Exercise as a treatment for depression: A meta-analysis

AIM: To provide a comprehensive overview of clinical studies on the clinical picture of Internet-use related addictions from a holistic perspective. A literature search was conducted using the database Web of Science. METHODS: Over the last 15 years, the number of Internet users has increased by 1000%, and at the same time, research on addictive Internet use has proliferated. Internet addiction has not yet been understood very well, and research on its etiology and natural history is still in its infancy. In 2013, the American Psychiatric Association included Internet Gaming Disorder in the appendix of the updated version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) as condition that requires further research prior to official inclusion in the main manual, with important repercussions for research and treatment. To date, reviews have focused on clinical and treatment studies of Internet addiction and Internet Gaming Disorder. This arguably limits the analysis to a specific diagnosis of a potential disorder that has not yet been officially recognised in the Western world, rather than a comprehensive and inclusive investigation of Internet-use related addictions (including problematic Internet use) more generally. RESULTS: The systematic literature review identified a total of 46 relevant studies. The included studies used clinical samples, and focused on characteristics of treatment seekers and online addiction treatment. Four main types of clinical research studies were identified, namely research involving (1) treatment seeker characteristics; (2) psychopharmacotherapy; (3) psychological therapy; and (4) combined treatment. CONCLUSION: A consensus regarding diagnostic criteria and measures is needed to improve reliability across studies and to develop effective and efficient treatment approaches for treatment seekers.

Internet addiction and problematic Internet use: A systematic review of clinical research.

markdownBackground: Studies comparing upfront surgery with neoadjuvant treatment in pancreatic cancer may report only patients who underwent resection and so survival will be skewed. The aim of this study was to report survival by intention to treat in a comparison of upfront surgery versus neoadjuvant treatment in resectable or borderline resectable pancreatic cancer. 
Methods: MEDLINE, Embase and the Cochrane Library were searched for studies reporting median overall survival by intention to treat in patients with resectable or borderline resectable pancreatic cancer treated with or without neoadjuvant treatment. Secondary outcomes included overall and R0 resection rate, pathological lymph node rate, reasons for unresectability and toxicity of neoadjuvant treatment. 
Results: In total, 38 studies were included with 3484 patients, of whom 1738 (49·9 per cent) had neoadjuvant treatment. The weighted median overall survival by intention to treat was 18·8months for neoadjuvant treatment and 14·8months for upfront surgery; the difference was larger among patients whose tumours were resected (26·1 versus 15·0months respectively). The overall resection rate was lower with neoadjuvant treatment than with upfront surgery (66·0 versus 81·3 per cent; P<0·001), but the R0 rate was higher (86·8 (95 per cent c.i. 84·6 to 88·7) versus 66·9 (64·2 to 69·6) per cent; P<0·001). Reported by intention to treat, the R0 rates were 58·0 and 54·9 per cent respectively (P=0·088). The pathological lymph node rate was 43·8 per cent after neoadjuvant therapy and 64·8 per cent in the upfront surgery group (P<0·001). Toxicity of at least grade III was reported in up to 64 per cent of the patients. 
Conclusion: Neoadjuvant treatment appears to improve overall survival by intention to treat, despite lower overall resection rates for resectable or borderline resectable pancreatic cancer. PROSPERO registration number: CRD42016049374.

/pdf/meta-analysis-comparing-upfront-surgery-with-neoadjuvant-2o1uskflgd.pdf

Meta-analysis comparing upfront surgery with neoadjuvant treatment in patients with resectable or borderline resectable pancreatic cancer.

https://www.europeanurology.com/article/S0302-2838(13)00861-0/pdf/adjuvant-chemotherapy-for-invasive-bladder-cancer-a-2013-updated-systematic-review-and-meta-analysis-of-randomized-trials

Adjuvant Chemotherapy for Invasive Bladder Cancer: A 2013 Updated Systematic Review and Meta-Analysis of Randomized Trials

Author(s): McCoy, C. Eric | Abstract: Clinicians, institutions, and policy makers use results from randomized controlled trials to makedecisions regarding therapeutic interventions for their patients and populations. Knowing the effectthe intervention has on patients in clinical trials is critical for making both individual patient as well aspopulation-based decisions. However, patients in clinical trials do not always adhere to the protocol.Excluding patients from the analysis who violated the research protocol (did not get their intendedtreatment) can have significant implications that impact the results and analysis of a study.Intention-to-treat analysis is a method for analyzing results in a prospective randomized studywhere all participants who are randomized are included in the statistical analysis and analyzedaccording to the group they were originally assigned, regardless of what treatment (if any) theyreceived. This method allows the investigator (or consumer of the medical literature) to draw accurate(unbiased) conclusions regarding the effectiveness of an intervention. This method preserves thebenefits of randomization, which cannot be assumed when using other methods of analysis.The risk of bias is increased whenever treatment groups are not analyzed according to the groupto which they were originally assigned. If an intervention is truly effective (truth), an intention-to-treatanalysis will provide an unbiased estimate of the efficacy of the intervention at the level of adherencein the study. This article will review the “intention-to-treat” principle and its converse, “per-protocol”analysis, and illustrate how using the wrong method of analysis can lead to a significantly biasedassessment of the effectiveness of an intervention.

/pdf/understanding-the-intention-to-treat-principle-in-randomized-3abmwweonh.pdf

Understanding the Intention-to-treat Principle in Randomized Controlled Trials.

Randomized controlled trials often suffer from two major complications, ie, noncompliance and missing outcomes One potential solution to this problem is a statistical concept called intention-to-treat (ITT) analysis ITT analysis includes every subject who is randomized according to randomized treatment assignment It ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization ITT analysis maintains prognostic balance generated from the original random treatment allocation In ITT analysis, estimate of treatment effect is generally conservative A better application of the ITT approach is possible if complete outcome data are available for all randomized subjects Per-protocol population is defined as a subset of the ITT population who completed the study without any major protocol violations

Intention-to-treat concept: A review.

Objective: The primary objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilance in Dhanalakshmi Srinivasan Medical College and Hospital (DSMCH), Perambalur (Tamil Nadu), a tertiary care teaching hospital. The second primary objective was to assess the causation of underreporting of adverse drug reactions (ADRs) as it needs to be well-assessed in India. The secondary objective was to compare the findings of this study with the results of the published studies from India on evaluation of the KAP of pharmacovigilance among healthcare professional. Materials and Methods: A cross-sectional study was carried out using a pretested questionnaire. The questionnaire was designed to assess the KAP regarding pharmacovigilance. The healthcare professionals (doctors, nurses, and pharmacists) working in the DSMCH, Perambalur (Tamil Nadu) during the study period were included. Only those who gave their consent to participate were included in the study. The data was analyzed by using the Statistical Package for Social Sciences (SPSS) statistical software, version 16. Results: One hundred and fifty pretested questionnaires were distributed among the healthcare professionals and 101 responded. 62.4% healthcare workers gave correct response regarding the definition of pharmacovigilance. 75.2% of healthcare workers were aware regarding the existence of a National Pharmacovigilance Program of India. 69.3% healthcare professional agreed that ADR reporting is a professional obligation for them. Among the participants, 64.4% have experienced ADRs in patients, but only 22.8% have ever reported ADR to pharmacovigilance center. Unfortunately only 53.5% healthcare workers have been trained for reporting adverse reactions. But, 97% healthcare professionals agreed that reporting of ADR is necessary and 92.1% were of the view that pharmacovigilance should be taught in detail to healthcare professional. Conclusion: This study demonstrated that knowledge and attitude towards pharmacovigilance is gradually improving among healthcare professionals, but unfortunately the actual practice of ADR reporting is still deficient among them.

A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India.

Off-label prescribing of medicines is prevalent worldwide because it gives freedom to physicians to apply new therapeutic options based on the latest evidence. Although physicians may lawfully prescribe approved drugs for any use consistent with available scientific data and proper medical practice, but unfortunately, usually this is done without adequate scientific data. Often, when the best available therapeutic option fails, patients demand new approach or new treatment which ultimately leads to off-label uses. Major concerns about efficacy and safety have been raised by inappropriate use of off-label drugs because it leads to drug being used without risk-benefit analysis by the regulatory agency. Although the regulatory approval process requires ample proof of efficacy and safety for granting approval for specific indications of prescription drugs but unfortunately, more clarity is required about regulations governing off-label use of medicine. Above all because of the financial aspects involved it is highly impractical to expect that pharmaceutical companies will restrict or stop off-label promotion. Off-label use might be compared to double-edged sword which might be very useful for some patients while it can also expose them to unrestricted experimentation, unknown health risks, or ineffective medicine. Hence, there is an urgent need for guidance to encourage proper off-label use of medicine by the distribution of scientifically valid and authentic information from the pharmaceutical companies. In fact, few countries such as the USA and France have taken an initiative and have come up with the regulations about off-label use of medicine.

Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities.

Only 2 new classes of antibiotics have emerged in the past 3 decades, namely, oxazolidinones (linezolid) and cyclic lipopeptides (daptomycin).[1] The antibacterial pipeline is scarce because of the costs associated with the development and licensure of antibiotics and the complexity of conducting clinical trials.[2] Recruitment and enrollment of an adequate number of patients in clinical trials for novel antibacterial remain very challenging and costly. In addition, no one can cut corners on safety. The US FDA has recently issued a draft guidance on scientific justification of margins in non‐inferiority trials for treatments of acute bacterial skin and skin structure infections. The US FDA has also required superiority trials for antibiotics used to treat self‐resolving nonlethal infections. This would increase the number of patients to be enrolled in antibiotic trials, and thus, increase the trial expenditure.[3] In this article, we attempt to discuss various regulatory bottlenecks in the development of novel antibacterial drugs. In the latter part of the article, we discuss various regulatory reforms that could improve novel antibacterial development.

Dry antibiotic pipeline: Regulatory bottlenecks and regulatory reforms.

Background: The assessment of doctor’s perceptions and understanding about generic medicines may help in recognizing possible barriers to greater generic medicine usage.

Aims & Objective: The primary objective of this study was to explore the knowledge, attitude, and practice (KAP) of doctors toward generic medicines.

Materials and Methods: A cross-sectional study was carried out using a pretested questionnaire in a tertiary-care teaching hospital of Perambalur district of Tamil Nadu (India). The questionnaire was designed to assess the KAP about generic medicines. The doctors working in this institute during the study period were included. All data were analyzed with the Statistical Package for Social Science (SPSS, version 16.0). p-Values of

Sandeep Kumar Gupta

Papers

Intention-to-treat concept: A review.

A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India.

Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities.

Dry antibiotic pipeline: Regulatory bottlenecks and regulatory reforms.

A study on the knowledge, attitude, and the practice of generic medicines among the doctors in a tertiary care teaching hospital in South India