Sample size estimation and power analysis for clinical research studies

Suresh, K; Chandrashekara, S

doi:10.4103/0974-1208.97779

Cited by 749 publications

(504 citation statements)

References 18 publications

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“…Power of test analysis and sample size estimation were performed by PS software (PS Power and Sample Size Calculations, DuPont and Walton D. Plummer), whereas power of study was considered to be 80%. 19 …”

Section: Discussionmentioning

confidence: 99%

The Effect of Harmonic Technique vs End Range Loading Exercises on Pain and Disability in Patients With Non-Specific Chronic Low Back Pain: A Preliminary Study

Arab

Saadati

Sheikhhoseini

2016

Journal of Chiropractic Medicine

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Objective: The purpose of this study was to compare the effects of end range loading (ERL) vs harmonic technique (HT) on patients with chronic low back pain (LBP). Method: Fourteen volunteer patients with LBP were randomly assigned to 2 groups based on a blocked randomization method with 7 patients in the HT group and 7 patients in the ERL group. The patients received 10 sessions of treatment for 5 sessions per week. Pain intensity and disability score were recorded using the numeric pain scale and Roland-Morris Disability questionnaire (RMQ), respectively, before and after the treatment period. ResultsAlthough pain intensity (P = .02) and the RMQ score (P = .03) decreased in the HT technique group, no statistically significant change was found in the ERL group for the RMQ score (P N .05). The effect size for HT was .6 and .3 for numeric pain scale and RMQ, respectively. Conclusion: This preliminary study showed that pain intensity and disability improved in subjects with chronic LBP in the HT group. More investigations with larger sample size are needed to clarify these findings.

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Section: Discussionmentioning

confidence: 99%

The Effect of Harmonic Technique vs End Range Loading Exercises on Pain and Disability in Patients With Non-Specific Chronic Low Back Pain: A Preliminary Study

Arab

Saadati

Sheikhhoseini

2016

Journal of Chiropractic Medicine

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“…Each cycle patient received 7Gy/fraction with bowel and bladder in normal limits with HDR application. [5][6][7][8] …”

Section: Chemotherapymentioning

confidence: 99%

Prospective comparative study of dose dense neo-adjuvant chemotherapy followed by chemo-radiation and definitive chemo-radiation alone in stage IB2-IVA cervical cancer

Karpurmath¹,

Nimma²,

Narayanan³

et al. 2016

Int J Reprod Contracept Obstet Gynecol

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INTRODUCTIONCervical cancer is the fourth most common cancer among women worldwide. 1 It is the second most common diagnosed cancer and third most leading cause of death in less developed countries. India accounts for 25% of cervical cancer deaths in less developed countries. Concurrent chemo radiotherapy (CRT) has become the standard of care for cervical cancer patients from stages 1B2 to IVA. 2 There is 6% improvement in the survival rates with the addition of chemotherapy to radiation as per the meta-analysis of 13 trials comparing chemoradiation and radiation alone. 3 There were no major advances in the treatment of cancer cervix after definitive chemo-radiation became the standard of care. There are still potential therapeutic advantages of giving chemotherapy before radiotherapy to reduce tumour size and control micro metastatic disease. A number of randomised trials have explored the use of neo-adjuvant chemotherapy (NACT) because of impressive response rates. As per the meta-analysis of neo-adjuvant chemotherapy for locally advanced cervical cancer 2003, there was no benefit for neo-adjuvant chemotherapy but the trials which used shorter cycle lengths showed 7% Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background:The standard of care for locally advanced cervical cancer is chemo-radiation. Role of neo-adjuvant chemotherapy not clear yet. Dose dense, short-term neo-adjuvant chemotherapy with early initiation of radiotherapy has shown survival benefit but randomised trials not available yet. Hence this study was done for feasibility of neoadjuvant chemotherapy and for its comparison with the standard chemo-radiation. Methods: Cervical cancer patients not randomly assigned into two arms. Arm A received 3 cycles NACT of paclitaxel and carboplatin weekly. All patients of arm A after NACT and arm B received EBRT on linear accelerator for a dose of 4500-5000cGy in 23-25 fractions with concurrent cisplatin 40mg/m2 followed by 3 applications of HDR intracavitary brachytherapy of 700 or 800cGy respectively. All patients were assessed clinically and radiologically with MRI after completion of CTRT and at follow up of 6 weeks. Results: A total of 15 patients treated in each arm. Stage IIB and IIIB constituted 93% of the patients, well matched in both the arms. The CR rate at follow up of 6 weeks after NACT was 73% compared to only 46.7% in arm B. Neutropenia of grade 3 were seen equally in both the arms and grade 2 neutropenia was seen in about 60% patients in arm A compared to only 20% patients in arm B which was manageable without growth factors. Conclusions: Dose dense neo-adjuvant chemotherapy is a feasible and effective option in treating cancer cervix.

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“…The Statistical software namely SAS 9.2, SPSS 15.0, Stata 10.1, MedCalc 9.0.1 ,Systat 12.0 and R environment ver.2.11.1 were used for the analysis of the data and Microsoft word and Excel have been used to generate graphs, tables etc 9,10 …”

Section: Statistical Softwarementioning

confidence: 99%

Outcomes of transvaginal multifetal pregnancy reduction without injecting potassium chloride

Gunasheela

Rao

Jain

et al. 2016

Int J Reprod Contracept Obstet Gynecol

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Background: Assisted reproductive technologies and the use of fertility drugs have significantly increased the prevalence of multiple pregnancy in last three decades. Various techniques and routes have been studied so far regarding fetal reduction to achieve healthy viable pregnancy. The current study aims to study different outcomes of multifetal pregnancy reduction without injecting potassium chloride.Methods: Total 57 patients were studied from October 2011 to November 2012 at our centre. 28 were higher order pregnancies who consented for fetal reduction and 29 were nonreduced twins as control group. It was a prospective comparative study. Fetal reduction was done transvaginally between 8-12 weeks by intracardiac puncture followed by manual aspiration of embryonic parts till asystole. Use of KCl was avoided. The most easily accessible sac was chosen for reduction. All were reduced to twins. Reduction to singleton and selective reduction of anomalous fetus were removed from the study as it could have created a bias in the comparison. The primary outcomes like miscarriage, post procedure complications, mean gestational age at delivery, preterm delivery, mean birth weight were studied. The outcomes of reduced twins were compared with that of nonreduced twins. The various secondary outcomes like IUGR, take home baby rate, neonatal morbidity, mortality, maternal morbidity and mortality, associated obstetric complications were studied.Results: Both groups were comparable with respect to age and parity. The average gestation of fetal reduction was 9.46 weeks. Abortion rate was 17.9% (n=5) in reduced group which was statistically significant. 4 patients were lost to follow up. There were no statistically significant differences with regard to cesarean section rate, preterm delivery, mean birth weight, mean gestational delivery between two groups. No incidence of IUGR in the series. One baby died in the control group, none in reduced group. Take home baby rate 79.1%. Overall the antenatal and post-operative complications were higher in control group than in reduced but it was not statistically significant.Conclusions: Fetal reduction is a feasible option for triplets and higher orders multiple pregnancies. Use of KCl is not mandatory for multifetal pregnancy reduction. It is best avoided as there are increased rates of preterm labour and PPROM. There is increase in abortion rate after multifetal pregnancy reduction in comparison to nonreduced twins. So couple should be counseled about the probability of losing the entire pregnancy. The obstetric and neonatal outcomes of reduced and nonreduced twins are comparable, thus fetal reduction as a procedure is not adding any extra risk on pregnancy outcome.

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Sample size estimation and power analysis for clinical research studies

Cited by 749 publications

References 18 publications

The Effect of Harmonic Technique vs End Range Loading Exercises on Pain and Disability in Patients With Non-Specific Chronic Low Back Pain: A Preliminary Study

The Effect of Harmonic Technique vs End Range Loading Exercises on Pain and Disability in Patients With Non-Specific Chronic Low Back Pain: A Preliminary Study

Prospective comparative study of dose dense neo-adjuvant chemotherapy followed by chemo-radiation and definitive chemo-radiation alone in stage IB2-IVA cervical cancer

Outcomes of transvaginal multifetal pregnancy reduction without injecting potassium chloride

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