Use of appropriate statistical tools in biomedical research: Current trend & status

Background & objectives: Due to lack of appropriate statistical knowledge, published research articles contain various errors related to the design, analysis and interpretation of results in the area of biomedical research. If research contains statistical error, however, costly, it may be of no use and the purpose of the investigation gets defeated. Many biomedical research articles published in different peer reviewed journals may retain several statistical errors and flaws in them. This study aimed to examine the trend and status of application of statistics in biomedical research articles. Study design, sample size estimation and statistical measures are crucial components of a study. These points were evaluated in published original research articles to understand the use or misuse of statistical tools. Methods: Three hundred original research articles from the latest issues of selected 37 journals were reviewed. These journals were from the five internationally recognized publication groups (CLINICAL KEY, BMJ Group, WILEY, CAMBRIDGE and OXFORD) accessible through the online library of SGPGI, Lucknow, India. Results: Among articles assessed under present investigation, 85.3 per cent (n=256) were observational, and 14.7 per cent (n=44) were interventional studies. In 93 per cent (n=279) of research articles, sample size estimation was not reproducible. The simple random sampling was encountered rarely in biomedical studies even though none of the articles was adjusted by design effect and, only five articles had used randomized test. The testing of assumption of normality was mentioned in only four studies before applying parametric tests. Interpretation & conclusions: In order to present biomedical research results with reliable and precise estimates based on data, the role of engaging statistical experts need to be appreciated. Journals must have standard rules for reporting study design, sample size and data analysis tools. Careful attention is needed while applying any statistical procedure as, it will not only help readers to trust in the published articles, but also rely on the inferences the published articles draw.

Clinical Outcome of Direct Pulp Therapy in Primary Teeth A Systematic Review and Meta-analysis

Background: Direct pulp treatment is carried out when a healthy pulp gets mechanically/accidentally exposed during the operative procedures or trauma. Aim: To determine the effects of various direct pulp capping materials as measured by the clinical and radiographic analysis. Design: Two reviewers performed a database search of the studies published between January 2005 and November 2020. The inclusion criteria were papers published in the English language; children aged 3–12 years having deep carious lesions in primary teeth. All potential studies were acknowledged by their title and abstract. The full-text analysis of potentially relevant studies, the selected studies were included in the systematic review. A meta-analysis calculation was performed for the overall data and the subgroup data. Results: The database searching led to 57 articles, which were of direct pulp treatment in primary teeth, after the removal of duplicates, 55 records remained but did not meet all inclusion criteria. A high variability was observed among the papers. Further filtering with criteria led to nine articles, which met all inclusion criteria. Meta-analysis demonstrated the success rates of DPT in primary teeth (95% confidence interval −0.799–0.898); P < 0.001. Clinical assessments of various direct pulp capping materials suggested 84.9% of success irrespective of the material used. The nine studies were heterogeneous according to the random effect model (P < 0.001, I2 = 84.08%). Conclusions: Direct pulp treatment has the advantage of being a conservative vital pulp therapy reducing the need for a more invasive treatment.

Expert survey on management of prostate cancer in India: Real?world insights into practice patterns

To gain insights on the diverse practice patterns and treatment pathways for prostate cancer (PC) in India, the Urological Cancer Foundation convened the first Indian survey to discuss all aspects of PC, with the objective of guiding clinicians on optimizing management in PC. A modified Delphi method was used, wherein a multidisciplinary panel of oncologists treating PC across India developed a questionnaire related to screening, diagnosis and management of early, locally advanced and metastatic PC and participated in a web朾ased survey (WBS) (n = 62). An expert committee meeting (CM) (n = 48, subset from WBS) reviewed the ambiguous questions for better comprehension and reanalyzed the evidence to establish a revote for specific questions. The threshold for strong agreement and agreement was ?90% and ?75% agreement, respectively. Sixty?two questions were answered in the WBS; in the CM 31 questions were revoted and 4 questions were added. The panelists selected answers based on their best opinion and closest to their practice strategy, not considering financial constraints and access challenges. Of the 66 questions, strong agreement was reached for 17 questions and agreement was achieved for 22 questions. There were heterogeneous responses for 27 questions indicative of variegated management approaches. This is one of the first Indian survey, documenting the diverse clinical practice patterns in the management of PC in India. It aims to provide guidance in the face of technological advances, resource constraints and sparse high?level evidence.

A Role of Udumbara Ksheer Sutra in Ano Rectal Fistula: An Ayurvedic Review

Acharya Sushrut has involved Bhagandara among the Ashtamahagad (8 dreadful diseases). At first it is present as Pidika (boil/abscess) in Apakwa (non-suppurated) state, become Bhagandara when it becomes Pakwa (suppurated). As defined in modern science, it is associated with fistula in ano. An anal fistula is an abnormal track having an external opening in the perianal region and internal opening in the anal canal and/or rectum. Ayurveda has a special approach to fistula management. All anal fistulas counter well to different forms of Kshar and Ksheer Sutra therapy. They are nothing but the medicated seton. The Ksheer sutra mechanical and chemical action of drugs coated on the thread work jointly to cut, cure, drain and clean the fistulous tract, thereby promoting track/wound healing. Though Bhrihattrayi, (chief three texts of Ayurveda) stated the use of Kshar Sutra, there is no proper description of their method of preparation. In eleventh century, Chakrapani Datta mentioned the preparation method of Ksheer sutra in his book Chakradatta for the first time which is indicated in Arsha and Bhagandara. Apamarga Kshar Sutra is the standard Kshar Sutra, and but it has some disadvantages. A variety of other Kshar Sutra, as well as Ksheer Sutra, have been prepared to resolve these inconveniences of Apamarga Kshar Sutra. One of them is Udumbara Ksheer Sutra which was founded by Prof. P.J Deshpande and M.K Jalan in 1984. Udumbara is one among the Nyagradhadi Gana Dravya mentioned by Acharya Sushrut. He described in Bhagandara Chikitsa that the Nyagradhadi Gana Dravyas are Bhagandaranashak.

Comparative evaluation of antimicrobial efficacy of silver diamine fluoride, chlorhexidine varnish with conventional fluoride varnish as a caries arresting agent. An in vivo sodium dodecyl sulfate-polyacrylamide gel electrophoresis study

Introduction: Silver diamine fluoride (SDF) is employed as an adjunct cariostatic agent in the management of dental caries in high-risk population. Other than fluorides, chlorhexidine (CHX) is the most potent antimicrobial and efficacious agent against Streptococcus mutans. Aim: The aim of this study is to evaluate and differentiate the efficacy of 38% silver diamine fluoride, CHX varnish, and fluoride varnish on carious primary teeth. Materials and Methods: Ninety children having a count of ?1 carious lesion were recruited. Thirty-eighty percent silver diamine fluoride or fluoride varnish and CHX varnish were topically applied on the lesion. The primary outcome measured was the arrest of carious lesion (lesion rendered inactive as per the Nyvad criteria) after a follow-up of 14–21 days. Dental biofilm sample was obtained from each child and subsequently assessed for microbial composition by colony-forming unit method before and after treatment followed by protein analysis by sodium dodecyl sulfate-polyacrylamide gel electrophoresis method. Results: Average proportion of arrested caries lesions in the SDF group was higher followed by CHX and fluoride varnish groups. Decreased total protein amount was found in SDF group. This proves that there is decrease in microbial load posttreatment in SDF group. Conclusion: Thirty-eight percent SDF is more effective than CHX varnish and fluoride varnish in arresting dentin carious lesions in young children.

Mental health, functional ability, and health-related quality of life in elderly patients attending a tertiary hospital of Patna

With changing socioeconomic, demographic, and development scenario, there is a cultural shift in looking after the elderly population which may lead to depression in this age group. Materials and Methods: The study was a hospital-based cross-sectional study conducted in the orthopedic department of a tertiary care setting on 157 elderly individuals. This study was conducted with objectives to estimate the proportion of depression using the Geriatric Depression Scale Short Form (GDS-SF) questionnaire along with its associated factors in geriatric population coming to the orthopedic department of the institute. The study tools were GDS-SF, Katz Index of Independence in activities of daily living (ADL), the Lawton instrumental ADL, and health-related quality of life by the Centers for Disease Control. Results: The proportion of depressed individuals was 70/157 (44.6%) using GDS as a tool. The maximum number was in the age group of 60–74 years. Women outnumbered men (51.3% vs. 38.31%) for depression. The depression using GDS score was more prevalent in rural elderly, illiterate, and elderly who were economically dependent on their children and who belonged to lower middle socioeconomic status. Approximately 98% of the study participants were found to be independent using ADL. Approximately 60% males and 68% females were dependent for the instrumental ADL using Lawton score. Most of the study participants had arthritis as a major impairment sharing almost equal proportion among males and females. Conclusion: The current study concludes that there is a very high proportion of elderly subjects who are experiencing depression using the GDS-SF tool. There should be regular screening for this disease in this age group even in a tertiary care setting.

Errors, omissions and medication patterns of handwritten outpatient prescriptions in Bangladesh: a cross-sectional health survey.

Handwritten prescription errors are worldwide common problem. We investigated the types and extent of prescription errors in three cities of Bangladesh. Total 900 outpatient prescriptions were surveyed following the guidelines of WHO and BNF. Prescription errors in superscription, inscription and subscription were analyzed by Microsoft Excel 2010. About 73% patients visited MBBS and 8% BDS doctors. The male outpatients (55%) were slightly higher than female (45%). Commonly found errors of prescription were in superscription part, i.e. gender (64.33%), age (17.67%) and name (5%) of the patients. In inscription part, most common error was the direction for drug use (42%) followed by the dosage regimens (28%), doses (26%), and dosage forms (12.67%) of the drug. In subscription part, illegible handwriting was most common (46%) followed by the prescribers sign (10.67%) and date (4%). In a single prescription, averagely 3 and maximally 8 drugs were found to be prescribed. Most frequently prescribed drugs were antibiotics (18.25%) followed by antacids (17.45%) and NSAIDs (13.60%). Errors in handwritten prescriptions are the primary causes of treatment failure in Bangladesh. More professional care by the prescribers’ and the inclusion of pharmacists in hospital can only reduce the errors and assure safer health.

Safety of 12 core transrectal ultrasound guided prostate biopsy in patients on aspirin

Objective: To prospectively assess safety outcome of TRUS guided prostate biopsy in patients taking low dose aspirin. Materials and methods: Consecutive patients, who were planned for 12 core TRUS guided prostate biopsy and satisfied eligibility criteria, were included in the study and divided into two Groups: Group A: patients on aspirin during biopsy, Group B: patients not on aspirin during biopsy, including patients in whom aspirin was stopped prior to the biopsy. Parameters included for statistical analysis were: age, serum prostate specific antigen (PSA), prostate volume, hemoglobin (Hb %), number of hematuria episodes, number of patient reporting hematuria, hematuria requiring intervention, number of patient reporting hematospermia and number of patient reporting rectal bleeding. Results: Of 681 eligible patients, Group A and B had 191 and 490 patients respectively. The mean age, prostate volume, serum PSA and pre-biopsy hemoglobin were similar in both Groups with no significant differences noted between them. None of the post-biopsy complications, including number of hematuria episodes (p=0.83), number of patients reporting hematuria (p=0.55), number of patients reporting hematospermia (p=0.36) and number of patients reporting rectal bleeding (p=0.65), were significantly different between Groups A and B respectively. None of the hemorrhagic complication in either group required intervention and were self limiting. Conclusion: Continuing low dose aspirin during TRUS guided prostate biopsy neither alters the minor bleeding episodes nor causes major bleeding complication. So, discontinuation of low dose aspirin prior to TRUS guided prostate biopsy is not required.

Tuberculosis As A Cause Of Change In Hematological Parameters In A Tertiary Care Hospital.

Abstracts: Background & Aim: Hematopoietic system is another organ seriously affected by tuberculosis. The hematological changes sometimes act as useful factors providing a clue to diagnosis, assessing the prognosis, indicating the complication of underlying infection as well as therapy and response to therapy. Aim is to study the various hematological parameters in Z-N positive pulmonary tuberculosis patients. Methodology & Results: Present study was conducted on hematological parameters in pulmonary tuberculosis patients in the department of Pathology in MM institute of Medical Science and Research, Mullana, Ambala. The study was conducted for a period of one year from March 2013 to march 2014. Total numbers of 80 subjects were selected of Z-N positive and changes were compared with normal hematological parameters. The testing protocol was followed in the hospital laboratory. Result: showed decreased values of hemoglobin (Hb), red blood cell (RBC), packed cell volume (PCV), mean cell volume (MCV) and mean cell hemoglobin (MCH) while increased value observed in total leukocyte count (TLC), mean cell hemoglobin concentration (MCHC), erythrocyte sedimentation rate (ESR), and platelet count. Anemia noticed in 59% patients, including mild, moderate and severe. In peripheral blood film examination, microcytic hypochromic blood picture was most common. Conclusion: Various hematological abnormalities have been demonstrated in patients with pulmonary tuberculosis. These all parameters can be used as indicator in assessment of response to therapy.

Seasonal ovarian cycle in freshwater teleost, Labeo rohita (Ham.) in Tarai region of Uttaranchal.

Seasonal ovarian cycle, based on histophysiological changes, and correlative variations in liver were studied in an Indian major carp, Labeo rohita reared in captivity under ambient environmental conditions in Tarai region of Uttaranchal. The oocyte features used for marking ovarian cycle included nuclear-ooplasmic ratio, yolk vesicle incorporation into ooplasm, number and size of nucleolus and differentiation of follicular layer. Based on these features the ovarian cycle in L. rohita was divided into five phases i.e. resting, preparatory, pre-spawning, spawning and post-spawning/regression. The resting and preparatory phases were characterized by the dominating presence of chromatin-nucleolar and yolk-vesicle stage oocytes. The pre-spawning phase ovary was marked by the prevalence of yolk globule stage oocytes having cortical alveoli and differentiating follicular wall. The oocytes containing densely packed yolk-granules and large masses of yolk vesicles and also exhibiting germinal vesicle movement (GVM) signified the ovary of spawning phase. The ovary in regression phase contained pre-ovulatory atretic oocytes and significant number of oogonia. The histophysiological changes in liver showing augmented biosynthetic activity during preparatory and pre-spawning phases seemed well correlated with the gonadal development. The increasing water temperature and day-length apparently was favourable for the gonadal development in L. rohita.