trials with for-profit agency sponsorship were significantly associated with favourable results (adjusted OR 2.30; [95%CI, 1.28 to 4.16]; P = 0.006). CONCLUSION: We found that the mITT trials were significantly more likely to perform post-randomization exclusions and were strongly associated with industry funding and authors' conflicts of interest.