Antibiotics Effective Alternative to Surgery for Acute Appendicitis. reveals breakthrough Study

In a groundbreaking study conducted at Sahlgrenska University Hospital, researchers have unveiled a game-changing approach to the treatment of acute appendicitis, challenging the conventional “wait and see” observation method. The study, involving 126 carefully selected patients, evaluated the effectiveness of early antibiotic treatment as superior compared to active in-hospital observation for the spontaneous regression of acute appendicitis.

The study was published in the journal Surgery.

Also Read: Elevation of total and direct bilirubin may predict acute complications among patients admitted for appendicitis

The administration of antibiotics to patients with acute appendicitis, regardless of specific selection criteria, has been deemed both safe and efficacious. Yet, uncertainties persist regarding the potential for early antibiotic provision to constitute overtreatment, given the possibility of spontaneous healing of appendix inflammation. This study seeks to address this ambiguity by examining the comparative impact of antibiotic treatment and active in-hospital observation on the natural regression of acute appendicitis.

Individuals seeking urgent medical attention at Sahlgrenska University Hospital underwent block randomization based on age (18-60 years) and systemic inflammation criteria (C-reactive protein <60 mg/L, white blood cell <13,000/μL). This process also considered the clinical and abdominal characteristics associated with acute appendicitis. Study participants were subjected to a treatment plan involving both antibiotic administration and active observation. Conversely, control group patients were assigned to the traditional “wait and see observation” approach, allowing for either the natural regression of the condition or the indication for surgical exploration.

Certified surgeons, following established surgical protocols, made the crucial decisions regarding the necessity and timing of appendectomy. A comprehensive screening process was conducted, involving a total of 1,019 patients assessed for eligibility. Among them, 203 met the inclusion criteria, leading to the acceptance of 126 participants. However, 29 individuals opted not to participate, and 48 were inadvertently excluded from the study.

Findings:

  • At the outset, both groups were comparable in terms of demographics and clinical presentation. However, the study revealed a stark contrast in outcomes.
  • Appendectomy at the first hospital stay was a mere 28% for the antibiotic group, whereas the control group saw a significantly higher rate of 53%.
  • This marked disparity in surgical intervention prompted the researchers to conduct a life table analysis, revealing a time-dependent difference in the need for appendectomy during the extended follow-up period (P < .03).
  • Throughout follow-ups spanning from 5 to an impressive 1,200 days, antibiotics demonstrated a substantial advantage, reducing the incidence of surgical intervention by 72% to 50%. In contrast, the control group exhibited lower rates of prevention, with a range of 47% to 37%.

The findings challenge the traditional approach to acute appendicitis, paving the way for a paradigm shift in treatment strategies. Early antibiotic treatment emerges as a superior alternative to the conventional “wait and see observation” method, offering a safe and effective means of avoiding surgical exploration and appendectomy.

Also Read: Risk factors for perforation of appendix among patients of appendicitis with appendicolithiasis?

This breakthrough could have far-reaching implications for the medical community, reshaping the standard of care for acute appendicitis and potentially sparing countless patients from unnecessary surgeries. As the medical field continues to evolve, this study provides a significant contribution toward more tailored and less invasive treatment options for a common abdominal emergency.

Further reading: Iresjö BM, Blomström S, Engström C, Johnsson E, Lundholm K. Acute appendicitis: A block-randomized study on active observation with or without antibiotic treatment. Surgery. Published online January 12, 2024. doi:10.1016/j.surg.2023.11.030

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ChatGPT may help residents improve their understanding of orthopaedic surgery and general orthopaedic principles

Publicly available AI language models such as ChatGPT have demonstrated utility in text generation and even problem-solving when provided with clear instructions. Amidst this transformative shift Diane Ghanem et al conducted a study to assess ChatGPT’s performance on the orthopaedic surgery in-training examination (OITE). Investigation performed at The Johns Hopkins Hospital, Baltimore, Maryland. It has been published in “JBJS Open Access.”

All 213 OITE 2021 web-based questions were retrieved from the AAOS-ResStudy website (https://www.aaos. org/education/examinations/ResStudy). Two independent reviewers copied and pasted the questions and response options into ChatGPT Plus (version 4.0) and recorded the generated answers. All media-containing questions were flagged and carefully examined. Twelve OITE media-containing questions that relied purely on images (clinical pictures, radio graphs, MRIs, CT scans) and could not be rationalized from the clinical presentation were excluded. Cohen’s Kappa coefficient was used to examine the agreement of ChatGPT-generated responses between reviewers. Descriptive statistics were used to summarize the performance (% correct) of ChatGPT Plus. The 2021 norm table was used to compare ChatGPT Plus’ performance on the OITE to national orthopaedic surgery residents in that same year.

Key findings of the study:

• A total of 201 questions were evaluated by ChatGPT Plus.

• Excellent agreement was observed between raters for the 201 ChatGPT-generated responses, with a Cohen’s Kappa coefficient of 0.947. 45.8% (92/201) were media containing questions.

• ChatGPT had an average overall score of 61.2% (123/201). Its score was 64.2% (70/109) on non media questions.

• When compared to the performance of all national orthopaedic surgery residents in 2021, ChatGPT Plus performed at the level of an average PGY3.

ChatGPT Plus is able to pass the OITE with an overall score of 61.2%, ranking at the level of a third-year orthopaedic surgery resident. It provided logical reasoning and justifications that may help residents improve their understanding of OITE cases and general orthopaedic principles. Further studies are still needed to examine their efficacy and impact on long-term learning and OITE/ABOS performance. 

Further reading:

ChatGPT Performs at the Level of a Third-Year Orthopaedic Surgery Resident on the Orthopaedic In-Training Examination

Diane Ghanem et al

JBJS Open Access 2023:e23.00103

http://dx.doi.org/10.2106/JBJS.OA.23.00103

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Hyperbaric Oxygen Therapy after adjuvant radiotherapy reduces fibrosis in breast cancer patients: JAMA

A recent randomized clinical trial published in the Journal of American Medical Association investigated the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in treating late local toxic effects experienced by women who underwent adjuvant radiotherapy for breast cancer. The trial from the UMBRELLA cohort study assess the impact of HBOT on pain, fibrosis, edema, movement restriction, and overall quality of life.

This trial was conducted in the Netherlands and involved a total of 189 women who were experiencing moderate to severe breast, chest wall, and/or shoulder pain, along with other symptoms, 12 months or more after breast irradiation. The participants were offered 30 to 40 HBOT sessions over 6 to 8 consecutive weeks. The pain levels were assessed using the European Organization for Research and Treatment of Cancer QLQ-BR23 questionnaire, while other symptoms assessed were the overall quality of life.

The trial found that while HBOT did not significantly reduce pain levels overall, it was effective in reducing fibrosis. Among women who completed HBOT, there was a significant reduction in both pain and fibrosis. Only 25% of women who were offered HBOT opted to undergo the treatment, with the main reason for refusal being mentioned as the high intensity of the therapy.

The outcomes suggest that while HBOT may not be universally effective in alleviating pain associated with late local toxic effects after breast irradiation, but, it shows promise in reducing fibrosis. The relatively low acceptance rate among participants indicates a need for further comprehensive investigation into the feasibility and acceptability of HBOT.

Reference:

Mink van der Molen, D. R., Batenburg, M. C. T., Maarse, W., van den Bongard, D. H. J. G., Doeksen, A., de Lange, M. Y., van der Pol, C. C., Evers, D. J., Lansdorp, C. A., van der Laan, J., van de Ven, P. M., van der Leij, F., & Verkooijen, H. M. (2024). Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer. In JAMA Oncology. American Medical Association (AMA). https://doi.org/10.1001/jamaoncol.2023.6776

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Cost effectiveness of home based albuminuria screening may help cut kidney and CV events

Cost-effectiveness of home-based albuminuria screening may help cut kidney and CV events suggests a new study published in the Lancet.

Chronic kidney disease (CKD) is often detected late, leading to substantial health loss and high treatment costs. Screening the general population for albuminuria identifies individuals at high risk of kidney events and cardiovascular disease (CVD) who may benefit from early start of preventive interventions. Previous studies on the cost-effectiveness of albuminuria population screening were inconclusive, but were based on survey or cohort data rather than an implementation study, modelled screening as performed by general practitioners rather than home-based screening, and often included only benefits with respect to kidney events. We evaluated the cost-effectiveness of home-based general population screening for increased albuminuria based on real-world data obtained from a prospective implementation study taking into account prevention of CKD as well as CVD events. They developed an individual-level simulation model to compare home-based screening using a urine collection device with usual care (no home-based screening) in individuals of the general population aged 45–80, based on the THOMAS study (Towards HOMe-based Albuminuria Screening). Cost-effectiveness was assessed from the Dutch healthcare perspective with a lifetime horizon. The costs of the screening process and benefits of preventing CKD progression (dialysis and kidney transplantation) and CVD events (non-fatal myocardial infarction, non-fatal stroke, fatal CVD event) were reflected. Albuminuria detection led to treatment of identified risk factors. The model subsequently simulated CKD progression, the occurrence of CVD events, and death. The risks of experiencing CVD events were calculated using the SCORE2 CKD risk prediction model and individual-level data from the THOMAS study. Relative treatment effectiveness, quality of life scores, resource use, and cost inputs were obtained from literature. Model outcomes were the number of CKD and CVD-related events, total costs, quality-adjusted life years (QALYs), and the incremental cost-effectiveness ratio (ICER) per QALY gained by screening versus usual care. All results were obtained through probabilistic analysis. Findings: The absolute difference between screening versus usual care in lifetime probability of dialysis, kidney transplantation, non-fatal myocardial infarction, non-fatal stroke, and fatal CVD events were 0.2%, 0.05%, 0.6%, 0.6%, and 0.2%, respectively. This led to relative decreases compared to usual care in lifetime incidence of these events of 10.7%, 11.1%, 5.1%, 4.1%, and 1.6%, respectively. The incremental costs and QALYs of screening were €1607 and 0.17 QALY, respectively, which led to a corresponding ICER of €9225/QALY. The probability of screening being cost-effective for the Dutch willingness-to-pay threshold for preventive population screening of €20,000/QALY was 95.0%. Implementing the screening in the subgroup of 45–64 years old reduced the ICER (€7946/QALY), whereas implementing screening in the subgroup of 65–80 years old increased the ICER (€10,310/QALY). A scenario analysis assuming treatment optimization in all individuals with newly diagnosed risk factors or known risk factors not within target range reduced the ICER to €7083/QALY, resulting from the incremental costs and QALY gain of €2145 and 0.30, respectively. Home-based screening for increased albuminuria to prevent CVD and CKD events is likely cost-effective. More health benefits can be obtained by screening younger individuals and better optimization of care in individuals identified with newly diagnosed or known risk factors outside target range.

Reference:

Pouwels XGLV, van Mil D, Kieneker LM, et al. Cost-effectiveness of home-based screening of the general population for albuminuria to prevent progression of cardiovascular and kidney disease. The Lancet. https://doi.org/10.1016/j.eclinm.2023.102414

Keywords:

Cost effectiveness, home based, albuminuria screening, kidney, CV events, lancet, Pouwels XGLV, van Mil D, Kieneker LM

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Intraoperative transesophageal echocardiography crucial for identifying intraabdominal bleeding during cardiac surgery

Recently published paper presents a case where intraoperative transesophageal echocardiography (TEE) played a crucial role in identifying intraabdominal bleeding during cardiac surgery. The patient, undergoing ascending aortic aneurysm and aortic valve repair, experienced increasing vasopressor and transfusion requirement during sternal closure, and TEE imaging revealed nonspecific, hypoechoic fluid anterior to the stomach. This prompted further investigation, leading to the confirmation of intraabdominal bleeding and successful hemostasis.

Communication Challenges in the Operating Room

The paper emphasizes the significance of effective communication between surgical and anesthesiology teams in guiding intraoperative management. It discusses a study by Raemer et al., which identified “uncertainty about the issue” as a common reason why anesthesiologists may choose not to speak up, highlighting the complexities of communication in the operating room. The presented case serves as an example where an anesthesiologist spoke up despite uncertainty about suspected intraabdominal hemorrhage, ultimately leading to timely intervention and patient recovery.

Clinical Course and Decision-Making Process

The study details the patient’s clinical course, highlighting the challenges in identifying the source of bleeding and the importance of TEE findings in guiding the decision-making process. The paper also discusses the rarity of intraabdominal complications in cardiac surgeries and the limited prior cases of TEE identifying intraabdominal bleeding. The successful outcome in this case underscores the critical role of effective communication and interdisciplinary collaboration in promptly addressing intraoperative complications.

Significance of TEE and Communication

Overall, the paper underscores the significance of TEE as an intraoperative monitoring tool and the pivotal role of effective communication between surgical and anesthesiology teams in guiding intraoperative management, particularly in cases of uncertainty. It provides valuable insights into the complexities of intraoperative decision-making and highlights the importance of utilizing TEE findings and fostering clear communication to ensure prompt evaluation and intervention, ultimately leading to improved patient outcomes.

Reference –

Mansoor A, Singhal A K, Hanada S (November 01, 2023) Transesophageal Echocardiography Assisting in the Identification of Intraabdominal Bleeding During Cardiac Surgery. Cureus 15(11): e48105. doi:10.7759/cureus.48105.

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NMC Rule to Cap MBBS Seats per population on Hold till Academic Year 2024-25: MoS Health informs Parliament

New Delhi: The Minister of State for Health, Dr. Bharati Pravin Pawar clarified recently before the Rajya Sabha that the National Medical Commission’s rule of capping the MBBS seats in a particular State/UT has been put on hold up to the academic year 2024-2025.

Referring to the “Guidelines for Under Graduate Courses under Establishment of New Medical Institutions, Starting of New Medical Courses, Increase of Seats for Existing Courses & Assessment and Rating Regulations, 2023”, which was issued by NMC on 16th August, 2023 and which prescribed a ratio of 100 MBBS seats for 10 lakh population in a State/UT, the MoS Health informed that the concerned rule has been put on hold for now.

The Minister was responding to the questions raised by Parliament member Shri P. Wilson who questioned whether the Government has taken any steps to address raised by Tamil Nadu government regarding the NMC notification, restricting new medical college and additional seats in existing medical colleges. He also asked whether any consultation process with the States had been undertaken by the Ministry regarding the notification in question.

Other queries included whether any clarification/report sought with regards to bill exempting NEET for medical examination in Tamil Nadu is pending for approval and whether the Government has considered approving the NEET exemption bill and if not, the reasons for the same.

Responding to these queries, the MoS Health Dr. Pawar informed, “The “Guidelines for Under Graduate Courses under Establishment of New Medical Institutions, Starting of New Medical Courses, Increase of Seats for Existing Courses & Assessment and Rating Regulations, 2023″ issued by the National Medical Commission (NMC) on 16th August, 2023 have provision of the ratio of 100 MBBS seats for 10 lakh population in the State/UT. However, NMC, vide Public Notice dated 15th November, 2023, has declared that ‘OBJECTIVE’ clause under Chapter-1 of these Guidelines, which includes this provision, has been put on hold upto academic year 2024-25.”

Regarding the queries on NEET exam, he informed that as per Section 14 of the NMC Act, 2019, all the admission to the undergraduate and postgraduate super-speciality medical/dental education courses in all medical/dental institutions of the Country are to be done based on performance in NEET UG/PG and this provision applies across the country without any exemption to any State.

“NEET is a historic reform promoting meritocracy and providing opportunity to meritorious students to get admission in the best medical institutions in the country. It has resulted in curbing malpractices in medical admission, greater transparency and reducing the burden on prospective students of appearing in multiple entrance exams,” the MoS Health mentioned.

Also Read: After deferring Rule to Cap MBBS Seats per population, NMC Reopens Portal to apply for new medical colleges or increase in MBBS seats

Medical Dialogues had earlier reported that in September last year, NMC released the “”Guidelines for Under Graduate Courses under Establishment of New Medical Institutions, Starting of New Medical Courses, Increase of Seats for Existing Courses & Assessment and Rating Regulations, 2023” and prescribed a ratio of 100 MBBS seats per 10 lakh population.

These Guidelines mentioned, “After A.Y. 2023-24, Letter of permission (LOP) for starting of new medical colleges shall be issued only for annual intake capacity of 50/100/150 seats; Provided that medical college shall follow the ratio of 100 MBBS seats for 10 lakh population in that state/ U.T.”

As a result of this new norm, several southern states including Tamil Nadu, Karnataka, Andhra Pradesh, Kerala and Telangana became ineligible to apply for any new medical college or MBBS seats.

All the Southern States including Tamil Nadu, Karnataka, and Andhra Pradesh opposed these new NMC rules for setting up new medical colleges. Kerala, on the other hand, decided to seek relaxation based on specific requirements.

Amid this opposition from the States and various stakeholders corresponding to a section of the medical fraternity hailing the move, the NMC had issued a statement standing by its decision pointing out how various courts had made observations on the crowding of medical colleges and how this decision will help add another 40,000 MBBS seats in India.

However, after the Health Ministry faced an intense pushback from the States which already have the required or more MBBS seats/medical colleges than the prescribed ratio.

Following a Health Ministry directive in this regard, NMC put the dictim on the MBBS seat cap per population till the year 2025. Issuing a notification, Dr Aruna Vanikar, President of NMC’s Undergraduate Medical Education Board (UGMEB), announced the deferment of the clause regarding provisions of the ratio of 100 MBBS seats for 10 lakh population for one year.

“With reference to Ministry of Health and Family Welfare letter No V. 11025/253/2023-MEP(Pt.1) dated 1 st November, 2023 for re-examining the provisions of the ratio of 100 MBBS Seats for 10 lakh population in the states, it is informed that a decision has been taken by the Undergraduate Medical Education Board, National Medical Commission that the “OBJECTIVE” clause under Chapter-1 of “Guidelines for Under Graduate Courses under Establishment of New Medical Institutions, Starting of New Medical Courses, Increase of Seats for Existing Courses & Assessment and Rating Regulations, 2023″ (notified by UGMEB on 16 th August, 2023) shall be implemented from academic year 2025-26,” mentioned the NMC notice.

Also Read: After severe backlash from states, NMC defers MBBS seat to population plan

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Minor patient’s Left ovary, tube removed without necessary preliminary tests: Surgeon, nursing home slapped compensation

Hyderabad: The Telangana State Consumer Disputes Redressal Commission dismissed a surgeon’s appeal challenging a District Commission’s order. The District Commission had held the doctor and a nursing home accountable for causing functional disability to a patient by unnecessarily removing her left ovary and tube without a proper pre-surgery assessment. The Commission affirmed the reasonable nature of the awarded compensation, amounting to Rs 6 lakh, despite acknowledging a possible lesser amount.

The State Commission clarified that if the doctor thought that the left ovarian tissue was necrotic or gangrenous, then it should be supported by a biopsy report and it needs to be diagnosed by blood tests.

The case, filed under Section 15 of the Consumer Protection Act, 1986, involved a minor patient who experienced intense abdominal pain and was admitted to a Nursing Home in Karimnagar. The General Surgeon (the first opposite party in the given case), performed an Exploratory Laparotomy on September 16, 2006. The patient claimed that the pain persisted, leading to a second admission on October 20, 2006, where she underwent Laparotomy again. She alleged that the doctor removed her vital reproductive organs i.e., the left tube and ovary without addressing the source of her pain, necessitating a third surgery in Hyderabad.

Aggrieved, a complaint was filed before the District Forum against the alleged negligent treatment provided by the doctor, seeking compensation. During the second surgical procedure, the father of the Respondent/Complainant stated that his daughter should have been advised to consult a Gynaecologist for diagnostic and curative technique of laparoscopy and Hysteroscopy; instead the surgeon removed the “left ovary and tube” without their consent.

In response to the allegations, the surgeon contended that he provided appropriate treatment, citing the diagnosis of a Hemtometra in the left horn of the uterus. “Needle aspiration POD revealed blood stained serous fluid and once again Laparotomy was done. Necrotic left ovarian tissue excised after explaining to the patient/Complainant’s parents and obtaining the consent for the same. They were further advised to go to Hyderabad for further management i.e., rectification of congenital anomalies,” the doctor submitted. He argued that the surgeries were conducted with due care, and any adverse outcomes were not due to negligence. The Nursing Home, represented by Dr. U.V. Vishnuvardhan Reddy, supported the doctor’s position.

The Opposite party No.2 in the case, ie. the Indian Medical Association (IMA), represented by its Telangana State Branch Chairman, opposed the complaint, asserting that the patient received proper treatment. The IMA contended that the complaint was vexatious and aimed at extracting money.

It was further submitted by the owner of the nursing home, an MBBS doctor, physician (Opposite party 3) that utmost care was taken throughout the procedures and requested the dismissal of the complaint with costs. He assisted in the surgeries conducted by the surgeon. Before the operations, detailed explanations about the procedure’s nature and risks were given to the patient’s father and attendants. All anomalies were recorded in the case sheet, and the family was advised to consult a Gynaecologist for anomaly rectification, he mentioned in his argument.

The District Commission partially allowed the complaint, instructing Opposite Parties No.1 to 3 to collectively pay the Complainant Rs.6,00,000 with 9% interest from the complaint filing date (10.11.2008) until realization. Additionally, they were directed to pay Rs.5,000 as costs within one month from receiving the order.

Aggrieved, the opposite parties challenged the District Forum’s decision and moved the State Commission, contending that critical aspects were disregarded. They said that a document (Ex.A8) showing the Complainant’s condition wasn’t properly considered. They pointed out that Ex.A8 had information about the disease and a surgery called Exploratory Laparotomy. They also stressed that the procedures during Laparotomy, like wedge resection and appendectomy, weren’t observed. They mentioned that the Complainant left against medical advice. The issues continued with the Complainant’s later visits, an ultrasound finding, and details from a surgery called Laparotomy.

They argued that the District Forum failed to recognize the Operation Notes from the first surgery, stating the left ovary was cystic, and the rationale for removing the diseased left ovary during the second surgery. They further criticized the inadequate examination of Dr. Kala’s testimony, emphasizing her failure to assert that the surgeon erroneously removed a healthy ovary or that their services were deficient. Lastly, they underscored the neglect in harmoniously assessing operative findings.

Deliberating the case, the State Commission noted the discrepancy in the patient’s age as presented in various documents and testimonies. It considered medical records, including ultrasound reports and laparotomy findings. The Commission acknowledged that the patient had a bicornuate uterus with hematometra in the left horn, a congenital condition requiring surgical intervention.

The Commission found that the surgeon failed to adequately consider pre-surgery ultrasound reports, leading to the unnecessary removal of the patient’s left ovary. The Commission determined this as a case of medical negligence and deficiency in service. It highlighted the absence of a biopsy report supporting the claim of necrotic tissue.

It noted;

“In his written version, the Opposite Party No.1 Doctor has submitted that “Laparotomy was done through same old incision. Uterus enlarged bicornuate, left horn tense thick, remains of left ovary were small necrotic? Gangrenous. Necrotic left ovarian tissue”, but this is not supported by the USG trans abdomen report nor does the discharge summary support the findings. If he thought that the left ovarian tissue was necrotic or gangrenous, then it should be supported by a biopsy report and it needs to be diagnosed by blood tests. This reveals the deficiency and negligence of the Opposite Party No.1 Doctor. He conducted the two procedures without due care and skill and further removed the young patient‟s left ovary and tube without the necessary preliminary tests to confirm the necrosis or that the gangrenous tissue was cancerous.”

“..the Appellants/Opposite Parties have failed to explain why they removed the “Necrotic ovarian tissues on the left side.”

Subsequently, the Commission dismissed the appeal filed by the Surgeon and the Nursing Home. It upheld the District Consumer Commission’s decision and affirmed the compensation awarded to the patient. It observed;

“In the glaring absence of a pathological report and the fact that Ex.A8 and A12 did not reveal any abnormality of the left ovary, we concur with the findings and conclusion of the Commission below and hold the Appellants/Opposite Parties as deficient and negligent. The Doctor who conducted the surgery is an Urologist and the hospital where the surgery was conducted did not have the necessary facilities and the patient should have been immediately referred to a hospital having the required imaging and diagnostic facilities and a Gynaecologist.”

The Commission emphasized the importance of informed consent and the need for doctors to exercise due care and skill, especially in cases involving surgical interventions. It noted;

“This Commission is compelled to deduce, especially in the absence of any plausible explanation or report that the Appellants/Opposite Parties 1 & 3 have not exhibited reasonable care and needlessly caused a functional disability to the Respondent/Complainant. Further, it is our considered opinion that the Commission below awarded a lesser amount towards compensation for the negligence and deficiency as exhibited by the Appellants/Opposite Parties No.1 & 3, but in the absence of cross appeal, we restricted ourselves to the amount awarded.”

To view the original order, click on the link below:

https://medicaldialogues.in/pdf_upload/telangana-state-medical-commission-upholds-compensation-231609.pdf

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Modify Clinical Study Protocol: CDSCO Panel Tells Roche On Multiple Sclerosis Drug Ocrelizumab

New Delhi: In response to the proposal presented by drug major Roche to conduct the Phase IV clinical trial for the drug product Ocrelizumab 300 mg Concentrate for solution for infusion 300 mg/10 mL (30 mg/mL) in a single-dose vial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has suggested the firm to modify the protocol and to submit the revised protocol for the further evaluation.

This came after the drug major Roche presented the protocol to conduct a Phase IV clinical trial for the drug product Ocrelizumab 300 mg Concentrate for solution for infusion 300 mg/10 mL (30 mg/mL) in a single-dose vial titled “A Multi-Center, Open-Label, Single Arm Phase IV Study to assess the safety and effectiveness of Ocrelizumab in Multiple Sclerosis (RMS and PPMS) patients in India (Overture)” vide protocol ML45008, Version 1.0 dated 12 Jul 2023.

Multiple sclerosis (MS) is a chronic condition that causes nerve damage. The four main types of MS are clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), primary-progressive MS (PPMS), and secondary-progressive MS (SPMS).

Relapsing-remitting multiple sclerosis (RRMS) is the most common course of MS. If one has RRMS, one will experience clearly defined attacks of new or increasing neurologic symptoms. These attacks — also called “relapses” or “exacerbations” — are followed by periods of partial or complete recovery (remissions). Primary progressive multiple sclerosis (PPMS) is a type of multiple sclerosis (MS) where symptoms get worse over time.

Ocrelizumab is a medication that treats multiple sclerosis. It works by slowing down an overactive immune system to prevent or delay symptoms. MS affects the central nervous system.

Ocrelizumab is a medication used in the management and treatment of primary progressive and relapsing multiple sclerosis. It is in the anti-CD20 monoclonal antibody class of medications.

Ocrelizumab is an anti-CD20 antibody that depletes circulating immature and mature B cells but spares CD20-negative plasma cells. The effector mechanisms of anti-CD20 antibodies are complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity.

At the recent SEC meeting for Neurology and Psychiatry held on 18th and 19th January 2023, the expert panel reviewed the protocol presented by drug major Roche for conducting the Phase IV clinical trial for drug product Ocrelizumab 300 mg Concentrate for a solution for infusion 300 mg/10 mL (30 mg/mL) in a single-dose vial.

After detailed deliberation, the committee recommended the following changes in the protocol:

1. Follow-up should be done for a minimum of 2 years.

2. The efficacy endpoint should be included as the co-primary objective of the study.

3. One Government independent site with a neurologist should evaluate the patients whether the patient is truly progressive for the PPMS before enrolment in the study.

4. A minimum of 10% of PPMS patients should be included in the study.

5. The number of evaluable patients in the study should be a minimum of 32.

6. The study sites should be geographically distributed.

Following the above, the expert panel suggested that the firm be required to submit a revised protocol to CDSCO for further evaluation before the committee.

Also Read: COMP a novel predictor of CVD and CAD in RA

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NBE notifies on Distribution of Pass Certificates to FMGE December 2023 candidates, details

New Delhi- The National Board of Examinations in Medical Sciences (NBEMS), New Delhi, has issued a notice regarding the issue of pass certificates to students who appeared for the Foreign Medical Graduate Examination (FMGE) (Screening Test) December 2023.

As per the notice, certificates will be distributed from February 20th to April 6th, 2024, at the National Board of Examination in Medical Sciences (NBEMS) office situated in PSP Area, Sector-09, Dwarka, New Delhi. It is recommended that candidates should report on time at the NBEMS office to avoid any crowd. Otherwise, they may need to wait for their turn depending on the availability of vacant slots.

Also Read: Result for FMGE December 2023 declared

Moreover, if a student is not able to collect their certificates on the scheduled dates due to any reasons then they cannot collect the certificates on any other day of their choice. These students must seek prior authorisation from NBEMS for a revised collection schedule by submitting a request through the Communication Web Portal (CWP) of NBEMS.

Students who fail to collect their Pass Certificates can collect it, within six months of the result being announced. Failure to do so will result in the cancellation of their candidature and FMGE December 2023 results. However, there will be no further chances to collect the Pass Certificate.

Also Read: FMGE December 2023 Results To Be Declared By 20th February

The eligible and qualified candidates are urged to bring their original documents and appear at the venue on the scheduled date to receive the certificate. The certificate will only be issued after confirming the authenticity of the original documents and verifying identity through biometrics/Face ID.

Students are further instructed to carry a hard copy of the “Entry Slip” when they visit the NBEMS office for admission. Furthermore, before collecting the FMGE Pass Certificate, candidates are advised to carefully read, understand, and complete a self-declaration form which is enclosed within the admission slip. If the students fail to submit the self-declaration then the FMGE pass certificates will not be given to the particular candidate.

Also Read: FMGE December 2023 Exam: Here are exam day guidelines

FMGE pass certificates will be granted individually to candidates who have been declared qualified in the FMGE December 2023 session. However, the pass certificates will not be issued to any unauthorised representative or any person other than the candidate himself/herself under any circumstances.

Candidates are also advised to make their return journey travel arrangements for the end of the certificate collection day, considering any unforeseen issues in the verification of identity and documentation.

To view the official notice, click the link below-

https://medicaldialogues.in/pdf_upload/nbejpg-232021.pdf

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Prophylactic pancreatic stent in addition to rectal indomethacin effective for preventing post-ERCP pancreatitis

Endoscopic retrograde cholangiopancreatography (ERCP) is a valuable diagnostic and therapeutic procedure, but it comes with the risk of pancreatitis, particularly in high-risk patients. A recent randomized trial assessed two preventive strategies—rectal indomethacin alone versus the combination of indomethacin plus a prophylactic pancreatic stent.

This study was published in the journal Lancet by Prof B Joseph E. and colleagues. The study aimed to evaluate efficacy and safety, providing valuable insights for enhancing post-ERCP patient care.Therandomized non-inferiority trial involving 1950 high-risk patients undergoing endoscopic retrograde cholangiopancreatography (ERCP), researchers evaluated the efficacy of two preventive strategies: rectal indomethacin alone versus the combination of indomethacin plus a prophylactic pancreatic stent.

  • The primary outcome, post-ERCP pancreatitis incidence, was 14.9% with indomethacin alone and 11.3% with the combination, resulting in a risk difference of 3.6% (95% CI 0.6–6.6; p=0.18 for non-inferiority).

  • However, a post-hoc analysis revealed the superiority of the combination strategy (p=0.011).

  • Safety outcomes, including serious adverse events, intensive care unit admission, and hospital length of stay, did not significantly differ between the two groups.

The trial concludes that, for high-risk patients undergoing ERCP, the strategy of using rectal indomethacin alone was not as effective as combining indomethacin with prophylactic pancreatic stent placement. These findings advocate for the adoption of a comprehensive approach, emphasizing the role of prophylactic stent placement in addition to indomethacin administration for optimal prevention of post-ERCP pancreatitis in high-risk patients.

Reference:

Elmunzer, B. J., Foster, L. D., Serrano, J., Coté, G. A., Edmundowicz, S. A., Wani, S., Shah, R., Bang, J. Y., Varadarajulu, S., Singh, V. K., Khashab, M., Kwon, R. S., Scheiman, J. M., Willingham, F. F., Keilin, S. A., Papachristou, G. I., Chak, A., Slivka, A., Mullady, D., … Durkalski-Mauldin, V. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial. Lancet,2024;403(10425):450–458. https://doi.org/10.1016/s0140-6736(23)02356-5

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