Culturally adapted psychosocial interventions (CaPSI) for early psychosis in a low-resource setting: study protocol for a large multi-center RCT.

BACKGROUND: Psychosis treatment guidelines recommend cognitive behaviour therapy (CBT) and family intervention (FI), for all patients with first episode psychosis (FEP), though guidance borrows heavily from literature in adults from high income countries. To our knowledge, there are few randomized controlled trials (RCTs) examining the comparative effect of these commonly endorsed psychosocial interventions in individuals with early psychosis from high-income countries and no such trials from low and middle-income countries (LMICs). The present study aims to confirm the clinical-efficacy and cost-effectiveness of delivering culturally adapted CBT (CaCBT) and culturally adapted FI (CulFI) to individuals with FEP in Pakistan. METHOD: A multi-centre, three-arm RCT of CaCBT, CulFI, and treatment as usual (TAU) for individuals with FEP (n = 390), recruited from major centres across Pakistan. Reducing overall symptoms of FEP will be the primary outcome. Additional aims will include improving patient and carer outcomes and estimating the economic impact of delivering culturally appropriate psychosocial interventions in low-resource settings. This trial will assess the clinical-efficacy and cost-effectiveness of CaCBT and CulFI compared with TAU in improving patient (positive and negative symptoms of psychosis, general psychopathology, depressive symptoms, quality of life, cognition, general functioning, and insight) and carer related outcomes (carer experience, wellbeing, illness attitudes and symptoms of depression and anxiety). CONCLUSIONS: A successful trial may inform the rapid scale up of these interventions not only in Pakistan but other low-resource settings, to improve clinical outcomes, social and occupational functioning, and quality of life in South Asian and other minority groups with FEP. TRIAL REGISTRATION: NCT05814913.

Quantifying the risk-adjusted hospital costs of postoperative complications after lower extremity bypass in patients with claudication.

OBJECTIVE: Increasing evidence has shown that the risks associated with surgical revascularization for intermittent claudication outweigh the benefits. The aim of our study was to quantify the cost of care associated with perioperative complications after elective lower extremity bypass (LEB) in patients presenting with intermittent claudication. METHODS: All patients undergoing first-time LEB for claudication in the Healthcare Database (2009-2015) were included. The primary outcome was in-hospital postoperative complications, including major adverse limb events (MALE), major adverse cardiac events (MACE), acute kidney injury, and wound complications. The overall crude hospital costs are reported, and a generalized linear model with log link and inverse Gaussian distribution was used to calculate the predicted hospital costs for specific complications. RESULTS: Overall, 7154 patients had undergone elective LEB for claudication during the study period. The median age was 66 years (interquartile range, 59-73 years), 67.5% were male, and 75.3% were white. Two thirds of patients (61.2%) had Medicare insurance, followed by private insurance (26.9%), Medicaid (7.7%), and other insurance (4.2%). In-hospital complications occurred in 8.5% of patients, including acute kidney injury in 3.0%, MALE in 2.8%, wound complications in 2.3%, and MACE in 1.0%. The overall median crude hospital cost was $11,783 (interquartile range, $8911-$15,767) per patient. The incremental increase in cost associated with a postoperative complication was significant, ranging from $6183 (95% confidence interval, $4604-$7762) for MALE to $10,485 (95% confidence interval, $6529-$14,441) for MACE after risk adjustment. CONCLUSIONS: Postoperative complications after elective LEB for claudication are not uncommon and increase the in-hospital costs by 46% to 78% depending on the complication. Surgical revascularization for claudication should be used sparingly in carefully selected patients.

Real-world cost analysis of endovascular repair versus open repair in patients with nonruptured abdominal aortic aneurysms.

BACKGROUND: The aim of this study was to provide a nationwide, all-payer, real-world cost analysis of endovascular aortic aneurysm repair (EVAR) versus open aortic aneurysm repair (OAR) in patients with nonruptured abdominal aortic aneurysms (non-rAAA). METHODS: All non-rAAA patients registered between July 2009 and March 2015 in the Premier Healthcare Database were analyzed. The Student t-test and the χ2 test were used for continuous and categorical variables, respectively; median value comparisons were done with the Wilcoxon-Mann-Whitney rank-sum test. The in-hospital absolute mean total cost (sum of fixed cost and variable cost) and subcategories were analyzed after adjustment for inflation at July 2015. Fixed costs included all overhead costs while variables costs included in-hospital services including procedures, room and board, services provided by hospital staff, and pharmacy costs. Total cost was stratified based on admission type (emergency vs nonemergency), 75th percentile of length of hospital stay among individual procedures (expected vs extended stay), mortality, and complications. Student t-test and Fisher's analysis of variance were used for comparing mean cost. Year-wise comparison of mean cost was done with analysis of variance to look for a trend over time. RESULTS: Our study cohort included 38,809 non-rAAA patients (33,171 EVAR and 5638 OAR). The mean total cost of index admission was lower in EVAR in comparison with OAR ($32,052 vs $36,091; P < .001), with lower fixed costs ($11,309 vs $16,818; P < .001) and higher variable costs ($20,743 vs $19,272; P < .001). Cost of pharmacy, labor, operating room, room and board and other costs were significantly higher with OAR, whereas the supply cost was higher with EVAR. The expected hospital length of stay of patients who underwent EVAR was associated with a higher total cost ($27,271 vs $25,680; P < .001) and a higher variable cost ($18,186 vs $13,671; P < .001) than OAR patients. However, the extended hospital stay of patients who underwent EVAR had lower costs in all categories compared with the extended length of stay of those who underwent OAR. Mortality associated with EVAR was costlier than OAR associated mortality (mean $72,483 vs $59,804; P = .017). From 2009 to 2014, the mean total cost of EVAR increased significantly by 18.5% ($28,745 vs $34,049; P < .001) owing to a 7.8% increase in fixed costs ($10,931 vs $11,789; P < .001) and a 25.0% increase in variable costs ($17,804 vs $22,257; P < .001). The mean total cost OAR remained stable over time. CONCLUSIONS: Overall hospitalization costs associated with EVAR of non-rAAA was lower than the hospitalization cost of OAR. Interestingly, we found that, among patients who had an expected hospital length of stay, the hospitalization cost after OAR was significantly lower than after EVAR. The average hospitalization cost of OAR was stable during the 5 years study period, whereas the hospitalization cost of EVAR increased significantly over time. Further studies are required to identify reasons for increased costs associated with EVAR.

Elective infrainguinal lower extremity bypass for claudication is associated with high postoperative intensive care utilization.

BACKGROUND: The overall use of intensive care units (ICUs) in the United States has been steadily increasing and is associated with tremendous health care costs. We suspect that the burden of ICU utilization after elective infrainguinal lower extremity bypass (LEB) procedures is high, despite relatively low risks of complications in the immediate postoperative period. We sought to identify the burden of ICU utilization after elective LEB in patients with claudication. METHODS: We queried the Premier Healthcare Database for all adult patients undergoing first recorded elective infrainguinal LEB for claudication from 2009 to 2015. Baseline characteristics and ICU utilization on postoperative day 0 (POD 0) were identified for each patient using Premier room and board chargemaster codes. A bivariate logistic regression was performed and postestimation concordance statistics were calculated to identify predictors of postoperative ICU vs regular surgical floor admission immediately after surgery. RESULTS: There were 6010 patients who met the selection criteria, of whom 2772 (46.1%) were admitted to the ICU and 3238 (53.9%) to the regular surgical floor on POD 0. Whereas patient-level factors were responsible for minor differences found in postoperative admission to the ICU after elective LEB, hospital characteristics made up the majority of variation in admission practices. Specifically, patients undergoing elective infrainguinal LEB in rural, nonteaching, small hospitals and those in certain geographic regions were more likely to be admitted to the ICU than to the floor (all, P < .001). Patient-level factors were poorly predictive of admission to the ICU immediately postoperatively, with C statistics ranging from 0.50 to 0.53. In contrast, hospital-level factors had higher C statistics ranging from 0.51 to 0.66, with geographic location being the strongest predictor of post-LEB ICU admission. There were no significant differences in the incidence of postoperative wound complications, major adverse limb events, major adverse cardiac events, or in-hospital mortality between groups (all, P ≥ .32). The median total hospital cost was $2340 higher for ICU compared with floor admission ($13,273 [interquartile range, $10,136-$17,883] vs $10,927 [interquartile range, $8342-$14,523]; P < .001). CONCLUSIONS: Nearly half of patients are admitted to an ICU directly after elective infrainguinal LEB for claudication. This practice is associated with significantly higher hospital cost and is predominantly influenced by hospital-level rather than by patient-level factors. Perioperative morbidity and mortality were similar regardless of postoperative disposition. To minimize ICU utilization, postoperative care intensity should be determined by clinical severity of the patient rather than by hospital routine.

Financial Impact of Acute Kidney Injury After Cardiac Operations in the United States.

BACKGROUND: Acute kidney injury (AKI) after major cardiac operations is a potentially avoidable complication associated with increased morbidity, death, and costly long-term treatment. The financial impact of AKI at the population level has not been well defined. We sought to determine the incremental index hospital cost associated with the development of AKI. METHODS: All patients undergoing coronary artery bypass grafting (CABG) or valve replacement operations, or both (clinical classification software codes 43 and 44), between 2008 and 2011 were identified from the Nationwide Inpatient Sample. AKI was identified using International Classification of Diseases, 9th Revision, Clinical Modification diagnosis codes (584.xx); patients with chronic renal failure were excluded. Mean total index hospitalization costs were compared between patients with and without AKI. RESULTS: At the population level, 1,078,036 individuals underwent major cardiac procedures from 2008 to 2011, with AKI developing in 105,648 (9.8%). Specifically, AKI developed in 8.0% of CABG, 11.4% of valve replacement, and 17.0% of CABG plus valve replacement patients (p < 0.001). Death was more common among patients with AKI vs those without (13.9% vs 1.3%, p < 0.001). Mean total index hospitalization cost was $77,178 for patients with AKI vs $38,820 for those without (p < 0.001). At the national level, the overall incremental annual index hospitalization cost associated with AKI was $1.01 billion. CONCLUSIONS: AKI developed in 1 in every 10 patients nationwide after a cardiac operation. Achieving a 10% reduction in AKI in this population would likely result in an annual savings of approximately $100,000,000 in index-hospital costs alone. Support for research on mechanisms to detect impending damage and prevent AKI may lead to reduced patient morbidity and death and to substantial health care cost savings.

Intensive care unit admission after endovascular aortic aneurysm repair is primarily determined by hospital factors, adds significant cost, and is often unnecessary.

BACKGROUND: A large proportion of endovascular aortic aneurysm repair (EVAR) patients are routinely admitted to the intensive care unit (ICU) for postoperative observation. In this study, we aimed to describe the factors associated with ICU admission after EVAR and to compare the outcomes and costs associated with ICU vs non-ICU observation. METHODS: All patients undergoing elective infrarenal EVAR in the Premier database (2009-2015) were included. Patients were stratified as ICU vs non-ICU admission according to location on postoperative day 0. Both patient-level (sociodemographics, comorbidities) and hospital-level (teaching status, hospital size, geographic location) factors were analyzed using univariate and multivariable logistic regression to determine factors associated with ICU vs non-ICU admission. Overall outcomes and hospital costs were compared between groups. RESULTS: Overall, 8359 patients underwent elective EVAR during the study period, including 4791 (57.3%) ICU and 3568 (42.7%) non-ICU admissions. Patients admitted to ICU were more frequently nonwhite and had more comorbidities, including congestive heart failure, coronary artery disease, chronic kidney disease, chronic obstructive pulmonary disease, diabetes, and hypertension, than non-ICU patients (all, P < .03). ICU admissions were more common in small (<300 beds), urban, and nonteaching hospitals and varied greatly depending on surgeon specialty and geographic region (P < .001). A pattern emerged when admission location was clustered by hospital; ICU patients were treated at hospitals where 96.7% (interquartile range, 84.5%-98.9%) of patients were admitted to ICU after EVAR, whereas non-ICU patients were treated at hospitals where only 7.5% (interquartile range, 4.9%-25.8%) were admitted to ICU after EVAR. A multivariable logistic regression model accounting for patient-, operative-, and hospital-level differences had a significantly lower area under the curve for predicting ICU admission after EVAR than a model accounting only for hospital factors (area under the curve, 0.76 vs 0.95; P < .001). The overall rate of adverse events was higher for ICU vs non-ICU patients (16.3% vs 13.7%; P < .001). Failure to rescue (2.9% vs 3.9%; P = .42) and in-hospital mortality (0.4% vs 0.4%; P = .81) were similar between groups. After adjusting for patient and hospital factors as well as for postoperative adverse events, ICU admission after EVAR cost $1475 (95% confidence interval, $768-2183) more than non-ICU admission (P < .001). CONCLUSIONS: Among patients undergoing elective EVAR, postoperative ICU admission is more closely associated with hospital practice patterns than with individual patient risk. Routine ICU admission after EVAR adds significant cost without reducing failure to rescue or in-hospital mortality.

"Halo effect" in trauma centers: does it extend to emergent colectomy?

BACKGROUND: Trauma centers (TCs) have been demonstrated to improve outcomes for some nontrauma surgical conditions, such as appendicitis, but it remains unclear if this extends to all emergency general surgery procedures. Using emergent colectomy in patients with diverticulitis as index condition, this study compared outcomes between TCs and nontrauma centers (NTCs). MATERIALS AND METHODS: The Nationwide Emergency Department Sample (2006-2011) was queried for patients ≥16 y with diverticulitis who underwent emergency surgical intervention. Outcomes included mortality, total charges, and length of stay (LOS). Mortality in TC and NTC was compared using logistic regression, controlling for patient, procedure, and hospital-level characteristics. Adjusted total charges and LOS were analyzed using generalized linear models with gamma and Poisson distributions, respectively. RESULTS: A total of 25,396 patients were included, 5189 (20.4%) were treated at TC and 20,207 (79.6%) at NTC. Median age and sex distribution were similar. Unadjusted proportional in-hospital mortality did not differ between TC and NTC; median charges and LOS were greater in TC. After adjusting, the odds of mortality were significantly higher in TC (odds ratio [OR], 1.23; 95% confidence interval [CI], 1.02-1.51; P = 0.003) as were mean charges and LOS (P < 0.001). CONCLUSIONS: The improved outcomes reported for other nontrauma conditions in TC were not observed for patients undergoing an emergent colectomy for diverticulitis after accounting for patient, procedure, and hospital-level characteristics. Future research is needed to assess differences in case mix between TC versus NTC and possible case-mix effects on outcomes to elucidate potential benefit of surgical care in a TC across the breadth of emergency general surgery conditions.

Cluster randomized trial of a parent-based intervention to support early development of children in a low-income country.

BACKGROUND: Programmes that promote early psychological development of children in the developed world have been found to be beneficial. However, such programmes are rare in underprivileged parts of the developing world. We adapted one such parent-based programme (Learning Through Play) for a rural Pakistani population and aimed to study if: (1) it was acceptable to community health workers; (2) the programme led to an improvement, after a period of 6 months, in mothers' knowledge and attitudes about early infant development; (3) it led to a reduction in the levels of maternal mental distress in the post-natal period. METHODS: Using a cluster randomized design with villages as unit of randomization, 163 mothers from 24 villages in a rural sub-district of Rawalpindi, Pakistan, received the 'Learning Through Play' programme, whereas 146 mothers from 24 villages acted as controls. Twenty-four community health workers were trained to carry out the programme. Assessments were conducted using a specially developed 15-item Infant Development Questionnaire and the 20-item Self-Reporting Questionnaire (SRQ). RESULTS: Over 80% of the community health workers trained found the programme to be relevant and were able to integrate it into their routine work. There was a significant increase in mothers' knowledge and positive attitudes about infant development in the intervention group, compared with the control group. Women in the intervention group answered correctly 4.3 (95% CI 3.7-14.9, P < 0.001) more questions than the control group. There was no difference in levels of mental distress measured by the SRQ. CONCLUSIONS: The 'Learning Through Play' programme was successfully integrated into the existing health system and accepted by community health workers. The programme succeeded in improving the knowledge and attitudes of mothers about infant development.

Assessment of therapeutic response in brain tuberculomas using serial dynamic contrast-enhanced MRI.

AIM: To assess the most useful dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) index in the evaluation of the therapeutic response in brain tuberculoma (BT) patients. SUBJECTS AND METHODS: Twenty-three patients with 25 BT lesions were serially evaluated using DCE MRI. All lesions were classified into two groups: group I (n=15) included patients who showed clinical, as well as imaging, improvement; and group II (n=10) included patients with either clinical or radiological deterioration. The group I and group II lesions were examined for up to 12 months at 4 monthly intervals. However, the lesions in five patients of group II were excised following clinical deterioration after 4 months of therapy. The perfusion indices, i.e., relative cerebral blood volume (rCBV), relative cerebral blood flow (rCBF), permeability (k(trans)), and leakage (v(e)), were quantified at each time point. The cellular, necrotic, and total volumes of lesion, together with the oedema volume, were also calculated. RESULTS: All patients in group I and three in group II showed a significant decrease in all perfusion indices, together with the oedema volume, after 1 year. In these three patients in group II, increase in rCBV was associated with increased cellular volume fraction whereas the k(trans), v(e), and oedema volume decreased significantly after 4 months. In five patients in group II who underwent excision of the lesion after 4 months of therapy due to clinical deterioration, the decrease in rCBV was associated with significant increase in k(trans) and oedema volume without any significant change in lesion volume. The rCBV correlated significantly with the cellular volume, whereas k(trans) showed a significant correlation with the v(e) and oedema volume at each time point. CONCLUSION: In BT, changes in k(trans) and oedema volume are associated with a therapeutic response at 4 months, even when there is a paradoxical increase in the lesion volume.

Prevalence and social correlates of postnatal depression in a low income country.

BACKGROUND: Postnatal depression is an important public health problem worldwide. Recent evidence suggests that rates may be relatively higher in developing countries. We aimed to explore the prevalence of postnatal depression and its association with social support and other risk factors in a sample of Pakistani women. METHODS: Population-based survey of 149 women at 12 weeks postnatal using the Edinburgh Postnatal Depression Scale (EPDS), Multidimensional Scale of Perceived Social Support (MSPSS) and Personal Information Questionnaire (PIQ). RESULTS: Thirty six percent women scored > or =12 on EPDS. High depression score was associated with lower social support, increased stressful life events in the preceding year and higher levels of psychological distress in the antenatal period. CONCLUSIONS: There is a high prevalence of postnatal depression in Pakistani women. Early interventions should be developed that target the antenatal period and strengthen social support networks in women at risk.

Automation in cervical cytology: an overview.

Cancer of the uterine cervix is one of the more common female cancers and a major source of premature female mortality. UK deaths in 1987 exceeded 2000. To reduce these rates, national screening programmes have been introduced using the Papanicolaou method. In screening for cancer, the examination of specimens is an intensive and expensive task. Its high cost has led to a number of attempts to automate the process, either fully or partially. Over the last 30 years, various experimental prescreening systems have been developed for the diagnosis of cytological samples including the use of image processing techniques. This paper presents a historical overview of automation in cervical cytology and the status of current developments for automated cytological diagnosis.