Tag: statistics

BMJ Open. 2021 Jun 29;11(6):e044281. doi: 10.1136/bmjopen-2020-044281.

ABSTRACT

INTRODUCTION: Surgery to remove the gallbladder (laparoscopic cholecystectomy (LC)) is the standard treatment for symptomatic gallbladder disease. One potential complication of gallbladder disease is that gallstones can pass into the common bile duct (CBD) where they may remain dormant, pass spontaneously into the bowel or cause problems such as obstructive jaundice or pancreatitis. Patients requiring LC are assessed preoperatively for their risk of CBD stones using liver function tests and imaging. If the risk is high, guidelines recommend further investigation and treatment. Further investigation of patients at low or moderate risk of CBD stones is not standardised, and the practice of imaging the CBD using magnetic resonance cholangiopancreatography (MRCP) in these patients varies across the UK. The consequences of these decisions may lead to overtreatment or undertreatment of patients.

METHODS AND ANALYSIS: We are conducting a UK multicentre, pragmatic, open, randomised controlled trial with internal pilot phase to compare the effectiveness and cost-effectiveness of preoperative imaging with MRCP versus expectant management (ie, no preoperative imaging) in adult patients with symptomatic gallbladder disease undergoing urgent or elective LC who are at low or moderate risk of CBD stones. We aim to recruit 13 680 patients over 48 months. The primary outcome is any hospital admission within 18 months of randomisation for a complication of gallstones. This includes complications of endoscopic retrograde cholangiopancreatography for the treatment of gallstones and complications of LC. This will be determined using routine data sources, for example, National Health Service Digital Hospital Episode Statistics for participants in England. Secondary outcomes include cost-effectiveness and patient-reported quality of life, with participants followed up for a median of 18 months.

ETHICS AND DISSEMINATION: This study received approval from Yorkshire & The Humber – South Yorkshire Research Ethics Committee. Results will be submitted for publication in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER: ISRCTN10378861.

PMID:34187817 | DOI:10.1136/bmjopen-2020-044281

BMJ Open. 2021 Jun 29;11(6):e046480. doi: 10.1136/bmjopen-2020-046480.

ABSTRACT

INTRODUCTION: Clostridioides difficile infection (CDI) is one of the most common healthcare-associated infections in the USA, having high incidence in intensive care units (ICU). Antibiotic use increases risk of CDI, with fluoroquinolones (FQs) particularly implicated. In healthcare settings, antibiotic stewardship (AS) and infection control interventions are effective in CDI control, but there is little evidence regarding the most effective AS interventions. Preprescription authorisation (PPA) restricting FQs is a potentially promising AS intervention to reduce CDI. The FQ Restriction for the Prevention of CDI (FIRST) trial will evaluate the effectiveness of an FQ PPA intervention in reducing CDI rates in adult ICUs compared with preintervention care, and evaluate implementation effectiveness using a human-factors and systems engineering model.

METHODS AND ANALYSIS: This is a multisite, stepped-wedge, cluster, effectiveness-implementation clinical trial. The trial will take place in 12 adult medical-surgical ICUs with ≥10 beds, using Epic as electronic health record (EHR) and pre-existing AS programmes. Sites will receive facilitated implementation support over the 15-month trial period, succeeded by 9 months of follow-up. The intervention comprises a clinical decision support system for FQ PPA, integrated into the site EHRs. Each ICU will be considered a single site and all ICU admissions included in the analysis. Clinical data will be extracted from EHRs throughout the trial and compared with the corresponding pretrial period, which will constitute the baseline for statistical analysis. Outcomes will include ICU-onset CDI rates, FQ days of therapy (DOT), alternative antibiotic DOT, average length of stay and hospital mortality. The study team will also collect implementation data to assess implementation effectiveness using the Systems Engineering Initiative for Patient Safety model.

ETHICS AND DISSEMINATION: The trial was approved by the Institutional Review Board at the University of Wisconsin-Madison (2018-0852-CP015). Results will be made available to participating sites, funders, infectious disease societies, critical care societies and other researchers.

TRIAL REGISTRATION NUMBER: NCT03848689.

PMID:34187821 | DOI:10.1136/bmjopen-2020-046480

J Complement Integr Med. 2020 Dec 23;18(2):397-403. doi: 10.1515/jcim-2019-0338.

ABSTRACT

OBJECTIVES: To determine the effects that an olive oil massage has on fatigue among patients undergoing hemodialysis, and the associated sociodemographic factors that can reduce fatigue.

METHODS: The study used true experimental pre- and post-test research design. A total of 200 patients were recruited in a selected hemodialysis unit in southern India and were allocated to either a study or control group by randomization, with 100 patients in each group. All the patients in the intervention group were given a lower back and lower leg massage using olive oil at the beginning, and after every hour, of their hemodialysis using olive oil for a period of eight weeks. In contrast, the control group continues to receive routine care. The level of fatigue was measured using the Fatigue Severity Scale both before and after massage therapy.

RESULTS: Between 73 and 80% of patients were suffering from severe fatigue and the mean fatigue score was 5.53 (SD 1.82) and 5.56 (SD 1.57) for the study and control group, respectively. After eight weeks of massage therapy, the results showed that 53% of patients in the study group showed borderline fatigue, with a mean score of 4.39 (SD 2.37), whereas in the control group 73% patients showed severe fatigue, with a mean score of 5.17 (SD 2.00). The independent t-test between the study and the control group showed a statistically significant reduction in fatigue in the study group with a mean difference (MD) of 3.56 (t=-1.24; p=0.000). There were also statistically significant changes noted in gender and in the duration of the hemodialysis (χ ² = 6.043; p=0.049) and (χ ² = 6.611; p=0.046) respectively.

CONCLUSION: The study concluded that patients undergoing hemodialysis experienced moderate to severe levels of fatigue. In patients with no or mild anemia, massage has been shown to decrease fatigue and increase energy levels among patients undergoing hemodialysis for chronic kidney disease.

PMID:34187126 | DOI:10.1515/jcim-2019-0338

Int J Adolesc Med Health. 2020 Nov 24;33(3):107-113. doi: 10.1515/ijamh-2018-0147.

ABSTRACT

BACKGROUND: Anemia is the most prevalent disease in teenage girls and like other chronic diseases not only affects different aspects of their quality of life (QOl) but also quality of life of their parents.

OBJECTIVE: The aim of present study is investigating the effectiveness of family centered empowerment model (FCEM) on adolescent girls with anemia and their mother’s quality of life.

METHODS: Semi-experimental practical research is performed by choosing 60 girls with anemia and their mothers classified in two case and control groups based on random allocation in Tehran city. The eight sessions of educational program based on educational needs of girls & mothers in case group done for two months. The post test was carried out 1/5 month after the end of intervention through QOl questionnaire in case and control groups. Data analysis was performed using statistical methods including t-test, paired t-test.

RESULTS: There was no significant difference in the QOl in adolescent girls and their mothers between the two case and control groups before intervention (P=0/473 & P=0/94 respectively). While, after the intervention independent t-test showed a significant difference between the two case and control groups (P>0/001).

CONCLUSIONS: Findings showed that the FCEM promote the QOl in adolescent girls with anemia and their mothers. It is recommended that extensive studies be performed on the effectiveness of this model for other chronic diseases in different age groups.

PMID:34187137 | DOI:10.1515/ijamh-2018-0147

Ann Geriatr Med Res. 2021 Jun;25(2):65-71. doi: 10.4235/agmr.21.0063. Epub 2021 Jun 29.

ABSTRACT

South Korea became an aged society in 2017 and is predicted to become a super-aged society by 2025. Therefore, knowing the trends among older adults and identifying the geriatric burden are crucial for both healthcare professionals and policymakers. We previously summarized the general health and socioeconomic profiles of Korean older adults from the 2017 National Survey of Living Conditions and Welfare Needs of Older Koreans. In this update, we briefly summarized the results of the 2020 National Survey of Living Conditions and Welfare Needs of Older Koreans by categorizing them according to their general aging profile, socioeconomic status, lifestyle, and health status. In addition, we reviewed recent updates in the field of frailty and sarcopenia from population-based community cohorts in Korea. We hope this study will serve as a current reference for nationwide statistical data on common clinical and social parameters used in geriatrics and gerontology.

PMID:34187140 | DOI:10.4235/agmr.21.0063

J Complement Integr Med. 2020 Dec 25;18(2):363-369. doi: 10.1515/jcim-2020-0089.

ABSTRACT

OBJECTIVES: Adhesive capsulitis results in a multidimensional disability which demands a polygonal approach. Although physiotherapy proves an essential for a complete and comprehensive recovery in adhesive capsulitis, evidence also suggest the role of yoga in the management, hence this study investigate their effectiveness.

METHODS: This is a quasi-randomised control study. A pre-diagnosed subacute and chronic adhesive capsulitis of shoulder, between the age group of 35-60 years of both genders of total 40 participants were randomly divided into Group ‘A’ (yogasana) and Group ‘B’ (physiotherapy). The parameters of pain, joint mobility and functional disabilities were measured at the baseline and after four-weeks.

RESULTS: The mean age of Group ‘A’ was 45.4 ± 7.78 years whereas 50.05 ± 5.98 years was in Group ‘B’. Intragroup analysis for both the groups showed statistically significant improvement in all the study variables. Whereas in intergroup analysis yogasana was found to be statistically significant in improving shoulder abduction mobility, p=0.03, effect size r=0.35 and also in shoulder flexion (p=0.15, r=0.23) and shoulder internal rotation (p=0.07, r=0.3), though statistically not significant, in view of small effect size response.

CONCLUSIONS: Both techniques improved the functional status in adhesive capsulitis, however additional effects on joint mobility was demonstrated by yogasana.

PMID:34187116 | DOI:10.1515/jcim-2020-0089

J Complement Integr Med. 2020 Dec 24;18(2):379-383. doi: 10.1515/jcim-2020-0081.

ABSTRACT

OBJECTIVES: The FIFA-Medical and Assessment Research Centre (F-MARC) introduced the warm-up FIFA 11+ program to reduce injuries and promote fair play. Although the FIFA11+ program is a well-established warm-up protocol for injury prevention, studies on the program’s performance enhancement aspects have had controversial results. Therefore, the objective of the study is to investigate the efficacy of FIFA11+ program on sports performance parameters such as running speed, agility, and vertical jump performance in amateur female basketball players.

METHODS: In this study, 59 amateur female basketball players were recruited and randomized into an experimental group (n=30) and a control group (n=29). The experimental group completed the FIFA 11+ program for 12 weeks (three times/week), while the control group members completed their regular training programs. The study adopted a pretest-posttest design. 20-yard sprint run, t test and vertical jump test were the outcome measures.

RESULTS: No statistically significant difference in the sports performance parameters (sprint test p=0.21, t test p=0.16, vertical jump test p=0.09) was found between groups’ post-test measurements. The paired sample t test revealed that the 12-week FIFA 11+ program did not demonstrate any significant improvement in the participants’ sprint, agility, and vertical jump performance (p>0.05).

CONCLUSIONS: The present study showed no enhancement in sports performance parameters such as sprint speed, agility, and vertical jump performance in amateur female basketball players. This lack of improvement in performance measures suggests that the program cannot be used as a training strategy for the targeted sports performance parameters.

PMID:34187120 | DOI:10.1515/jcim-2020-0081

Med J Aust. 2021 Jun 29. doi: 10.5694/mja2.51146. Online ahead of print.

NO ABSTRACT

PMID:34187097 | DOI:10.5694/mja2.51146

J Basic Clin Physiol Pharmacol. 2021 Jun 29. doi: 10.1515/jbcpp-2020-0349. Online ahead of print.

ABSTRACT

OBJECTIVES: Infertility has disastrous consequences, particularly for women. Causes of infertility in developed countries have been investigated but there is a significant lack of data among Indian female population. The aim of the present study was to analyze the causes and the proportion of the individual factors contributing to infertility, considering the age factor.

METHODS: The data of 204 infertile women (18-45 years) were collected from the files in tertiary care hospitals. Causes and age of infertile women were grouped. The prevalence of each cause was evaluated. Data analysis was done using SPSS (Statistical Package for Social Sciences) version 17.0.

RESULTS: Polycystic ovarian syndrome (PCOS) was the most common (14.71%) cause of female infertility. Ovulatory dysfunctions (25.55%) were the foremost cause in primary infertility, whereas in secondary infertility, uterine factors (26.86%) were most common. The incidence of primary and secondary infertility was more evident in patients who were more than 30 years of age.

CONCLUSIONS: Causes of infertility vary according to the age. The causes of female infertility were unexplained infertility, ovulatory disorders and uterine factors most commonly affecting women at ≤30 years.

PMID:34187113 | DOI:10.1515/jbcpp-2020-0349

Milbank Q. 2021 Jun 29. doi: 10.1111/1468-0009.12524. Online ahead of print.

ABSTRACT

Policy Points The increased use of nurse practitioners represents a viable policy option to address continuing access-to-care deficiencies across the United States, but state scope-of-practice laws limit the ability of nurse practitioners to deliver health care. Groups in favor of restrictive scope-of-practice laws have argued that relaxing these laws will lead to increases in opioid prescriptions during an already severe opioid crisis, implicating patient safety concerns. An examination of a data set of 1.5 billion opioid prescriptions demonstrates that relaxing nurse practitioner scope-of-practice laws generally reduces opioid prescriptions. This evidence supports eliminating restrictive scope-of-practice laws that currently govern nurse practitioners in many states.

CONTEXT: As many parts of the United States continue to face physician shortages, the increased use of nurse practitioners (NPs) can improve access to care. However, state scope-of-practice (SOP) laws limit the ability of NPs to provide care by restricting the services they can provide and often requiring physician supervision of their practices. One important justification for the continuation of these restrictive SOP laws is preventing the overprescription of certain medications, particularly opioids.

METHODS: This study examined a data set of approximately 1.5 billion individual opioid prescriptions between 2011 and 2018, which were aggregated to the individual provider-year level. A series of difference-in-differences regression models was estimated to examine the association between laws allowing NPs to practice independently and opioid prescribing patterns among physicians and NPs. Opioid prescriptions were measured in total annual morphine milligram equivalents (MMEs) prescribed by individual providers.

FINDINGS: Across all NPs and physicians, independent NP practice was associated with a statistically significant decline of 6%, 2%, 3%, 7%, and 5% in total annual MMEs prescribed to commercially insured, cash-paying, Medicare, government-assistance, and all patients, respectively. Medicaid patients saw no statistically significant change in annual MMEs. Across all payers, NPs generally increase and physicians generally decrease the number of opioids they prescribe following a grant of NP independence. These counterbalancing changes result in an overall net decline in MMEs.

CONCLUSIONS: No evidence supports the contention that allowing NPs to practice independently increases opioid prescriptions. The results support policy changes that allow NPs to practice independently.

PMID:34187087 | DOI:10.1111/1468-0009.12524