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Does state malpractice environment affect outcomes following spinal fusions? A robust statistical and machine learning analysis of 549,775 discharges following spinal fusion surgery in the United States
Chan, Andrew K; Santacatterina, Michele; Pennicooke, Brenton; Shahrestani, Shane; Ballatori, Alexander M; Orrico, Katie O; Burke, John F; Manley, Geoffrey T; Tarapore, Phiroz E; Huang, Michael C; Dhall, Sanjay S; Chou, Dean; Mummaneni, Praveen V; DiGiorgio, Anthony M
OBJECTIVE:Spine surgery is especially susceptible to malpractice claims. Critics of the US medical liability system argue that it drives up costs, whereas proponents argue it deters negligence. Here, the authors study the relationship between malpractice claim density and outcomes. METHODS:The following methods were used: 1) the National Practitioner Data Bank was used to determine the number of malpractice claims per 100 physicians, by state, between 2005 and 2010; 2) the Nationwide Inpatient Sample was queried for spinal fusion patients; and 3) the Area Resource File was queried to determine the density of physicians, by state. States were categorized into 4 quartiles regarding the frequency of malpractice claims per 100 physicians. To evaluate the association between malpractice claims and death, discharge disposition, length of stay (LOS), and total costs, an inverse-probability-weighted regression-adjustment estimator was used. The authors controlled for patient and hospital characteristics. Covariates were used to train machine learning models to predict death, discharge disposition not to home, LOS, and total costs. RESULTS:Overall, 549,775 discharges following spinal fusions were identified, with 495,640 yielding state-level information about medical malpractice claim frequency per 100 physicians. Of these, 124,425 (25.1%), 132,613 (26.8%), 130,929 (26.4%), and 107,673 (21.7%) were from the lowest, second-lowest, second-highest, and highest quartile states, respectively, for malpractice claims per 100 physicians. Compared to the states with the fewest claims (lowest quartile), surgeries in states with the most claims (highest quartile) showed a statistically significantly higher odds of a nonhome discharge (OR 1.169, 95% CI 1.139-1.200), longer LOS (mean difference 0.304, 95% CI 0.256-0.352), and higher total charges (mean difference [log scale] 0.288, 95% CI 0.281-0.295) with no significant associations for mortality. For the machine learning models-which included medical malpractice claim density as a covariate-the areas under the curve for death and discharge disposition were 0.94 and 0.87, and the R2 values for LOS and total charge were 0.55 and 0.60, respectively. CONCLUSIONS:Spinal fusion procedures from states with a higher frequency of malpractice claims were associated with an increased odds of nonhome discharge, longer LOS, and higher total charges. This suggests that medicolegal climate may potentially alter practice patterns for a given spine surgeon and may have important implications for medical liability reform. Machine learning models that included medical malpractice claim density as a feature were satisfactory in prediction and may be helpful for patients, surgeons, hospitals, and payers.
PMID: 33130616
ISSN: 1092-0684
CID: 5015322
Optimal probability weights for estimating causal effects of time-varying treatments with marginal structural Cox models
Santacatterina, Michele; García-Pareja, Celia; Bellocco, Rino; Sönnerborg, Anders; Ekström, Anna Mia; Bottai, Matteo
Marginal structural Cox models have been used to estimate the causal effect of a time-varying treatment on a survival outcome in the presence of time-dependent confounders. These methods rely on the positivity assumption, which states that the propensity scores are bounded away from zero and one. Practical violations of this assumption are common in longitudinal studies, resulting in extreme weights that may yield erroneous inferences. Truncation, which consists of replacing outlying weights with less extreme ones, is the most common approach to control for extreme weights to date. While truncation reduces the variability in the weights and the consequent sampling variability of the estimator, it can also introduce bias. Instead of truncated weights, we propose using optimal probability weights, defined as those that have a specified variance and the smallest Euclidean distance from the original, untruncated weights. The set of optimal weights is obtained by solving a constrained quadratic optimization problem. The proposed weights are evaluated in a simulation study and applied to the assessment of the effect of treatment on time to death among people in Sweden who live with human immunodeficiency virus and inject drugs.
PMID: 30592073
ISSN: 1097-0258
CID: 5015312
Risk behaviour determinants among people who inject drugs in Stockholm, Sweden over a 10-year period, from 2002 to 2012
Karlsson, Niklas; Santacatterina, Michele; Käll, Kerstin; Hägerstrand, Maria; Wallin, Susanne; Berglund, Torsten; Ekström, Anna Mia
BACKGROUND:People who inject drugs (PWID) frequently engage in injection risk behaviours exposing them to blood-borne infections. Understanding the underlying causes that drive various types and levels of risk behaviours is important to better target preventive interventions. METHODS:A total of 2150 PWID in Swedish remand prisons were interviewed between 2002 and 2012. Questions on socio-demographic and drug-related variables were asked in relation to the following outcomes: Having shared injection drug solution and having lent out or having received already used drug injection equipment within a 12Â month recall period. RESULTS:Women shared solutions more than men (odds ratio (OR) 1.51, 95% confidence interval (CI) 1.03; 2.21). Those who had begun to inject drugs before age 17 had a higher risk (OR 1.43, 95% CI 0.99; 2.08) of having received used equipment compared to 17-19Â year olds. Amphetamine-injectors shared solutions more than those injecting heroin (OR 2.43, 95% CI 1.64; 3.62). A housing contract lowered the risk of unsafe injection by 37-59% compared to being homeless. CONCLUSIONS:Women, early drug debut, amphetamine users and homeless people had a significantly higher level of injection risk behaviour and need special attention and tailored prevention to successfully combat hepatitis C and HIV transmission among PWID. TRIAL REGISTRATION:ClinicalTrials.gov Identifier, NCT02234167.
PMCID:5559856
PMID: 28814336
ISSN: 1477-7517
CID: 5015302
Effect of therapy switch on time to second-line antiretroviral treatment failure in HIV-infected patients
Häggblom, Amanda; Santacatterina, Michele; Neogi, Ujjwal; Gisslen, Magnus; Hejdeman, Bo; Flamholc, Leo; Sönnerborg, Anders
BACKGROUND:Switch from first line antiretroviral therapy (ART) to second-line ART is common in clinical practice. However, there is limited knowledge of to which extent different reason for therapy switch are associated with differences in long-term consequences and sustainability of the second line ART. MATERIAL AND METHODS/METHODS:Data from 869 patients with 14601 clinical visits between 1999-2014 were derived from the national cohort database. Reason for therapy switch and viral load (VL) levels at first-line ART failure were compared with regard to outcome of second line ART. Using the Laplace regression model we analyzed the median, 10th, 20th, 30th and 40th percentile of time to viral failure (VF). RESULTS:Most patients (n = 495; 57.0%) switched from first-line to second-line ART without VF. Patients switching due to detectable VL with (n = 124; 14.2%) or without drug resistance mutations (DRM) (n = 250; 28.8%) experienced VF to their second line regimen sooner (median time, years: 3.43 (95% CI 2.90-3.96) and 3.20 (95% 2.65-3.75), respectively) compared with those who switched without VF (4.53 years). Furthermore level of VL at first-line ART failure had a significant impact on failure of second-line ART starting after 2.5 years of second-line ART. CONCLUSIONS:In the context of life-long therapy, a median time on second line ART of 4.53 years for these patients is short. To prolong time on second-line ART, further studies are needed on the reasons for therapy changes. Additionally patients with a high VL at first-line VF should be more frequently monitored the period after the therapy switch.
PMCID:5519043
PMID: 28727795
ISSN: 1932-6203
CID: 5015292
Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam
Cuong, Do Duy; Sönnerborg, Anders; Van Tam, Vu; El-Khatib, Ziad; Santacatterina, Michele; Marrone, Gaetano; Chuc, Nguyen Thi Kim; Diwan, Vinod; Thorson, Anna; Le, Nicole K; An, Pham Nhat; Larsson, Mattias
BACKGROUND:The effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam. METHODS:Seventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating ART were enrolled. The intervention group received peer support with weekly home-visits. Both groups received first-line ART regimens according to the National Treatment Guidelines. Viral load (VL) (ExaVir™ Load) and CD4 counts were analyzed every 6 months. The primary endpoint was virologic failure (VL >1000 copies/ml). Patients were followed up for 24 months. Intention-to-treat analysis was used. Cluster longitudinal and survival analyses were used to study time to virologic failure and CD4 trends. RESULTS:Of 640 patients, 71% were males, mean age 32 years, 83% started with stavudine/lamivudine/nevirapine regimen. After a mean of 20.8 months, 78% completed the study, and the median CD4 increase was 286 cells/μl. Cumulative virologic failure risk was 7.2%. There was no significant difference between intervention and control groups in risk for and time to virologic failure and in CD4 trends. Risk factors for virologic failure were ART-non-naïve status [aHR 6.9;(95% CI 3.2-14.6); p < 0.01]; baseline VL ≥100,000 copies/ml [aHR 2.3;(95% CI 1.2-4.3); p < 0.05] and incomplete adherence (self-reported missing more than one dose during 24 months) [aHR 3.1;(95% CI 1.1-8.9); p < 0.05]. Risk factors associated with slower increase of CD4 counts were: baseline VL ≥100,000 copies/ml [adj.sq.Coeff (95% CI): -0.9 (-1.5;-0.3); p < 0.01] and baseline CD4 count <100 cells/μl [adj.sq.Coeff (95% CI): -5.7 (-6.3;-5.4); p < 0.01]. Having an HIV-infected family member was also significantly associated with gain in CD4 counts [adj.sq.Coeff (95% CI): 1.3 (0.8;1.9); p < 0.01]. CONCLUSION:There was a low virologic failure risk during the first 2 years of ART follow-up in a rural low-income setting in Vietnam. Peer support did not show any impact on virologic and immunologic outcomes after 2 years of follow up. TRIAL REGISTRATION:NCT01433601 .
PMCID:5162085
PMID: 27986077
ISSN: 1471-2334
CID: 5015282
Inferences and conjectures in clinical trials: a systematic review of generalizability of study findings [Letter]
Santacatterina, M; Bottai, M
PMID: 26126506
ISSN: 1365-2796
CID: 5043952
Correlates of mobile phone use in HIV care: Results from a cross-sectional study in South Africa
Madhvani, Naieya; Longinetti, Elisa; Santacatterina, Michele; Forsberg, Birger C; El-Khatib, Ziad
OBJECTIVE:Human Immunodeficiency Virus (HIV) is a major disease burden worldwide. Challenges include retaining patients in care and optimizing adherence to Antiretroviral Therapy (ART). One possible solution is using mobile phones as reminder tools. The main aim of our study was to identify patient demographic groups least likely to use mobile phones as reminder tools in HIV care. DESIGN/METHODS:The data came from a cross-sectional study at the Chris Hani Baragwanath Hospital, Soweto Township, South Africa. METHODS:A comprehensive questionnaire was used to interview 883 HIV infected patients receiving ART. Logistic regression analysis was performed to identify the influence of age, gender, education level, marital status, number of sexual partners in the last three months, income level, and employment status on the use of mobile phone as reminders for clinic appointments and taking medication. RESULTS:Patient groups significantly associated with being less likely to use mobile phones as clinic appointment reminders were: a) patients 45Â years or older, b) women, and c) patients with only primary or no schooling level. Patient groups significantly associated with being less likely to use mobile phones as medication reminders were: a) patients 35Â years or older and b) patients with a lower monthly income. CONCLUSIONS:In this setting being a woman, of older age, lower education, and socio-economic level were risk factors for the low usage of mobile phones as reminder aids. Future studies should assimilate reasons for this, such that patient-specific barriers to implementation are identified and interventions can be tailored.
PMCID:4721279
PMID: 26844111
ISSN: 2211-3355
CID: 5015272
Temporal trends in the Swedish HIV-1 epidemic: increase in non-B subtypes and recombinant forms over three decades
Neogi, Ujjwal; Häggblom, Amanda; Santacatterina, Michele; Bratt, Göran; Gisslén, Magnus; Albert, Jan; Sonnerborg, Anders
BACKGROUND:HIV-1 subtype B (HIV-1B) still dominates in resource-rich countries but increased migration contributes to changes in the global subtype distribution. Also, spread of non-B subtypes within such countries occurs. The trend of the subtype distribution from the beginning of the epidemic in the country has earlier not been reported in detail. Thus the primary objective of this study is to describe the temporal trend of the subtype distribution from the beginning of the HIV-1 epidemic in Sweden over three decades. METHODS:HIV-1 pol sequences from patients (n = 3967) diagnosed in Sweden 1983-2012, corresponding to >40% of patients ever diagnosed, were re-subtyped using several automated bioinformatics tools. The temporal trends of subtypes and recombinants during three decades were described by a multinomial logistic regression model. RESULTS:All eleven group M HIV-1 subtypes and sub-subtypes (78%), 17 circulating recombinant forms (CRFs) (19%) and 32 unique recombinants forms (URF) (3%) were identified. When all patients were analysed, there was an increase of newly diagnosed HIV-1C (RR, 95%CI: 1.10, 1.06-1.14), recombinants (1.20, 1.17-1.24) and other pure subtypes (1.11, 1.07-1.16) over time compared to HIV-1B. The same pattern was found when all patients infected in Sweden (n = 1165) were analysed. Also, for MSM patients infected in Sweden (n = 921), recombinant forms and other pure subtypes increased. SIGNIFICANCE/CONCLUSIONS:Sweden exhibits one of the most diverse subtype epidemics outside Africa. The increase of non-B subtypes is due to migration and to a spread among heterosexually infected patients and MSM within the country. This viral heterogeneity may become a hotspot for development of more diverse and complex recombinant forms if the epidemics converge.
PMCID:4055746
PMID: 24922326
ISSN: 1932-6203
CID: 5015252
The state-led large scale public private partnership 'Chiranjeevi Program' to increase access to institutional delivery among poor women in Gujarat, India: How has it done? What can we learn?
De Costa, Ayesha; Vora, Kranti S; Ryan, Kayleigh; Sankara Raman, Parvathy; Santacatterina, Michele; Mavalankar, Dileep
BACKGROUND:Many low-middle income countries have focused on improving access to and quality of obstetric care, as part of promoting a facility based intra-partum care strategy to reduce maternal mortality. The state of Gujarat in India, implements a facility based intra-partum care program through its large for-profit private obstetric sector, under a state-led public-private-partnership, the Chiranjeevi Yojana (CY), under which the state pays accredited private obstetricians to perform deliveries for poor/tribal women. We examine CY performance, its contribution to overall trends in institutional deliveries in Gujarat over the last decade and its effect on private and public sector deliveries there. METHODS:District level institutional delivery data (public, private, CY), national surveys, poverty estimates, census data were used. Institutional delivery trends in Gujarat 2000-2010 are presented; including contributions of different sectors and CY. Piece-wise regression was used to study the influence of the CY program on public and private sector institutional delivery. RESULTS:Institutional delivery rose from 40.7% (2001) to 89.3% (2010), driven by sharp increases in private sector deliveries. Public sector and CY contributed 25-29% and 13-16% respectively of all deliveries each year. In 2007, 860 of 2000 private obstetricians participated in CY. Since 2007, >600,000 CY deliveries occurred i.e. one-third of births in the target population. Caesareans under CY were 6%, higher than the 2% reported among poor women by the DLHS survey just before CY. CY did not influence the already rising proportion of private sector deliveries in Gujarat. CONCLUSION/CONCLUSIONS:This paper reports a state-led, fully state-funded, large-scale public-private partnership to improve poor women's access to institutional delivery - there have been >600,000 beneficiaries. While caesarean proportions are higher under CY than before, it is uncertain if all beneficiaries who require sections receive these. Other issues to explore include quality of care, provider attrition and the relatively low coverage.
PMCID:4006779
PMID: 24787692
ISSN: 1932-6203
CID: 5015242
Gender perspective of risk factors associated with disclosure of HIV status, a cross-sectional study in Soweto, South Africa
Longinetti, Elisa; Santacatterina, Michele; El-Khatib, Ziad
BACKGROUND:Human Immunodeficiency Virus (HIV) status disclosure has been shown to provide several benefits, both at the individual and societal levels. AIM/OBJECTIVE:To determine risk factors associated with disclosing HIV status among antiretroviral therapy (ART) recipients in South Africa. SETTING/METHODS:A cross-sectional study on risk factors for viremia and drug resistance took place at two outpatient HIV clinics in 2008, at a large hospital located in Soweto, South Africa. METHODS:We conducted a secondary data analysis on socio-economic characteristics and HIV status disclosure to anyone, focusing on gender differences. Descriptive and multivariable logistic regression analyses were performed to model the associations between risk factors and HIV status disclosure. Additionally, descriptive analysis was conducted to describe gender differences of HIV status disclosure to partner, parents, parents in law, partner, child, family, employer, and other. PATIENTS/METHODS:A total of 883 patients were interviewed. The majority were women (73%) with median age of 39 years. RESULTS:Employed patients were less likely to disclose than unemployed (odds ratio (OR) 0.36; 95% confidence interval (CI) 0.1-1.0; p = 0.05)). Women with higher income were more likely to disclose (OR 3.25; 95% CI 0.90-11.7; p = 0.07) than women with lower income, while men with higher income were less likely (OR 0.20; 95% CI 0.02-1.99; p = 0.17) than men with lower income. Men were more likely than women to disclose to their partner (p<0.01), and to partner and family (p<0.01), women were more likely than men to disclose to child and family (p<0.01), to child, family and others (p = 0.01). CONCLUSION/CONCLUSIONS:Being employed imposed a risk factor for HIV status disclosure, additionally we found an interaction effect of gender and income on disclosure. Interventions designed to reduce workplace discrimination and gender-sensitive interventions promoting disclosure are strongly recommended.
PMCID:3990640
PMID: 24743189
ISSN: 1932-6203
CID: 5015232