Tag: pubmed

Trials. 2022 Oct 6;23(1):856. doi: 10.1186/s13063-022-06706-x.

ABSTRACT

BACKGROUND: The COVID-19 pandemic significantly impacted the conduct of clinical trials through delay, interruption or cancellation. Decentralised methods in clinical trials could help to continue trials during a pandemic. This paper presents the results of an exploratory study conducted early in the pandemic to gain insight into and describe the experiences of organisations involved in clinical trials, with regard to the impact of COVID-19 on the conduct of trials, and the adoption of decentralised methods prior to, and as mitigation for the impact, of COVID-19.

METHODS: A survey with 11 open-ended and four multiple choice questions was conducted in June 2020 among member organisations of the public-private “Trials@Home” consortium. The survey investigated (1) the impact and challenges of COVID-19 on the continuation of ongoing clinical trials, (2) the adoption of decentralised methods in clinical trials prior to and as a mitigation strategy for COVID-19, (3) the challenges of conducting clinical trials during COVID-19, (4) the expected permanency of COVID-19-driven changes to the adoption of decentralised methods in clinical trials, and (5) lessons learned from conducting clinical trials during the COVID-19 pandemic. A thematic, inductive analysis of open survey questions was performed, complemented with descriptive statistics (frequencies and distributions).

RESULTS: The survey had a response rate of 81%. All organisations included in the analysis (n = 18) implemented (some) decentralised methods in their clinical trials prior to COVID-19, and 15 (83%) implemented decentralised methods as mitigation for COVID-19. Decentralised methods for IMP supply, patient-health care provider interaction and communication, clinic visits and source document verification were used more often as mitigation strategies than they were used prior to COVID-19. Many respondents expect to maintain those decentralised methods they implemented during COVID-19 in ongoing trials, as well as implement them in future trials.

CONCLUSIONS: Decentralised methods are a widely implemented mitigation strategy for trial conduct in the face of the COVID-19 pandemic. The results of this survey show that there is an interest to continue the use of decentralised methods in future trials, but important points of attention have been identified that need solutions to help guide the transition from the traditional trial model to a more decentralised trial model.

PMID:36203202 | DOI:10.1186/s13063-022-06706-x

Matern Health Neonatol Perinatol. 2022 Oct 6;8(1):8. doi: 10.1186/s40748-022-00143-z.

ABSTRACT

BACKGROUND: Several international studies have indicated an association between socioeconomic deprivation levels and adverse birth outcomes. In contrast, those investigating an association between socioeconomic status and low birth weight using nationwide data are limited in Japan. In this study, we investigated an association between municipal socioeconomic deprivation level and low birth weight by an ecological study.

METHODS: Nationwide municipal-specific Vital Statistics data from 2013 to 2017 were used. We calculated the low birth weight rate and standardized incidence ratio (SIR) for low birth weight for each municipality and plotted them on a Japanese map. Furthermore, the correlation coefficient between them and the deprivation level were calculated. In addition, a spatial regression model including other municipal characteristics was used to investigate an association between low birth weight and the deprivation level.

RESULTS: Municipalities with relatively high SIR for low birth weight were dispersed across all of Japan. The correlation coefficient between the socioeconomic deprivation level and low birth weight rate was 0.196 (p-value < 0.001) among municipalities, and that between the socioeconomic deprivation level and the SIR for low birth weight was 0.260 (p-value < 0.001). In addition, the spatial regression analysis showed the deprivation level was significantly and positively associated with low birth weight.

CONCLUSIONS: The socioeconomic deprivation level and low birth weight were positively associated, and a further study using individual data is warranted to verify reasons for the association.

PMID:36203206 | DOI:10.1186/s40748-022-00143-z

J Pharm Policy Pract. 2022 Oct 6;15(1):59. doi: 10.1186/s40545-022-00455-7.

ABSTRACT

BACKGROUND: To promote an acceptance rate of COVID-19 immunization among Thai children, concerns about parental vaccination hesitancy should be urgently studied. This study aimed to examine the parental COVID-19 vaccination hesitancy (PVh) level and influencing factors among Thai parents of children 5-18 years of age.

METHODS: This cross-sectional survey was conducted in Thailand during May and June of 2022. The Google forms for data collection were distributed to parents (a father, a mother, or one who nurtures and raises a child) via various online social media. Data regarding PVh level, relevant attitudes, experiences of COVID-19 and COVID-19 vaccination (EC&V), and family contexts (FC) were collected and analyzed using descriptive statistics. Mann-Whitney U test was used to compare the differences among groups of parents based on EC&V and FC. The factors influencing PVh were assessed by multiple regression analysis.

RESULTS: Four hundred and eighty-eight parents completed the online questionnaire. Their median (IQR) age was 41 (35-47) years. They lived in different provinces from all regions across Thailand. Ninety percent of them were authorized persons to make decision about children vaccination. Fifty-eight percent of the respondents had vaccine hesitancy, defined as PVh level at moderate or above. Parents who had ever refused COVID-19 vaccination for themselves or refused to vaccinate their children against any other diseases had statistically significant higher levels of PVh (p value < 0.001). Conversely, the parents who had finished the initial COVID-19 vaccine had lower PVh levels with statistical significance (p value = 0.001). Attitude towards COVID-19 (AC), attitude towards COVID-19 vaccine (AV), and perceived behavioral control (PC) of the parents negatively influenced PVh with statistical significance, according to the results of the multiple regression analysis (Betas = – 0.307, – 0.123, and – 0.232, respectively).

CONCLUSIONS: COVID-19 vaccination hesitancy was commonly found among Thai parents. The factors of the hesitancy were multifaceted. Different experiences regarding COVID-19 vaccination for themselves and any vaccinations for their children were associated with different PVhs. The attitudes especially AC, AV, and PC statistically influenced PVh. These findings should be exploited for national and local policy planning as well as public campaigns.

PMID:36203192 | DOI:10.1186/s40545-022-00455-7

BMC Palliat Care. 2022 Oct 6;21(1):174. doi: 10.1186/s12904-022-01059-3.

ABSTRACT

BACKGROUND: Prognostic accuracy is important throughout all stages of the illness trajectory as it has implications for the timing of important conversations and decisions around care. Physicians often tend to over-estimate prognosis and may under-recognize palliative care (PC) needs. It is therefore essential that all relevant stakeholders have as much information available to them as possible when estimating prognosis.

AIMS: The current study examined whether the interRAI Changes in Health, End-Stage Disease, Signs and Symptoms (CHESS) Scale is a good predictor of mortality in a known PC population and to see how it compares to the Palliative Performance Scale (PPS) in predicting 90-day mortality.

METHODS: This retrospective cohort study used data from 2011 to 2018 on 80,261 unique individuals receiving palliative home care and assessed with both the interRAI Palliative Care instrument and the PPS. Logistic regression models were used to evaluate the relationship between the main outcome, 90-day mortality and were then replicated for a secondary outcome examining the number of nursing visits. Comparison of survival time was examined using Kaplan-Meier survival curves.

RESULTS: The CHESS Scale was an acceptable predictor of 90-day mortality (c-statistic = 0.68; p < 0.0001) and was associated with the number of nursing days (c = 0.61; p < 0.0001) and had comparable performance to the PPS (c = 0.69; p < 0.0001). The CHESS Scale performed slightly better than the PPS in predicting 90-day mortality when combined with other interRAI PC items (c = 0.72; p < 0.0001).

CONCLUSION: The interRAI CHESS Scale is an additional decision-support tool available to clinicians that can be used alongside the PPS when estimating prognosis. This additional information can assist with the development of care plans, discussions, and referrals to specialist PC teams.

PMID:36203180 | DOI:10.1186/s12904-022-01059-3

BMC Oral Health. 2022 Oct 6;22(1):438. doi: 10.1186/s12903-022-02480-z.

ABSTRACT

BACKGROUND: Down syndrome (DS), a most frequently occurring genetic disorder, is associated with oral morphological abnormalities and higher incidence rates of oral diseases. Recent studies have analyzed the oral microbiome to elucidate their relationships with oral diseases and general health; however, reports on the oral microbiome in individuals with DS are scarce. This study aimed to characterize the oral microbiome in children with DS.

METHODS: A total of 54 children aged 1-13 years were enrolled in this case-control study. Of these children, 27 had DS (Case: DS group) and 27 were age-matched healthy children (Control: ND group). Saliva in the oral cavity was collected with a swab, cultured, and tested for cariogenic and periodontopathic bacteria by quantitative polymerase chain reaction (qPCR) detection, and the salivary microbiome was analyzed using next-generation sequencing. The student’s t-test, Fisher’s exact test, Mann-Whitney U test, and permutational multivariate analysis of variance were used for statistical analysis.

RESULTS: Results of culture and qPCR detection tests for cariogenic and periodontopathic bacteria showed no significant differences in the detected bacteria between the DS and ND groups, with the exception of a significantly higher detection rate of Candida albicans in children with DS with mixed dentition. A comparison of the salivary microbiomes by 16S sequencing showed no significant difference in α diversity; however, it showed a significant difference in β diversity. Children with DS had a higher relative abundance of Corynebacterium and Cardiobacterium, and lower relative abundance of TM7.

CONCLUSIONS: This study provided basic data on the salivary microbiome of children with DS and showed the microbiological markers peculiar to children with DS. However, further research to identify the relationship with oral diseases is warranted.

PMID:36203175 | DOI:10.1186/s12903-022-02480-z

Diabetol Metab Syndr. 2022 Oct 6;14(1):144. doi: 10.1186/s13098-022-00916-8.

ABSTRACT

AIM: Maternal complications of pregnancy, including hypertensive disorders of pregnancy, gestational diabetes mellitus, intrauterine growth restriction, preterm labour, and placental abruption, are associated with increased risk of future cardiometabolic disease. Lifestyle interventions that focus on preventative strategies for this young, high-risk population of women may assist in cardiometabolic disease risk reduction. The aim of this preliminary registry analysis was to observe the change in maternal metabolic syndrome status after receiving a nurse practitioner-led lifestyle intervention delivered soon after a complicated pregnancy.

METHOD: This preliminary analysis included 64 eligible women who had attended both baseline (approximately 6 months postpartum) and review (approximately eighteen months postpartum) appointments at the postpartum lifestyle clinic after an index pregnancy complicated by at least one maternal complication of pregnancy. Metabolic syndrome status at both appointments was assessed.

RESULTS: At the baseline appointment, 22 (34.4%) women met the criteria for metabolic syndrome. This number reduced at the review appointment to 19 (29.7%). This difference was not statistically significant. There were some modest improvements in the individual cardiometabolic risk factors, as well as marked improvements in the women who had recovered from metabolic syndrome over twelve months.

CONCLUSION: There was a high percentage of metabolic syndrome present early in the postpartum period. The results of this preliminary analysis highlight the importance of continuing preventative care and ongoing research for this group of high-risk women.

PMID:36203165 | DOI:10.1186/s13098-022-00916-8

BMC Palliat Care. 2022 Oct 6;21(1):173. doi: 10.1186/s12904-022-01065-5.

ABSTRACT

BACKGROUND: Little is known about the nature and intensity of palliative care needs of hospitalised older people. We aimed to describe the palliative care symptoms, concerns, and well-being of older people with frailty and complex care needs upon discharge from hospital to home, and to examine the relationship between palliative care symptoms and concerns, and well-being.

METHODS: Cross-sectional study using baseline survey data of a pilot randomised controlled trial. Hospital staff identified patients (≥ 70 years) about to be discharged home, with a clinical frailty score of 5 to 7 and complex needs based on physician-assessment. Patients completed structured interviews, using the Integrated Palliative Care Outcome Scale (IPOS), ICEpop CAPability measure for supportive care (ICECAP-SCM) and IPOS Views on Care quality of life item. We calculated descriptive statistics.

RESULTS: We assessed 37 older people with complex needs (49% women, mean age 84, standard deviation 6.1). Symptoms rated as causing severe problems were weakness (46%) and poor mobility (40%); 75% reported that their family felt anxious at least occasionally. Of the 17 IPOS items, 41% of patients rated five or more symptoms as causing severe problems, while 14% reported that they were not severely affected by any symptom. 87% expressed feeling supported. There was a negative correlation between symptoms (IPOS) and well-being (ICECAP); r = -0.41.

CONCLUSION: We identified a large variety of symptoms experienced by older people identified as having frailty and complex needs upon hospital discharge. Many were severely affected by multiple needs. This population should be considered for palliative care follow-up at home.

PMID:36203161 | DOI:10.1186/s12904-022-01065-5

BMC Geriatr. 2022 Oct 6;22(1):783. doi: 10.1186/s12877-022-03235-9.

ABSTRACT

BACKGROUND: Anticholinergic medications are drugs that block cholinergic transmission, either as their primary therapeutic action or as a secondary effect. Patients with dementia may be particularly sensitive to the central effects of anticholinergic drugs. Anticholinergics also antagonise the effects of the main dementia treatment, cholinesterase inhibitors. Our study aimed to investigate anticholinergic prescribing for dementia patients in UK acute hospitals before and after admission.

METHODS: We included 352 patients with dementia from 17 UK hospital sites in 2019. They were all inpatients on surgical, medical or Care of the Elderly wards. Information about each patient’s medications were collected using a standardised form, and the anticholinergic drug burden of each patient was calculated with an evidence-based online calculator. Wilcoxon’s rank test was used to look at the correlation between two subgroups upon admission and discharge.

RESULTS: On admission to hospital, 37.8% of patients had an anticholinergic burden score ≥ 1 and 5.68% ≥3. On discharge, 43.2% of patients with an anticholinergic burden score ≥ 1 and 9.1% ≥3. The increase in scores was statistically significant (p = 0.001). Psychotropics were the most common group of anticholinergic medications prescribed at discharge. Of those patients taking cholinesterase inhibitors, 44.9% were also prescribed anticholinergic medications.

CONCLUSIONS: Our cross-sectional, multicentre study found that people with dementia are commonly prescribed anticholinergic medications, even if concurrently taking cholinesterase inhibitors, and are significantly more likely to be discharged from hospital with a higher anticholinergic burden than on admission.

PMID:36203156 | DOI:10.1186/s12877-022-03235-9

BMC Med. 2022 Oct 7;20(1):352. doi: 10.1186/s12916-022-02536-5.

ABSTRACT

BACKGROUND: A recent trial of 5920 children in Burkina Faso and Mali showed that the combination of seasonal vaccination with the RTS,S/AS01_E malaria vaccine (primary series and two seasonal boosters) and seasonal malaria chemoprevention (four monthly cycles per year) was markedly more effective than either intervention given alone in preventing clinical malaria, severe malaria, and deaths from malaria.

METHODS: In order to help optimise the timing of these two interventions, trial data were reanalysed to estimate the duration of protection against clinical malaria provided by RTS,S/AS01_E when deployed seasonally, by comparing the group who received the combination of SMC and RTS,S/AS01_E with the group who received SMC alone. The duration of protection from SMC was also estimated comparing the combined intervention group with the group who received RTS,S/AS01_E alone. Three methods were used: Piecewise Cox regression, Flexible parametric survival models and Smoothed Schoenfeld residuals from Cox models, stratifying on the study area and using robust standard errors to control for within-child clustering of multiple episodes.

RESULTS: The overall protective efficacy from RTS,S/AS01_E over 6 months was at least 60% following the primary series and the two seasonal booster doses and remained at a high level over the full malaria transmission season. Beyond 6 months, protective efficacy appeared to wane more rapidly, but the uncertainty around the estimates increases due to the lower number of cases during this period (coinciding with the onset of the dry season). Protection from SMC exceeded 90% in the first 2-3 weeks post-administration after several cycles, but was not 100%, even immediately post-administration. Efficacy begins to decline from approximately day 21 and then declines more sharply after day 28, indicating the importance of preserving the delivery interval for SMC cycles at a maximum of four weeks.

CONCLUSIONS: The efficacy of both interventions was highest immediately post-administration. Understanding differences between these interventions in their peak efficacy and how rapidly efficacy declines over time will help to optimise the scheduling of SMC, malaria vaccination and the combination in areas of seasonal transmission with differing epidemiology, and using different vaccine delivery systems.

TRIAL REGISTRATION: The RTS,S-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT03143218.

PMID:36203149 | DOI:10.1186/s12916-022-02536-5

BMC Musculoskelet Disord. 2022 Oct 6;23(1):898. doi: 10.1186/s12891-022-05858-w.

ABSTRACT

BACKGROUND: Morton’s neuroma is a painful enlargement of the plantar digital nerve between the metatarsal heads that causes pain of the forefoot. Several approaches have been used to treat Morton’s neuroma, each of them having distinct advantages and disadvantages.

OBJECTIVES: The purpose of this study was to investigate and compare the clinical outcomes of neurectomy in the treatment of Morton’s neuroma through plantar and dorsal approaches.

MATERIALS AND METHODS: A total of 20 patients with a mean age of 48.5 ± 13.0 years (range: 19-66 years) who underwent excision of a Morton’s neuroma that did not respond to conservative treatment were retrospectively analysed from June 2014 to June 2021. All the neurectomies were performed using a plantar or dorsal approach. Outcomes were evaluated using visual analogue scale (VAS) scores, American Orthopedic Foot and Ankle Society (AOFAS) scores, the Foot and Ankle Ability Measure (FAAM), and complications. The appearance index (AI) was also used to assess the influence of foot appearance on the quality of life after surgery.

RESULTS: Eight patients underwent neurectomy by the dorsal approach, and 12 patients underwent neurectomy by the plantar approach. The average follow-up time was 28.9 ± 12.9 months (range: 15-72 months). No statistically significant difference was found between the dorsal and plantar approach groups with respect to postoperative pain measured by the VAS score. The postoperative AOFAS scores and FAAM outcomes were not significantly different between the groups. The complications reported in the dorsal approach group were significantly less than those of the plantar group, mainly discomfort in wearing shoes. The AI of the plantar group and the dorsal group were significantly different.

CONCLUSION: The excision of the Morton’s neuroma by both the dorsal and plantar approach resulted in satisfactory outcomes. However, the foot appearance after surgery by the plantar approach had less influence on the quality of life than that using the dorsal approach. Our recommendation is that surgeons should choose the approach they are most familiar with and with which they are most confident in performing. In addition, the plantar approach is recommended if the patient needs a better appearance.

PMID:36203146 | DOI:10.1186/s12891-022-05858-w