A scoping review of the outcome reporting following surgery for chronic osteomyelitis of the lower limb.

Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set. A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy. A total of 3,303 records were screened, of which 99 studies were included. Most studies were case series (77/99; 78%) and assessed one method of reconstruction (68/99; 69%). A total of 511 outcomes were reported, which were grouped into 58 distinct outcomes. Overall, 143/511 of all outcomes (28%) were provided with a clear, in-text definition, and 231 outcomes (45%) had details reported of how and when they were measured. The most commonly reported outcome was 'recurrence of osteomyelitis' (62; 12%). The single-most patient-reported outcome measure was 'pain'. This study has highlighted significant inconsistencies in the defining, reporting, and measuring of outcomes across studies investigating surgical management for chronic osteomyelitis of the lower limb in adults. Future studies should clearly report complete details of how outcomes are defined and measured, including timing. The development of a standardized core outcome set would be of significant benefit in order to allow evidence synthesis and comparison across studies.

Influence of intrauterine growth status on aortic intima-media thickness and aortic diameter in near-term fetuses: a comparative cross-sectional study.

Intrauterine undernutrition may lead to fetal vascular programming. We compared abdominal aortic intima-media thickness (aIMT) and aortic diameter (aD) between appropriate for gestational age (AGA) and growth-restricted fetuses (GRF). We recruited 136 singleton fetuses at 34-37 weeks of gestation from Fetal Medicine Unit of Aga Khan University Hospital, Karachi (January-November 2017). Subjects were classified as AGA (n = 102) and GRF (n = 34) using INTER-GROWTH 21st growth reference and standard ultrasound protocol. Their far- and near-wall aIMT and aD were compared after adjustment of maternal age, first-trimester body mass index, fetal gender, hypertension and hyperglycemia in pregnancy. As the severity of growth restriction increased in GRF, aIMT and aD showed an increasing and a decreasing trend, respectively. Both far- and near-wall aIMT in GRF [(adj. ß = 0.082, 95% confidence interval [CI] 0.042-0.123) and (adj. ß = 0.049, 95% CI 0.010-0.089)] were significantly greater with reference to AGA fetuses. GRF subgroup analysis into small for gestational age (SGA) fetuses and intrauterine growth restricted (IUGR) revealed highly significant difference between AGA and IUGR for far (0.142 mm, P-value < 0.001) and near-wall aIMT (0.115 mm, P-value < 0.001) and marginally significant aD difference (0.51 mm, P-value 0.05). These findings suggest that the extent of fetal aortic remodelling is influenced by the severity of growth restriction. Hence, the targeted interventions for the cardiovascular health promotion of IUGR and SGA born neonates are desirable during early childhood, particularly in set ups with high prevalence of low birth weight babies.

Association of Diabetes With Lower Back Pain: A Narrative Review.

Diabetes mellitus with its increasing prevalence is one of the four major non-communicable diseases. It is characterized by hyperglycemia, which may progress to chronic complications such as peripheral vascular disease and neuropathy. This paper highlights the pathophysiology associated with diabetes, which is restricted to not only hyperglycemia but also other comorbidities including chronic lower back pain. Diabetes is a metabolic disorder associated with hypercholesteremia, hypertriglyceridemia, and hypertension. This chain of events leads to free plasma fatty acids and a pro-inflammatory state, therefore promoting calcification of blood vessels, which may block the blood supply to vertebral discs and thereby increase vulnerability in the patients with ongoing inflammatory disease such as osteoarthritis and also causing costochondritis. Functional limitation due to increased load on the weight-bearing joints is a common mechanical complication of diabetes. Obesity in diabetes is more prevalent due to a disturbed metabolism, which is aggravated with a persistent inflammatory state. Moreover, the aim of this review is to encourage further conduction of clinical studies to explore the definite cause and potential therapy for chronic lower back pain in diabetes, thereby investigating the association of lipid metabolism and skeletal muscle atrophy leading to chronic back pain, the role of diabetic medications, and vulnerability in the female gender. Diminished physical activity and depression in diabetic patients disrupt the hypothalamic-pituitary-adrenal axis (HPA), which further contributes to lower back pain. Further clinical investigation and research in this regard will establish substantial data for the linkage between depression in diabetes and back pain. However, despite all the advancements of medical literature, the exact cause of lower back pain in diabetes is arguable. Pain impedes the health status and life quality; therefore, it is essential to maintain the quality of health in patients with diabetes by treating not only hyperglycemia but also other multifactorial causes leading to lower back pain.

Major adverse cardiovascular events in patients undergoing percutaneous coronary intervention or coronary artery bypass graft with underlying chronic kidney disease.

OBJECTIVE: To assess early and late outcome in severe chronic kidney disease patients undergoing revascularisation. METHODS: The retrospective ambi-directional cohort study was conducted at Tabba Heart Institute, Karachi, and comprised data from May, 2012, to July,2016, related to severe chronic kidney disease patients with creatinine clearance <30ml/min or end-stage renal disease on haemodialysis who had undergone coronary artery bypass graft / percutaneous coronary intervention. Early outcome was in-hospital major adverse cardiac event, like mortality, stroke and new haemodialysis. Late outcome was major adverse cardiac event, like mortality, stroke, re infarction and re-revascularisation. Data was analysed using Stata 12.1. RESULTS: Of the 228 patients with mean age of 64.2±10.8 years, 109(47.8%) with a maen age of 65.4±11.6 had undergone percutaneous coronary intervention, and 119(52.2%) with a mean age of 64.2±10.8 years had undergone coronary artery bypass graft. Overall mortality was 36(15.8%) patients; 15(13.7%) percutaneous coronary intervention, 21(17.6%)coronary artery bypass graft (p>0.05). Predictors of in-hospital adverse events were coronary artery bypass graft and cardiogenic shock (p<0.05). Follow-up was available in 181(94.3%) patients with a mean duration of 22.0±13.9 months. Heart failure and post-procedure stroke were independent predictors of late outcome (p<0.05). CONCLUSIONS: Among patients with severe chronic kidney disease or end stage renal disease undergoing revascularisation, percutaneous coronary intervention PCI was performed in patients with less complex anatomy or as emergency for acute ST-elevation myocardial infarction. Coronary artery bypass graft patients had higher early mortality, but improved late survival.

Compliance of smokeless tobacco supply chain actors and products with tobacco control laws in Bangladesh, India and Pakistan: protocol for a multicentre sequential mixed-methods study.

INTRODUCTION: South Asia is home to more than 300 million smokeless tobacco (ST) users. Bangladesh, India and Pakistan as signatories to the Framework Convention for Tobacco Control (FCTC) have developed policies aimed at curbing the use of tobacco. The objective of this study is to assess the compliance of ST point-of-sale (POS) vendors and the supply chain with the articles of the FCTC and specifically with national tobacco control laws. We also aim to assess disparities in compliance with tobacco control laws between ST and smoked tobacco products. METHODS AND ANALYSIS: The study will be carried out at two sites each in Bangladesh, India and Pakistan. We will conduct a sequential mixed-methods study with five components: (1) mapping of ST POS, (2) analyses of ST samples packaging, (3) observation, (4) survey interviews of POS and (5) in-depth interviews with wholesale dealers/suppliers/manufacturers of ST. We aim to conduct at least 300 POS survey interviews and observations, and 6-10 in-depth interviews in each of the three countries. Data collection will be done by trained data collectors. The main statistical analysis will report the frequencies and proportions of shops that comply with the FCTC and local tobacco control policies, and provide a 95% CI of these estimates. The qualitative in-depth interview data will be analysed using the framework approach. The findings will be connected, each component informing the focus and/or design of the next component. ETHICS AND DISSEMINATION: Ethical approvals for the study have been received from the Health Sciences Research Governance Committee at the University of York, UK. In-country approvals were taken from the National Bioethics Committee in Pakistan, the Bangladesh Medical Research Council and the Indian Medical Research Council. Our results will be disseminated via scientific conferences, peer-reviewed research publications and press releases.

Protocol for a feasibility study of longitudinal surveys to assess the impact of policies on tobacco use among school-going adolescents in South Asia.

Background: Smokeless tobacco (ST) use is common among youth in South Asia where 85% of the world's 300 million ST users live and use the most lethal ST forms. Little is known about the impact of tobacco control policies on the youth ST uptake in those countries. We planned to conduct longitudinal surveys among secondary school students to evaluate existing tobacco control policies on ST uptake and use, and a feasibility study for that prospective, observational cohort study. Study objectives: (1) To demonstrate the feasibility of selection, recruitment and retention of schools and of study participants; (2) To assess the feasibility and acceptability of the study procedure and study tool (questionnaire); (3) To assess if the questionnaire can assess tobacco uptake and use, and the potential predictors of tobacco uptake and use of the envisaged main study. Methods and analysis: The feasibility study will be conducted in two administrative areas within each of three South Asian countries: Bangladesh, India and Pakistan. We will use both quantitative and qualitative data collection methods. Eight eligible secondary schools will be randomly selected within purposively selected sub-districts from each country. We plan to conduct one baseline and one follow up survey among secondary school students, one year apart. At each time point, data on tobacco uptake and the potential predictors will be collected from students via self-administered questionnaires. The qualitative component will be embedded into the study with each round of data collection to assess the acceptability of the study instrument (questionnaire) and data collection methods, via focus group discussions with students and semi-structured interviews with schoolteachers. Recruitment and retention rates, completeness of the questionnaires, frequencies and associations of tobacco use and explanatory variables will be reported. Data gathered from the focus group and interviews will be analysed using the framework approach.

Clinical characteristics and in-hospital outcome in percutaneous coronary interventions with ST elevation myocardial infarction patients developing acute kidney injury.

OBJECTIVE: To find predictors, incidence and hospital mortality of acute kidney injury in ST elevation myocardial infarction patients undergoing percutaneous coronary interventions. METHODS: The retrospective cross-sectional study was conducted at Tabba Heart Institute Karachi, and comprised data from June 2013 to December 2017 of ST elevation myocardial infarction patients undergoing percutaneous coronary interventions during index admission. Acute kidney injury was defined as serum creatinine ≥0.3 mg/dl 48hrs after percutaneous coronary intervention, and was further graded into stages I-III and the need for haemodialysis. Predicted acute kidney injury risks were calculated using Mehran and National Cardiovascular Data Registry risk scores. Stata 14 was used for statistical analysis. RESULTS: Of the 2766 cases evaluated, the incidence of acute kidney injury was found in 543(19.6%) case. Diabetes, pre-percutaneous coronary intervention heart failure, ejection fraction <40%, post-percutaneous coronary intervention thrombolysis in myocardial infarction flow<3, glomerular filtration rate<60 ml/min and increased contrast volume were significant predictors of acute kidney injury. Hospital mortality was reported in 144(5.2%) cases. CONCLUSION: Acute kidney injury is a serious complication in ST elevation myocardial infarction patients undergoing percutaneous coronary interventions and is related to adverse hospital outcomes. Pre-procedural risk scores may underestimate acute kidney injury in such patients.

Mortality and deciding factors for no revascularization in cardiogenic shock patients; a cross sectional study.

OBJECTIVE: To assess the frequency of acute coronary syndrome patients with cardiogenic shock and not undergoing revascularisation, their in- hospital outcome and reasons underlying management decisions. METHODS: The retrospective cross-sectional study was conducted at Tabba Heart Institute, Karachi, and comprised data from July 2013 to December 2017 of acute coronary syndrome with hypotension and not having under gone revascularisation. Data was analyzed using Stata 12.1. RESULTS: Of the 383 patients, 55(14.3%) did not undergo revascularisation. Overall mean age was 63.2±9.8years. Overall mortality was 45(81.8%). Revascularisation was intended in 28(51%) patients of whom 19(68%) died before undergoing cardiac catheterisation. Another 9(32%) patients died after cardiac catheterisation but before revascularisation. Common clinical reasons in the remaining 27(49%) patients not considered for revascularisation were hypoxic brain injury secondary to cardiac arrest, patient refusal, perceived patient frailty, multi-organ failure, sepsis or pre-existing stroke/ malignancy. CONCLUSIONS: Cardiogenic shock complicating myocardial infarction not treated by revascularization had a very poor early outcome. In the two-third of patients before treatment was initiated, there was cardiac arrest with failed resuscitation or poor recovery.

In-hospital management and intermediate term outcomes in stable patients with ST segment elevation myocardial infarction presenting between 12-48 hours of symptom onset versus 2-7 days after the onset of chest pain; a single center study.

OBJECTIVE: To evaluate hospital management, revascularisation and intermediate-term major adverse cardiac events amongst ST elevation myocardial infarction patients and to compare them in early and late presentations. . METHODS: The retrospective study was conducted at Tabba Heart Institute, Karachi, and comprised data from July 2013 to December 2016. ST elevation myocardial infarction patients presenting between 12-48 hours of symptom onset were designated as early-late, while those presenting 2-7 days after the onset of symptoms were designated as late-late. Data included related to patients admitted consecutively with >12hrs of chest pain without immediate reperfusion. Major adverse cardiac events were composite of death, re- myocardial infarction, need for revascularisation or heart failure. SPSS 19 was used for data analysis. RESULTS: Out of 234, patients, 110(47%) were early-late and 124(53%) were late-late. Overall mean age was 58.5±12.2years, and 188(80.3%) subjects were men. Anterior all myocardial infarction was in 134(57.3%) cases. Non-invasive assessment for ischaemia/viability was performed in 96(41%) cases and angiography in 196(83.8%). Early-late were revascularised more frequently 53(48.2%) than late-late 49(39.5%) (p>0.05). Median follow-up was 23 months (interquartile range: 13-34 months). Major adverse cardiac events occurred in 45(19.6%) patients but there was no significant difference between earlylate and late-late patients (p>0.05). CONCLUSIONS: Revascularisation was found to have favourable impact on intermediate-term adverse cardiac events.

Management, hospital outcome and revascularization trends in non-ST elevation myocardial infarction with high GRACE risk score.

OBJECTIVE: To assess clinical characteristics, management strategies and in-hospital outcome among high-risk patients of non-ST elevation myocardial infarction. METHODS: The retrospective cross-sectional study was conducted at Tabba Heart Institute, Karachi, and comprised data from July 2013 to December 2016 of adult non-ST elevation myocardial infarction patients who had first cardiac event having Global Registry of Acute Coronary Eventsrisk score>140. Subcategories were formed on the basis of score range 140-159, 160-189 and ?190.Stata 12.1 was used for data analysis. RESULTS: Of the 817 patients, 567(69.4%) were men. Overall, mean age was 66.3}9.3 years. Coronary angiography was performed in 692(84.4%). With higher risk score categories, there was less frequent use of guideline directed medical therapy, coronary angiography and percutaneous or surgical revascularisation (p<0.05 each). Overall mortality was 59(7.2%). Mortality rates increased with increase in risk score subcategory (p<0.05). Multivariable model identified higher risk score category, no revascularisation and lack of guideline directed medical therapy as significant independent predictors of mortality (p<0.05 each). CONCLUSIONS: Mortality increased with higher risk score category. Paradoxically, high-risk patients were less likely to receive guideline directed medical therapy, to undergo coronary angiography and revascularisation, possibly suggesting a risk aversion approach by the treating physicians.

In-Hospital outcomes in acute coronary syndrome patients with concomitant severe chronic kidney disease undergoing percutaneous coronary intervention.

OBJECTIVE: To determine in-hospital mortality and major adverse cardiac events (MACE) in acute coronary syndrome (AMI) patients with underlying severe chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI). METHODS: We conducted a retrospective cohort study from June'2013-December'2017 at Tabba Heart Institute, Karachi. Data was drawn from institutes' database modeled after US National Cardiovascular data CathPCI registry. All AMI (STEMI: ST-elevation myocardial infarction and NSTEMI: non-ST-elevation myocardial infarction) patients undergoing PCI with creatinine clearance <30ml/min or ESRD on hemodialysis were included in the study. RESULTS: During 54 months study period, 160 severe CKD patients underwent PCI. Mean age was 62.9±12.2 years. Men were 61.9%, hypertensive (81.3%) and diabetic (63.8%). Excluding dialysis patients, Creatinine clearance was 21.1±6.6ml/min/1.73m2. STEMI were 46.9% and 61.9% were Killip I. Mean SYNTAX score was 16.6±7.3. MACE occurred in 32.5% patients, of which 6(11.5%) had new hemodialysis and mortality: 17.5% were deceased. MACE predictor were cardiogenic shock (OR: 2.81, 95%CI: 1.17-6.74) and prior heart failure (OR: 6.84, 95%CI: 1.39-33.74), Predictor of mortality was cardiogenic shock or cardiac arrest (OR: 7.90, 95%CI: 2.95-21.17). CONCLUSION: Severe CKD patients undergoing PCI for AMI have drastically poor outcomes therefore individualization and patient-centric care management is mandatory.