Hand hygiene compliance of respiratory physiotherapists: An analysis of trends over eight years including the COVID-19 pandemic period.

BACKGROUND: Respiratory physiotherapists (RPs) are an integral part of healthcare workers delivering care to intubated patients. Our study aimed to evaluate the effect of awareness campaigns on hand hygiene (HH) compliance among RPs. METHOD: An observational single-center study was conducted between 2015 and 2022 in different ICU types in both adult and paediatric settings. The hand hygiene compliance rates were monitored prospectively and the quality improvement interventions included various hand hygiene campaigns and awareness sessions with RPs. Compliance was calculated as a percentage of events over total opportunities observed. RESULTS: There was a significant increase in compliance rates for all five moments of HH (p-value: <0.05). Overall, mean compliance rate in ICUs was significantly higher than wards for Moment 1 (p-value: 0.0045), Moment 4 (p-value: 0.0372) and Moment 5 (p-value: 0.0036) by 24.2%, 22.7% and 21.5% respectively. Also, paediatric ICUs had higher HH compliance than adult ICUs for Moment 1 (87.5% vs 61.1%; p-value: 0.0459) and Moment 4 (93.7% vs 79.3%; p-value: 0.0255). A significant increase in HH compliance was observed in post-COVID-19 period compared to pre-COVID-19 period with respect to Moment 1, 2 and 5. CONCLUSION: This study adds to the almost non-existent literature on this important category of healthcare workers working in respiratory ICUs. Our results project an increase compliance after the HH awareness programmes over the years among RP which is critical to prevent spread infection by multidrug resistant organisms among the hospitals.

Imparting child nutritional assessment skills among medical students using hybrid problem-based learning approach in a community setting.

Background: Malnutrition affects up to a third of children in India, with severe and acute malnutrition prevalent among under five children. Nutritional assessment skills for detecting malnutrition in children in primary care settings are vital. Hybrid problem-based learning (HPBL) is an innovative, collaborative, and adaptable instructional learning strategy that can be used to teach medical students clinical skills in a community setting. Methods: A two-month quasi-experimental study was undertaken in a rural setting with third-year medical students. Faculty members were sensitized and subject experts developed a training module addressing the knowledge, attitude, communication, and practice domains. The students underwent a 3-week training module where pre-testing, case presentation, and group formation in first week, an anchoring lecture, tutorial and self-directed learning and role-play by students in subsequent week, and in last week, case discussion, post-testing, and feedback rounds were done. Results: In all domains, knowledge (3.8, 0.01), practice (4.3, 0.01), attitude and communication (3.7, 0.01), and proportional satisfactory responses, the HPBL approach resulted in a significant improvement in nutritional assessment competency. Teachers preferred the practical and engaging character of the approach, stating that doubts and questions were better addressed and that they would use it to teach similar topics. Conclusion: HPBL is an excellent teaching method for clinical skills, like nutritional assessment in simulated/field settings. The novel teaching-learning approach was well received by students and faculty members. Learning outcomes and satisfaction rates enhanced in students and faculty were encouraged to apply the approach to other topics.

A Study to Assess Biochemical Profile of Tobacco Chewers with Chewing Habit Over a Period of 10 Years.

The study was conducted to evaluate the systemic adverse effects of smokeless tobacco (SLT) on hematological as well as other biochemical parameters and find out if any correlation between them which may be worthy of creating awareness among the masses against its usage. The current observational study was carried out among 250 tobacco chewers, and complete hemogram, LFT profile, and electrolyte profile were studied. The mean values of hemoglobin (Hb) gram % was 12.74 ± 1.6, total leucocyte count (TLC/cu mm) is 6608.33 ± 1752.083, and platelet count lakh cell/cu mm is 2.55 ±0.806. The mean values of Na+ mmol/1 of the S. electrolyte profile was 132 ± 18.05 and K+ mmol/1 was 3.89 ± 0.538. The study deliberates imperative perception into smokeless tobacco-mediated effects on body systemic functions and reports a crucial part into SLT-mediated effects on biochemical profile and metabolism which can be revealed in promoting tobacco cessation.

Use of exemplars-based feedforward to improve the performance of medical students in constructed response assessment.

Background: Exemplars are the graded responses to theory questions from previous examinations and are considered as means to guide students about what is valued by assessors; hence giving feed forward to students before the exam and developing self-regulated learning among students. The present study was undertaken to compare the effect on performance of students between intervention (didactic lecture and exemplar) and control group (didactic lecture). Methods: This study was an interventional study conducted among 256 students of a medical college in Rajasthan, India. Participants were randomized to either the control group A or to the interventional group B. Outcomes included a post intervention test evaluating the knowledge gained after the session and students 'attitudes about the same. A focus group discussion was conducted investigating the perceptions. The feedback from faculty was also taken. Results: The mean post test score of intervention group was found to be 6.1 ± 1.74 and of the control group was 5.5 ± 1.6; significantly higher with p-value of 0.03. Out of 128 participants in group B, majority (n = 94,73%) believed that exemplars improve learning and created their interest in topic (n = 78, 60.9%). Most of students (66%) were of the opinion that exemplars should be regularly used with didactic lectures. Key themes identified from focus group were: advantages of the exemplars-based feedforward, challenges in implementation and ways to improve the method. Conclusion: Exemplars improved the performance of students. The faculty members and students agreed that they are an effective tool to enhance learning.

Hand hygiene behavior change: a review and pilot study of an automated hand hygiene reminder system implementation in a public hospital.

Objective: To review and study implementation of an automated hand hygiene reminder system (AHHRS). Design: Prospective, nonrandomized, before-after quality improvement pilot study conducted over 6 months. Setting: Medical-surgical unit (MSU) and medical intensive care unit (MICU) at a public hospital in New York City. Participants: There were 2,642 healthcare worker observations in the direct observation (DO) period versus 265,505 in the AHHRS period, excluding AHHRS observations collected during the 1-month crossover period when simultaneous DO occurred. Intervention: We compared hand hygiene adherence (HHA) measured by DO prior to the pilot and after AHHRS implementation. We compared changes in HHA and potential cross-contamination events (CCEs) (room exit and subsequent entry without HHA) from baseline for each biweekly period during the pilot. Results: Engagement, education/training, data transparency, and optimization period resulted in successful implementation and adoption of the AHHRS. Observations were greater utilizing AHHRS than DO (265,505 vs 2,642, P < .01). Due to the expected Hawthorne effect, HHA was significantly less for AHHRS than DO in MSU (90.99% vs 97.21%, P < .01) and MICU (91.21% vs 98.65%, P < .01). HHA significantly improved from 86.47% to 89.68% in MSU (P < .001) and 85.93% to 91.24% in the MICU (P < .001) from the first biweekly period of AHHRS utilization to the last. CCE decreased from 73.42% to 65.11% in the MSU and significantly decreased from 81.22% to 53.19% in the MICU (P < .05). Conclusions: We describe how an AHHRS approach was successfully implemented at our facility. With ongoing feedback and system optimization, AHHRS improved HHA and reduced CCE over time.

Plasma Fibrinogen Degradation Products as the Nonsurgical Diagnostic Tool for Oral Submucous Fibrosis: A Systematic Review.

Aims and Objectives: Oral submucous fibrosis (OSMF) is known to be one of the most common premalignant conditions of the oral cavity. Areca nut (AN) is considered to be the disease's primary cause, while there are other potential causes as well. However, routine clinical practice has revealed that not all people who chew AN exhibit clinical signs of OSMF, and few people are reported to have it even without chewing AN. So, there must be other factors contributing to OSMF. Plasma fibrinogen degradation products (FDPs) have recently been discovered to be an early sign of this disease, indicating a potential link between the two. This review aims to examine the studies which have been published in the literature that explain the role of plasma FDPs in contributing to OSMF. Materials and Methods: An electronic search of the published literature was performed without publication year limitation in PubMed/ Medline, Scopus, Google Scholar, Web of Science, Science Direct, Embase, and Research gate databases, using mesh keywords like ('Oral submucous fibrosis' OR 'Oral submucous fibrosis') AND ('Fibrinogen degradation products' OR 'Plasma fibrinogen degradation products') AND ('Clinical grades' OR 'Histological grades') AND ('Diagnosis'). A manual search of all related journals was also done. We also referred to the reference lists of papers. The risk of bias was evaluated with the GRADE criteria (from the Grading of Recommendations Assessment, Development, and Evaluation Working Group). Results: The search revealed a total of 12 relevant studies from 1979 to 2022. Nine out of 12 studies demonstrated the definite presence of plasma FDPs in such cases. Conclusions: Although the studies documented in the literature showing evidence of plasma FDPs in patients with OSMF are very few in number, their detection signifies an important clinical finding. More research is still required in this aspect to establish stronger evidence.

Quantification of diurnal variation in "glove hygiene" compliance in COVID ICUs: An exploratory study.

BACKGROUND: Hand hygiene compliance (HHC) monitoring is almost always done in daytime. Documentation of HHC in health care workers (HCWs) is limited during odd hours and nighttime. The objective of the study was to determine diurnal variation in HHC in different categories of health care workers in tertiary care hospital in North India. METHODS: A prospective, observational study was conducted in 3 COVID-19 intensive care units (ICUs) with closed-circuit television (CCTV) cameras. Dedicated infection control nurses monitored HHC among various HCWs (doctors, nursing staff, technicians, hospital and sanitary attendants) during day and nighttime, in 20-minute durations. The difference in HHC by-professional category and for each WHO moment was assessed using χ² test and P value. RESULTS: A total of 705 opportunities were observed over a period of 7 days, with overall compliance of 53%. Day and nighttime compliance was recorded to be 60.7% and 42.1%, respectively (P < .001). HCC was highest amongst resident doctors with little diurnal variation. However, nurses and housekeeping staff exhibited significant diurnal variation. The compliance at "after" moments was much higher than "before" moments in all professional categories. CONCLUSION: There was a significant decrease in compliance during nighttime, amongst all HCWs, with maximum variation exhibited by nursing staff. The present study underlines the importance of monitoring HHC at odd hours, to elicit a more accurate picture round the clock. Health care facilities monitoring compliance only during the daytime may substantially overestimate HHC.

Lung cancer metastasizing to salivary glands: Systematic review.

ABSTRACTS: Metastasis to salivary glands from the secondary source outside the head and neck region is extremely rare and Carcinoma Lung is one of the rarest sources of distant spread to salivary glands. Owing to missed diagnosis and misdiagnosis, accurate identification of clinical and pathological aspects of these metastatic lesions remains a challenging task. Many studies regarding metastasis to the oral cavity have been already documented in the literature, but very little research work has been done to analyse the cases of lung cancer metastasis as the sole primary source, particularly to salivary glands. Thus this review was conducted to analyse the published cases of lung cancer metastasizing to salivary glands as the only primary source till date. An electronic search of the published literature was performed without publication year limitation in PubMed/ Medline, Scopus, Google Scholar, Web of Science, Science direct, Embase, and Research gate databases, using Mesh keywords like (Lung cancer', OR 'Lung carcinoma), AND (Metastasis OR Metastases), And (Salivary glands OR Parotid gland OR Submandibular gland OR Sublingual gland). We also searched all related journals manually. The reference list of all articles was also checked. Our research revealed 34 relevant papers between 1965-2022 with a total of 44 patients. The most prevalent diagnosed metastatic Lung cancer was Small cell lung cancer. Parotid was the most common gland involved in metastasis. 48% of patients died of metastasis with a mean survival time of 2.2 years. Salivary gland metastasis from Lung cancer is very rare and has a poor prognosis. More cases need to be published in order to raise awareness of these lesions and gain a better understanding of their characteristics.

Quality-of-life outcomes in older patients with early-stage rectal cancer receiving organ-preserving treatment with hypofractionated short-course radiotherapy followed by transanal endoscopic microsurgery (TREC): non-randomised registry of patients unsuitable for total mesorectal excision.

BACKGROUND: Older patients with early-stage rectal cancer are under-represented in clinical trials and, therefore, little high-quality data are available to guide treatment in this patient population. The TREC trial was a randomised, open-label feasibility study conducted at 21 centres across the UK that compared organ preservation through short-course radiotherapy (SCRT; 25 Gy in five fractions) plus transanal endoscopic microsurgery (TEM) with standard total mesorectal excision in adults with stage T1-2 rectal adenocarcinoma (maximum diameter ≤30 mm) and no lymph node involvement or metastasis. TREC incorporated a non-randomised registry offering organ preservation to patients who were considered unsuitable for total mesorectal excision by the local colorectal cancer multidisciplinary team. Organ preservation was achieved in 56 (92%) of 61 non-randomised registry patients with local recurrence-free survival of 91% (95% CI 84-99) at 3 years. Here, we report acute and long-term patient-reported outcomes from this non-randomised registry group. METHODS: Patients considered by the local colorectal cancer multidisciplinary team to be at high risk of complications from total mesorectal excision on the basis of frailty, comorbidities, and older age were included in a non-randomised registry to receive organ-preserving treatment. These patients were invited to complete questionnaires on patient-reported outcomes (the European Organisation for Research and Treatment of Cancer Quality of Life [EORTC-QLQ] questionnaire core module [QLQ-C30] and colorectal cancer module [QLQ-CR29], the Colorectal Functional Outcome [COREFO] questionnaire, and EuroQol-5 Dimensions-3 Level [EQ-5D-3L]) at baseline and at months 3, 6, 12, 24, and 36 postoperatively. To aid interpretation, data from patients in the non-randomised registry were compared with data from those patients in the TREC trial who had been randomly assigned to organ-preserving therapy, and an additional reference cohort of aged-matched controls from the UK general population. This study is registered with the ISRCTN registry, ISRCTN14422743, and is closed. FINDINGS: Between July 21, 2011, and July 15, 2015, 88 patients were enrolled onto the TREC study to undergo organ preservation, of whom 27 (31%) were randomly allocated to organ-preserving therapy and 61 (69%) were added to the non-randomised registry for organ-preserving therapy. Non-randomised patients were older than randomised patients (median age 74 years [IQR 67-80] vs 65 years [61-71]). Organ-preserving treatment was well tolerated among patients in the non-randomised registry, with mild worsening of fatigue; quality of life; physical, social, and role functioning; and bowel function 3 months postoperatively compared with baseline values. By 6-12 months, most scores had returned to baseline values, and were indistinguishable from data from the reference cohort. Only mild symptoms of faecal incontinence and urgency, equivalent to less than one episode per week, persisted at 36 months among patients in both groups. INTERPRETATION: The SCRT and TEM organ-preservation approach was well tolerated in older and frailer patients, showed good rates of organ preservation, and was associated with low rates of acute and long-term toxicity, with minimal effects on quality of life and functional status. Our findings support the adoption of this approach for patients considered to be at high risk from radical surgery. FUNDING: Cancer Research UK.

Empowered Nurses: A Win-Win Situation in Pediatric Critical Care.

The atmosphere of a pediatric intensive care unit (PICU) is charged, fast paced, stressful, and tiring with emphasis on precision of care. Pediatric critical care nursing is still in its infancy stage in India and other low middle income countries. The lack of resources, staff shortage, migration and brain drain are persistent issues in India. There is lack of career advancement as well as exposure to research activities. Keeping these barriers in mind, over the years, we have adopted certain multipronged strategies in our PICU with the objective of empowering, and motivating our nursing personnel. We have been able to 'build a horizontal team' where each member feels wanted and works to his/her maximum capacity. This model of nurse empowerment may be reproduced by other institutions especially in low middle income countries that are also struggling with similar problems.

A Multicenter Randomized Controlled Trial Comparing Safety, Efficacy, and Cost-effectiveness of the Surgisis Anal Fistula Plug Versus Surgeon's Preference for Transsphincteric Fistula-in-Ano: The FIAT Trial.

OBJECTIVE: To undertake a randomized comparison of the Biodesign Surgisis anal fistula plug against surgeon's preference in treating cryptoglandular transsphincteric fistula-in-ano. SUMMARY BACKGROUND DATA: The efficacy of the Biodesign Surgisis anal fistula plug in healing anal fistulae is uncertain. METHODS: Participants were randomized to the fistula plug with surgeon's preference (advancement flap, cutting seton, fistulotomy, Ligation of the Intersphincteric Fistula Tract procedure). The primary outcome was faecal incontinence quality of life (FIQoL) at 12-months. Secondary outcomes were fistula healing, incontinence rates, and complication and reintervention rates. RESULTS: Between May 2011 and March 2016, 304 participants were randomized to fistula plug or surgeon's preference. No differences were seen in FIQoL between the 2 groups at 12 months. Clinical fistula healing was reported in 66/122 (54%) of the fistula plug and 66/119 (55%) of the surgeon's preference groups at 12 months. Fecal incontinence rates improved marginally in both the groups. Complications and reinterventions were frequent, with significantly more complications in the fistula plug group at 6-weeks (49/142, 35% vs 25/137, 18%; P=0.002). The mean total costs were £2738 (s.d. £1151) for the fistula plug and £2308 (s.d. £1228) for the surgeon's preference group (mean difference +£430, P=0.0174). The average total quality adjusted life years (QALYs) gained was marginally higher in the fistula plug group. The fistula plug was 35% to 45% likely to be cost-effective across a willingness to pay threshold of £20,000 to £30,000 / QALY. CONCLUSIONS: The Biodesign Surgisis anal fistula plug is associated with similar FIQoL and healing rates to surgeon's preference at 12 months. Higher costs and highly uncertain gains in QALYs mean that the fistula plug may not be considered as a cost-effective treatment in the UK NHS.

Radical surgery versus organ preservation via short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomised, open-label feasibility study.

BACKGROUND: Radical surgery via total mesorectal excision might not be the optimal first-line treatment for early-stage rectal cancer. An organ-preserving strategy with selective total mesorectal excision could reduce the adverse effects of treatment without substantially compromising oncological outcomes. We investigated the feasibility of recruiting patients to a randomised trial comparing an organ-preserving strategy with total mesorectal excision. METHODS: TREC was a randomised, open-label feasibility study done at 21 tertiary referral centres in the UK. Eligible participants were aged 18 years or older with rectal adenocarcinoma, staged T2 or lower, with a maximum diameter of 30 mm or less; patients with lymph node involvement or metastases were excluded. Patients were randomly allocated (1:1) by use of a computer-based randomisation service to undergo organ preservation with short-course radiotherapy followed by transanal endoscopic microsurgery after 8-10 weeks, or total mesorectal excision. Where the transanal endoscopic microsurgery specimen showed histopathological features associated with an increased risk of local recurrence, patients were considered for planned early conversion to total mesorectal excision. A non-randomised prospective registry captured patients for whom randomisation was considered inappropriate, because of a strong clinical indication for one treatment group. The primary endpoint was cumulative randomisation at 12, 18, and 24 months. Secondary outcomes evaluated safety, efficacy, and health-related quality of life assessed with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C30 and CR29 in the intention-to-treat population. This trial is registered with the ISRCTN Registry, ISRCTN14422743. FINDINGS: Between Feb 22, 2012, and Dec 19, 2014, 55 patients were randomly assigned at 15 sites; 27 to organ preservation and 28 to radical surgery. Cumulatively, 18 patients had been randomly assigned at 12 months, 31 at 18 months, and 39 at 24 months. No patients died within 30 days of initial treatment, but one patient randomly assigned to organ preservation died within 6 months following conversion to total mesorectal excision with anastomotic leakage. Eight (30%) of 27 patients randomly assigned to organ preservation were converted to total mesorectal excision. Serious adverse events were reported in four (15%) of 27 patients randomly assigned to organ preservation versus 11 (39%) of 28 randomly assigned to total mesorectal excision (p=0·04, χ2 test). Serious adverse events associated with organ preservation were most commonly due to rectal bleeding or pain following transanal endoscopic microsurgery (reported in three cases). Radical total mesorectal excision was associated with medical and surgical complications including anastomotic leakage (two patients), kidney injury (two patients), cardiac arrest (one patient), and pneumonia (two patients). Histopathological features that would be considered to be associated with increased risk of tumour recurrence if observed after transanal endoscopic microsurgery alone were present in 16 (59%) of 27 patients randomly assigned to organ preservation, versus 24 (86%) of 28 randomly assigned to total mesorectal excision (p=0·03, χ2 test). Eight (30%) of 27 patients assigned to organ preservation achieved a complete response to radiotherapy. Patients who were randomly assigned to organ preservation showed improvements in patient-reported bowel toxicities and quality of life and function scores in multiple items compared to those who were randomly assigned to total mesorectal excision, which were sustained over 36 months' follow-up. The non-randomised registry comprised 61 patients who underwent organ preservation and seven who underwent radical surgery. Non-randomised patients who underwent organ preservation were older than randomised patients and more likely to have life-limiting comorbidities. Serious adverse events occurred in ten (16%) of 61 non-randomised patients who underwent organ preservation versus one (14%) of seven who underwent total mesorectal excision. 24 (39%) of 61 non-randomised patients who underwent organ preservation had high-risk histopathological features, while 25 (41%) of 61 achieved a complete response. Overall, organ preservation was achieved in 19 (70%) of 27 randomised patients and 56 (92%) of 61 non-randomised patients. INTERPRETATION: Short-course radiotherapy followed by transanal endoscopic microsurgery achieves high levels of organ preservation, with relatively low morbidity and indications of improved quality of life. These data support the use of organ preservation for patients considered unsuitable for primary total mesorectal excision due to the short-term risks associated with this surgery, and support further evaluation of short-course radiotherapy to achieve organ preservation in patients considered fit for total mesorectal excision. Larger randomised studies, such as the ongoing STAR-TREC study, are needed to more precisely determine oncological outcomes following different organ preservation treatment schedules. FUNDING: Cancer Research UK.

Anal fistula plug versus surgeon's preference for surgery for trans-sphincteric anal fistula: the FIAT RCT.

BACKGROUND: The aim of fistula surgery is to eradicate the disease while preserving anal sphincter function. The efficacy of the Surgisis® anal fistula plug (Cook Medical, Bloomington, IN, USA) in the treatment of trans-sphincteric fistula-in-ano has been variably reported. OBJECTIVES: To undertake a randomised comparison of the safety and efficacy of the Surgisis anal fistula plug in comparison with surgeon's preference for the treatment of trans-sphincteric anal fistulas. DESIGN: A randomised, unblinded, parallel-arm, prospective, multicentre clinical trial. SETTING: Hospitals in the UK NHS involving colorectal surgeons accredited by the Association of Coloproctology of Great Britain and Ireland. PARTICIPANTS: Adult patients suffering from trans-sphincteric fistula-in-ano of cryptoglandular origin. INTERVENTIONS: Patients were randomised on a 1 : 1 basis to either the fistula plug or the surgeon's preference [e.g. fistulotomy, cutting seton, advancement flap or ligation of intersphincteric fistula tract (LIFT) procedure]. MAIN OUTCOME MEASURES: The primary outcome measure was quality of life as measured by the Faecal Incontinence Quality of Life (FIQoL) questionnaire at 12-month follow-up. Secondary outcome measures included clinical and radiological fistula healing rates, faecal incontinence rates, complications rates, reintervention rates and cost-effectiveness. RESULTS: Between May 2011 and March 2016, 304 participants were recruited (152 fistula plug vs. 152 surgeon's preference). No difference in FIQoL score between the two trial groups was seen at the 6-week, 6-month or 12-month follow-up. Clinical evidence of fistula healing was reported in 66 of 122 (54%) participants in the fistula plug group and in 66 of 119 (55%) participants in the surgeon's preference group at 12 months. Magnetic resonance imaging (MRI) showed fistula healing in 54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon's preference group. Variation in 12-month clinical healing rates was observed: 55%, 64%, 75%, 53% and 42% for fistula plug, cutting seton, fistulotomy, advancement flap and LIFT procedure, respectively. Faecal incontinence rates were low at baseline, with small improvement in both groups post treatment. Complications and reinterventions were frequent. The mean total costs were £2738 [standard deviation (SD) £1151] in the fistula plug group and £2308 (SD £1228) in the surgeon's preference group. The average total quality-adjusted life-years (QALYs) gain was much smaller in the fistula plug group (0.829, SD 0.174) than in the surgeon's preference group (0.790, SD 0.212). Using multiple imputation and probabilistic sensitivity analysis, and adjusting for differences in baseline EuroQol-5 Dimensions, three-level version utility, there was a 35-45% chance that the fistula plug was as cost-effective as surgeon's preference over a range of thresholds of willingness to pay for a single QALY of £20,000-30,000. LIMITATIONS: Limitations include a smaller sample size than originally calculated, a lack of blinding that perhaps biased patient-reported outcomes and a lower compliance rate with MRI at 12-month follow-up. CONCLUSIONS: The Surgisis anal fistula plug is associated with similar FIQoL score to surgeon's preference at 12-month follow-up. The higher costs and highly uncertain and small gains in QALYs associated with the fistula plug mean that this technology is unlikely to be considered a cost-effective use of resources in the UK NHS. FUTURE WORK: Further in-depth analysis should consider the clinical and MRI characteristics of fistula-in-ano in an attempt to identify predictors of fistula response to treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78352529. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 21. See the NIHR Journals Library website for further project information.

Fistula-in-ano is a common condition in which the inside of the anus is in communication with the outside skin. It is a cause of long-term suffering owing to recurrent infection. Many surgical operations have been proposed to treat fistula-in-ano, with varying degrees of success. These carry the risk of faecal incontinence. The aim of the Fistula-In-Ano Trial (FIAT) was to assess the benefits of a new technology, the Surgisis^® anal fistula plug (Cook Medical, Bloomington, IN, USA), compared with other surgical techniques. The FIAT involved 304 participants; 152 participants were treated with the fistula plug and 152 participants were treated with an alternative surgical technique. There were no differences in quality of life (QoL) among participants treated with the fistula plug compared with those receiving other treatments when assessed 12 months following the operation. Successful fistula healing was achieved in 54% of fistula plug-treated participants and in 55% of participants treated with an alternative technique at 12 months following the operation. Few patients suffered from faecal incontinence before their operation and there was a slight improvement following treatment with the fistula plug and other surgical treatments. The only difference seen between the group treated with the fistula plug and those receiving other surgical treatments was in the complication rate at the 6-week assessment time, with the fistula plug group having higher rates of unexpected pain. Economic analysis of the fistula plug compared with the other surgical treatments showed that the fistula plug was more expensive and only produced very small improvements in QoL. On this basis, it is unlikely that decision-makers in the NHS will support the routine use of the fistula plug.

Antimicrobial Potential of Benzimidazole Derived Molecules.

Structural resemblance of benzimidazole nucleus with purine nucleus in nucleotides makes benzimidazole derivatives attractive ligands to interact with biopolymers of a living system. The most prominent benzimidazole compound in nature is N-ribosyldimethylbenzimidazole, which serves as an axial ligand for cobalt in vitamin B12. This structural similarity prompted medicinal chemists across the globe to synthesize a variety of benzimidazole derivatives and to screen those for various biological activities, such as anticancer, hormone antagonist, antiviral, anti-HIV, anthelmintic, antiprotozoal, antimicrobial, antihypertensive, anti-inflammatory, analgesic, anxiolytic, antiallergic, coagulant, anticoagulant, antioxidant and antidiabetic activities. Hence, benzimidazole nucleus is considered as a privileged structure in drug discovery, and it is exploited by many research groups to develop numerous compounds that are purported to be antimicrobial. Despite a large volume of research in this area, no novel benzimidazole derived compound has emerged as clinically effective antimicrobial drug. In the present review, we have compiled various reports on benzimidazole derived antimicrobials, classified as monosubstituted, disubstituted, trisubstituted and tetrasubstituted benzimidazoles, bisbenzimidazoles, fused-benzimidazoles, and benzimidazole derivative-metal complexes. The purpose is to collate these research reports, and to generate a generalised outlay of benzimidazole derived molecules that can assist the medicinal chemists in selecting appropriate combination of substituents around the nucleus for designing potent antimicrobials.

Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo) Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study.

INTRODUCTION: Total mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery. METHODS AND ANALYSIS: STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ≤cT3b (up to 5 mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2. ETHICS AND DISSEMINATION: The medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN14240288, 20 October 2016. NCT02945566; Pre-results, October 2016.

Relationship Between Knee Pain and Patient Preferences for Joint Replacement: Health Care Access Matters.

OBJECTIVE: To determine if severity of osteoarthritis-related knee pain is associated with a willingness to undergo total knee replacement (TKR) and whether this association is confounded or modified by components of socioeconomic status and health care coverage. METHODS: Cross-sectional analysis was conducted among 3,530 Osteoarthritis Initiative study participants. Logistic regression models were used to assess the effect of knee pain severity (where 0 = none, 1-3 = mild, 4-7 = moderate, and 8-10 = severe) on willingness to undergo TKR. Stratified analyses were conducted to evaluate whether socioeconomic status and health care coverage modify the effect of knee pain severity on willingness. RESULTS: Participants with severe knee pain, compared to participants without pain, were less willing to undergo TKR (odds ratio [OR] 0.73, 95% confidence interval [95% CI] 0.57-0.93). This association was attenuated when adjusted for age, sex, comorbidity, depression, health insurance coverage, prescription medicine coverage, health care source, education, income, employment, race, and marital status (adjusted OR 0.92, 95% CI 0.68-1.24). The odds of willingness to undergo TKR were significantly lower in those with the highest level of pain, compared to those without pain, among participants without health insurance (adjusted OR 0.08, 95% CI 0.01-0.56), but not among those with health insurance (adjusted OR 1.03, 95% CI 0.73-1.38), when adjusted for demographic, clinical, health care access, and socioeconomic factors (P = 0.015). However, <5% of participants were without health insurance. CONCLUSION: Among participants without health insurance, severe knee pain was paradoxically associated with less willingness to undergo TKR. Policies that improve access to quality health care may affect patient preferences and increase utilization of TKR surgery among vulnerable populations.

Evaluation of Placental Extracts as an Adjuvant Therapy to Phenol in Treatment of Idiopathic Guttate Hypomelanolsis.

INTRODUCTION: Idiopathic Guttate Hypomelanolsis (IGH) macules are hypo pigmented lesions occurring due to decreased functioning of melanocytes due to photosensitivity or persistent irritation of skin in middle aged and elderly. AIM: To find out the efficacy of placental extracts when used as an adjunct with 88% phenol for the treatment of IGH macules. MATERIALS AND METHODS: A total of 40 patients were randomly divided into two groups (n=20 in each group), viz group P, (the control group, treated with only 88% phenol) and Group PP (study group, treated with Placental extracts along with 88% phenol). Spot peeling was done with 88% phenol in both the groups while group PP was advised to use placental extract at night for 3 months. Patients of both groups were assessed both subjectively and objectively after every session and at the end of 3 months of initiation of therapy. The statistical analysis was done using Chi-square test, Z-test and a p-value<0.05 was considered significant. RESULTS: Both the groups showed significant re-pigmentation of lesions i.e., 76.8% in group P and 79.1% in group PP; whereas, what group PP had shown was non- significantly (p=0.8203) better as compared to group P. CONCLUSION: The clinical and patient acceptability of phenol along with the placental extracts as an adjuvant was better with similar results. Hence, the use of placental extract is recommended along with phenol in IGH lesions.

Hyperuricaemia - A Potential Indicator to Diagnose the Risk of Essential Hypertension.

INTRODUCTION: Hypertension has turned out to be the major cause of morbidity among the life style diseases. Studies in human and animal models have documented an independent association of hyperuricaemia with early hypertension. Hyperuricaemia is a modifiable and treatable risk factor, which might reduce the incidence of Essential Hypertension (EHT). AIM: Hence, the present study was designed to find out the association between hyperuricaemia and EHT in the population of Southern Rajasthan as there is a dearth of literature on Indian scenario especially in Rajasthan. MATERIALS AND METHODS: A cross-sectional, case control study was carried out in the Department of Physiology among 125 subjects; aged 20-50 years of both sexes, which were chosen randomly from Medicine OPD and healthy volunteers. The subjects were broadly divided into two groups (A & B); group A comprised of newly diagnosed cases of EHT (n=75) and group B had healthy normotensive controls (n=50). S. Uric Acid (SUA), Serum creatinine and fasting blood glucose levels were estimated by using the respective kit methods on semi auto-analyser in both groups. S. creatinine and fasting blood glucose levels were estimated to exclude renal disorder and diabetes mellitus respectively. The data was analysed by student t-test, chi-square test and Odds Ratio. RESULTS: The mean SUA level in group A was significantly higher than group B (6.56 ± 0.76, 4.91 ± 0.97 mg/dl, p<0.001 respectively). 37.33% of patients had hyperuricaemia in group A as compared to 14% in group B (p<0.01, OR=3.66) indicating that a hyperuricaemic individual has 3.66 times more risk of developing EHT as compared to the one with lower value of SUA. CONCLUSION: The mean SUA level and the frequency of hyperuricaemia was significantly higher in newly diagnosed cases of EHT as compared to healthy controls. Hence, SUA could be useful as a potential indicator for early risk detection of development of EHT.

Correlation of α-Lipoic Acid and S. Glutathione Level with Free Radical Excess in Tobacco Consumers.

INTRODUCTION: Tobacco consumption is a serious health hazard and most important avoidable cause of death worldwide. Tobacco is recognized as lethal toxin, ripping off 7-11 minutes of human life with each cigarette through harmful compounds and inducing free radical synthesis and a high rate of lipid peroxidation. These free radicals are scavenged by the endogenous antioxidants viz. S. Glutathione (S.GSH) and S. α-Lipoic acid (S. α-LA), thus preventing the endothelial damage. AIM: The present study was designed with an aim to find out the lipid peroxidative stress through S. Malondialdehyde (S.MDA) and its correlation with antioxidant levels like S. Glutathione (S. GSH) and S. α- Lipoic acid (S. α- LA) among tobacco users (in both smokers and chewers). MATERIALS AND METHODS: A case control cross-sectional study was carried out in the Department of Physiology among 200 subjects; aged 18-50 years of both sexes which were chosen randomly from institutional campus and healthy volunteers. The subjects were broadly divided into two groups (A & B); group A comprised of tobacco users (n=150) with history of smoking cigarette/biddies and chewing tobacco daily, for at least one year and group B had controls (non tobacco users) (n=50). S. MDA, S.GSH and S. α-LA levels were estimated by standardized methods. The data was analysed by unpaired student t-test and Pearson's correlation coefficient (r) for finding the correlation between antioxidants and S.MDA in group-A and group-B. RESULTS: The present study reports the significantly higher (p<0.0001) levels of S.MDA and lower (p<0.0001) levels of S.GSH and S. α-LA in tobacco users as compared to nontobacco users. The observed value of S.MDA was (2.72±0.87, 1.39±0.47) nmol/ml, S. α-LA was (9.94±5.96, 14.24 ± 4.34) µg/ml and S.GSH was (23.24±7.04, 32.82±2.95) mg/dl respectively in group-A and group-B. A significant (p<0.01) strong negative correlation was observed between S. MDA and antioxidants (S.GSH and S. α-LA) with a Pearson co-efficient of r=-0.619, r= -0.625 respectively, in group A. CONCLUSION: The decreased level of S. α-LA and S. GSH, in our study clearly indicates potential risk of cellular damage in tobacco users due to lipid peroxidation. Hence, the present study recommends supplementation of S. α-LA and Vitamin C in tobacco users to prevent this damage whereas quitting this evil habit will be the best available option.