{"article_id": "PMC4810892", "article_text": ["approximately , one - third of patients with symptomatic vte manifests pe , whereas two - thirds manifest dvt alone .", "both dvt and pe can be clinically silent ( asymptomatic ) and hence not suspected .", "if undiagnosed , asymptomatic vte can lead to chronic venous disease or recurrent vte and long - term debilitating sequelae such as postthrombotic syndrome and chronic thromboembolic pulmonary hypertension .", "vte is not only disabling but also prolongs hospital stay and increases the cost of treatment .", "along with myocardial infarction and arrhythmia ( due to electrolyte imbalance ) , pe is one of the commonest causes of sudden unexplained deaths in hospitalized patients .", "it is estimated that 20 million cases of lower extremity dvt occur in the usa alone .", "the prevailing notion that the incidence of vte in asians is less than that in the western population has been disproved by recent studies .", "the incidence of postoperative dvt in indian patients undergoing major lower limb surgery is as high ( 43.2% and 60% patients in the groups with and without prophylaxis , respectively ) as seen in the western world .", "given the growing burden of vte in india and lack of substantial indian data on characteristics of vte patients , use of diagnostics tools , prophylaxis , treatment options , and clinical outcomes in vte , there was a need to systematically collect such data .", "data on patient characteristics , clinical outcomes , predictors of mortality in acute dvt , management strategies and temporal trends in vte .", "the intent was to collect and provide data that would reflect actual day - to - day clinical practice , rather than results of highly controlled clinical trials with restricted study populations and imposed experimental intervention .", "consecutive medical records of inpatients and outpatients between january 2006 and december 2010 , meeting eligibility criteria ( confirmed diagnosis of acute or acute - on - chronic dvt by doppler ultrasound scan and/or pe by chest computed tomography scan , pulmonary angiography or v / q scan ) were identified and collected from the general medical records and/or radiology departments at each of the three participating hospitals .", "hospital data were used to obtain the total number of patients who were annually registered at the hospital from 2006 to 2010 .", "data were processed and analyzed using sas ( version 9.1 , statistical analysis system ) . for the purpose of analysis ,  acute - on - chronic ", "descriptive statistics were used to present patient characteristics , management strategies , and clinical outcomes of patients .", "annual incidence rates ( 95% ci ) of vte per 100,000 hospital registrations over a period of 5 years were reported for each site .", "fisher 's exact test was used to determine differences in the incidence of acute dvt ( pe ) over the years 20062010 .", "armitage trend test was used to examine the direction ( positive or negative ) of the trend . as primary analyses", "the remaining 41% ( 393/949 ) medical records were not included because they did not satisfy the inclusion criteria .", "data from seven patients were excluded as there was no radiologically confirmed diagnosis of pe .", "a total of 64% ( 352/549 ) patients had acute dvt without pe , 23% ( 124/549 ) had acute dvt with pe , and 13% ( 73/549 ) had pe .", "eighty - seven percent ( 476/549 ) of patients had acute dvt ( pe ) , and 36% ( 197/549 ) had pe (  acute dvt ) [ figure 1 ] .", "overall distribution of venous thromboembolism patients ( n = 549 ) a total of 21% ( 115/549 ) of patients visited the hospitals directly without being referred by a physician .", "venous thromboembolism patients referred from different medical specialties ( n=434 ) the demographic characteristics of the vte patients are mentioned in table 2 .", "demographic characteristics of venous thromboembolism patients ( n=549 ) a total of 182 patients had evidence of one risk factor , 126 had evidence of two risk factors , 70 had evidence of three risk factors and 31 had four or more risk factors recorded .", "patients undergoing orthopedic surgery constituted 22% ( 33/152 ) of all surgical patients [ table 3 ] .", "risk factors for venous thromboembolism based on a review of the available records , 157 patients had a single co - morbidity , 81 had two co - morbidities , 23 had three co - morbidities , and 16 had four or more co - morbidities .", "( myocardial infarction , heart failure , chronic obstructive pulmonary disease , ventilator dependency , sepsis , or pneumonia ) [ table 4 ] .", "co - morbidities in venous thromboembolism patients of the 476 patients with dvt , 2% ( 9 ) had upper extremity dvt , 97% ( 462 ) had lower extremity dvt and the site of dvt was not known in 5 patients .", "a total of 31% ( 143/462 ) patients had dvt in the right limb , 54% ( 249/462 ) in the left limb and 9% ( 41/462 ) in both limbs ( site not known in 29 patients ) .", "of the 462 patients with lower extremity dvt , 61% had proximal dvt , 13% had distal dvt , and 7% had proximal and distal dvt .", "a total of 39% ( 215/549 ) patients were diagnosed with vte during their hospital stay , 54% ( 296/549 ) were admitted to hospital with a diagnosis of vte , and 7% ( 38/549 ) were diagnosed and continued to be managed in the outpatient department [ figure 2 ] .", "place of detection of venous thromboembolism ( n = 549 ) duration of hospitalization after diagnosis of venous thromboembolism a smaller proportion of patients ( 15% ; 81/549 ) was diagnosed with vte during the postoperative period .", "figure 3 shows the proportion of patients with vte at different time points during the postoperative period .", "of those diagnosed beyond 6 weeks , 21% ( 3/14 ) had orthopedic surgery ( hip fracture surgery ) .", "diagnosis of venous thromboembolism during the postoperative period ( n = 81 ) the most common ( 73% ) symptom was  swelling of the limb  among patients with vte [ table 6 ] .", "symptoms in venous thromboembolism patients in merely 4% of all the patients , dvt was also confirmed by venography .", "pe was confirmed by pulmonary angiography in 27% of all the patients [ table 7 ] .", ". heparin ( low molecular weight heparin [ lmwh]/unfractionated heparin [ ufh ] ) alone , a combination of heparin ( lmwh / ufh ) and oral anticoagulant ( warfarin ) , and fondaparinux sodium alone were recommended to 82% ( 420/515 ) , 13% ( 66/515 ) , and 2% ( 12/515 ) patients , respectively as initial anticoagulation .", "five percent ( 25/515 ) of patients were recommended lmwh alone , and 76% ( 393/515 ) were recommended either warfarin or acenocoumarol alone for long - term anticoagulation .", "the median duration of initial anticoagulation was 5 days while that of long - term anticoagulation was 180 days ( 6 months ) .", "anticoagulants were needed to be stopped because of bleeding in only 2% ( 9/515 ) patients .", "clinical outcomes in patients diagnosed with venous thromboembolism during hospital stay clinical outcomes in patients admitted to hospital with a diagnosis of venous thromboembolism the annual incidence of acute dvt ( pe ) increased from 2006 to 2010 at all the three sites [ figure 4 ] .", "however , a formal site - wise statistical analysis could not be performed to analyse trends in the incidence rates in acute dvt ( pe ) and pe alone as there were zero observations in some instances .", "incidence of acute deep vein thrombosis ( with or without pulmonary embolism ) over a 5 years period ( 20062010 ) at three sites", "demographic characteristics of venous thromboembolism patients ( n=549 ) a total of 182 patients had evidence of one risk factor , 126 had evidence of two risk factors , 70 had evidence of three risk factors and 31 had four or more risk factors recorded .", "patients undergoing orthopedic surgery constituted 22% ( 33/152 ) of all surgical patients [ table 3 ] .", "risk factors for venous thromboembolism based on a review of the available records , 157 patients had a single co - morbidity , 81 had two co - morbidities , 23 had three co - morbidities , and 16 had four or more co - morbidities .", "( myocardial infarction , heart failure , chronic obstructive pulmonary disease , ventilator dependency , sepsis , or pneumonia ) [ table 4 ] .", "2% ( 9 ) had upper extremity dvt , 97% ( 462 ) had lower extremity dvt and the site of dvt was not known in 5 patients .", "a total of 31% ( 143/462 ) patients had dvt in the right limb , 54% ( 249/462 ) in the left limb and 9% ( 41/462 ) in both limbs ( site not known in 29 patients ) . of the 462 patients with lower extremity dvt", ", 61% had proximal dvt , 13% had distal dvt , and 7% had proximal and distal dvt .", "a total of 39% ( 215/549 ) patients were diagnosed with vte during their hospital stay , 54% ( 296/549 ) were admitted to hospital with a diagnosis of vte , and 7% ( 38/549 ) were diagnosed and continued to be managed in the outpatient department [ figure 2 ] .", "place of detection of venous thromboembolism ( n = 549 ) duration of hospitalization after diagnosis of venous thromboembolism a smaller proportion of patients ( 15% ; 81/549 ) was diagnosed with vte during the postoperative period .", "figure 3 shows the proportion of patients with vte at different time points during the postoperative period . of those diagnosed beyond 6 weeks", "diagnosis of venous thromboembolism during the postoperative period ( n = 81 ) the most common ( 73% ) symptom was  swelling of the limb  among patients with vte [ table 6 ] .", "a total of 182 patients had evidence of one risk factor , 126 had evidence of two risk factors , 70 had evidence of three risk factors and 31 had four or more risk factors recorded .", "patients undergoing orthopedic surgery constituted 22% ( 33/152 ) of all surgical patients [ table 3 ] .", "based on a review of the available records , 157 patients had a single co - morbidity , 81 had two co - morbidities , 23 had three co - morbidities , and 16 had four or more co - morbidities .", "( myocardial infarction , heart failure , chronic obstructive pulmonary disease , ventilator dependency , sepsis , or pneumonia ) [ table 4 ] .", "of the 476 patients with dvt , 2% ( 9 ) had upper extremity dvt , 97% ( 462 ) had lower extremity dvt and the site of dvt was not known in 5 patients .", "a total of 31% ( 143/462 ) patients had dvt in the right limb , 54% ( 249/462 ) in the left limb and 9% ( 41/462 ) in both limbs ( site not known in 29 patients ) .", "of the 462 patients with lower extremity dvt , 61% had proximal dvt , 13% had distal dvt , and 7% had proximal and distal dvt .", "a total of 39% ( 215/549 ) patients were diagnosed with vte during their hospital stay , 54% ( 296/549 ) were admitted to hospital with a diagnosis of vte , and 7% ( 38/549 ) were diagnosed and continued to be managed in the outpatient department [ figure 2 ] .", "place of detection of venous thromboembolism ( n = 549 ) duration of hospitalization after diagnosis of venous thromboembolism a smaller proportion of patients ( 15% ; 81/549 ) was diagnosed with vte during the postoperative period .", "figure 3 shows the proportion of patients with vte at different time points during the postoperative period . of those diagnosed beyond 6 weeks", "diagnosis of venous thromboembolism during the postoperative period ( n = 81 ) the most common ( 73% ) symptom was  swelling of the limb  among patients with vte [ table 6 ]", "pe was confirmed by pulmonary angiography in 27% of all the patients [ table 7 ] .", "heparin ( low molecular weight heparin [ lmwh]/unfractionated heparin [ ufh ] ) alone , a combination of heparin ( lmwh / ufh ) and oral anticoagulant ( warfarin ) , and fondaparinux sodium alone were recommended to 82% ( 420/515 ) , 13% ( 66/515 ) , and 2% ( 12/515 ) patients , respectively as initial anticoagulation .", "five percent ( 25/515 ) of patients were recommended lmwh alone , and 76% ( 393/515 ) were recommended either warfarin or acenocoumarol alone for long - term anticoagulation .", "the median duration of initial anticoagulation was 5 days while that of long - term anticoagulation was 180 days ( 6 months ) .", "anticoagulants were needed to be stopped because of bleeding in only 2% ( 9/515 ) patients .", "clinical outcomes in patients diagnosed with venous thromboembolism during hospital stay clinical outcomes in patients admitted to hospital with a diagnosis of venous thromboembolism the annual incidence of acute dvt ( pe ) increased from 2006 to 2010 at all the three sites [ figure 4 ] .", "however , a formal site - wise statistical analysis could not be performed to analyse trends in the incidence rates in acute dvt ( pe ) and pe alone as there were zero observations in some instances .", "incidence of acute deep vein thrombosis ( with or without pulmonary embolism ) over a 5 years period ( 20062010 ) at three sites", "pe was confirmed by pulmonary angiography in 27% of all the patients [ table 7 ] .", "heparin ( low molecular weight heparin [ lmwh]/unfractionated heparin [ ufh ] ) alone , a combination of heparin ( lmwh / ufh ) and oral anticoagulant ( warfarin ) , and fondaparinux sodium alone were recommended to 82% ( 420/515 ) , 13% ( 66/515 ) , and 2% ( 12/515 ) patients , respectively as initial anticoagulation .", "five percent ( 25/515 ) of patients were recommended lmwh alone , and 76% ( 393/515 ) were recommended either warfarin or acenocoumarol alone for long - term anticoagulation .", "the median duration of initial anticoagulation was 5 days while that of long - term anticoagulation was 180 days ( 6 months ) .", "anticoagulants were needed to be stopped because of bleeding in only 2% ( 9/515 ) patients .", "clinical outcomes in patients diagnosed with venous thromboembolism during hospital stay clinical outcomes in patients admitted to hospital with a diagnosis of venous thromboembolism", "the annual incidence of acute dvt ( pe ) increased from 2006 to 2010 at all the three sites [ figure 4 ] .", "however , a formal site - wise statistical analysis could not be performed to analyse trends in the incidence rates in acute dvt ( pe ) and pe alone as there were zero observations in some instances .", "incidence of acute deep vein thrombosis ( with or without pulmonary embolism ) over a 5 years period ( 20062010 ) at three sites", "to our knowledge , this is the first multicenter , retrospective registry in india involving patients with vte that reflect real - world clinical practice . in contrast with the western data in which vte is predominantly a disease of older age , 44% patients in our study were between 40 and 59 years of age while 34% were below 40 years , particularly those with pe . in a study from north india ,", "men constituted 70% of our registry , more than those reported from vellore registry ( 48% ) , but similar to those reported in the endorse ( epidemiologic international day for the evaluation of patients at risk for vte in the acute hospital care setting ) study ( 69% ) .", "one of the reasons for this could be significantly high levels of homocysteine ( thrombophilia marker ) in males as compared to females as reported in an indian study .", "fewer indian women use oral contraceptives and postmenopausal hormone replacement therapy , which are known to be risk factors for thrombosis .", "this is supported by the fact that only 1% of women in this registry reported the use of oral contraceptives , and none reported use of hormonal replacement therapy .", "a total of 28% of the overall referrals were from cardiologists . the majority ( 82% ) of the referrals were from medical rather than surgical ( 15% ) specialties as against a referral rate of 93% from surgeons at vellore .", "our finding complements that from the endorse study in which 55% of the medical patients at risk of vte had cardiovascular disease . majority ( 53% ) of patients in our study had co - morbid cardiovascular disease including diabetes mellitus ; it is possible that these patients visited a cardiologist for their cardiovascular ailment ( s ) and were then referred by the cardiologist to vascular disease specialist ( investigator ) .", "most ( 89% ) of these patients had swelling of the ( lower ) limb .", "it is possible that these patients may not have felt the need to visit a specialist for a symptom like  swelling of limb ,  instead visited their family physician .", "it is very encouraging to know that family physicians suspected dvt in these situations and referred the patient to a specialist .", "patients with a history of vte are about 8 times more likely to develop a new episode during a subsequent high - risk period compared with patients without a history of dvt or pe .", "prior history of dvt was the most ( 34% ) common risk factor in patients who had only dvt , whereas past history of pe , trauma , and immobilization for more than 3 days were the most common risk factors in patients who had only pe .", "our results ( major lower limb surgery as a risk factor in 3% patients ) appear to be consistent with those reported in the endorse study , which reported dvt in 4.4% patients undergoing major lower limb surgery .", "other studies from india have reported a dvt incidence rate ranging from 8% to 20% in major lower limb surgery .", "however , in our study , only 7% of patients had malignancy as a predisposing factor . among the malignancies , genitourinary cancer had the highest incidence ( 45% ) .", "hypertension ( 25% ) was the most common co - morbidity followed by diabetes mellitus ( 19% ) in this patient population .", "in addition , obesity ( 11% ) was a common risk factor in dvt complicated by pe .", "our findings support an asian ( korean ) study that demonstrated prevalence of the metabolic syndrome in 48% patients with vte .", "co - morbid neurological disease ( other than stroke ) and ventilator dependency were also commonly found in patients with dvt ( 10% ) and pe ( 11% ) respectively .", "both these conditions immobilize patients for prolonged periods of time , predisposing them to vte .", "venography and pulmonary angiography are the gold standard for diagnosis of dvt and pe respectively . in our study", ", venography was used in just 4% patients and pulmonary angiography in less than one - third of the patients .", "perhaps the relatively high cost of these tests and limited availability of such procedures may be the limiting factors .", "overall , most ( 93% ) patients were managed as inpatients ( 39% diagnosed with vte during hospital stay and 54% admitted to hospital with a diagnosis of vte ) .", "a mean duration of hospitalization of 79 days after diagnosis of vte is supported by published data . in selected low - risk patients , outpatient treatment of dvt and pe may be considered .", "this approach was observed in a small proportion ( 7% ) of patients who were managed on an outpatient basis , nearly all ( 97% ) of whom had only dvt .", "the reported prevalence of postsurgical vte in our study ( 15% ) was half of that ( 30% ) reported in vellore registry .", "this could be explained by higher referral rate from surgeons at vellore compared to that of our sites .", "most ( 40% ; 32/81 ) dvt cases were diagnosed between 2 and 6 postoperative weeks , but pe in most cases ( 70% ; 7/10 ) was diagnosed during the first postoperative week .", "we notice that acute dvt complicated by pe was less ( 6% ; 7/124 ) frequently diagnosed during the postoperative period as against 18% ( 64/352 ) and 14% ( 10/73 ) of acute dvt alone and pe alone , respectively .", "the use and duration of anticoagulants in our registry appears to be consistent with the american college of chest physicians treatment guidelines , which recommend at least 5 days of initial anticoagulation with parenteral anticoagulation ( lmwh , fondaparinux , intravenous ufh , or subcutaneous ufh ) and at least 3 months of long - term anticoagulation treatment with vitamin k antagonist .", "bleeding is the most serious complication of anticoagulation treatment and is a major concern for clinicians particularly as the patient 's age advances . in this registry ,", "anticoagulant treatment was needed to be stopped because of bleeding in only 2% of the study population .", "the prospective reite registry has reported a rate of 3% for major / fatal bleeds .", "thus , the fear of bleeding complications , which decreases the use of anticoagulant treatment , appears to be minimal .", "dvt complicated by pe ( 60% ) and pe alone ( 75% ) were more frequently shifted to intensive care unit than those who had dvt alone ( 25% ) . similar to published data in which hospital readmission rate for vte was 5% for primary and 14% for secondary diagnosis , we report a hospital readmission rate of 6% ; however we do not know the cause for readmission .", "the death rate was 7% among those diagnosed with vte during hospital stay as against a rate of 1% among those who were hospitalized with a diagnosis of vte .", "over 90% of patients treated on an outpatient basis obtained symptomatic relief with treatment . in our study , the hospital discharge rate ( 97% ) was more than triple and death rate was a quarter of that reported by pandey et al .", "( hospital discharge rate 31% and death rate 16% ) at a university hospital in delhi .", "our data show a significant increase in acute dvt ( pe ) from 2006 to 2010 .", "this can be explained by the increased awareness of vte in india as well as the advent of better diagnostic modalities , such as duplex ultrasonography becoming more readily available and accepted .", "although there was no significant change in the number of pe cases from 2006 to 2010 , the burden of pe is almost double ( 13% of all vte ) of 7% , rate reported at christian medical college , vellore during a 10-year period from 1996 to 2005 .", "our finding is consistent with a study from north india that reported a 16% incidence of pe in adult medical autopsies .", "this study has the expected limitations of any retrospective review including the availability of complete records for all patients , although a robust review of the data on medical charts was conducted .", "controlling for bias and confounders is difficult as there is no randomization and no blinding .", "follow - up data of patients after hospital discharge were not available . in cases of death ,", "further , the clinic charts reviewed in this study included a mix of those from vascular surgery and hematology departments , limiting the generalizability of the study results . despite these limitations ,", "this study provides large amount of useful information in a short span of time on patient characteristics , clinical outcomes , management strategies , and temporal trends in vte , based on  real world ", "data that reflect actual day - to - day clinical practice over a period of 5 years across three sites in india .", "we believe that this information will serve as a guide in the optimal implementation of vte prophylaxis and treatment , to improve patient outcomes and to decrease the occurrence of vte in india .", "real world data reflecting actual day - to - day clinical practice in vte over a period of 5 years across three sites in india showed that vte is not uncommon in indian patients and that acute dvt was responsible for the substantial burden of vte .", "we believe that this information will serve as a guide in the optimal implementation of vte prophylaxis and treatment , to improve patient outcomes and to decrease the occurrence of vte in india .", "liesel c. dsilva is and dr . sadhna j. joglekar was full - time employee of glaxosmithkline pharmaceuticals limited ."], "abstract_text": ["<S> background and aim : there is lack of substantial indian data on venous thromboembolism ( vte ) . </S>", "<S> the aim of this study was to provide real - world information on patient characteristics , management strategies , clinical outcomes , and temporal trends in vte.subjects and methods : multicentre retrospective registry involving 549 medical records of patients with confirmed diagnosis of vte ( deep vein thrombosis [ dvt ] confirmed by doppler ultrasonography ; pulmonary embolism [ pe ] by computed tomography , pulmonary angiography and/or v / q scan ) from 2006 to 2010 at three indian tertiary care hospitals.results:acute dvt without pe , acute dvt with pe , and pe alone were reported in 64% ( 352/549 ) , 23% ( 124/549 ) , and 13% ( 73/549 ) patients , respectively . </S>", "<S> mean age was 47 ( 16 ) years , and 70% were males . </S>", "<S> h / o dvt ( 34% ) , surgery including orthopedic surgery ( 28% ) , trauma ( 16% ) , and immobilization > 3 days ( 14% ) were the most common risk factors for vte . </S>", "<S> hypertension ( 25% ) , diabetes ( 19% ) , and neurological disease ( other than stroke ) ( 8% ) were the most common co - morbidities . </S>", "<S> most ( 94% ) were treated with heparin alone ( 82% ) or fondaparinux ( 2% ) for initial anticoagulation ; low molecular weight heparin alone ( 5% ) or warfarin / acenocoumarol ( 76% ) for long - term anticoagulation . </S>", "<S> anticoagulant treatment was stopped because of bleeding in 2% ( 9/515 ) patients . </S>", "<S> mortality was 7% among patients diagnosed with vte during hospital stay versus 1% in those hospitalized with diagnosed vte . </S>", "<S> the annual incidence of dvt ( pe ) increased from 2006 to 2010.conclusion:acute dvt alone was responsible for the substantial burden of vte in indian patients . </S>", "<S> bleeding was not the limiting factor for anticoagulant treatment in most patients . </S>"], "labels": null, "section_names": ["Introduction", "Subjects and Methods", "Results", "Demographics and characteristics of venous thromboembolism patients", "Risk factors for venous thromboembolism patients", "Co-morbidities in venous thromboembolism patients", "Clinical presentation of venous thromboembolism", "Management strategies for venous thromboembolism patients", "Diagnostic tools for venous thromboembolism", "Anticoagulant treatment in venous thromboembolism", "Annual incidence of acute deep venous thrombosis including the trend over a period of 5 years", "Discussion", "Conclusion", "None", "Financial support and sponsorship", "Conflicts of interest"], "sections": [["venous thromboembolism ( vte ) comprising of deep vein thrombosis ( dvt ) and pulmonary embolism ( pe ) can result in significant mortality , morbidity , and healthcare expenditure .", "approximately , one - third of patients with symptomatic vte manifests pe , whereas two - thirds manifest dvt alone .", "both dvt and pe can be clinically silent ( asymptomatic ) and hence not suspected .", "if undiagnosed , asymptomatic vte can lead to chronic venous disease or recurrent vte and long - term debilitating sequelae such as postthrombotic syndrome and chronic thromboembolic pulmonary hypertension .", "vte is not only disabling but also prolongs hospital stay and increases the cost of treatment .", "along with myocardial infarction and arrhythmia ( due to electrolyte imbalance ) , pe is one of the commonest causes of sudden unexplained deaths in hospitalized patients .", "it is estimated that 20 million cases of lower extremity dvt occur in the usa alone .", "the prevailing notion that the incidence of vte in asians is less than that in the western population has been disproved by recent studies .", "the incidence of postoperative dvt in indian patients undergoing major lower limb surgery is as high ( 43.2% and 60% patients in the groups with and without prophylaxis , respectively ) as seen in the western world .", "given the growing burden of vte in india and lack of substantial indian data on characteristics of vte patients , use of diagnostics tools , prophylaxis , treatment options , and clinical outcomes in vte , there was a need to systematically collect such data .", "data on patient characteristics , clinical outcomes , predictors of mortality in acute dvt , management strategies and temporal trends in vte .", "the intent was to collect and provide data that would reflect actual day - to - day clinical practice , rather than results of highly controlled clinical trials with restricted study populations and imposed experimental intervention ."], ["consecutive medical records of inpatients and outpatients between january 2006 and december 2010 , meeting eligibility criteria ( confirmed diagnosis of acute or acute - on - chronic dvt by doppler ultrasound scan and/or pe by chest computed tomography scan , pulmonary angiography or v / q scan ) were identified and collected from the general medical records and/or radiology departments at each of the three participating hospitals .", "hospital data were used to obtain the total number of patients who were annually registered at the hospital from 2006 to 2010 .", "data were processed and analyzed using sas ( version 9.1 , statistical analysis system ) . for the purpose of analysis ,  acute - on - chronic ", "descriptive statistics were used to present patient characteristics , management strategies , and clinical outcomes of patients .", "annual incidence rates ( 95% ci ) of vte per 100,000 hospital registrations over a period of 5 years were reported for each site .", "fisher 's exact test was used to determine differences in the incidence of acute dvt ( pe ) over the years 20062010 .", "armitage trend test was used to examine the direction ( positive or negative ) of the trend . as primary analyses"], ["the remaining 41% ( 393/949 ) medical records were not included because they did not satisfy the inclusion criteria .", "data from seven patients were excluded as there was no radiologically confirmed diagnosis of pe .", "a total of 64% ( 352/549 ) patients had acute dvt without pe , 23% ( 124/549 ) had acute dvt with pe , and 13% ( 73/549 ) had pe .", "eighty - seven percent ( 476/549 ) of patients had acute dvt ( pe ) , and 36% ( 197/549 ) had pe (  acute dvt ) [ figure 1 ] .", "overall distribution of venous thromboembolism patients ( n = 549 ) a total of 21% ( 115/549 ) of patients visited the hospitals directly without being referred by a physician .", "venous thromboembolism patients referred from different medical specialties ( n=434 ) the demographic characteristics of the vte patients are mentioned in table 2 .", "demographic characteristics of venous thromboembolism patients ( n=549 ) a total of 182 patients had evidence of one risk factor , 126 had evidence of two risk factors , 70 had evidence of three risk factors and 31 had four or more risk factors recorded .", "patients undergoing orthopedic surgery constituted 22% ( 33/152 ) of all surgical patients [ table 3 ] .", "risk factors for venous thromboembolism based on a review of the available records , 157 patients had a single co - morbidity , 81 had two co - morbidities , 23 had three co - morbidities , and 16 had four or more co - morbidities .", "( myocardial infarction , heart failure , chronic obstructive pulmonary disease , ventilator dependency , sepsis , or pneumonia ) [ table 4 ] .", "co - morbidities in venous thromboembolism patients of the 476 patients with dvt , 2% ( 9 ) had upper extremity dvt , 97% ( 462 ) had lower extremity dvt and the site of dvt was not known in 5 patients .", "a total of 31% ( 143/462 ) patients had dvt in the right limb , 54% ( 249/462 ) in the left limb and 9% ( 41/462 ) in both limbs ( site not known in 29 patients ) .", "of the 462 patients with lower extremity dvt , 61% had proximal dvt , 13% had distal dvt , and 7% had proximal and distal dvt .", "a total of 39% ( 215/549 ) patients were diagnosed with vte during their hospital stay , 54% ( 296/549 ) were admitted to hospital with a diagnosis of vte , and 7% ( 38/549 ) were diagnosed and continued to be managed in the outpatient department [ figure 2 ] .", "place of detection of venous thromboembolism ( n = 549 ) duration of hospitalization after diagnosis of venous thromboembolism a smaller proportion of patients ( 15% ; 81/549 ) was diagnosed with vte during the postoperative period .", "figure 3 shows the proportion of patients with vte at different time points during the postoperative period .", "of those diagnosed beyond 6 weeks , 21% ( 3/14 ) had orthopedic surgery ( hip fracture surgery ) .", "diagnosis of venous thromboembolism during the postoperative period ( n = 81 ) the most common ( 73% ) symptom was  swelling of the limb  among patients with vte [ table 6 ] .", "symptoms in venous thromboembolism patients in merely 4% of all the patients , dvt was also confirmed by venography .", "pe was confirmed by pulmonary angiography in 27% of all the patients [ table 7 ] .", ". heparin ( low molecular weight heparin [ lmwh]/unfractionated heparin [ ufh ] ) alone , a combination of heparin ( lmwh / ufh ) and oral anticoagulant ( warfarin ) , and fondaparinux sodium alone were recommended to 82% ( 420/515 ) , 13% ( 66/515 ) , and 2% ( 12/515 ) patients , respectively as initial anticoagulation .", "five percent ( 25/515 ) of patients were recommended lmwh alone , and 76% ( 393/515 ) were recommended either warfarin or acenocoumarol alone for long - term anticoagulation .", "the median duration of initial anticoagulation was 5 days while that of long - term anticoagulation was 180 days ( 6 months ) .", "anticoagulants were needed to be stopped because of bleeding in only 2% ( 9/515 ) patients .", "clinical outcomes in patients diagnosed with venous thromboembolism during hospital stay clinical outcomes in patients admitted to hospital with a diagnosis of venous thromboembolism the annual incidence of acute dvt ( pe ) increased from 2006 to 2010 at all the three sites [ figure 4 ] .", "however , a formal site - wise statistical analysis could not be performed to analyse trends in the incidence rates in acute dvt ( pe ) and pe alone as there were zero observations in some instances .", "incidence of acute deep vein thrombosis ( with or without pulmonary embolism ) over a 5 years period ( 20062010 ) at three sites"], ["demographic characteristics of venous thromboembolism patients ( n=549 ) a total of 182 patients had evidence of one risk factor , 126 had evidence of two risk factors , 70 had evidence of three risk factors and 31 had four or more risk factors recorded .", "patients undergoing orthopedic surgery constituted 22% ( 33/152 ) of all surgical patients [ table 3 ] .", "risk factors for venous thromboembolism based on a review of the available records , 157 patients had a single co - morbidity , 81 had two co - morbidities , 23 had three co - morbidities , and 16 had four or more co - morbidities .", "( myocardial infarction , heart failure , chronic obstructive pulmonary disease , ventilator dependency , sepsis , or pneumonia ) [ table 4 ] .", "2% ( 9 ) had upper extremity dvt , 97% ( 462 ) had lower extremity dvt and the site of dvt was not known in 5 patients .", "a total of 31% ( 143/462 ) patients had dvt in the right limb , 54% ( 249/462 ) in the left limb and 9% ( 41/462 ) in both limbs ( site not known in 29 patients ) . of the 462 patients with lower extremity dvt", ", 61% had proximal dvt , 13% had distal dvt , and 7% had proximal and distal dvt .", "a total of 39% ( 215/549 ) patients were diagnosed with vte during their hospital stay , 54% ( 296/549 ) were admitted to hospital with a diagnosis of vte , and 7% ( 38/549 ) were diagnosed and continued to be managed in the outpatient department [ figure 2 ] .", "place of detection of venous thromboembolism ( n = 549 ) duration of hospitalization after diagnosis of venous thromboembolism a smaller proportion of patients ( 15% ; 81/549 ) was diagnosed with vte during the postoperative period .", "figure 3 shows the proportion of patients with vte at different time points during the postoperative period . of those diagnosed beyond 6 weeks", "diagnosis of venous thromboembolism during the postoperative period ( n = 81 ) the most common ( 73% ) symptom was  swelling of the limb  among patients with vte [ table 6 ] ."], ["a total of 182 patients had evidence of one risk factor , 126 had evidence of two risk factors , 70 had evidence of three risk factors and 31 had four or more risk factors recorded .", "patients undergoing orthopedic surgery constituted 22% ( 33/152 ) of all surgical patients [ table 3 ] ."], ["based on a review of the available records , 157 patients had a single co - morbidity , 81 had two co - morbidities , 23 had three co - morbidities , and 16 had four or more co - morbidities .", "( myocardial infarction , heart failure , chronic obstructive pulmonary disease , ventilator dependency , sepsis , or pneumonia ) [ table 4 ] ."], ["of the 476 patients with dvt , 2% ( 9 ) had upper extremity dvt , 97% ( 462 ) had lower extremity dvt and the site of dvt was not known in 5 patients .", "a total of 31% ( 143/462 ) patients had dvt in the right limb , 54% ( 249/462 ) in the left limb and 9% ( 41/462 ) in both limbs ( site not known in 29 patients ) .", "of the 462 patients with lower extremity dvt , 61% had proximal dvt , 13% had distal dvt , and 7% had proximal and distal dvt .", "a total of 39% ( 215/549 ) patients were diagnosed with vte during their hospital stay , 54% ( 296/549 ) were admitted to hospital with a diagnosis of vte , and 7% ( 38/549 ) were diagnosed and continued to be managed in the outpatient department [ figure 2 ] .", "place of detection of venous thromboembolism ( n = 549 ) duration of hospitalization after diagnosis of venous thromboembolism a smaller proportion of patients ( 15% ; 81/549 ) was diagnosed with vte during the postoperative period .", "figure 3 shows the proportion of patients with vte at different time points during the postoperative period . of those diagnosed beyond 6 weeks", "diagnosis of venous thromboembolism during the postoperative period ( n = 81 ) the most common ( 73% ) symptom was  swelling of the limb  among patients with vte [ table 6 ]"], ["pe was confirmed by pulmonary angiography in 27% of all the patients [ table 7 ] .", "heparin ( low molecular weight heparin [ lmwh]/unfractionated heparin [ ufh ] ) alone , a combination of heparin ( lmwh / ufh ) and oral anticoagulant ( warfarin ) , and fondaparinux sodium alone were recommended to 82% ( 420/515 ) , 13% ( 66/515 ) , and 2% ( 12/515 ) patients , respectively as initial anticoagulation .", "five percent ( 25/515 ) of patients were recommended lmwh alone , and 76% ( 393/515 ) were recommended either warfarin or acenocoumarol alone for long - term anticoagulation .", "the median duration of initial anticoagulation was 5 days while that of long - term anticoagulation was 180 days ( 6 months ) .", "anticoagulants were needed to be stopped because of bleeding in only 2% ( 9/515 ) patients .", "clinical outcomes in patients diagnosed with venous thromboembolism during hospital stay clinical outcomes in patients admitted to hospital with a diagnosis of venous thromboembolism the annual incidence of acute dvt ( pe ) increased from 2006 to 2010 at all the three sites [ figure 4 ] .", "however , a formal site - wise statistical analysis could not be performed to analyse trends in the incidence rates in acute dvt ( pe ) and pe alone as there were zero observations in some instances .", "incidence of acute deep vein thrombosis ( with or without pulmonary embolism ) over a 5 years period ( 20062010 ) at three sites"], ["pe was confirmed by pulmonary angiography in 27% of all the patients [ table 7 ] ."], ["heparin ( low molecular weight heparin [ lmwh]/unfractionated heparin [ ufh ] ) alone , a combination of heparin ( lmwh / ufh ) and oral anticoagulant ( warfarin ) , and fondaparinux sodium alone were recommended to 82% ( 420/515 ) , 13% ( 66/515 ) , and 2% ( 12/515 ) patients , respectively as initial anticoagulation .", "five percent ( 25/515 ) of patients were recommended lmwh alone , and 76% ( 393/515 ) were recommended either warfarin or acenocoumarol alone for long - term anticoagulation .", "the median duration of initial anticoagulation was 5 days while that of long - term anticoagulation was 180 days ( 6 months ) .", "anticoagulants were needed to be stopped because of bleeding in only 2% ( 9/515 ) patients .", "clinical outcomes in patients diagnosed with venous thromboembolism during hospital stay clinical outcomes in patients admitted to hospital with a diagnosis of venous thromboembolism"], ["the annual incidence of acute dvt ( pe ) increased from 2006 to 2010 at all the three sites [ figure 4 ] .", "however , a formal site - wise statistical analysis could not be performed to analyse trends in the incidence rates in acute dvt ( pe ) and pe alone as there were zero observations in some instances .", "incidence of acute deep vein thrombosis ( with or without pulmonary embolism ) over a 5 years period ( 20062010 ) at three sites"], ["to our knowledge , this is the first multicenter , retrospective registry in india involving patients with vte that reflect real - world clinical practice . in contrast with the western data in which vte is predominantly a disease of older age , 44% patients in our study were between 40 and 59 years of age while 34% were below 40 years , particularly those with pe . in a study from north india ,", "men constituted 70% of our registry , more than those reported from vellore registry ( 48% ) , but similar to those reported in the endorse ( epidemiologic international day for the evaluation of patients at risk for vte in the acute hospital care setting ) study ( 69% ) .", "one of the reasons for this could be significantly high levels of homocysteine ( thrombophilia marker ) in males as compared to females as reported in an indian study .", "fewer indian women use oral contraceptives and postmenopausal hormone replacement therapy , which are known to be risk factors for thrombosis .", "this is supported by the fact that only 1% of women in this registry reported the use of oral contraceptives , and none reported use of hormonal replacement therapy .", "a total of 28% of the overall referrals were from cardiologists . the majority ( 82% ) of the referrals were from medical rather than surgical ( 15% ) specialties as against a referral rate of 93% from surgeons at vellore .", "our finding complements that from the endorse study in which 55% of the medical patients at risk of vte had cardiovascular disease . majority ( 53% ) of patients in our study had co - morbid cardiovascular disease including diabetes mellitus ; it is possible that these patients visited a cardiologist for their cardiovascular ailment ( s ) and were then referred by the cardiologist to vascular disease specialist ( investigator ) .", "most ( 89% ) of these patients had swelling of the ( lower ) limb .", "it is possible that these patients may not have felt the need to visit a specialist for a symptom like  swelling of limb ,  instead visited their family physician .", "it is very encouraging to know that family physicians suspected dvt in these situations and referred the patient to a specialist .", "patients with a history of vte are about 8 times more likely to develop a new episode during a subsequent high - risk period compared with patients without a history of dvt or pe .", "prior history of dvt was the most ( 34% ) common risk factor in patients who had only dvt , whereas past history of pe , trauma , and immobilization for more than 3 days were the most common risk factors in patients who had only pe .", "our results ( major lower limb surgery as a risk factor in 3% patients ) appear to be consistent with those reported in the endorse study , which reported dvt in 4.4% patients undergoing major lower limb surgery .", "other studies from india have reported a dvt incidence rate ranging from 8% to 20% in major lower limb surgery .", "however , in our study , only 7% of patients had malignancy as a predisposing factor . among the malignancies , genitourinary cancer had the highest incidence ( 45% ) .", "hypertension ( 25% ) was the most common co - morbidity followed by diabetes mellitus ( 19% ) in this patient population .", "in addition , obesity ( 11% ) was a common risk factor in dvt complicated by pe .", "our findings support an asian ( korean ) study that demonstrated prevalence of the metabolic syndrome in 48% patients with vte .", "co - morbid neurological disease ( other than stroke ) and ventilator dependency were also commonly found in patients with dvt ( 10% ) and pe ( 11% ) respectively .", "both these conditions immobilize patients for prolonged periods of time , predisposing them to vte .", "venography and pulmonary angiography are the gold standard for diagnosis of dvt and pe respectively . in our study", ", venography was used in just 4% patients and pulmonary angiography in less than one - third of the patients .", "perhaps the relatively high cost of these tests and limited availability of such procedures may be the limiting factors .", "overall , most ( 93% ) patients were managed as inpatients ( 39% diagnosed with vte during hospital stay and 54% admitted to hospital with a diagnosis of vte ) .", "a mean duration of hospitalization of 79 days after diagnosis of vte is supported by published data . in selected low - risk patients , outpatient treatment of dvt and pe may be considered .", "this approach was observed in a small proportion ( 7% ) of patients who were managed on an outpatient basis , nearly all ( 97% ) of whom had only dvt .", "the reported prevalence of postsurgical vte in our study ( 15% ) was half of that ( 30% ) reported in vellore registry .", "this could be explained by higher referral rate from surgeons at vellore compared to that of our sites .", "most ( 40% ; 32/81 ) dvt cases were diagnosed between 2 and 6 postoperative weeks , but pe in most cases ( 70% ; 7/10 ) was diagnosed during the first postoperative week .", "we notice that acute dvt complicated by pe was less ( 6% ; 7/124 ) frequently diagnosed during the postoperative period as against 18% ( 64/352 ) and 14% ( 10/73 ) of acute dvt alone and pe alone , respectively .", "the use and duration of anticoagulants in our registry appears to be consistent with the american college of chest physicians treatment guidelines , which recommend at least 5 days of initial anticoagulation with parenteral anticoagulation ( lmwh , fondaparinux , intravenous ufh , or subcutaneous ufh ) and at least 3 months of long - term anticoagulation treatment with vitamin k antagonist .", "bleeding is the most serious complication of anticoagulation treatment and is a major concern for clinicians particularly as the patient 's age advances . in this registry ,", "anticoagulant treatment was needed to be stopped because of bleeding in only 2% of the study population .", "the prospective reite registry has reported a rate of 3% for major / fatal bleeds .", "thus , the fear of bleeding complications , which decreases the use of anticoagulant treatment , appears to be minimal .", "dvt complicated by pe ( 60% ) and pe alone ( 75% ) were more frequently shifted to intensive care unit than those who had dvt alone ( 25% ) . similar to published data in which hospital readmission rate for vte was 5% for primary and 14% for secondary diagnosis , we report a hospital readmission rate of 6% ; however we do not know the cause for readmission .", "the death rate was 7% among those diagnosed with vte during hospital stay as against a rate of 1% among those who were hospitalized with a diagnosis of vte .", "over 90% of patients treated on an outpatient basis obtained symptomatic relief with treatment . in our study , the hospital discharge rate ( 97% ) was more than triple and death rate was a quarter of that reported by pandey et al .", "( hospital discharge rate 31% and death rate 16% ) at a university hospital in delhi .", "our data show a significant increase in acute dvt ( pe ) from 2006 to 2010 .", "this can be explained by the increased awareness of vte in india as well as the advent of better diagnostic modalities , such as duplex ultrasonography becoming more readily available and accepted .", "although there was no significant change in the number of pe cases from 2006 to 2010 , the burden of pe is almost double ( 13% of all vte ) of 7% , rate reported at christian medical college , vellore during a 10-year period from 1996 to 2005 .", "our finding is consistent with a study from north india that reported a 16% incidence of pe in adult medical autopsies .", "this study has the expected limitations of any retrospective review including the availability of complete records for all patients , although a robust review of the data on medical charts was conducted .", "controlling for bias and confounders is difficult as there is no randomization and no blinding .", "follow - up data of patients after hospital discharge were not available . in cases of death ,", "further , the clinic charts reviewed in this study included a mix of those from vascular surgery and hematology departments , limiting the generalizability of the study results . despite these limitations ,", "this study provides large amount of useful information in a short span of time on patient characteristics , clinical outcomes , management strategies , and temporal trends in vte , based on  real world ", "data that reflect actual day - to - day clinical practice over a period of 5 years across three sites in india .", "we believe that this information will serve as a guide in the optimal implementation of vte prophylaxis and treatment , to improve patient outcomes and to decrease the occurrence of vte in india ."], ["real world data reflecting actual day - to - day clinical practice in vte over a period of 5 years across three sites in india showed that vte is not uncommon in indian patients and that acute dvt was responsible for the substantial burden of vte .", "we believe that this information will serve as a guide in the optimal implementation of vte prophylaxis and treatment , to improve patient outcomes and to decrease the occurrence of vte in india .", "liesel c. dsilva is and dr . sadhna j. joglekar was full - time employee of glaxosmithkline pharmaceuticals limited ."], [""], [""], [""]]}
{"article_id": "PMC4852153", "article_text": ["there is an epidemic of stroke in low and middle - income countries due to rapidly increasing prevalence of vascular risk factors such as hypertension , diabetes mellitus , dyslipidaemia .", "the need has thus arisen to conduct studies aimed at epidemiologic , genetic and phenotypic characterisation of stroke in sub - saharan africa to provide evidence - based information to confront this menace . to this end", ", it is important that controls selected for comparison with cases are recruited with a high degree of certainty that they indeed do not have stroke or tia to allow for valid comparisons to be made . in view of this simple , quick and accurate assessment of symptoms of stroke", "is needed for epidemiologic studies particularly those of the case  control type . in 2000 , meschia et al . developed the questionnaire for verifying stroke - free status ( qvsfs ) as a method for verifying the stroke - free phenotype in participants of clinical , epidemiological and genetic studies .", "having one or more affirmative answers to any of the questionnaire was associated with finding stroke , tia , or either stroke or tia on medical record review .", "jones et al . showed by directly interviewing participants and review of medical records that the qvsfs had a nppv and ppv of 0.96 and 0.71 respectively making the 8-item qvsfs a sensitive and valid tool , and a structured telephone interview format of questionnaire administration still had an excellent sensitivity of 1.0 , specificity of 0.86 , positive predictive value of 0.36 and negative predictive value of 1.0 among participants aged 60 years and above .", "the qvsfs is also reliable with intra - rater and inter - rater agreement of stroke - free status classification of 0.90 and 0.94 respectively .", "the qvsfs is easy to administer as a self - report pencil - and - paper questionnaire or by an interview in person or by telephone and has been translated into spanish by castillo et al . for use among hispanic populations .", "two questions in the instrument assess previous diagnosis of either stroke / tia together with six questions about stroke symptoms .", "thus not only is the 8-item qvsfs a useful tool in identifying stroke - free individuals but it could be used to screen for undiagnosed stroke .", "the sensitivity and specificity of having any of the six symptom questions for stroke detection was 0.82 and 0.62 respectively .", "indeed the qvsfs has been successfully used in the recruitment of controls involved genetic studies into ischaemic stroke , to screen for cerebrovascular end points in the carotid revascularisation endarterectomy versus stent trial ( crest )   and in the reasons for geographic and racial differences in stroke ( regards ) study .", "this instrument could have tremendous potential in developing countries where stroke prevalence is increasing , awareness of stroke symptoms low and the confirmation of stroke diagnosis either missed by health workers or constrained by the pervasive lack of neuro - imaging modalities . in these low literacy settings", "the lack of knowledge of stroke symptoms might impact negatively on the performance of stroke symptom questionnaires .", "furthermore there is a lack of specific medical terminology for symptoms of stroke in local dialects across sub - saharan africa .", "the performance of the questionnaire could be enhanced further by the introduction of culturally acceptable pictures of stroke symptoms .", "one of the key comments regarding the 8-item qvsfs questionnaire is that the benchmark for verification of strokes has relied on review of medical records of patients but this approach may be problematic in settings where medical records are kept under less than optimal circumstances and where patients may not always seek health services for ailments from medical facilities but from herbalists , chemical shops and so forth .", "an approach to overcome this limitation would be to examine participants by neurologists or to use a cranial ct scan for verification in a subset of participants .", "this study seeks to validate the 8-item qvsfs at 5 centers in nigeria and ghana which are involved in the on - going nih supported stroke investigative research and educational networks ( siren ) study .", "participants will be recruited from five tertiary referral medical centers in west africa namely the komfo anokye teaching hospital ( kath ) in kumasi , ghana ; the university college hospital ( uch ) , ibadan , nigeria ; federal medical centre ( fmc ) , abeokuta , nigeria ; ahmadu bello university hospital ( abuh ) , zaria , nigeria and aminu kano teaching hospital ( akth ) , kano , nigeria ( fig .", "kumasi where kath is situated is the principal city of the akan tribe in central ghana and serves a population of 4 million .", "uch and fmc situated in ibadan and abeokuta respectively are located in southern nigeria and serve a combined population of 4 million nigerians of predominantly yoruba ethnicity .", "abuh and akth in zaria and kano provide health care services to 15 million nigerians of mainly hausa and fulani descent .", "ethical approval for the study will be sought from the ethics committees of the 5 participating sites . the original questionnaire developed by meschia et al .  ", "will be translated into the local languages ( yoruba  southern nigeria , hausa  northern nigeria , akan  middle & lower belts of ghana ) , pre - tested and back - translated into english language to establish semantic equivalence . at each of the study sites ,", "a panel comprising of a neurologist , three to five doctors and nurses , and public health practitioners will translate the questionnaire into the local dialect by consensus .", "the translated versions of the questionnaires in 3 languages are shown in supplementary information section ( s1 ) .", "another version of the questionnaire will be developed where question items 3 to 8 will have line pictures of the neurological symptoms being elicited by the interviewer ( fig .", "participants attending general medicine and neurology out - patient clinic appointments will be approached and enrolled into the study after obtaining informed consent .", "baseline demographic details will be obtained and the questionnaire administered by a medicine resident in the local dialect and the answers recorded as  yes  ,  no  , or  do n't know  to each question item .", "the version of the questionnaire without pictures will be administered first followed by the version with pictograms by the same interviewer .", "furthermore , participant awareness of known vascular risk factors such as hypertension , diabetes mellitus , dyslipidaemia , cigarette smoking , excessive alcohol intake , physical inactivity , known heart disorders , family history of stroke will be assessed using 8 questions assessing knowledge of the presence of these specific risk factors . after the interview participants will undergo a 3-staged evaluation by a neurologist .", "the first stage will involve a review of the medical records of patients to determine if a previous diagnosis of stroke has ever been made , the duration of stroke diagnosis , whether neuro - imaging information on stroke type is available .", "the second stage entails an examination for presence of hemiparesis , hemi - anesthesia , mono - ocular / binocular visual loss , hemianopsia , receptive or expressive aphasia , and cerebellar deficits .", "the third stage will comprise of an evaluation of a cranial ct scan in a subset of participants .", "this neuro - imaging validation will be performed within 48 h among a subset of subjects ( at least 4 stroke and 4 stroke - free ) per site", "after this thorough evaluation the neurologist makes a diagnosis which is our gold standard . assuming that the standard test has an accuracy of 75% as measured by the area under the roc curve ( auc ) , a sample of 35 cases and 35 controls achieve 82% power to detect an extra accuracy by the proposed test of 15% ( auc = 90% in the proposed test ) using a two - sided test at a significance level of 0.05 . the sample size required increases to 80 per group in order to detect a difference of 10% ( auc = 85% in the proposed test ) under the same conditions .", "thus , the sample size of 100 per linguistic category ( akan , yoruba , hausa ) will be sufficient detect an effect size as small as 10% allowing up to 10% false positive rates and control to case ratio of the standard deviation of the responses to be 0.5 as suggested by obuchowski and mcclish .", "given that the 8 items qvsfs is going to be translated into three ( yoruba , hausa , chi ) different languages , we will evaluate the reliability of the translation before it is implemented to predict stroke status using a sample size of 50 consistency and validity of the translation for each language using exploratory factor analysis and cronbach 's alpha .", "patients who score 0/8 will be deemed as stroke free whereas those with any positive score will be deemed as not stroke free according to the 8-item qvsfs .", "sensitivity analysis will be performed where  do n't know  will be assumed to be = 1 .", "baseline demographic characteristics between patients who are symptom free for stroke and those with stroke will be compared using either chi - squared test ( categorical variables ) or student 's t - test or mann  whitney 's u - test for means / medians respectively ( continuous variables ) .", "the sensitivity , specificity , positive predictive value , negative predictive value , positive and negative likelihood ratios as well as the accuracy and reliability of the 8-item qvsfs will be assessed in comparison with the benchmark stroke determination by history and examination by a neurologist .", "furthermore , the performance of the questionnaire will be compared with neuro - imaging results in a small randomly selected subset .", "the sensitivity and specificity of the 6 stroke symptom questions will be determined for stroke diagnosis among patients with stroke .", "the performance of the questionnaire will also be compared with the modified version of the questionnaire with images illustrating the neurological deficits being elicited by items 3 to 6 .", "we will use factor analysis approach to assess and confirm the structure relationship between each item and the qvsfs score overall .", "kappa statistics will be employed to compare inter - rater and intra - rater performance of the tool administered by medicine residents , at each site and also between study sites .", "participants will be recruited from five tertiary referral medical centers in west africa namely the komfo anokye teaching hospital ( kath ) in kumasi , ghana ; the university college hospital ( uch ) , ibadan , nigeria ; federal medical centre ( fmc ) , abeokuta , nigeria ; ahmadu bello university hospital ( abuh ) , zaria , nigeria and aminu kano teaching hospital ( akth ) , kano , nigeria ( fig .", "kumasi where kath is situated is the principal city of the akan tribe in central ghana and serves a population of 4 million .", "uch and fmc situated in ibadan and abeokuta respectively are located in southern nigeria and serve a combined population of 4 million nigerians of predominantly yoruba ethnicity .", "abuh and akth in zaria and kano provide health care services to 15 million nigerians of mainly hausa and fulani descent .", "ethical approval for the study will be sought from the ethics committees of the 5 participating sites .", "the original questionnaire developed by meschia et al .   will be translated into the local languages ( yoruba  southern nigeria , hausa  northern nigeria , akan  middle & lower belts of ghana ) , pre - tested and back - translated into english language to establish semantic equivalence . at each of the study sites , a panel comprising of a neurologist , three to five doctors and nurses , and public health practitioners will translate the questionnaire into the local dialect by consensus .", "the translated versions of the questionnaires in 3 languages are shown in supplementary information section ( s1 ) .", "another version of the questionnaire will be developed where question items 3 to 8 will have line pictures of the neurological symptoms being elicited by the interviewer ( fig .", "participants attending general medicine and neurology out - patient clinic appointments will be approached and enrolled into the study after obtaining informed consent . baseline demographic details will be obtained and the questionnaire administered by a medicine resident in the local dialect and the answers recorded as  yes  ,  no  , or  do n't know  to each question item .", "the version of the questionnaire without pictures will be administered first followed by the version with pictograms by the same interviewer .", "furthermore , participant awareness of known vascular risk factors such as hypertension , diabetes mellitus , dyslipidaemia , cigarette smoking , excessive alcohol intake , physical inactivity , known heart disorders , family history of stroke will be assessed using 8 questions assessing knowledge of the presence of these specific risk factors .", "the first stage will involve a review of the medical records of patients to determine if a previous diagnosis of stroke has ever been made , the duration of stroke diagnosis , whether neuro - imaging information on stroke type is available .", "the second stage entails an examination for presence of hemiparesis , hemi - anesthesia , mono - ocular / binocular visual loss , hemianopsia , receptive or expressive aphasia , and cerebellar deficits .", "the third stage will comprise of an evaluation of a cranial ct scan in a subset of participants .", "this neuro - imaging validation will be performed within 48 h among a subset of subjects ( at least 4 stroke and 4 stroke - free ) per site .", "assuming that the standard test has an accuracy of 75% as measured by the area under the roc curve ( auc ) , a sample of 35 cases and 35 controls achieve 82% power to detect an extra accuracy by the proposed test of 15% ( auc = 90% in the proposed test ) using a two - sided test at a significance level of 0.05 .", "the sample size required increases to 80 per group in order to detect a difference of 10% ( auc = 85% in the proposed test ) under the same conditions .", "thus , the sample size of 100 per linguistic category ( akan , yoruba , hausa ) will be sufficient detect an effect size as small as 10% allowing up to 10% false positive rates and control to case ratio of the standard deviation of the responses to be 0.5 as suggested by obuchowski and mcclish .", "given that the 8 items qvsfs is going to be translated into three ( yoruba , hausa , chi ) different languages , we will evaluate the reliability of the translation before it is implemented to predict stroke status using a sample size of 50 consistency and validity of the translation for each language using exploratory factor analysis and cronbach 's alpha .", "yes = 1 , no = 0 , do n't know = 0 . patients who score 0/8 will be deemed as stroke free whereas those with any positive score will be deemed as not stroke free according to the 8-item qvsfs .", "sensitivity analysis will be performed where  do n't know  will be assumed to be = 1 .", "baseline demographic characteristics between patients who are symptom free for stroke and those with stroke will be compared using either chi - squared test ( categorical variables ) or student 's t - test or mann  whitney 's u - test for means / medians respectively ( continuous variables ) .", "the sensitivity , specificity , positive predictive value , negative predictive value , positive and negative likelihood ratios as well as the accuracy and reliability of the 8-item qvsfs will be assessed in comparison with the benchmark stroke determination by history and examination by a neurologist .", "furthermore , the performance of the questionnaire will be compared with neuro - imaging results in a small randomly selected subset .", "the sensitivity and specificity of the 6 stroke symptom questions will be determined for stroke diagnosis among patients with stroke .", "the performance of the questionnaire will also be compared with the modified version of the questionnaire with images illustrating the neurological deficits being elicited by items 3 to 6 .", "we will use factor analysis approach to assess and confirm the structure relationship between each item and the qvsfs score overall .", "kappa statistics will be employed to compare inter - rater and intra - rater performance of the tool administered by medicine residents , at each site and also between study sites .", "yes = 1 , no = 0 , do n't know = 0 . patients who score 0/8 will be deemed as stroke free whereas those with any positive score will be deemed as not stroke free according to the 8-item qvsfs .", "sensitivity analysis will be performed where  do n't know  will be assumed to be = 1 .", "baseline demographic characteristics between patients who are symptom free for stroke and those with stroke will be compared using either chi - squared test ( categorical variables ) or student 's t - test or mann  whitney 's u - test for means / medians respectively ( continuous variables ) . the sensitivity , specificity , positive predictive value , negative predictive value , positive and negative likelihood ratios as well as the accuracy and reliability of the 8-item qvsfs will be assessed in comparison with the benchmark stroke determination by history and examination by a neurologist .", "furthermore , the performance of the questionnaire will be compared with neuro - imaging results in a small randomly selected subset .", "the sensitivity and specificity of the 6 stroke symptom questions will be determined for stroke diagnosis among patients with stroke .", "the performance of the questionnaire will also be compared with the modified version of the questionnaire with images illustrating the neurological deficits being elicited by items 3 to 6 .", "we will use factor analysis approach to assess and confirm the structure relationship between each item and the qvsfs score overall .", "kappa statistics will be employed to compare inter - rater and intra - rater performance of the tool administered by medicine residents , at each site and also between study sites .", "the questionnaire for verifying stroke - free status ( qvsfs ) , developed and validated primarily in english - speaking western world populations , is a method for verifying stroke - free status in participants of clinical , epidemiological and genetic studies .", "however , the performance of this tool in settings where levels of education and awareness of stroke symptoms are low such as sub - saharan africa has not been conducted .", "the tool has tremendous potential for widespread use in regions such as ours where stroke incidence , prevalence and mortality are escalating and questions on the epidemiology and genetic underpinnings of the stroke epidemic remain unresolved .", "we propose to validate qvsfs for ascertainment of stroke - free status of control subjects enrolled in an ongoing stroke epidemiological study in west africa funded by the national institute of health for h3africa .", "the novel aspects of our validation study are : firstly , to carry out this validation study simultaneously at five tertiary hospitals across nigeria and ghana involving participants speaking three different languages ( yoruba , hausa and akan ) .", "the qvsfs will be translated into these languages and administered to participants enrolled from neurology and general clinics in these hospitals .", "secondly , given the low levels of education , the lack of awareness of stroke symptoms , and general paucity of semantically equivalent medical terminology in the local dialects for stroke symptoms in our settings , we will evaluate the performance of the tool with and without pictograms .", "finally , ascertainment of stroke status will be conducted by neurologists across the 5 sites using a combination of structured medical history , neurological examination , review of medical records and neuro - imaging ( gold standard ) compared with previously published studies which relied on medical records review and neurological examination .", "the 8-item qvsfs is a simple , accurate and cheap tool which could have widespread use for ascertaining stroke status in clinical , epidemiological and genetic studies in settings where facilities for stroke confirmation are lacking ."], "abstract_text": ["<S> backgroundthe questionnaire for verifying stroke - free status ( qvsfs ) has been validated in western populations as a method for verifying stroke - free status in participants of clinical , epidemiological and genetic studies . </S>", "<S> this instrument has not been validated in low - income settings where populations have limited knowledge of stroke symptoms and literacy levels are low.objectiveto simultaneously validate the 8-item qvsfs in 3 languages spoken in west africa ( yoruba , hausa and akan ) for ascertainment of stroke - free status of control subjects in siren.methodsusing a cross - sectional study design , 100 participants each from the 3 linguistic groups will be consecutively recruited from neurology and general medicine clinics of 5 tertiary referral hospitals in nigeria and ghana . </S>", "<S> ascertainment of stroke status will be determined by neurologists using structured neurological examination , review of case records and neuro - imaging ( gold standard ) . </S>", "<S> the relative performance of qvsfs without and with pictures of stroke symptoms ( pictograms ) will be assessed using sensitivity , specificity , positive predictive value ( ppv ) and negative predictive value ( npv).conclusionthe proposed study will provide valuable data on the performance of the qvsfs in resource - limited settings . </S>"], "labels": null, "section_names": ["1. Introduction", "2. Methods", "2.1. Study sites", "2.2. Translation of QVSFS into 3 languages", "2.2.1. Inclusion criteria", "2.2.2. Exclusion criteria", "2.3. Procedure for administration of questionnaires", "2.4. Evaluation of participants by neurologist", "2.5. ROC curve power analysis for sample size calculation", "2.6. Proposed analysis", "2.6.1. Interpretation of results", "2.6.2. Statistical analysis", "3. Discussion", "4. Conclusion", "Supplementary Material"], "sections": [["there is an epidemic of stroke in low and middle - income countries due to rapidly increasing prevalence of vascular risk factors such as hypertension , diabetes mellitus , dyslipidaemia .", "the need has thus arisen to conduct studies aimed at epidemiologic , genetic and phenotypic characterisation of stroke in sub - saharan africa to provide evidence - based information to confront this menace . to this end", ", it is important that controls selected for comparison with cases are recruited with a high degree of certainty that they indeed do not have stroke or tia to allow for valid comparisons to be made . in view of this simple , quick and accurate assessment of symptoms of stroke", "is needed for epidemiologic studies particularly those of the case  control type . in 2000 , meschia et al . developed the questionnaire for verifying stroke - free status ( qvsfs ) as a method for verifying the stroke - free phenotype in participants of clinical , epidemiological and genetic studies .", "having one or more affirmative answers to any of the questionnaire was associated with finding stroke , tia , or either stroke or tia on medical record review .", "jones et al . showed by directly interviewing participants and review of medical records that the qvsfs had a nppv and ppv of 0.96 and 0.71 respectively making the 8-item qvsfs a sensitive and valid tool , and a structured telephone interview format of questionnaire administration still had an excellent sensitivity of 1.0 , specificity of 0.86 , positive predictive value of 0.36 and negative predictive value of 1.0 among participants aged 60 years and above .", "the qvsfs is also reliable with intra - rater and inter - rater agreement of stroke - free status classification of 0.90 and 0.94 respectively .", "the qvsfs is easy to administer as a self - report pencil - and - paper questionnaire or by an interview in person or by telephone and has been translated into spanish by castillo et al . for use among hispanic populations .", "two questions in the instrument assess previous diagnosis of either stroke / tia together with six questions about stroke symptoms .", "thus not only is the 8-item qvsfs a useful tool in identifying stroke - free individuals but it could be used to screen for undiagnosed stroke .", "the sensitivity and specificity of having any of the six symptom questions for stroke detection was 0.82 and 0.62 respectively .", "indeed the qvsfs has been successfully used in the recruitment of controls involved genetic studies into ischaemic stroke , to screen for cerebrovascular end points in the carotid revascularisation endarterectomy versus stent trial ( crest )   and in the reasons for geographic and racial differences in stroke ( regards ) study .", "this instrument could have tremendous potential in developing countries where stroke prevalence is increasing , awareness of stroke symptoms low and the confirmation of stroke diagnosis either missed by health workers or constrained by the pervasive lack of neuro - imaging modalities . in these low literacy settings", "the lack of knowledge of stroke symptoms might impact negatively on the performance of stroke symptom questionnaires .", "furthermore there is a lack of specific medical terminology for symptoms of stroke in local dialects across sub - saharan africa .", "the performance of the questionnaire could be enhanced further by the introduction of culturally acceptable pictures of stroke symptoms .", "one of the key comments regarding the 8-item qvsfs questionnaire is that the benchmark for verification of strokes has relied on review of medical records of patients but this approach may be problematic in settings where medical records are kept under less than optimal circumstances and where patients may not always seek health services for ailments from medical facilities but from herbalists , chemical shops and so forth .", "an approach to overcome this limitation would be to examine participants by neurologists or to use a cranial ct scan for verification in a subset of participants .", "this study seeks to validate the 8-item qvsfs at 5 centers in nigeria and ghana which are involved in the on - going nih supported stroke investigative research and educational networks ( siren ) study ."], ["participants will be recruited from five tertiary referral medical centers in west africa namely the komfo anokye teaching hospital ( kath ) in kumasi , ghana ; the university college hospital ( uch ) , ibadan , nigeria ; federal medical centre ( fmc ) , abeokuta , nigeria ; ahmadu bello university hospital ( abuh ) , zaria , nigeria and aminu kano teaching hospital ( akth ) , kano , nigeria ( fig .", "kumasi where kath is situated is the principal city of the akan tribe in central ghana and serves a population of 4 million .", "uch and fmc situated in ibadan and abeokuta respectively are located in southern nigeria and serve a combined population of 4 million nigerians of predominantly yoruba ethnicity .", "abuh and akth in zaria and kano provide health care services to 15 million nigerians of mainly hausa and fulani descent .", "ethical approval for the study will be sought from the ethics committees of the 5 participating sites . the original questionnaire developed by meschia et al .  ", "will be translated into the local languages ( yoruba  southern nigeria , hausa  northern nigeria , akan  middle & lower belts of ghana ) , pre - tested and back - translated into english language to establish semantic equivalence . at each of the study sites ,", "a panel comprising of a neurologist , three to five doctors and nurses , and public health practitioners will translate the questionnaire into the local dialect by consensus .", "the translated versions of the questionnaires in 3 languages are shown in supplementary information section ( s1 ) .", "another version of the questionnaire will be developed where question items 3 to 8 will have line pictures of the neurological symptoms being elicited by the interviewer ( fig .", "participants attending general medicine and neurology out - patient clinic appointments will be approached and enrolled into the study after obtaining informed consent .", "baseline demographic details will be obtained and the questionnaire administered by a medicine resident in the local dialect and the answers recorded as  yes  ,  no  , or  do n't know  to each question item .", "the version of the questionnaire without pictures will be administered first followed by the version with pictograms by the same interviewer .", "furthermore , participant awareness of known vascular risk factors such as hypertension , diabetes mellitus , dyslipidaemia , cigarette smoking , excessive alcohol intake , physical inactivity , known heart disorders , family history of stroke will be assessed using 8 questions assessing knowledge of the presence of these specific risk factors . after the interview participants will undergo a 3-staged evaluation by a neurologist .", "the first stage will involve a review of the medical records of patients to determine if a previous diagnosis of stroke has ever been made , the duration of stroke diagnosis , whether neuro - imaging information on stroke type is available .", "the second stage entails an examination for presence of hemiparesis , hemi - anesthesia , mono - ocular / binocular visual loss , hemianopsia , receptive or expressive aphasia , and cerebellar deficits .", "the third stage will comprise of an evaluation of a cranial ct scan in a subset of participants .", "this neuro - imaging validation will be performed within 48 h among a subset of subjects ( at least 4 stroke and 4 stroke - free ) per site", "after this thorough evaluation the neurologist makes a diagnosis which is our gold standard . assuming that the standard test has an accuracy of 75% as measured by the area under the roc curve ( auc ) , a sample of 35 cases and 35 controls achieve 82% power to detect an extra accuracy by the proposed test of 15% ( auc = 90% in the proposed test ) using a two - sided test at a significance level of 0.05 . the sample size required increases to 80 per group in order to detect a difference of 10% ( auc = 85% in the proposed test ) under the same conditions .", "thus , the sample size of 100 per linguistic category ( akan , yoruba , hausa ) will be sufficient detect an effect size as small as 10% allowing up to 10% false positive rates and control to case ratio of the standard deviation of the responses to be 0.5 as suggested by obuchowski and mcclish .", "given that the 8 items qvsfs is going to be translated into three ( yoruba , hausa , chi ) different languages , we will evaluate the reliability of the translation before it is implemented to predict stroke status using a sample size of 50 consistency and validity of the translation for each language using exploratory factor analysis and cronbach 's alpha .", "patients who score 0/8 will be deemed as stroke free whereas those with any positive score will be deemed as not stroke free according to the 8-item qvsfs .", "sensitivity analysis will be performed where  do n't know  will be assumed to be = 1 .", "baseline demographic characteristics between patients who are symptom free for stroke and those with stroke will be compared using either chi - squared test ( categorical variables ) or student 's t - test or mann  whitney 's u - test for means / medians respectively ( continuous variables ) .", "the sensitivity , specificity , positive predictive value , negative predictive value , positive and negative likelihood ratios as well as the accuracy and reliability of the 8-item qvsfs will be assessed in comparison with the benchmark stroke determination by history and examination by a neurologist .", "furthermore , the performance of the questionnaire will be compared with neuro - imaging results in a small randomly selected subset .", "the sensitivity and specificity of the 6 stroke symptom questions will be determined for stroke diagnosis among patients with stroke .", "the performance of the questionnaire will also be compared with the modified version of the questionnaire with images illustrating the neurological deficits being elicited by items 3 to 6 .", "we will use factor analysis approach to assess and confirm the structure relationship between each item and the qvsfs score overall .", "kappa statistics will be employed to compare inter - rater and intra - rater performance of the tool administered by medicine residents , at each site and also between study sites ."], ["participants will be recruited from five tertiary referral medical centers in west africa namely the komfo anokye teaching hospital ( kath ) in kumasi , ghana ; the university college hospital ( uch ) , ibadan , nigeria ; federal medical centre ( fmc ) , abeokuta , nigeria ; ahmadu bello university hospital ( abuh ) , zaria , nigeria and aminu kano teaching hospital ( akth ) , kano , nigeria ( fig .", "kumasi where kath is situated is the principal city of the akan tribe in central ghana and serves a population of 4 million .", "uch and fmc situated in ibadan and abeokuta respectively are located in southern nigeria and serve a combined population of 4 million nigerians of predominantly yoruba ethnicity .", "abuh and akth in zaria and kano provide health care services to 15 million nigerians of mainly hausa and fulani descent .", "ethical approval for the study will be sought from the ethics committees of the 5 participating sites ."], ["the original questionnaire developed by meschia et al .   will be translated into the local languages ( yoruba  southern nigeria , hausa  northern nigeria , akan  middle & lower belts of ghana ) , pre - tested and back - translated into english language to establish semantic equivalence . at each of the study sites , a panel comprising of a neurologist , three to five doctors and nurses , and public health practitioners will translate the questionnaire into the local dialect by consensus .", "the translated versions of the questionnaires in 3 languages are shown in supplementary information section ( s1 ) .", "another version of the questionnaire will be developed where question items 3 to 8 will have line pictures of the neurological symptoms being elicited by the interviewer ( fig ."], [""], [""], ["participants attending general medicine and neurology out - patient clinic appointments will be approached and enrolled into the study after obtaining informed consent . baseline demographic details will be obtained and the questionnaire administered by a medicine resident in the local dialect and the answers recorded as  yes  ,  no  , or  do n't know  to each question item .", "the version of the questionnaire without pictures will be administered first followed by the version with pictograms by the same interviewer .", "furthermore , participant awareness of known vascular risk factors such as hypertension , diabetes mellitus , dyslipidaemia , cigarette smoking , excessive alcohol intake , physical inactivity , known heart disorders , family history of stroke will be assessed using 8 questions assessing knowledge of the presence of these specific risk factors ."], ["the first stage will involve a review of the medical records of patients to determine if a previous diagnosis of stroke has ever been made , the duration of stroke diagnosis , whether neuro - imaging information on stroke type is available .", "the second stage entails an examination for presence of hemiparesis , hemi - anesthesia , mono - ocular / binocular visual loss , hemianopsia , receptive or expressive aphasia , and cerebellar deficits .", "the third stage will comprise of an evaluation of a cranial ct scan in a subset of participants .", "this neuro - imaging validation will be performed within 48 h among a subset of subjects ( at least 4 stroke and 4 stroke - free ) per site ."], ["assuming that the standard test has an accuracy of 75% as measured by the area under the roc curve ( auc ) , a sample of 35 cases and 35 controls achieve 82% power to detect an extra accuracy by the proposed test of 15% ( auc = 90% in the proposed test ) using a two - sided test at a significance level of 0.05 .", "the sample size required increases to 80 per group in order to detect a difference of 10% ( auc = 85% in the proposed test ) under the same conditions .", "thus , the sample size of 100 per linguistic category ( akan , yoruba , hausa ) will be sufficient detect an effect size as small as 10% allowing up to 10% false positive rates and control to case ratio of the standard deviation of the responses to be 0.5 as suggested by obuchowski and mcclish .", "given that the 8 items qvsfs is going to be translated into three ( yoruba , hausa , chi ) different languages , we will evaluate the reliability of the translation before it is implemented to predict stroke status using a sample size of 50 consistency and validity of the translation for each language using exploratory factor analysis and cronbach 's alpha ."], ["yes = 1 , no = 0 , do n't know = 0 . patients who score 0/8 will be deemed as stroke free whereas those with any positive score will be deemed as not stroke free according to the 8-item qvsfs .", "sensitivity analysis will be performed where  do n't know  will be assumed to be = 1 .", "baseline demographic characteristics between patients who are symptom free for stroke and those with stroke will be compared using either chi - squared test ( categorical variables ) or student 's t - test or mann  whitney 's u - test for means / medians respectively ( continuous variables ) .", "the sensitivity , specificity , positive predictive value , negative predictive value , positive and negative likelihood ratios as well as the accuracy and reliability of the 8-item qvsfs will be assessed in comparison with the benchmark stroke determination by history and examination by a neurologist .", "furthermore , the performance of the questionnaire will be compared with neuro - imaging results in a small randomly selected subset .", "the sensitivity and specificity of the 6 stroke symptom questions will be determined for stroke diagnosis among patients with stroke .", "the performance of the questionnaire will also be compared with the modified version of the questionnaire with images illustrating the neurological deficits being elicited by items 3 to 6 .", "we will use factor analysis approach to assess and confirm the structure relationship between each item and the qvsfs score overall .", "kappa statistics will be employed to compare inter - rater and intra - rater performance of the tool administered by medicine residents , at each site and also between study sites ."], ["yes = 1 , no = 0 , do n't know = 0 . patients who score 0/8 will be deemed as stroke free whereas those with any positive score will be deemed as not stroke free according to the 8-item qvsfs .", "sensitivity analysis will be performed where  do n't know  will be assumed to be = 1 ."], ["baseline demographic characteristics between patients who are symptom free for stroke and those with stroke will be compared using either chi - squared test ( categorical variables ) or student 's t - test or mann  whitney 's u - test for means / medians respectively ( continuous variables ) . the sensitivity , specificity , positive predictive value , negative predictive value , positive and negative likelihood ratios as well as the accuracy and reliability of the 8-item qvsfs will be assessed in comparison with the benchmark stroke determination by history and examination by a neurologist .", "furthermore , the performance of the questionnaire will be compared with neuro - imaging results in a small randomly selected subset .", "the sensitivity and specificity of the 6 stroke symptom questions will be determined for stroke diagnosis among patients with stroke .", "the performance of the questionnaire will also be compared with the modified version of the questionnaire with images illustrating the neurological deficits being elicited by items 3 to 6 .", "we will use factor analysis approach to assess and confirm the structure relationship between each item and the qvsfs score overall .", "kappa statistics will be employed to compare inter - rater and intra - rater performance of the tool administered by medicine residents , at each site and also between study sites ."], ["the questionnaire for verifying stroke - free status ( qvsfs ) , developed and validated primarily in english - speaking western world populations , is a method for verifying stroke - free status in participants of clinical , epidemiological and genetic studies .", "however , the performance of this tool in settings where levels of education and awareness of stroke symptoms are low such as sub - saharan africa has not been conducted .", "the tool has tremendous potential for widespread use in regions such as ours where stroke incidence , prevalence and mortality are escalating and questions on the epidemiology and genetic underpinnings of the stroke epidemic remain unresolved .", "we propose to validate qvsfs for ascertainment of stroke - free status of control subjects enrolled in an ongoing stroke epidemiological study in west africa funded by the national institute of health for h3africa .", "the novel aspects of our validation study are : firstly , to carry out this validation study simultaneously at five tertiary hospitals across nigeria and ghana involving participants speaking three different languages ( yoruba , hausa and akan ) .", "the qvsfs will be translated into these languages and administered to participants enrolled from neurology and general clinics in these hospitals .", "secondly , given the low levels of education , the lack of awareness of stroke symptoms , and general paucity of semantically equivalent medical terminology in the local dialects for stroke symptoms in our settings , we will evaluate the performance of the tool with and without pictograms .", "finally , ascertainment of stroke status will be conducted by neurologists across the 5 sites using a combination of structured medical history , neurological examination , review of medical records and neuro - imaging ( gold standard ) compared with previously published studies which relied on medical records review and neurological examination ."], ["the 8-item qvsfs is a simple , accurate and cheap tool which could have widespread use for ascertaining stroke status in clinical , epidemiological and genetic studies in settings where facilities for stroke confirmation are lacking ."], [""]]}
