Combined partial knee arthroplasty versus total knee arthroplasty: A systematic review and meta-analysis of randomised control trials.

Introduction: Postoperative pain management is of prime importance to the surgeon, as it significantly influences a patient’s recovery. A multimodal approach to pain management is an essential component of postoperative care. Curcumin, a natural antioxidant and anti-inflammatory compound, also exhibits analgesic properties. However, its use in the postoperative setting has not been extensively studied. Aim: To evaluate the role of oral curcumin as an analgesic in the management of postoperative pain following breast cancer surgery. Materials and Methods: This was a single-blind, randomised controlled trial that was conducted in the Department of Surgical Oncology, Cancer Research Institute, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India and included 60 patients undergoing surgery for breast cancer between October 2023 and April 2024. The study group was administered oral curcumin lozenges twice daily, along with standard analgesics, from Postoperative Day (POD) 1. The control group received a placebo. Postoperative pain was assessed from POD 0 to POD 7 using the 11-point Numeric Pain Scale (NPS) and compared using the independent t-test performed with the Statistical Package for the Social Sciences (SPSS) version 25.0. Results: Sixty patients were enrolled (30 in each group). One patient in the study group was excluded from the final analysis as the study protocol was not followed; therefore, 59 patients were analysed. A statistically significant difference in pain scores between the study and control groups was observed on POD 6 and POD 7 (p-value=0.006). No significant difference was observed between the groups regarding the use of SOS analgesics (p-value=0.322) or drain output (p-value>0.05). No adverse events were reported by any patient in the study group. Conclusion: This study demonstrated that curcumin may be beneficial in postoperative pain management. The use of a nutraceutical such as curcumin, with its favourable safety profile and minimal side-effects, offers a promising option. A longer follow-up period is warranted to fully explore the analgesic potential of curcumin. Additionally, studies employing a doubleblind design and larger sample sizes are recommended to provide further evidence of its effectiveness in postoperative pain management.

“Indocyanine green enhanced TTT Vs TTT for treatment of thicker tumors in Retinoblastoma- a randomised control trial”

Introduction: Postoperative pain management is of prime importance to the surgeon, as it significantly influences a patient’s recovery. A multimodal approach to pain management is an essential component of postoperative care. Curcumin, a natural antioxidant and anti-inflammatory compound, also exhibits analgesic properties. However, its use in the postoperative setting has not been extensively studied. Aim: To evaluate the role of oral curcumin as an analgesic in the management of postoperative pain following breast cancer surgery. Materials and Methods: This was a single-blind, randomised controlled trial that was conducted in the Department of Surgical Oncology, Cancer Research Institute, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India and included 60 patients undergoing surgery for breast cancer between October 2023 and April 2024. The study group was administered oral curcumin lozenges twice daily, along with standard analgesics, from Postoperative Day (POD) 1. The control group received a placebo. Postoperative pain was assessed from POD 0 to POD 7 using the 11-point Numeric Pain Scale (NPS) and compared using the independent t-test performed with the Statistical Package for the Social Sciences (SPSS) version 25.0. Results: Sixty patients were enrolled (30 in each group). One patient in the study group was excluded from the final analysis as the study protocol was not followed; therefore, 59 patients were analysed. A statistically significant difference in pain scores between the study and control groups was observed on POD 6 and POD 7 (p-value=0.006). No significant difference was observed between the groups regarding the use of SOS analgesics (p-value=0.322) or drain output (p-value>0.05). No adverse events were reported by any patient in the study group. Conclusion: This study demonstrated that curcumin may be beneficial in postoperative pain management. The use of a nutraceutical such as curcumin, with its favourable safety profile and minimal side-effects, offers a promising option. A longer follow-up period is warranted to fully explore the analgesic potential of curcumin. Additionally, studies employing a doubleblind design and larger sample sizes are recommended to provide further evidence of its effectiveness in postoperative pain management.

Introduction: I-gel®, a second-generation supraglottic airway device with a soft, anatomically shaped cuff, which produces an airway seal without the need for air inflation. Distinctive features of the paediatric airway may interfere with ideal insertion of Supraglottic Airway Devices (SADs). Therefore, it is important to recognise the most effective technique for I-gel® placement in paediatric patients to minimise airway-related complications. Aim: To compare the triple airway manoeuvre and reverse insertion technique for I-gel® placement in paediatric patients under general anaesthesia. Materials and Methods: This single blinded, Randomised Controlled Trial (RCT) was conducted at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, Haryana, India, over a period of 14 months from July 2023 to September 2024 in 100 paediatric patients (7-12 years), American Society of Anaesthesiologists-Physical Status (ASA-PS) grade I and II of either gender planned for elective surgery. Randomisation was performed into two groups using a computer-generated random number table, with 50 patients in each group. In Group R, I-gel® placement was done using the reverse insertion technique (n=50) and in Group TAM, I-gel® was placed using the triple airway manouvre, i.e. head tilt, jaw thrust, mouth open (n=50). Mean insertion time was measured as the primary outcome. Other parameters studied were the number of attempts, overall success rate, ease of I-gel® insertion, ease of nasogastric tube insertion and postoperative complications. Wilcoxon-Mann-Whitney U test, Chi-squared test, Fisher’sexact test were used to analyse data. A p-value <0.05 was considered statistically significant. Results: The demographic profile of all 100 patients was comparable in both groups, based on age, gender, Body Mass Index (BMI) and ASA-PS classification. The mean±SD of insertion time in group R was 18.65±8.07 sec and in group TAM was 16.84±6.93 sec. The device was successfully placed on the first attempt in 90% of patients in group R compared with 84% in group TAM. The overall success rate was 100% in both groups. Conclusion: TAM and reverse insertion techniques of I-gel® placement were comparable clinically. The experience of the investigator with the technique should determine the choice of technique.

EEG microstate beta-band abnormalities in obsessive-compulsive disorder: Associations with disease symptoms and sensitivity to repetitive transcranial magnetic stimulation.

Radiofrequency ablation versus surgical resection as first-line treatment for very early stage hepatocellular carcinoma: a systematic review with meta-analysis.

Randomized controlled trials (RCTs) assessing the implementation of evidence-based psychological treatments (EBPTs) into clinical practice may involve variations that are not always systematically investigated. This study aimed to investigate the impact of such variations in the context of an effectiveness-implementation hybrid trial - specifically, the relationship between trial outcomes and number of treatment sessions, dropout, and differences in assessment timing. Adults (N = 539) with sleep and circadian problems were randomized to the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TSC; Adapted or Standard version) or usual care followed by delayed treatment (UC-DT). Participants who completed the recommended number of TSC sessions showed larger effect sizes and more significant improvements relative to UC-DT, when compared to participants who received a partial session dose. Notably, a substantial number of participants who dropped out of treatment showed a meaningful clinical change by mid-treatment (20%), though this number did not differ significantly from the number of patients who received the full dose of treatment. Larger treatment effects were observed when assessments were completed within 3 months of their planned date. Kaplan-Meier Survival Analyses indicated that the dose to optimize the primary outcome of sleep disturbance at post-treatment was eight sessions for Standard TSC and six sessions for Adapted TSC. This study underscores the impact of methodological variations on treatment outcomes in the implementation of TSC into clinical practice. Furthermore, our findings establish specific session thresholds for Standard and Adapted TSC to optimize clinical outcomes.

Introduction: The oral cavity is the second largest microbial niche in the human body, following the gut. The colonisation of microorganisms on the teeth and gums harbours harmful bacteria, which can trigger inflammation, potentially leading to periodontal breakdown and tooth loss. To eliminate bacterial biofilms, several methods are employed. Among these, the most effective are chemical methods, which include antiseptic and antimicrobial agents. Although these agents can have potential benefits, they also come with side-effects. To minimise the sideeffects of chemical-based plaque control, there is a paradigm shift towards herbal alternatives. One such plant known for its medicinal properties is Commiphora myrrha, which possesses antimicrobial properties that improve plaque control. Aim: To assess the efficacy of Commiphora myrrha in the management of gingivitis. Materials and Methods: A comprehensive search was conducted using Medline via PubMed, Cochrane, ProQuest and Google Scholar. The combination of keywords used was: Myrrh OR Commiphora myrrha OR Herbal extract AND Gingivitis AND Plaque AND Inflammation, Myrrh AND Commiphora myrrha AND Gingivitis. Articles published from January 1, 2014, to December 31, 2024, were included to identify the efficacy of Commiphora myrrha in the management of gingivitis. After a thorough search, a total of five articles were included in the review. The inclusion criteria were: patients aged between 18-35 years, signs of chronic gingivitis in at least six sites, Bleeding on Probing (BOP) and periodontal pockets with a depth of no more than 3 mm. Exclusion criteria included patients with periodontal pockets greater than 3 mm, those with severe malocclusion, use of antibiotic or anti-inflammatory medication, pregnant or breastfeeding women, oral prophylaxis in the past six months, a history of allergy to chemical or herbal products and patients using smoking or smokeless tobacco. The reporting of this systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The quality assessment of the studies was performed using the Cochrane risk of bias assessment tool for Randomised Controlled Trials (RCT), the Risk of Bias in Non randomised Studies (ROBINS) tool for non randomised trials and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Results: A total of five studies were included (four randomised and one non randomised controlled trial), comprising 166 patients who met the inclusion criteria. One of these studies was conducted in India, three in the Kingdom of Saudi Arabia and one in Egypt. Diagnoses in all five studies were based on clinical and histological examination. The p-values of the included studies were as follows: p<0.006, p<0.05, p=0.08, p<0.001 and Zahid p>0.05. All five studies found Commiphora myrrha to be effective in reducing gingival inflammation, with results comparable to chemical plaque control and minimal side-effects. Therefore, Commiphora myrrha shows promise as an effective adjunct therapy for managing gingivitis. Conclusion: The present systematic review demonstrates that Commiphora myrrha exhibits significant anti-inflammatory properties. When used in combination with other oral healthcare regimens, Commiphora myrrha could offer beneficial effects in improving overall oral health and managing gingivitis.

Early supplemental parenteral nutrition shortens ventilation and intensive care unit stay in ICU patients aged ≥60 Years requiring mechanical ventilation: A randomized controlled trial.

This study aimed to evaluate the role of egocentric and allocentric perspectives in facilitating far transfer (improvement of emotional state and psychomotor functions) following cognitive training in stroke patients. In a three-arm, non-blind, randomized clinical trial, 128 patients with acute stroke were randomly allocated to one of the following groups: 1) control, 2) allocentric perspective, or 3) egocentric perspective groups. Each group received a 2-week intervention, with the experimental groups completing an additional 10 sessions. Cognitive function was measured by the Addenbrooke Cognitive Evaluation-III, depression by the Patient Health Questionnaire-9, anxiety by the Generalized Anxiety Disorder-7 scale, and psychomotor function by the Finger Tapping Test. Cognitive training tasks based on allocentric and egocentric perspectives, when combined with conventional rehabilitation, did not yield a statistically significant far transfer effect compared to conventional rehabilitation alone. No significant differences between-groups were observed for changes in anxiety (F(2, 111) = .056, p = .945, η2 = .058), depression (F(2, 109) = 0.831, p = .160, η2 = .074), or dominant (F(2, 111) = 0.059, p = .943, η2 = .001) and non-dominant (F(2, 108) = 1.375, p = .257, η2 = .290) psychomotor functions. The incorporation of an allocentric and egocentric perspective based cognitive training tasks in conventional rehabilitation do not provide significantly better improvements in emotional state and psychomotor functions. The ISRCTN clinical trial registry (https://doi.org/10.1186/ISRCTN14922230).

Idiopathic normal pressure hydrocephalus (iNPH) is a treatable condition characterized by impaired gait, cognition, and bladder function. Neuropsychiatric symptoms may be important in iNPH but are poorly understood. We report the first systematic review and meta-analysis estimating the prevalence, severity, and treatment responsiveness of neuropsychiatric symptoms and diagnoses in iNPH. We searched PubMed, CINAHL, Embase, Ovid, MEDLINE, Cochrane, and PsycINFO from inception until October 23, 2024, for peer-reviewed, original studies in adults with definite, probable, or possible iNPH that reported neuropsychiatric features using validated tools or clinician diagnosis (PROSPERO CRD42021287293). Case studies and series, as well as studies where diagnostic criteria for iNPH were unclear, were excluded. Study quality assessment and data extraction were independently performed by 2 authors, according to a proforma developed iteratively. Random-effects meta-analysis was used to pool proportions and standardized mean differences. Meta-regression, subgroup analysis, and sensitivity analysis were performed. Twenty-two studies were included, of which 1 was a randomized-controlled trial. For our primary outcome, we found a high prevalence of apathy (69.2%, 95% CI 63.1-74.6, n = 293) and depression (30.1%, 20.1-42.3, n = 7,670) in iNPH. Agitation (22.6%, 11.8-39.1), anxiety (21.9%, 13.2-34.2), disinhibition (21.0%, 11.8-34.7), and psychotic syndromes (8.0%, 3.3-18.3) were relatively less prevalent. Depression scores were higher in patients with iNPH than in controls (Hedge's g 1.31, 0.39-2.23). Treatment of iNPH was associated with a reduction in depression scores (-0.30, -0.62 to 0.01), although the confidence interval contained the null. A total of 12 of 22 studies were rated 'low' quality. Apathy and depression are highly prevalent in iNPH, maybe more so than in other neurodegenerative conditions. Little is known about other neuropsychiatric features in iNPH. Treatment of iNPH may reduce neuropsychiatric symptoms, particularly depression. However, our study was limited by heterogeneity in populations and assessment tools and a lack of baseline data on neuropsychiatric symptoms before iNPH diagnosis. These findings highlight the urgent need for further research into neuropsychiatric features in iNPH, their mechanisms, and their potential response to treatment.

Fatigue is a common problem that significantly affects intensive care unit (ICU) survivors' physical, psychological, and social functioning. ICU survivors often experience a loss of self-worth and identity, struggle to return to their normal roles, and face ongoing challenges with cognitive and emotional recovery. Despite its profound impact, there are limited rehabilitation interventions targeting this population. This research aims to evaluate the acceptability of implementing the Fatigue After CriTical illness (FACT) self-management intervention into usual care for patients experiencing fatigue after critical illness and the feasibility of the intervention for a future clinical trial. This is a multicentre, open-label, feasibility randomised controlled trial (RCT) with an embedded qualitative evaluation, conducted across. Seventy participants recruited from three United Kingdom (UK) National Health Service (NHS) Trusts will be randomised either to the FACT self-management intervention following hospital discharge, which focuses on fatigue management, goal setting, and personal action planning, in addition to usual care, or to a control group receiving usual care alone. The intervention will be accessible for six months and will include a 30-min phone or video call with an ICU follow-up healthcare professional (HCP) in the third month. HCPs will attend an online training session and follow a protocol to guide patients in goal setting. Outcome assessments will occur at baseline, three months, and six months post-randomisation to evaluate feasibility and acceptability. Semi-structured interviews with patients and HCPs will explore their experiences and acceptability outcomes at 6months. This study aims to provide insights into the feasibility and acceptability of the FACT intervention, with the goal of improving fatigue management among survivors of critical illness. Preliminary findings will inform the design of a larger-scale RCT to evaluate its effectiveness in enhancing recovery from critical illness in patients who are experiencing fatigue. Study ID: ISRCTN1381359. Date registered: 01/04/2025.

This opinion piece discusses the challenges of managing a person with sight-threatening papilloedema due to idiopathic intracranial hypertension (IIH). With no available randomised controlled trials, clinicians often choose a locally available surgical intervention. An increasing number of studies have advocated using dural venous sinus stenting in IIH. Big data studies show that shunts have been the mainstay of surgical treatment for IIH, and recent evidence shows improved outcomes and fewer revision surgeries. There remains genuine equipoise in the choice of intervention between shunting and dural venous stenting in IIH. The IIH Intervention Trial funded by the National Institute of Health Research is underway in the UK, the first randomised control trial to evaluate both of these surgical interventions in people with sight-threatening IIH.

Evidence on the performance of foetal growth ultrasound parameters to detect the Small-for-Gestational-Age (SGA) foetus for a selective cohort is limited. We report the performance of estimated foetal weight under the 10th percentile (EFW < 10th) at the last selective screening ultrasound to detect SGA based on gestational age of scan and scan to birth interval. We performed a prospective cohort study to analyse ultrasound data obtained from the DESiGN trial. The DESiGN trial was the first cluster randomised controlled trial to evaluate the impact of the Growth Assessment Protocol (GAP) on antenatal detection of SGA. Ninety-four thousand, nine hundred twenty-five women included in DESiGN who had at least 1 ultrasound scan after 24 weeks' gestational age with complete ultrasound data underwent analysis. Test performance characteristics of EFW (by Hadlock 1991) < 10th percentile to predict birthweight < 10th percentile (by 1990 UK Population Charts) were reported at different gestational ages of scan categories and scan to birth intervals. The performance of EFW < 10th percentile at the last selective screening ultrasound to correctly identify SGA declined from 34 weeks and with increasing scan to birth intervals. A scan between 34 and 37 + 6 weeks' gestation more than 4 weeks prior to birth had a particularly poor performance (sensitivity 4.0%, 95% CI 3.8-4.1). In a selected population, the performance of late third-trimester ultrasound estimation of foetal size to detect SGA at birth is poor.

Conventional occlusion is an effective treatment for amblyopia; however, adherence remains a significant barrier. This is the first randomised controlled trial (RCT) investigating whether objective, electronically monitored adherence "feedback" improves amblyopia treatment adherence. This unmasked, parallel two-armed multicentre RCT included 102 children aged 3-8 yrs with monocular amblyopia (≥0.3 logMAR interocular difference). Participants could have up to 18 months of previous patching and were prescribed 10 h/6days of patching. Participants were randomised to a Feedback Group (n = 51), receiving feedback from treatment monitors, or Controls (n = 51). Change in adherence (CA) was measured from the first to last available monitor for patching and glasses over 12 weeks. Regression models explored factors influencing visual outcome and adherence. Of 102 participants, 74 were analysed for patching and 78 for glasses. Mean patching CA was -0.39 ± 2.01 h/day (control) versus -0.32 ± 2.20 h/day (feedback), with no significant group difference (P = 0.89). Median glasses-wearing CA was -0.55 IQR:2.55 h/day (control) vs. -0.05 IQR:1.73 h/day (feedback), also non-significant (P = 0.38). Overall average adherence to glasses was 10.3 h/day and 7.9 h/day for patching. Younger age, less previous patching, and higher adherence to treatment significantly predicted better visual outcome. Females had significantly lower glasses-wearing adherence. This study shows for the first time that patching and glasses adherence can be monitored and fed back to patients and their carers. While we found no additional influence of feedback on adherence, we observed that when children and their guardians were aware of active monitoring and frequently seen, we observed high and sustained levels of adherence. The significant correlations to visual outcomes further highlight the importance of early treatment in amblyopia.

Health services research faces the challenge of providing sound recommendations for action for the further development of health systems and care. The application of causal inference methods offers health services researchers an excellent opportunity to identify causal relationships under everyday conditions. The role of clinical trials with a classic randomised controlled trial (RCT) design is recognised as suitable for gaining insights that help establish causal inference, but other methodological approaches to generating evidence also play an important role in health services research.The discussion paper presents key concepts and assumptions of causal inference and highlights their relevance for health services research. The paper makes it clear that in order to fulfil the assumptions, it is necessary to integrate theory, contextual knowledge, understanding of mechanisms and formal concepts, such as directed acyclic graphs (DAGs), into a suitable empirical study design. To this end, RCTs, quasi-experimental methods, causal machine learning, target trial emulation, in silico trials and the mixed-methods approach of integrated inference are presented and discussed in terms of their applicability in health services research and their internal and external validity.All of the approaches presented here can contribute to the estimation of causal effects when used in a targeted manner and in accordance with the central assumptions. Their suitability depends largely on the research question, data quality, theoretical modelling and contextual knowledge. The combination of complementary designs and high quality data sources can increase the robustness of causal conclusions.Causal inference in health services research is not only a methodological procedure, but an integrative process that systematically combines theory, methodology and contextual knowledge. By consistently linking these aspects, health services research can generate differentiated and actionable insights that go beyond correlative analyses and enable an understanding of the mechanisms of causal processes. This can lead, for example, to evidence-supported recommendations that critically examine the often non-evidence-based status quo and reliably evaluate the benefits of new models.

To test the feasibility and safety of a randomized controlled trial (RCT) delivering nitric oxide into the sweep gas of extracorporeal membrane oxygenation (ECMO) circuits (sNO) in critically ill children. Second, we explored whether use of sNO may influence clinical outcomes. Prospective pilot single-center open-label RCT (trial registration number ACTRN12619001518156). Single-center, tertiary PICU with enrollment between July 2020 and July 2023. Patients from birth to 16 years requiring venoarterial or venovenous ECMO support were enrolled. Randomization to sweep flow with an oxygen/nitrogen mix vs. a mix of oxygen, nitrogen and sNO (20 parts per milliion). Randomization was stratified by type of ECMO support (venoarterial vs. venovenous). Of 60 eligible patients 53 underwent randomization. The median (interquartile range [IQR]) was 1 month (0.1-33.5 mo) and 6.2 months (0.5-120.2 mo) for the intervention and control arms, respectively. Venoarterial and venovenous support were used in 35 of 53 (65%) and 18 of 53 (35%) patients, respectively. In all, 17 of 53 (32%) received pulmonary, 23 of 53 (43%) cardiac and 13 of 53 (25%) extracorporeal cardiopulmonary resuscitation support. Median (IQR) survival free of ECMO and survival free of PICU censored at 30 and 90 days were similar: 18.2 days (0-25.2 d) and 69.1 days (0-85.2 d) vs. 20.8 days (0-26.3 d) and 77.7 days (0-85.9 d) with an effect estimate of -3.2 days (-16.6 to 10.1 d) and -8.8 days (-54.2 to 36.6 d) between the intervention and standard care arm. Blood product use, circuit duration to replacement, free plasma hemoglobin, degree of oxygenator thrombus, and incidence of methemoglobinemia were similar between the two groups. No major adverse events occurred related to the treatment allocation or intervention. This single-center pilot RCT of sNO vs. standard sweep flow in the ECMO circuit demonstrated that such a trial is safe and feasible. However, given no effect of sNO on clinical outcomes was detected further exploration of dose and route of administration of NO should be undertaken before larger, definitive trials are conducted.

A commentary on “Efficacy of a smartphone application assisting home-based rehabilitation and symptom management for patients with lung cancer undergoing video-assisted thoracoscopic lobectomy: a prospective, single-blinded, randomised control trial (POPPER study)”

Spinal hardware infection (SHI) is one of the most devastating complications of spine surgery with challenging and undefined antibiotic treatment modalities. Retrospective cohort study of patients ≥ 18 years of age who underwent surgery for the treatment of SHI at a university center between 1st January2015, to 1st January 2020. The aim was to determine the appropriate duration of suppressive antibiotic therapy (SAT) for SHI based on recurrent infection rate on SAT, rate of adverse drug reaction (ADR) from SAT, and rate of antibiotic resistance to SAT in patients with SHI. The median age of the 82 patients who met eligibility criteria for the study was 61 years (53-73), 55% were female, 60% had multimorbidity and 54% had early infection. Staphylococcus aureus was the most common cultured organism (45%) and 29 (35%) of patients had bacteremia. 54 (66%) received SAT with a median duration of 52 weeks (12 to 191 weeks). 12 (15%) had recurrence, while 8 (10%) developed recurrence on SAT. Neither SAT nor SAT duration (< 24 weeks, 24-52 or > 52 weeks) was associated with recurrence in early or late infection, regardless of hardware status. There was a non-significant higher recurrence rate with partial hardware revision, 7.3% (OR 6.30 [0.70-57.07]) and full hardware retention, 6.1% (OR 3.62 [0.39-33.30]) compared to complete hardware removal, (1.2%). ADR occurred in 6 (11%) of patients on SAT and in 11 (14%) of patents while on intravenous therapy, with no significant difference (mid-p exact 95% CI [0.32-1.80], p = 0.82). Only one case of drug resistance occurred with SAT. In patients who underwent surgery for SHI, neither the use of SAT nor SAT duration had any impact on recurrence of SHI regardless of SHI onset or hardware status. The rate of ADR with SAT was comparable to ADR with intravenous antibiotics and the rate of development of drug resistance was low. A randomized control trial is urgently needed to determine the role of SAT and its optimal application in the treatment of SHI. Not applicable.