A systematic review and meta-analysis of the clinimetric properties of the core outcome measurement instruments for clinical effectiveness trials of nutritional and metabolic interventions in critical illness (CONCISE).

BACKGROUND: CONCISE is an internationally agreed minimum set of outcomes for use in nutritional and metabolic clinical research in critically ill adults. Clinicians and researchers need to be aware of the clinimetric properties of these instruments and understand any limitations to ensure valid and reliable research. This systematic review and meta-analysis were undertaken to evaluate the clinimetric properties of the measurement instruments identified in CONCISE. METHODS: Four electronic databases were searched from inception to December 2022 (MEDLINE via Ovid, EMBASE via Ovid, CINAHL via Healthcare Databases Advanced Search, CENTRAL via Cochrane). Studies were included if they examined at least one clinimetric property of a CONCISE measurement instrument or recognised variation in adults ≥ 18 years with critical illness or recovering from critical illness in any language. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist for systematic reviews of Patient-Reported Outcome Measures was used. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were used in line with COSMIN guidance. The COSMIN checklist was used to evaluate the risk of bias and the quality of clinimetric properties. Overall certainty of the evidence was rated using a modified Grading of Recommendations, Assessment, Development and Evaluation approach. Narrative synthesis was performed and where possible, meta-analysis was conducted. RESULTS: A total of 4316 studies were screened. Forty-seven were included in the review, reporting data for 12308 participants. The Short Form-36 Questionnaire (Physical Component Score and Physical Functioning), sit-to-stand test, 6-m walk test and Barthel Index had the strongest clinimetric properties and certainty of evidence. The Short Physical Performance Battery, Katz Index and handgrip strength had less favourable results. There was limited data for Lawson Instrumental Activities of Daily Living and the Global Leadership Initiative on Malnutrition criteria. The risk of bias ranged from inadequate to very good. The certainty of the evidence ranged from very low to high. CONCLUSIONS: Variable evidence exists to support the clinimetric properties of the CONCISE measurement instruments. We suggest using this review alongside CONCISE to guide outcome selection for future trials of nutrition and metabolic interventions in critical illness. TRIAL REGISTRATION: PROSPERO (CRD42023438187). Registered 21/06/2023.

Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE).

BACKGROUND: Clinical research on nutritional and metabolic interventions in critically ill patients is heterogenous regarding time points, outcomes and measurement instruments used, impeding intervention development and data syntheses, and ultimately worsening clinical outcomes. We aimed to identify and develop a set of core outcome domains and associated measurement instruments to include in all research in critically ill patients. METHODS: An updated systematic review informed a two-stage modified Delphi consensus process (domains followed by instruments). Measurement instruments for domains considered 'essential' were taken through the second stage of the Delphi and a subsequent consensus meeting. RESULTS: In total, 213 participants (41 patients/caregivers, 50 clinical researchers and 122 healthcare professionals) from 24 countries contributed. Consensus was reached on time points (30 and 90 days post-randomisation). Three domains were considered 'essential' at 30 days (survival, physical function and Infection) and five at 90 days (survival, physical function, activities of daily living, nutritional status and muscle/nerve function). Core 'essential' measurement instruments reached consensus for survival and activities of daily living, and 'recommended' measurement instruments for physical function, nutritional status and muscle/nerve function. No consensus was reached for a measurement instrument for Infection. Four further domains met criteria for 'recommended,' but not 'essential,' to measure at 30 days post-randomisation (organ dysfunction, muscle/nerve function, nutritional status and wound healing) and three at 90 days (frailty, body composition and organ dysfunction). CONCLUSION: The CONCISE core outcome set is an internationally agreed minimum set of outcomes for use at 30 and 90 days post-randomisation, in nutritional and metabolic clinical research in critically ill adults.

Indocyanine green enhanced near-infrared fluorescence imaging for perfusion assessment of colonic conduit for esophageal replacement: Utility of a novel technique.

Esophagectomy, followed by esophageal replacement using gastric/colonic conduits, is a complex surgical procedure with significant perioperative morbidity. The most significant and potentially life-threatening complication associated with esophageal replacement is conduit ischaemia, resulting in anastomotic leak and conduit necrosis. Ensuring adequate perfusion of the conduit remains the key to preventing conduit ischaemia. Indocyanine green (ICG) enhanced near-infrared fluorescence imaging is a novel technique which has been used for assessing bowel perfusion. While numerous studies have focused on ICG fluorescence imaging for assessment of gastric conduit perfusion after esophagectomy, data regarding its use for colonic conduits is limited to case reports. ICG fluorescence imaging can help in resolving intraoperative issues by predicting the adequacy of colonic conduit perfusion, thereby preventing postoperative morbidity. To the best of our knowledge, this is the first report in Indian literature describing the utility of ICG fluorescence imaging for assessment of perfusion of colonic interposition.

Use of ABO-incompatible grafts in living donor liver transplantation--first report from India.

ABO incompatibility is the commonest reason for rejection of donors in living donor liver transplantation (LDLT). The donor pool could be expanded by 25 % to 35 % if the ABO barrier is overcome. In the absence of pre-conditioning, transplantation across the blood groups is fraught with the almost universal risk of antibody-mediated rejection (AMR) that rapidly leads to graft loss. However, AMR can be prevented by removal of preformed antibodies and reducing their production by B cells. We describe our initial experience of three cases of ABO-incompatible (ABO-i) LDLT: a 42-year-old male, an 8-month-old male and a 28-month-old female, all of blood group O+ who received blood group B + right lobe, B + left lateral segment, and A + left lateral segment liver grafts, respectively. Pre-LDLT conditioning included administration of anti-CD20 antibody (Rituximab(®)) to the adult 4 weeks prior, and four to seven sessions of double-filtration plasmapheresis to all, to remove preformed antibodies and achieve anti-donor blood group antibody (ADA) titers of ≤ 1:16 IgG and ≤ 1:8 IgM, respectively. In addition, cases 1 and 3 received mycophenolate mofetil for 7 days prior to LDLT. After LDLT, all three patients achieved normal graft function over 8-17 days with no evidence of AMR and without the need for further plasmapheresis. Postoperative complications included portal vein thrombosis (one successfully re-explored), CMV (one), Pseudomonas and Klebsiella sepsis (one each), and abdominal collection (one treated with percutaneous drainage). All are currently well with normal graft function and low ADA titers at 8, 16, and 19 months after ABO-i LDLT.

Renal functions in obstructive jaundice: a pre and post operative assessment.

Surgery in patients with surgical obstructive jaundice is known to be associated with increased risk of post-operative acute renal failure. A prospective study was carried out to evaluate the renal function in patients with obstructive jaundice. Renal functions of thirty two patients with jaundice secondary to mechanical obstruction of the biliary tract were evaluated pre-operatively and 7 days after surgical biliary decompression. Although no significant difference was seen in the mean values of pre and post operative renal function variables, two patients had overt renal failure, one with pre-operative cholangitis and acute tubular necrosis and another with carcinoma of the pancreas and postoperative acute renal failure. The overall satisfactory outcome in our obstructive jaundice patients may be related to pre-operative and intraoperative preparation with intravenous fluids and mannitol. It is concluded that patients with obstructive jaundice can be satisfactorily treated with special preoperative care including good hydration and mannitol therapy during anaesthesia and surgery.

Lichen planus limited to the nails.

The nails are commonly involved in cases of lichen planus of the skin and mucous membranes. However, in rare instances, the nails alone may be affected. A case of lichen planus limited to the nails in a 10-year-old boy is reported.

Contact Hypersensitivity to Topical Antimicrobial and Antifungal Agents.

To find out the incidence of hypersensitivity to antimicrobial drugs patch tests with various commercially available antimicrobial agents were carried out in 112 patients suspected of contact sensitivity to these substances. Eighty eight patients showed positive reaction to one or more drugs. H incidence of contact sensitivity was observed with neomycin (48%), nitrofurazone (460/o) and bromsalicyl chloranilide (45%), while gentian violet gentamicin and povidone iodine were found to be the least sensitizers (5%, 6% and 70/o - respectively). Multiple hypersensitivity (four or more drugs) was observed in 25 patients and a large number of them had ulcers at the time of study or in the past.

Evaluation of Sub-population of Lymphocytes and Serum Immunoglobulins in Psoriasis.

Sub-populations of lymphocytes and serum immunoglobulins were studied in 50 patients with psoriasis. Absolute T lymphocyte count was found to be significantly decreased. Though the null cells showed an increase, absolute B Lymphocyte count was normal. The decrease in T cells was found to be directly proportional to the extent of cutaneous involvement. Quantititive estimations of serum IgA and IgM were as IgO was found,to bc raised. The possible mechanism of these changes in psoriasis has been discussed.

Contact Depigmentation.

A case of depigmentation due to self sticking bindi, spectacles and plastic watch strap authenticated by loss of pigment on patch pigment on patch testing is reported. The relevant literature has been reviewed.

Sequential renal functions in leprosy.

Sequential renal functions have been studied in eight patients of lepromatous leprosy during and after subsidence of erythema nodosum leprosum. The renal functions which were impaired during reaction were observed to improve during quiescent phase unless there were associated complications like amyloidosis. The possible mechanisms for altered renal functions during reactive phase of the disease have been discussed.

A study of percutaneous renal biopsy in lepromatous leprosy.

Twenty one patients of lepromatous leprosy were investigated for evidence of renal diseases. Histological lesions were observed in 76 percent cases. Sixty two percent of the cases showed a proliferative type of glomerulonephritis. Amyloidosis was present in 14 percent. The remaining 24 percent had either non-specific changes confined to renal tubules or were normal.

Sequential renal functions in leprosy

Sequential renal functions have been studied in eight patients of lepromatous leprosy during and after subsidence of erythema nodosum leprosum. The renal functions which were impaired during reaction were observed to improve during quiescent phase unless there were associated complications like amyloidosis. The possible mechanisms for altered renal functions during reactive phase of the disease have been discussed.

A study of percutaneous renal biopsy in lepromatous leprosy

Twenty one patients of lepromatous leprosy were investigated for evidence of renal diseases. Histological lesions were observed in 76 percent cases. Sixty two percent of the cases showed a proliferative type of glomerulonephritis. Amyloidosis was present in 14 percent. The remaining 24 percent had either non-specific changes confined to renal tubules or were normal.

Renal functional status in lepromatous leprosy.

Renal functional status was evaluated in 122 patients with lepromatous leprosy. Renal functions were found to be markedly impaired in patients with erythema nodosum leprosum (ENL) in the active or quiescent phases. Although uncomplicated lepromatous leprosy patients did show significant renal impairment as compared to healthy controls, the degree of impairment was less than that of the reactive cases. Diminished endogenous creatinine clearance and proteinuria were the common abnormalities detected. Serum creatinine was significantly increased only in reactive cases. Blood urea was found to be marginally increased in a few patients although not to a statistically significant degree. Renal involvement did not bear any relation to the duration of illness or to the Bacteriological Index.

Chloracne.

A family of nine members developed chloracne possibly due to accidental ingestion of mobil oil. Among them two children died almost within a month following anorexia and severe vomiting.