Nevin Manimala

Cancer Epidemiol Biomarkers Prev. 2021 Jun 29:cebp.0404.2021. doi: 10.1158/1055-9965.EPI-21-0404. Online ahead of print.

ABSTRACT

BACKGROUND: Results of observational studies of the association between dietary fat and risk of invasive breast cancer (BC) have been inconsistent. In the Women’s Health Initiative Dietary Modification (DM) randomized trial designed to lower fat intake, the intervention was not associated with a statistically significant reduction of overall BC risk. However, the DM association with risk of ductal carcinoma in situ (DCIS) of the breast, a putative breast cancer precursor, has not been reported.

METHODS: A total of 48,835 postmenopausal women, ages 50-79 years (y) at enrollment, with no BC history and {greater than or equal to}32% of total energy intake from fat, were randomly assigned either to a dietary intervention (n=19,541) designed to reduce total fat intake to 20% of energy and to increase vegetable, fruit and grain consumption, or to a comparison group (n=29,294). Cox proportional hazards models were used to estimate hazard ratios and 95% confidence intervals for the association between the intervention and DCIS risk.

RESULTS: During 18.7y (median) cumulative follow-up, including intervention (~8.7y) and post-intervention phases (~13.0y), 817 DCIS cases were ascertained. No evidence of an association between the DM intervention and DCIS risk was observed overall, or by trial phase (intervention and post-intervention). Similarly, no associations were found in subgroups defined by potential risk factors for DCIS.

CONCLUSIONS: Dietary modification aiming to reduce fat intake was not associated with altered risk of DCIS.

IMPACT: These results do not provide evidence of an association between dietary fat reduction and the risk of DCIS among postmenopausal women.

PMID:34187856 | DOI:10.1158/1055-9965.EPI-21-0404

BMJ Open. 2021 Jun 29;11(6):e049590. doi: 10.1136/bmjopen-2021-049590.

ABSTRACT

OBJECTIVES: To evaluate the impact of the first COVID-19 lockdown in 2020 on the burnout and study satisfaction of medical students.

DESIGN: A cross-sectional study with a presurvey and postsurvey.

SETTING: University of Split School of Medicine (USSM), Split, Croatia. The lockdown in the COVID-19 pandemic lasted from late March to mid-May 2020. There was a full switch to e-learning at the USSM during this period, and all clinical teaching was stopped.

PARTICIPANTS: Students enrolled in the 2019/2020 academic year. Data were collected before lockdown in December 2019 and January 2020 and again after the end of lockdown in June 2020.

PRIMARY AND SECONDARY OUTCOME MEASURES: Study satisfaction was assessed using the study satisfaction survey. Burnout was assessed using two instruments: Oldenburg Burnout Inventory and Copenhagen Burnout Inventory. We used Bayesian statistics to compare before-and-after differences.

RESULTS: 437 independent responses (77.2% response rate) were collected before and 235 after lockdown (41.5% response rate). 160 participant responses were eligible for pairing. There was no significant difference for both paired and unpaired participants in study satisfaction before (3.38 on a 1-5 scale; 95% credible interval (95% CrI) 3.32 to 3.44) and after (3.49, 95% CrI 3.41 to 3.57) lockdown. We found no evidence (Bayes factor (BF₁₀) >3.00 as a cut-off value) for an increase in the level of burnout before and after lockdown, both in independent and paired samples.

CONCLUSIONS: It seems that the first pandemic-related lockdown and a switch to e-learning did not affect burnout levels among medical students or their perception of their study programme. More insight is needed on the short-term and long-term effects of the COVID-19 pandemic on medical students and their education. Well-structured longitudinal studies on medical student burnout during the COVID-19 pandemic are needed.

PMID:34187830 | DOI:10.1136/bmjopen-2021-049590

BMJ Open. 2021 Jun 29;11(6):e046943. doi: 10.1136/bmjopen-2020-046943.

ABSTRACT

INTRODUCTION: Non-pharmacological approaches are recommended as first-line treatment for patients with fibromyalgia. This randomised controlled trial investigated the effects of a multicomponent rehabilitation programme for patients with recently diagnosed fibromyalgia in primary and secondary healthcare.

METHODS: Patients with widespread pain ≥3 months were referred to rheumatologists for diagnostic clarification and assessment of study eligibility. Inclusion criteria were age 20-50 years, engaged in work or studies at present or during the past 2 years, and fibromyalgia diagnosed according to the American College of Rheumatology 2010 criteria. All eligible patients participated in a short patient education programme before inclusion and randomisation. The multicomponent programme, a 10-session mindfulness-based and acceptance-based group programme followed by 12 weeks of physical activity counselling was evaluated in comparison with treatment as usual, that is, no treatment or any other treatment of their choice. The primary outcome was the Patient Global Impression of Change (PGIC). Secondary outcomes were self-reported pain, fatigue, sleep quality, psychological distress, physical activity, health-related quality of life and work ability at 12-month follow-up.

RESULTS: In total, 170 patients were randomised, 1:1, intervention:control. Overall, the multicomponent rehabilitation programme was not more effective than treatment as usual; 13% in the intervention group and 8% in the control group reported clinically relevant improvement in PGIC (p=0.28). No statistically significant between-group differences were found in any disease-related secondary outcomes. There were significant between-group differences in patient’s tendency to be mindful (p=0.016) and perceived benefits of exercise (p=0.033) in favour of the intervention group.

CONCLUSIONS: A multicomponent rehabilitation programme combining patient education with a mindfulness-based and acceptance-based group programme followed by physical activity counselling was not more effective than patient education and treatment as usual for patients with recently diagnosed fibromyalgia at 12-month follow-up.

TRIAL REGISTRATION NUMBER: BMC Registry (ISRCTN96836577).

PMID:34187823 | DOI:10.1136/bmjopen-2020-046943

BMJ Open. 2021 Jun 29;11(6):e046913. doi: 10.1136/bmjopen-2020-046913.

ABSTRACT

INTRODUCTION: Metacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society; however, there is a lack of evidence to guide their treatment. Identifying the most beneficial and cost-efficient treatment will ensure optimisation of care and provide economic value for the National Health Service. The aim of this study is to assess the feasibility of a randomised controlled trial comparing surgical and non-surgical treatment for MSF in adults.

METHODS AND ANALYSIS: This is a multicentre prospective cohort study, with a nested qualitative study consisting of patient interviews and focus groups, and an embedded factorial randomised substudy evaluating the use of text messages to maximise data collection and participant retention. The outcomes of interest include eligibility, recruitment and retention rates, completion of follow-up, evaluation of primary outcome measures, calculation of the minimal clinically important difference (MCID) for selected outcome measures and establishing the feasibility of data collection methods and appropriate time-points for use in a future trial. Data will be captured using a secure online data management system. Data analyses will be descriptive and a thematic inductive analysis will be used for qualitative data. Minimum clinically important effects for each patient-reported outcome measure will be estimated using anchor-based responsiveness statistics and distribution-based methods.

ETHICS AND DISSEMINATION: This study has received ethical approval from the Research Ethics Committee and the Health Research Authority (REC reference 20/EE/0124). Results will be made available to patients, clinicians, researchers and the funder via peer-reviewed publications and conference presentations. Social media platforms, local media and feedback from the Patient Advisory Group will be used to maximise circulation of findings to patients and the public.

TRIAL REGISTRATION NUMBER: ISRCTN13922779.

PMID:34187822 | DOI:10.1136/bmjopen-2020-046913

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

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

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

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

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

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