Showing papers by "Atul A. Gawande published in 2019"

Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial.

Abstract: Importance High-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently. Objective To examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes. Design, Setting, and Participants A cluster randomized clinical trial of the Serious Illness Care Program in an outpatient oncology setting was conducted. Patients with advanced cancer (n = 278) and oncology clinicians (n = 91) participated between September 1, 2012, and June 30, 2016. Data analysis was performed from September 1, 2016, to December 27, 2018. All analyses were conducted based on intention to treat. Interventions Tools, training, and system changes. Main Outcomes and Measures The coprimary outcomes included goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire) at the end of life. Secondary outcomes included therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival. Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were evaluated. Results Data from 91 clinicians in 41 clusters (72.9% participation; intervention, n = 48; control, n = 43; 52 [57.1%] women) and 278 patients (45.8% participation; intervention, n = 134; control, n = 144; 148 [53.2%] women) were analyzed. Forty-seven clinicians (97.9%) rated the training as effective (mean [SD] score, 4.3 [0.7] of 5.0 possible); of 39 who received a reminder, 34 (87.2%) completed at least 1 conversation (median duration, 19 minutes; range, 5-70). Peacefulness, therapeutic alliance, anxiety, and depression did not differ at baseline. The coprimary outcomes were evaluated in 64 patients; no significant differences were found between the intervention and control groups. However, the trial demonstrated significant reductions in the proportion of patients with moderate to severe anxiety (10.2% vs 5.0%; P = .05) and depression symptoms (20.8% vs 10.6%; P = .04) in the intervention group at 14 weeks after baseline. Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31). Survival and therapeutic alliance did not differ between groups. Conclusions and Relevance The results of this cluster randomized clinical trial were null with respect to the coprimary outcomes of goal-concordant care and peacefulness at the end of life. Methodologic challenges for the primary outcomes, including measure selection and sample size, limit the conclusions that can be drawn from the study. However, the significant reductions in anxiety and depression in the intervention group are clinically meaningful and require further study. Trial Registration ClinicalTrials.gov identifier:NCT01786811

Evaluating an Intervention to Improve Communication Between Oncology Clinicians and Patients With Life-Limiting Cancer: A Cluster Randomized Clinical Trial of the Serious Illness Care Program.

Abstract: Importance Earlier clinician-patient conversations about patients’ values, goals, and preferences in serious illness (ie,serious illness conversations) are associated with better outcomes but occur inconsistently in cancer care. Objective To evaluate the efficacy of a communication quality-improvement intervention in improving the occurrence, timing, quality, and accessibility of documented serious illness conversations between oncology clinicians and patients with advanced cancer. Design, Setting, Participants This cluster randomized clinical trial in outpatient oncology was conducted at the Dana-Farber Cancer Institute and included physicians, advanced-practice clinicians, and patients with cancer who were at high risk of death. Main Outcomes and Measures The primary outcomes (goal-concordant care and peacefulness at the end of life) are published elsewhere. Secondary outcomes are reported herein, including (1) documentation of at least 1 serious illness conversation before death, (2) timing of the initial conversation before death, (3) quality of conversations, and (4) their accessibility in the electronic medical record (EMR). Results We enrolled 91 clinicians (48 intervention, 43 control) and 278 patients (134 intervention, 144 control). Of enrolled patients, 58% died during the study (n=161); mean age was 62.3 years (95% CI, 58.9-65.6 years); 55% were women (n=88). These patients were cared for by 76 of the 91 enrolled clinicians (37 intervention, 39 control); years in practice, 11.5 (95% CI, 9.2-13.8); 57% female (n=43). Medical record review after patients’ death demonstrated that a significantly higher proportion of intervention patients had a documented discussion compared with controls (96% vs 79%,P = .005) and intervention conversations occurred a median of 2.4 months earlier (median, 143 days vs 71 days,P Conclusions and Relevance This communication quality-improvement intervention resulted in more, earlier, better, and more accessible serious illness conversations documented in the EMR. To our knowledge, this is the first such study to demonstrate improvement in all 4 of these outcomes. Trial Registration ClinicalTrials.gov identifier:NCT01786811

Reducing surgical mortality in Scotland by use of the WHO Surgical Safety Checklist

Abstract: Acknowledgements R. Munro and R. Black of NHS National Services Scotland, UK, provided data intelligence. B. Robson helped review this paper; A. Longmate was involved in the preliminary design of this study; J. Ingram, J. Ferbrache and SPSP managers from health boards in Scotland provided some of the information on surgical checklist implementation practices at hospitals across NHS Scotland. Data, analytical methods and study materials used may be made available to other researchers on request. The lead author affirms that the manuscript is an honest, accurate and transparent account of the study being reported. No important aspects of the study have been omitted. Any discrepancies from the study as planned (and, if relevant, registered) have been explained. This study was not funded by any individual or group. The Research Governance Department of the University of Aberdeen sponsored this project and supported the application through ethical review and data management. Disclosure: A.A.G. has received royalties from multiple publishers for writing on improving healthcare, including through use of checklists: Objetiva, Sextante (Brazil); Profile Books Ltd (British Commonwealth); Cheers Publishing Company, Commonwealth Publishing Co (People's Republic of China); Jesenski & Turk, Mizaik Knjiga, Mozaik Knjiga (Croatia); Dokoran (Czech Republic); Lindhart og Rinhoft Forlag (Denmark); Pilgrim Group (Estonia); Editions Moyen‐Courrier, Fayard, Libraire Artheme Fayard, Moyen‐Courrier (France); Radarami (Georgia), S Fischer, Verlagsgruppe Random House (Germany); Crete University Press (Greece); Tericam Kindo (Hungary); Mehta Publishing House, Penguin Random House Books (India); Gramedia Pustaka Utama, Serambi Ilmu Semesta (Indonesia); Arjmand Press (Iran); Am Oved, Modan (Israel); Einaudi Editore (Italy); Misuzu Shobo, Shinyusha Co Ltd (Japan); Janis Roze Publishers (Latvia); Vaga (Lithuania); Mime Forlag (Norway); Magnum, Znak (Poland); Lua de Papel (Portugal); Codecs, Grup Media Litera, Litera, Streamland Ltd (Romania); Slovant Publishers (Slovakia); Mladinska Knjiga (Slovenia); Antoni Bosch Editor, Editorial Empuries, Galaxia Gutenberg (Spain); Asa Editore, Bookie Publishing House, Book21, Sosoh Publishing (South Korea); Volante (Sweden); Alpina, AST (Russia); Matichon, Openworlds (Thailand); Arbeiderspers, Nieuwezijds, Uitgeverij De Arbeiderspers, Uitgeverij Nieuwezijds (the Netherlands); Domingo, Koton Kitap (Turkey); Verlagsgruppe Vivat (Ukraine); CBS Television, Henry Holt, Houghton Mifflin, Harvard Business School Press, McGraw Hill, Pearson Publishing, Public Broadcasting Service, Picador USA (USA), First News‐Tn Viet Publishing Co, Suc Manh Ngoi But Co (Vietnam); and Harper Collins (World). The authors declare no other conflict of interest.

A Cohort Analysis of Clinical and Ultrasound Variables Predicting Cancer Risk in 20,001 Consecutive Thyroid Nodules.

Abstract: CONTEXT Assessing thyroid nodules for malignancy is complex. The impact of patient and nodule factors on cancer evaluation is uncertain. OBJECTIVES To determine precise estimates of cancer risk associated with clinical and sonographic variables obtained during thyroid nodule assessment. DESIGN Analysis of consecutive adult patients evaluated with ultrasound-guided fine-needle aspiration for a thyroid nodule ≥1 cm between 1995 and 2017. Demographics, nodule sonographic appearance, and pathologic findings were collected. MAIN OUTCOME MEASURES Estimated risk for thyroid nodule malignancy for patient and sonographic variables using mixed-effect logistic regression. RESULTS In 9967 patients [84% women, median age 53 years (range 18 to 95)], thyroid cancer was confirmed in 1974 of 20,001 thyroid nodules (9.9%). Significant ORs for malignancy were demonstrated for patient age 75% compared with predominantly solid, P < 0.0001 for both], and the presence of additional nodules ≥1 cm [OR: 0.69 (0.60 to 0.79) for two nodules, OR: 0.41 (0.34 to 0.49) for three nodules, and OR: 0.19 (0.16 to 0.22) for greater than or equal to four nodules compared with one nodule, P < 0.0001 for all]. A free online calculator was constructed to provide malignancy-risk estimates based on these variables. CONCLUSIONS Patient and nodule characteristics enable more precise thyroid nodule risk assessment. These variables are obtained during routine initial thyroid nodule evaluation and provide new insights into individualized thyroid nodule care.

Multisource Evaluation of Surgeon Behavior Is Associated With Malpractice Claims.

Abstract: Objective:We merged direct, multisource, and systematic assessments of surgeon behavior with malpractice claims, to analyze the relationship between surgeon 360-degree reviews and malpractice history.Background:Previous work suggests that malpractice claims are associated with a poor physician-patie

Is WHO’s surgical safety checklist being hyped?

Abstract: Studies show that the World Health Organization’s surgery checklist saves lives around the world, say Alex Haynes and Atul Gawande. But David Urbach and Justin Dimick argue that there’s not enough evidence to say for sure

Facility management associated with improved primary health care outcomes in Ghana.

Abstract: Background Strong primary health care (PHC) is essential for achieving universal health coverage, but in many low- and middle-income countries (LMICs) PHC services are of poor quality. Facility management is hypothesized to be critical for improving PHC performance, but evidence about management performance and its associations with PHC in LMICs remains limited. Methods We quantified management performance of PHC facilities in Ghana and assessed the experiences of women who sought care at sampled facilities. Using multi-level models, we examined associations of facility management with five process outcomes and eight experiential outcomes. Findings On a scale of 0 to 1, the average overall management score in Ghana was 0·76 (IQR = 0·68-0·85). Facility management was significantly associated with one process outcome and three experiential outcomes. Controlling for facility characteristics, facilities with management scores at the 90th percentile (management score = 0·90) had 22% more essential drugs compared to facilities with management scores at the 10th percentile (0·60) (p = 0·002). Positive statistically non-significant associations were also seen with three additional process outcomes-integration of family planning services (p = 0·054), family planning types provided (p = 0·067), and essential equipment availability (p = 0·104). Compared to women who sought care at facilities with management scores at the 10th percentile, women who sought care at facilities at the 90th percentile reported 8% higher ratings of trust in providers (p = 0·028), 15% higher ratings of ease of following provider's advice (p = 0·030), and 16% higher quality rating (p = 0·020). However, women who sought care in the 90th percentile facilities rated their waiting times as worse (22% lower, p = 0·039). Interpretation Higher management scores were associated with higher scores for some process and experiential outcomes. Large variations in management performance indicate the need to strengthen management practices to help realize the full potential of PHC in improving health outcomes.

Effect of Noninvasive Follicular Thyroid Neoplasm with Papillary-Like Nuclear Features (NIFTP) on Malignancy Rates in Thyroid Nodules: How to Counsel Patients on Extent of Surgery.

Abstract: To investigate the impact of the nomenclature change to “noninvasive follicular thyroid neoplasm with papillary-like nuclear features” (NIFTP) on reported malignancy rates following thyroidectomy. Retrospective cohort study of patients with thyroid nodules sampled preoperatively with fine-needle aspiration (FNA) and subsequently removed at one tertiary-care hospital from 4/2016 to 2/2017. Surgical procedure, anatomic pathology, thyroid cytopathology classification, and demographic characteristics were recorded. Thyroidectomy was performed in 353 patients. Twenty-six patients (7.3%) had NIFTP on anatomic pathology. Preoperative FNA demonstrated atypia of undetermined significance (AUS/Bethesda III) in 13 (50%), suspicious for malignancy (SUS/Bethesda V) in 6 (23%), suspicious for follicular neoplasm (SFN/Bethesda IV) in 4 (15%), benign/Bethesda I in 2 (8%), and malignant/Bethesda VI in 1 (4%). Invasive malignancy rates across cytologic categories changed as follows: benign (n = 74) from 4 to 1%, AUS (n = 85) from 33 to 18% (p < 0.05), SFN (n = 58) from 29 to 22%, SUS (n = 33) from 91 to 73% (p < 0.05), and malignant (n = 99) from 99 to 98%. Overall decrease in invasive malignancy was 7.3% for the entire population and 13.1% for indeterminate preoperative FNA cytology (Bethesda III–V). Among 26 NIFTP patients, 17 had thyroid lobectomy (TL) and 9 underwent total thyroidectomy (TT). Eight of the nine patients with TT could have been definitively treated with TL, an 89% decrease. The NIFTP nomenclature change led to an overall decrease in the malignancy rate at our institution, especially for Bethesda III–V categories. Patients may be counseled toward more conservative surgical options if NIFTP is in the differential.

Availability of Safe Childbirth Supplies in 284 Facilities in Uttar Pradesh, India.

Abstract: Objectives Vital to implementation of the World Health Organization (WHO) Safe Childbirth Checklist (SCC), designed to improve delivery of 28 essential birth practices (EBPs), is the availability of safe birth supplies: 22 EBPs on the SCC require one or more supplies. Mapping availability of these supplies can determine the scope of shortages and need for supply chain strengthening. Methods A cross-sectional survey on the availability of functional and/or unexpired supplies was assessed in 284 public-sector facilities in 38 districts in Uttar Pradesh, India. The twenty-three supplies were categorized into three non-mutually exclusive groups: maternal (8), newborn (9), and infection control (6). Proportions and mean number of supplies available were calculated; means were compared across facility types using t-tests and across districts using a one-way ANOVA. Log-linear regression was used to evaluate facility characteristics associated with supply availability. Results Across 284 sites, an average of 16.9 (73.5%) of 23 basic childbirth supplies were available: 63.4% of maternal supplies, 79.1% of newborn supplies, and 78.7% of infection control supplies. No facility had all 23 supplies available and only 8.5% had all four medicines assessed. Significant variability was observed by facility type and district. In the linear model, facility type and distance from district hospital were significant predictors of higher supply availability. Conclusions for Practice In Uttar Pradesh, more remote sites, and primary and community health centers, were at higher risk of supply shortages. Supply chain management must be improved for facility-based delivery and quality of care initiatives to reduce maternal and neonatal harm.

Self-Expanding Metallic Stents in Malignant Biliary Obstruction-Patency and Clinical Efficacy: A Prospective Study from North India Tertiary Center

Abstract: Background and Aims: Endoscopic insertion of self-expandable metallic stent (SEMS) is now accepted as first line modality of treatment for palliation in un-resectable extra-hepatic biliary obstructive jaundice. This study was done to assess the clinical efficacy and duration of patency of endoscopically inserted metallic stent in un-resectable malignant biliary obstruction. Materials and Methods: Between 2015 to 2017, 101 patients who underwent ERCP and SEMS placement for palliation of malignant biliary obstruction were included prospectively. Main outcome measures were technical success, clinical success, mean duration of SEMS patency, clinical efficacy,rate of biliary re-intervention and survival of patients. Results: Overall technical success and clinical success was achieved in 93% and 82.2% respectively. Mean duration of SEMS patency was 109 days. Analysis in subgroup of patients classified according to site of obstruction (Hilar -68, Distal CBD-33) showed that median duration of stent patency was significantly better in distal biliary stricture (135 days vs 95 days), whereas re-intervention rates were higher in higher biliary stricture than distal stricture (41% Vs 6%). Seven patients with hilar biliary stricture suffered post-SEMS insertion cholangitis. Conclusion: SEMS placement is feasible palliative method for un-resectable malignant biliary obstruction with acceptable technical and clinical success. The duration of SEMS patency and clinical efficacy is significantly better in distal biliary stricture whereas re-intervention rate is higher in hilar biliary stricture.

A Baby Feeding Nipple: Simple, Cost effective, and Safe Technique for Removal of Denture

Abstract: Introduction: Denture ingestion occurs commonly in the elderly and frequently impacted in the esophagus due to the sharp edges. This can lead to serious complications such as perforation. We are describing here a simple, cost effective and safe technique for removal of dentures. Material and methods: We used a handmade hood protector made from baby feeding nipple with rat-toothed forceps to safely remove ingested denture in two middle aged patients. Both patients had subcutaneous emphysema. Results: Dentures were removed successfully in both patients. Following denture removal, endoscopic examination of the esophagus did not show any sign of mucosal damage, ulceration, bleeding, or perforation. Conclusion: We successfully and safely removed denture from the stomach using handmade hood designed from a baby feeding tube. It may be beneficial for wide visual field and safety. It is an easy, effective, and safe design for the removal of sharp foreign bodies like dentures.