Alessandro Montedori - Academia.edu (original) (raw)
Papers by Alessandro Montedori
Allergy, 2009
The GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach provides g... more The GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach provides guidance to grading the quality of underlying evidence and the strength of recommendations in health care. The GRADE system’s conceptual underpinnings allow for a detailed stepwise process that defines what role the quality of the available evidence plays in the development of health care recommendations. The merit of GRADE is not that it eliminates judgments or disagreements about evidence and recommendations, but rather that it makes them transparent. This first article in a three‐part series describes the GRADE framework in relation to grading the quality of evidence about interventions based on examples from the field of allergy and asthma. In the GRADE system, the quality of evidence reflects the extent to which a guideline panel’s confidence in an estimate of the effect is adequate to support a particular recommendation. The system classifies quality of evidence as high, moderate, l...
The Cochrane library, Mar 28, 2013
Recenti progressi in medicina, 2019
INTRODUCTION Postpartum haemorrhage (PPH) is one of the main causes of mortality and severe mater... more INTRODUCTION Postpartum haemorrhage (PPH) is one of the main causes of mortality and severe maternal morbidity and its incidence is increasing also in Western countries. Aim of this study is to estimate the incidence and the trend of PPH in the Umbrian population using the validated Umbrian health database and to identify possible determinants for the development of PPH. METHODS The source of the data was the regional Healthcare Database of the Umbria Region. The population of interest was represented by women who gave birth in Umbria between 2006 and 2017. The PPH was identified from the hospital data using the ICD-9-CM 666.x codes. Demographic data, principal and secondary diagnoses and data on maternal morbidity and blood component transfusion were collected. The incidence of PPH was calculated taking into account cases of PPH over the total number of births. The determinants of PPH, the associated morbidity and the variation in the severity of the PPH over time have been identif...
European journal of paediatric dentistry, 2017
AIM The aim of this paper was to review the published scientific literature to quantify the preva... more AIM The aim of this paper was to review the published scientific literature to quantify the prevalence and mean score of dental fear/anxiety (DFA) in children/adolescents and its variation according to several variables. MATERIALS AND METHODS Cross- sectional and cohort studies published from 2000 to 2014, that measured DFA in children /adolescents (aged 0-19 years), in the general population, or visiting private or public dental services (general or pediatric) or attending school and kindergarten, were searched, with specific terms, in 3 electronic databases (Medline, Embase, Web Of Science). Primary data, collected with specific questionnaires of demonstrated reliability and/or validity, were extracted. RESULTS After screening 743 abstracts and evaluating 164 full-text publications, 36 articles were selected. Dental fear/anxiety prevalence rates were 12.2%, 10.0%, 12.2%,11.0% and 20.0% for the CFSS-DS, DAS, MDAS, DFS, and DFSS-SF scores, respectively. In the studies that used MCDA...
PLOS ONE, 2020
Background Peptic ulcer is a widespread disease, frequently complicated by perforation and bleedi... more Background Peptic ulcer is a widespread disease, frequently complicated by perforation and bleeding. Administrative databases are useful tool to perform epidemiological and drug utilization studies, but they need a validation process based on a comparison with the original data contained in the medical charts. Our aim was to evaluate the accuracy of the ICD-9 codes in identifying patients with peptic ulcer and gastrointestinal hemorrhage in the regional administrative database of Umbria. Methods The index test of our study was the hospital discharge abstract database of the Umbria region (Italy), while the reference standard was the clinical information collected in the medical charts. The study population were adult patients with a hospital discharge for peptic ulcer or gastrointestinal hemorrhage in the period 2012-2014. A random sample of cases and non-cases was selected and the corresponding medical charts were reviewed. Cases of peptic ulcer were confirmed based on endoscopy, radiology, and surgery, while adjudication of gastrointestinal hemorrhage was based on presence of hematemesis, melena, and rectal bleeding. Results Overall, we reviewed 445 clinical charts of cases and 80 clinical charts of non-cases. The diagnostic accuracy results were: code 531 (gastric ulcer), sensitivity and NPV 98%, specificity 88%, and PPV 91%; code 532 (duodenal ulcer), sensitivity and NPV 100%, specificity
Medicine, 2020
Aim: To compare the effects of sutures and staples for skin closure of surgical wounds. Material ... more Aim: To compare the effects of sutures and staples for skin closure of surgical wounds. Material and methods: We included published and unpublished randomized controlled trials (RCTs) and cluster-randomized trials comparing staples with sutures. Patients were adults (aged 18 years or over) who had undergone any type of surgery. The primary outcomes were risk of overall and severe wound infection. Secondary outcomes included length of hospital stay, readmission rate, adverse events, patient satisfaction with cosmetic results, postoperative pain. Results: Forty-two very low to low quality RCTs with a total of 11,067 patients were included. Sutures resulted in slightly fewer overall wound infections (4.90%) compared to staples (6.75%) but it is uncertain whether there is a difference between the groups (risk ratio [RR] 1.20, 95% confidence intervals [CI] 0.80-1.79; patients = 9864; studies = 34; I 2 = 70%). The evidence was also insufficient to state a difference in terms of severe wound infection (staples 1.4% vs sutures 1.3%; RR 1.08, 95% CI 0.61-1.89; patients = 3036; studies = 17; I 2 = 0%), grade of satisfaction (RR 0.99, 95% CI 0.91-1.07; patients = 3243; studies = 14; I 2 = 67%) and hospital stay. Staples may increase the risk of adverse events (7.3% for staples vs 3.5% for sutures; RR 2.00, 95% CI 1.44-2.79; patients = 6246; studies = 21; I 2 = 33%), readmission rate (RR 1.28, 95% CI 0.18-9.05; patients = 2466; studies = 5; I 2 = 66%) and postoperative pain (standardized mean difference [SMD] 0.41,95%CI À0.35 to 1.16; I 2 = 88%, patients = 390 patients, studies = 5). Conclusions: Due to the lack of high quality evidence, we could not state if sutures are better than staples in terms of wound infection, readmission rate, adverse events, and postoperative pain. With a low quality of evidence, sutures reduce postoperative pain and improve grade of satisfaction with the cosmetic outcome. Abbreviations: BMI = body mass index, CI = confidence intervals, OIS = optimal information size, RCTs = randomized controlled trials, RR = risk ratio, SMD = standardized mean difference.
PLOS ONE, 2020
Background Validation of administrative databases for cerebrovascular diseases is crucial for epi... more Background Validation of administrative databases for cerebrovascular diseases is crucial for epidemiological, outcome, and health services research. The aim of this study was to validate ICD-9 codes for hemorrhagic or ischemic stroke in administrative databases, to use them for a comprehensive assessment of the burden of disease in terms of major outcomes, such as mortality, hospital readmissions, and use of healthcare resources. Methods We considered the hospital discharge abstract database of the Umbria Region (890,000 residents). Source population was represented by patients aged >18 discharged from hospital with a diagnosis of hemorrhagic or ischemic stroke between 2012 and 2014 using ICD-9-CM codes in primary position. We randomly selected and reviewed medical charts of cases and non-cases from hospitals. For case ascertainment we considered symptoms and instrumental tests reported in the medical charts. Diagnostic accuracy measures were computed using 2x2 tables. Results We reviewed 767 medical charts for cases and 78 charts for non-cases. Diagnostic accuracy measures were: subarachnoid hemorrhage: sensitivity (SE) 100% (95% CI: 97%-100%), specificity (SP) 96% (90-99), positive predictive value (PPV) 98% (93-100), negative predictive value (NPV) 100% (95-100); intracerebral hemorrhage: SE 100% (97-100), SP 98% (91-100), PPV 98% (94-100), NPV 100% (95-100); other and unspecified intracranial hemorrhage: SE 100% (97-100), SP 96% (90-99), PPV 98% (93-100), NPV 100% (95-100); ischemic stroke due to occlusion and stenosis of precerebral arteries: SE 99%
Journal of Evidence-Based Medicine, 2019
The aim of this work was to summarize and update the evidence concerning oral ironbased intervent... more The aim of this work was to summarize and update the evidence concerning oral ironbased interventions compared to placebo or no iron-based interventions to prevent critical outcomes in pregnancy or treat critical outcomes in the postpartum phase. Method: Published systematic reviews (Feb 2018) and primary studies (from 2015 to March 2018) retrieved from MEDLINE, EMBASE, and the Cochrane Library were examined. The AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool was used to assess the quality of reviews. GRADE was used to rate the quality of the evidence for critical outcomes.
BMJ open, Jan 20, 2018
To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modi... more To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying subjects with melanoma. 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. Administrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli Venezia Giulia (FVG) Region. 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. Sensitivity and specificity for ICD-9-CM code 172.x located in primary position. 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,...
BMJ open, Jan 17, 2018
To assess the accuracy of International Classification of Diseases 9th Revision-Clinical Modifica... more To assess the accuracy of International Classification of Diseases 9th Revision-Clinical Modification (ICD-9-CM) codes in identifying subjects with lung cancer. A cross-sectional diagnostic accuracy study comparing ICD-9-CM 162.x code (index test) in primary position with medical chart (reference standard). Case ascertainment was based on the presence of a primary nodular lesion in the lung and cytological or histological documentation of cancer from a primary or metastatic site. Three operative units: administrative databases from Umbria Region (890 000 residents), ASL Napoli 3 Sud (NA) (1 170 000 residents) and Friuli Venezia Giulia (FVG) Region (1 227 000 residents). Incident subjects with lung cancer (n=386) diagnosed in primary position between 2012 and 2014 and a population of non-cases (n=280). Sensitivity, specificity and positive predictive value (PPV) for 162.x code. 130 cases and 94 non-cases were randomly selected from each database and the corresponding medical charts w...
BMJ open, Jan 5, 2018
To assess the accuracy of (ICD-9-CM) codes in identifying subjects with colorectal cancer. A diag... more To assess the accuracy of (ICD-9-CM) codes in identifying subjects with colorectal cancer. A diagnostic accuracy study comparing ICD-9-CM codes (index test) for colorectal cancers with medical chart (as a reference standard). Case ascertainment based on neoplastic lesion(s) within the colon/rectum and histological documentation from a primary or metastatic site positive for colorectal cancer. Administrative databases from the Umbria region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) region and Friuli Venezia Giulia (FVG) region. We randomly selected 130 incident patients from each hospital discharge database, admitted between 2012 and 2014, having colorectal cancer ICD-9 codes located in primary position, and 94 non-cases, that is, patients having a diagnosis of cancer (ICD-9 140-239) other than colorectal cancer in primary position. Sensitivity, specificity and predictive values for 153.x code (colon cancer) and for 154.x code (rectal cancer). The positive predictive value (P...
BMJ open, Jan 23, 2018
To define the accuracy of administrative datasets to identify primary diagnoses of breast cancer ... more To define the accuracy of administrative datasets to identify primary diagnoses of breast cancer based on the International Classification of Diseases (ICD) 9th or 10th revision codes. Systematic review. MEDLINE, EMBASE, Web of Science and the Cochrane Library (April 2017). The inclusion criteria were: (a) the presence of a reference standard; (b) the presence of at least one accuracy test measure (eg, sensitivity) and (c) the use of an administrative database. Eligible studies were selected and data extracted independently by two reviewers; quality was assessed using the Standards for Reporting of Diagnostic accuracy criteria. Extracted data were synthesised using a narrative approach. From 2929 records screened 21 studies were included (data collection period between 1977 and 2011). Eighteen studies evaluated ICD-9 codes (11 of which assessed both invasive breast cancer (code 174.x) and carcinoma in situ (ICD-9 233.0)); three studies evaluated invasive breast cancer-related ICD-10...
BMJ open, Jan 23, 2018
To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modi... more To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying patients diagnosed with incident carcinoma in situ and invasive breast cancer in three Italian administrative databases. A diagnostic accuracy study comparing ICD-9-CM codes for carcinoma in situ (233.0) and for invasive breast cancer (174.x) with medical chart (as a reference standard). Case definition: (1) presence of a primary nodular lesion in the breast and (2) cytological or histological documentation of cancer from a primary or metastatic site. Administrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli VeneziaGiulia (FVG) Region. Women with breast carcinoma in situ (n=246) or invasive breast cancer (n=384) diagnosed (in primary position) between 2012 and 2014. Sensitivity and specificity for codes 233.0 and 174.x. For invasive breast cancer the sensitivities were 98% (95% CI 93% to 99%) for Umbr...
The Cochrane database of systematic reviews, Jan 25, 2017
Diverticular disease is a common condition in Western industrialised countries. Most individuals ... more Diverticular disease is a common condition in Western industrialised countries. Most individuals remain asymptomatic throughout life; however, 25% experience acute diverticulitis. The standard treatment for acute diverticulitis is open surgery. Laparoscopic surgery - a minimal-access procedure - offers an alternative approach to open surgery, as it is characterised by reduced operative stress that may translate into shorter hospitalisation and more rapid recovery, as well as improved quality of life. To evaluate the effectiveness of laparoscopic surgical resection compared with open surgical resection for individuals with acute sigmoid diverticulitis. We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2) in the Cochrane Library; Ovid MEDLINE (1946 to 23 February 2017); Ovid Embase (1974 to 23 February 2017); clinicaltrials.gov (February 2017); and the World Health Organization (WHO) International Clinical Trials R...
International Journal of Technology Assessment in Health Care, 2017
Objectives: In the past decade, there has been a growing interest in health technology disinvestm... more 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 afte...
BMJ open, Mar 29, 2017
Administrative healthcare databases can provide a comprehensive assessment of the burden of disea... more 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. 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 ...
Journal of Clinical Epidemiology, 2017
Objectives To describe the characteristics, and estimate the incidence, of trials included in sys... more Objectives To describe the characteristics, and estimate the incidence, of trials included in systematic reviews deviating from the intention-to-treat (ITT) principle. Study Design and Setting A 5% random sample of reviews (Medline 2006 to 2010). Trials from reviews were classified based on the intention-to-treat: 1) ITT trials (trials reporting standard ITT analyses); 2) mITT trials (modified ITT; trials deviating from standard ITT); or 3) no ITT trials. Results Of 222 reviews, 81 (36%) included at least one mITT trial. Reviews with mITT trials were more likely to contain trials that used placebo, that investigated drugs, and that reported favourable results. The incidence of reviews with mITT trial ranged from 29% (17/58) to 48% (23/48). Of the 2349 trials, 597 (25.4%) were classified as ITT trials, 323 (13.8%) as mITT trials and 1429 (60.8%) as no ITT trials. The mITT trials were more likely to have reported exclusions compared to studies classified as ITT trials and to have received funding. Conclusion The reporting of the type of intention-to-treat may differ according to the clinical area and the type of intervention. Deviation from intention-to-treat in randomised controlled trials is a widespread phenomenon that significantly affects systematic reviews.
Clinical and Translational Degenerative Diseases, 2016
Background: The activity of caregiving for people affected with Alzheimer's disease (AD) is a... more Background: The activity of caregiving for people affected with Alzheimer's disease (AD) is associated with an augmentation in health problems (anxiety, depression, stress, increased mortality), as well as in social and financial problems. Different methods of counselling, to reduce caregiver anxiety and depression, have been shown to be effective. Methods/Design: This study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled superiority trial with two parallel groups. Two hundred and sixty-four caregivers of AD patients will be randomly allocated to the modified Mittelmann psychosocial intervention or an educational intervention. The treatment will consist of 6 hours of counselling and psychosocial support to caregivers, administered by psychologists, along with a specific telephone support service, whereas the active control treatment will be 6 hours of general information about AD. The primary endpoint is change in caregiver burden measured with the Zarit Burden Interview. Secondary endpoints comprise caregiver depression, anxiety and quality of life. All endpoints will be measured at baseline, 6, 12 and 24 months post treatment. Discussion: The results of this trial will be helpful to supply the efficacy of early counselling and psychosocial support for AD caregivers and offer in-depth useful information for stakholders and policy makers to implement strategies for caregivers. Trial registration: Clinical Trials.gov identifier: NCT02685787; registered on 6 February 2016. Ethics: This trial has been approved by Umbria Ethical Review Committee, Italy and will be performed in accordance with the norms on Good Clinical Practice and the Helsinki Declaration. Informed consent: Written informed consent will be obtained from the caregivers.
Allergy, 2009
The GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach provides g... more The GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach provides guidance to grading the quality of underlying evidence and the strength of recommendations in health care. The GRADE system’s conceptual underpinnings allow for a detailed stepwise process that defines what role the quality of the available evidence plays in the development of health care recommendations. The merit of GRADE is not that it eliminates judgments or disagreements about evidence and recommendations, but rather that it makes them transparent. This first article in a three‐part series describes the GRADE framework in relation to grading the quality of evidence about interventions based on examples from the field of allergy and asthma. In the GRADE system, the quality of evidence reflects the extent to which a guideline panel’s confidence in an estimate of the effect is adequate to support a particular recommendation. The system classifies quality of evidence as high, moderate, l...
The Cochrane library, Mar 28, 2013
Recenti progressi in medicina, 2019
INTRODUCTION Postpartum haemorrhage (PPH) is one of the main causes of mortality and severe mater... more INTRODUCTION Postpartum haemorrhage (PPH) is one of the main causes of mortality and severe maternal morbidity and its incidence is increasing also in Western countries. Aim of this study is to estimate the incidence and the trend of PPH in the Umbrian population using the validated Umbrian health database and to identify possible determinants for the development of PPH. METHODS The source of the data was the regional Healthcare Database of the Umbria Region. The population of interest was represented by women who gave birth in Umbria between 2006 and 2017. The PPH was identified from the hospital data using the ICD-9-CM 666.x codes. Demographic data, principal and secondary diagnoses and data on maternal morbidity and blood component transfusion were collected. The incidence of PPH was calculated taking into account cases of PPH over the total number of births. The determinants of PPH, the associated morbidity and the variation in the severity of the PPH over time have been identif...
European journal of paediatric dentistry, 2017
AIM The aim of this paper was to review the published scientific literature to quantify the preva... more AIM The aim of this paper was to review the published scientific literature to quantify the prevalence and mean score of dental fear/anxiety (DFA) in children/adolescents and its variation according to several variables. MATERIALS AND METHODS Cross- sectional and cohort studies published from 2000 to 2014, that measured DFA in children /adolescents (aged 0-19 years), in the general population, or visiting private or public dental services (general or pediatric) or attending school and kindergarten, were searched, with specific terms, in 3 electronic databases (Medline, Embase, Web Of Science). Primary data, collected with specific questionnaires of demonstrated reliability and/or validity, were extracted. RESULTS After screening 743 abstracts and evaluating 164 full-text publications, 36 articles were selected. Dental fear/anxiety prevalence rates were 12.2%, 10.0%, 12.2%,11.0% and 20.0% for the CFSS-DS, DAS, MDAS, DFS, and DFSS-SF scores, respectively. In the studies that used MCDA...
PLOS ONE, 2020
Background Peptic ulcer is a widespread disease, frequently complicated by perforation and bleedi... more Background Peptic ulcer is a widespread disease, frequently complicated by perforation and bleeding. Administrative databases are useful tool to perform epidemiological and drug utilization studies, but they need a validation process based on a comparison with the original data contained in the medical charts. Our aim was to evaluate the accuracy of the ICD-9 codes in identifying patients with peptic ulcer and gastrointestinal hemorrhage in the regional administrative database of Umbria. Methods The index test of our study was the hospital discharge abstract database of the Umbria region (Italy), while the reference standard was the clinical information collected in the medical charts. The study population were adult patients with a hospital discharge for peptic ulcer or gastrointestinal hemorrhage in the period 2012-2014. A random sample of cases and non-cases was selected and the corresponding medical charts were reviewed. Cases of peptic ulcer were confirmed based on endoscopy, radiology, and surgery, while adjudication of gastrointestinal hemorrhage was based on presence of hematemesis, melena, and rectal bleeding. Results Overall, we reviewed 445 clinical charts of cases and 80 clinical charts of non-cases. The diagnostic accuracy results were: code 531 (gastric ulcer), sensitivity and NPV 98%, specificity 88%, and PPV 91%; code 532 (duodenal ulcer), sensitivity and NPV 100%, specificity
Medicine, 2020
Aim: To compare the effects of sutures and staples for skin closure of surgical wounds. Material ... more Aim: To compare the effects of sutures and staples for skin closure of surgical wounds. Material and methods: We included published and unpublished randomized controlled trials (RCTs) and cluster-randomized trials comparing staples with sutures. Patients were adults (aged 18 years or over) who had undergone any type of surgery. The primary outcomes were risk of overall and severe wound infection. Secondary outcomes included length of hospital stay, readmission rate, adverse events, patient satisfaction with cosmetic results, postoperative pain. Results: Forty-two very low to low quality RCTs with a total of 11,067 patients were included. Sutures resulted in slightly fewer overall wound infections (4.90%) compared to staples (6.75%) but it is uncertain whether there is a difference between the groups (risk ratio [RR] 1.20, 95% confidence intervals [CI] 0.80-1.79; patients = 9864; studies = 34; I 2 = 70%). The evidence was also insufficient to state a difference in terms of severe wound infection (staples 1.4% vs sutures 1.3%; RR 1.08, 95% CI 0.61-1.89; patients = 3036; studies = 17; I 2 = 0%), grade of satisfaction (RR 0.99, 95% CI 0.91-1.07; patients = 3243; studies = 14; I 2 = 67%) and hospital stay. Staples may increase the risk of adverse events (7.3% for staples vs 3.5% for sutures; RR 2.00, 95% CI 1.44-2.79; patients = 6246; studies = 21; I 2 = 33%), readmission rate (RR 1.28, 95% CI 0.18-9.05; patients = 2466; studies = 5; I 2 = 66%) and postoperative pain (standardized mean difference [SMD] 0.41,95%CI À0.35 to 1.16; I 2 = 88%, patients = 390 patients, studies = 5). Conclusions: Due to the lack of high quality evidence, we could not state if sutures are better than staples in terms of wound infection, readmission rate, adverse events, and postoperative pain. With a low quality of evidence, sutures reduce postoperative pain and improve grade of satisfaction with the cosmetic outcome. Abbreviations: BMI = body mass index, CI = confidence intervals, OIS = optimal information size, RCTs = randomized controlled trials, RR = risk ratio, SMD = standardized mean difference.
PLOS ONE, 2020
Background Validation of administrative databases for cerebrovascular diseases is crucial for epi... more Background Validation of administrative databases for cerebrovascular diseases is crucial for epidemiological, outcome, and health services research. The aim of this study was to validate ICD-9 codes for hemorrhagic or ischemic stroke in administrative databases, to use them for a comprehensive assessment of the burden of disease in terms of major outcomes, such as mortality, hospital readmissions, and use of healthcare resources. Methods We considered the hospital discharge abstract database of the Umbria Region (890,000 residents). Source population was represented by patients aged >18 discharged from hospital with a diagnosis of hemorrhagic or ischemic stroke between 2012 and 2014 using ICD-9-CM codes in primary position. We randomly selected and reviewed medical charts of cases and non-cases from hospitals. For case ascertainment we considered symptoms and instrumental tests reported in the medical charts. Diagnostic accuracy measures were computed using 2x2 tables. Results We reviewed 767 medical charts for cases and 78 charts for non-cases. Diagnostic accuracy measures were: subarachnoid hemorrhage: sensitivity (SE) 100% (95% CI: 97%-100%), specificity (SP) 96% (90-99), positive predictive value (PPV) 98% (93-100), negative predictive value (NPV) 100% (95-100); intracerebral hemorrhage: SE 100% (97-100), SP 98% (91-100), PPV 98% (94-100), NPV 100% (95-100); other and unspecified intracranial hemorrhage: SE 100% (97-100), SP 96% (90-99), PPV 98% (93-100), NPV 100% (95-100); ischemic stroke due to occlusion and stenosis of precerebral arteries: SE 99%
Journal of Evidence-Based Medicine, 2019
The aim of this work was to summarize and update the evidence concerning oral ironbased intervent... more The aim of this work was to summarize and update the evidence concerning oral ironbased interventions compared to placebo or no iron-based interventions to prevent critical outcomes in pregnancy or treat critical outcomes in the postpartum phase. Method: Published systematic reviews (Feb 2018) and primary studies (from 2015 to March 2018) retrieved from MEDLINE, EMBASE, and the Cochrane Library were examined. The AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool was used to assess the quality of reviews. GRADE was used to rate the quality of the evidence for critical outcomes.
BMJ open, Jan 20, 2018
To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modi... more To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying subjects with melanoma. 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. Administrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli Venezia Giulia (FVG) Region. 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. Sensitivity and specificity for ICD-9-CM code 172.x located in primary position. 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,...
BMJ open, Jan 17, 2018
To assess the accuracy of International Classification of Diseases 9th Revision-Clinical Modifica... more To assess the accuracy of International Classification of Diseases 9th Revision-Clinical Modification (ICD-9-CM) codes in identifying subjects with lung cancer. A cross-sectional diagnostic accuracy study comparing ICD-9-CM 162.x code (index test) in primary position with medical chart (reference standard). Case ascertainment was based on the presence of a primary nodular lesion in the lung and cytological or histological documentation of cancer from a primary or metastatic site. Three operative units: administrative databases from Umbria Region (890 000 residents), ASL Napoli 3 Sud (NA) (1 170 000 residents) and Friuli Venezia Giulia (FVG) Region (1 227 000 residents). Incident subjects with lung cancer (n=386) diagnosed in primary position between 2012 and 2014 and a population of non-cases (n=280). Sensitivity, specificity and positive predictive value (PPV) for 162.x code. 130 cases and 94 non-cases were randomly selected from each database and the corresponding medical charts w...
BMJ open, Jan 5, 2018
To assess the accuracy of (ICD-9-CM) codes in identifying subjects with colorectal cancer. A diag... more To assess the accuracy of (ICD-9-CM) codes in identifying subjects with colorectal cancer. A diagnostic accuracy study comparing ICD-9-CM codes (index test) for colorectal cancers with medical chart (as a reference standard). Case ascertainment based on neoplastic lesion(s) within the colon/rectum and histological documentation from a primary or metastatic site positive for colorectal cancer. Administrative databases from the Umbria region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) region and Friuli Venezia Giulia (FVG) region. We randomly selected 130 incident patients from each hospital discharge database, admitted between 2012 and 2014, having colorectal cancer ICD-9 codes located in primary position, and 94 non-cases, that is, patients having a diagnosis of cancer (ICD-9 140-239) other than colorectal cancer in primary position. Sensitivity, specificity and predictive values for 153.x code (colon cancer) and for 154.x code (rectal cancer). The positive predictive value (P...
BMJ open, Jan 23, 2018
To define the accuracy of administrative datasets to identify primary diagnoses of breast cancer ... more To define the accuracy of administrative datasets to identify primary diagnoses of breast cancer based on the International Classification of Diseases (ICD) 9th or 10th revision codes. Systematic review. MEDLINE, EMBASE, Web of Science and the Cochrane Library (April 2017). The inclusion criteria were: (a) the presence of a reference standard; (b) the presence of at least one accuracy test measure (eg, sensitivity) and (c) the use of an administrative database. Eligible studies were selected and data extracted independently by two reviewers; quality was assessed using the Standards for Reporting of Diagnostic accuracy criteria. Extracted data were synthesised using a narrative approach. From 2929 records screened 21 studies were included (data collection period between 1977 and 2011). Eighteen studies evaluated ICD-9 codes (11 of which assessed both invasive breast cancer (code 174.x) and carcinoma in situ (ICD-9 233.0)); three studies evaluated invasive breast cancer-related ICD-10...
BMJ open, Jan 23, 2018
To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modi... more To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying patients diagnosed with incident carcinoma in situ and invasive breast cancer in three Italian administrative databases. A diagnostic accuracy study comparing ICD-9-CM codes for carcinoma in situ (233.0) and for invasive breast cancer (174.x) with medical chart (as a reference standard). Case definition: (1) presence of a primary nodular lesion in the breast and (2) cytological or histological documentation of cancer from a primary or metastatic site. Administrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli VeneziaGiulia (FVG) Region. Women with breast carcinoma in situ (n=246) or invasive breast cancer (n=384) diagnosed (in primary position) between 2012 and 2014. Sensitivity and specificity for codes 233.0 and 174.x. For invasive breast cancer the sensitivities were 98% (95% CI 93% to 99%) for Umbr...
The Cochrane database of systematic reviews, Jan 25, 2017
Diverticular disease is a common condition in Western industrialised countries. Most individuals ... more Diverticular disease is a common condition in Western industrialised countries. Most individuals remain asymptomatic throughout life; however, 25% experience acute diverticulitis. The standard treatment for acute diverticulitis is open surgery. Laparoscopic surgery - a minimal-access procedure - offers an alternative approach to open surgery, as it is characterised by reduced operative stress that may translate into shorter hospitalisation and more rapid recovery, as well as improved quality of life. To evaluate the effectiveness of laparoscopic surgical resection compared with open surgical resection for individuals with acute sigmoid diverticulitis. We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2) in the Cochrane Library; Ovid MEDLINE (1946 to 23 February 2017); Ovid Embase (1974 to 23 February 2017); clinicaltrials.gov (February 2017); and the World Health Organization (WHO) International Clinical Trials R...
International Journal of Technology Assessment in Health Care, 2017
Objectives: In the past decade, there has been a growing interest in health technology disinvestm... more 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 afte...
BMJ open, Mar 29, 2017
Administrative healthcare databases can provide a comprehensive assessment of the burden of disea... more 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. 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 ...
Journal of Clinical Epidemiology, 2017
Objectives To describe the characteristics, and estimate the incidence, of trials included in sys... more Objectives To describe the characteristics, and estimate the incidence, of trials included in systematic reviews deviating from the intention-to-treat (ITT) principle. Study Design and Setting A 5% random sample of reviews (Medline 2006 to 2010). Trials from reviews were classified based on the intention-to-treat: 1) ITT trials (trials reporting standard ITT analyses); 2) mITT trials (modified ITT; trials deviating from standard ITT); or 3) no ITT trials. Results Of 222 reviews, 81 (36%) included at least one mITT trial. Reviews with mITT trials were more likely to contain trials that used placebo, that investigated drugs, and that reported favourable results. The incidence of reviews with mITT trial ranged from 29% (17/58) to 48% (23/48). Of the 2349 trials, 597 (25.4%) were classified as ITT trials, 323 (13.8%) as mITT trials and 1429 (60.8%) as no ITT trials. The mITT trials were more likely to have reported exclusions compared to studies classified as ITT trials and to have received funding. Conclusion The reporting of the type of intention-to-treat may differ according to the clinical area and the type of intervention. Deviation from intention-to-treat in randomised controlled trials is a widespread phenomenon that significantly affects systematic reviews.
Clinical and Translational Degenerative Diseases, 2016
Background: The activity of caregiving for people affected with Alzheimer's disease (AD) is a... more Background: The activity of caregiving for people affected with Alzheimer's disease (AD) is associated with an augmentation in health problems (anxiety, depression, stress, increased mortality), as well as in social and financial problems. Different methods of counselling, to reduce caregiver anxiety and depression, have been shown to be effective. Methods/Design: This study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled superiority trial with two parallel groups. Two hundred and sixty-four caregivers of AD patients will be randomly allocated to the modified Mittelmann psychosocial intervention or an educational intervention. The treatment will consist of 6 hours of counselling and psychosocial support to caregivers, administered by psychologists, along with a specific telephone support service, whereas the active control treatment will be 6 hours of general information about AD. The primary endpoint is change in caregiver burden measured with the Zarit Burden Interview. Secondary endpoints comprise caregiver depression, anxiety and quality of life. All endpoints will be measured at baseline, 6, 12 and 24 months post treatment. Discussion: The results of this trial will be helpful to supply the efficacy of early counselling and psychosocial support for AD caregivers and offer in-depth useful information for stakholders and policy makers to implement strategies for caregivers. Trial registration: Clinical Trials.gov identifier: NCT02685787; registered on 6 February 2016. Ethics: This trial has been approved by Umbria Ethical Review Committee, Italy and will be performed in accordance with the norms on Good Clinical Practice and the Helsinki Declaration. Informed consent: Written informed consent will be obtained from the caregivers.