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11
Radiostereometric analysis
fracture, fractures, Fracture
IMPACTION
Screw migration in the femoral head/neck was similar between the HA-coated group and the NON-coated group at 6 weeks, 3 months, and 6 months (Screw migration displayed as means in mm and degrees with 95% confidence intervals (CI 95%) at 6 weeks (Furthermore, there was no statistically significant difference between gro...
PMC10503211
RSA precision
For screw migration (A. Repeatability of screw migration with reference to the head/neck fracture segment given in the coordinate system of the EGS model of the screw as absolute values from RSA double-examinations (PI = Prediction interval of precision
PMC10503211
Discussion
fracture, fractures
EVANS, IMPACTION
Only few studies have assessed screw fixation and fracture migration in pertrochanteric fractures using RSA. The key-finding in this RSA study was similar and low migration of lag screws with HA-coated and NON-coated threads of a SHS in the femoral head/neck fragment in stable (Evans type I, II, IV) pertrochanteric hip...
PMC10503211
Screw migration
In general, HA has been shown to improve osseointegration and fixation with various orthopedic implants including screws [
PMC10503211
Fracture stability
femoral neck fractures, pertrochanteric fractures, fracture, Fracture, fractures, non-union
In the treatment of pertrochanteric fractures a stable internal fixation accomplished with dynamic compression of the fracture sites is important to achieve stability and healing. Van Embden et al. described a mean shortening of 7.1 mm (range 4.6–10.7) after 6 weeks in 4 pertrochanteric fractures treated with a SHS [Th...
PMC10503211
Clinical outcomes
At baseline this fragile patient group reported a pre-fracture mean HHS of 85 points, which was lower than the similar aged background population [
PMC10503211
Strengths and limitations
fractures
The strength of this study lies in the double-blinded randomized controlled study design, the high precision of RSA as a validated method to measure migrations of both implants and fractures, and the protocolled similarity of the treatment algorithm in both inclusion sites [
PMC10503211
Conclusion
fracture, fractures
There was no clinical benefit of hydroxyapatite coating on SHS screw migration in this patient cohort, which may be explained by a good screw placement. Migration of the pertrochanteric fractures stabilized around 6 weeks follow-up and with acceptable fracture displacement and no mechanical failures.
PMC10503211
Acknowledgements
LARSEN
The authors would like to thank project nurse Anne-Birgitte Larsen for her valued help with project coordination and Anne Dorthe Riedel for her valued help with project coordination and RSA analyses.
PMC10503211
Author contributions
ACK contributed to image analysis, statistical analysis and data interpretation, writing of the original draft and manuscript revision. JKT performed statistical analyses and contributed to data interpretation, writing of the original draft and manuscript revision. TBH contributed to study planning, data collection and...
PMC10503211
Funding
Biomet supported the study financially but had no influence on the manuscript or publication. The authors of this study report no conflict of interest.
PMC10503211
Declarations
PMC10503211
Ethics approval and consent to participate
-11
The study was approved by the Data Protection Agency (1-16-02-175-11) and the Central Denmark Regions Committee on Biomedical Research Ethics (M-20110224) and was carried out in agreement with the Helsinki II Declaration.
PMC10503211
Competing interests
The authors declare no competing interests.
PMC10503211
References
PMC10503211
Purpose
endometriosis, pelvic pain, pain
ENDOMETRIOSIS
Despite standard medical treatment endometriosis is often associated with disabling pain and poor quality of life (QoL). Studies indicate that psychological interventions (PIs) may improve pain and QoL, yet studies on the effects of PIs for women with endometriosis are sparse and limited by low-quality study designs. T...
PMC10172241
Methods
endometriosis, pelvic pain, pain, endometriosis-related, WL, NRS
ENDOMETRIOSIS
This three-armed parallel, multi-center randomized controlled trial included fifty-eight endometriosis patients reporting severe CPP [≥ 5 for pain intensity measured on a 0–10-point numeric rating scale (NRS)]. Patients were randomly assigned to (1) Specific mindfulness- and acceptance-based psychological intervention ...
PMC10172241
Results
endometriosis-related, constipation, dyschezia’, pain
Compared to WL, psychological intervention (MY-ENDO + Non-specific) did not significantly reduce pain. However, psychological intervention did significantly improve the QoL-subscales ‘control and powerlessness’, ‘emotional well-being’, and ‘social support’ as well as the endometriosis-related symptoms ‘dyschezia’ and ‘...
PMC10172241
Conclusions
endometriosis
ENDOMETRIOSIS
Women with endometriosis may have significant and large effects of psychological intervention on QoL despite an ongoing experience of severe CPP.
PMC10172241
Trial registration
12 April 2016, clinicaltrials.gov (NCT02761382), retrospectively registered.
PMC10172241
Keywords
PMC10172241
Plain English summary
Endometriosis, endometriosis, pelvic pain, pain, constipation, endometriosis-related, chronic gynecological disease
ENDOMETRIOSIS, ENDOMETRIOSIS
Endometriosis is a chronic gynecological disease affecting 5–10% of women worldwide. It can lead to disabling pelvic pain and poor quality of life. The traditional treatments for painful endometriosis consist of medical and/or surgical treatment. However, these treatments are, in many cases, insufficient in relieving t...
PMC10172241
Background
Endometriosis, endometriosis, bleeding, gynecological disease, pain, endometrial lesions, chronic pain, WL, adhesions
ENDOMETRIOSIS, BLEEDING, ENDOMETRIOSIS, RECURRENCE, GYNECOLOGICAL DISEASE, INFLAMMATION, SECONDARY, CHRONIC PAIN, UTERUS, ADHESIONS
Endometriosis is a chronic and often painful gynecological disease defined as the presence and growth of endometrium-like tissue outside the uterus, usually in the pelvis, where it causes bleeding, inflammation, and adhesions [Current standard treatment for painful endometriosis includes hormonal treatment, pain medica...
PMC10172241
Methods
PMC10172241
Study design
WL, pain
Patients were randomly assigned to one of three conditions: (1) A specific mindfulness- and acceptance-based PI called “Mind Your ENDOmetriosis” (MY-ENDO), (2) A non-specific PI (Non-specific) that matched MY-ENDO in non-specific factors such as empathy, the therapeutic alliance, a cogent rationale, and expectations of...
PMC10172241
Participants
endometriosis, MRI-confirmed endometriosis, Endometriosis, pain
ENDOMETRIOSIS, ENDOMETRIOSIS
Participants were recruited from three specialized outpatient clinics for endometriosis in Denmark and from the Danish Endometriosis Patients Association. All patients considered for inclusion underwent screening to assess in- and exclusion criteria. Inclusion criteria were: (a) 18–47 years old, (b) surgery or MRI-conf...
PMC10172241
Procedure
pain
A letter was sent to interested patients with study details and a pain diary to be filled out before the screening session. At the screening, patients were informed about study requirements and screened for in- and exclusion criteria. They provided written informed consent before enrolment in the study and randomizatio...
PMC10172241
Interventions
PMC10172241
Non-specific
To properly test whether MY-ENDO was truly superior to other psychological interventions and if the effects were due to specific mindfulness ingredients, the control condition had to be an intervention based on psychological principles. This means: (1) to have a cogent and acceptable rationale (2) to include correspond...
PMC10172241
Waitlist
gynecological pain
The Wait-list group received medical treatment as usual and completed the same questionnaires and gynecological pain assessment as the intervention groups.
PMC10172241
Therapists
Two private practicing clinical psychologists, both licensed by the Danish board of psychologists and closely matched on essential parameters (training, apprenticeship, and competence), were recruited to deliver the interventions in a “crossed-therapist” design, with both therapists providing both treatments within the...
PMC10172241
Study outcome measures
Along with a sociodemographic questionnaire, patients received the following questionnaires:
PMC10172241
Sample size
Pelvic pain, WL, pelvic pain
SECONDARY
Sample size was based on power analysis of a small randomized 3-armed pilot study (unpublished) for the primary outcome of pelvic pain between the groups: (1) PI vs. WL and (2) MY-ENDO vs. Non-specific and for the secondary outcome of QoL between the groups PI vs. WL. Pelvic pain was measured on NRS. The NRS scale scor...
PMC10172241
Statistical analysis
Baseline group differences were compared by the
PMC10172241
Results
PMC10172241
MY-ENDO vs. non-specific
pelvic pain, diarrhea
SECONDARY
Statistically significant time × group effects were found for pelvic pain intensity (Neither did we find any statistically significant time × group interactions for the secondary outcomes except for diarrhea (With regards to the time spent on home practice, we did not find a significant difference between MY-ENDO (Mean...
PMC10172241
Post-hoc analyses
pelvic pain, pain
When dividing participants into two groups (taking vs. not taking pain medication) independent of randomization allocation, statistically significant time × group effects were found for pelvic pain intensity (F = 11.3, Differences in pelvic pain between the groups “taking pain medication” vs. “not taking pain medicatio...
PMC10172241
Discussion
endometriosis, pelvic pain, constipation, pain, endometriosis-related, chronic pain
CHRONIC PAIN, ENDOMETRIOSIS
In this rigorous three-armed design we have demonstrated that psychological intervention (PI) does not significantly reduce pelvic pain in women suffering from endometriosis. Instead, PI led to large and significant improvements in QoL despite an ongoing experience of severe CPP.Cochrane meta-analyses of psychological ...
PMC10172241
Strengths and limitations
fatigue, pain
STILL
Notably, this study has some strengths that are rarely seen in RCTs examining the effects of psychological interventions. The inclusion of a carefully matched non-specific control condition and a no-treatment control in a 3-armed RCT together with the attempt to reduce significant threats to internal validity (e.g., ba...
PMC10172241
Author contributions
RP
KEH coordinated the project KEH, BB, LV, MK, RP, AF and USK conceived and designed the study. KEH, BB, MK, RP, OD and DH executed the study and KEH obtained the data. KEH, USK AF and LV analyzed and interpreted the data. KEH drafted the manuscript and BB, MK, AF, RP, OD, DH, USK and LV critically revised the manuscript...
PMC10172241
Funding
Endometriosis
ENDOMETRIOSIS, ENDOMETRIOSIS
This work was supported by a donation from TrygFonden, a donation from Ladywalk, and a donation from the Danish Endometriosis Patient Association, a non-governmental organization run by women with endometriosis.
PMC10172241
Data availability
Data from this study is not publicly available due to restrictions pertaining to the general data protection regulation in Denmark but will be shared on reasonable request to the corresponding author.
PMC10172241
Declarations
PMC10172241
Competing interests
The authors declare that they have no competing interests.
PMC10172241
Ethical approval
The study was preregistered with The Danish Data Protection Agency (journal no. 2015-57-0002) and approved by The Central Denmark Region Committees on Health Research Ethics (registration no. 1-10-72-138-15).
PMC10172241
Consent to participate
All patients were informed about study requirements and provided written informed consent before enrolment in the study.
PMC10172241
References
PMC10172241
Methods
asphyxia, weight loss, illness, infection
BLOOD GROUP INCOMPATIBILITY, ASPHYXIA, INFECTION
This study included newborn infants who were part of a multicenter randomized trial conducted from August 2016 to September 2019. The ethical review board in Uppsala, Sweden, approved the study (D 2015/226) and it was registered at clinicaltrials.gov 24/05/2018 (NCT03536078). The original dataset included 147 patients ...
PMC10317991
Health economic evaluation method
In a cost-effectiveness analysis, the result is traditionally presented in terms of the incremental cost-effectiveness ratio (ICER). For the strategies being compared or evaluated, the ICER estimates the difference in costs (measured in monetary units) divided by the difference in effects, thus expressing the cost of a...
PMC10317991
Data on costs
Recently updated standards recommend that health economic evaluations present results from both a societal and a health care perspectiveTime and materials costs were based on actual resource use as registered in the study and monetarily valued mainly based on regional price tariffs. Details are presented in Table Unit ...
PMC10317991
Ethics approval
This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the regional ethical review board in Uppsala, Sweden (2015/336).
PMC10317991
Consent to participate
Written informed consent was obtained from the parents.
PMC10317991
Consent for publication
Written informed consent was obtained from the parents.
PMC10317991
Sensitivity analysis
In the sensitivity analysis by bootstrapping, all 1000 drawings showed home phototherapy as the cost-saving alternative, with savings ranging from €483 to €1152 when hospital treatment was offered at the maternity unit.For treatment duration, 40% of the drawings showed home phototherapy as the more effective, i.e. havi...
PMC10317991
Author contributions
M.P., M.E. and A.O. all contributed to the study conception and design. Material preparation and data collection was performed by M.P., M.E., and A.O. Analysis was performed by M.P., M.E., A.O. and L.R. The first draft of the manuscript was written by A.O. and all authors commented on previous versions of the manuscrip...
PMC10317991
Funding
Open access funding provided by Örebro University. This study was funded by the Uppsala and Örebro regional county council.
PMC10317991
Data availability
The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.
PMC10317991
Competing interests
The authors declare no competing interests.
PMC10317991
References
PMC10317991
1. Introduction
cancers
CHRONIC INFLAMMATION, CANCERS, TUMOUR NECROSIS, CHRONIC DISEASES, ADHESION, CHRONIC INFLAMMATION, INFLAMMATORY RESPONSE
Increasing evidence supports that a higher dietary inflammatory index (DIIThe inflammatory response involves the production of a range of pro-inflammatory biomarkers including cytokines, interleukins (IL), adhesion molecules, tumour necrosis factor, and high sensitivity C-reactive protein (hsCRP) as part of the body’s ...
PMC9866776
2. Methods
The MedLey study was a dietitian-led, randomized, controlled, parallel dietary intervention trial comparing the effect of a traditional MedDiet with a habitual diet on cognitive and cardiometabolic health outcomes in a healthy elderly population. The protocol has been described elsewhere [
PMC9866776
2.1. Calculating the DII and E-DII Scores
The DII was developed to estimate the inflammatory potential of an overall food pattern and has been described elsewhere [Food-specific parameters used to calculate the DII that were available from the MedLey study WFR include energy (kJ), carbohydrate (CHO, g), protein (g), total fat (g), monounsaturated fat (MUFA, g)...
PMC9866776
2.2. Statistical Analysis
Statistical analyses were performed using SPSS version 21.0 (SPSS Inc., Chicago, IL, USA).Descriptive statistics were presented as mean ± SD with outcome variables reported as mean ± SEM. Statistical significance was set at
PMC9866776
2.2.1. Statistical Analysis of Changes in DII and E-DII Scores with Dietary Intervention
The effects of dietary interventions on the DII
PMC9866776
2.2.2. Statistical Analysis of Intervention Impacts Relating to DII and E-DII Scores
Results from the MedLey study showed significant improvements to cardiovascular risk factors. To assess if there was an association of the change in DII
PMC9866776
2.2.3. Statistical Analysis of Cross-Sectional Relationships of DII
INSULIN RESISTANCE, ADIPOSITY
Baseline data were examined irrespective of dietary intervention group to determine relationships between DII and body composition (BMI, weight, WHR, and abdominal adiposity), cardiometabolic health (hsCRP, blood cholesterol levels, homeostatic model of insulin resistance (HOMA)), and vascular health (blood pressure, f...
PMC9866776
3. Results
Baseline characteristics of the MedLey population are published elsewhere [
PMC9866776
3.1. Dietary Adherence to a MedDiet
Adherence to a MedDiet was calculated using a 15-point adherence score based on the methodology of Trichopoulou [
PMC9866776
3.2. Dietary Inflammatory Index
There was no significant difference in the DII score at baseline between the MedDiet and HabDiet groups (
PMC9866776
3.3. Cardiometabolic Health Outcomes of the MedLey Trial
Data from the MedLey study has been published elsewhere in detail [
PMC9866776
3.4. Relationship of DII
overweight
There was no association found between the changes in cardiometabolic outcomes and the changes in DII, and these results did not change when the population was split into normal weight and overweight categories. We then explored if BP status at baseline may influence cardiometabolic outcomes and divided the data into “...
PMC9866776
3.5. Cross-Sectional Relationships of DII
BLOOD
As there was no relationship between the change in cardiometabolic health outcomes of the dietary intervention and DII, baseline data from both groups were combined to explore relationships between DII status and cardiometabolic parameters. DII tertiles were established; the most anti-inflammatory dietary pattern (tert...
PMC9866776
4. Discussion
obesity
OBESITY, EVENTS, ADIPOSITY, CVD
In this randomised dietary intervention trial, we demonstrated that high adherence to a MedDiet over 6 months led to improved DII/E-DII scores and anti-inflammatory activity compared to the HabDiet group in an older Australian cohort. However, no associations between DII/E-DII and cardiometabolic risk factors were foun...
PMC9866776
5. Conclusions
inflammation, cognitive and cardiovascular health
CVD, INFLAMMATION
Our results provide further evidence regarding the relationship between the dietary inflammatory index of a MedDiet and cardiometabolic outcomes. We demonstrated that high adherence to a MedDiet intervention over 6 months significantly lowered mean DII compared to a HabDiet in older Australians. The reduction of the in...
PMC9866776
Author Contributions
Conceptualization, K.J.M., K.A.D., N.S. and J.R.H.; methodology; K.J.M., C.R.D., N.S. and J.M.H.; investigation; K.A.D., C.R.D. and K.J.M.; data curation, R.W., K.A.D., K.J.M. and J.S.C.; writing—original draft preparation, K.A.D. and J.S.C.; writing—review and editing; K.J.M., K.A.D., C.R.D., N.S., J.R.H., J.M.H., R.W...
PMC9866776
Institutional Review Board Statement
MAY
This study was conducted in accordance with the Declaration of Helsinki, and approved by the University of South Australian Ethics Committee, protocol code (#31163) on the 22 June 2013. The trial was registered with the Australia New Zealand Clinical Trials Register (ACTRN12613000602729), on the 27 May 2013.
PMC9866776
Informed Consent Statement
Written informed consent was obtained from all participants before commencement.
PMC9866776
Data Availability Statement
Data from the MedLey study contains sensitive participant information. For data access, please contact the University of South Australia Human Research Ethics Committee
PMC9866776
Conflicts of Interest
The authors declare no conflict of interest.
PMC9866776
Abbreviations
CVD, CARDIOVASCULAR DISEASE
BMI, body mass index; BP, blood pressure; CHO, carbohydrate; hsCRP, high sensitivity C-reactive protein; CVD, cardiovascular disease; DBP, diastolic blood pressure; DII, dietary inflammatory index; F
PMC9866776
References
adiposity
ADIPOSITY
Changes in the dietary inflammatory index during the MedLey intervention: (Baseline dietary inflammatory index (adjusted for energy intake) stratified into tertiles. Tertile 1 represents the lowest E-DII, being the most anti-inflammatory, while tertile 3 represents the highest E-DII, being the most pro-inflammatory.Ter...
PMC9866776
Methods
Hepatitis B
REGRESSION, HEPATITIS B, NAIROBI
We conducted a cross sectional analysis of data collected from individuals who were screened in Kenya (Nairobi) and Uganda (Entebbe and Kampala). The studies followed hypothetical procedures of an HIV vaccine efficacy trial and aimed to enroll HIV negative key and vulnerable populations at elevated risk of HIV acquisit...
PMC10351693
Results
acute infection, chronic infection, HBV infection, infection, HBV infected
ACUTE INFECTION, CHRONIC INFECTION, NAIROBI, INFECTION, SECONDARY
We screened 1,366 participants with mean age (SD) 28.7 (7.3) years. Overall, 46.6% were from Entebbe, 50.7% had secondary or higher level of education, 76.4% had informal high-risk jobs and 56.3% were male. Kampala had only female participants contributing 60.6% of females screened. Of the screened participants, 94.7% ...
PMC10351693
Conclusion
HIV vaccine, low among HIV negative, HBV infection
HBV prevalence and immunity due to vaccination were low among HIV negative individuals who are eligible for HIV vaccine trials and prevalence varies by age, education level and main occupation. Younger individuals and those recruited from existing cohorts/ clinics have a higher likelihood of having no prior HBV infecti...
PMC10351693
Data Availability
All relevant data are within the manuscript and its
PMC10351693
Introduction
hepatitis B, Simulated HIV vaccine, liver cirrhosis, primary liver cancer, KPs living with HIV show varied HBV
HEPATITIS B, VIRUS, CHRONIC INFECTION, LIVER CIRRHOSIS, PRIMARY LIVER CANCER
Worldwide in 2019, an estimated 1.5 million people acquired hepatitis B virus (HBV), a chronic infection of public health concern because it is complicated by liver cirrhosis and primary liver cancer in 20–30% of individuals [Recent surveys done among KPs living with HIV show varied HBV prevalence, including 4.0% from ...
PMC10351693
Materials and methods
PMC10351693
Study design
We conducted a cross sectional analysis of data collected from individuals who were screened for SiVET studies at three sites: two in Uganda and one in Kenya.
PMC10351693
Study populations
RECRUITMENT, NAIROBI
All three SiVETs, following the hypothetical procedures of an HIV vaccine efficacy trial, aimed to enroll key and vulnerable populations at elevated risk of HIV acquisition. Each site followed a similar visit schedule and study procedures but focused on different populations based on site experience and expertise. The ...
PMC10351693
Study settings and sampling
PMC10351693
Entebbe site
AIDS
AIDS
The Uganda Virus Research Institute/ International AIDS Vaccine Initiative (UVRI-IAVI) HIV vaccine program conducted the study in two conveniently selected fishing communities (FCs) on Lake Victoria, one island and one on the mainland. Volunteers were randomly selected from the two FCs. Screening was conducted from Dec...
PMC10351693
Kampala site
The study was conducted at the Good Health for Women Project (GHWP) clinic of the Medical Research Council/ Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine (MRC/UVRI and LSHTM) Uganda Research Unit. The clinic was in a peri-urban community in southern Kampala and enrolled and followed...
PMC10351693
Nairobi site
NAIROBI
The KAVI- Institute for Clinical Research (KAVI-ICR), conducted the study at the college of health sciences, University of Nairobi. KAVI-ICR set enrollment numbers at 80% MSM, 20% FSWs. Screening was conducted from the Sex Workers Outreach Program (SWOP-Kenya) clinics in Nairobi from September 2015 to September 2017 an...
PMC10351693
Eligibility and screening procedures
Hepatitis B infection
HEPATITIS B INFECTION, NAIROBI
Potential volunteers were invited for SiVET study screening if they had been community residents in the FCs for at least 6 months (Entebbe), had been attending the GHWP clinic for 6 to 18 months and had tested HIV negative at the last clinic visit (Kampala) or had been enrolled for at least 6 months in the SWOP network...
PMC10351693
Laboratory procedures
infection
HEPATITIS B, HEPATITIS B, INFECTION
HIV testing was performed on serum using two or more rapid antibody diagnostic tests administered serially (Entebbe and Kampala) as follows: Determine screening test (Alere DetermineAll sites measured hepatitis B surface antigen (HBsAg) and total hepatitis B core antibody (HBcAb (Total)). The site in Kampala also measu...
PMC10351693
Assays used by participating research centers to screen for Hepatitis B.
PMC10351693
Statistical analysis
Data analyses were conducted using STATA version 16.0 (Stata Corporation, College Station, Texas, USA) and R version 4.2.1 (
PMC10351693
Ethical considerations
NAIROBI
The Uganda National Council for Science and Technology (HS 1850, HS 1584) and Uganda Virus Research Institute-Research Ethics Committee (GC/127/15/07/439, GC/127/14/04/454) approved the Entebbe and Kampala SiVET studies, respectively. The Nairobi SiVET was approved by Kenyatta National Hospital/University of Nairobi Et...
PMC10351693
Results
PMC10351693
Socio-demographic characteristics of participants screened for SiVET studies in Kenya and Uganda (2014–2017)
As shown in
PMC10351693